Package leaflet: Information for the user Quinapril 5 mg, 10 mg, 20 mg and 40 mg Film-Coated Tablets

quinapril hydrochloride

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. See section 4.

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 drugs called Angiotensin Converting Enzyme (ACE) Inhibitors.This medicine works by widening the blood vessels, making it easier for the heart to pump blood around the body. This helps to lower blood pressure.

Quinapril is used:

•    in the treatment of high blood pressure.

•    in the treatment of heart failure (a condition when your heart is not coping with its workload properly).

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).

• If you have ever experienced an allergic reaction to another ACE-inhibitor drug e.g, captopril, ramipril, which has led to swelling of hands, lips, tongue or throat.

•    If you have ever been diagnosed with a condition known as hereditary angioedema (rapid swelling of the face, tongue or throat).

•    If you are more than 3 months pregnant (it is also better to avoid quinapril in early pregnancy - see section ‘Pregnancy and breast-feeding’).

•    If you have an obstruction in your heart that slows blood in the heart.

•    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 have aortic stenosis (narrowing of the main blood vessel from the heart)

•    If you suffer from allergies or asthma

If you may be dehydrated, for example, you have suffered from excessive vomiting or diarrhoea recently or are on a low salt diet.

•    If you suffer from kidney problems, including narrowing of the blood vessels leading to you kidneys, or you are on dialysis, or have had a kidney transplant.if you suffer from liver problems.

•    If you are about to have a treatment called ‘LDL apheresis’, which is the removal of cholesterol from your blood by a machine.

•    If you    are to undergo any desensitisation treatment to reduce the effects of an allergic condition.

•    If you    suffer from a collagen vascular disease such as lupus erythematosus.

•    If you suffer from a condition called ‘hyperaldosteronism’ (excess of aldosterone hormone is produced).

•    If you have diabetes.

•    If you    are going to have an anaesthetic (even at the dentist) or undergo any surgery.

•    If you    are a black patient, this medicine might not work as well for you or you might be    more likely to

suffer    serious side effects (e.g. angioedema- swelling of the face, eyes, tongue or throat).

•    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 Quinapril’.

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 section ‘pregnancy and breast-feeding’).

Quinapril can cause cough, talk to your doctor if you develop a dry, persistent cough.

Quinapril can cause changes in your blood test results. Talk to your doctor if you develop a severe sore throat or severe mouth ulcers, particularly if you suffer from kidney problems or collagen vascular disease. This may mean you do not have enough of certain white blood cells (neutropenia/agranulocytosis), which may lead to an increased risk of infection or fever.

Other medicines and Quinapril

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in

particular:

•    Diuretics (also known as water tablets) e.g amiloride, spironolactone or triamterene, as the risk of low blood pressure may be increased.

•    Potassium supplements (this includes salt substitutes that often contain potassium), as potassium may increase above expected levels.

•    Other medicine for high blood pressure e.g. atenolol, diltiazem, methyldopa as the effects of Quinapril may be increased.

•    Non-steroidal anti-inflammatory drugs (NSAIDs) e.g. aspirin, diclofenac, ibuprofen, piroxicam, as the effectiveness of Quinapril may be reduced.

•    Anti-diabetic medicines, tablets as well as insulin.

•    Tetracycline (an antibiotic).

•    Immunosuppressant drugs (medicines that reduce the body’s natural defence system) e.g. azathioprine, ciclosporin and corticosteroids.

•    Hypnotics (medicines to help you sleep).

•    Tricyclic antidepressants e.g. amitriptyline.

•    Narcotic drugs (used to treat moderate or severe pain) e.g. diamorphine, morphine, pethidine, as the risk of low blood pressure may be increased.

•    Lithium (used to help treat mood swings and severe depression), as levels of lithium 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) occurring.

•    Antipsycotics (medicines to treat schizophrenia, manias, depression and paranoia) e.g. haloperidol, as the risk of low blood pressure may be increased.

