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Quinapril 5mg Tablets

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Quinapril 5mg, 10mg, 20mg and 40mg Tablets

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet you may nee to read it again.

•    If you have any further questions, ask you 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.

In this leaflet

1.    What Quinapril tablets are and what they are used for

2.    Before you take

3.    How to take

4.    Possible side effects

5.    How to store

6.    Further information

1.    What Quniapril Tablets are and what they are used for

Quinapril is one of a group of medicines called angiotensin converting enzyme (ACE) inhibitors. These

medicines work by widening blood vessels in the body, which can lower pressure in the blood vessels.

Quinapril may be used for treating:

•    High blood pressure

•    Heart failure

2.    Before you take

Do not take Quinapril Tablets and tell your doctor if you:

•    are more than 3 months pregnant.(It is also better to avoid Quinapril Tablets in early pregnancy - see ‘Pregnancy and breast feeding’.)

•    have ever had an allergic reaction to Quinapril Tablets, any of the ingredients in the tablet or any other ACE inhibitor treatment. (An allergic reaction may include swelling, a rash, itching or difficulty breathing)

•    have ever experienced angioedema (a puffy swollen face, tongue or body) either without knowing the cause, because the condition runs in your family or after taking previous ACE inhibitor treatments

•    suffer from obstruction of the left side of the heart (dynamic left ventricular out flow obstruction)

•    have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Check with your doctor or pharmacist before taking Quinapril Tablets if you:

•    have aortic stenosis (narrowing of the main blood vessel from the heart), heart valve problems (mitral valve stenosis) or an enlarged heart, heart failure

•    have kidney problems, have had a kidney transplant or you use a haemodialysis machine (an artificial kidney), have kidney artery stenosis (narrowing of the main blood vessel to the kidney)

•    low blood, high blood pressure

•    have liver problems

•    have diabetes mellitus, hyperaldosteronism (an overproduction of aldosterone) or collagen vascular disease (deposits of collagen in the blood vessels)

•    are having desensitisation treatment e.g. with snake venom

•    are due to have an operation that may involve use of an anaesthetic

•    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, telmesartan, irbesartan), in particular if you have diabetes-related kidney problems.

•    Aliskerin

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 Tablets’

You must tell your doctor if you think you are (or might become) pregnant. Quinapril Tablets are not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as they may cause serious harm to your baby if used at that stage (see ‘Pregnancy and breast feeding’).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

•    Tetracycline-an antibiotic used to treat various infections

•    Diuretics (“water tablets”) e.g. amiloride-used to remove excess fluid or treat high blood pressure or other drugs used to lower blood pressure e.g. atenolol, methyldopa

•    Potassium supplements or potassium-containing salt substitutes e.g. Lo-Salt, used to increase potassium levels in the body

•    Heparin to dissolve blood clots such as deep vein thrombosis (DVT)

•    Lithium-used to moderate mood in certain conditions including depression and mania

•    NSAIDs-Drugs used to calm inflammation and pain associated with conditions like arthritis e.g. ibuprofen, diclofenac and high doses of aspirin

•    “Sympathomimetic” medicines such as salbutamol for asthma; the decongestant pseudoephedrine; phenylephrine, brimonidine or dipivefrine used in eye drops; ephedrine or noradrenaline (norepinephrine) used in heart surgery

•    Allopurinol- for prevention of attacks of gout

•    Drugs used to calm the immune or inflammatory responses of the body e.g. azathioprine, ciclosporin, prednisolone

•    Procainamide-used to treat irregular heart rhythm

•    Barbiturates-used for treating epilepsy e.g. phenobarbital

•    Strong pain-killers containing codeine, dihydrocodeine or morphine

•    Indigestion remedies e.g. magnesium trisilicate, aluminium hydroxide

•    Insulin or tablets to treat diabetes e.g. metformin, tolbutamide, glibenclamide

•    Sodium aurothiomalate (injectable gold) for treatment of progressive rheumatoid arthritis

•    Atorvastatin used to treat symptomatic cardiovascular disease

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 Tablets’ and ‘Warnings and precautions’)

Alcohol - You should take care drinking alcohol with this medication as the combination might cause your blood pressure to fall too far. Please discuss with your doctor if in doubt.

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 Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Quinapril Tablets. Quinapril Tablets are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as they may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

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 Tablets.

In the case of an older baby your doctor should advise you on the benefits and risks of taking Quinapril Tablets whilst breast-feeding, compared with other treatments.

Driving and using machines:

Quinapril Tablets may make you feel dizzy or tiredness. Make sure you are not affected before you drive or operate machinery.

Sugar intolerance

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.

Other precautions you should take:

If you see another doctor or go into hospital, let them know what medicines you are taking. An anaesthetist needs to know you are taking Quinapril Tablets before an operation.

3. How to take

Always take Quinapril tablets exactly as your doctor has told you. If you are not sure, check with you doctor or pharmacist.

Doses:

Adult

High Blood Pressure

If no other medicines are being taken to treat high blood pressure the usual starting dose is 10mg Quinapril once daily. This may be increased gradually according to response to 20mg to 40mg daily, taken as either one single or two doses per day.

If diuretics are already being taken to treat high blood pressure, your doctor may tell you to stop taking them two to three days before starting treatment with Quinapril Tablets. The starting dose is usually 2.5mg Quinapril once daily. The dose may be increased or adjusted as above.

Heart Failure

The usual starting dose is 2.5mg Quinapril once daily. This may be increased or adjusted as above to a maximum of 40mg Quinapril per day, taken as a single or twice daily dose. The usual maintenance dose is 10mg to 20mg Quinapril as either one single or two doses per day, usually with an additional drug e.g. a diuretic.

