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.
Ramipril 2.5 mg/5 ml Oral solution
⚠ 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 Ramipril may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for 2. What you need to know before you take Ramipril Oral Solution 3. How to take Ramipril Oral Solution 4. Possible side effects 5. How to store Ramipril Oral Solution 6. Contents of the pack and other information
1. What is Ramipril Oral Solution and what is it used for The name of your medicine is Ramipril 2.5mg/5ml Oral Solution (called ramipril in this leaflet). Ramipril belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme inhibitors). Ramipril works by: ■ decreasing your body's production of substances that could raise your blood pressure. ■ making your blood vessels relax and widen. ■ making it easier for your heart to pump blood around your body. Ramipril can be used: ■ to treat high blood pressure (hypertension) ■ to reduce the risk of you having a heart attack or stroke ■ to reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes) ■ to treat your heart when it cannot pump enough blood to the rest of your body (heart failure) ■ as treatment following heart attack (myocardial infarction) complicated with heart failure.
What you need to know before you take it
e Ramipril Oral Solution Do not take Ramipril Oral Solution: ■ if you are allergic (hypersensitive) to ramipril, any other ACE inhibitor medicine or any of the other ingredients of ramipril listed in section 6. Signs of an allergic reaction may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. ■ if you have ever had a serious allergic reaction called "angioedema." The signs include itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing. ■ if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults. ■ if you are having dialysis or any other type of blood filtration. Depending on the machine that is used, ramipril may not be suitable for you. ■ if you have kidney problems where the blood supply to your kidneys is reduced (renal artery stenosis) ■ during the last 6 months of pregnancy (see section below on "Pregnancy and breast-feeding) ■ if your blood pressure is abnormally low or unstable.Your doctor will need to make this assessment. ■ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. Do not take ramipril if any of the above apply to you. If you are not sure, talk to your doctor before taking ramipril. Warnings and precautions Talk to your doctor or pharmacist before taking Ramipril Oral Solution: ■ if you have heart, liver or kidney problems. ■ if you have lost a lot of body salts or fluids (through being sick (vomiting), having diarrhoea, sweating more than usual, being on a low salt diet, taking diuretics (water tablets) for a long time or having had dialysis) ■ if you are going to have treatment to reduce your allergy to bee or wasp stings (desensitization) ■ if you are going to receive an anaesthetic.This may be given for an operation or any dental work.You may need to stop your ramipril treatment one day beforehand; ask your doctor for advice. ■ if you have high amounts of potassium in your blood (shown in blood test results) ■ if you are taking medicines or have conditions which may decrease sodium levels in your blood.Your doctor may carry out regular blood tests, particularly for checking the levels of sodium in your blood especially if you are elderly. ■ If you are taking medicines that may increase the risk of angioedema, a serious allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin (NEP) inhibitors (such as racecadontril) or sacubitril/ valsartan. For sacubitril/ valsartan, see section 2 "Do not take Ramipril Oral Solution" ■ if you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus ■ you must tell your doctor if you think that you are (or might become) pregnant. Ramipril is not recommended in the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section below on "Pregnancy and breast-feeding") ■ if you are taking any of the following medicines used to treat high blood pressure:
- an angiotensin II receptor blocker (ARBs) (also known as sartans – for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.