•    Procainamide (used to treat some heart conditions).

•    Cytostatic agents (medicine to treat cancer) e.g. mercaptopurine, as there is an increased risk of leucopenia (decrease in the number of white cells in the blood).

•    Antacids (used to treat indigestion and heartburn) e.g. aluminium hydroxide, dimeticone, as the effectiveness of Quinapril may be reduced.

•    Sympathomimetics e.g. dopamine, terbutaline, salmeterol, salbutamol, ephedrine, adrenaline, or phenylpropanolamine. Phenylpropanolamine and ephedrine may be present in medicines for colds and nasal stuffiness.

•    Trimethoprim (an antibiotic) as if given with Quinapril may raise your blood potassium level.

•    Gold injections (for example, sodium aurothiomalate) which may cause flushing, dizziness, nausea (feeling sick) and your blood pressure to drop too much.

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 and alcohol

•    You should keep your alcohol intake to a minimum while you are taking this medicine.

•    Quinapril can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

Pregnancy

DO NOT take Quinapril if you are more than 3 months pregnant.

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 breast-feeding. Breast-feeding newborn babies (in the 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 blurred vision, dizziness or weariness. If you are affected, DO NOT drive or operate machinery.

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.

The tablets should be swallowed preferably with a drink of water. The tablets should usually be taken once a day, in the morning, but your doctor may ask you to take them twice a day e.g. in the morning and in the evening. The recommended dose is:

•    Adults:

High Blood Pressure:

The recommended starting dose is 10 mg once daily. Your doctor may, if necessary, increase your dose to 20 or 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. Your doctor will adjust your dose to suit you.

Heart Failure:

For heart failure the recommended starting dose is 2.5 mg once daily. After this, your doctor will gradually increase your dose over 2 to 3 weeks to reach an effective dose. The maximum dose is 40 mg a day, taken as one or two doses.

Occasionally some people need higher doses than those stated above.

•    Older people or patients with kidney problems:

If you are older people or have kidney problems the dose may be lower. An initial dosage in high blood pressure of 2.5 mg is recommended. Your dose will then be adjusted by your doctor.

•    Use in children and adolescents

Efficacy and safety of use in children and adolescents has not been established. Use in children and adolescents is therefore not recommended.

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 accidentally swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

An overdose can cause very low blood pressure leading to dizziness and fainting; weak pulse and clammy skin; stupor, a slow heart beat, chemical imbalance in the body fluids 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 tablet. Take the remaining doses at the correct time.

If you stop taking Quinapril

Do not stop taking your medicine without talking to your doctor first, even if you feel better.

If you see another doctor or go into a hospital, let him or the staff know what medicines you are taking.

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 the following occurs, stop taking Quinapril and tell your doctor immediately or go to the casualty department at your nearest hospital:

swelling of the lips, face and neck, leading to severe difficulty breathing; severe skin rash or hives. This is a very serious but very rare side effect. You may need urgent medical attention or hospitalisation.

You may feel dizzy, light-headed or have visual problems for a short time after you take your first dose, or when you first take an increased dose. This may mean your heart pressure is too low. It may help to lie down until you feel better. If you are worried, or if these effects continue, talk to your doctor or pharmacist.

The following side effects have been reported

Common (may affect up to 1 in 10 people) :

•    dizziness

•    very low blood pressure

•    cough

•    shortness of breath

•    nausea (feeling sick), vomiting, diarrhoea, abdominal pain, indigestion and/or heartburn

•    headache

•    fatigue, weakness, chest pain

•    sore throat

•    runny and itchy nose

•    pins-and-needles (tingling sensation in the skin)

•    muscle and back pain

•    sleeplessness

•    increased creatinine and urea in blood

•    high levels of potassium in blood

Uncommon( may affect up to1 in 100 people):

