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Accuretic 10/12.5mg Tablets

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Document: leaflet MAH BRAND_PLPI 15184-0717 change

Accuretic 10/12.5mg Tablets

(quinapril hydrochloride/hydrochlorothiazide)

Ref: 0717/071016/1/F

Patient Information Leaflet

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. Most people do not have serious problems when taking Accuretic but side effects can occur. If you experience swelling of the face, tongue or throat, see your doctor immediately.

*    Accuretic is a treatment for high blood pressure.

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

*    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.

Your medicine is called Accuretic 10/12.5mg tablets and will be referred to

as Accuretic throughout this Patient Information Leaflet.

What is in this leaflet

What Accuretic is and what it is used for

r® What you need to know before you take Accuretic How to take Accuretic Possible side effects How to store Accuretic Contents of the pack and other information

^ 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 (HCTZ). 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. HCTZ 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'.

You must talk to a doctor if you do not feel better or if you feel worse.

[2) What you need to know before you take Accuretic

Do not take Accuretic:

*    If you are allergic to quinapril, hydrochlorothiazide, any of the other ingredients of this medicine (listed in section 6), similar drugs or to a group of antibiotics called sulphonamides.

*    If you are in your second or third trimester of pregnancy. It is also better to avoid Accuretic in early pregnancy - see Pregnancy, breast-feeding and fertility section.

*    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 angioedema 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Accuretic if:

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

*    You have kidney disease, a transplanted kidney, or use a haemodialysis machine (an artificial kidney).

*    You have liver disease.

*    You have heart disease or heart failure.

*    You are elderly.

*    You are of African-Caribbean ethnic origin.

*    You have low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (water tablets), low-salt diet, diarrhoea, vomiting, or haemodialysis.

*    You have a dry cough.

*    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 have a history of severe allergic reactions, asthma or angioedema (such as swelling of the eyes, face, lips, tongue or throat).

*    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 planning to become pregnant, or you just became aware of being pregnant (see Pregnancy, breast-feeding and fertility section).

*    You are breast-feeding or about to start breast-feeding (see Pregnancy, breast-feeding and fertility section).

*    You are taking medicines containing lithium.

*    You have diabetes or gout.

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

*    You have a salt or electrolyte imbalance in your blood (e.g. sodium or potassium), your doctor may want to monitor you more closely.

*    You experience 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.

*    You are about to have surgery or receive anaesthetics (even at the dentist), remember to tell any medical staff that you are taking Accuretic.

*    You have a fever, sore throat, mouth ulcers, tiredness, unexplained bruising or bleeding, or a blood problem such as low or lack of white blood cells (neutropenia or agranulocytosis).

*    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 Accuretic'.

Children and adolescents

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

Other medicines and Accuretic

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. 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 (including aliskiren and water tablets).

*    Medicines called tetracyclines used to treat infections.

*    Cholestyramine and colestipol (medicines used to treat high levels of fats in the blood).

*    Medicines called ‘pressor amines' such as norepinephrine and epinephrine.

*    Antibiotics like sulfamethoxazole and trimethoprim.

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

*    Anaesthetics.

*    Lithium (used to treat depression).

*    Non-steroidal anti-inflammatory pain killers (including aspirin or ibuprofen).

*    Corticosteroids (including hydrocortisone, dexamethasone or prednisolone) and ACTH (tetracosactide) or drugs known to reduce the amount of potassium in the blood.

*    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, uricosurics and xanthine oxidase inhibitors (for the treatment of chronic gout).

*    Indigestion and heartburn medicines (antacids).

*    Medicines that have a sedative effect. This includes alcoholic drinks and sleeping pills.

*    Medicines to treat diabetes (including vildagliptin).

*    Digitalis glycosides (e.g. digoxin, for the treatment of heart problems).

*    mTOR inhibitors used to treat kidney cancer (including temsirolimus).

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.

*    Accuretic with food and drink

See section 3 How to take Accuretic.

*    Pregnancy, breast-feeding and fertility

Do not start taking Accuretic if you are pregnant or planning to become pregnant.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will normally advise you to stop taking Accuretic before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Accuretic. Accuretic is not recommended during 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.

Tell your doctor if you are breast-feeding or about to start breast-feeding. Accuretic is not recommended for mothers who are breast-feeding.

*    Driving and using machines:

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

Accuretic contains lactose monohydrate

Lactose monohydrate is 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

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Do not wait until your tablets are finished before seeing your doctor.

Adults

The recommended dose is one tablet each day. Try to take the tablet at about the same time every day. Accuretic can be taken with or without food.

Accuretic is not recommended for use in patients who suffer with kidney disease with a creatinine clearance of less than 40 mL/min.