- aliskiren. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading "Do not take Ramipril Oral Solution". Children and adolescents Ramipril is not recommended for use in children and adolescents below 18 years of age because safety and efficacy of ramipril in children has not yet been established. If any of the above apply to you (or you are not sure), talk to your doctor before taking ramipril. Other medicines and Ramipril Oral Solution Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.This is because ramipril can affect the way some other medicines work. Also, some medicines can affect the way ramipril works. Tell your doctor if you are taking any of the following medicines.They can make ramipril work less well: ■ medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin) ■ medicines used for the treatment of low blood pressure, shock, cardiac failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline.Your doctor will need to check your blood pressure. Tell your doctor if you are taking any of the following medicines.They can increase the chance of getting side effects if you take them with ramipril: ■ sacubitril/valsartan – used for treating a type of long term (chronic) heart failure in adults (see section 2 'Do not take Ramipril Oral Solution') ■ medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin) ■ medicines for cancer (chemotherapy) ■ medicines to stop the rejection of organs after a transplant such as ciclosporin. ■ diuretics (water tablets) such as furosemide ■ medicines which can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections) and heparin (for thinning blood) ■ steroid medicines for inflammation such as prednisolone ■ allopurinol (used to lower the uric acid in your blood) ■ procainamide (for heart rhythm problems) ■ temsirolimus (for cancer) ■ sirolimus, everolimus (for prevention of graft rejection) ■ vildagliptin (used for treating type 2 diabetes) ■ racecadotril (used against diarrhoea). ■ your doctor may need to change your dose and/or to take other precautions if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings "Do not take Ramipril Oral Solution" and "Warnings and precautions"). Tell your doctor if you are taking any of the following medicines.They may be affected by ramipril: ■ medicines for diabetes such as oral glucose lowering medicines and insulin. ramipril may lower your blood sugar amounts. Check your blood sugar amounts closely while taking ramipril. ■ lithium (for mental health problems). Ramipril may increase the amount of lithium in your blood.Your lithium amount will need to be closely checked by your doctor. If any of the above apply to you (or you are not sure), talk to your doctor before taking ramipril. Ramipril Oral Solution with food and alcohol ■ drinking alcohol with ramipril may make you feel dizzy or light-headed. If you are concerned about how much you can drink while you are taking ramipril, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects. ■ ramipril may be taken with or without food. Pregnancy and breast-feeding Pregnancy You must tell your doctor if you think that you are (or might become) pregnant. You should not take ramipril in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby. If you become pregnant while on ramipril, tell your doctor immediately. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. Breast-feeding You should not take ramipril if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines You may feel dizzy while taking ramipril.This is more likely to happen when you start taking ramipril or start taking a higher dose. If this happens, do not drive or use any tools or machines. Ramipril Oral Solution contains sodium benzoate ■ sodium benzoate(E211).This medicine contains 5.31mg per 5ml. sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old). ■ This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially 'sodium-free'.
How to take it
Ramipril Oral Solution Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. How much to take Treatment of high blood pressure ■ the usual starting dose is 1.25mg (2.5ml) or 2.5mg (5ml) once daily. ■ your doctor will adjust the amount you take until your blood pressure is controlled. ■ the maximum dose is 10mg (20ml) once daily. ■ if you are already taking diuretics (water tablets), your doctor may stop or reduce the amount of the diuretic you take before beginning treatment with ramipril. To reduce the risk of you having a heart attack or stroke ■ the usual starting dose is 2.5mg (5ml) once daily. ■ your doctor may then decide to increase the amount you take. ■ the usual dose is 10mg (20ml) once daily. Treatment to reduce or delay the worsening of kidney problems ■ you may be started on a dose of 1.25mg (2.5ml) or 2.5mg (5ml) once daily. ■ your doctor will adjust the amount you are taking. ■ the usual dose is 5mg (10ml) or 10mg (20ml) once daily. Treatment of heart failure ■ the usual starting dose is 1.25mg (2.5ml) once daily. ■ your doctor will adjust the amount you take. ■ the maximum dose is 10mg (20ml) daily.Two administrations per day are preferable. Treatment after you have had a heart attack ■ the usual starting dose is 1.25mg (2.5ml) once daily to 2.5mg (5ml) twice daily. ■ your doctor will adjust the amount you take. ■ the usual dose is 10mg (20ml) daily.Two administrations per day are preferable. Elderly your doctor will reduce the initial dose and adjust your treatment more slowly.
Continued overleaf
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Taking this medicine ■ this medicine contains 2.5 milligram (2.5mg) of ramipril in each 5 millilitre (5ml) of solution. ■ take this medicine at the same time of the day each day. ■ take this medicine by mouth. ■ this medicine can also be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. ■ do not use with a tube which is made of latex. ■ instructions for use via NG or PEG tube: 1. ensure the tube is clear before taking the medicine. 2. flush the tube with 5ml of water. 3. administer the medicine into the tube, with a suitable measuring device. 4. flush the tube again with 5ml of water. Measuring your dose ■ Open the bottle: press the cap and turn it anticlockwise (Figure 1). ■ Separate the syringe adaptor from the syringe and insert the adaptor securely into the bottle neck (Figure 2). ■ Take the syringe and put it in the adaptor opening (Figure 3). ■ Turn the bottle upside down (Figure 4).
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Fill the syringe with a small amount of solution by pulling the plunger down (Figure 4A).Then push the plunger upward in order to remove any possible bubbles (Figure 4B). Finally, pull the plunger down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor.The top flat edge of the plunger should be in line with the graduation mark you are measuring to (Figure 4C). Turn the bottle the right way up (Figure 5A). Remove the syringe from the adaptor (Figure 5B). Put the end of the syringe into your mouth and push the plunger slowly back in to take the medicine. Wash the syringe with water and let it dry before you use it again (Figure 6).
