Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Insulin glargine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Insulin glargine

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for Toujeo is a type of long-acting insulin called 'insulin glargine'.

  • It is very similar to human insulin.
  • It contains 3 times more insulin in 1 ml than standard insulin, which contains 100 unit/ml.
  • It lowers your blood sugar steadily over a long period of time.
  • It is injected once a day.
  • You can change the time of your injection if you need to (for more information see section 3). Toujeo is used to treat diabetes mellitus (diabetes) in adults, adolescents and children from the age of 6 years. This is an illness where your body does not make enough insulin to control your blood sugar.

What you need to know before you take it

e Toujeo Do not use Toujeo

  • if you are allergic to insulin glargine or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before using Toujeo. Closely follow your doctors instructions for how much Toujeo to use, how to monitor your blood and urine, your diet and physical activity levels and injection technique. Important:
  • If your blood sugar is too low (hypoglycaemia)
  • see 'what to do if you have low blood sugar' at the end of this leaflet.
  • Switching insulin – If you switch from another type, brand or manufacturer of insulin your dose may need to be changed.
  • Pioglitazone used together with insulin can cause serious problems – see 'Pioglitazone' below.
  • Make sure you use the right type of insulin
  • always check the insulin label before each injection to avoid mix-ups with other insulins, particularly between long-acting insulins and short-acting insulins.
  • Never use a syringe to remove Toujeo from your pen. This is to avoid dosing errors and potential overdose which may lead to low blood sugar.
  • If you are blind or have poor eyesight, do not use the pre-filled pen without help. This is because you will not be able to read the dose window on the pen. Get help from a person with good eyesight who is trained in using the pen. Skin changes where the injection is given Change where you inject regularly. This is to prevent skin changes such as thickening, shrinking or lumps. The insulin may not work well if you inject into a lumpy area.
  • Tell your doctor, pharmacist or nurse if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust the dose of your insulin or other anti-diabetic medications. Illnesses and injuries You may need to check your blood and urine more carefully to manage your diabetes if:
  • you are ill or have a major injury. Your blood sugar level may increase – hyperglycaemia.
  • you are not eating enough. Your blood sugar level may get too low – hypoglycaemia. Tell a doctor as soon as you feel ill or get an injury. If you have Type 1 diabetes and you have an illness or injury:
  • do not stop your insulin
  • keep eating enough carbohydrates. Always tell people who are caring or treating you, that you have diabetes. Insulin antibodies Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). However, only very rarely, this will require a change to your insulin dose. Travel and Toujeo If you are going abroad, travelling over time zones may affect your insulin needs and the timing of your injections. Talk to your doctor before travelling. Children and adolescents Do not give this medicine to children under 6 years of age. This is because there is no experience with Toujeo in children of this age. Other medicines and Toujeo Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Some medicines can change your blood sugar level. Your doctor will tell you if your insulin dose has to change. You also need to be careful when you stop taking a medicine. Listed below are the most common medicines which may affect your insulin treatment: Your blood sugar level may fall (hypoglycaemia) if you take:
  • any other medicine for diabetes
  • disopyramide – for some heart problems
  • fluoxetine – for depression
  • pentamidine – for some parasitic infections. This may cause too low blood sugar which is sometimes followed by too high blood sugar
  • sulfonamide antibiotics – for infection

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  • fibrates – for lowering high levels of fat in the blood
  • monoamine oxidase inhibitors (MAOIs) – for depression
  • pentoxifylline, propoxyphene and salicylates (such as aspirin) – for pain and mild fever
  • angiotensin converting enzyme (ACE) inhibitors
  • for heart problems or high blood pressure. Your blood sugar level may rise (hyperglycaemia) if you take:
  • danazol – for endometriosis
  • diazoxide – for high blood pressure
  • glucagon – for very low blood sugar
  • isoniazid – for tuberculosis
  • somatropin – a growth hormone
  • thyroid hormones – for thyroid gland problems
  • oestrogens and progestogens – such as in the contraceptive pill, for birth control
  • corticosteroids such as cortisone – for inflammation
  • protease inhibitors – for HIV
  • diuretics – for high blood pressure or fluid retention
  • clozapine, olanzapine and phenothiazine derivatives – for mental health problems
  • sympathomimetics such as epinephrine (adrenaline), salbutamol and terbutaline – for asthma Your blood sugar level may either rise or fall if you take:
  • beta-blockers or clonidine – for high blood pressure.
  • lithium salts – for mental health problems. Beta-blockers
  • Beta-blockers like other "Sympatholytic medicines" (such as clonidine, guanethidine, reserpine – for high blood pressure) can hide or stop the signs of your blood sugar being too low (hypoglycaemia) or may make it harder to recognise warning signs. Pioglitazone Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke treated with pioglitazone and insulin developed heart failure.
  • Tell your doctor straight away if you have signs of heart failure – such as feeling unusually short of breath, rapid weight gain or localised swelling. If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist or nurse before using Toujeo. Toujeo with alcohol Your blood sugar level may rise or fall if you drink alcohol – you will need to check your blood sugar level more often than usual. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before using this medicine:
  • you may need to change your insulin dose during pregnancy and after giving birth, or both insulin dose and diet during breast-feeding
  • to protect your baby it is very important to control your diabetes and prevent low blood sugar. Driving and using machines Having too low or too high blood sugar or sight problems can affect your ability to drive, use tools or machines. Your concentration may be affected. This could be dangerous to yourself and others. Ask your doctor, pharmacist or nurse whether you can drive, use tools or machines if:
  • you often get low blood sugar
  • you find it hard to recognise your low blood sugar.

