Package leaflet: Information for the user Teva Lisinopril 2.5 mg, 5 mg, 10 mg and 20 mg Tablets

Lisinopril dihydrate

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 illiness are the same as yours.

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

What is in this leaflet:

1.    What Teva Lisinopril is and what it is used for

2.    What you need to know before you take Teva Lisinopril

3.    How to take Teva Lisinopril

4.    Possible side effects

5.    How to store Teva Lisinopril

6.    Contents of the pack and other information

1.    What Teva Lisinopril is and what it is used for

Teva Lisinopril belongs to a group of drugs called angiotensin-converting enzyme (ACE) inhibitors. These tablets are vasodilators (drugs which widen the blood vessels), making it easier for the heart to pump blood around the body. This helps lower blood pressure.

Teva Lisinopril is used:

•    to treat a condition known as symptomatic heart failure where the heart no longer pumps blood as effectively as it should

•    to treat high blood pressure

•    to help prevent any more heart problems in patients who have recently had a heart attack

•    to treat kidney disease resulting from diabetes and high blood pressure.

Lisinopril is recommended in children (above 6 years old) only for the treatment of high blood pressure (hypertension).

Lisinopril should not be used in children with severe kidney impairment.

2.    What you need to know before you take Teva Lisinopril Do not take Teva Lisinopril :

•    if you are allergic to lisinopril dihydrate, any other angiotensin converting enzyme (ACE) inhibitor or any of the other ingredients of this medicine (listed in section 6).

•    if you have suffered an allergic reaction to any other ACE inhibitors e.g. captopril, enalapril, which led to swelling of the face, lips, tongue and/or throat

•    if you or a member of your close family have a history of face or body swelling (angioneurotic oedema) which may be unrelated to the use of medicines

•    if you are more than 3 months pregnant. (It is also better to avoid Teva Lisinopril in early pregnancy -see section 2: Pregnancy and breast-feeding.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Teva Lisinopril:

•    if you have narrowing of the arteries leading to the kidneys, any other kidney problems or are undergoing dialysis

•    if you recently suffered from diarrhoea or vomiting

•    if you have been on a low-salt diet

•    if you have low blood pressure (you may notice this as dizziness or light-headedness especially when standing)

•    if you have liver disease

•    if you have insufficient blood supply to your heart (ischaemic heart disease)

•    if you have insufficient blood supply to your brain (cerebrovascular disease)

•    if you have aortic stenosis or outflow tract obstruction (a narrowing of the main artery leading from your heart), a narrowing of the heart valves (mitral valve stenosis) or an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy)

•    if you have a collagen vascular disease e.g. systemic lupus erythematosus, an allergic condition which causes joint pain, skin rashes and fever

•    if you are to undergo desensitisation treatment (e.g. to reduce the effects of an allergy to wasp or bee stings)

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

•    if you recently had a heart attack and are suffering from low blood pressure or kidney    problems

•    if you have been told you have severe congestive heart failure.

•    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 Teva Lisinopril’.

You must tell your doctor if you think you are (or might become) pregnant. Teva Lisinopril 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 section 2: Pregnancy and breast-feeding).

If you are to have an operation requiring an anaesthetic (including treatment at the dentist), tell the doctor or dentist that you are taking Teva Lisinopril tablets.

Other medicines and TEVA Lisinopril

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

Talk to your doctor if you are taking any of the following:

•    other drugs to reduce blood pressure such as diuretics (“water tablets”) e.g. amiloride as your blood pressure may become too low

•    anti-psychotics e.g. chlorpromazine (to treat mental disorders) or tricyclic antidepressants e.g. amitriptyline, which may cause low blood pressure

•    lithium, as lithium levels may be increased

•    insulin or tablets for diabetes as the risk of hypoglycaemia (low blood sugar) may be increased

•    potassium-containing salt substitutes or potassium supplements as Teva Lisinopril may increase potassium levels

•    medicines that contain gold, such as sodium aurothiomalate, which may be given to you as an injection .

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 Teva Lisinopril’ and ‘Warnings and precautions’).

