Quinapril 20 Mg Film-Coated Tablets
Read all of this leaflet carefully before you start taking this
medicine 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.
- This medicine has been prescribed for you only. Do not pass it on to others. It 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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
QUINAPRIL 5 MG FILM-COATED TABLETS QUINAPRIL 10 MG FILM-COATED TABLETS QUINAPRIL 20 MG FILM-COATED TABLETS QUINAPRIL 40 MG FILM-COATED TABLETS
(quinapril hydrochloride)
What is in this leaflet:
1. What Quinapril is and what it is used for.
2. What you need to know before you take Quinapril.
3. How to take Quinapril.
4. Possible side effects.
5. How to store Quinapril.
6. Contents of the pack and other information.
1. WHAT QUINAPRIL IS AND WHAT IT IS USED FOR
Quinapril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors, which make the blood vessels become wider, reducing the pressure in the vessels. This makes blood flow more easily and reduces the effort needed for the heart to pump blood around the body.
Quinapril can be used to:
• lower your blood pressure if it is too high (a condition called hypertension)
• help your heart pump blood around your body if you have a condition known as congestive heart failure (along with other medicines).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE Quinapril Do not take Quinapril:
• if you are allergic to quinapril or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include itching, a rash on the skin or difficulty breathing
• if you have taken an ACE inhibitor before and had an allergic reaction to it resulting in swelling of the face, lips, tongue and/ or throat with difficulty swallowing or breathing, or you or any member of your family have suffered a similar allergic reaction for any reason in the past (angioedema)
• if you suffer from a severe allergic skin reaction called hereditary/ idiopathic angioneurotic oedema, where itchy swellings erupt on the face, hands and/or genitals and in the mouth
• if you are more than 3 months pregnant (it is also better to avoid Quinapril in early pregnancy - see pregnancy section)
• if you have a condition causing obstruction to blood flow from the heart like heart valve disease.
• 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 taking quinapril if:
• you suffer from a heart problem (other than the one being treated) or narrowing of the main artery carrying blood out of the heart (aortic stenosis)
• you have liver problems
• you suffer from kidney problems, narrowing of the blood vessels to the kidney (renal artery stenosis), have had a kidney transplant or need haemodialysis treatment
• you suffer from a collagen vascular disease (deposits of collagen in your blood vessels) e.g. lupus erythematosus or scleroderma
• you are dehydrated (dry) due to treatment with diuretics ('water tablets'), dialysis, a low salt diet, vomiting or diarrhoea. You may be more likely to suffer from a very large drop in your blood pressure (hypotension) when you start taking the tablets and may feel faint or light-headed
• you have excessive production of aldosterone causing high blood pressure also called primary hyperaldosteronism
=B= • you have a history of allergy or asthma
• you are diabetic, as the dose of anti-diabetic medicine may need adjusting
• you are having treatment to remove cholesterol from your blood by machine also called low density lipoprotein apheresis
• you are having or about to have treatment to reduce the effects of an allergy to a bee or wasp sting also called desensitisation treatment
• 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)
• you are going to have an operation or need an anaesthetic
• 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 Quinapril".
You should be aware that this medicine may be less effective at lowering the blood pressure in black patients than in nonblack patients.
Other medicines and Quinapril
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, or the following:
• other medicines to lower blood pressure e.g. methyldopa, atenolol
• other diuretics e.g. triamterene, amiloride, furosemide, spironolactone
• potassium supplements (or salt substitutes containing potassium)
• procainamide, to treat abnormal heart rhythms
• lithium, to treat mental illness
• other medicines that interact with magnesium salts e.g. the antibiotic tetracycline
• antidiabetic medicines such as insulin, gliclazide, metformin; doses may need to be adjusted
• painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen and aspirin
• allopurinol, often used to treat gout
• medicine to treat cancer
• immunosuppressive agents e.g. ciclosporin, used after transplant surgery or for autoimmune disorders such as rheumatoid arthritis
• corticosteroids e.g. prednisolone
• antacids, to relieve indigestion and heartburn
• medicines that act on your nervous system e.g. barbiturates, alcohol and narcotics
• medicines used to treat stiffness and inflammation of your muscles, bones and joints including gold therapy such as sodium aurothiomalate, which can lead to flushing of your face, feeling sick (nausea), being sick (vomiting) and low blood pressure.