<MAT>961688

Package leaflet: information for the user

Toujeo contains sodium This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially 'sodium-free'.

How to take it

Toujeo Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure. Toujeo and insulin glargine 100 units/ml, are not interchangeable, even though they contain same active substance. The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring. Talk to your doctor for further information. How much to use The Toujeo SoloStar pre-filled pen can provide a dose of 1 to 80 units in one injection, in steps of 1 unit. The dose window of the SoloStar pen shows the number of units of Toujeo to be injected and no dose re-calculation is required. Your doctor will decide:

  • how much Toujeo you need each day and at what time
  • when to check your blood sugar level and if you need to carry out urine tests
  • when you may need a higher or lower dose These are based on your life-style, your blood sugar (glucose) tests and your insulin use in the past. Talk to your doctor as you may need a lower dose if:
  • you are 65 years or older
  • you have kidney or liver problems. Toujeo is a long-acting insulin. Your doctor may tell you to use it with a short-acting insulin, or with other medicines for high blood sugar. Make sure you use the right type of insulin.
  • Always check the insulin label before each injection to avoid mix-ups with other insulins, particularly between long-acting insulins and short-acting insulins.
  • The strength "300" is highlighted in honey gold on the label of your Toujeo SoloStar pre-filled pen. Ask your doctor or pharmacist if you are not sure. Many factors may affect your blood sugar level – learn what these are and what to do if your blood sugar level changes. This will help stop it becoming too high or too low. See 'hyperglycaemia and hypoglycaemia' at the end of this leaflet for more information. When to use Toujeo
  • Use Toujeo once a day, preferably at the same time every day.
  • You can inject it up to 3 hours before or after the usual time that you use it. Before injecting Toujeo
  • Read the instructions for use that come with this package leaflet.
  • If you do not follow all the instructions, you may get too much or too little insulin. How to inject
  • Inject Toujeo under the skin. This is called 'subcutaneous use' or 'SC'.
  • Inject it into the front of your thighs, upper arms or the front of your waist (abdomen).

Druckbare Farben / Printing colours

Technische Information / Technical information

Black

Kontur / Outline

  • Change the place within the area where you inject each day – to reduce the risk of skin shrinking or thickening (see section 4).
  • Always use a new sterile needle for each injection
  • to reduce the risk of infection and blocked needles which can lead to you getting too much or too little insulin.
  • Throw away the used needle in a puncture resistant container, or as instructed by your pharmacist.
  • Do not share your insulin pen with anyone else, even when the needle is changed – to prevent spreading disease.
  • Do not use a syringe to remove Toujeo from your pen – to avoid potential overdose. Do not use Toujeo
  • in a vein – this changes the way it works and may cause your blood sugar to become too low.
  • in an insulin infusion pump.
  • if there are particles in the insulin – the liquid should be clear, colourless and water-like. Throw the pen away and use a new one if:
  • you notice that your blood sugar control is unexpectedly getting worse.
  • the pen is damaged or has not been stored correctly. Talk to your doctor, pharmacist or nurse if you are not sure your pen is working properly. If you use more Toujeo than you should If you use too much of this medicine, your blood sugar level may get too low – see 'low blood sugar' at the end of this leaflet for advice. If you forget to use Toujeo
  • If you forget a dose, inject the missed dose within 3 hours of the time you usually inject it.
  • If you remember when more than 3 hours have passed, do not inject the missed dose – check your blood sugar and then inject your next dose at the usual time the next day.
  • Do not inject a double dose to make up for a forgotten dose.
  • If you miss a dose of Toujeo or if you have not injected enough insulin, your blood sugar level may get too high – see 'high blood sugar (hyperglycaemia)' at the end of this leaflet for advice. If you stop using Toujeo Do not stop using this medicine without talking to your doctor. If you stop using this medicine, this could lead to very high blood sugar and a build-up of acid in the blood called 'ketoacidosis', see 'high blood sugar' at the end of this leaflet for advice. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Tell your doctor, pharmacist or nurse straight away if you notice any of the following serious side effects – you may need urgent medical treatment: Low blood sugar (hypoglycaemia) – very common: may affect more than 1 in 10 people

  • If your blood sugar falls too much, you may pass out.
  • Serious low blood sugar may cause brain damage and may be life-threatening.