Tell your doctor before taking Teva Lisinopril in combination with any of the following as they may reduce the effectiveness of Teva Lisinopril:

•    non-steroidal anti-inflammatory agents (a type of painkiller, e.g. indomethacin); kidney function may also be affected

•    sympathomimetic drugs e.g. ephedrine, adrenaline or isoprenaline. Ephedrine may be present in medicines for colds and nasal stuffiness

Tell your doctor before taking Teva Lisinopril in combination with any of the following as they may increase the risk of the blood disorder leucopenia (a reduction in the number of white blood cells) occurring:

•    procainamide (to treat abnormal heart rhythms)

•    allopurinol (to treat gout)

•    immunosuppressive drugs (used following organ transplant)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or 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 Teva Lisinopril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Teva Lisinopril. Teva Lisinopril 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.

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Teva Lisinopril 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 newborn, or was born prematurely.

Driving and using machines

Teva Lisinopril may cause dizziness or make you feel light headed especially if you are taking Teva Lisinopril tablets for the first time. If affected do not drive or operate machinery.

Teva Lisinopril contains mannitol

Teva Lisinopril contains mannitol which may have a mild laxative effect.

3. How to take Teva Lisinopril

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed preferably with a glass of water at approximately the same time each day. Teva Lisinopril can be taken with or without food.

The recommended dose is:

Adults and the elderly

•    High blood pressure

Treatment is generally started with one 10 mg tablet daily. Some patients, such as those with kidney problems may require a lower starting dose. The dose will then be gradually increased every 2-4 weeks until your blood pressure is controlled. The usual long-term dosage is 20 mg once daily.

•    Heart failure

Treatment is generally started in hospital with one 2.5 mg tablet daily. The dose will then be gradually increased until your symptoms are controlled. The usual long-term dosage is 5-35 mg once daily. The dose of any diuretics (“water tablets”) that you are taking may be reduced before starting treatment with Teva Lisinopril.

•    After a heart attack

The usual dosage is 5 mg on the first and second days, then 10 mg taken once daily which would normally continue for six weeks. Patients that have a low blood pressure (hypotension) are usually given a lower dose of 2.5 mg with a maintenance dose of 5 mg with temporary reductions to 2.5 mg if needed. If prolonged low blood pressure occurs your doctor may withdraw your Teva Lisinopril treatment.

• Kidney disease resulting from diabetes and high blood pressure

Treatment is generally started with one 10 mg tablet daily. The dose will then be gradually adjusted according to your needs. The usual long-term dosage is 10-20 mg once daily.

Some Afro-Caribbean patients may require higher doses of Teva Lisinopril to obtain adequate control of symptoms.

Children under 6 years

The use of Lisinopril is not recommended.

Children and adolescents aged 6 to 16 years

The dose depends on your weight. The usual starting dose is between 2.5mg and 5mg once daily, which can

be increased to a maximum of 20mg to 40mg once daily. Patients with

kidney problems should take a lower dose. Your doctor will decide the correct dose for

you.

If you take more Teva Lisinopril 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 contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause severe lowering of blood pressure, changes in heart rate, dizziness, anxiety, cough, disturbances in the salt balance of the blood and failure of the kidneys to function, symptoms of which are drowsiness, nausea, vomiting, breathlessness and fainting. 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 Teva Lisinopril

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.

If you stop taking Teva Lisinopril

Do not stop taking your medicine without talking to your doctor first even if you feel better.

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

4. Possible side effects

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

Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if any of the following happen:

•    a severe allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

•    severe blistering, bleeding of the lips, eyes, mouth, nose and genital areas (Stevens-Johnson syndrome)

These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.

If you are taking Teva Lisinopril tablets for the first time you may feel dizzy or light-headed for a short time afterwards. This is unlikely to happen if you are taking the tablets regularly. Tell your doctor if you are worried.

The following side effects have been reported at the approximate frequencies shown:

Common (may affect up to 1 in 10 people):

•    headache

•    dizziness or light headedness, especially on standing up

•    vomiting, diarrhoea

•    cough

•    problems with kidney function.

