Lisinopril 10mg Tablets
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Artwork Creative1 Desians |
Artwork No. |
180116/1 |
Colours Used | |||
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Customer |
Relon Chem |
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Description |
Lisinopril Pil | |||||
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Market |
UK | |||||
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_c |
Language |
English |
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Keyline (not to print) | ||
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Size |
148 x 390 mm (Finished) | |||||
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/ e-mail : prasad.pdp@gmail.com Ph : +91-9845609386 |
Min. Font Size |
9 pt | ||||
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Page No. |
1 of 1 | |||||
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Version No. |
3 | |||||
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Date |
22-01-16 | |||||
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Software |
Coreldraw 12 | |||||
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Packaging Development |
Quality Assurance (QA) |
Quality Control (QC) |
Production | |||
Lisinopril 2.5mg, 5.0mg, I0mg and 20mg Tablets
Lisinopril dihydrate
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you
start taking these tablets 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 or nurse.
• Your doctor has prescribed these tablets for you only. Do not pass them on to others. They may harm them even if their signs of illness 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 Lisinopril Tablets are and what they are used for
2. What you need to know before you take Lisinopril Tablets
3. How to take Lisinopril Tablets
4. Possible side effects
5. How to store Lisinopril Tablets
6. Contents of the pack and other information
1. What Lisinopril Tablets are and what they are used for
The active ingredient Lisinopril belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme inhibitors). These allow blood vessels to dilate, widening the blood vessels which helps reduce blood pressure and makes it easier for the heart to pump blood through the body in patients with heart failure or following a heart attack.
Your doctor has prescribed Lisinopril Tablets for one of the following reasons:
• High blood pressure (hypertension) where they can be used on their own or with other blood pressure lowering medicines.
• Heart failure where they are used with other treatments.
• Within 24 hours of a heart attack as part of a long-term treatment.
• To treat kidney problems caused by Type II diabetes in people with high blood pressure.
2. What you need to know before you take Lisinopril Tablets
Do not take Lisinopril Tablets:
• If you have taken ACE inhibitors before and suffered an allergic reaction (such as angioneurotic oedema/ angioedema); symptoms of a reaction may include sudden appearance of nettle-like rash and swellings particularly of the lips, face or neck.
• If you are more than 3 months pregnant. (It is also better to avoid Lisinopril in early pregnancy - see pregnancy section).
• If you are allergic to Lisinopril or any of the other ingredients in these tablets.
• If you suffer from swellings particularly of the hands, feet, face, tongue or throat that have no apparent cause (angioedema) or a member of your family has had a similar reaction (hereditary angioedema).
• 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 you start taking these tablets:
• if you have a narrowing (stenosis) of the aorta (an artery in your heart) or a narrowing of the heart valves (mitral valves).
• if you have a narrowing (stenosis) of the kidney artery.
• if you have an increase in the thickness of the heart muscle (known as hypertrophic cardiomyopathy).
• if you have problems with your blood vessels (collagen vascular disease).
• if you have low blood pressure. You may notice this as feeling dizzy or light-headed, especially when standing up.
• if you have kidney problems or you are having kidney dialysis.
• if you have liver problems.
• if you have diabetes.
• 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 Lisinopril Tablets".
• if you have recently had diarrhoea or vomiting (being sick).
• if your doctor has told you to control the amount of salt in your diet.
• if you have high levels of cholesterol and you are having a treatment called 'LDL apheresis'.
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• if you think you are (or might become) pregnant. Lisinopril is not recemended 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).
• if you are of black origin as Lisinopril may be less effective. You may also more readily get the side effect 'angioedema' (a severe allergic reaction).
If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking this medicine.
Treatment for allergies such as insect stings
Tell your doctor if you are having or are going to have treatment to lower the effects of an allergy such as insect stings (desensitisation treatment). If you take Lisinopril while you are having this treatment, it may cause a severe allergic reaction.
Operations
If you are going to have an operation (including dental surgery) tell your doctor or dentist that you are taking Lisinopril. This is because you can get low blood pressure (hypotension) if you are given certain local or general anaesthetics while you are taking Lisinopril.
Other medicines and Lisinopril tablets Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to change your dose and/or to take other precautions.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• An angiotensin II receptor blocker (ARB) or aliskiren, (see also information under the headings "Do not take Lisinopril" and "Warnings and precautions").