Elderly

The doctor may prescribe a lower starting dose for high blood pressure of 2.5mg once daily in certain patients.

Reduced Kidney Function

Your doctor may prescribe a lower starting dose.

Children

Not recommended.

Swallow these tablets with water. Take them at the same time each day. This medicine should be taken for as long as your doctor tells you to; it may be dangerous to stop without their advice.

If you forget to take Quinapril Tablets:

If you forget to take a dose, take one as soon as you remember. Then go on as before. DO NOT take two doses at the same time. If you are worried ask your pharmacist or doctor for advice.

If you take more Quinapril Tablets than you should:

Do not take more tablets than your doctor tells you to. If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell you doctor immediately. Signs of an overdose include feeling faint due to low blood pressure. Take the container and any remaining tablets with you to show to the doctor.

4. Possible side effects

Like all medicines, Quinapril tablets can cause side effects, although not everybody gets them.

Stop taking Quinapril tablets and contact your doctor at once if you experience the following allergic reaction: skin rash, swelling of the face, lips, tongue or throat, or difficulty or shallow breathing (i.e. asthma)

Tell your doctor if you notice and of the following side effects or notice any other side effects not listed:

Common (Less than 1 in 10 users but more than 1 in 100 users) - Raised blood potassium levels, sleeping problems, dizziness, headache, tingling or pins and needles, low blood pressure, persistent dry cough, sore throat, difficulty breathing, runny nose, feeling or being sick, diarrhoea, indigestion, stomach pain, muscle or back pain, chest pain, tiredness, weakness and loss of strength, changes in the blood seen in tests.

Uncommon (Less than 1 in 100 users but more than 1 in 1000 users) - Changes in sleep pattern, nervousness, numbness, depression, confusion, sleepiness or drowsiness, temporary blockage of blood supply (e.g. stroke), poor eyesight, irregular heart beat, angina pectoris (a crushing pain often radiating from the chest and down the left arm), racing heart beat, heart attack, widening of the blood vessels, inflammation of the sinus, throat and nose infections, inflammation of the airways (bronchitis), Dry mouth or throat, wind, itching, rash (including exanthema), increased sweating, bladder infections, protein in the urine (detected by urine test), reduced sexual potency in men, rise in body temperature (fever), water retention in the hands, body and feet, vertigo, ringing in the ear (tinnitus)

Rare (Less than 1 in 1000 users) - Unsteady balance, nervous system problems, fainting, bleeding on the brain, inflammation in the lung, worsening of asthma, taste disturbance, constipation, inflammation of the tongue, altered liver function, itchy skin rash caused by allergic reaction-pale or red irregular raised patches with severe itching (hives), severe skin rashes including erythema multiforme, serious blistering (pemphigus), joint pain, changes in the amount or the need to pass water.

Very Rare (Less than 1 in 10,000 users )- Blurred vision, inflammation of the lungs, intestinal blockage, swelling of the wall of the bowels (intestines), a rash resembling psoriasis, kidney failure

Not Known (Cannot be estimated from the available data) - reduction in white blood cell count (detected in blood tests or through getting infections), agranulocytosis (symptoms include fever, joint or muscle pain, and mouth or throat ulcers) reduction in red blood cells which cause pale yellow skin, weakness and breathlessness, reduction in platelets in the blood, stroke, feeling faint on standing or sitting up due to low blood pressure, inflammation of the pancreas causing pain and tenderness in the abdomen and back, jaundice (yellow of the skin and eyes), inflammation of the liver, Stevens Johnson syndrome (localised or widespread reddening with lumps or blisters), exfoliative dermatitis (reddening, scaling and peeling of the skin), hair loss, breakdown of the surface layer of the skin, oversensitivity to light, changes in the blood seen in test,

Changes to that skin may also be caused by fever, muscle and joint pain, vascular inflammation, inflammations of serous tissues and certain changes in laboratory values.

Quinapril Tablets can cause changes to results of blood tests for certain naturally occurring substances.

Tell your doctor if you notice or are worried by any of these side effects or notice any other effects not listed. Most people taking this medicine will not experience any problems.

5.    How to store

Keep out of reach and sight of children Do not store above 25°C

Do not use the tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of the month.

Medicine should not be disposed of via waterwater or household waste. Ask you pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further information

Quinapril Tablets come in four strengths.

Each 5mg film-coated tablet contains 5.415mg of the active ingredient quinapril hydrochloride, equivalent to 5mg quinapril.

Each 10mg film-coated tablet contains 10.83mg of the active ingredient quinapril hydrochloride, equivalent to 10mg quinapril.

Each 20mg film-coated tablet contains 21.66mg of the active ingredient quinapril hydrochloride, equivalent to 20mg quinapril.

Each 40mg film-coated tablet contains 43.32mg of the active ingredient quinapril hydrochloride, equivalent to 40mg quinapril.

The tablets also contain: magnesium carbonate heavy, calcium hydrogen phosphate anhydrous (E341), starch pregelatinised, croscarmellose sodium and magnesium stearate.

The coating contains: hypromellose 6cP (E464), hydroxypropylcellulose (E464), titanium dioxide (E171), macrogol and iron oxide red (E172).

Quinapril tablets are available in pack sizes of 14, 28, 30, 50, 56, 60, 84, 90, 100.*

*only the marketed pack size will appear on the final leaflet

Your tablets are made by Actavis hf, Reykjavikurvegur 78, IS-220 Hafnarfjordur, Iceland. The Marketing Authorisation holder is Actavis, Barnstaple, EX32 8NS, UK.

Date of last revision: July 2014