Ramipril

• Used to treat high blood pressure
• Also used for heart problems
• Can cause dizziness
• Avoid drinking alcohol while taking this medicine
• Not to be used while pregnant

Ramipril tablets contain the active ingredient ramipril which belongs to a group of medicines

called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors). Ramipril Sandoz tablets work 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 tablets are used to:

• Treat high blood pressure (hypertension).
• Reduce the risk of heart attack or stroke.
• Reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes).
• 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.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How to take this medicine

• Take this medicine by mouth at the same time of the day each day.
• Swallow the tablets with liquid.
• Do not chew or crush the tablets.
• Ramipril can be taken with or without food.

Dosage in adults

Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
  Your doctor will adjust the amount you take until your blood pressure is controlled. The maximum daily dose is 10 mg.

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 Sandoz tablets.

Treatment to reduce the risk of heart attack or stroke

• The usual starting dose is 2.5 mg once daily.
  Your doctor may adjust the amount you take. The usual dose is 10 mg once daily.

Treatment to reduce or delay the worsening of kidney problems

• You may be started on a dose of 1.25 mg or 2.5 mg once daily.
  Your doctor will adjust the amount you take. The usual dose is 5 mg or 10 mg once daily.

Treatment of heart failure

• The usual starting dose is 1.25 mg once daily.
  Your doctor will adjust the amount you take. The maximum dose is 10 mg daily. Two administrations per day are preferable.

Treatment after you have had a heart attack

• The usual starting dose is 1.25 mg once daily to 2.5 mg twice daily.
  Your doctor will adjust the amount you take. The usual dose is 10 mg daily. Two administrations per day are preferable.

Elderly/young patients Your doctor will reduce the initial dose and adjust your treatment more slowly.

This medicine is not suitable for use in children and adolescents under 18 years of age.

Alcohol/driving

You may feel dizzy while taking Ramipril tablets. This is more likely to happen when you start taking

Ramipril tablets or start taking a higher dose. If this happens, do not drive or use any tools or machines.

Alcohol may intensify side effects such as dizziness. Limit or stop drinking alcohol while taking this medicine.

If you take more or less Ramipril than you should

If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor at once.

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 tablet.

Ramipril is not suitable for everyone. Do not take Ramipril if:

• You are allergic to ramipril or any of the ingredients of this medicine listed at the end of this leaflet under 'What Ramipril contains'.
• You have ever had a serious allergic reaction called angioedema. The signs include itching, swelling around the eyes and lips, difficulty breathing and swallowing.
• You are having dialysis or any other type of blood filtration. Depending on the machine that is used, Ramipril tablets may not be suitable for you.
• You have kidney problems where the blood supply to your kidney is reduced (renal artery stenosis).
• Your blood pressure is abnormally low or unstable.
• You are pregnant.

When should this medicine be used with caution?

Talk to your doctor or pharmacist before taking this medicine if:

• You have heart, liver or kidney problems.
• You have lost a lot of body salts or fluids (through vomiting, having diarrhoea, sweating more than usual, taking diuretics (water tablets) for a long time or having had dialysis).
• You are going to have treatment to reduce your allergy to bee or wasp stings (desensitisation).
• You are going to receive an anaesthetic.
• You have high amounts of potassium in your blood.
• You have collagen vascular disease such as scleroderma or systemic lupus erythematosus.

Pregnancy and breastfeeding

You must tell your doctor if you think that you are (or might become) pregnant. This medicine could cause abnormalities in a developing baby. Do not take this medicine if you are pregnant. Consult your doctor if you fall pregnant during the treatment.

This medicine should not be used while breastfeeding.

Other medicines and Ramipril

Some medicines may interfere with the effectiveness of other medicines. Ramipril is known to interact with the following medicines:

• 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.
• 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 and heparin.
• Steroid medicines for inflammation such as prednisolone.
• Allopurinol (used to lower the uric acid in your blood).
• Procainamide (for heart rhythm problems).
• Medicines used for treating type 2 diabetes.
• Lithium (for mental health problems).

The doctor will have a list of medicines that you should avoid mixing Ramipril with.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects that are known to be associated with this medicine include:

• Headache or feeling tired.
• Dizziness.
• 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.
• Problems affecting the stomach and intestines.
• Skin rash with or without raised area.
• Chest pain.
• Cramps or pain in your muscles.
• Increased levels of potassium in the blood.

For a complete list of side effects, see the package leaflet. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What ingredients are in this medicine?

Ramipril Sandoz 1.25 mg

Each 1.25-mg tablet contains 1.25 mg ramipril.

The other ingredients (expedients) are: microcrystalline cellulose, pregelatinised (maize) starch, sodium stearyl fumarate, glycine hydrochloride (E640), glycerol dibehenate.

Ramipril Sandoz 2.5 mg

Each 2.5-mg tablet contains 2.5 mg ramipril.

The other ingredients (expedients) are: microcrystalline cellulose, pregelatinised (maize) starch, sodium stearyl fumarate, glycine hydrochloride (E640), glycerol dibehenate, iron oxide yellow (E172).

Ramipril Sandoz 5 mg

Each 5-mg tablet contains 5 mg ramipril.

The other ingredients (expedients) are: microcrystalline cellulose, pregelatinised (maize) starch, sodium stearyl fumarate, glycine hydrochloride (E640), glycerol dibehenate, iron oxide red (E172).

Ramipril Sandoz 10 mg

Each 10-mg tablet contains 10 mg ramipril.

The other ingredients (expedients) are: microcrystalline cellulose, pregelatinised (maize) starch, sodium stearyl fumarate, glycine hydrochloride (E640), glycerol dibehenate.

The manufacturers of Ramipril are:

Lek S.A.
ul. Domaniewska 50 C
02-672 Warschau
Poland

Salutas Pharma GmbH
Dieselstraße 5
D-70839 Gerlingen
Germany

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Read the package leaflet before use.