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■ Close the bottle with the plastic screw cap – leave the syringe adaptor in the bottle. If you take more Ramipril Oral Solution than you should Tell a doctor or go to the nearest hospital casualty department straight away. Do not drive to the hospital, get somebody else to take you or call for an ambulance.Take the medicine pack with you.This is so the doctor knows what you have taken. If you forget to take Ramipril Oral Solution ■ if you miss a dose, take your normal dose when it is next due. ■ do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Ramipril and see a doctor straight away, if you notice any of the following serious side effects – you may need urgent medical treatment: ■ swelling of the face, lips or throat which make it difficult to swallow or breathe, as well as itching and rashes.This could be a sign of a severe allergic reaction to ramipril. ■ severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin disease, reddening, blistering or detachment of skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiform). Tell your doctor immediately if you experience: ■ faster heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness in your chest or more serious problems including heart attack and stroke. ■ shortness of breath or a cough.These could be signs of lung problems. ■ bruising more easily, bleeding for longer than normal, any sign of bleeding (e.g. bleeding from the gums), purple spots, blotching on the skin or getting infections more easily than usual, sore throat and fever, feeling tired, faint, dizzy or having pale skin.These can be signs of blood or bone marrow problems. ■ severe stomach pain which may reach through to your back.This could be a sign of pancreatitis (inflammation of the pancreas) ■ fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice).These can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage. Other side effects include: Tell your doctor if any of the following gets serious or lasts longer than a few days. Common (affects less than 1 in 10 people): ■ headache or feeling tired. ■ feeling dizzy.This is more likely to happen when you start taking ramipril or start taking a higher dose. ■ fainting, hypotension (abnormally low blood pressure), especially when you stand or sit up quickly. ■ dry tickly cough, inflammation of your sinuses (sinusitis) or bronchitis, shortness of breath ■ stomach or gut pain, diarrhoea, indigestion, feeling or being sick. ■ skin rash with or without raised area. ■ chest pain ■ cramps or pain in your muscles ■ blood tests showing more potassium than usual in your blood. Uncommon (affects less than 1 in 100 people): ■ balance problems (vertigo) ■ itching and unusual skin sensations such as numbness, tingling, prickling, burning or creeping on your skin (paraesthesia) ■ loss or change in the way things taste. ■ sleep problems ■ feeling depressed, anxious, more nervous than usual or restless ■ blocked nose, difficulty breathing or worsening of asthma. ■ a swelling in your gut called "intestinal angioedema" presenting with symptoms like abdominal pain, vomiting and diarrhoea. ■ heartburn, constipation or dry mouth ■ passing more water (urine) than usual over the day ■ sweating more than usual ■ loss or decrease of appetite (anorexia) ■ increased or irregular heart beats ■ swollen arms and legs.This may be a sign of your body holding onto more water than usual. ■ flushing ■ blurred vision ■ pain in your joints ■ fever ■ sexual inability in men, reduced sexual desire in men or women. ■ an increased number of certain white blood cells (eosinophilia) found during a blood test. ■ blood tests showing changes in the way your liver, pancreas or kidneys are working. Rare (affects less than 1 in 1,000 people): ■ feeling shaky or confused ■ red and swollen tongue ■ severe flaking or peeling skin, itchy, lumpy rash. ■ nail problems (e.g., loosening or separation of a nail from its bed) ■ skin rash or bruising ■ blotches on your skin and cold extremities ■ red, itchy, swollen or watery eyes ■ disturbed hearing or ringing in your ears. ■ feeling weak ■ blood tests showing a decrease in the number of red blood cells, white blood cells or platelets or in the amount of haemoglobin. Very rare (affects less than 1 in 10,000 people): ■ being more sensitive to the sun than usual. Other side effects reported: Please tell your doctor if any of the following gets serious or lasts longer than a few days. ■ difficulty concentrating ■ swollen mouth. ■ blood tests showing too few blood cells in your blood. ■ blood tests showing less sodium than usual in your blood. ■ concentrated urine (dark in colour), feel or are sick, have muscle cramps, confusion and fits which may be due to inappropriate ADH (anti-diuretic hormone) secretion. If you have these symptoms, contact your doctor as soon as possible. ■ fingers and toes changing colour when you are cold and then tingling or feeling painful when you warm up (Raynaud's phenomenon) ■ breast enlargement in men ■ slowed or impaired reactions ■ burning sensation ■ change in the way things smell. ■ hair loss. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRAYellow 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.
