Quinapril 5mg Film-Coated Tablets
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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.
IN THIS LEAFLET:
1, What Quinapril is and what it is used for
2, Before you take Quinapril
3, How to take Quinapril
4, Possible side effects
5, How to store Quinapril
6, Further information
OWHAT QUINAPRIL IS AND WHAT IT IS USED FOR
Quinapril belongs to a group of drugs called Angiotensin Converting Enzyme (ACE) Inhibitors which are vasodilators (drugs which widen the blood vessels, reduce blood pressure and make it easier for the heart to pump blood around the body).
Quinapril is used to treat:
• high blood pressure
• congestive heart failure (a condition where the heart no longer pumps blood as effectively as it should).
^2 BEFORE YOU TAKE QUINAPRIL
DO NOT take Quinapril and contact your doctor immediately if you:
• are allergic (hypersensitive) to quinapril or any of the other ingredients of this medicine • have suffered an allergic reaction to any other ACE inhibitors e.g. captopril, enalapril, which has led to swelling of the face, lips, tongue and/or throat • have a condition known as hereditary angioedema which is a serious allergic reaction which causes swelling of the face or throat, or have ever had a similar unexplained allergic reaction • are more than 3 months pregnant. (It is also better to avoid Quinapril in early pregnancy - see pregnancy section).
Take special care with Quinapril
Tell your doctor before you start to take this
medicine if you have:
• any of the following heart problems: narrowing of your heart valves, a condition called hypertrophic cardiomyopathy (inflammation of the heart muscle fibres leading to less efficient pumping of blood around the body), or ischaemic heart disease (a disease characterised by lack of blood flow and oxygen to the heart)
• kidney problems, or disease of the arteries to the kidneys, or you are undergoing dialysis • recently had a kidney transplant or are suffering from primary hyperaldosteronism (a condition in which too much aldosterone hormone is produced), as Quinapril is not recommended • cerebrovascular disease which is a disorder of the blood vessels of the brain and its covering membranes
• collagen vascular disease e.g. rheumatoid arthritis, SLE (systemic lupus erythematosus) which is an autoimmune condition which causes joint pain, skin rashes and fever • been on a low salt diet • recently suffered vomiting or diarrhoea.
You must tell your doctor if you think you are (or might become) pregnant. Quinapril 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).
Tell your doctor you are taking Quinapril if you:
• are to have haemodialysis, as a different dialysis membrane may be needed • are about to have a treatment called 'LDL apheresis', which is the removal of cholesterol from your blood by a machine. The doctor treating you may wish to stop your medicine temporarily to prevent a possible allergic reaction • are to have desensitising therapy to prevent allergy to wasps, ants or bees • are to have an operation requiring an anaesthetic (including treatment at the dentist): tell the doctor or dentist that you are taking Quinapril.
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 potassium may increase above expected levels
• non-steroidal anti-inflammatory drugs (NSAIDs) e.g. aspirin, diclofenac, ibuprofen, piroxicam, as the effectiveness of Quinapril may be reduced
• antacids (used to treat indigestion and heartburn) e.g. aluminium hydroxide, dimeticone, as the effectiveness of Quinapril may be reduced
• tetracycline (an antibiotic), as Quinapril may reduce its effectiveness
• trimethoprim (an antibiotic), as your blood potassium level may be raised
• procainamide (used to treat an abnormal heartbeat) and cytostatic agents e.g. mercaptopurine, as there is an increased risk of leucopenia
• medicines for diabetes, including insulin, as your dosage may need to be adjusted
• lithium (used to help treat mood swings and severe depression), as levels of lithium may be increased
• barbiturates (sleeping pills) e.g. phenobarbital, as the risk of low blood pressure may be increased
• narcotic drugs (used to treat moderate or severe pain) e.g. diamorphine, morphine, pethidine, as the risk of low blood pressure may be increased
• allopurinol (used to treat gout), as there is an increased risk of the blood disorder leucopenia, a reduction in the number of white blood cells which makes infections more likely
• immunosuppressant drugs e.g. azathioprine, ciclosporin and corticosteroids e.g. prednisolone and hydrocortisone, as there is an increased risk of leucopenia, a reduction in white blood cells which makes infections more likely
• sympathomimetics e.g. dopamine, terbutaline, salmeterol, salbutamol, ephedrine, adrenaline, or phenylpropanolamine. Phenylpropanolamine and ephedrine may be present in medicines for colds and nasal stuffiness.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Quinapril with food and drink
• DO NOT take alcohol whilst being treated with Quinapril.
