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PACKAGE LEAFLET: INFORMATION FOR THE USER SZ00000LT000

Enalapril maleate/Hydrochlorothiazide 20 mg/12.5 mg Tablets

Enalapril maleate / Hydrochlorothiazide (HCT)

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 any further questions, ask your doctor or pharmacist.

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

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2.    Before you take Enalapril maleate/Hydrochlorothiazide

3.    How to take Enalapril maleate/Hydrochlorothiazide

4.    Possible side effects

5.    How to store Enalapril maleate/Hydrochlorothiazide

6.    Further information

Enalapril belongs to a group of medicines called angiotensin converting enzyme inhibitors (ACE inhibitors) and lowers blood pressure by widening the blood vessels.

Hydrochlorothiazide belongs to a group of drugs called diuretics (“water tablets”) and lowers blood pressure by increasing urine output.

Enalapril maleate/Hydrochlorothiazide tablets contain a combination of enalapril and hydrochlorothiazide and are used as a treatment for high blood pressure when treatment with enalapril as a single agent on its own has proven insufficient.

Your doctor may also prescribe Enalapril maleate/ Hydrochlorothiazide tablets instead of separate tablets of the same doses of enalapril and hydrochlorothiazide.

This fixed dose combination is not suitable for initial therapy.

Do not take Enalapril maleate/Hydrochlorothiazide:

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

•    if you are allergic (hypersensitive) 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)

•    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

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

•    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 Enalapril maleate/ Hydrochlorothiazide:

•    if you have narrowing of the arteries (atherosclerosis), cerebrovascular problems such as a stroke or transient ischemic attack (TIA, a “mini-stroke”)

•    if you suffer from a disease, distinguished by reduced blood supply of the heart muscle, usually due to coronary blood vessel diseases (ischemic heart disease)

•    if you have heart failure

•    if you have low blood pressure, are on a salt restricted diet or are taking diuretics (“water tablets”)

•    if you have abnormal levels of water and minerals in your body (fluid/electrolyte imbalance) distinguished by nausea, abdominal cramping, and/or vomiting, headache, edema (swelling), muscle weakness and/or tremor amongst others

•    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 a narrow of the artery to the only functioning kidney, have a kidney transplantation or other forms of a heart problem called outflow obstruction

•    if you undergo LDL apheresis (removal of cholesterol from the blood by a machine)

•    if you undergo desensitization therapy to some insect venoms, such as bee or wasp stings

•    if you have diabetes

•    if you suffer from gout, have high levels of uric acid in your blood or are being treated with allopurinol

•    if you need to have an anesthetic

•    if you have recently suffered from prolonged, violent vomiting and/or serious diarrhoea

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

•    if you have or have had liver or kidney problems, or you have narrow arteries to your kidneys (renal artery stenosis) or only have one functioning kidney, or you are undergoing dialysis

•    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 take an agent capable of suppressing immune responses (immunosuppressant) or procainamide, which is used to treat heart rhythm disturbances amongst others

•    if you have allergy problems or asthma.

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

•    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”.

You must tell your doctor if you think you are (or might become) pregnant. Enalapril maleate/Hydrochlorothiazide 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). Breast-feeding is not recommended when you take Enalapril maleate/Hydrochlorothiazide

Enalapril maleate/Hydrochlorothiazide is not generally recommended if the following apply, so talk to your doctor before starting to take this medicine:

-    if you have recently had a kidney transplant

-    if you have too much potassium in the blood, your potassium values should be supervised during the treatment. Risk factors for raised potassium values include a reduced kidney function, age (> 70 years), dehydration, acute heart failure, acidification of the blood (metabolic acidose), diabetes (diabetes mellitus), concurrent taking of potassium sparing water tablet (diuretic), a potassium supplement or potassium-containing salt substitutes or taking medicines that increase the concentration of potassium in the blood. It is also possible that you can develop low levels of potassium in your blood distinguished by elevated blood pressure, disturbed heart rhythm etc. (e.g. to be caused by drug interactions, excessive loss of urine etc.).

Please refer also to “Other medicines and Enalapril maleate/Hydrochlorothiazide ” below.