• Other medicines to help lower your blood pressure.
• Water tablets (diuretic medicines).
• Heparin, a medicine to break up blood clots (usually given in hospital).
• Beta-blocker medicines, such as atenolol and propranolol.
• Nitrate medicines (for heart problems).
• Non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and arthritis, such as ibuprofen or indometacin.
• Aspirin (acetylsalicylic acid), if you are taking more than 3 grams each day.
• Medicines for depression and for mental problems, including lithium.
• Potassium tablets or salt substitutes that have potassium in them.
• Insulin or medicines that you take by mouth for diabetes.
• Medicines used to treat asthma.
• Medicines to treat nose or sinus congestion or other cold remedies (including those you can buy in the pharmacy).
• Medicines to suppress the body's immune response (immunosuppressants).
• Allopurinol (for gout).
• Procainamide (for heart beat problems).
• Medicines that contain gold, such as sodium aurothiomalate, which may be given to you as an injection.
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 before you become or as soon as you know you are pregnant and will advise you to take another medicine instead of Lisinopril. 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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding as Lisinopril is not recommended for mothers who are breastfeeding, 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.
3. How to take Lisinopril Tablets
Always take this medicine exactly as your doctor has told you. Exactly how many tablets and how often you must take them will be written on the label. Check with your doctor or pharmacist if you are not sure.
Taking your medicine
• 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 Lisinopril before or after food.
• Once you have started taking Lisinopril your doctor may take blood tests. Your doctor may then adjust your dose so you take the right amount of medicine for you.
Taking your first dose
• Take special care when you take your first dose or if your dose is increased. It may cause a greater fall in blood pressure than later doses. This may make you feel dizzy or lightheaded. If this happens, it may help to lie down. If you are concerned, please talk to your doctor as soon as possible.
Adults
For high blood pressure
• Your dose depends on your medical condition and whether you are taking any other medicines. The usual recommended starting dose is 10 mg once a day. For some patients a lower starting dose of 2.5 or 5mg is necessary.
• The usual long-term dose is 20 mg once a day.
For heart failure
• The recommended starting dose is 2.5 mg once a day.
• The long-term dose is 5 to 35 mg once a day.
After a heart attack
• The recommended starting dose is 5 mg within 24 hours of your attack followed by 5 mg after 24 hours and I0mg after 48hours.
• The usual long-term dose is 10 mg once a day.
For kidney problems caused by diabetes
• The recommended dose is either 10 mg or 20 mg once a day.
If you are elderly, have kidney problems or are taking diuretic medicines your doctor may give you a lower dose than the usual dose.
Use in children and adolescents (6 to 16 years old) with high blood pressure
• Lisinopril is not recommended for children under 6 years or in any children with severe kidney problems.
• The doctor will work out the correct dose for your child. The dose depends on the child's body weight.
• For children who weigh between 20 kg and 50 kg, the recommended starting dose is 2.5 mg once a day. This may be gradually increased to a maximum daily dose of 20mg
• For children who weigh more than 50 kg, the recommended starting dose is 5 mg once a day. This may be gradually increased to a maximum daily dose of 40mg
If you take more Lisinopril Tablets than you should:
If you have taken one extra dose this is unlikely to cause problems. If you or someone else has taken more than one extra dose or a large overdose of Lisinopril Tablets, contact your doctor or local hospital accident and emergency department immediately.
If you forget to take Lisinopril Tablets:
If you have forgotten to take your medicine, take the missed dose as soon as you remember. If the next dose is due within 8 hours, take the missed dose now and skip the next dose, then continue as before. Do not double the next dose to make up for the missed one. If you are concerned about this you should consult your doctor or pharmacist.
If you stop taking Lisinopril Tablets:
Do not stop taking Lisinopril Tablets without first discussing it with your doctor.
If you have any further questions on the use of Lisinopril Tablets ask your doctor or pharmacist.
4. Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following reactions, stop taking Lisinopril Tablets and contact your doctor immediately:
• Severe allergic reactions. The signs may include:
• Swelling of your face, lips, tongue or throat. This may make it difficult to swallow.
• Severe or sudden swelling of your hands, feet and ankles.