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.

Swallow the tablets whole with water. Do not chew, divide or crush the tablets.

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 forget to take 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 forgotten dose.

Patient Information Leaflet (continued)

If you stop taking Accuretic

Do not stop taking your tablets or alter the dose you are currently taking without seeing your doctor first. It is important to keep taking your tablets. They help to control your blood pressure.

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

Possible side effects

Like all medicines, this medicine 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 as they can be serious:

Common: may affect up to 1 in 10 people

*    Severe chest pain, tightness of the chest, shortness of breath, wheezing or trouble breathing, irregular or strong heartbeat (palpitations). These symptoms may be due to heart attack or angina.

Uncommon: may affect up to 1 in 100 people

*    Ringing or noise in the ears.

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

*    Severe allergic (anaphylactoid) reaction to this medicine such as swelling of the face, tongue and throat which cause great difficulty breathing (angioedema).

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

*    Fever, cough, and other nonspecific symptoms, followed by redness and sloughing of the skin and mucous membranes (Toxic epidermal necrolysis). A skin rash with irregular red spots or ‘target' lesions (erythema multiforme). Intense skin rash including hives, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome).

*    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.

*    Neutropenia/agranulocytosis resulting in decreased numbers of white blood cells or decrease in blood platelets which may result in bruising or easy bleeding.

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

*    Liver inflammation (hepatitis), abdominal pain, nausea, dark brown urine, yellowing of the skin or the eyes (jaundice).

*    Inflammation of the kidneys (tubulointerstitial nephritis) symptoms include fever and a rash but occasionally patients might notice blood in urine as well.

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: may affect up to 1 in 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

*    increased levels of creatinine in the blood

*    increased levels of blood urea

*    chest pain

*    increased levels of Potassium in serum

*    rapid heart rate

Uncommon: may affect up to 1 in 100 people

*    kidney and urinary problems, urinary tract infection

*    numbness or tingling sensation in your limbs, aching joints

*    depression, nervousness, confusion

*    wind

*    lazy eye

*    feeling of spinning or rotation of surroundings (vertigo)

*    fainting, low blood pressure

*    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

*    heart attack (myocardial infarction)

*    increased glucose levels in blood

*    painful joints

*    shortness of breath

*    swelling under the skin

*    protein in urine

Rare: may affect up to 1 in 1,000 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

*    psoriasis

*    swelling of the hands, face and tongue (angioedema)

*    skin disorders

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

*    obstruction of the digestive system (bowel)

*    blurred vision

*    hives

Not known: frequency cannot be estimated from the available data

*    allergic condition which causes joint pain, skin rashes and fever (systemic lupus erythematosus)

*    inflammation of the lining of the lungs, heart or abdomen (serositis)

*    erythema and scaling of the skin (dermatitis exfoliative)

*    bruising or a purple or red rash (purpura)

*    small fluid-filled blisters on the skin (pemphigus)

*    skin discolouration

*    low numbers of red blood cells (anaemia)

*    bleeding from blood vessels in the brain

*    narrowing of the airways in the lungs (bronchospasm)

*    short-sightedness

*    acute closure glaucoma (increased pressure in the eyes)

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.

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.

[a How to store Accuretic

Expiry date

Do not use this medicine after the expiry date shown on the carton label or blister strip. If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to. If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

Storing your medicine

*    Do not store above 25°C

*    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Important

Remember this medicine is for you. Only a doctor can prescribe it. Never give this medicine to other people, it may harm them, even if their symptoms are the same as yours. This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. He/she will have additional information about this medicine and will be able to advise you..

Contents of the pack and other information

What this medicine contains:

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

Accuretic tablets also contains the following inactive ingredients: crospovidone, lactose, magnesium carbonate, magnesium stearate and povidone K25. The coating of Accuretic tablets contains candelilla wax and opadry pink OY-S-6937, which contains titanium dioxide, hydroxypropylcellulose, macrogol 400, red iron oxide (E172), yellow iron oxide (E172) and hypromellose.

What this medicine looks like and contents of the pack

Accuretic comes as pink film-coated oval shaped tablets. Each tablet is marked with a score line and “PD” and “22” on one side and a score line on the other side.

They are available in packs of 30 Tablets.

Manufacturer and Licence Holder

This medicine is manufactured by Pfizer Manufacturing Deutschland GmbH, Mooswaldallee 1, D-79090 Freiburg, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,

B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 15184/0717 Accuretic 10/12.5mg Tablets Accuretic is a registered trademark of Pfizer Limited.

Revision date: 07/10/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Patient Information Leaflet

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. Most people do not have serious problems when taking Accuzide but side effects can occur. If you experience swelling of the face, tongue or throat, see your doctor immediately.

