PERINDOPRIL / INDAPAMIDE 4 MG / 1.25 MG TABLETS - patient leaflet, side effects, dosage

SAME SIZE ARTWORK LEAFLET SIZE: 180 mm x 500 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Perindopril/In­dapamide 2 mg/0.625 mg and 4 mg/1.25 mg Tablets

Perindopril tert-butylamine 2 mg / Indapamide 0.625 mg

Perindopril tert-butylamine 4 mg / Indapamide 1.25 mg

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.

What is in this leaflet:

• 1. What Perindopril/In­dapamide Tablets is and what it is used for

• 2. What you need to know before you take Perindopril/ Indapamide Tablets

• 3. How to take Perindopril/In­dapamide Tablets

• 4. Possible side effects

• 5. How to store Perindopril/In­dapamide Tablets

• 6. Contents of the pack and other information

1. what perindopril/indapamide tablets is and what it is used for

Perindopril/In­dapamide Tablets is a combination of two active ingredients, Perindopril and Indapamide. They belong to a group of anti-hypertensive medicines, which are used in the treatment of high blood pressure (hypertension) in adults.

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.

2. what you need to know before you take perindopril/ indapamide

Do not take Perindopril/In­dapamide Tablets

• – if you are allergic to perindopril or any other ACE inhibitor, or to indapamide or any other sulphonamide 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 itches 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, where the blood supply to your kidneys is reduced (renal artery stenosis),

• – if you are receiving dialysis, or any other type of blood filtration. Depending on the machine that is used, perindopril/in­dapamide may not be suitable for you,

• – if you have low 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/In­dapamide Tablets in early pregnancy-see “Pregnancy and Breast-feeding”.)

• – if you are breastfeeding

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

• – if you have taken or are currently taking sacubitril/ valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased.

Warnings and Precautions

Talk to your doctor or pharmacist or nurse before taking Perindopril/In­dapamide Tablets:

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

• – if you have heart failure or any other heart problems

• – if you have kidney problems, or if you are receiving dialysis,

• – if you have abnormally increased levels of a hormone called aldosterone in your blood (primary aldosteronism),

• – 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 drugs (spironolactone, triamterene) or potassium supplements as their use with Perindopril/In­dapamide Tablets should be avoided (see „Other medicines and Perindopril/ Indapamide Tablets“).

• – if you are elderly,

• – if you have had photosensitivity reactions,

• – if you are of black origin since you may have a higher risk of angioedema and this medicine may be less effective in lowering your blood pressure than in non-black patients,

• – if you are a haemodialysis patient dialysed with high-flux membranes

• – if you are taking any of the following medicines, the risk of angioedema may be increased:

• racecadotril (a medicine used to treat diarrhoea)
• medicines used to prevent organ transplant rejection and for cancer (e.g. sirolimus, everolimus, temsirolimus)
• sacubitril (available as fixed-dose combination with valsartan),used to treat long-term heart failure.
• vildagliptin, a medicine used to treat diabetes

– 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, 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 heading “Do not take Perindopril/In­dapamide Tablets”.

Angioedema

Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Perindropril. This may occur at any time during treatment. If you develop such symptoms, you should stop taking Perindopril/In­dapamide Tablets and see a doctor immediately. See also section 4.

When you are taking Perindopril/In­dapamide 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),

• – if you have changes in your vision or pain in one or both of your eyes while taking perindopril/in­dapamide. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to weeks of taking Perindopril/In­dapamide tablets. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this. You should discontinue perindopril/in­dapamide treatment and seek medical attention.

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

Children and adolescents

Perindopril/In­dapamide Tablets should not be given to children and adolescents.

Other medicines and Perindopril/In­dapamide Tablets

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

You should avoid Perindopril/In­dapamide Tablets with:

• – lithium (used to treat mania or depression),

• – aliskiren (medicine used to treat hypertension) if you have no diabetes mellitus or kidney problems,

• – potassium-sparing diuretics (e.g. triamterene, amiloride) potassium salts, other drugs which can increase potassium in your body (such as heparin and co-trimoxazole also known as trimethoprim/sul­famethoxazole),

• – estramustine (used in cancer therapy),

• – other medicines used to treat high blood pressure: angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers.

Treatment with Perindopril/In­dapamide Tablets can be affected by other medicines. Your doctor may need to change your dose and/or to take other precuations. 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 including angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Perindopril/In­dapamide Tablets” and “Warnings and precautions”), take special care with <Perindopril/ Indapamide Tablets or diuretics (medicines which increase the amount of urine produced by the kidneys)

• – potassium-sparing drugs used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg to 50 mg per day,

• – sacubitril/val­sartan (used to treat long-term heart failure). See sections “Do not take Perindopril/In­dapamide Tablets” and “Warnings and precautions”.

