Informations for option: Zaneril 10 Mg/10 Mg Film-Coated Tablets, show other option

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Zanerd 10 mg/10 mg

enalapril maleate/lercanidipine hydrochloride

In this leaflet:

1.    What Zaneril is and what it is used for

2.    Before you take Zaneril

3.    How to take Zaneril

4.    Possible side effects

5.    How to store Zaneril

6.    Further information

1.    WHAT ZANERIL IS AND WHAT IT IS USED FOR

Zaneril is a fixed combination of an ACE-inhibitor (enalapril) and a calcium channel blocker (lercanidipine), two medicines that lower blood pressure.

Zaneril is used:

for the treatment of high blood pressure (hypertension) in patients whose blood pressure is not adequately controlled by lercanidipine 10 mg alone. Zaneril should not be used for initial treatment of hypertension.

2.    BEFORE YOU TAKE ZANERIL Do not take Zaneril:

•    if you are allergic to either of the pharmacologically active ingredients (enalapril or lercanidipine) or to any of the other ingredients of Zaneril tablets.

•    if you are allergic to medicines closely related to Zaneril (e.g. amlodipine, felodipine, nifedipine, captopril, fosinopril, lisinopril, ramipril).

•    if you are more than 3 months pregnant. (It is also better to avoid Zaneril in early pregnancy - see pregnancy section).

•    if you suffer from certain heart diseases:

•    untreated congestive heart failure.

•    obstruction to the flow of blood from the left ventricle of the heart, including a narrowing of the aorta (aortic stenosis).

•    unstable angina pectoris (angina at rest or progressively increasing angina).

•    within one month after suffering a heart attack (myocardial infarction).

•    if you have severe liver or kidney problems, or if you are undergoing dialysis.

•    if you use medicines such as:

•    antifungals (e.g. ketoconazole, itraconazole).

•    macrolide antibiotics (e.g. erythromycin, troleandomycin).

•    antivirals (e.g. ritonavir).

•    if you are simultaneously using a medicine known as cyclosporin or ciclosporin.

•    together with grapefruit or grapefruit juice.

•    if you have ever developed angioedema (oedema of the face, lips, tongue, and/or larynx, hands, and feet), either hereditary in type or after previous treatment with an ACE-inhibitor.

•    if you have a hereditary tendency to tissue swelling or if you develop tissue swelling of unknown cause (hereditary or idiopathic angioedema).

Take special care with Zaneril

Please inform your doctor or pharmacist:

•    if you suffer from heart disease involving interruption of blood flow (ischaemia).

•    if you suffer from a disturbance of blood flow in the brain (cerebrovascular disease).

•    if you have renal problems.

•    if your liver enzyme levels rise or if you develop jaundice.

•    if your white blood cells are reduced to various degrees (leucopenia, agranulocytosis), possibly resulting in susceptibility to infection and severe general symptoms.

•    if you suffer from certain diseases of the connective tissue with involvement of blood vessels (collagen vascular diseases).

•    if you are simultaneously taking allopurinol (an anti-gout medicine), procainamide (a medicine used to combat irregular heartbeat), or lithium (a medicine used to combat certain types of depression).

•    if you develop hypersensitivity reactions or tissue swelling (angioedema) during treatment with Zaneril.

•    if you suffer from diabetes mellitus.

•    if you develop a persistent dry cough.

•    if you are at risk of an elevation of the potassium level in your blood.

•    if the reduction in blood pressure is inadequate because of your ethnic origin (especially in patients with black skin).

•    if you think you are (or might become) pregnant. Zaneril is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

If you require desensitisation therapy for insect venom (e.g. from bees or wasps), Zaneril should be temporarily replaced by a suitable medicine of a different type. Otherwise, life-threatening general symptoms may occur. Such reactions can also occur after insect bites (e.g. bee or wasp stings).

Use of Zaneril while receiving dialysis or treatment for greatly elevated blood lipid levels can result in severe hypersensitivity reactions and even life-threatening shock.

Please inform your doctor that you are being treated with Zaneril or that you require dialysis, so that the doctor can take this into account when prescribing treatment.

If you are shortly to undergo an operation or anaesthesia (including dental anaesthesia), please inform your doctor that you are taking Zaneril, since an abrupt fall in blood pressure could occur during anaesthesia.

Please inform your doctor immediately if you develop any of the following signs or symptoms:

•    Swelling of the face, limbs, lips, mucous membranes, tongue, and/or larynx, or shortness of breath.

•    Yellow colouration of the skin and mucous membranes.

•    Fever, swelling of the lymph nodes, and/or inflammation of the throat.

In such cases you must stop taking Zaneril and your doctor will take appropriate measures.

The safety and efficacy of Zaneril has not been demonstrated in controlled studies in children.

Use of this medicine requires regular medical monitoring. Therefore, please be absolutely sure to undergo whatever laboratory tests and examinations your doctor orders.

Taking other medicines

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

When Zaneril is taken simultaneously with certain other medicines, the effect of Zaneril or of the other medicine may be intensified or weakened, or certain side effects may occur more frequently.

The blood pressure-lowering effect can be intensified if you use any of the following medicines together with Zaneril:

•    Ciclosporin (a medicine that suppresses the immune system).

•    Oral antifungal drugs such as ketoconazole and itraconazole.

•    Antiviral agents such as ritonavir.

•    Macrolide antibiotics such as erythromycin or troleandomycin.

•    The anti-ulcer drug cimetidine at daily doses of more than 800 mg.

•    Diuretics such as hydrochlorothiazide, chlorthalidone, furosemide, triamterene, amiloride, indapamide, spironolactone, or other blood pressure-lowering medicines.