*    Accuzide is a treatment for high blood pressure.

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

*    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 Accuzide and tell your doctor.

Your medicine is called Accuzide 10/12.5mg tablets and will be referred to

as Accuzide throughout this Patient Information Leaflet.

What is in this leaflet

What Accuzide is and what it is used for

r® What you need to know before you take Accuzide How to take Accuzide Possible side effects How to store Accuzide Contents of the pack and other information

^ What Accuzide is and what it is used for

Accuzide is used to treat high blood pressure.

Accuzide contains the active ingredients quinapril and hydrochlorothiazide (HCTZ). 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. HCTZ 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'.

You must talk to a doctor if you do not feel better or if you feel worse.

[2) What you need to know before you take Accuzide

Do not take Accuzide:

*    If you are allergic to quinapril, hydrochlorothiazide, any of the other ingredients of this medicine (listed in section 6), similar drugs or to a group of antibiotics called sulphonamides.

*    If you are in your second or third trimester of pregnancy. It is also better to avoid Accuzide in early pregnancy - see Pregnancy, breast-feeding and fertility section.

*    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 angioedema 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Accuzide if:

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

*    You have kidney disease, a transplanted kidney, or use a haemodialysis machine (an artificial kidney).

*    You have liver disease.

*    You have heart disease or heart failure.

*    You are elderly.

*    You are of African-Caribbean ethnic origin.

*    You have low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (water tablets), low-salt diet, diarrhoea, vomiting, or haemodialysis.

*    You have a dry cough.

*    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 have a history of severe allergic reactions, asthma or angioedema (such as swelling of the eyes, face, lips, tongue or throat).

*    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 planning to become pregnant, or you just became aware of being pregnant (see Pregnancy, breast-feeding and fertility section).

*    You are breast-feeding or about to start breast-feeding (see Pregnancy, breast-feeding and fertility section).

*    You are taking medicines containing lithium.

*    You have diabetes or gout.

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

*    You have a salt or electrolyte imbalance in your blood (e.g. sodium or potassium), your doctor may want to monitor you more closely.

*    You experience 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.

*    You are about to have surgery or receive anaesthetics (even at the dentist), remember to tell any medical staff that you are taking Accuzide.

*    You have a fever, sore throat, mouth ulcers, tiredness, unexplained bruising or bleeding, or a blood problem such as low or lack of white blood cells (neutropenia or agranulocytosis).

*    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 Accuzide'.

Children and adolescents

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

Other medicines and Accuzide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. There are some medicines that may interact with Accuzide.

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 Accuzide' and ‘Warnings and precautions').

*    Other blood pressure treatments and diuretics (including aliskiren and water tablets).

*    Medicines called tetracyclines used to treat infections.

*    Cholestyramine and colestipol (medicines used to treat high levels of fats in the blood).

*    Medicines called ‘pressor amines' such as norepinephrine and epinephrine.

*    Antibiotics like sulfamethoxazole and trimethoprim.

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

*    Anaesthetics.

*    Lithium (used to treat depression).

*    Non-steroidal anti-inflammatory pain killers (including aspirin or ibuprofen).

*    Corticosteroids (including hydrocortisone, dexamethasone or prednisolone) and ACTH (tetracosactide) or drugs known to reduce the amount of potassium in the blood.

*    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, uricosurics and xanthine oxidase inhibitors (for the treatment of chronic gout).

*    Indigestion and heartburn medicines (antacids).

*    Medicines that have a sedative effect. This includes alcoholic drinks and sleeping pills.

*    Medicines to treat diabetes (including vildagliptin).

*    Digitalis glycosides (e.g. digoxin, for the treatment of heart problems).

*    mTOR inhibitors used to treat kidney cancer (including temsirolimus).

Laboratory Tests

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

*    Accuzide with food and drink

See section 3 How to take Accuzide.

*    Pregnancy, breast-feeding and fertility

Do not start taking Accuzide if you are pregnant or planning to become pregnant.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will normally advise you to stop taking Accuzide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Accuzide. Accuzide is not recommended during 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.

Tell your doctor if you are breast-feeding or about to start breast-feeding. Accuzide is not recommended for mothers who are breast-feeding.

*    Driving and using machines:

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

Accuzide contains lactose monohydrate

Lactose monohydrate is 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 Accuzide

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Do not wait until your tablets are finished before seeing your doctor.

Adults

The recommended dose is one tablet each day. Try to take the tablet at about the same time every day. Accuzide can be taken with or without food.

Accuzide is not recommended for use in patients who suffer with kidney disease with a creatinine clearance of less than 40 mL/min.

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.

Swallow the tablets whole with water. Do not chew, divide or crush the tablets.

