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Accupro Tablets 5mg

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Patient Information Leaflet

Accupro™

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

Important things that you SHOULD know about your medicine.

•    Accupro is a treatment for high blood pressure and to help treat heart failure.

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

•    Keep this leaflet. You may need to read it again.

•    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.

•    You should take Accupro regularly to get the maximum benefit, even if you are feeling well.

•    Most people do not have serious problems when taking Accupro but side effects can occur - see Section 4 for details. If you experience swelling of the face, tongue or throat, see your doctor immediately. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

•    Taking other medicines may sometimes cause problems. Check with your doctor or pharmacist before taking this or any other medicines.

•    If you think you are (or might become) pregnant, you must tell your doctor. Do not take Accupro if you are more than 3 months pregnant.

Please read the rest of this leaflet.

It includes other important information on the safe and effective use of this medicine that might be especially important to you. If you have any further questions, ask your doctor or pharmacist.


In this leaflet:

1.    What Accupro is and what it is used for

2.    Before you take Accupro

3.    How to take Accupro

4.    Possible side effects

5.    How to store Accupro

6.    Further information

1. What Accupro is and what it is used for

Accupro is one of a group of medicines called angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors work by widening blood vessels in the body, which can reduce the pressure in the vessels.

It is used to treat high blood pressure, or to help treat heart failure.

02. Before you take Accupro

Do not take Accupro

• If you have had an allergic reaction in the past to Accupro, the active ingredient quinapril hydrochloride, or any of the other ingredients listed in Section 6. This may have been itching, a rash on the skin or difficulty in breathing.

• If you are more than 3 months pregnant.

(It is also better to avoid Accupro in early pregnancy - see pregnancy section.)

• If you have a condition called angioeurotic oedema (a swelling of the face, tongue or throat which causes difficulty breathing).

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

Take special care with Accupro

If any of the following statements applies to you, and you have not already discussed the matter with your doctor, you must contact your doctor before taking Accupro, as this medicine may not be suitable for you:

• You have kidney disease or use a haemodialysis machine (an artificial kidney). • You have liver disease.

• You have heart disease.

• You have collagen vascular disease (deposits of collagen in your blood vessels).

• You are having, or about to have, low density lipoprotein apheresis treatment (removal of cholesterol from your blood by machine).

• You suffer from allergies or asthma.

• If you are having, or about to have, desensitisation treatment, i.e. to reduce the effects of an allergy to a bee or wasp sting.

• You have diabetes.

• You are also taking other medicines.

• You must tell your doctor if you think you are (or might become) pregnant. Accupro 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).

Taking other medicines

There are some medicines that may interact with Accupro:

•    Other blood pressure treatments and diuretics (water tablets).

•    Medicines to treat infections called tetracyclines.

•    Potassium supplements (this includes salt substitutes which often contain potassium).

•    Lithium (used to treat to depression).

•    Non-steroidal anti-inflammatory pain killers (for example aspirin or ibuprofen).

•    Steroids (for example hydrocortisone, dexamethasone or prednisolone).

•    Procainamide (used to correct irregular heartbeats), cytostatic drugs (cancer therapy), immunosuppressants (for the treatment of autoimmune diseases e.g. Crohn’s disease and rheumatoid arthritis), allopurinol (for the treatment of chronic gout).

•    Indigestion and heartburn medicines (antacids).

•    Drugs that have a sedative effect. This includes alcoholic drinks and sleeping pills.

•    Drugs to treat diabetes.

•    ACTH (tetracosactrin) (used to treat adrenal disorders).

•    Sympathomimetics (used to treat heart failure and shock).

You should always tell your doctor if you are taking or have recently taken any other medicine, even those not prescribed, because they might interact with Accupro.

Laboratory Tests

Accupro may affect the results of some laboratory tests. Tell your doctor or hospital you are taking Accupro if you need to have any tests carried out by your doctor or in hospital.

Taking Accupro with food and drink

Accupro can be taken with or without food.

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 Accupro before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Accupro. Accupro 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 Accupro.

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

You will find more about Accupro

united kingdom    on the back of this leaflet

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More information on Accupro

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Driving and using machinery

Your tablets may affect your ability to drive or operate machinery safely. They may make you feel dizzy or weary. If affected, do not drive or operate machinery and contact your doctor immediately.

Important information about some of the ingredients in Accupro

Accupro contains lactose (a type of sugar), if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.    How to take Accupro

For treatment of hypertension (high blood pressure) the starting dose is usually 10 mg a day, which may be increased gradually up to a maximum of 80 mg a day.

For the treatment of heart failure, if you are also taking water tablets (diuretics) to treat your high blood pressure, you are aged 65 or over, or you have kidney disease, the starting dose is usually 2.5 mg, which may be increased up to a maximum of 40 mg a day. Accupro should not be used in children and adolescents under 18 years of age.

