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Package leaflet: Information for the user

Innozide® 20/12.5mg Tablets

enalapril maleate/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor of pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Innozide is and what it is used for

2.    What you need to know before you take Innozide

3.    How to take Innozide

4.    Possible side effects

5.    How to store Innozide

6.    Contents of the pack and other information

1. What Innozide is and what it is used for

Innozide contains enalapril maleate 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. Innozide is used to treat high blood pressure (hypertension). Taking both medicines that Innozide contains can increase their effect compared to taking just one.

2. What you need to know before you take Innozide

Do not take Innozide:

•    if you are allergic to enalapril maleate, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).

•    if you have previously been treated with a medication in the same group of drugs as this medicine (ACE inhibitors) and have had allergic reactions with swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing. You should not take this medicine if you have had these types of reactions without a known cause, or if you have been diagnosed with hereditary or idiopathic angioedema.

•    if you are allergic to any sulfonamide-derived drugs. (Ask your doctor if you are not sure what sulfonamide-derived drugs are.)

•    if you are not passing urine

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

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

•    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 kidney or liver problems

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warning and precautions

Talk to your doctor or pharmacist before taking Innozide

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

•    if you have blood disorders or liver problems

•    if you are on a salt restricted diet, or have suffered from excessive vomiting or diarrhoea recently

•    if you have a heart condition called 'aortic stenosis', 'hypertrophic cardiomyopathy' or 'outflow obstruction'

•    if you have collagen vascular disease, are taking immunosuppressant therapy (used for the treatment of autoimmune disorders such as rheumatoid arthritis or following transplant surgery)

•    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 itching, nettle rash, wheezing or swelling of your hands, throat, mouth or eyelids

•    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 are taking potassium supplements or potassium containing salt substitutes

•    if you are taking lithium, used for the treatment of some psychiatric illnesses

•    if you have been told by your doctor that you have an intolerance to some sugars.

•    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).

•    tell your doctor if you are taking either of the following medicines used to treat high blood pressure:

-    an angiotensin II receptor blocker (ARB) (also known as sartans - for

example valsartan, telmisartan, irbesartan etc), in particular if you    m B"iBTnii“i’fTTi

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 Innozide."

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

•    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 Innozide, 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 since this medication can produce a positive result.

Children and adolescents

Innozide is not recommended for use in children.

Other medicines and Innozide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.

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

In general, Innozide can be taken with other drugs. For prescribing the correct dose of Innozide, it is especially important for your doctor to know whether you are taking any of the following medicines:

•    an angiotensin II-receptor blocker (ARB) or aliskiren (see also information under the headings "Do not take Innozide" and "Warnings and precautions"),

•    potassium sparing water tablets (diuretics) such as spironolactone, eplerenone, triamterene or amiloride, potassium supplements, or potassium-containing salt substitutes. Innozide 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) such as thiazides, furosemide, bumetanide,

•    other medicines that lower blood pressure, such as nitroglycerine, nitrates, and vasodilators,

•    lithium, used for the treatment of some psychiatric illnesses. Innozide should not be taken with this drug

•    barbiturates (sedatives used for sleeplessness or epilepsy),

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

•    pain killers such as morphine or anaesthetics, because your blood pressure may become too low,

•    cholestyramine or colestipol (used to help control cholesterol levels),

•    medicines used for, stiffness and inflammation associated with painful conditions, particularly those affecting your muscles, bones and joints:

-    including gold therapy which can lead to flushing of your face, feeling sick (nausea), vomiting and low blood pressure, when taken with Innozide, and

-    non-steroidal anti-inflammatory drugs (NSAIDs), for example diflunisal or diclofenac. They may prevent your blood pressure from being well controlled and may increase the level of potassium in your blood

•    medicines such as ephedrine, used in some cough and cold remedies, or noradrenaline and adrenaline used for low blood pressure, shock, cardiac failure, asthma or allergies. If used with Innozide these drugs may keep your blood pressure high,

•    ACTH (to test whether your adrenal glands are working properly),

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

•    allopurinol (used to treat gout),

•    ciclosporins (immunosuppressive agents used for autoimmune disorders),

•    medicines for the treatment of cancer,

•    antacids (used for indigestion relief),

•    procainamide, amiodarone or sotalol (used to treat abnormal heart rhythms),

•    digitalis (used to treat heart rhythm problems),

•    carbenoxalone (used to treat stomach ulcers),

•    excessive use of laxatives,

•    antidiabetic medicines such as insulin. Innozide may cause your blood sugar levels to drop even further if you take it with antidiabetics

•    an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) as coadministration could increase the risk for an allergic reaction called angioedema.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Innozide. Innozide with food, drink and alcohol

Most people take Innozide with a drink of water.

Innozide can be taken with or without food. However, if you drink alcohol while taking Innozide, it may cause your blood pressure to drop too much and you may experience dizziness, light-headedness or faintness. You should keep your alcohol intake to a minimum.

Pregnancy and breast-feeding Pregnancy

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. Your doctor will normally advise you to stop taking Innozide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine