QUINAPRIL 10MG FILM-COATED TABLETS

Active substance: QUINAPRIL HYDROCHLORIDE

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PAGE 1: FRONT FACE (INSIDE OF REEL)

QUINAPRIL 5 mg, 10 mg, 20 mg AND 40 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Other important information: Quinapril may not work as well in Afro-Caribbean patients, and they may be at greater risk of certain side effects (see section 4, Possible side effects) Your doctor may monitor you when you first start taking Quinapril. This may involve urine and blood tests.

Taking other medicines Talk to your doctor if you are taking any of the following: diuretics (water tablets), as the risk of low blood pressure may be increased other medicines for high blood pressure e.g. atenolol, diltiazem, as the effects of Quinapril may be increased potassium supplements (this includes salt substitutes that often replace potassium), as IN THIS LEAFLET: potassium may increase above expected levels 1. What Quinapril is and what it is used for non-steroidal anti-inflammatory drugs (NSAIDs) 2. Before you take Quinapril e.g. aspirin, diclofenac, ibuprofen, piroxicam, as 3. How to take Quinapril the effectiveness of Quinapril may be reduced 4. Possible side effects antacids (used to treat indigestion and heartburn) 5. How to store Quinapril e.g. aluminium hydroxide, dimeticone, as the 6. Further information effectiveness of Quinapril may be reduced tetracycline (an antibiotic), as Quinapril may WHAT QUINAPRIL IS AND WHAT IT IS USED reduce its effectiveness FOR trimethoprim (an antibiotic), as your blood Quinapril belongs to a group of drugs called potassium level may be raised Angiotensin Converting Enzyme (ACE) Inhibitors procainamide (used to treat an abnormal heartbeat) which are vasodilators (drugs which widen the blood and cytostatic agents e.g. mercaptopurine, as there vessels, reduce blood pressure and make it easier for is an increased risk of leucopenia the heart to pump blood around the body). medicines for diabetes, including insulin, as your Quinapril is used to treat: dosage may need to be adjusted high blood pressure lithium (used to help treat mood swings and congestive heart failure (a condition where the severe depression), as levels of lithium may be heart no longer pumps blood as effectively as it increased should). barbiturates (sleeping pills) e.g. phenobarbital, as the risk of low blood pressure may be increased BEFORE YOU TAKE QUINAPRIL narcotic drugs (used to treat moderate or severe pain) e.g. diamorphine, morphine, pethidine, as DO NOT take Quinapril and contact your doctor the risk of low blood pressure may be increased immediately if you: allopurinol (used to treat gout), as there is an are allergic (hypersensitive) to quinapril or any of increased risk of the blood disorder leucopenia, a the other ingredients of this medicine reduction in the number of white blood cells which have suffered an allergic reaction to any other ACE makes infections more likely inhibitors e.g. captopril, enalapril, which has led to immunosuppressant drugs e.g. azathioprine, swelling of the face, lips, tongue and/or throat ciclosporin and corticosteroids e.g. prednisolone have a condition known as hereditary angioedema and hydrocortisone, as there is an increased risk of which is a serious allergic reaction which causes leucopenia, a reduction in white blood cells which swelling of the face or throat, or have ever had a makes infections more likely similar unexplained allergic reaction sympathomimetics e.g. dopamine, terbutaline, are more than 3 months pregnant. (It is also better salmeterol, salbutamol, ephedrine, adrenaline, or to avoid Quinapril in early pregnancy - see phenylpropanolamine. Phenylpropanolamine and pregnancy section). ephedrine may be present in medicines for colds Take special care with Quinapril and nasal stuffiness. Tell your doctor before you start to take this Please tell your doctor or pharmacist if you are taking medicine if you have: or have recently taken any other medicines, including any of the following heart problems: narrowing of medicines obtained without a prescription. your heart valves, a condition called hypertrophic Taking Quinapril with food and drink cardiomyopathy (inflammation of the heart muscle DO NOT take alcohol whilst being treated with fibres leading to less efficient pumping of blood Quinapril. around the body), or ischaemic heart disease (a Pregnancy and breast-feeding disease characterised by lack of blood flow and Pregnancy oxygen to the heart) You must tell you doctor if you think you are (or kidney problems, or disease of the arteries to the might become) pregnant. Your doctor will normally kidneys, or you are undergoing dialysis advise you to stop taking Quinapril before you recently had a kidney transplant or are suffering become pregnant or as soon as you know you are from primary hyperaldosteronism (a condition in pregnant and will advise you to take another which too much aldosterone hormone is medicine instead of Quinapril. Quinapril is not produced), as Quinapril is not recommended recommended in early pregnancy, and must not be cerebrovascular disease which is a disorder of the taken when more than 3 months pregnant, as it blood vessels of the brain and its covering may cause serious harm to your baby if used after membranes the third month of pregnancy. collagen vascular disease e.g. rheumatoid arthritis, Breast-feeding SLE (systemic lupus erythematosus) which is an Tell your doctor if you are breast-feeding or about autoimmune condition which causes joint pain, to start breast-feeding. Breast-feeding newborn skin rashes and fever babies (first few weeks after birth), and especially been on a low salt diet premature babies, is not recommended whilst recently suffered vomiting or diarrhoea. taking Quinapril. You must tell your doctor if you think you are (or In the case of an older baby your doctor should might become) pregnant. Quinapril is not advise you on the benefits and risks of taking recommended in early pregnancy, and must not be Quinapril whilst breast-feeding, compared with taken if you are more than 3 months pregnant, as it other treatments. may cause serious harm to your baby if used at that Driving and using machines stage (see pregnancy section). Quinapril may cause dizziness or drowsiness, Tell your doctor you are taking Quinapril if you: especially at the beginning of treatment or if taken are to have haemodialysis, as a different dialysis with alcohol. If you are affected, DO NOT drive or membrane may be needed operate machinery. are about to have a treatment called LDL apheresis, which is the removal of cholesterol HOW TO TAKE QUINAPRIL from your blood by a machine. The doctor treating you may wish to stop your medicine temporarily Always take Quinapril exactly as your doctor has told to prevent a possible allergic reaction you. You should check with your doctor or pharmacist are to have desensitising therapy to prevent if you are not sure. allergy to wasps, ants or bees In some cases, your treatment may be started in are to have an operation requiring an anaesthetic (including treatment at the dentist): tell the doctor hospital so that you can be closely monitored. or dentist that you are taking Quinapril.