Your doctor may need to change your dose and/or to take other precautions:
• if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Quinapril" and “Warnings and precautions").
quinapril with food, drink and alcohol
Quinapril can be taken with or without food. Drinking alcohol while being treated with this medicine may make you dizzy or sleepy.
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 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 breastfeeding. 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine may affect your ability to drive a car or operate machinery. However, do not perform these tasks if you suffer from side effects such as dizziness or feeling tired. These effects can sometimes occur at the start of treatment, and may become worse if you drink alcohol at the same time.
quinapril contains lactose monohydrate
This medicine contains lactose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicinal product.
3. HOW TO TAKE Quinapril
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults
To treat high blood pressure
The recommended starting dose is 10 mg once a day. If you are already taking a diuretic ('water' tablet) the starting dose is 2.5 mg a day.
After 3 to 4 weeks, your doctor may increase this to a dose that best controls your blood pressure. The usual daily dose needed is between 20 mg and 40 mg, taken as a single dose or divided into two doses. A few patients have been treated with doses up to 80 mg a day.
To treat heart failure
You will also be taking other medicine for your condition, such as a diuretic ('water' tablet) or digoxin.
The recommended starting dose is 2.5 mg in the morning. Every 2 to 3 weeks your doctor may increase this to a dose of between 10 mg and 40 mg a day. Most patients will only need 10-20 mg per day, when given with water tablets or digoxin. This may be taken as a single dose or divided into two doses. The maximum daily dose is 40 mg and this dose should not be exceeded. At the start of treatment your doctor will monitor your condition closely. In some cases your doctor may wish to take the precaution of placing you in hospital just for the start of therapy.
Use in the elderly or people with kidney problems
If you are elderly or have kidney problems, you may be more sensitive to the effects of Quinapril. The usual starting dose for treating high blood pressure is 2.5 mg. Your doctor will slowly increase the dose until your condition is under control.
Use in children and adolescents
Quinapril tablets are not recommended for children and adolescents under 18 years of age.
Method of administration
• Try to take the tablets at the same time every day.
• Swallow the tablets with a glass of water.
• Do not chew or crush the tablets.
• The score lines on the 10 mg and 20 mg tablets are not intended for breaking the tablet.
If you take more quinapril than you should
Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose include severe low blood pressure, shock, feeling disorientated, a slow heart rate and kidney failure.
If you forget to take Quinapril
Miss out the forgotten dose completely and take the next dose at the normal time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Quinapril
Do not stop taking Quinapril without talking to your doctor first. It is important to keep taking your tablets. They help to control your blood pressure. Do not wait until your tablets are finished before seeing your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, stop taking quinapril and tell your doctor immediately or go to your nearest hospital emergency department:
Uncommon: may affect up to 1 in 100 people:
• allergic reactions causing swelling of the face, lips, tongue and/ or throat which may cause difficulty breathing or swallowing. Swelling is more likely to occur in black patients (angioedema) severe chest pain which may spread to the neck and shoulders (symptoms of a heart attack or angina)
• tightness of the chest, shortness of breath, wheezing or trouble breathing, irregular or strong heartbeat (palpitations).
Rare: may affect up to 1 in 1,000 people:
• skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with dark ring around the edge) (erythema multiforme)
• blistering of the skin and surrounding surfaces (pemphigus).
Very rare: may affect up to 1 in 10,000 people:
• severe abdominal pain causing you to be sick (intestinal angioedema).
Not known: frequency cannot be estimated from the available data:
• sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing (anaphylaxis)
• severe headache, eyesight changes, numbness or weakness, and difficulty speaking (symptoms of a stroke)
• severe abdominal and back pain accompanied by feeling very unwell (pancreatitis)
• skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens- Johnson syndrome)
• severe skin reaction that starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell (toxic epidermal necrolysis)
• feel unusually tired, look pale, notice unusual bleeding, bruise easily, or suffer from frequent nosebleeds, sore throats or fever (these may occur due to a decrease in the number of blood cells, known as neutropenia and agranulocytosis)
• yellowing of your skin or whites of your eyes, dark urine, pale stools.