How to store it
Ramipril Oral Solution ■ ■ ■ ■ ■ ■
Keep this medicine out of the sight and reach of children. Store in a refrigerator (2-8°C). Do not use this medicine after the expiry date which is stated on the label and carton after EXP.The expiry date refers to the last day of that month. Once you open the bottle, it can only be used for 1 month. Write the date you open the bottle on the label. Do not use this medicine if you notice anything wrong with the medicine.Talk to your pharmacist. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help to protect the environment.
Contents of the pack and other information
What Ramipril Oral Solution contains ■ The active substance is ramipril. Each 5 ml of oral solution contains 2.5mg of ramipril. ■ The other ingredients are citric acid monohydrate (E330), sodium citrate (E331), sodium benzoate (E211), acesulfame potassium (E950), strawberry flavour and purified water. What Ramipril Oral Solution looks like and contents of the pack A clear, colourless solution. It comes in a brown glass bottle holding 150ml of solution. Polypropylene body, purple HDPE plunger with a capacity of 5ml and dosage graduation at every 0.25ml. Marketing Authorisation Holder and Manufacturer Rosemont Pharmaceuticals Ltd.,Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. This leaflet was last revised in Jul. 2024
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Frequently asked questions about Ramipril 2.5 mg/5 ml Oral solution
How do I take Ramipril 2.5 mg/5 ml Oral solution?
Ramipril 2.5 mg/5 ml Oral solution comes as oral solution containing 2.5mg / 5ml. 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 Ramipril 2.5 mg/5 ml Oral solution?
The active substance in Ramipril 2.5 mg/5 ml Oral solution is ramipril.
Are there equivalent medicines to Ramipril 2.5 mg/5 ml Oral solution?
Medicines with the same active substance, strength and form include: Ramipril 2.5mg/5ml Oral Solution. 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 Ramipril 2.5 mg/5 ml Oral solution, 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 Ramipril 2.5 mg/5 ml Oral solution 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.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ramipril
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
- Treatment of hypertension.
- Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with:
• manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or
• diabetes with at least one cardiovascular risk factor (see section 5.1).
- Treatment of renal disease:
• Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria,
• Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1),
• Manifest glomerular non diabetic nephropathy as defined by macroproteinuria ≥ 3 g/day (see section 5.1).
- Treatment of symptomatic heart failure.
- Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction.
4.2. Posology and method of administration
Posology
It is recommended that ramipril is taken each day at the same time of the day.
It can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2).
Adults
Diuretic-Treated patients
Hypotension may occur following initiation of therapy with ramipril; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume and/or salt depleted.
If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with ramipril (see section 4.4).
In hypertensive patients in whom the diuretic is not discontinued, therapy with ramipril should be initiated with a 1.25mg (2.5ml) dose. Renal function and serum potassium should be monitored. The subsequent dosage of ramipril should be adjusted according to blood pressure target.
Hypertension
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Ramipril may be used in monotherapy or in combination with other classes of antihypertensive medicinal products (see sections 4.3, 4.4, 4.5 and 5.1).
Starting dose
Ramipril Oral Solution should be started gradually with an initial recommended dose of 2.5mg (5ml) daily.
Patients with a strongly activated renin-angiotensin-aldosterone system may experience an excessive drop in blood pressure following the initial dose. A starting dose of 1.25mg (2.5ml) is recommended in such patients and the initiation of treatment should take place under medical supervision (see section 4.4).
Titration and maintenance dose
The dose can be doubled at intervals of two to four weeks to progressively achieve target blood pressure; the maximum permitted dose of Ramipril Oral Solution is 10mg (20ml) daily. Usually, the dose is administered once daily.
Cardiovascular prevention
Starting dose
The recommended initial dose is 2.5mg (5ml) of Ramipril Oral Solution once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose should be gradually increased. It is recommended to double the dose after one or two weeks of treatment and - after another two to three weeks - to increase it up to the target maintenance dose of 10mg (20ml) Ramipril Oral Solution once daily.
See also posology on diuretic treated patients above.
Treatment of renal disease
In patients with diabetes and microalbuminuria:
Starting dose:
The recommended initial dose is 1.25mg (2.5ml) of Ramipril Oral Solution once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the once daily dose to 2.5mg (5ml) after two weeks and then to 5mg (10ml) after a further two weeks is recommended.
In patients with diabetes and at least one cardiovascular risk
Starting dose:
The recommended initial dose is 2.5mg (5ml) of Ramipril Oral Solution once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the daily dose to 5 mg (10ml) Ramipril Oral Solution after one or two weeks and then to 10mg (20ml) Ramipril Oral Solution after a further two or three weeks is recommended. The target daily dose is 10mg (20ml).