If you take more Accuzide than you should

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

If you forget to take Accuzide

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 forgotten dose.

Patient Information Leaflet (continued)

If you stop taking Accuzide

Do not stop taking your tablets or alter the dose you are currently taking without seeing your doctor first. It is important to keep taking your tablets. They help to control your blood pressure.

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

Possible side effects

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

STOP taking Accuzide and seek immediate medical attention if you

experience any of the following symptoms as they can be serious:

Common: may affect up to 1 in 10 people

*    Severe chest pain, tightness of the chest, shortness of breath, wheezing or trouble breathing, irregular or strong heartbeat (palpitations). These symptoms may be due to heart attack or angina.

Uncommon: may affect up to 1 in 100 people

*    Ringing or noise in the ears.

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

*    Severe allergic (anaphylactoid) reaction to this medicine such as swelling of the face, tongue and throat which cause great difficulty breathing (angioedema).

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

*    Fever, cough, and other nonspecific symptoms, followed by redness and sloughing of the skin and mucous membranes (Toxic epidermal necrolysis). A skin rash with irregular red spots or ‘target' lesions (erythema multiforme). Intense skin rash including hives, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome).

*    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 Accuzide, 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.

*    Neutropenia/agranulocytosis resulting in decreased numbers of white blood cells or decrease in blood platelets which may result in bruising or easy bleeding.

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

*    Liver inflammation (hepatitis), abdominal pain, nausea, dark brown urine, yellowing of the skin or the eyes (jaundice).

*    Inflammation of the kidneys (tubulointerstitial nephritis) symptoms include fever and a rash but occasionally patients might notice blood in urine as well.

The following side effects have also been reported in patients with high blood pressure being treated with Accuzide. 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: may affect up to 1 in 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

*    increased levels of creatinine in the blood

*    increased levels of blood urea

*    chest pain

*    increased levels of Potassium in serum

*    rapid heart rate

Uncommon: may affect up to 1 in 100 people

*    kidney and urinary problems, urinary tract infection

*    numbness or tingling sensation in your limbs, aching joints

*    depression, nervousness, confusion

*    wind

*    lazy eye

*    feeling of spinning or rotation of surroundings (vertigo)

*    fainting, low blood pressure

*    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

*    heart attack (myocardial infarction)

*    increased glucose levels in blood

*    painful joints

*    shortness of breath

*    swelling under the skin

*    protein in urine

Rare: may affect up to 1 in 1,000 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

*    psoriasis

*    swelling of the hands, face and tongue (angioedema)

*    skin disorders

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

*    obstruction of the digestive system (bowel)

*    blurred vision

*    hives

Not known: frequency cannot be estimated from the available data

*    allergic condition which causes joint pain, skin rashes and fever (systemic lupus erythematosus)

*    inflammation of the lining of the lungs, heart or abdomen (serositis)

*    erythema and scaling of the skin (dermatitis exfoliative)

*    bruising or a purple or red rash (purpura)

*    small fluid-filled blisters on the skin (pemphigus)

*    skin discolouration

*    low numbers of red blood cells (anaemia)

*    bleeding from blood vessels in the brain

*    narrowing of the airways in the lungs (bronchospasm)

*    short-sightedness

*    acute closure glaucoma (increased pressure in the eyes)

Accuzide 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.

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.

[a How to store Accuzide

Expiry date

Do not use this medicine after the expiry date shown on the carton label or blister strip. If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to. If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

Storing your medicine

*    Do not store above 25°C

*    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Important

Remember this medicine is for you. Only a doctor can prescribe it. Never give this medicine to other people, it may harm them, even if their symptoms are the same as yours. This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. He/she will have additional information about this medicine and will be able to advise you..

Contents of the pack and other information

What this medicine contains:

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

Accuzide tablets also contains the following inactive ingredients: crospovidone, lactose, magnesium carbonate, magnesium stearate and povidone K25. The coating of Accuzide tablets contains candelilla wax and opadry pink OY-S-6937, which contains titanium dioxide, hydroxypropylcellulose, macrogol 400, red iron oxide (E172), yellow iron oxide (E172) and hypromellose.

What this medicine looks like and contents of the pack

Accuzide comes as pink film-coated oval shaped tablets. Each tablet is marked with a score line and “PD” and “22” on one side and a score line on the other side.

They are available in packs of 30 Tablets.

Manufacturer and Licence Holder

This medicine is manufactured by Pfizer Manufacturing Deutschland GmbH, Mooswaldallee 1, D-79090 Freiburg, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,

B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 15184/0717 Accuzide 10/12.5mg Tablets Accuzide is a registered trademark of Pfizer Limited.

Revision date: 07/10/16

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