If you have signs of low blood sugar, try to increase your blood sugar level straight away. See advice in 'low blood sugar' at the end of this leaflet. The signs of severe allergic reactions (rare: may affect up to 1 in 1,000 people) may include:

  • feeling short of breath
  • swelling of the skin or mouth
  • rash and itching all over the body
  • feeling faint with fast heartbeat and sweating. Tell your doctor, pharmacist or nurse straight away as severe allergic reactions may become lifethreatening. Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Skin changes where the injection is given If you inject insulin too often at the same place, the skin may change which include:
  • skin shrinking (lipoatrophy) (may affect up to 1 in 100 people)
  • skin thickening (lipohypertrophy) (may affect up to 1 in 10 people)
  • lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy area. Change the area where the injection is given regularly to prevent skin changes. Common: may affect up to 1 in 10 people
  • skin and allergic reactions where the injection is given. The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation. This can spread around the injection site. Most minor reactions to insulins usually disappear within a few days to a few weeks. Rare: may affect up to 1 in 1,000 people
  • eye problems – a large change in your blood sugar control, getting better or worse, can disturb your vision. If you have a diabetic eye disorder called "proliferative retinopathy", very low blood sugar attack may cause temporary loss of vision.
  • swelling in the calves and ankles – due to your body keeping more water than it should. Very rare: may affect up to 1 in 10,000 people
  • changes in taste (dysgeusia).
  • muscular pain (myalgia). Tell your doctor, pharmacist or nurse if you notice any of the side effects above. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Toujeo Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after "EXP". The expiry date refers to the last day of that month. Before first use
  • Store in a refrigerator, 2°C – 8°C.
  • Do not freeze or place next to the freezer compartment or a freezer pack.
  • Keep the pen in the outer carton in order to protect from light.

After first use or if carried as a spare

  • Do not store the pen in a refrigerator.
  • The pen may be stored for up to 6 weeks at room temperature – below 30°C and away from direct heat or direct light. Discard the pen after this time period.
  • Do not leave your insulin in a car on a very warm or cold day.
  • Always keep the cap on the pen when you are not using it in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer used. These measures will help protect the environment.

How to store it

your pen

  • Only use your pen for up to 6 weeks after its first use.

Before first use

  • Keep new pens in a fridge, at 2°C to 8°C.
  • Do not freeze.
  • Talk with your doctor, pharmacist or nurse about how to inject, before using your pen.
  • Ask for help if you have problems handling the pen, for example if you have problems with your sight.
  • Read all of these instructions before using your pen. If you do not follow all of these instructions, you may get too much or too little insulin.

Need help?

Extra items you will need:

If you have any questions about your pen or about diabetes, ask your doctor, pharmacist or nurse or call Sanofi number on the front of this leaflet.

  • a new sterile needle (see STEP 2).
  • a puncture resistant container for used needles and pens.

Get to know your pen

Pen cap

Cartridge holder

Rubber seal

Plunger*

Insulin scale

Dose Insulin name selector

Dose pointer

Injection button

  • You will not see the plunger until you have injected a few doses.

Throwing your pen away

How to care for your pen After first use

  • Keep your pen at room temperature, below 30°C.
  • Never put your pen back in the fridge.
  • Never store your pen with the needle attached.
  • Store your pen with the pen cap on.

Dose window

Handle your pen with care

  • Do not drop your pen or knock it against hard surfaces.
  • If you think that your pen may be damaged, do not try to repair it, use a new one.

Protect your pen from dust and dirt

  • You can clean the outside of your pen by wiping it with a damp cloth. Do not soak, wash or lubricate your pen – this may damage it.
  • Remove the needle before throwing your pen away.
  • Throw away your used pen as told by your pharmacist or local authority.

STEP 1: Check your pen

STEP 2: Attach a new needle

STEP 3: Do a safety test

STEP 4: Select the dose

STEP 5: Inject your dose

STEP 6: Remove the needle

✓ Take a new pen out of the fridge at least 1 hour before you inject.

