Ramipril 5mg Tablets

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What you should know about Ramipril Tablets

Please read this carefully before you start to take your medicine.

•    This leaflet provides a summary of the information available on your medicine.

•    If you have any questions or are not sure about anything, ask your doctor or pharmacist.

•    This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

The name of your medicine is Ramipril 1.25mg, 2.5mg, 5mg, and 10mg


Marketing authorisation holder. Sandoz Ltd, 37 Woolmer Way, Bordon,

Hampshire, GU35 9QE.

The manufacturer responsible for batch release is: Sandoz Pharmaceuticals

GmbH, Carl-Zeiss-Ring 3, 85737 Ismaning, Germany.

And/or: LEK S.A., UI. Podlipie 16, 95-010 Strykow, Poland.

What is in this leaflet?

1.    What Ramipril Tablets are and what they are used for.

2.    Before you take Ramipril Tablets.

3.    How to take Ramipril Tablets.

4.    Possible side effects.

5.    Storing Ramipril Tablets.

1. What Ramipril Tablets are and what they are used for

The active substance in your Ramipril Tablets is ramipril. Ramipril Tablets are available in four strengths. They are supplied in tablet containers or blister packs of 20, 28, 30, 50 and 100, 100 x 1 and 250 tablets.

Each tablet contains 1.25mg, 2.5mg, 5mg, or 10mg of ramipril, the active ingredient. The other ingredients are microcrystalline cellulose, pregelatinised starch, silicium dioxide precipitated, glycine hydrochloride and glycerol dibehenate. The 2.5mg tablets also contains yellow iron oxide (E172), 5mg tablets contains red iron oxide (E172).

Ramipril 1.25mg is an oblong shaped tablet, white, scoreline on both sides.

Ramipril 2.5mg is an oblong shaped tablet light yellow speckled, scoreline on one side.

Ramipril 5mg is an oblong shaped tablet, light pink speckled, scoreline on one side.

Ramipril 10mg is an oblong shaped tablet, white, scoreline on one side. Ramipril is one of a group of medicines called ACE (angiotensin converting enzyme) inhibitors. These work by widening blood vessels, which makes it easier for the heart to pump blood through them, to all parts of the body. This helps to reduce raised blood pressure. It can also help the heart to work better if the heart does not pump as well as is needed.


Your doctor has probably prescribed Ramipril Tablets for one of the following reasons:

• To reduce the risk of a heart attack and heart disease, to decrease the need for heart bypass surgery and to reduce your chances of having a stroke. This applies to patients who have been shown to already have

heart disease or peripheral vascular disease.

•    In diabetic patients who show symptoms of high blood pressure, high cholesterol, peripheral vascular disease, have known microalbuminuria (small amounts of a protein called albumin in the urine), or are smokers. In these patients, Ramipril Tablets can reduce the risk of heart attack, heart disease and stroke and decreases the risk of requiring surgery to increase blood flow to the heart.

•    To lower mild to moderately high blood pressure.

2. Before you take Ramipril Tablets

Do not take Ramipril Tablets if:

•    You are hypersensitive (allergic) to ramipril or any of the other ingredients listed above.

•    You are pregnant.

•    You are breast-feeding.

•    You have a history of angioedema.

•    You have low blood pressure.

•    You are undergoing haemodialysis (using high flux polyacrylonitrile, speak to your doctor if you are unsure).

•    You have had certain types of heart problems e.g. aortic and mitral stenosis (narrowing of the inlet valve into the left ventricle of the heart), hypertrophic cardiomyopathy (disease of the heart muscle) and cardiac arrhythmias (irregular heart beat).

Take special care with Ramipril Tablets if:

•    You have heart problems (particularly if you are taking medicine for it), or if you have any kidney or liver disease. Your doctor may need to change the dose of your medicine.

•    If you are dehydrated or have a salt imbalance.

•    You are taking diuretic medication (water tablets). Your doctor may discontinue diuretic therapy and correct volume and/or salt depletion before starting treatment with ramipril.

•    You have severe high blood pressure.

•    You are taking any medications which may affect your blood picture. Your doctor can advise you of this.

•    You are taking medication for low potassium levels.

•    You are taking allopurinol and/or other immunosuppressants as this may increase the likelihood of blood picture changes.

Alcohol can increase the effect of ramipril, this can be dangerous and you should speak to your doctor if you are unsure.

You need to tell your doctor or dentist that you are taking ramipril if you are about to undergo a surgical / dental procedure where an aesthetic might be used.


Ramipril should not be used in the first trimester of pregnancy. When pregnancy is planned/confirmed switch to an alternative treatment. Do not take blood pressure lowering drugs as this may cause defects to the unborn baby. Ask your doctor or pharmacist for advice before taking any medicine.


Ramipril Tablets should not be taken by women who are breast-feeding as Ramipril passes into breast milk and may be harmful to the baby.

Driving and using machines:

It is not advisable to drive or operate machinery for several hours

after the first dose of Ramipril Tablets or after an increase in dose.

Do not take alcohol.You should not drive or operate machinery if you feel dizzy or tired while taking Ramipril Tablets.

This is more likely to occur at the start of treatment or when your dose is increased.

Drinking alcohol may make the dizziness or sleepiness worse.

Using other medicines:

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

You should especially inform your doctor if you have been taking diuretics (water tablets), medicines for high blood pressure, medicines for diabetes, lithium, antidepressants, treatment for gout, types of painkillers called NSAIDs (these include drugs like ibuprofen and diclofenac), corticosteroids, drugs to suppress the immune system (e.g. after transplant surgery) or medicines containing potassium.

3. How to take Ramipril Tablets

Always follow your doctor's instructions as to how and when to take your medicine, your pharmacist may be able to advise you if you are not sure. Exactly how many tablets, and how often you must take them, will be written on the label. Please read it carefully. The recommended doses are given below. However, doctors sometimes prescribe different doses to these: if this applies to you, discuss it with your doctor, if you have not already done so. Swallow the tablet whole with a glass of water. Take the dose at approximately the same time each day.


For people who have a weakened heart after having a heart attack: The usual starting dose begins between 3-10 days after the heart attack and consists of one 1.25mg or 2.5mg tablet twice a day. After at least 2 days your doctor will increase your dose to 2.5mg or 5mg. This dose will usually be increased by your doctor to a maintenance dose of 10mg once a day taken as one 5mg tablet twice a day, then eventually one 10mg tablet once per day.

Reducing the risk of heart attack and cardiac death in patients at high risk of cardiovascular diseases, and in high-risk diabetics: Your starting dose will probably be one 1,25mg once daily. Your doctor will probably double the dose after 2-3 weeks. The maintenance daily dose is 5mg. You may eventually have your dose increased to 10mg taken as a single dose or divided into two doses, if your doctor thinks it is necessary.

Hypertension (high blood pressure): The usual dose for patients is 1.25mg to 2.5mg tablet once a day. Your doctor may decide to increase the dose after two to three weeks of treatment. Most people with hypertension need doses of 2.5mg or 5mg once a day, but your doctor may decide you need a different dose, up to a maximum of 10mg once a day. Alternatively your doctor may decide to treat you with a diuretic (water tablets) and ramipril.

Kidney Disease: For patients with kidney disease, your doctor will adjust your dose so it is suitable foryou.

If you have a creatinine clearance more than 50ml/min, the maximum dosage should not exceed 10mg.

If you have a creatinine clearance between 50 - 20ml/min, the maximum dosage should not exceed 5mg.

If you have a creatinine clearance less than 20ml/min, the maximum dosage should not exceed 2.5mg.

Patients receiving diuretic treatment: It can be dangerous to take ramipril and diuretics (water tablets) at the same time. Your doctor may ask you to stop taking your diuretics 2-3 days before taking your ramipril. If this is not possible your doctor may give you a special dosing schedule.

Liver Problems: For patients with liver problems, the maximum daily dosage should be no more than 2.5mg once daily and even then only underdose medical supervision.

Elderly: Your doctor should adjust your dose according to the renal function of the elderly patient, as shown above under 'Kidney Disease'.

Children: Ramipril Tablets are not recommended for use in children.

If you have any concerns regarding your treatment, discuss them with your doctor. Do not stop taking Ramipril Tablets without first consulting your doctor, as your original symptoms will return.

