Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Ramipril 2.5mg/5ml Oral Solution (called Ramipril oral solution in this leaflet) contains a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
Ramipril oral solution 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 oral solution 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.
Do not take Ramipril oral solution: • If you are allergic (hypersensitive) to ramipril, any other ACE inhibitor medicine or any of the ingredients of this medicine 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 oral solution may not be suitable for you.
• If you have kidney problems where the blood supply to your kidney 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 oral solution if any of the above apply to you. If you are not sure, talk to your doctor before taking Ramipril oral solution.
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 oral solution 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 oral solution 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 oral solution is not recommended for use in children and adolescents below 18 years of age because the safety and efficacy of Ramipril oral solution 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 oral solution.
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 oral solution can affect the way some other medicines work. Also, some medicines can affect the way Ramipril oral solution works.
Tell your doctor if you are taking any of the following medicines. They can make Ramipril oral solution work less well:
• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin 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 oral solution:
• 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 indometacin 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 oral solution:
• Medicines for diabetes such as oral glucose lowering medicines and insulin. Ramipril oral solution may lower your blood sugar amounts. Check your blood sugar amounts closely while taking Ramipril oral solution.
• Lithium (for mental health problems). Ramipril oral solution 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 oral solution.
Ramipril oral solution with food and alcohol • Drinking alcohol with Ramipril oral solution may make you feel dizzy or light-headed. If you are concerned about how much you can drink while you are taking Ramipril oral solution, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects.
• Ramipril oral solution may be taken with or without food.
Pregnancy and breastfeeding Pregnancy
You must tell your doctor if you think that you are (or might become) pregnant.
You should not take Ramipril oral solution in the first 12 weeks of pregnancy and you must not take them at all from the 13th week as their use during pregnancy may possibly be harmful to the baby. If you become pregnant while on Ramipril oral solution, 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 oral solution 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 oral solution. This is more likely to happen when you start taking Ramipril oral solution or start taking a higher dose. If this happens, do not drive or use any tools or machines.
Ramipril oral solution contains Benzoic acid (E 210), Propylene glycol (E 1520) and Sodium: Benzoic acid (E 210): This medicine contains 5mg benzoic acid in each 5ml dose. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
Propylene glycol (E 1520): This medicine contains 750mg propylene glycol in each 5ml dose. If you are pregnant or breast-feeding or if you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
Sodium: This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially 'sodium-free'.
Always take this medicine exactly as your doctor has told you. You should 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 2.5ml (1.25mg) or 5ml (2.5mg) once daily.
• Your doctor will adjust the amount you take until your blood pressure is controlled.
• The maximum dose is 20ml (10mg) 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 oral solution.
To reduce the risk of you having a heart attack or stroke
• The usual starting dose is 5ml (2.5mg) once daily.
• Your doctor may then decide to increase the amount you take.
• The usual dose is 20ml (10mg) once daily.
Treatment to reduce or delay the worsening of kidney problems
• You may be started on a dose of 2.5ml (1.25mg) or 5ml (2.5mg) once daily.
• Your doctor will adjust the amount you are taking.
• The usual dose is 10ml (5mg) or 20ml (10mg) once daily.
Treatment of heart failure
• The usual starting dose is 2.5ml (1.25mg) once daily.
• Your doctor will adjust the amount you take.
• The maximum dose is 20ml (10mg) daily. Two administrations per day are preferable.
Treatment after you have had a heart attack
• The usual starting dose is 2.5ml (1.25mg) once daily to 5ml (2.5mg) twice daily.
• Your doctor will adjust the amount you take.
• The usual dose is 20ml (10mg) daily. Two administrations per day are preferable.
Elderly
Your doctor will reduce the initial dose and adjust your treatment more slowly.
Taking this medicine Take this medicine by mouth at the same time of the day each day using the measuring cup provided.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Ramipril oral solution 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 oral solution
• 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 (may affect up to 1 in 10 people)
• Headache or feeling tired
• Feeling dizzy. This is more likely to happen when you start taking Ramipril oral solution 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 (may affect up to 1 in 100 people)
• Balance problems (vertigo)
• Itching and unusual skin sensations such as numbness, tingling, pricking, 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 heartbeat
• 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 (may affect up to 1 in 1,000 people)
• Feeling shaky or confused
• Red and swollen tongue
• Severe flaking or peeling of the 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 and 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 (may affect up to 1 in 10,000 people)
• Being more sensitive to the sun than usual.
Other side effects reported:
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 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.
• 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 bottle label after EXP. The expiry date refers to the last day of that month.
• Once opened use within 60 days.
• Store in a refrigerator (2°C — 8°C).
• 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 protect the environment.
What Ramipril oral solution contains • The active substance is ramipril. Each 5ml of Ramipril oral solution contains 2.5mg of the active ingredient ramipril.