•    dry mouth or throat, flatulence

•    itching, rash, skin reaction causing skin peeling, increased perspiration, or nettle rash

•    palpitations (a sensation of the heart beating) or chest pain

•    absence of heartbeat or fast heartbeat, and a more serious condition such as heart attack

• 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

•    inflammation of the sinuses or upper chest

•    disturbance of kidney function, protein in the urine, impotence

•    sleepiness or nervousness, vertigo (a sensation that your surroundings are spinning either up and down or from side to side), depression, confusion

•    sudden fall in blood pressure upon standing up or stretching

•    widening of blood vessels

•    ringing in the ears

•    ‘lazy eye’

•    bronchitis (infection of the main airways)

•    urinary tract infection

•    swelling of the extremities, face, lips, tongue and throat (a condition known as angioedema)

•    swelling of the deeper layer of skin, usually in lower extremities, due to the accumulation of fluids

•    swelling of the legs, face and arms

•    fever

•    mini-stroke

Rare(may affect up to 1 in 1,000 people):

•    disturbances of balance, numbness

•    blurred vision

•    fainting, bleeding in the brain or stroke-like symptoms

•    worsening of asthma ( causes the airways of the lungs to become inflamed and swollen) , swelling of the lungs from an increase in eosinophils, a type of white blood cell (eosinophilic pneumonia), narrowing of the airways in lungs (bronchospasm)

•    taste disturbances, constipation, pancreatitis (inflammation of the pancreas), inflammation of the tongue, intestinal obstruction

•    disturbance of liver 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 pain

•    a condition including fever, inflammation of the blood vessels, muscle pain, joint pain or arthritis and changes in blood chemistry has been reported.

•    gynaecomastia (a condition in which one or both breasts in males enlarge) and inflammation of blood vessels have been reported with other ACE inhibitors

•    changes in blood test results may occur while being treated with Quinapril

•    you may not have enough of certain white blood cells (agranulocytosis) which may lead to an increased risk of infection or fever.

Very rare( may affect up to 1 in 10, 000 people):

•    inflammation of the lungs

•    jaundice (yellowing of the skin and whites of the eyes), inflammation of the liver

•    kidney failure

•    pale stool, dark urine, itchiness

•    kidney failure

•    severe abdominal pain, causing you to be sick, resulting from inflammation of the bowel (intestinal angioedema)

•    different inflammatory conditions of the skin

Not known (frequency cannot be estimated from the available data):

•    weakness of arms, legs or problems speaking which may be symptoms of a possible stroke

•    decrease in blood platelets (thrombocytopenia)

•    a condition in which red blood cells are destroyed (haemolytic anaemia)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

Store in the original package. Do not store above 25 ^oC.

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 transfer the tablets to another container. Keep them in a secure place where children cannot get at them.

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 protect the environment.

6. Contents of the pack and other information What Quinapril tablets contain

•    The active substance is 5 mg, 10mg, 20mg or 40 mg Quinapril as quinapril hydrochloride.

•    The other ingredients are magnesium carbonate, calcium hydrogen phosphate, gelatin, crospovidone, magnesium stearate, hypromellose (E464), titanium dioxide (E171) and macrogol. The 40 mg tablets also contain 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 with a break line on both sides.

Quinapril 10 mg tablets are white, oval film-coated tablets debossed “10” on one side with a score line on the other side.

Quinapril 20 mg tablets are white, oval film-coated tablets debossed “20” on one side with a score line on the other side.

Quinapril 40 mg tablets are yellow, oval film-coated tablets debossed “40” on one side with a score line on the other side.

The product is available in pack sizes of 28, 30, 50, 56, 100, or 300 tablets.

The 5 mg and 20 mg tablets are also available in packs of 14 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva UK Ltd,

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex,

BN22 9AG,

England

Manufacturer

Teva pharmaceuticals limited pallagi street 13, debrecen, hu-4042,

Hungary

This leaflet was last revised in December 2014