Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have further questions, please 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.

Who should not take this medicine?

You should NOT take COVERSYL® tablets:

• if you are allergic to COVERSYL® or any other ACE inhibitor, or to any of the other ingredients in the tablet;
• if you have had symptoms such as wheezing, swelling of the face, tongue or throat, intense itching, skin rashes, fainting or dizziness with previous ACE inhibitor treatment or have had these symptoms in any other circumstances (this is a condition called angioedema);
• if you are pregnant or breast-feeding.

COVERSYL® tablets should not be given to children.

If you think any of the above situations applies to you do not take the tablets. Consult your doctor and take his/her advice.

What else should you know before taking your medicine?

You should check with your doctor BEFORE taking COVERSYL®:

• if you have aortic stenosis (narrowing of the main blood vessel leading from the heart) or hypertrophic cardiomyopathy (cardiac muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood);
• if you have any other heart or liver or kidney problems, or if you are receiving dialysis;
• if you suffer from a collagen disease such as systemic lupus erythematosus or scleroderma;
• if you are on a salt restricted diet or use salt substitutes which contain potassium;
• if you suffer from diabetes which is not well controlled;
• if you are allergic to lactose; if you have or think you have problems in absorbing sugars (eg glucose, lactose, galactose) you must not take these tablets and must talk to your doctor. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

You should also inform your doctor or the medical staff that you are taking COVERSYL®:

• if you are to undergo anaesthesia and/or surgery;
• if you have suffered from recent diarrhoea or vomiting;
• if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings;
• if you are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine).

What about pregnancy and breast-feeding?

 

You should not take COVERSYL®:

• if you are pregnant, planning to become pregnant or if you suspect you are pregnant;
• if you are breast-feeding.

Can you take your tablets with other medicines?

In order to avoid possible interactions between different medicines, you should always inform your doctor or your pharmacist of any other medicines that you are taking – even those bought without a doctor’s prescription – before taking COVERSYL®. In particular, you should check with your doctor if you are taking any of the following to be sure that it is safe to take COVERSYL® at the same time:

• other medicines for treating high blood pressure including diuretics (water tablets);
• potassium-sparing diuretics (eg spironolactone, triamterene or amiloride); potassium supplements and potassium-containing salt substitutes;
• medicines for the treatment of diabetes (insulin or tablets) to lower blood sugar;
• lithium for mania or depression;
• medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia or other psychoses;
• allopurinol used for the treatment of gout;
• immunosuppressants used for the treatment of auto-immune disorders (eg rheumatoid arthritis) or following transplant surgery;
• procainamide, a treatment for irregular heartbeat;
• non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief, including aspirin;
• medicines used for the treatment of low blood pressure, shock or asthma (eg ephedrine, noradrenaline or adrenaline);
• vasodilators including nitrates (products that make the blood vessels become wider)
• heparin (used to thin the blood).

Ask your doctor if you are not sure what these medicines are.

Taking your medicine with food and alcohol:

It is recommended that COVERSYL® should be taken before a meal in order to reduce the influence of food on the way in which the medicine works. Drinking alcohol with COVERSYL® may make you feel dizzy or light-headed. You should check with your doctor whether drinking is advisable for you.

What about driving and using machines?

You may experience dizziness or weariness while taking COVERSYL®. If this occurs do not drive or use machinery. You should talk to your doctor.

How to take your tablets

Your doctor will decide on the right starting dose for you and on any increase in the dose depending on your condition and whether you are taking any other medicines. Do not change your dosage unless your doctor tells you to do so. Coversyl may be used on its own or with other medicines which lower blood pressure.

The usual dosages for COVERSYL® are as follows:

High blood pressure: the usual starting and maintenance dose for treatment in adults is 4 mg once a day. After a month, this can be increased to 8 mg a day which is the maximum recommended dose.

If you are 65 or over, the usual starting dose is 2 mg once a day. After a month, this can be increased to 4 mg a day and if necessary to 8 mg a day.

Heart failure: treatment should be started under close medical supervision with 2 mg once a day. After two weeks, it can be increased to 4 mg once a day if required.

Stable coronary artery disease: the usual starting dose is 4 mg once daily. After two weeks and if 4 mg is well tolerated, this can be increased to 8 mg once daily.

If you are 65 or over, the usual starting dose is 2 mg once daily. After one week, this can be increased to 4 mg once daily and after a further week to 8 mg once daily.

Your doctor may give you a blood test to check that your kidneys are working properly before increasing the dose to 8 mg.

Treatment for these conditions is usually life-long.

Take your tablet(s) with a glass of water, preferably at the same time each day, in the morning, before a meal. If you are taking water tablets (diuretics), your doctor may decide to reduce or even discontinue these at the beginning of your treatment with COVERSYL®.

COVERSYL® is not suitable for use in children.

If you take more tablets than you should:

If you have taken too many tablets, contact your nearest hospital accident and emergency department or tell your doctor immediately.

If you forget to take your tablets:

It is important to take your medicine every day. However, if you forget to take one or more doses, take another as soon as you remember and then go on as prescribed. Do not take a double dose.

Common

• cough, shortness of breath
• light-headedness due to low blood pressure (particularly after the first few doses, if the dose is increased or when water tablets are also taken)
• headache, dizziness, vertigo, tiredness, pins and needles, muscle cramps, visual disturbances (eg blurred vision, eye pain), tinnitus (sensation of noises in the ears)
• nausea, vomiting, abdominal pain, changes in your sense of taste, feeling of indigestion, diarrhoea, constipation
• skin rashes, itching

Uncommon

• changes in mood or sleep
• bronchospasm (tightening of the chest, wheezing and shortness of breath)
• dry mouth
• kidney problems
• impotence
• sweating
• angioedema. If you experience any of the following effects, stop taking your tablets at once and TELL YOUR DOCTOR IMMEDIATELY: swelling of the face, lips, mouth, tongue or throat, difficulty in breathing, dizziness or fainting, unusually fast or irregular heart beat. This is a serious reaction which can occur with all drugs of this type (ACE inhibitors). It must be treated immediately, usually in hospital.

Very rare

• confusion
• irregular heart beat, angina, heart attack and stroke (these have been reported with ACE inhibitors in association with low blood pressure)
• eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose)
• pancreatitis (inflammation of the pancreas)
• hepatitis (inflammation of the liver)
• erythema multiforme (skin reaction like an allergy)
• changes in the blood: your doctor may decide to carry out blood tests at intervals to monitor for this.

If you experience any of the above symptoms and they persist or become troublesome, you should tell your doctor.

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