Talk to your doctor if you are an athlete taking a doping test, as Enalapril maleate/Hydrochlorothiazide contains an active ingredient that can cause positive results in a doping test. Elderly (> 70 years) or malnourished patients should be particularly careful when using Enalapril maleate/ Hydrochlorothiazide.

Enalapril maleate/Hydrochlorothiazide may be less effective in Black people.

This medicine is not recommended for use in children.

While taking Fnalapril maleate/Hydrochlorothiazide if you develop any of the following symptoms you should let your doctor know immediately:

•    You feel dizzy after your first dose. A few people react to their first dose or when their dose is increased by feeling dizzy, weak faint and sick.

•    Sudden swelling of the lips and face neck, possibly also hands and feet, or wheezing or hoarseness. This condition is called angioedema. This may occur at any time during treatment. ACE inhibitors cause a higher rate of angioedema in black patients than in non-black patients.

•    High temperature, sore throat or mouth ulcers (these may be symptoms of infection caused by the lowering of the number of white blood cells).

•    Yellowing of the skin and whites of eyes (jaundice) that may be sign of liver disease.

•    A dry cough which is persistent for a long time. Cough has been reported with the use of ACE inhibitors but may be also a symptom of other upper respiratory track disease.

Other medicines and Enalapril maleate/ Hydrochlorothiazide

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

Enalapril maleat/hydrochlorothiazide and other medicines can influence each other's effect and side effects:

•    potassium supplements, or potassium-containing salt substitutes

•    diuretics (“water tablets”) which are used to treat high blood pressure including potassium-sparing diuretics such as spironolactone, triamterene or amiloride.

•    other medicines used to treat high blood pressure.

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”).

•    anesthetics and medicines for mental disorders or depressions, medicines to treat psychoses, tricyclic antidepressants or sedatives

•    lithium (medicine for treatment of psychic disorders)

•    painkillers and anti-inflammatory medicines, such as acetylsalicylic acid or indomethacin

•    gold injections (sodium aurothiomalat), a medicine to injection against rheumatic arthritis

•    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.

•    blood sugar lowering medicines, such as insulin or those taken orally.

•    colestyramine resin and colestipol, active substances for lowering blood lipid values

•    corticosteroids, anti-inflammatory hormone-like substances

•    corticotropin (ACTH), it is used mainly 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, medicinal products 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 cyclophoshamide or methotrexate

•    medicines that inhibit your body's immune system, medicines to prevent rejection reactions after organ or bone marrow transplants such as ciclosporin

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

•    medicines that as a side effect may cause abnormalities in the stimulus conduction in the heart such as medicines for disturbances for heart rhythm, some medicines for psychosis and other medicines such as drugs used to treat bacterial infections

•    calcium salts and vitamin D, elevated calcium levels in the blood (can lead to gastrointestinal disorders, excessive thirst, excessive urination, tiredness, weakness and decrease in weight)

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

•    amphotericin B, medicines against fungal infections

•    laxatives, medicines to promote defection

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

•    barbiturates, medicines that act as central nervous system depressant resulting in sedation

•    opioid analgesics, strong pain killers with no antiinflammatory effect

•    carbenoxolone, medicine to treat inflammation of the intestinal tract

•    salicylates, medicines to treat pain and/or inflammatory diseases

Taking Enalapril maleate/Hydrochlorothiazide with food and drink

Enalapril maleate/Hydrochlorothiazide can be taken without regard to meals. Drinking alcohol together with this medicine can increase the blood pressure-lowering effect (and can then cause dizziness on standing up, among other things).

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any 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.

Continued on the next page >>

Enalapril maleate/Hydrochlorothiazide 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. Enalapril maleate/Hydrochlorothiazide is not recommended for mothers who are breast-feeding.

Driving and using machines

Dizziness and tiredness have been reported by people taking Enalapril maleate / Hydrochlorothiazide. If you experience either of these do not drive a car and do not operate machinery (see also “4. Possible side effects”).

Important information about some of the ingredients of Enalapril maleate/Hydrochlorothiazide

Patients who are intolerant to lactose should note that Enalapril maleate/Hydrochlorothiazide tablets contain a small amount of 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.