In patients with non-diabetic nephropathy as defined by macroproteinuria ≥3 g/day
Starting dose:
The recommended initial dose is 1.25mg (2.5ml) of Ramipril Oral Solution once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the once daily dose to 2.5mg (5ml) after two weeks and then to 5mg (10ml) after a further two weeks is recommended.
Symptomatic heart failure
Starting dose
In patients stabilized on diuretic therapy, the recommended initial dose is 1.25mg daily (2.5ml).
Titration and maintenance dose
Ramipril Oral Solution should be titrated by doubling the dose every one to two weeks up to a maximum daily dose of 10mg (20ml). Two administrations per day are preferable.
Secondary prevention after acute myocardial infarction and with heart failure
Starting dose
After 48 hours, following myocardial infarction in a clinically and haemodynamically stable patient, the starting dose is 2.5mg (5ml) twice daily for three days. If the initial 2.5 mg dose is not tolerated a dose of 1.25mg (2.5ml) twice a day should be given for two days before increasing to 2.5mg (5ml) and 5mg (10ml) twice a day. If the dose cannot be increased to 2.5mg (5ml) twice a day the treatment should be withdrawn.
See also posology on diuretic treated patients above.
Titration and maintenance dose
The daily dose is subsequently increased by doubling the dose at intervals of one to three days up to the target maintenance dose of 5mg (10ml) twice daily.
The maintenance dose is divided in 2 administrations per day where possible.
If the dose cannot be increased to 2.5mg (5ml) twice a day treatment should be withdrawn. Sufficient experience is still lacking in the treatment of patients with severe (NYHA IV) heart failure immediately after myocardial infarction. Should the decision be taken to treat these patients, it is recommended that therapy be started at 1.25mg (2.5ml) once daily and that particular caution be exercised in any dose increase.
Special populations
Patients with renal impairment
Daily dose in patients with renal impairment should be based on creatinine clearance (see section 5.2):
- if creatinine clearance is ≥60ml/min, it is not necessary to adjust the initial dose (2.5mg/day (5ml)); the maximal daily dose is 10mg (20ml);
- if creatinine clearance is between 30-60 ml/min, it is not necessary to adjust the initial dose (2.5mg/day (5ml)); the maximal daily dose is 5mg (10ml);
- if creatinine clearance is between 10-30 ml/min, the initial dose is 1.25 mg/day (2.5ml) and the maximal daily dose is 5 mg (10ml);
- in haemodialysed hypertensive patients: ramipril is slightly dialysable; the initial dose is 1.25mg/day (2.5ml) and the maximal daily dose is 5mg (10ml); the medicinal product should be administered few hours after haemodialysis is performed.
Patients with hepatic impairment (see section 5.2)
In patients with hepatic impairment, treatment with Ramipril Oral Solution must be initiated only under close medical supervision and the maximum daily dose is 2.5mg (5ml) Ramipril Oral Solution.
Elderly
Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable effects especially in very old and frail patients. A reduced initial dose of 1.25mg (2.5ml) ramipril should be considered.
Paediatric population
The safety and efficacy of ramipril in children has not yet been established. Currently available data for ramipril are described in sections 4.8, 5.1, 5.2 & 5.3 but no specific recommendation on posology can be made.
Method of Administration
- Oral use.
- Suitable for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. For further instructions see section 6.6.
- It is recommended to start initial doses with lowest strength (2.5mg/5ml) oral solution.
- If a dose of 10 mg is required, it is recommended to use higher strength oral solution. (5mg/5ml and 10mg/5ml)
4.3. Contraindications
• Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or any other ACE (Angiotensin Converting Enzyme) inhibitors.
• History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or AIIRAs).
• Concomitant use with sacubitril/valsartan therapy (see sections 4.4 and 4.5).
• Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5).
• Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney.
• Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
• Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.
• The concomitant use of ramipril with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m2) (see sections 4.5 and 5.1).
4.4. Special warnings and precautions for use
Special populations
Pregnancy
ACE inhibitors such as ramipril or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued ACE inhibitor/AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors/AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Patients at particular risk of hypotension
• Patients with strongly activated renin-angiotensin-aldosterone system
Patients with strongly activated renin-angiotensin-aldosterone system are at risk of an acute pronounced fall in blood pressure and deterioration of renal function due to ACE inhibition, especially when an ACE inhibitor or a concomitant diuretic is given for the first time or at first dose increase.
