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1. Perindopril Tosilate/Indapamide 5 Mg/1.25 Mg Film-Coated Tablets
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Iteva UK Ref: 231-30-84010-D LEA PERINDOPRIL TOSILATE/INDAPAMIDE A/S TAB TUK<DEB    Version: 1    14 October 2014

PERINDOPRIL TOSILATE/INDAPAMIDE 5 mg/1.25 mg FILM-COATED TABLETS

Pharma Code

cage 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.

1.    What Perindopril Tosilate/ Indapamide 5 mg/1.25 mg Film-coated Tablets are and what they are used for

2.    What you need to know before you take Perindopril Tosilate/ Indapamide 5 mg/1.25 mg Film-coated Tablets

3.    How to take Perindopril Tosilate/ Indapamide 5 mg/1.25 mg Film-coated Tablets

4.    Possible side effects

5.    How to store Perindopril Tosilate/ Indapamide 5 mg/1.25 mg Film-coated Tablets

6.    Contents of the pack and other information

What Perindopril Tosilate/Indapamide 5 mg/1.25 mg Film-coated Tablets are and what they are used for

What is Perindopril Tosilate/ Indapamide Film-coated Tablets?

Perindopril Tosilate/Indapamide Film-coated Tablets is a combination of two active ingredients, perindopril and indapamide. It is an antihypertensive and is used in the treatment of high blood pressure (hypertension).

What is Perindopril Tosilate/ Indapamide Film-coated Tablets used for?

Perindopril belongs to a class of medicines called ACE inhibitors. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced. Each of the active ingredients reduces blood pressure and they work together to control your blood pressure.

What you need to know before you take Perindopril Tosilate/Indapamide 5 mg/1.25 mg Film-coated Tablets

Do not take Perindopril Tosilate/ Indapamide Film-coated Tablets

♦    if you are allergic to perindopril or any other ACE inhibitor, or to indapamide or any other sulphonamides or any of the other ingredients of this medicine (listed in section 6)

♦    if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes with previous ACE inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema)

♦    if you have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative disease of the brain)

♦    if you have a severe kidney disease or if you are receiving dialysis

♦    if you have low or high blood potassium

♦    if you are suspected of having untreated decompensated heart failure (severe water retention, difficulty in breathing)

♦    if you are more than 3 months pregnant (It is also better to avoid Perindopril Tosilate/ Indapamide 5 mg/1.25 mg Film-coated Tablets in early pregnancy - see section "Pregnancy, breast-feeding and fertility”)

♦    if you are breast-feeding

♦    ifyouhavediabetesorimpaired 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 PerindoprilTosilate/ Indapamide Film-coated Tablets:

♦    if you have aortic stenosis (narrowing of the main blood vessel leading from the heart) or hypertrophic cardiomyopathy (cardiac muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood)

♦    if you have any other heart problems or problems with your kidneys

♦    if you have liver problems

♦    if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus or scleroderma

♦    if you have atherosclerosis (hardening of the arteries)

♦    if you suffer from hyperparathyroidism (overactive parathyroid gland)

♦    if you suffer from gout

♦    if you have diabetes

♦    if you are on a salt restricted diet or use salt substitutes which contain potassium

♦    if you take lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with Perindopril Tosilate Indapamide Film-coated Tablets should be avoided (see section "Other medicines and Perindopril Tosilate/Indapamide 5 mg/1.25 mg Film-coated Tablets”)

♦    if you are taking any of the following medicines used to treat high blood pressure:

♦ anangiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes- related kidney problems

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 Perindopril Tosilate/Indapamide 5 mg/1.25 mg Film-coated Tablets”.

You must tell your doctor if you think that you are (or might become) pregnant. Perindopril Tosilate/Indapamide Film-coated Tablets 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, breast-feeding and fertility”).

When you are taking Perindopril Tosilate/Indapamide Film-coated Tablets, you should also inform your doctor or the medical staff:

♦    if you are to undergo anaesthesia and/or surgery

♦    if you have recently suffered from diarrhoea or vomiting, or are dehydrated

♦    if you are to undergo dialysis or LDL apheresis (which is removal of cholesterol from your blood by a machine)

♦    if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings

♦    if you are to undergo a medical test that requires injection of an iodinated contrast agent (a substance that makes organs like kidney or stomach visible on an X-ray).

Athletes should be aware that Perindopril Tosilate/Indapamide Film-coatedTablets contains an active ingredient (indapamide) which may give a positive reaction in drug tests.

Perindopril Tosilate/Indapamide Film-coatedTablets should not be given to children.

Other medicines and Perindopril Tosilate/Indapamide 5 mg/1.25 mg Film-coated Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You should avoid Perindopril Tosilate/Indapamide Film-coated Tablets with:

♦    lithium (used to treat depression)

♦    potassium-sparing diuretics (spironolactone, triamterene), potassium salts.

Treatment with Perindopril Tosilate/Indapamide Film-coated Tablets can be affected by other medicines. Make sure to tell your doctor if you are taking any of the following medicines as special care may be required:

♦    other medicines for treating high blood pressure

♦    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 and Perindopril Tosilate/Indapamide 5 mg/1.25 mg Film-coated Tablets” and "Warnings and precautions”)

♦    procainamide (for the treatment of an irregular heart beat)

♦    allopurinol (for the treatment of

♦    terfenadine or astemizole (antihistamines for hay fever or

♦    corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis

♦    immunosuppressants used for the treatment of auto-immune disorders or following transplant surgery to prevent rejection (e.g. ciclosporin)

♦    medicines for the treatment of

♦    erythromycin by injection (an antibiotic)

♦    halofantrine (used to treat certain types of malaria)

♦    pentamidine (used to treat pneumonia)

♦    injectable gold (used to treat rheumatoid polyarthritis)

♦    vincamine (used to treat symptomatic cognitive disorders in elderly including memory loss)

♦    bepridil (used to treat angina pectoris)

♦    sultopride (for the treatment of psychoses)

♦    medicines used for heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol)

♦    digoxin or other cardiac glycosides (for the treatment of heart problems)

♦    baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis)

♦    medicines to treat diabetes such as insulin or metformin

♦    calcium including calcium supplements