Uncommon (may affect up to 1 in 100 people):

•    palpitations (awareness of overactivity of the heart), fast heart rate

•    heart attacks or stroke in susceptible patients (possibly due to an excessive drop in blood pressure)

•    poor circulation which makes the fingers and toes pale, cold and numb

•    pins-and-needles

•    vertigo (a sensation that your surroundings are spinning, either up and down or from side to side)

•    mood swings, changes in your sense of taste

•    feeling sleepy or other sleeping problems such as inability to sleep

•    runny nose

•    abdominal pain, indigestion, feeling sick

•    skin rash, itching

•    tiredness, loss of muscle    strength    (asthenia)

•    high potassium levels in the blood

•    increased levels of liver    enzymes    in the blood

•    impotence (an inability to get or keep an erection).

Rare (may affect up to 1 in 1,000 people):

•    a reduction in red blood cells (anaemia), symptoms may include tiredness, pale skin

•    acute kidney failure resulting in nausea, vomiting, lethargy, drowsiness

•    confusion

•    dry mouth

•    skin rash with dark red, raised, itchy bumps (hives)

•    hair loss

•    psoriasis (condition causing red, flaky, crusty patches on the skin)

•    severe allergic reactions

•    development of breasts    in men

•    changes to some of the cells or other parts of your blood. Your doctor may occasionally take blood samples to check if Teva Lisinopril has had any effect on your blood

•    syndrome of inappropriate antidiuretic hormone secretion (condition where body makes too much antidiuretic hormone).

Very rare (may affect up to 1 in 10,000 people):

•    blood disorders (which may be characterised by unusual bleeding or unexplained bruising, fever or chills, sore throat, ulcers in the mouth or throat)

•    low blood sugar levels (hypoglycaemia)

•    passing less urine than usual or none at all

•    wheezing, bronchitis, sinus problems, inflammation of the lungs

•    jaundice (symptoms of which are yellowing of the skin and whites of the eyes), inflammation of the liver (symptoms may include feeling tired, loss of appetite, fever, jaundice)

•    inflammation of the pancreas (symptoms may include feeling or being sick, severe abdominal or back pain)

•    sweating

•    blisters which may burst easily becoming raw and painful or may bleed, red itchy spots, or peeling skin leaving red, raw patches over the body

•    a combination of symptoms including fever, blood disorders or pain in the muscles and joints, sensitivity to sunlight and a severe reduction in white blood cells making infection more likely.

Not known (frequency cannot be estimated from the available data):

•    symptoms of depression

•    fainting.

A higher incidence of angioedema (facial or body swelling) has been reported in the Afro-Caribbean population.

While taking Teva Lisinopril there may be changes in the chemistry of your blood and urine. Your treatment may therefore be monitored by regular tests.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Teva Lisinopril

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original container. Do not transfer to another container. Do not use this medicine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information What Teva Lisinopril contains

•    The active substance is lisinopril (as dihydrate), 2.5 mg, 5 mg, 10 mg, or 20 mg.

•    The other ingredients are pregelatinised starch, maize starch, calcium hydrogen phosphate, mannitol and magnesium stearate.

What Teva Lisinopril looks like and contents of the pack

•    Teva Lisinopril 20 mg Tablets are white oval tablets marked “LSN 20”on one side and a breakline on the other

•    Teva Lisinopril 10 mg Tablets are white oval tablets, marked “LSN 10” on one side and a breakline on the other.

•    Teva Lisinopril 5 mg Tablets are white oval tablets, marked “LSN 5” on one side and a breakline on the other

•    Teva Lisinopril 2.5 mg Tablets are white oval tablets, marked “LSN 2.5” on one side and plain on the other.

•    The product is available in blister packs of 28, 30, 50 and 100 tablets and hospital packs of 50 (EAV) and 100.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva Pharma BV, Swensweg 5, 2031 GA Haarlem, The Netherlands

Company responsible for manufacture:

Pharmachemie BV, Haarlem, The Netherlands or

Teva Pharmaceutical Works Private Limited Company, H-4042 Debrecen, Pallagi str. 13, Hungary This leaflet was last revised in July 2015 PL 14776/0056-9

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