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PAGE 2: REAR FACE (OUTSIDE OF REEL)

The tablets should be swallowed preferably with a glass of water. The usual dose is: Adults including the elderly High blood pressure 10 mg once daily. Your doctor may, if necessary, increase your dose to 20 to 40 mg a day, taken as one or two doses. If you are already taking a diuretic (water tablet), your doctor may recommend an initial dose of 2.5 mg once daily, gradually increasing this as necessary. Your doctor may have told you to stop taking your diuretic medicine 2 or 3 days before starting Quinapril. Heart failure The usual recommended dose is 2.5 mg once daily. Your doctor will then gradually increase your dose usually to 10 or 20 mg a day, taken as one or two doses. The maximum dose that may be taken is 40 mg a day. Patients with liver or kidney problems Your doctor may give you a lower dose if you have liver or kidney problems. Children Quinapril is not recommended for use in children under 18 years of age.

vertigo which is a sensation that your surroundings are spinning either up and down or from side to side. Rare (affecting less than one person in 1,000 but more than one person in 10,000): depression, confusion disturbances of balance, nerve problems causing numbness blurred vision or squint ringing in the ears fast heart beat, fainting, heart attack, severe chest pain, bleeding in the brain or transient stroke-like symptoms changes in blood test results agranulocytosis which is a severe reduction in the number of white blood cells which makes infections more likely wheezing, breathlessness, bronchitis, worsening of asthma, runny and itchy nose taste disturbances, constipation, inflammation of the pancreas, inflammation of the tongue, spasm of the intestine disturbance of liver or kidney function skin redness, blisters/bleeding of the lips, eyes, nose, mouth and genitals, severe blistering rash, patches of thickened and sore skin, skin photosensitivity and hair loss joint, muscle and back pain a condition which includes fever, inflammation of the blood vessels, muscle pain, joint pain or arthritis and changes in blood chemistry has been reported gynaecomastia which is a condition in which one or both breasts in males enlarge inflammation of blood vessels have been reported with other ACE inhibitors.

