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PATIENT INFORMATION LEAFLET LISINOPRIL 2.5 MG, 5 MG, 10 MG AND 20 MG TABLETS

Lisinopril Dihydrate

Please read all of this leaflet carefully before you start taking this medicine. It is an important source of information about your medicine and how to take it safely.

- 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 personally and you should 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 on this leaflet, please tell your doctor or pharmacist.

In This Leaflet:

1 What Lisinopril Tablets are and what they are used for.

2 Before you take Lisinopril Tablets.

3 How to take this medicine.

4 Possible side effects.

5 How to store this medicine.

6 Further information.

1. WHAT LISINOPRIL TABLETS ARE AND WHAT THEY ARE USED FOR

Lisinopril belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme inhibitors). Lisinopril works by widening your blood vessels, which helps reduce your blood pressure and makes it easier for your heart to pump blood to all parts of your body. Your doctor has prescribed Lisinopril for one of the following reasons:

• Your blood pressure is too high (hypertension).

• You have a heart condition known as symptomatic heart failure, where the heart does not pump your blood around your body as well as it should.

• You have had a heart attack (myocardial infarction) that may lead to a weakening of your heart. Lisinopril slows the weakening down.

• ou have kidney problems related to your 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. BEFORE YOU TAKE LISINOPRIL TABLETS

Do not take Lisinopril

• you are more than 3 month pregnant. (It is also better to avoid Lisinopril tablets in early pregnancy - see pregnancy section).

• you have previously been treated with a medicine in the same group of drugs as Lisinopril (ACE inhibitors) and have had an allergic reaction which caused swelling of the hands, feet, or ankles, the face, lips, tongue and/or throat with difficulty in swallowing or breathing or if you or a member of your family have had a similar reaction.

• you have ever had an allergic reaction to Lisinopril or to any of its other ingredients.

If you are not sure whether to start taking Lisinopril, talk to your doctor.

Take special care with Lisinopril

Tell your doctor if you have or have had any medical condition, especially the following:

• narrowing of the aorta (aortic stenosis), the kidney artery (renal artery stenosis) or the heart valves (mitral valve stenosis), or an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy, 'HOCM').

• ither health problems such as:

- Low blood pressure (you may notice this as dizziness or lightheadedness especially when standing).

- Kidney disease or you are undergoing dialysis.

- Liver disease.

- Blood vessel disease (collagen vascular disease) and/or treatment with allopurinol (for gout), procainamide (for abnormal heartbeats), immunosuppressants (medicines which suppress the body's immune response), diuretics and drugs which increase potassium levels (including heparin).

- Diarrhoea or vomiting.

- A salt-restricted diet or you are taking potassium supplements.

- You must tell your doctor if you think you are (or might become) pregnant. Lisinopril tablets 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)

Stop taking Lisinopril and seek medical attention immediately if

any of the following situations occur (an allergic reaction):

• you develop difficulty in breathing with or without swelling of the face, lips, tongue and/or throat.

• you develop swelling of the face, lips, tongue and/or throat which may cause difficulty in swallowing.

• you develop severe itching of the skin (with raised lumps).

Tell your doctor if you are undergoing/or will undergo desensitisation treatment for an allergy, for example, to insect stings. The desensitisation treatment reduces the effects of the allergy (e.g. bee or wasp stings) but sometimes it can cause a more severe allergic reaction if you are taking ACE inhibitors during the desensitisation treatment.

Tell your doctor if you are going into hospital for an operation.

Tell your doctor or dentist that you are taking Lisinopril before you are given a local or general anaesthetic. Lisinopril, combined with some anaesthetics, may cause a short-term drop in blood pressure soon after taking the tablets.

Take special care when taking the first dose of Lisinopril. It may

cause a greater fall in blood pressure than will occur following continued treatment. You may notice this as dizziness or lightheadedness and it may help to lie down. If you are concerned, please consult your doctor.

There is limited information on the safety and effectiveness of Lisinopril in children.

Taking Lisinopril with other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including herbal remedies, health foods or supplements that you have bought yourself. This also applies to medicines used some time ago. Some medicines may affect the actions of other medicines. Talk to your doctor if you are taking any of the following medicines:

• iuretics (water tablets including those which conserve potassium).

• 'ther medicines for your high blood pressure (antihypertensives).

• on-steroidal anti-inflammatory medicines (NSAIDs) such as indometacin and high doses of aspirin (more than 3 grams per day), which are used to treat arthritis or muscle pain.

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

• I edicines for mental disorders such as lithium, antipsychotics or tricyclic antidepressants.

• otassium tablets or potassium containing salt substitutes.

• I edicines for the treatment of diabetes, such as insulin or those taken orally, to lower blood sugar.

• Iedicines that stimulate the central nervous system (sympathomimetics). These include ephedrine, pseudoephedrine and salbutamol and may be found in some decongestants, cough/cold remedies and asthma medication.

• edicines that suppress the body's immune response (immunosuppressants), treatment with allupurinol (for gout) or procainamide (for abnormal heartbeats).

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 Lisinopril tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Lisinopril tablets. Lisinopril tablets are 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 breastfeeding. Lisinopril tablets are 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.

Safety and effectiveness have been studied in 6-16 year old children with high blood pressure. Lisinopril has not been studied in children under 6 years of age. Lisinopril is not recommended in children under the age of 6 years or in children with severe kidney problems.

Driving and using machines

Lisinopril may have a minor or moderate effect on ability to drive and use machines. If you experience side effects like dizziness or tiredness, you should not drive or operate machines.

If you are not sure whether you should start taking Lisinopril, contact your doctor.