Significant activation of renin-angiotensin-aldosterone system is to be anticipated and medical supervision including blood pressure monitoring is necessary, for example in:
- patients with severe hypertension
- patients with decompensated congestive heart failure
- patients with haemodynamically relevant left ventricular inflow or outflow impediment (e.g., stenosis of the aortic or mitral valve)
- patients with unilateral renal artery stenosis with a second functional kidney
- patients in whom fluid or salt depletion exists or may develop (including patients with diuretics)
- patients with liver cirrhosis and/or ascites
- patients undergoing major surgery or during anaesthesia with agents that produce hypotension.
Generally, it is recommended to correct dehydration, hypovolaemia or salt depletion before initiating treatment (in patients with heart failure, however, such corrective action must be carefully weighed out against the risk of volume overload).
• Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
• Transient or persistent heart failure post MI
• Patients at risk of cardiac or cerebral ischemia in case of acute hypotension
The initial phase of treatment requires special medical supervision.
• Elderly
See section 4.2.
Surgery
It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery.
Monitoring of renal function
Renal function should be assessed before and during treatment and dose adjusted especially in the initial weeks of treatment. Particularly careful monitoring is required in patients with renal impairment (see section 4.2). There is a risk of impairment of renal function, particularly in patients with congestive heart failure or after a renal transplant.
Angioedema
Angioedema has been reported in patients treated with ACE inhibitors including ramipril (see section 4.8). This risk of angioedema (e.g. swelling of the airways or tongue, with or without respiratory impairment) may be increased in patients taking concomitant medications which may cause angioedema such as mTOR (mammalian target of rapamycin) inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin or neprilysin (NEP) inhibitors (such as racecadotril). The combination of ramipril with sacubitril/valsartan is contraindicated due to the increased risk of angioedema (see sections 4.3 and 4.5).
In case of angioedema, ramipril must be discontinued.
Emergency therapy should be instituted promptly. Patient should be kept under observation for at least 12 to 24 hours and discharged after complete resolution of the symptoms.
Intestinal angioedema has been reported in patients treated with ACE inhibitors including ramipril (see section 4.8). These patients presented with abdominal pain (with or without nausea or vomiting).
Anaphylactic reactions during desensitization
The likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens are increased under ACE inhibition. A temporary discontinuation of ramipril should be considered prior to desensitization.
Electrolyte Monitoring: Hyperkalaemia
Hyperkalaemia has been observed in some patients treated with ACE inhibitors including ramipril. Patients at risk for development of hyperkalaemia include those with renal insufficiency, age (> 70 years), uncontrolled diabetes mellitus, or those using potassium salts, potassium retaining diuretics and other plasma potassium increasing active substances, or conditions such as dehydration, acute cardiac decompensation, metabolic acidosis. If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended (see section 4.5).
Electrolyte Monitoring: Hyponatraemia
Syndrome of Inappropriate Anti-diuretic Hormone (SIADH) and subsequent hyponatraemia has been observed in some patients treated with ramipril. It is recommended that serum sodium levels be monitored regularly in the elderly and in other patients at risk of hyponatraemia.
Neutropenia/agranulocytosis
Neutropenia/agranulocytosis, as well as thrombocytopenia and anaemia, have been rarely seen and bone marrow depression has also been reported. It is recommended to monitor the white blood cell count to permit detection of a possible leucopoenia. More frequent monitoring is advised in the initial phase of treatment and in patients with impaired renal function, those with concomitant collagen disease (e.g. lupus erythematosus or scleroderma), and all those treated with other medicinal products that can cause changes in the blood picture (see sections 4.5 and 4.8).
Ethnic differences
ACE inhibitors cause higher rate of angioedema in black patients than in non-black patients.
As with other ACE inhibitors, ramipril may be less effective in lowering blood pressure in black people than in non-black patients, possibly because of a higher prevalence of hypertension with low renin level in the black hypertensive population.
Cough
Cough has been reported with the use of ACE inhibitors. Characteristically, the cough is nonproductive, persistent and resolves after discontinuation of therapy. ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
Excipient Warnings:
The product contains:
• sodium benzoate- This medicine contains 5.31mg per 5ml. sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
• sodium- This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Contra-indicated combinations
The concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated as this increases the risk of angioedema (see sections 4.3 and 4.4). Treatment with ramipril must not be started until 36 hours after taking the last dose of sacubitril/valsartan. Sacubitril/valsartan must not be started until 36 hours after the last dose of ramipril.
Extracorporeal treatments leading to contact of blood with negatively charged surfaces such as dialysis or haemofiltration with certain high-flux membranes (e.g. polyacrylonitril membranes) and low density lipoprotein apheresis with dextran sulphate due to increased risk of severe anaphylactoid reactions (see section 4.3). If such treatment is required, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.