Accupro tablets should be taken either once or twice a day. Whatever dose you have been prescribed, follow your doctor’s instructions exactly and never change the dose yourself.

Swallow the tablets whole with water.

Do not chew, divide or crush the tablets.

If you are still not sure, ask your doctor or pharmacist.

It is important to keep taking your tablets. They help to control your blood pressure. Don’t wait until your tablets are finished before seeing your doctor.

If you take more Accupro than you should

Taking too many tablets at once may make you unwell. Tell your doctor or go to your nearest hospital casualty department immediately.

If you miss a dose of Accupro

Do not worry. If you forget to take a dose, 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 missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    Possible side effects

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

STOP taking Accupro and call an ambulance immediately if you experience any of the following symptoms. Although they are very rare, they can be serious.

•    Swelling of the face, tongue and throat which cause great difficulty breathing (angioedema)

•    Severe abdominal pain causing you to be sick (intestinal angioedema)

•    Heart attack, speeding up of the heart rate

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

•    Intense skin rash including hives, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome)

•    Severe allergic (anaphylactoid) reaction to this medicine.

Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare, these symptoms can be serious.

•    Feeling faint, particularly when standing. This may mean your blood pressure is too low (hypotension). This is more likely to occur if you have been taking diuretics (water tablets), other blood pressure medication in addition to Accupro, alcohol or if you are dehydrated or on dialysis. If you feel light headed or faint, lie down until this feeling passes.

•    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 increased risk of infection or fever.

•    Chest pain, tightness of the chest, shortness of breath, wheezing or trouble breathing, irregular or strong heartbeat (palpitations).

•    Severe abdominal and back pain accompanied with feeling very unwell (pancreatitis)

•    Yellowing of the skin or the eyes (jaundice) The following side-effects have also been reported in patients with high blood pressure being treated with Accupro. If any of these side-effects gets serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor:

The most common side effects are:

•    feeling or being sick

•    headache; dizziness

•    tiredness

•    coughing; chest infection

•    nasal stuffiness and/or runny nose (rhinitis)

Less common side effects are:

•    diarrhoea, indigestion; wind

•    painful muscles; muscle weakness; back pain; join pain (gout)

•    feeling weak; sleeplessness

•    kidney and urinary problems

•    numbness or tingling sensation in your limbs

•    depression; nervousness

•    fluid retention in the body

•    inflammation of your sinuses (sinusitis)

•    blurred vision

•    failure/ inability to achieve erection in males

Other side effects of Accupro:

•    ringing or noise in the ears, disorders of balance

•    fainting

•    bronchitis; narrowing of the airways in the lungs (bronchospasm)

•    constipation; obstruction of the digestive system (bowel)

•    dry mouth; taste disturbances

•    lazy eye

•    confusion

•    hair loss

•    hepatitis (liver inflammation)

•    increased numbers of white blood cells or decrease in blood platelets which may result in bruising or easy bleeding; low numbers of red blood cells (anaemia).

Accupro may cause certain changes in your blood and your doctor may do blood tests to monitor this. If you notice bruising, feeing very tired or if you are diabetic and notice sugar levels rising let your doctor know so blood tests can be arranged if necessary.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5.    How to store Accupro

Keep your tablets out of the reach and sight of children.

Do not use Accupro after the expiry date which is stated on carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measure will help protect the environment.

6.    Further information

What Accupro contains and its package

The other ingredients in each tablet are: magnesium carbonate, lactose, gelatin, crospovidone and magnesium stearate.

The tablet coating contains candelilla wax and opadry Y-5-9020G, which is hydroxypropylmethylcellulose, hydroxypropylcellulose, polyethylene glycol, red iron oxide (E172) and titanium dioxide (E171).

Accupro tablets contain 5, 10, 20 or 40 mg of the active ingredient quinapril.

The 5 mg tablets are brown, oval and stamped with the strength on both sides and have a line dividing them in half on both sides.

The 10 mg tablets are brown, triangular, stamped with the strength on one side only and have a line dividing them in half on both sides.

The 20 mg tablets are brown, round, stamped with the strength on one side only and have a line dividing them in half on both sides.

The 40 mg tablets are reddish-brown, stamped with the strength on one side and “PD 535” on the other side.

Each strength of Accupro is supplied in blister packs 28 tablets.

Marketing Authorisation Holder

Pfizer Limited, Sandwich, Kent,

CT13 9NJ, United Kingdom.

Manufacturer

Goedecke GmbH, Freiburg, Germany.

Date last revised: July 2009 Ref: AC 12_1 UK

A Pfizer

Sandwich, England.

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