• The other ingredients are propylene glycol (E 1520), benzoic acid (E 210), sodium saccharin (E 954), hydrochloric acid and purified water.
What Ramipril oral solution looks like and contents of the pack Ramipril oral solution is a clear, colourless solution supplied in an amber glass bottle containing 150ml and sealed with a child-resistant, tamper-evident cap. It contains a measuring cup with multiple graduations.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Roma Pharmaceuticals Ltd
Gibraltar House
Centrum 100
Burton-upon-Trent
DE14 2WE
Manufacturer
Labomed Pharmaceutical Company S.A.
84 Ioannou Metaxa str.
Koropi
Attica
19441
Greece
This leaflet was last revised in June 2024
For information in other formats contact [email protected]
Roma Pharmaceuticals Limited
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01283 890091
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Ramipril 2.5mg/5ml Oral Solution comes as 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.
The active substance in Ramipril 2.5mg/5ml Oral Solution is ramipril.
Medicines with the same active substance include: Ramipril 10mg Tablets, Ramipril 2.5mg Tablets, Ramipril 5mg Tablets, Ramipril 1.25 mg Capsules, Ramipril 1.25mg Capsule, Ramipril 1.25mg Hard Capsules. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Ramipril 2.5mg/5ml 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.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- 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.
Posology
It is recommended that Ramipril oral solution is taken each day at the same time of the day.
Ramipril oral solution 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 oral solution; 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 oral solution (see section 4.4).
In hypertensive patients in whom the diuretic is not discontinued, therapy with Ramipril oral solution should be initiated with a 1.25 mg (2.5 ml) dose. Renal function and serum potassium should be monitored. The subsequent dosage of Ramipril oral solution 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 oral solution 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 2.5 mg (5 ml) 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 1.25 mg (2.5 ml) 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 interval of two to four weeks to progressively achieve target blood pressure; the maximum permitted dose of Ramipril oral solution is 10 mg (20 ml) daily. Usually, the dose is administered once daily.
Cardiovascular prevention
Starting dose
The recommended initial dose is 2.5 mg (5 ml) 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 10 mg (20 ml) 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 1.25 mg (2.5 ml) 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 2.5 mg (5 ml) after two weeks and then to 5 mg (10 ml) after a further two weeks is recommended.
In patients with diabetes and at least one cardiovascular risk
Starting dose:
The recommended initial dose is 2.5 mg (5 ml) 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 (10 ml) Ramipril oral solution after one or two weeks and then to 10 mg (20 ml) Ramipril oral solution after a further two or three weeks is recommended. The target daily dose is 10 mg (20 ml).
In patients with non- diabetic nephropathy as defined by macroproteinuria ≥ 3 g/day.
Starting dose:
The recommended initial dose is 1.25 mg (2.5 ml) 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 2.5 mg (5 ml) after two weeks and then to 5 mg (10 ml) after a further two weeks is recommended.
Symptomatic heart failure
Starting dose
In patients stabilized on diuretic therapy, the recommended initial dose is 1.25 mg (2.5 ml) daily.
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 10 mg (20 ml). 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 2.5 mg (5 ml) twice daily for three days. If the initial 2.5 mg (5 ml) dose is not tolerated a dose of 1.25 mg (2.5 ml) twice a day should be given for two days before increasing to 2.5 mg (5 ml) and 5 mg (10 ml) twice a day. If the dose cannot be increased to 2.5 mg (5 ml) 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 5 mg (10 ml) twice daily.
The maintenance dose is divided in 2 administrations per day where possible.
If the dose cannot be increased to 2.5 mg (5 ml) 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 1.25 mg (2.5 ml) 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 ≥ 60 ml/min, it is not necessary to adjust the initial dose (2.5 mg/day) (5 ml/day); the maximal daily dose is 10 mg (20 ml);
• if creatinine clearance is between 30-60 ml/min, it is not necessary to adjust the initial dose (2.5 mg/day) (5 ml/day); the maximal daily dose is 5 mg (10 ml);
• if creatinine clearance is between 10-30 ml/min, the initial dose is 1.25 mg (2.5 ml)/ day and the maximal daily dose is 5 mg (10 ml);
• in haemodialysed hypertensive patients: ramipril is slightly dialysable; the initial dose is 1.25 mg (2.5 ml)/day and the maximal daily dose is 5 mg (10 ml); 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 2.5 mg (5 ml).
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 1.25 mg (2.5 ml) 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 and 5.3 but no specific recommendation on posology can be made.
Method of administration
Oral use.
• 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).
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 oral solution.
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 oral solution:
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 oral solution 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.
Pregnancy
Ramipril oral solution 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 also 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 oral solution is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
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.
Symptoms
Symptoms associated with overdosage of ACE inhibitors may include excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure.
Treatment
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.
Ask anything about Ramipril 2.5mg/5ml 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.
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