• Difficulty breathing.
• Severe itching of the skin (with raised lumps).
• Severe skin disorders (pemphigus, toxic epidermal necrolysis and Stevens Johnson syndrome) with symptoms that can include unexpected rash, burning, reddening, swelling and peeling skin (resembling severe burns), extensive blistering.
• Yellowing of the skin or whites of the eyes (jaundice).
Other possible side effects:
Common (may affect up to I in I0 people)
• Headache.
• Feeling dizzy or light-headed, especially if you stand up quickly.
• Diarrhoea.
• Being sick (vomiting).
• A dry cough that does not go away.
• Kidney problems (shown in a blood test).
Uncommon (may affect up to I in I00 people)
• Mood changes.
• Pins and needles
• Change of colour in your fingers or toes (pale blue followed by redness) or numbness or tingling in your fingers or toes (Raynauds phenomenon).
• Changes in the way things taste.
• Spinning feeling (vertigo).
• Having difficulty sleeping.
• Heart attack or stroke - possibly as a result of excessively low blood pressure in high risk patients
• Fast heart beat, palpitations
• Runny nose.
• Feeling sick (nausea), stomach pain or indigestion.
• Skin rash or itching.
• Being unable to get an erection (impotence).
• Feeling tired or feeling weak (loss of strength).
• Changes in blood tests that show how well your liver and kidneys are working.
Rare (may affect up to I in I000 people)
• Feeling confused.
• A lumpy rash (hives).
• Dry mouth.
• Hair loss, psoriasis (a skin problem).
• Changes in the way things smell.
• Development of breasts in men.
• Low levels of sodium in your blood (the symptoms may be tiredness, headache, nausea, vomiting), increased blood levels of bilirubin, decrease in the amount of haemoglobin in the blood
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH) - symptoms can include nausea, vomiting, cramps or tremors, depressed mood, hallucinations and fits
• Kidney failure.
Very rare (may affect up to I in I0,000 people)
• Decrease bone marrow production, disease or enlargement of the lymph nodes, autoimmune disease, changes in the numbers and types of blood cells. If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness or abnormally pale skin you should tell your doctor who may want you to have a blood test.
• Sinusitis, wheezing, inflammation of the lungs (signs include cough, feeling short of breath and high temperature).
• Low levels of sugar in your blood (hypoglycaemia). The signs may include feeling hungry or weak, sweating and a fast heart beat.
• Inflammation of the liver (loss of appetite, yellowing of the skin and eyes and dark coloured urine), liver failure
• Inflammation of the pancreas (moderate to severe pain in the stomach)
• Inflamed gut.
• Sweating.
• Passing less water (urine) than normal or passing no water.
• Nodules on the body (cutaneous pseudolymphoma), circular or irregular red patches on the hands and arms (erythema multiforme)
• A "symptom complex" that may include one or more of the following: fever; inflammation of blood vessels; muscle pain; joint pain or inflammation; changes in blood; sensitivity to sunlight or sun beds or other skin reactions.
Not known (frequency cannot be estimated from available data)
• Symptoms of depression.
• Fainting.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: HYPERLINK "http://www.mhra.gov.uk/yellowcard" 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 Lisinopril Tablets
Keep out of the sight and reach of children.
Do not use Lisinopril Tablets after the expiry date which is stated on the carton.
Do not keep the tablets above 25°C.
6. Contents of the pack and other information
What Lisinopril Tablets contain
Each tablet contains 2.5mg, 5mg, I0mg, or 20mg of lisinopril as the active ingredient lisinopril dihydrate.
The other ingredients are mannitol, calcium hydrogen phosphate dihydrate, pregelatinised maize starch, croscarmellose sodium and magnesium stearate. The I0mg and 20mg tablets also contain red, black and yellow oxide colourings (EI72).
What Lisinopril Tablets look like and contents of the pack
Lisinopril 2.5mg and 5.0mg Tablets are white circular biconvex tablets. The Lisinopril I0mg and 20mg Tablets are light pink circular biconvex tablets.
The tablets are supplied in packs of 28 or 50 tablets.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited, Cheshire House, Gorsey Lane Widnes, Cheshire, WA8 0RP UK
Date leaflet last revised: January 20I6.
PL 20395/00I9 - 0022 |POM