WHAT CYPLOSART IS AND WHAT IT IS USED FOR

Cyplosart belongs to a group of medicines known as angiotensin – II receptor antagonists. Angiotensin – II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Cyplosart prevents the binding of angiotensin – II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Cyplosart slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Cyplosart is used

• to treat patients with high blood pressure (hypertension), including adults, children and teenagers of age 16-18.
• to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired  renal function and proteinuria ≥ 0.5 g per day (a condition in which urine contains an abnormal amount of protein).
• to treat patients with chronic heart failure when therapy with specific medicines called angiotensin – converting – enzyme inhibitors ( ACE inhibitors, medicine used to lower high blood pressure) is not considered suitable by your doctor. If your heart failure has been stabilised with an ACE inhibitor you should not be switched to Cyplosart.
• in patients with high blood pressure and thickening of the wall of the left ventricle, Cyplosart has been shown to decrease the risk of stroke ( “LIFE indication’’).

BEFORE YOU TAKE CYPLOSART

Do not take Cyplosart:

• If you are allergic (hypersensitive) to Cyplosart or to any of its other ingredients,
• If you have liver function is severely impaired,
• If you are  more than 3 months pregnant. (it is also better to avoid Cyplosart Potassium in early pregnancy – see section “Pregnancy and breast-feeding”)
• If you are breast – feeding.

Take special care with Cyplosart

Inform your doctor:

• If you have had a history of angiooedema (swelling of the face , lips, throat, and/or tongue) (see also section 4 ‘Possible side effects’),
• If you suffer from excessive vomiting or diarrhoea leading to an extreme loss of l fluid and salt in your body,
• if you receive diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are under dietary salt restriction leading to extreme loss of fluid and salt in your body (see section 3 ‘Dosage in special patient groups’)
• If you are known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently,
• If your liver function is impaired (see sections 2 ‘‘Do not take Cyplosart ‘’ and 3 ‘’Dosage in special patients groups’’),
• If you suffer from heart failure with or without renal impairment or concomitant severe life threatening cardiac arrhythmias. Special caution is necessary when you are treated with a b – blocker concomitantly,
• If you have problems with your heart valves or heart muscle,
• If you suffer from coronary heart disease (caused by a reduced blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by a reduced blood circulation in the brain), 
• If you suffer from primary hyperldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland).

Taking other medicine:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines and natural products.

Take particular care if you are taking the following medicines while under treatment with Cyplosart:

• Other blood pressure lowering medicines as they may additionally reduce your blood pressure. Blood pressure may also be lowered by one of the following drugs/class of drugs: tricyclic antidepressants, antipsychotics, baclofene, amifostine,
• Medicines which retain potassium or may increase potassium levels (e.g. potassium supplements, potassium – containing salt substitutes or potassium – sparing medicines such as certain diuretics [amiloride, triamteren, spironolactone] or heparine),
• Non – steroidal anti – inflammatory drugs such as indomethacin, including COX-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain) as they may reduce the blood lowering effect of Cyplosart.

If your kidney function is impaired, the concomitant use of these medicines may lead to a worsening of the kidney function.

Lithium containing medicines should not be taken in combination with Cyplosart without close supervision by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate.

Taking Cyplosart with food and drink:

Cyplosart may be taken with or without food.

Pregnancy and Breast-feeding: 

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advice you to stop taking Cyplosart before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Cyplosart. Cyplosart is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Cyplosart is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a new born, or was born prematurely.

Ask your doctor or pharmacist for advice before taking this medicine.

Use in children and adolescents

Cyplosart has been studied in children. For more information, talk to your doctor.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Cyplosart is unlikely to affect your ability to drive or use machines. However, as with many other medicines used to treat high blood pressure, Cyplosart may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.

Important information about some of the ingredients of Cyplosart:

Cyplosart contains Lactose.  If you suffer from rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption you should not take this medicine.

HOW TO TAKE CYPLOSART

Always take Cyplosart exactly as your doctor has instructed you. Your doctor will decide on the appropriate dose of Cyplosart, depending on your condition and whether you are taking other medicines. It is important to continue taking Cyplosart for as long as your doctor prescribes it in order to maintain smooth control of your blood  pressure.

Patients with High Blood Pressure

Treatment usually starts with 50 mg Cyplosart once a day. The maximal blood pressure lowering effect should be reached 3-6 weeks after beginning treatment. In some patients the dose may later be increased to 100 mg Cyplosart once daily

If you have the impression that the effect of Cyplosart is too strong or too weak, please talk to your doctor or pharmacist.

Patients with high blood pressure and type 2 diabetes

Treatment usually starts with 50 mg Cyplosart once a day. The dose may later be increased to 100 mg Cyplosart once daily depending on your blood pressure response.

Cyplosart tablets may be administered with other blood pressure lowering medicines (e.g. diuretics, calcium channel blockers, alpha-  or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used medicines that decrease the level of glucose in the blood (e.g. sulfonylurea’s, glitazones and glycosidase inhibitors). 

Patients with Heart Failure

Treatment usually starts with 12.5mg Cyplosart once a day.

Generally, the dose should be increased weekly step-by-step (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week) up to the usual maintenance dose of 50 mg Cyplosart once daily, according to your condition.

In the treatment of heart failure, Cyplosart is usually combined with a diuretic (medicine that increases the amount of water that you pass out through your kidneys) and/or digitalis (medicine that helps to make the heart stronger and more efficient) and /or beta-blocker.

Dosage in special patient groups

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those treated with diuretics in high doses, in patients with liver impairment, or in patients over the age of 75 years. The use of Cyplosart is not recommended in patients with severe hepatic impairment (see section “Do not take Cyplosart”).

Administration

The tablets should be swallowed with a glass of water. You should try to take your daily dose at about the same time each day. It is important that you continue to take Cyplosart until your doctor tells you otherwise.

If you take higher dose of Cyplosart than you should:

Contact your doctor or emergency department if you have taken higher dose Cyplosart than stated in this leaflet or more than the doctor has prescribed. Take this leaflet and any tablets you still have with you.

Symptoms of overdose are low blood pressure, increased heart beat, possibly decreased heart beat.

If you forget to take Cyplosart:

If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten tablet. If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Cyplosart can cause side effects, although not everybody gets them.

If you experience the following, stop taking Cyplosart tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:

A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).

This is a serious but rare side effect, which affects more than 1 out of 10.000 patients but fewer than 1 out of 1.000 patients. You may need urgent medical attention or hospitalisation.

The side effects of medicines are classified as follows:

Very common:             affects more than 1 user in 10

Common:                     affects 1 to 10 users in 100

Uncommon:                 affects 1 to 10 users in 1000

Rare:                            affects 1 to 10 users in 10,000

Very rare:                     affects less than 1 user in 10,000

Not known:                   frequency can not be estimated from the available data

Keep out of the reach and sight of children

Expiry date:

Do not use Cyplosart after the expiry date stated on the inner and outer packaging.

Storage Conditions:

Store below 25°C, away from light and moisture.

Marketing Authorisation Holder:

Remedica Ltd, Limassol Industrial Estate, Limassol, Cyprus, EU.

This leaflet was last approved on:

04/10/10

Legal Category:

This medicine is dispensed only by medical prescription