✓ Always use a new sterile needle for each injection. This helps stop blocked needles, contamination and infection. ✓ Only use needles that are compatible for use with Toujeo (e.g.

✓ Always do a safety test before each injection – this is to:

✗

✗

✓ Take care when handling needles – this is to prevent needle injury and cross-infection. ✗ Never put the inner needle cap back on.

Cold insulin is more painful to inject.

needles from BD, Ypsomed, Artsana or Owen Mumford).

Check the name and expiration date on the label of your pen.

  • Make sure you have the correct insulin. This is especially important if you have other injector pens.
  • Never use your pen after the expiration date.

Take a new needle and peel off the protective seal.

  • check your pen and the needle are working properly.
  • make sure that you get the correct insulin dose.

Select 3 units by turning the dose selector until the dose pointer is at the mark between 2 and 4.

Never select a dose or press the injection button without a needle attached. This may damage your pen.

Make sure a needle is attached and the dose is set to '0'.

Choose a place to inject as shown in the picture Places to inject Upper arms

Keep the needle straight and screw it onto the pen until fixed. Do not overtighten.

3 units selected

Pull off the pen cap.

Turn the dose selector until the dose pointer lines up with your dose.

  • If you turn past your dose, you can turn back down.
  • If there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left.
  • If you cannot select your full prescribed dose, split the dose into two injections or use a new pen.

Pull off the outer needle cap. Keep this for later.

Pull off the inner needle cap and throw away.

How to read the dose window Even numbers are shown in line with the dose pointer:

If no insulin appears:

  • You may need to repeat this step up to 3 times before seeing insulin.
  • If no insulin comes out after the third time, the needle may be blocked. If this happens:
  • change the needle (see STEP 6 and STEP 2),
  • then repeat the safety test (STEP 3).
  • Do not use your pen if there is still no insulin coming out of the needle tip. Use a new pen.
  • Never use a syringe to remove insulin from your pen.

Stomach Thighs

Push the needle into your skin as shown by your doctor, pharmacist or nurse.

  • Do not touch the injection button yet.

Press the injection button all the way in.

  • When insulin comes out of the needle tip, your pen is working correctly.

Check that the insulin is clear.

  • Do not use the pen if the insulin looks cloudy, coloured or contains particles.

If you find it hard to press the injection button in, do not force it as this may break your pen. See the section below for help.

Place your thumb on the injection button. Then press all the way in and hold.

  • Do not press at an angle – your thumb could block the dose selector from turning.

30 units selected Odd numbers are shown as a line between even numbers:

29 units selected

Keep the injection button held in and when you see "0" in the dose window, slowly count to 5.

  • This will make sure you get your full dose.

After holding and slowly counting to 5, release the injection button. Then remove the needle from your skin. Handling needles

  • Take care when handling needles – this is to prevent needle injury and cross-infection.

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If you see air bubbles

  • You may see air bubbles in the insulin. This is normal, they will not harm you.

Druckbare Farben / Printing colours

Technische Information / Technical information

Cyan Magenta Yellow Black

Kontur / Outline

Units of insulin in your pen

  • Your pen contains a total of 450 units of insulin. You can select doses from 1 to 80 units in steps of 1 unit. Each pen contains more than one dose.
  • You can see roughly how many units of insulin are left by looking at where the plunger is on the insulin scale.

If you find it hard to press the button in:

  • Change the needle (see STEP 6 and STEP 2) then do a safety test (see STEP 3).
  • If you still find it hard to press in, get a new pen.
  • Never use a syringe to remove insulin from your pen.

Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen.

  • To reduce the risk of accidental needle injury, never replace the inner needle cap.
  • If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
  • Follow recommended safety measures for removal and disposal of needles (contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases. Throw away the used needle in a puncture resistant container, or as told by your pharmacist or local authority.

Put the pen cap back on.

  • Do not put the pen back in the fridge.

Contents of the pack and other information

What Toujeo contains

  • The active substance is insulin glargine. Each ml of the solution contains 300 units of insulin glargine (equivalent to 10.91 mg). Each pen contains 1.5 ml of solution for injection, equivalent to 450 units.
  • The other ingredients are: zinc chloride, metacresol, glycerol, water for injections, and sodium hydroxide (see section 2 'Toujeo contains sodium') and hydrochloric acid (for pH adjustment).