•    Certain vasodilating agents such as glyceryl trinitrate and organic nitrates (isosorbide) or anaesthetic agents.

•    Certain antidepressant and antipsychotic medicines.

•    Baclofene.

The blood pressure-lowering effect can be weakened if you use any of the following medicines together with Zaneril:

•    Certain painkillers (e.g. paracetamol, ibuprofen, naproxen, indomethacin, or aspirin unless used at low dosage).

•    Drugs acting on blood vessels (e.g. noradrenaline, isoprenaline, dopamine, salbutamol).

•    Anticonvulsants such as phenytoin and carbamazepine.

•    Rifampicin (a drug for the treatment of tuberculosis).

If you use digoxin (a medicine that influences the tone of the heart muscle) please ask your doctor what signs you should look out for.

If you use potassium-sparing diuretics (spironolactone) or potassium supplements, the level of potassium in your blood may increase.

Simultaneous use of lithium carbonate and Zaneril can lead to lithium toxicity.

If you use immunosuppressant or anti-gout medicines, you may in very rare cases be susceptible to severe infections. If you suffer from diabetes, please note that simultaneous use of Zaneril and either insulin or oral antidiabetic agents such as sulfonylureas and biguanides can result in hypoglycaemia (excessive reduction of blood sugar level) during the first month of treatment.

Please inform your doctor if you are using antihistamines such as terfenadine or astemizole or anti-arrhythmic agents such as amiodarone or quinidine, or estramustine or amifostine or gold, since certain drug interactions can occur with these agents.

Taking Zaneril with food and drinks

Zaneril should be taken at least 15 minutes before a meal.

Alcohol can increase the effect of Zaneril. You are therefore advised either to consume no alcohol or to strictly limit your alcohol intake.

Pregnancy and breast-feeding Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Zaneril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Zaneril. Zaneril 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. Breast-feeding newborn babies (first few weeks after birth), and especially premature babies, is not recommended whilst taking Zaneril. In the case of an older baby your doctor should advise you on the benefits and risks of taking Zaneril whilst breast-feeding, compared with other treatments.

Driving and using machines

If you develop dizziness, weakness, tiredness, or drowsiness during treatment with this medicine, you must not drive a vehicle or operate machines.

Important information about some of the ingredients of Zaneril

Zaneril contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE ZANERIL

Always take Zaneril exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is one tablet once daily at the same time each day. The tablet should preferably be taken in the morning at least 15 minutes before breakfast. The tablets should be swallowed whole with water.

The tablets should not be taken with grapefruit or grapefruit juice.

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

If you take more Zaneril than you should

If you have taken more than the dose prescribed by your doctor or in the event of overdosage, seek medical attention immediately and if possible take the tablets and/or the container with you to the doctor.

Taking more than the correct dose can cause your blood pressure to fall too far and your heart to beat irregularly or faster. This can result in loss of consciousness.

In addition, a severe fall in blood pressure can result in reduced blood flow to important organs, cardiovascular failure, and renal failure.

If you forget to take Zaneril

If you forget to take your tablet, take the missed tablet as soon as possible unless it is almost time for your next dose. Then continue taking the tablets as usual. Do not take a double dose on the same day.

If you stop taking Zaneril

If you stop taking Zaneril your blood pressure may rise again. Please talk to your doctor before you stop taking Zaneril. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

The most frequent side effects (1 to 10% frequency) observed with Zaneril 10 mg/10 mg are cough, dizziness and drowsiness. All adverse effect observed either with Zaneril 10 mg/10 mg or with enalapril or lercanidipine alone are listed below.

Frequencies are defined as: very common (affecting more than 1 in 10 patients); common (affecting less than 1 in 10 patients); uncommon (affecting less than 1 in 100 patients); rare (affecting less than 1 in 1,000 patients); very rare (affecting less than 1 in 10,000 patients).

Eves

Very common: Nervous system Very common: Common: Uncommon: Rare:

Cardiovascular system

Common:    Excessive reduction in blood pressure including excessive fall in blood pressure when standing up,

brief loss of consciousness (fainting), heart attack or stroke, chest pain, a feeling of tightness in the chest, abnormal heart rhythm, increased heart rate.

Uncommon:    Swelling of the ankles, heart pounding.

Rare:    Coldness of the hands and feet.

5. HOW TO STORE ZANERIL

Keep out of the reach and sight of children.

Do not use Zaneril after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Your Zaneril tablets are best stored in their original package in order to protect from light and moisture. Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Zaneril contains

The active substances are enalapril maleate and lercanidipine hydrochloride.

Each film-coated tablet contains: 10 mg enalapril maleate (equivalent to 7.64 mg enalapril) and 10 mg lercanidipine hydrochloride (equivalent to 9.44 mg lercanidipine).

The other ingredients are:

Core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, sodium hydrogen carbonate, magnesium stearate.

Film-coating: hypromellose, titanium dioxide (E171), talc, macrogol 6000.

What Zaneril looks like and contents of the pack

Zaneril 10 mg/10 mg tablets are white, round and biconvex film-coated tablets.

Zaneril 10 mg/10 mg is available in packs of 7, 14, 28, 30, 35, 42, 50, 56, 90, 98 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder:

Recordati Pharmaceuticals Limited

Isis House, 43 Station Road - Henley-on-Thames - Oxfordshire - RG9 1AT - United Kingdom Manufacturer:

RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali 1 - I-20148 Milan, Italy This medicinal product is authorised in the Member States of the EEA under the following names:

& RECORDATI

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