Precautions for use
Potassium salts, heparin, potassium-retaining diuretics and other plasma potassium increasing active substances (including Angiotensin II antagonists, trimethoprim and in fixed dose combination with sulfamethoxazole, tacrolimus, ciclosporin):
Hyperkalaemia may occur, therefore close monitoring of serum potassium is required.
Antihypertensive agents (e.g. diuretics) and other substances that may decrease blood pressure (e.g. nitrates, tricyclic antidepressants, anaesthetics, acute alcohol intake, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin):
Potentiation of the risk of hypotension is to be anticipated (see section 4.2 for diuretics)
Vasopressor sympathomimetics and other substances (e.g. isoproterenol, dobutamine, dopamine, epinephrine) that may reduce the antihypertensive effect of ramipril:
Blood pressure monitoring is recommended.
Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count:
Increased likelihood of haematological reactions (see section 4.4).
Lithium salts:
Excretion of lithium may be reduced by ACE inhibitors and therefore lithium toxicity may be increased. Lithium level must be monitored.
Antidiabetic agents including insulin:
Hypoglycaemic reactions may occur. Blood glucose monitoring is recommended.
Non-steroidal anti-inflammatory drugs and acetylsalicylic acid:
Reduction of the antihypertensive effect of ramipril is to be anticipated. Furthermore, concomitant treatment of ACE inhibitors and NSAIDs may lead to an increased risk of worsening of renal function and to an increase in kalaemia.
mTOR inhibitors or DPP-IV inhibitors:
An increased risk of angioedema is possible in patients taking concomitant medications such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus) or vildagliptin. Caution should be used when starting therapy (see section 4.4).
Neprilysin (NEP) inhibitors:
An increased risk of angioedema has been reported with concomitant use of ACE inhibitors and NEP inhibitor such as racecadotril (see section 4.4).
Sacubitril/valsartan
The concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated as this increases the risk of angioedema.
4.6. Fertility, pregnancy and lactation
Pregnancy
Ramipril is not recommended during the first trimester of pregnancy (see section 4.4) and is contraindicated during the second and third trimesters of pregnancy (see section 4.3).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
ACE inhibitor/Angiotensin II Receptor Antagonist (AIIRA) therapy exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (See section 5.3 “Preclinical safety data”). Should exposure to ACE inhibitors have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Newborns whose mothers have taken ACE inhibitors should be closely observed for hypotension, oliguria and hyperkalaemia (see also sections 4.3 and 4.4).
Breast-feeding
Because insufficient information is available regarding the use of ramipril during breast-feeding (see section 5.2), ramipril is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
4.7. Effects on ability to drive and use machines
Some adverse effects (e.g. symptoms of a reduction in blood pressure such as dizziness) may impair the patient's ability to concentrate and react and, therefore, constitute a risk in situations where these abilities are of particular importance (e.g. operating a vehicle or machinery).
This can happen especially at the start of treatment, or when changing over from other preparations. After the first dose or subsequent increases in dose it is not advisable to drive or operate machinery for several hours.
4.8. Undesirable effects
Summary of safety profile
The safety profile of ramipril includes persistent dry cough and reactions due to hypotension. Serious adverse reactions include angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/agranulocytosis.
Tabulated list of adverse reactions
Adverse reactions frequency is defined using the following convention:
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, undesirable effects are presented in order of decreasing seriousness.
Common
Uncommon
Rare
Very rare
Not known
Blood and lymphatic system disorders
Eosinophilia
White blood cell count decreased (including neutropenia or agranulocytosis), red blood cell count decreased, haemoglobin decreased, platelet count decreased
Bone marrow failure, pancytopenia, haemolytic anaemia
Immune system disorders
Anaphylactic or anaphylactoid reactions, antinuclear antibody increased
Endocrine disorders
Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Metabolism and nutrition disorders
Blood potassium increased
Anorexia, decreased appetite,
Blood sodium decreased
Psychiatric disorders
Depressed mood, anxiety, nervousness, restlessness, sleep disorder including somnolence
Confusional state
Disturbance in attention
Nervous system disorders
Headache, dizziness
Vertigo, paraesthesia, ageusia, dysgeusia
Tremor, balance disorder
Cerebral ischaemia including ischaemic stroke and transient ischaemic attack, psychomotor skills impaired, burning sensation, parosmia
Eye disorders
Visual disturbance including blurred vision
Conjunctivitis
Ear and labyrinth disorders
Hearing impaired, tinnitus
Cardiac disorders
Myocardial ischaemia including angina pectoris or myocardial infarction, tachycardia, arrhythmia, palpitations, oedema peripheral
Vascular disorders
Hypotension, orthostatic blood pressure decreased, syncope
Flushing
Vascular stenosis, hypoperfusion, vasculitis
Raynaud's phenomenon
Respiratory, thoracic and mediastinal disorders
Non-productive tickling cough, bronchitis, sinusitis, dyspnoea
Bronchospasm including asthma aggravated, nasal congestion
Gastrointestinal disorders
Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting
Pancreatitis (cases of fatal outcome have been very exceptionally reported with ACE inhibitors), pancreatic enzymes increased, small bowel angioedema, abdominal pain upper including gastritis, constipation, dry mouth
Glossitis
Aphtous stomatitis
Hepatobiliary disorders
Hepatic enzymes and/or bilirubin conjugated increased
Jaundice cholestatic, hepatocellular damage
Acute hepatic failure, cholestatic or cytolytic hepatitis (fatal outcome has been very exceptional).