What Toujeo looks like and contents of the pack

  • Toujeo is a clear and colourless solution.
  • Each pen contains 1.5 ml of solution for injection (equivalent to 450 units).
  • Packs of 1, 3, 5 and 10 pre-filled pens.
  • Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK Tel: 0800 035 2525 email: [email protected] Manufacturer Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in April 2026

Hyperglycaemia and hypoglycaemia If you take insulin, you should always carry the following things with you:

  • Sugar (at least 20 grams).
  • Information so that others know you have diabetes. High blood sugar (hyperglycaemia) Warning signs of high blood sugar:
  • feeling thirsty, needing to urinate more often
  • feeling tired or dry skin, reddening of the face, loss of appetite
  • low blood pressure, fast heartbeat
  • glucose and ketone bodies in urine
  • stomach pain, fast and deep breathing, feeling sleepy or passing out (becoming unconscious) may be signs of a serious condition (ketoacidosis) resulting from lack of insulin. What to do if you have high blood sugar:
  • Test your blood sugar level and your urine for ketones as soon as you notice any of the above signs.
  • Contact your doctor straight away if you have severe hyperglycaemia or ketoacidosis. This must always be treated by a doctor, normally in a hospital. High blood sugar can happen if:
  • you have not injected your insulin or not injected enough.
  • your insulin is not working properly
  • this could be because it was not stored properly.
  • your insulin pen does not work properly.
  • you do less exercise than usual.
  • you are under stress – such as emotional distress or excitement.
  • you have an injury, infection or fever or have had an operation.
  • you take or have taken some other medicines, see section 2 – 'Other medicines and Toujeo'. Low blood sugar (hypoglycaemia) Very low blood sugar may make you pass out (unconscious), cause a heart attack or brain damage and be life-threatening. Learn to recognise the signs when your blood sugar is falling – and what to do to stop it getting worse. Warning signs of low blood sugar The first signs may be in your body generally:
  • feeling sweaty
  • having clammy skin
  • feeling anxious
  • fast or irregular heartbeat, high blood pressure, palpitations Other signs in your brain may come slightly later:
  • headache, trembling, feeling dizzy
  • changes in your sight
  • feeling very hungry, feeling sick (nausea) or vomiting
  • changes in behaviour, aggression, depression
  • feeling tired or sleepy, sleeping problems, feeling restless
  • difficulty concentrating, confusion, slowed reactions or difficulty speaking (sometimes total loss of speech)
  • not being able to move (paralysis), tingling in hands or arms, feeling numb and tingling often around the mouth
  • loss of self-control, being unable to look after yourself, fits or passing out. What to do if you have low blood sugar 1. Do not inject insulin. 2. Take about 10 to 20 grams sugar straight away – such as glucose, sugar cubes or a sugary-drink. Do not drink or eat foods that contain

artificial sweeteners (such as diet drinks). They do not help treat low blood sugar. 3. Then eat something such as bread or pasta that will raise your blood sugar over a longer time. Ask your doctor or nurse if you are not sure which foods you should eat. With Toujeo, it may take longer to recover from low blood sugar because it is long-acting. 4. If the low blood sugar comes back again, take another 10 to 20 grams of sugar. 5. Speak to a doctor straight away if you are not able to control the low blood sugar – or if it comes back. What other people should do if you have low blood sugar

  • Tell your relatives, friends and close colleagues to get medical help straight away if you are not able to swallow or if you pass out (become unconscious).
  • You will require glucagon (a medicine which increases blood sugar) or an injection of glucose. These treatments should be given even if it is not certain that you have hypoglycaemia.
  • You should test your blood sugar straight away after taking glucose to check that you really have hypoglycaemia. Low blood sugar can happen if:
  • you inject too much insulin.
  • you miss meals or eat late.
  • you do not eat enough, or eat food containing less sugar than normal
  • artificial sweeteners are not sugars.
  • you drink alcohol – especially when you have not eaten much.
  • you are sick (vomit) or have diarrhoea.
  • you do more exercise than usual or a different type of physical activity.
  • you are recovering from an injury, operation or other stress.
  • you are recovering from an illness or from fever.
  • you take or have taken some other medicines, see section 2 – 'Other medicines and Toujeo'. Low blood sugar is more likely to happen if:
  • you have just started insulin treatment or changed to another insulin – if low blood sugar occurs, it may be more likely to happen in the morning.
  • your blood sugar levels are almost normal or are unstable.
  • you change the area of body where you inject insulin, for example from the thigh to the upper arm.
  • you have severe kidney or liver disease, or some other disease such as hypothyroidism. Signs of low blood sugar may be different, less clear or missing if:
  • you are elderly
  • you have had diabetes for a long time.
  • you have a nervous disease called "diabetic autonomic neuropathy".
  • you have recently had too low blood sugar, for example the day before.
  • your low blood sugar comes on slowly.
  • your low blood sugar is always around "normal" or your blood sugar has got much better.
  • you have recently changed from an animal insulin to a human insulin, like Toujeo.
  • you take or have taken some other medicines, see section 2, 'Other medicines and Toujeo'. In such cases, you may get very low blood sugar and even pass out before you know what is happening. Know your warning signs. You may need to test your blood sugar more often – to help you spot low blood sugar. If you find it difficult to spot your warning signs, you should avoid situations (such as driving a car) in which you or others would be put at risk by low blood sugar.