If you take more Quinapril 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 very low blood pressure leading to dizziness and fainting, weak pulse and clammy skin, stupor (a condition of near unconsciousness) a slow heart beat and kidney failure. Very rare (affecting less than one person in 10,000): Please take this leaflet, any remaining tablets and the jaundice (yellowing of the skin and whites of the container with you to the hospital or doctor so that eyes), inflammation of the liver they know which tablets were consumed. kidney failure serious allergic reaction which causes difficulty in If you forget to take Quinapril breathing or dizziness If you forget to take a tablet, take one as soon as you inflammation of the lungs. remember, unless it is nearly time to take the next one. DO NOT take a double dose to make up for a If any of the side effects get serious, or if you notice forgotten dose. any side effects not listed in this leaflet, please tell your doctor or pharmacist. If you stop taking Quinapril DO NOT stop taking your medicine without talking to HOW TO STORE QUINAPRIL your doctor first even if you feel better. If you have any further questions on the use of this product, ask your doctor or pharmacist.

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Keep out of the reach and sight of children. Do not store above 25C. Store in the original package. Do not use Quinapril POSSIBLE SIDE EFFECTS after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of Like all medicines, Quinapril can cause side effects, that month. although not everybody gets them. Medicines should not be disposed of via wastewater Stop taking the tablets and tell your doctor or household waste. Ask your pharmacist how to immediately or go to the casualty department at your dispose of medicines no longer required. These nearest hospital if the following happens: measures will help to protect the environment. an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin FURTHER INFORMATION rash or hives). This is a very serious side effect. You may need What Quinapril Tablets contain: urgent medical attention or hospitalisation. The active ingredient is quinapril (as quinapril hydrochloride), 5 mg, 10 mg, 20 mg or 40 mg. The following side effects have been reported at the The other ingredients are magnesium carbonate approximate frequencies shown: heavy, calcium hydrogen phosphate, anhydrous Common (affecting less than one person in 10 but gelatin, crospovidone Type A, magnesium stearate, more than one person in 100): film coat, hypromellose titanium dioxide (E171) dizziness and macrogol 600, macrogol 400. very low blood pressure Quinapril 40 mg also includes iron oxide yellow cough (E172). nausea, vomiting or diarrhoea headache What Quinapril Tablets look like and contents of the fatigue. pack: Quinapril 5 mg Tablets are white oval film-coated Uncommon (affecting less than one person in 100 tablets debossed 5 on one side and breakline on but more than one person in 1,000): both sides. serious allergic reactions causing swelling of the Quinapril 10 mg Tablets are white, oval film-coated face and throat (may be more common in tablets debossed 10 on one side and scoreline Afro-Caribbean patients) on the other. blood disorders that may be characterised by fever Quinapril 20 mg Tablets are white oval film-coated or chills, sore throat or ulcers in the mouth or tablets debossed 20 on one side and scoreline throat, unusual tiredness or weakness, unusual on the other. bleeding or unexplained bruising dry mouth or throat, indigestion and/or heartburn, Quinapril 40 mg Tablets are yellow, oval film-coated tablets debossed 40 on one side and abdominal pain or flatulence scoreline on the other. pins and needles Quinapril is available in pack sizes of 28, 28 asthenia which is weakness or loss of strength (calendar), 30, 50, 50 (hospital pack), 56, 100, or nervousness 300 (10 x 30) tablets. palpitations (sensation of the heart beating) or Not all pack sizes may be marketed. chest pain very low blood pressure on standing, leading to Marketing Authorisation Holder and Manufacturer dizziness and possibly fainting The Marketing Authorisation holder is TEVA UK pain in the sinuses, throat or upper chest (possibly Limited, Eastbourne, BN22 9AG and the company with pain or difficulty in swallowing), earache and responsible for manufacture is Teva Pharmaceutical swollen glands Works Co. Ltd, Debrecen, Hungary. itching, rash, skin reaction causing skin peeling, This leaflet was last revised: July 2010 increased perspiration, or nettle rash protein in the urine, impotence which is difficulty PL 00289/0462-0465 in getting or maintaining an erection difficulty sleeping, sleepiness, lethargy or a feeling of weakness 35958-V

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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.

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