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Document: leaflet MAH GENERIC_PL 11311-0490 change

• leaflet MAH GENERIC_PL 04416-1358
• leaflet MAH GENERIC_PL 11311-0490

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PATIENT INFORMATION LEAFLET

Enalapril maleate / Hydrochlorothiazide 20mg / 12.5mg tablets

Enalapril maleate / Hydrochlorothiazide

What Enalapril maleate / Hydrochlorothiazide is and what it is used for

Enalapril maleate / Hydrochlorothiazide tablets contain a combination of enalapril and hydrochlorothiazide.

Enalapril belongs to a group of medicines called angiotensin converting enzyme inhibitors (ACE inhibitors), which work by widening your blood vessels.

Hydrochlorothiazide belongs to a group of medicines known as water tablets (diuretics), which increase the volume of urine you produce.

The effect of these medicines is to lower your blood pressure. Enalapril maleate / Hydrochlorothiazide is used to treat high blood pressure (hypertension). Taking both medicines that Enalapril maleate / Hydrochlorothiazide contains can increase their effect compared to taking just one.

This fixed dose combination is not suitable for initial therapy.

What you need to know before you |2 take Enalapril maleate / Hydrochlorothiazide

Do NOT take Enalapril maleate / Hydrochlorothiazide

■    if you are allergic (hypersensitive) to enalapril, hydrochlorothiazide or any of the other ingredients of this medicine (see Section 6 “Contents of the pack and other information”)

■    if you are allergic (hypersensitive) to other ACE inhibitors e.g. ramipril or to sulphonamide-derived medicines (mostly antibiotics e.g. sulphamethoxazole)

■    if you have previously suffered from swelling of the extremities, face, lips, throat, mouth or tongue (angioedema) when treated with other medicines belonging to a group of drugs called ACE inhibitors (angiotensin-converting enzyme inhibitors) such as ramipril

■    if you have previously suffered from swelling of the extremities, face, lips, throat, mouth or tongue (angioedema) under any other circumstances

■    if anyone among your blood relatives has previously suffered from swelling of the extremities, face, lips, throat, mouth or tongue (angioedema)

■    if you have severe kidney problems

■    if you are not passing urine (anuria)

■    if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

■    if you have a condition known as renal artery stenosis (narrowing of the arteries that supply the blood to your kidneys)

■    if you have severe liver problems or a neurological disorder as a result of severe liver problems (hepatic encephalopathy)

■    if you are more than 3 months pregnant. (It is also better to avoid Enalapril maleate / Hydrochlorothiazide in early pregnancy - see pregnancy section.)

Warnings and precautions

Talk to your doctor before taking this medicine:

■    if you have narrowing of the arteries (atherosclerosis), cerebrovascular problems such as a stroke or transient ischaemic attack (TIA, a "mini-stroke")

■    if you have heart failure

■    if you have low blood pressure, are on a salt restricted diet or have recently suffered from excessive vomiting and/or diarrhoea

■    if you have abnormal levels of water and minerals in your body (fluid/electrolyte imbalance)

■    if you have heart muscle disease (hypertrophic cardiomyopathy), a narrowing of the main artery carrying blood away from the heart, the aorta (aortic stenosis), or other forms of a heart problem called outflow obstruction

■    if you have diabetes and are taking antidiabetic medicines, including insulin to control your diabetes (you should monitor your blood for low blood glucose levels, especially during the first month of treatment)

■    if you suffer from gout, have high levels of uric acid in your blood

■    if you are taking allopurinol, (used for the treatment of gout), or procainamide, (used to treat abnormal heart rhythms). If you develop an infection (symptoms may be high temperature or fever), you should let your doctor know immediately. Your doctor may take a blood sample from time to time to check your white blood cell count

■    if you have a history of ‘angioedema' while taking other medicines. The signs may have been rash, itching, swelling of the extremities, face, lips, mouth or throat (see Section 4 “Possible side effects”).

ACE inhibitors cause a higher rate of angioedema in black patients than in non-black patients

■    if you are going to have tests to check your parathyroid function

■    if you have kidney problems, have had a recent kidney transplantation, are a dialysis patient, only have one functioning kidney or are taking water tablets (diuretics)

■    if you have blood disorders or liver problems

■    if you are taking potassium supplements or potassium containing salt substitutes

■    if you are taking other medicines that can affect the level of potassium in your blood, such as heparin (an anticoagulant)

■    if you have high levels of potassium in the blood

■    if you have collagen vascular disease such as systemic lupus erythematosus (SLE) or scleroderma, which may be associated with skin rashes, joint pain and fever

■    if you are taking immunosuppressant therapy (used for the treatment of autoimmune disorders such as rheumatoid arthritis or following transplant surgery)

■    if you are taking lithium, used for the treatment of some psychiatric illnesses (see “Other medicines and Enalapril maleate / Hydrochlorothiazide” section)

■    if you have allergy problems or asthma

■    if you think you are (or might become) pregnant.

This medicine 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 are taking any of the following medicines used to treat high blood pressure:

-    an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.

-    aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

(See also information under the heading “Do not take Enalapril maleate / Hydrochlorothiazide”)

Elderly or malnourished patients should be particularly careful when using Enalapril maleate / Hydrochlorothiazide.