3. HOW TO TAKE LISINOPRIL TABLETS

How much to take

Your doctor will tell you how many tablets to take each day. The dosage is individual and it is important that you take it as prescribed by your doctor. Your starting dose and long term dose will depend on your medical condition and whether you are taking any other medicines. Check with your doctor or pharmacist if you are unsure.

Children under 6 years

The use of Lisinopril is not recommended.

For raised blood pressure

The usual recommended starting dose is 10 mg taken once a day. The usual long-term dose is 20 mg taken once a day.

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.

For symptomatic heart failure

The usual recommended starting dose is 2.5 mg taken once a day. The usual long term dose is 5 to 35 mg taken once a day.

After a heart attack

The usual recommended starting dose is 5 mg on day 1 and day 2, then 10 mg taken once a day.

For problems related to diabetes

The usual dose is either 10 mg or 20 mg taken once a day.

How to take Lisinopril

• wallow the tablet with a drink of water.

• y to take your tablets at the same time each day. It does not matter if you take Lisinopril before or after food.

• o not stop taking your tablets if you are feeling well, unless your doctor tells you.

• emember, the first dose of Lisinopril may cause a greater fall in blood pressure than will occur following continued treatment. This is especially likely if patients are also taking diuretics. You may notice this as dizziness or lightheadedness and it may help to lie down. If concerned, please consult your doctor as soon as possible.

• you have the impression that the effect of Lisinopril is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

If you take more Lisinopril than you should

Contact your doctor or nearest hospital immediately if you have taken more than you should (overdose).

If you forget to take a dose

If you miss a dose, do not take an extra dose to make up for the missed dose. Just resume your usual schedule.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Lisinopril can cause side effects. Do not be alarmed by this list of possible side effects, you may not have any of them. Most patients do not notice any side effects. However if you do and they bother you, talk to your doctor.

Common side effects that may occur (between 1 in 10 and 1 in

100 patients):

Headache

Dizziness or light-headedness especially when standing up quickly

Diarrhoea

Cough

Vomiting

Lisinopril may affect the kidneys, causing abnormally low or no urine to be passed.

Uncommon side effects that may occur (between 1 in 100 and 1

in 1,000 patients):

Mood changes

Change of colour (pale blue followed by redness) and/or numbness or tingling in the fingers or toes Changes in the way things taste

Feeling sleepy or difficulty in going to sleep, strange dreams Rapid heartbeat Running nose Nausea

Stomach pain or indigestion

Skin rash

Itching

Impotence

Tiredness

Weakness (loss of strength).

An excessive drop in blood pressure may be experienced in patients with coronary heart disease, or those with a narrowing of the aorta (aortic stenosis), the kidney artery (renal artery stenosis) or the heart valves (mitral valve stenosis), or those patients with an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy).

Rare side effects that may occur (between 1 in 1,000 and 1 in 10,000 patients):

Allergic reactions: Stop taking Lisinopril and seek medical attention immediately if any of the following situations occur:

• you develop difficulty in breathing with or without swelling of the face, lips, tongue and/or throat.

• you develop swelling of the face, lips, tongue and/or throat which may cause difficulty in swallowing.

• you develop severe itching of the skin (with raised lumps).

Rarely, there may be changes to some of the cells or other parts of your blood. It is possible that your doctor may occasionally take blood samples to check whether Lisinopril has had any effect on your blood. Sometimes these changes may show themselves as tiredness or a sore throat, or they may be accompanied by a fever, joint and muscle pains, swelling of the joints or glands, or sensitivity to sunlight.

Other rare side effects are:

Confusion Dry mouth Hair loss Skin rash Psoriasis

Development of breasts in men.

Low levels of sodium in your blood (the symptoms may be tiredness, headache, nausea, vomiting)

Very rare side effects that may occur (less than 1 in 10,000 patients)

Sinus pain heezing

Inflammation of the lungs Yellow skin and/or eyes (jaundice)

Inflammation of the liver or pancreas

Severe skin disorders (symptoms of which include redness, blistering and peeling)

Sweating.

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

Symptoms of depression Fainting

Tell your doctor if you have any side effects that are not mentioned in this leaflet.

5. HOW TO STORE LISINOPRIL TABLETS

Store below 25°C. Store in the original package.

Do not take your tablets after the expiry date stated on the label. The expiry date refers to the last day of that month.

Return any unused Lisinopril tablets to your pharmacist.

Keep out of the reach and sight of children.

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 Lisinopril Tablet contains

The active substance is Lisinopril Dihydrate.

The other ingredients are Mannitol, Calcium Hydrogen Phosphate, Maize Starch, Pregelatinised Starch, Colloidal Anhydrous Silica, Magnesium Stearate and in the case of 5mg, 10 mg and 20 mg tablets, Red Iron Oxide (E172).

What Lisinopril Tablets looks like and contents of the pack

Lisinopril tablets are supplied in 4 strengths:

2.5 mg, 5 mg, 10 mg, 20 mg

The 2.5 mg tablets are white, round tablets and the 5mg, 10 mg and 20 mg tablets are pink, round tablets. The tablets have a number denoting tablet strength on one side and a scoreline on the other.

They are supplied as PVC / PVDC Aluminium blister packs in a carton in pack sizes of 28 tablets.

Marketing Authorization Holder and Manufacturer The Marketing Authorisation Holder:

Lupin (Europe) Limited,

Victoria Court,

Bexton Road,

Knutsford,

Cheshire, WA16 0PF

United Kingdom

Tel.: + 44 (0) 1565 751378.

Manufacturer:

Lupin Limited,

15 B, Phase 1A,

Verna Industrial Area, Verna,

Goa 403722,

India.

Tel: +91- 83-26682222

For any information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.