Skin and subcutaneous tissue disorders
Rash in particular maculo-papular
Angioedema; very exceptionally, the airway obstruction resulting from angioedema may have a fatal outcome; pruritus, hyperhidrosis
Exfoliative dermatitis, urticaria, onycholysis
Photosensitivity reaction
Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, psoriasis aggravated, dermatitis psoriasiform, pemphigoid or lichenoid exanthema or enanthema, alopecia
Musculoskeletal and connective tissue disorders
Muscle spasms, myalgia
Arthralgia
Renal and urinary disorders
Renal impairment including renal failure acute, urine output increased, worsening of a pre-existing proteinuria, blood urea increased, blood creatinine increased
Reproductive system and breast disorders
Transient erectile impotence, libido decreased
Gynaecomastia
General disorders and administration site conditions
Chest pain, fatigue
Pyrexia
Asthenia
Paediatric Population
The safety of ramipril was monitored in 325 children and adolescents, aged 2-16 years old during 2 clinical trials. Whilst the nature and severity of the adverse events are similar to that of the adults, the frequency of the following is higher in the children:
• Tachycardia, nasal congestion and rhinitis, “common” (i.e. ≥ 1/100 to <1/10) in paediatric, and “uncommon” (i.e. ≥ 1/1,000 to <1/100) in adult population.
• Conjunctivitis “common” (i.e. ≥ 1/100 to <1/10) in paediatric, while “rare” (i.e. ≥ 1/10,000 to <1/1,000) in adult population.
• Tremor and urticaria “uncommon” (i.e., ≥ 1/1,000 to <1/100) in paediatric population while “rare” (i.e. ≥ 1/10,000 to <1/1,000) in adult population.
The overall safety profile for ramipril in paediatric patients does not differ significantly from the safety profile in adults.
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 the 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
Symptoms associated with overdose of ACE inhibitors may include excessive peripheral vasodilation (with marked hypotension, shock), bradycardia, electrolyte disturbances and renal failure.
Management
The patient should be closely monitored, and the treatment should be symptomatic and supportive. Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including, administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration. Ramiprilat, the active metabolite of ramipril is poorly removed from the general circulation by haemodialysis.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- TRITACE 10 mg prescriptionRAMIPRILUM · taken by mouth
- ZENRA 10 mg prescriptionRAMIPRILUM · taken by mouth
- TRITACE 2,5 mg prescriptionRAMIPRILUM · taken by mouth
- TRITACE 5 mg prescriptionRAMIPRILUM · taken by mouth
- ZENRA 2,5 mg prescriptionRAMIPRILUM · taken by mouth
- ZENRA 5 mg prescriptionRAMIPRILUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- Tritace 2,5Ramiprilum · taken by mouth
- Tritace 5Ramiprilum · taken by mouth
- Tritace 10Ramiprilum · taken by mouth
- Piramil 1,25 mgRamiprilum · taken by mouth
- Piramil 2,5 mgRamiprilum · taken by mouth
- Piramil 5 mgRamiprilum · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Ramipril 2.5 mg/5 ml Oral solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Ramipril
- Ramipril 10mg Tablets
- Ramipril 2.5mg Tablets
- Ramipril 5mg Tablets
- Ramipril 1.25 mg Capsules
- Ramipril 1.25mg Capsule
- Ramipril 1.25mg Hard Capsules
- Ramipril 1.25mg Tablets
- Ramipril 10 mg capsules
- Ramipril 10 mg/5 ml Oral solution
- Ramipril 10mg Hard Capsules
- Ramipril 2.5 mg Capsules
- Ramipril 2.5mg Capsule
- Ramipril 2.5mg Hard Capsules
- Ramipril 5 mg capsules