Always take Enalapril maleate/Hydrochlorothiazide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults

The usual dose is one tablet taken once a day.

Elderly

Your doctor may adjust the dose of enalapril and hydrochlorothiazide carefully.

Kidney problems

Your doctor will adjust the dose of enalapril and hydrochlorothiazide carefully.

Method of administration

The tablets should be swallowed with a drink of water. Enalapril maleate/Hydrochlorothiazide can be taken with meal or to empty stomach.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

If you take more Enalapril maleate/Hydrochlorothiazide than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, seek medical advice immediately. An overdose is likely to cause low blood pressure, an excessively fast or slow heart beat, palpitations (a feeling of unduly rapid or irregular heart beat), shock, rapid breathing, cough, feeling and being sick, cramps, dizziness, feeling sleepy and confused or anxious, excessive urination or not being able to urinate. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Enalapril maleate/ Hydrochlorothiazide

Do not take a double dose to make up for a forgotten tablet, take your next dose at the normal time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you stop taking Enalapril maleate/Hydrochlorothiazide

The treatment of hypertension is a long term treatment and interruption of treatment must be discussed with the doctor. Interruption or stopping your treatment could cause your blood pressure to increase.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Enalapril maleate/Hydrochlorothiazide can cause side effects, although not everybody gets them.

If you experience the following, stop taking Enalapril maleate/Hydrochlorothiazide and tell your doctor immediately or go to the emergency department of your nearest hospital:

•    A severe allergic reaction called angioedema (rash, itching, swelling of the extremities, face, lips, mouth or throat that may cause difficulty in swallowing or breathing). This is a serious and common (affecting more than 1 out of 100 patients and less than 1 out of 10 patients) side effect. You may need urgent medical attention or hospitalization.

•    Jaundice (yellowing of the skin and the whites of the eyes). This is a potentially serious but rare (affecting more than 1 out of 10000 patients and less than 1 out of 1000 patients) side effect indicative of inflammation of the liver. You may need urgent medical attention or hospitalization.

Enalapril maleate/Hydrochlorothiazide commonly causes low blood pressure which may be associated with feelings of light-headedness and weakness. In some patients, this may occur after the first dose or when the dose is increased. If you experience these symptoms, you should contact your doctor immediately.

Enalapril maleate/Hydrochlorothiazide rarely causes a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.

A dry cough, which may persist for a long time, has been reported very commonly (in more than 1 out of 10 patients) with the use of Enalapril maleate/Hydrochlorothiazide and other ACE inhibitors, but may be also a symptom of other upper respiratory tract disease. You should contact your doctor if you develop this symptom.

The following side effects have also been reported:

Very common (more than 1 out of 10 patients)

•    blurred vision

•    dizziness

•    nausea

•    weakness

Common (more than 1 out of 100 patients and less than 1 out of 10 patients)

•    low level of potassium in the blood, which can cause muscle weakness, twitching or abnormal heart rhythm

•    high level of fat or uric acid in the blood

•    headache, depression

•    fainting, low blood pressure associated with changes in posture (such as feeling light-headed or weak when you stand up after lying down), chest pain, abnormal heart rhythm, excessively fast heart beat (tachycardia)

•    shortness of breath

•    diarrhoea, abdominal pain

•    a distorted sense of taste

•    rash

•    tiredness

•    high level of potassium in the blood, which can cause an abnormal heart rhythm; increase in the amount of creatinine in the blood

•    muscle cramps

Uncommon (more than 1 out of 1000 patients and less than 1 out of 100 patients)

•    reduction in the number of red blood cells, which can make the skin pale and cause weakness or breathlessness (anaemia)

•    hypoglycaemia (low blood sugar levels)

(see “Take special care with Enalapril maleate /

Hydrochlorothiazide” in section 2)

•    low level of magnesium in the blood

•    uric acid crystals in the joints (gout)

•    confusion, sleepiness, insomnia, nervousness, tingling feeling or numbness, vertigo, decreased sexual desire

•    palpitations (a sensation of a fast or particularly strong or irregular heart beat)

•    heart attack or cerebrovascular accident (“mini-stroke”) (mainly in patients suffering from low blood pressure)