If you are about to have any of the following procedures, you should tell your doctor who is treating you that you are taking Enalapril maleate / Hydrochlorothiazide:

■    any surgery or receive anaesthetics (even at the dentist)

■    a treatment called LDL apheresis, to remove cholesterol from your blood using a machine

■    desensitisation treatment, to reduce the effect of an allergy to bee or wasp stings.

Routine tests

When you first start to take Enalapril Maleate and Hydrochlorothiazide, your doctor will monitor your blood pressure frequently to ensure you have been given the correct dose. In addition, for some patients the doctor may want to do some tests to measure your potassium, sodium, magnesium, creatinine and liver enzyme levels.

Tell your doctor if you have or will take an anti-doping test, as Enalapril maleate / Hydrochlorothiazide contains an active ingredient that can produce a positive result.

Children

This medicine is not recommended for use in children.

Other medicines and Enalapril maleate / Hydrochlorothiazide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Medicines which may interact with or be affected by

Enalapril maleate / Hydrochlorothiazide:

■    potassium-sparing water tablets (diuretics) such as spironolactone,eplerenone, triamterene or amiloride, potassium supplements, or potassium-containing salt substitutes. Enalapril maleate / Hydrochlorothiazide may increase the levels of potassium in your blood leading to high potassium levels. This causes few signs and is usually seen by a test.

■    water tablets (diuretics), used to treat high blood pressure including kaliuretic diuretics such as furosemide, thiazides, bumetanide

■    other medicines used to treat high blood pressure, such as nitroglycerine, nitrates, and vasodilators

■    pain killers such as morphine or anaesthetics

■    tricyclic antidepressants such as amitriptyline, used for depression, antipsychotics such as phenothiazines, used for severe anxiety

■    lithium, used for the treatment of some psychiatric illnesses

■    non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin (>3000 mg/day) or indomethacin

■    gold injection (sodium aurothiomalate), a medicine used to treat rheumatic arthritis

■    medicines such as ephedrine, used in some cough and cold remedies, or noradrenaline and adrenaline for low blood pressure, shock, cardiac failure, asthma or allergies

■    blood sugar lowering medicines, such as insulin and metformin

■    barbiturates (sedatives used for sleeplessness or epilepsy)

■    cholestyramine or colestipol, used to help control cholesterol levels

■    corticosteroids, used to treat certain conditions such as rheumatism, arthritis, allergic conditions, asthma or certain blood disorders

■    ACTH, used to test whether your adrenal glands are working properly

■    muscle relaxants (e.g. tubocurarine chloride, medicines for relaxing muscles that are used in operations)

■    allopurinol, probenecide, sulfinpyrazone, used to treat gout

■    medicines such as atropine or biperiden which are used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms and as an aid to anesthesia

■    medicines to treat cancer, such as cyclophosphamide or methotrexate

■    methyldopa, used to treat high blood pressure

■    ciclosporin medicines to prevent rejection reactions after organ or bone marrow transplants

■    cardiac glycosides (e.g. digoxin, medicines for strengthening the heart)

■    medicines that as a side effect cause abnormalities in the stimulus conduction in the heart such as:

-    medicines to treat abnormal heart rhythms e.g. quinidine, hydroquinidine, disopyramide, procainamide, amiodarone, sotalol, dofetilide and ibutilide

-    some medicines for psychosis e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpride, sultopride, amisulpride, tiapride, pimozide, haloperidol and droperidol

-    other medicines e.g. bepridil (for angina), cisapride (for heartburn), diphemanil (for stomach ulcers), erythromycin IV (for bacterial infections), halofantrin (for malaria), mizolastin and terfenadine (antihistamines for hayfever and skin reactions), pentamidine (for pneumonia) and vincamine IV (vasodilator)

■    calcium salts and vitamin D, elevated calcium levels in the blood

■    carbamazepine, drug used primarily in the treatment of epilepsy and bipolar disorder

■    amphotericin B, medicines against fungal infections

■    laxatives, medicines to promote defecation

■    iodinated contrast media, enhances the visibility of vascular structures and organs during radiographic procedures

■    carbenoxolone, used to treat stomach ulcers

Your doctor may need to change your dose and/or to take other precautions:

■    If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Enalapril maleate / Hydrochlorothiazide” and “Warnings and precautions”)

Taking Enalapril maleate / Hydrochlorothiazide with food, drink and alcohol

■    These tablets can be taken with or without food.

■    Drinking alcohol together with this medicine may increase the blood pressure-lowering effect and may cause dizziness, light-headedness or fainting.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Enalapril maleate / Hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Enalapril maleate / Hydrochlorothiazide. Enalapril maleate / Hydrochlorothiazide is not recommended during 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. Enalapril maleate / Hydrochlorothiazide is not recommended for mothers who are breast-feeding. Both enalapril and hydrochlorothiazide are excreted into breast milk.

Hydrochlorothiazide can also reduce the amount of milk and cause other side effects.

Driving and using machines

Dizziness, feeling of 'spinning' and tiredness have been reported by people taking Enalapril maleate / Hydrochlorothiazide. If you experience either of these symptoms, it may be necessary to avoid driving or operating machinery (see also Section 4 "Possible side effects").

Enalapril maleate / Hydrochlorothiazide tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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