Pregnancy and breast-feeding Pregnancy
• You must tell you doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Quinapril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Quinapril. Quinapril 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. Breast-feeding newborn babies (first few weeks after birth), and especially premature babies, is not recommended whilst taking Quinapril.
• In the case of an older baby your doctor should advise you on the benefits and risks of taking Quinapril whilst breast-feeding, compared with other treatments.
Driving and using machines
• Quinapril may cause dizziness or drowsiness, especially at the beginning of treatment or if taken with alcohol. If you are affected, DO NOT drive or operate machinery.
HOW TO TAKE QUINAPRIL
Always take Quinapril exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
In some cases, your treatment may be started in hospital so that you can be closely monitored.
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.
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. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Quinapril
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. DO NOT take a double dose to make up for a forgotten dose.
If you stop taking Quinapril
DO NOT stop taking your medicine without talking to 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.
POSSIBLE side effects
Like all medicines, Quinapril can cause side effects, although not everybody gets them.
Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:
• an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).
This is a very serious side effect. You may need urgent medical attention or hospitalisation.
The following side effects have been reported at the approximate frequencies shown:
Common (affecting less than one person in 10 but more than one person in 100):
• dizziness
• very low blood pressure
• cough
• nausea, vomiting or diarrhoea
• headache
• fatigue.
Uncommon (affecting less than one person in 100 but more than one person in 1,000):
• serious allergic reactions causing swelling of the face and throat (may be more common in Afro-Caribbean patients)
• blood disorders that may be characterised by fever or chills, sore throat or ulcers in the mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruising
• dry mouth or throat, indigestion and/or heartburn, abdominal pain or flatulence
• pins and needles
• asthenia which is weakness or loss of strength
• nervousness
• palpitations (sensation of the heart beating) or chest pain
• very low blood pressure on standing, leading to dizziness and possibly fainting
• pain in the sinuses, throat or upper chest (possibly with pain or difficulty in swallowing), earache and swollen glands
• itching, rash, skin reaction causing skin peeling, increased perspiration, or nettle rash
• protein in the urine, impotence which is difficulty in getting or maintaining an erection
• difficulty sleeping, sleepiness, lethargy or a feeling of weakness
• 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.
Very rare (affecting less than one person in 10,000):
• jaundice (yellowing of the skin and whites of the eyes), inflammation of the liver
• kidney failure
• serious allergic reaction which causes difficulty in breathing or dizziness
• inflammation of the lungs.
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.
how to store quinapril
Keep out of the reach and sight of children.
Do not store above 250C.
Store in the original package. Do not use Quinapril after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.
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.
FURTHER INFORMATION
What Quinapril Tablets contain:
• The active ingredient is quinapril (as quinapril hydrochloride), 5 mg, 10 mg, 20 mg or 40 mg.
• The other ingredients are magnesium carbonate heavy, calcium hydrogen phosphate, anhydrous gelatin, crospovidone Type A, magnesium stearate, film coat, hypromellose titanium dioxide (E171) and macrogol 600, macrogol 400.
• Quinapril 40 mg also includes iron oxide yellow (E172).
What Quinapril Tablets look like and contents of the pack:
• Quinapril 5 mg Tablets are white oval film-coated tablets debossed "5" on one side and breakline on both sides.
• Quinapril 10 mg Tablets are white, oval film-coated tablets debossed "10" on one side and scoreline on the other.
• Quinapril 20 mg Tablets are white oval film-coated tablets debossed "20" on one side and scoreline on the other.
• Quinapril 40 mg Tablets are yellow, oval film-coated tablets debossed "40" on one side and scoreline on the other.
• Quinapril is available in pack sizes of 28, 28 (calendar), 30, 50, 50 (hospital pack), 56, 100, or 300 (10 x 30) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is TEVA UK Limited, Eastbourne, BN22 9AG and the company responsible for manufacture is Teva Pharmaceutical Works Co. Ltd, Debrecen, Hungary.
This leaflet was last revised: July 2010 PL 00289/0462-0465
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TEVA UK LIMITED 35958-V