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The product codes for this leaflet are: PL 17901/0060, PL 17901/0061, PL 17901/0062, PL 17901/0063

 

Zestril 2.5mg, 5mg,10mg, and 20mg tablets.

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AstraZeneca UK Limited


Horizon Place600 Capability GreenLutonBedfordshireLU1 3LU
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Patient Information Leaflet

Zestril Tablets

lisinopril

2.5 mg, 5 mg, 10 mg and 20 mg

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 further questions, please ask your doctor or your 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.

In this leaflet

  • 1. What Zestril is and what it is used for
  • 2. Before you take Zestril
  • 3. How to take Zestril
  • 4. Possible side effects
  • 5. Storing Zestril
  • 6. Further information

The active substance in Zestril Tablets is lisinopril (as dihydrate).

The other ingredients are mannitol, calcium hydrogen phosphate, maize starch, pregelatinised starch and magnesium stearate. In addition, the pink tablets contain red iron oxide (E172).

Zestril Tablets are supplied in 4 strengths containing either 2.5 mg, 5 mg, 10 mg or 20 mg of lisinopril (as dihydrate).

The 2.5 mg tablets are white and the 5 mg, 10 mg and 20 mg tablets are pink. They are supplied in boxes containing blister calendar packs of 28 tablets.

The Marketing Authorisations for Zestril Tablets are held by

AstraZeneca UK Limited
600 Capability Green
Luton
LU1 3LU
UK

Zestril Tablets are manufactured by

AstraZeneca UK Limited
Silk Road Business Park
Macclesfield
Cheshire
SK10 2NA
UK
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What Zestril is and what it is used for

Zestril belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme inhibitors). Zestril 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 Zestril 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. Zestril slows the weakening down.
  • You have kidney problems related to your diabetes and high blood pressure.
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Before you take Zestril

Do not take Zestril

  • If you are pregnant (see the section on ‘Pregnancy and breast-feeding’).
  • If you have previously been treated with a medicine in the same group of drugs as Zestril (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.
  • If you have ever had an allergic reaction to Zestril or to any of its other ingredients.

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

Take special care with Zestril

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

  • A 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’).
  • Other health problems such as:
    • Low blood pressure (you may notice this as dizziness or light-headedness 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).
    • Diarrhoea or vomiting.
    • A salt-restricted diet or you are taking potassium supplements.

Stop taking Zestril and seek medical attention immediately if any of the following situations occur (an allergic reaction):

  • If you develop difficulty in breathing with or without swelling of the face, lips, tongue and/or throat.
  • If you develop swelling of the face, lips, tongue and/or throat which may cause difficulty in swallowing.
  • If 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 Zestril before you are given a local or general anaesthetic. Zestril, 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 Zestril. It may cause a greater fall in blood pressure than will occur following continued treatment. You may notice this as dizziness or light-headedness and it may help to lie down. If you are concerned, please consult your doctor.

Do not give Zestril to children under 18 years. There is limited information on the safety and effectiveness of Zestril in children.

Pregnancy and breast-feeding

  • Do not start taking Zestril if you know you are pregnant. This is because it may harm your unborn baby.
  • If you become pregnant or plan to become pregnant while you are taking Zestril, talk to your doctor as soon as possible.
  • If you are breast-feeding or plan to breast-feed, talk to your doctor before taking this medicine.

Taking 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:

  • Diuretics (water tablets including those which conserve potassium).
  • Other medicines for your high blood pressure (antihypertensives).
  • Non-steroidal anti-inflammatory medicines (NSAIDs) such as indomethacin and high doses of aspirin (more than 3 grams per day), which are used to treat arthritis or muscle pain.
  • Medicines for mental disorders such as lithium, antipsychotics or tricyclic antidepressants.
  • Potassium tablets or potassium-containing salt substitutes.
  • Medicines for the treatment of diabetes, such as insulin or those taken orally, to lower blood sugar.
  • Medicines 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.
  • Medicines that suppress the body’s immune response (immunosuppressants), treatment with allopurinol (for gout) or procainamide (for abnormal heartbeats).
  • Gold (such as sodium aurothiomalate). This may be given to you as an injection and possible side effects of gold include feeling flushed, sick or dizzy and low blood pressure. These reactions are more likely to occur if you are also taking an ACE-inhibitor such as Zestril.

Driving and using machines

Your Zestril Tablets are unlikely to affect your ability to drive a car or to operate machinery. However, you should not perform tasks that require special attention until you know how your medicine will affect you.

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

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How to take Zestril

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.

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.

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 Zestril

  • Swallow the tablet with a drink of water.
  • Try to take your tablets at the same time each day. It does not matter if you take Zestril before or after food.
  • Do not stop taking your tablets if you are feeling well, unless your doctor tells you.
  • Remember, the first dose of Zestril may cause a greater fall in blood pressure than will occur following continued treatment. You may notice this as dizziness or light-headedness and it may help to lie down. If concerned, please consult your doctor as soon as possible.
  • If you have the impression that the effect of Zestril is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

If you take more Zestril 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.

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Possible side effects

Like all medicines, Zestril 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 (in 1% or more of patients but less than 10%; between 1 in 10 and 1 in 100 patients):

Headache

Dizziness or light-headedness especially when standing up quickly

Diarrhoea

Cough

Vomiting

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

Uncommon side effects that may occur (in 0.1% or more of patients but less than 1%; between 1 in 100 and 1 in 1,000 patients):

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

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

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

Other uncommon side effects are:

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 (in 0.01% or more of patients and less than 0.1%; between 1 in 1,000 and 1 in 10,000 patients):

Confusion

Dry mouth

Hair loss

Psoriasis

Development of breasts in men.

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 Zestril 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.

Very rare side effects that may occur (in less than 0.01% patients; less than 1 in 10,000 patients):

Sinus pain

Wheezing

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)

A patch or lump on the skin which slowly grows in size.

Sweating.

Side effects of unknown frequency that may occur:

Fainting

Mood changes including feeling depressed.

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

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Storing Zestril

Keep out of the reach and sight of children.

Do not take your tablets after the expiry date that is stated on the blister strip and the carton.

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

Zestril 2.5 mg Tablets: Do not store above 25°C.

Zestril 5 mg, 10 mg and 20 mg Tablets: Do not store above 30°C.

Keep your tablets in the container they came in. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

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Further information

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

United Kingdom

AstraZeneca UK Limited
600 Capability Green
Luton
LU1 3LU
UK
Telephone:01582 836 836
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Leaflet updated: November 2008

© AstraZeneca 2008

Zestril is a trade mark of the AstraZeneca group of companies.

CV 08 0091

P024258


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