•    runny nose, sore throat, hoarseness, difficulty breathing, wheezing

•    intestinal obstruction, inflammation of the pancreas which causes severe pain in the abdomen and

back (pancreatitis), vomiting, indigestion, constipation, loss of appetite, stomach irritation, dry mouth, peptic ulcer, flatulence

•    sweating, itching, hives, hair loss

•    joint pain

•    kidney problems, protein in the urine

•    impotence

•    hot flushes, ringing in the ears

•    feeling unwell, fever

•    low levels of sodium in the blood, which can cause tiredness and confusion, muscle twitching, fits or coma, also leading to dehydration and low blood pressure that makes you feel dizzy when you stand up; increase in the amount of urea in the blood

Rare (more than 1 out of 10000 patients and less than 1

out of 1000 patients)

•    reduction in the number of white blood cells, which makes infection more likely, reduction in the number

of other blood cells, changes in blood composition, poor production of bone marrow, disease of the lymph nodes, autoimmune disease, in which the body attacks itself.

•    strange dreams, sleep disorders

•    paresis

•    Raynaud's syndrome, a blood vessel disorder which may cause your fingers and toes to tingle, and turn pale, then bluish, then reddish.

•    lung problems including pneumonia, inflammation of the lining of the nose causing the nose to run (rhinitis)

•    mouth ulcers, inflammation of the tongue

•    liver problems, inflammation of the gallbladder

•    skin rash, severe blisters, redness of the skin, Stevens Johnson syndrome (blistering of the skin, mouth, eyes and genitals), skin looking as if it were burnt and peeling off, sensitivity of the skin to light, skin conditions with red scaly patches over the nose and cheeks (lupus erythematosus), pemphigus (a condition causing blisters and lesions normally starting in the mouth, nettle rash, hair loss and itching). Sometimes, skin problems may be accompanied by fever, serious inflammation, inflammation of blood vessels, muscle pain and/or joint pain, changes in blood composition and an increased sedimentation rate (a blood test used to detect inflammation).

•    reduced urine production

•    inflammation in the kidneys (interstitial nephritis)

•    breast enlargement including in men

•    increase in the amount of enzymes and waste products produced by the liver

•    increased blood sugar levels

Very rare (less than 1 out of 10000 patients)

•    swelling in the intestines

•    high levels of calcium in the blood (see “Take special care with Enalapril maleate / Hydrochlorothiazide” in section 2)

Not known (cannot be estimated from available data)

•    inappropriate antidiuretic hormone secretion (known as SIADH) causing amongst others the general symptoms confusion, nausea, altered mood, seizures and loss of consciousness

Further side effects:

•    inflammation of a salivary gland

•    excretion of glucose into the urine (glycosuria)

•    decreased appetite, light-headedness

•    predominance of yellow in vision due to a yellowing of the optic media of the eye (xanthopsia)

If any of the side effects gets serious, or if you notice any

side effects not listed in this leaflet, please tell your doctor

or pharmacist.

Keep out of the reach and sight of children.

Do not store above 30°C. Store in the original package.

Do not use Enalapril maleate/Hydrochlorothiazide after the expiry date that is stated on the outer packaging.

Do not use after the expiry (EXP) date which is stated on the label.

The expiry date refers to the last day of the month. 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.

What Enalapril maleate/Hydrochlorothiazide contains

•    The active substances are enalapril maleate and hydrochlorothiazide.

•    Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.

•    The other ingredients are sodium hydrogen carbonate, maize starch, lactose monohydrate, calcium hydrogen phosphate dehydrate, talc, magnesium stearate.

What Enalapril maleate/Hydrochlorothiazide looks like and contents of the pack

Enalapril maleate/Hydrochlorothiazide 20 mg/12.5 mg tablets are white, oval, biconvex, with a break-line on one side of the tablet and the stamp “E H” on the other side of the tablet.

Enalapril maleate/Hydrochlorothiazide 20 mg/12.5 mg tablets are available in pack sizes of 10, 14, 20, 28, 30, 49, 50, 50x1,56, 60, 98, 100 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Salutas Pharma GmbH Otto-von-Guericke-Alle 1,39179 Barleben Germany

This leaflet was last revised in 11/2014.

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