If you have forgotten to take your medicine, take the missed dose as soon as you remember, unless it is nearly time for the next dose. Do not double the next dose to make up for the missed one. If you are at all concerned about this you should consult your doctor or pharmacist.

If you have taken too many Ramipril Tablets, contact your doctor or local hospital accident and emergency department immediately.

You may experience low blood pressure, which will result in dizziness.

If you take more Ramipril than you should:

If you have taken too many tablets, or if someone accidentally swallows some, immediately contact your doctor or the nearest hospital for advice.

4. Possible side effects

As with all medicines, Ramipril Tablets may cause undesirable effects in some people. These include:

Common side effects (affecting 1 in 10 people in every 100 people) include:

Dizziness, headache and faintness may occur on standing due to low blood pressure, chest pain, angina, temporary loss of consciousness, diarrhoea, vomiting, kidney problems, cough.

Uncommon side effects (affecting 1 in 10 people every 1000 people) include:

Mood swings, taste disturbance, sleep disturbance, dizziness and spinning sensation, tingling, prickling, pins and needles, electrical-type buzzing, burning, itching and partial numbness, heart attack, stroke, irregular heart beat, blood not reaching extremities of the body (a condition called Raynaud's), inflammation of the nasal membrane, shortness of breath, nausea, abdominal pain and indigestion, anorexia, rash, eczema, dermatitis, impotence, fatigue, weakness, kidney

pharmacist for disposal. If you notice any visible signs of deterioration in the tablets, take them to your pharmacist for advice before taking them.

problems, liver problems.

Rare side effects (affecting 1 in 10 people in every 10,000 people) include:

Decreases in protein molecule (haemoglobin), decrease in cell count, mental confusion, dry mouth, build-up of excess fluid in body tissues, kidney failure, enlarged male breasts, low concentration of sodium in the blood.

Very rare side effects (affecting less than 1 person in every 10,000 people) include:

Decrease in production of essential parts of blood and immune system, anaemia, reduced white cell count, increase loss of red blood cells, an increase in white blood cells, auto immune disease, abnormal contraction of the wind pipe, infection of the nasal cavities, chronic asthma, inflammation of the pancreas, liver abnormalities, swelling of the face and airways, sweating, skin blistering and peeling of the top layer of the skin, skin disease resulting from drug reaction, kidney failure.

Tell your doctor at once If:

•    You feel ill after your first dose (a few people may react to their first dose and feel very dizzy, weak, faint and sick).

•    You get a lot of infections with sore throats or mouth ulcers.

•    You notice a rash, skin eruption or other effects on your skin or eyes, itching ora high temperature.

•    You notice swelling of the face, tongue or throat.

Ask your doctor if you should continue taking the tablets.

Stop taking Ramipril Tablets immediately and go to your doctor or casualty department if:

•    Your breathing becomes difficult and noisy.

•    You get any swelling of the face, tongue or throat.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. Storing your Ramipril Tablets

Do not take this medicine after the expiry date stated on the container. Any out of date or unused medicines should be returned to your

Do not store above 25°C.

Container: Store in the original container. Keep the container tightly closed.

Date of preparation: May 2006.

Keep out of the reach and sight of children. REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others, it may harm them even if their symptoms are the same as yours.

This leaflet applies to Ramipril 1.25mg, 2.5mg, 5mg, and 10mg Tablets only.









29JaBlets *

Each tablet contains ramipril 5m g.

For oral administration only.

Use as directed by your physraan®

® Prease reffd the enclosed leaflet. •

Do not store above 25°C.

Store in the original container. Keep container tightly closed. Keep out of the reach and sight of children.

# •

® S^ndoz Ltd,

V^olmerWay, Bordon, Hants, GU35 9QE.

PL04416/0649 SZ94109LL01 B


Expiry Date:

Each tablet contains ramipril 5mg.

For oral administration only. Use as directed by your physician.

Please read the enclosed leaflet.

Do not store above 25°C.

Store in the original container. Keep container tightly closed. Keep out of the reach and sight of children.

Sandoz Ltd,

Woolmer Way, Bordon, Hants, GU35 9QE.