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

Tablets.

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.

Uses

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.

Pregnancy:

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.

Lactation:

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.

Adults:

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.