Toujeo 300 units/ml solution for injection in a pre-filled pen (SoloStar) Read this first

Toujeo SoloStar contains 300 units/ml insulin glargine in a 1.5 ml disposable prefilled pen

  • Never re-use needles. If you do you might not get your dose (underdosing) or get too much (overdosing) as the needle could block.
  • Never use a syringe to remove insulin from your pen. If you do you will get too much insulin. The scale on most syringes is made for non-concentrated insulin only.

INSTRUCTIONS FOR USE Learn to inject

Important information

✗ Never share your pen – it is only for you. ✗ Never use your pen if it is damaged or if you are not sure that it is working properly.

✓ Always perform a safety test. ✓ Always carry a spare pen and spare needles in case they got lost or stop working.

Use by

Frequently asked questions about Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen

How do I take Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen?

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen comes as injection containing 300iu. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen?

The active substance in Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen is insulin glargine.

Are there equivalent medicines to Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen?

Medicines with the same active substance, strength and form include: Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Insulin glargine (9 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years.

4.2. Posology and method of administration

Posology

Toujeo is a basal insulin for once‑daily administration at any time of the day, preferably at the same time every day.

The dose regimen (dose and timing) should be adjusted according to individual response.

In type 1 diabetes mellitus, Toujeo must be combined with short-/rapid‑acting insulin to cover mealtime insulin requirements.

In patients with type 2 diabetes mellitus, Toujeo can also be given together with other anti‑hyperglycaemic medicinal products.

The potency of this medicinal product is stated in units. These units are exclusive to Toujeo and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1).

Flexibility in dosing time

When needed, patients can administer Toujeo up to 3 hours before or after their usual time of administration (see section 5.1).

Patients who forget a dose, should be advised to check their blood sugar and then resume their usual once‑daily dosing schedule. Patients should be informed not to inject a double dose to make up for a forgotten dose.

Initiation

Patients with type 1 diabetes mellitus

Toujeo is to be used once‑daily with meal‑time insulin and requires individual dose adjustments.

Patients with type 2 diabetes mellitus

The recommended daily starting dose is 0.2 units/kg followed by individual dose adjustments.

Switch between insulin glargine 100 units/ml and Toujeo

Insulin glargine 100 units/ml and Toujeo are not bioequivalent and are not directly interchangeable.

- When switching from insulin glargine 100 units/ml to Toujeo, this can be done on a unit‑to‑unit basis, but a higher Toujeo dose (approximately 10-18%) may be needed to achieve target ranges for plasma glucose levels.

- When switching from Toujeo to insulin glargine 100 units/ml, the dose should be reduced (approximately by 20%) to reduce the risk of hypoglycaemia.

Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter.

Switch from other basal insulins to Toujeo

When switching from a treatment regimen with an intermediate or long‑acting insulin to a regimen with Toujeo, a change of the dose of the basal insulin may be required and the concomitant anti‑hyperglycaemic treatment may need to be adjusted (dose and timing of additional regular insulins or fast‑acting insulin analogues or the dose of non‑insulin anti‑hyperglycaemic medicinal products).

- Switching from once‑daily basal insulins to once‑daily Toujeo can be done unit‑to‑unit based on the previous basal insulin dose.

- Switching from twice‑daily basal insulins to once‑daily Toujeo, the recommended initial Toujeo dose is 80% of the total daily dose of basal insulin that is being discontinued.

Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Toujeo.

Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter.

With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary. Dose adjustment may also be required, for example, if the patient's weight or life‑style changes, if there is a change in the timing of insulin dose or if other circumstances arise that increase susceptibility to hypo‑or hyperglycaemia (see section 4.4).

Switch from Toujeo to other basal insulins

Medical supervision with close metabolic monitoring is recommended during the switch and in the initial weeks thereafter.

Please refer to the prescribing information of the medicinal product to which the patient is switching.

Special populations

Toujeo can be used in elderly people, renal and hepatic impaired patients, and children and adolescents from the age of 6 years.

Elderly population (≥65 years old)

In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements (see section 4.8 and 5.1).

Renal impairment

In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism (see section 4.8).

Hepatic impairment

In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.

