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Accuretic Tablets 10/12.5 Mg

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461 LEAFLET Accuretic 20150227

PACKAGE LEAFLET: INFORMATION FOR THE USER ACCURETIC TABLETS 10/12.5 (quinapril hydrochloride and hydrochlorothiazide)

Your medicine is known as Accuretic 10/12.5mg Tablets but will be referred to as Accuretic throughout the following leaflet.

Important things that you SHOULD know about your medicine:

•    Accuretic is a treatment for high blood pressure.

•    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 Accuretic regularly to get the maximum benefit, even if you are feeling well.

•    Most people do not have serious problems when taking Accuretic 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 are pregnant, trying to become pregnant or are of child bearing potential and not using adequate contraception, do not take Accuretic and tell your doctor.

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 Accuretic is and what it is used for

2.    Before you take Accuretic

3.    How to take Accuretic

4.    Possible side effects

5.    How to store Accuretic

6.    Further information

1. WHAT ACCURETIC IS AND WHAT IT IS USED FOR

Accuretic is used to treat high blood pressure.

Accuretic contains the active ingredients quinapril and hydrochlorothiazide. Quinapril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors work by widening blood vessels in the body, which can help to reduce the pressure in the vessels. Hydrochlorothiazide belongs to a group of medicines called diuretics. Diuretics help the body to get rid of extra fluid and are used in patients with high blood pressure. Because they get rid of fluid diuretics are sometimes called ‘water tablets'.

2. BEFORE YOU TAKE ACCURETIC

4 Do not take Accuretic

•    If you ever had a reaction to Accuretic, any of its ingredients, similar drugs or to a group of antibiotics called sulphonamides.

•    If you are pregnant, trying to become pregnant, or are of child bearing potential and are not using adequate contraception.

•    If you have kidney disease or are experiencing problems passing water (anuria).

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

•    If you have hereditary (inherited)/idiopathic (unknown cause) angioneurotic oedema (a swelling of the face, tongue or throat which causes difficulty breathing).

•    If you have a history of angiooedema relating to previous treatment with an ACE inhibitor.

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

4 Warnings and precautions

Talk to your doctor or pharmacist before taking Accuretic.

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 Accuretic, as this medicine may not be

suitable for you:

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

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

•    You have liver disease

•    You have heart disease

•    You are elderly

•    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

•    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 are of child bearing potential, talk to your doctor about adequate contraception.

•    You are breast-feeding or about to start breast-feeding

•    You have diabetes or gout

•    You have systemic lupus erythematosus (SLE) an allergic condition which causes joint pain, skin rashes and fever.

•    The active ingredient hydrochlorothiazide can cause an unusual reaction resulting in visual disturbances and increased pressure in the eye. Symptoms of increased pressure in the eye are intense pain, redness of the eye, headaches, tender eye area, misty vision and loss of vision.

If this is not treated, it can lead to permanent loss of vision. If you experience any such symptoms, you should seek immediate medical attention.

•    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

•    You are also taking other medicines.

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 Accuretic'. Other medicines and Accuretic

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. There are some medicines that may interact with Accuretic. Your doctor may need to change your dose and/or to take other precautions:

•    Angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings ‘Do not take Accuretic' and ‘Warnings and precautions').

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

•    Medicines to treat infections called tetracyclines.

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

•    Anaesthetics.

•    Lithium (used to treat depression).

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

•    Corticosteroids (for example hydrocortisone, dexamethasone or prednisolone) and ACTH (tetracosactide).

•    Procainamide (used to correct irregular heartbeats), cytostatic drugs (cancer therapy), immunosuppressants (for the treatment of autoimmune diseases such as 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.

•    Digitalis glyocsides (for the treatment of heart problems).

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 Accuretic.

Surgery

Remember to tell any medical staff that you are taking Accuretic. This is important if you go into hospital for an operation as your anaesthetist will want to know.

Laboratory Tests

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

4 Taking Accuretic with food and drink

Accuretic can be taken with or without food.

4 Pregnancy

Do not take Accuretic if you are pregnant or trying to become pregnant. Ask your doctor for advice before taking any medicine.

4 Breast-feeding

Tell your doctor if you are breast-feeding or about to start breastfeeding. Your doctor will advise you on the benefits and risks of taking Accuretic whilst breast-feeding and decide whether or not you should continue taking Accuretic.

