LISINOPRIL 20 MG TABLETS
Active substance: LISINOPRIL DIHYDRATE
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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 ef fects gets serious, or if you notice any side ef fects 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 ef fects. 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). have a heart condition known as symptomatic heart failure, You where the heart does not pump your blood around your body as well as it should. You have had a heart at tack (myocardial infarction) that may lead to a weakening of your heart. Lisinopril slows the weakening down. You have kidney problems related to your diabetes and high blood pressure.
Lisinopril Lisinopril
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 A (renal artery stenosis) or the heart valves (mitral valve stenosis), or an increase in the thickness of the hear t muscle (hypertrophic cardiomyopathy, 'HOCM'). Other health problems such as: - Low blood pressure (you may notice this as d i z z i n e s s o r 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 at tention immediately if any of the following situations occur (an allergic reaction): you develop dif ficulty in breathing with or without swelling of If the face, lips, tongue and/or throat. you develop swelling of the face, lips, tongue and/or throat If which may cause dif ficulty in swallowing. you develop severe itching of the skin (with raised lumps). If 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 ef fects 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 af ter 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 ef fectiveness 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 af fect 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). ther medicines for your high blo od pressure O (antihypertensives). Non-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. Medicines that contain gold, such as sodium aurothiomalate, which may be given to you as an injection. 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 ner vous 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 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 af ter the third month of pregnancy. Breast feeding: 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 ef fectiveness 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 ef fect on ability to drive and use machines. If you experience side ef fects 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.
is recommended in children (above 6 years old) only for the treatment of high blood pressure (hypertension).
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 bet ter to avoid If Lisinopril tablets in early pregnancy - see pregnancy section). you have previously been treated with a medicine in the same If 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 dif ficulty 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 If its other ingredients.
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 ma ximum 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. Af ter a heart at tack 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 Swallow the tablet with a drink of water. to take your tablets at the same time each day. It does not Try mat ter if you take Lisinopril before or af ter food. not stop taking your tablets if you are feeling well, unless Do your doctor tells you. Remember, 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 ef fect of Lisinopril is too If 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 ex tra dose to make up for the missed dose. Just resume your usual schedule. 4. POSSIBLE SIDE EFFECTS Like all medicines, Lisinopril can cause side ef fects. Do not be alarmed by this list of possible side ef fects, you may not have any of them. Most patients do not notice any side ef fects. However if you do and they bother you, talk to your doctor. Common side ef fects 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
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 dif ficulty 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 ef fects that may occur (between 1 in 1,000 and 1 in 10,000 patients): Allergic reactions: Stop taking Lisinopril and seek medical at tention immediately if any of the following situations occur: you develop dif ficulty in breathing with or without swelling of If the face, lips, tongue and/or throat. you develop swelling of the face, lips, tongue and/or throat If which may cause dif ficulty in swallowing. you develop severe itching of the skin (with raised lumps). If 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 ef fect 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 ef fects 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 ef fects that may occur (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) Sweating.
Tell your doctor if you have any side ef fects that are not mentioned in this leaflet. 5. HOW TO STORE LISINOPRIL TABLETS Store below 25C. Store in the original package. Do not take your tablets af ter 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, Bex ton 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. Lupin (Europe) Limited, Victoria Court, Bex ton Road, Knutsford, Cheshire, WA16 0PF United Kingdom Tel.: + 44 (0) 1565 751378. MANUFACTURER CODE NO. GO/DRUGS/654 This leaflet was last revised in October 2011. ID#: 222328
Not known (frequency cannot be estimated from the available data) Symptoms of depression Uncommon side ef fects that may occur (between 1 in 100 and 1 Fainting in 1,000 patients): Lisinopril may af fect the kidneys, causing abnormally low or no urine to be passed.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