Paediatric population

Toujeo can be used in adolescents and children from the age of 6 years based on the same principles as for adult patients (see sections 5.1 and 5.2). When switching basal insulin to Toujeo, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to mimimize the risk of hypoglycaemia (see section 4.4).

The safety and efficacy of Toujeo in children below 6 years of age have not been established. No data are available.

Method of administration

Toujeo is for subcutaneous use only.

Toujeo is administered subcutaneously by injection in the abdominal wall, the deltoid or the thigh.

Injection sites must be rotated within a given injection area from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and 4.8).

Toujeo must not be administered intravenously. The prolonged duration of action of Toujeo is dependent on its injection into subcutaneous tissue. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia.

Toujeo must not be used in insulin infusion pumps.

Toujeo is available in two pre-filled pens. The dose window shows the number of units of Toujeo to be injected. The Toujeo SoloStar and Toujeo DoubleStar pre-filled pens have been specifically designed for Toujeo and no dose re-calculation is required for either pen.

Before using Toujeo SoloStar pre-filled pen or Toujeo DoubleStar pre-filled pen, the instructions for use included in the package leaflet must be read carefully (see section 6.6).

With Toujeo SoloStar pre-filled pen, a dose of 1-80 units per single injection, in steps of 1 unit, can be injected.

When changing from Toujeo SoloStar to Toujeo DoubleStar, if the patient's previous dose was an odd number (e.g. 23 units) then the dose must be increased or decreased by 1 unit (e.g. 24 or 22 units).

Toujeo must not be drawn from the cartridge of the Toujeo SoloStar pre-filled pen or Toujeo DoubleStar pre-filled pen into a syringe or severe overdose can result (see section 4.4, 4.9 and 6.6).

A new sterile needle must be attached before each injection. Re-use of needles increases the risk of blocked needles which may cause underdosing or overdosing (see section 4.4 and 6.6).

To prevent possible transmission of disease, insulin pens should never be used for more than one person, even when the needle is changed (see section 6.6).

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Toujeo is not the insulin of choice for the treatment of diabetic ketoacidosis. Instead, regular insulin administered intravenously is recommended in such cases.

In case of insufficient glucose control or a tendency to hyper‑ or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.

Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered.

Hypoglycaemia

The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed.

Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenosis of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).

Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished. The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups. These include patients:

- in whom glycaemic control is markedly improved,

- in whom hypoglycaemia develops gradually,

- who are elderly,

- after transfer from animal insulin to human insulin,

- in whom an autonomic neuropathy is present,

- with a long history of diabetes,

- suffering from a psychiatric illness,

- receiving concurrent treatment with certain other medicinal products (see section 4.5).

Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.

The prolonged effect of insulin glargine may delay recovery from hypoglycaemia.

If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.

Adherence of the patient to the dose and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment. These factors include:

- change in the injection area,

- improved insulin sensitivity (e.g., by removal of stress factors),

- unaccustomed, increased or prolonged physical activity,

- intercurrent illness (e.g. vomiting, diarrhoea),

- inadequate food intake,

- missed meals,

- alcohol consumption,

- certain uncompensated endocrine disorders, (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency),

- concomitant treatment with certain other medicinal products (see section 4.5).

Switch between insulin glargine 100 units/ml and Toujeo

Since insulin glargine 100 units/ml and Toujeo are not bioequivalent and are not interchangeable, switching may result in the need for a change in dose and should only be done under strict medical supervision (see section 4.2).

Switch between other insulins and Toujeo

Switching a patient between another type or brand of insulin and Toujeo should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose (see section 4.2).

Intercurrent illness

Intercurrent illness requires intensified metabolic monitoring. In many cases urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose. The insulin requirement is often increased. Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.

Insulin antibodies

Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper‑or hypoglycaemia.

Combination of Toujeo with pioglitazone

Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Toujeo is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

Medication errors prevention

Medication errors have been reported in which other insulins, particularly rapid‑acting insulins, have been accidentally administered instead of long‑acting insulins. Insulin label must always be checked before each injection to avoid medication errors between Toujeo and other insulins (see section 6.6).

To avoid dosing errors and potential overdose, the patients must be instructed to never use a syringe to remove Toujeo (insulin glargine 300 units/ml) from the Toujeo SoloStar pre‑filled pen or Toujeo DoubleStar pre-filled pen (see section 4.9 and 6.6).

A new sterile needle must be attached before each injection. Patients must also be instructed to not re‑use needles. Re‑use of needles increases the risk of blocked needles which may cause underdosing or overdosing. In the event of blocked needle, the patients must follow the instructions described in Step 3 of the Instructions for Use accompanying the package leaflet (see section 6.6).