4 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 Accuretic

Accuretic 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 ACCURETIC

The usual dose of Accuretic is one tablet each day. Your doctor may increase the dose to two tablets which may be taken together once a day or may be taken separately, one tablet in the morning and one in the evening.

Accuretic should not be used in children and adolescents under 18 years of age.

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 Accuretic than you should

Taking too many tablets at once may make you unwell. If you take too many Accuretic tablets, tell your doctor or go to your nearest hospital casualty department immediately.

If you miss a dose of Accuretic:

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, Accuretic can cause side effects although not everybody gets them.

STOP taking Accuretic and seek immediate medical attention if

you experience any of the following symptoms. Although they are very rare, they can be serious.

•    Severe allergic (anaphylactoid) reaction to this medicine such as 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 (symptoms may include chest pain, tightness of the chest, shortness of breath or trouble breathing), 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).

Tell your doctor immediately if you experience any of the following symptoms after taking Accuretic. 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 Accuretic, alcohol, or if you are dehydrated or are 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. You may not have enough of certain white blood cells (neutropenia/agranulocytosis) which may lead to increased risk of infection or fever.

•    Chest pain (angina), 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 Accuretic. If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Common side effects

These can affect up to 1 in every 10 people:

•    diarrhoea, indigestion, mild stomach pain, feeling or being sick

•    dizziness, headache, tiredness, feeling weak, sleepiness or sleeplessness

•    painful muscles, muscle weakness, back pain,

•    high levels of uric acid in your blood causing swollen, painful joints (gout)

•    coughing, bronchitis

•    nose or throat infections, nasal stuffiness and/or runny nose (rhinitis)

•    widening of blood vessels Uncommon side effects:

These can affect up to 1 in every 100 people:

•    kidney and urinary problems, urinary tract infection

•    numbness or tingling sensation in your limbs, aching joints

•    depression, nervousness, confusion

•    ringing or noise in the ears

•    wind

•    dry mouth, or throat, taste disturbances

•    fluid retention in the body

•    inflammation of your sinuses (sinusitis)

•    increased sweating, feeling hot (fever)

•    hair loss, itching, sensitivity of skin to light

•    failure/inability to achieve penile erection

•    viral infection Rare side effects

These can affect up to 1 in every 1000 people:

•    problems with balance

•    inflammation of the lungs which can cause breathlessness, cough and raised temperature

•    constipation

• inflammation of the tongue

• inflammation of blood vessels

Very Rare side effects

These can affect up to 1 in every 10,000 people:

•    obstruction of the digestive system (bowel)

•    blurred vision

Other side effects (how often they happen is not known):

•    skin discolouration

•    decreased 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)

•    bleeding from blood vessels in the brain

•    narrowing of the airways in the lungs (bronchospasm)

•    liver inflammation (hepatitis).

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

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

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 ACCURETIC

   KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C.

•    Do not use the tablets after the expiry date on the package. For example "Expiry 11-05" means you should not take your tablets after Nov 2005. Return any out-of- date tablets to your pharmacist.

•    If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. FURTHER INFORMATION

What Accuretic contains

•    Each film-coated tablet contains 10mg quinapril (as the hydrochloride) and 12.5mg of hydrochlorothiazide.

•    Accuretic also contains the following inactive ingredients: lactose monohydrate, heavy magnesium carbonate, povidone, magnesium stearate, crospovidone. Film Coat: pink opadry OY-6937, candelilla wax.

What Accuretic looks like and contents of the pack

Accuretic tablets are pink, elliptical film-coated tablet scored on both sides.

Accuretic Tablets are available as calendar blister packs of 28 tablets.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane, Wembley, Middlesex, HA0 1DX.

Manufacturer

This product is manufactured by Pfizer Manufacturing Deutschland GmbH Betriebstatte Freiburg, Mooswaldallee 1, D-79090 Freiburg, Germany.

| POM | PL No: 08747/0461

Leaflet revision date: 27 February 2015

Accuretic is a registered trade mark of Parke, Davis & Company LLC.

461 LEAFLET Accuretic 20150227

lazy eye

feeling of spinning or rotation of surroundings (vertigo) fainting, low blood pressure