These are serious side effects. You may need medical attention.
It is very important that you stop taking Quinapril immediately and see your doctor if you feel dizzy, lightheaded or faint (especially at the start of treatment or when the dose has increased or when you stand up). These side effects are caused by a large drop in your blood pressure and could lead to a heart attack (severe chest pain) or stroke. This is more likely to occur if you have been taking diuretics (water tablets), other blood pressure medication in addition to quinapril or if you are dehydrated or on dialysis. The frequency of this side effect is not known (cannot be estimated from the available data).
Other side effects include:
Common side effects (may affect up to 1 in 10 people):
• sore throat and discomfort when swallowing
• runny or blocked, sneezing, facial pressure or pain
• high potassium levels in the blood
• difficulty sleeping
• dizziness
• headache
• tingling or numbness in the fingers and toes
• low blood pressure
• shortness of breath
• coughing
• nausea
• vomiting
• diarrhoea
• indigestion
• abdominal pain
• back pain
• muscle pain
• tiredness (fatigue)
• feeling of weakness
• chest pain
• increase of creatinine and urea in your blood.
Uncommon side effects (may affect up to 1 in 100 people):
• inflammation of the airways (bronchitis)
• nose or throat infections
• urinary tract infection
• feeling of tension or fullness in the nose, cheeks and behind your eyes, sometimes with a throbbing ache, fever, stuffy nose and loss of the sense of smell (sinusitis)
• confusion
• depression
• feeling nervous
• lazy eye
• drowsiness
• mini-stroke
• feeling of spinning around
• buzzing, hissing, whistling, ringing or other persistent noise in the ears
• fast heart rate
• widening of blood vessels
• dry throat
• wind (flatulence)
• dry mouth
• increase in liver blood test values
• itchy skin or rash
• excessive sweating
• protein in the urine, kidney problems
• inability to get or maintain an erection
• fluid retention in the body
• fever
• swelling of hands, ankles or feet
• illness resulting from the destruction of red blood cells (haemolytic anaemia) in patients with a congenital glucose-6-phosphate dehydrogenase deficiency, a decrease in the oxygen carrying substance in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
• loss of balance
• fainting or loss of consciousness
• inflammation of the lungs which can cause breathlessness, cough and raise temperature (eosinophilic pneumonia)
• inflammation of the tongue
• constipation
• taste changes, hives, skin eruption.
Very rare side effects (may affect up to 1 in 10,000 people):
• blurred vision
• obstruction of the digestive system (bowel)
• skin rash with white, silvery coloured appearance.
Not known side effects (frequency cannot be estimated from the available data):
• illness resulting from the destruction of red blood cells (haemolytic anaemia), low blood platelet count (thrombocytopenia)
• constriction of the airways
• yellowing of the skin and/or eyes
• skin sensitive to light
• severe flaking or peeling of the skin (exfoliative dermatitis)
• hair loss
• narrowing or blockage of blood vessels (vasculitis) and breast enlargement in men (gynaecomastia) have been reported with other ACE inhibitors.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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: 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 Quinapril
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Quinapril contains
The active substance is quinapril hydrochloride. Each tablet contains either 5 mg, 10 mg, 20 mg or 40 mg of quinapril hydrochloride.
The other ingredients are lactose monohydrate; cellulose, microcrystalline; magnesium stearate; magnesium oxide and crospovidone. The coating includes hypromellose, macrogol 400, polysorbate 80, iron oxide yellow (E172), iron oxide black (E172) and titanium dioxide (E171).
What quinapril looks like and contents of the pack
The 5 mg, 10 mg and 40 mg tablets are beige and oval. The 20 mg tablets are beige and round.
The 5 mg tablets are scored on both sides and marked QP/5 on one side and “G" on the other. The 10 mg tablets are marked QP/10 on one side and “G" on the other. The 20 mg tablets are marked QP/20 on one side and “G" on the other. The 40 mg tablets are marked QP/40 on one side and “G" on the other. Quinapril is available in blister packs of 10, 14, 28, 30, 50, 60 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Manufacturers
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komarom, Mylan utca.1, Hungary.
This leaflet was last revised in
May 2015. 625758