Patients must visually verify the number of selected units on the dose counter of the pen. Patients who are blind or have poor vision should be instructed to get help/assistance from another person who has good vision and is trained in using the insulin device.

See also section 4.2 under “Method of administration”.

Excipients

This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially 'sodium‑free'.

4.5. Interaction with other medicinal products and other forms of interaction

A number of substances affect glucose metabolism and may require dose adjustment of insulin glargine.

Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include anti-hyperglycaemic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.

Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (e.g. clozapine and olanzapine) and protease inhibitors.

Beta‑blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood‑glucose‑lowering effect of insulin. Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia.

In addition, under the influence of sympatholytic medicinal products such as beta‑blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter‑regulation may be reduced or absent.

4.6. Fertility, pregnancy and lactation

Pregnancy

There is no clinical experience with use of Toujeo in pregnant women.

For insulin glargine no clinical data on exposed pregnancies from controlled clinical studies are available. A large amount of data on pregnant women (more than 1,000 pregnancy outcomes with a medicinal product containing insulin glargine 100 units/ml) indicate no specific adverse effects on pregnancy and no specific malformative nor foeto/neonatal toxicity of insulin glargine.

Animal data do not indicate reproductive toxicity.

The use of Toujeo may be considered during pregnancy, if clinically needed.

It is essential for patients with pre‑existing or gestational diabetes to maintain good metabolic control throughout pregnancy to prevent adverse outcomes associated with hyperglycaemia. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential.

Breast‑feeding

It is unknown whether insulin glargine is excreted in human milk. No metabolic effects of ingested insulin glargine on the breast‑fed newborn/infant are anticipated since insulin glargine as a peptide is digested into aminoacids in the human gastrointestinal tract.

Breast‑feeding women may require adjustments in insulin dose and diet.

Fertility

Animal studies do not indicate direct harmful effects with respect to fertility.

4.7. Effects on ability to drive and use machines

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia. It should be considered whether it is advisable to drive or use machines in these circumstances.

4.8. Undesirable effects

Summary of the safety profile

The following adverse reactions were observed during clinical studies conducted with Toujeo (see section 5.1) and during clinical experience with insulin glargine 100 units/ml.

Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.

Tabulated list of adverse reactions

The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000; not known: cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

MedDRA system organ classes

Very common

Common

Uncommon

Rare

Very rare

Not known

Immune system disorders

Allergic reactions

Metabolism and nutrition disorders

Hypoglycaemia

Nervous system disorders

Dysgeusia

Eyes disorders

Visual impairment

Retinopathy

Skin and subcutaneous tissue disorders

Lipohypertrophy

Lipoatrophy

Cutaneous amyloidosis

Musculoskeletal and connective tissue disorders

Myalgia

General disorders and administration site conditions

Injection site reactions

Oedema

Description of selected adverse reactions

Metabolism and nutrition disorders

Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage. Prolonged or severe hypoglycaemic episodes may be life‑threatening.

In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counter-regulation. Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.

Immune system disorders

Immediate-type allergic reactions to insulin are rare. Such reactions to insulin (including insulin glargine) or the excipients may, for example, be associated with generalised skin reactions, angio‑oedema, bronchospasm, hypotension and shock, and may be life-threatening. In Toujeo clinical studies in adult patients, the incidence of allergic reactions was similar in Toujeo‑treated patients (5.3%) and insulin glargine 100 units/ml‑treated patients (4.5%).

Eyes disorders

A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.

Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy. In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.

Skin and subcutaneous tissue disorders

Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions (see section 4.4).

General disorders and administration site conditions

Injection site reactions include redness, pain, itching, hives, swelling, or inflammation. Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks. In Toujeo clinical studies in adult patients, the incidence of injection site reactions was similar in Toujeo‑treated patients (2.5%) and insulin glargine 100 units/ml‑treated patients (2.8%).

Rarely, insulin may cause oedema particularly if previously poor metabolic control is improved by intensified insulin therapy.

Paediatric population

Safety and efficacy of Toujeo have been demonstrated in a study in children aged 6 to less than 18 years. The frequency, type and severity of adverse reactions in the paediatric population do not indicate differences to the experience in the general diabetes population (see section 5.1). Clinical study safety data are not available for children under 6 years.

Other special populations

Based on the results from clinical studies, the safety profile of Toujeo in elderly patients and in patients with renal impairment was similar to that of the overall population (see section 5.1).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Symptoms

Insulin overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.

Management

Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates. Adjustments in dose of the medicinal product, meal patterns, or physical activity may be needed.

More severe episodes with coma, seizure, or neurologic impairment may be treated with glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.

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