• – anaesthetic medicines,

• – iodinated contrast agent,

• – moxifloxacin, sparfloxacin (antibiotic: medicine used to treat infection),

• – methadone (used to treat addiction),

• – procainamide (for the treatment of an irregular heart beat),

• – allopurinol (for the treatment of gout),

• – mizolastine, terfenadine or astemizole (antihistamines for hay fever or allergies),

• – 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, tacrolimus),

• – erythromycin by injection (an antibiotic),

• – halofantrine (used to treat certain types of malaria)

• – pentamidine (used to treat pneumonia)

• – injectable gold (used to treat rheumathoid polyarthritis),

• – vincamine (used to treat symptomatic cognitive disorders in elderly including memory loss

• – bepidril (used to treat angina pectoris),

• – sultopride (for the treatment of psychoses),

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

• – cisapride, diphemanil (used to treat gastric and digestive problems),

• – 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 or gliptins,

• – calcium including calcium supplements,

• – stimulant laxatives (e.g. senna),

• – non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high dose salicylates (e.g. aspirin),

• – amphotericin B by injection (to treat severe fungal disease),

• – medicines to treat mental disorders such as depression, anxiety, schizophrenia…(e.g. tricyclic antidepressants, neuroleptics),

• – tetracosactide (to treat Crohn's disease)

• – medicines, which is most often used to treat diarrhoea (racecadotril) or avoid rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other drugs belonging to the class of mTor inhibitors). See section “Warnings and precautions”.

• – vasodilators including nitrates (products that make the blood vessels become wider),

• – medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or

adrenaline).

• – Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in your blood (e.g. trimethoprim and co-trimoxazole for infections caused by

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bacteria; ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots)

Perindopril/In­dapamide Tablets with food and drink

It is preferable to take Perindopril/In­dapamide Tablets before a meal.

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

Breastfeeding

You must not take Perindopril/In­dapamide Tablets if you are breast-feeding. Tell your doctor if you are breast-feeding or about to start breast-feeding.

See your doctor immediately

Driving and using machines

Perindopril/In­dapamide Tablets usually does not affect alertness but different reactions such as dizziness or weakness in relation to the decrease in blood pressure may occur in certain patients. If affected your ability to drive or operate machinery may be impaired.

Perindopril/In­dapamide Tablets contains lactose

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 perindopril/indapamide tablets

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

The recommended dose is one tablet once a day. Your doctor may decide to modify the dosage regimen if you suffer from renal impairment. Take your tablet preferably in the morning and before a meal. Swallow the tablet with a glass of water.

If you take more Perindopril/In­dapamide Tablets than you should

If you take more too many tablets contact your doctor or nearest hospital casualty department. The most likely effect in case of overdose is low blood pressure. If marked low blood pressure occurs (associated with nausea, vomiting, cramps, dizziness, sleepiness, mental confusion, changes in the amount or urine produced by kidneys), lying down with the legs raised can help.

If you forget to take Perindopril/In­dapamide Tablets

It is important to take your medicine every day as regular treatment is more effective. However, if you forget to take a dose of Perindopril/In­dapamide Tablets, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Perindopril/In­dapamide Tablets

As the treatment for high blood pressure is usually life-long, you should discuss with your doctor before stopping this medicinal product.

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

4. possible side effects

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

Stop taking the medicinal product and tell your doctor immediately, if you experience any of the following side effects that can be serious:

• Severe dizziness or fainting due to low blood pressure (Common – may affect up to 1 in 10 people),
• Bronchospasm (tightening of the chest, wheezing and shortness of breath (Uncommon) (may affect up to 1 in 100 people),
• swelling of the face, lips, mouth, tongue or throat, difficulty in breathing, (angioedema) (See section 2 “Warnings and precautions“), (Uncommon) (may affect up to 1 in 100 people),
• Severe skin reactions including erythema multiforme (a skin rash which often starts with red itchy patches on your face, arms or legs) or intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome) or other allergic reactions (Very rare) (may affect up to 1 in 10,000 people),
• cardiovascular disorders (irregular heartbeat, angina pectoris (pains to the chest, jaw and back, brought on by physical effort) heart attack) (Very rare) (may affect up to 1 in 10,000 people),
• Weakness of arms or legs, or problems speaking which could be a sign of a possible stroke (Very rare) (may affect up to 1 in 10,000 people),
• Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell (Very rare) (may affect up to 1 in 10,000 people),
• Yellowing of the skin or eyes (jaundice) which could be a sign of hepatitis (Very rare) (may affect up to 1 in 10,000 people),
• Life-threatening irregular beat (Not known),
• Disease of the brain caused by liver illness (Hepatic encephalopathy) (Not known).

In decreasing order of frequency, side effects can include:

Common (may affect up to 1 in 10 people):

Skin reactions in subjects predisposed to allergic and asthmatic reactions, headache, dizziness, vertigo, pins and needles, vision disturbances, tinnitus (sensation of noises in the ears), cough, shortness of breath (dyspnoea), gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or difficulty of digestion, diarrhoea, constipation), allergic reactions (such as skin rashes, itching), cramps, feeling of tiredness,

Uncommon( may affect up to 1 in 100 people):

Mood swings, sleep disturbances, urticaria, purpura (red pinpoints on skin), blister cluster, kidney problems, impotence, sweating, an excess of eosinophils (a type of white blood cells), change in laboratory parameters: high blood level of potassium reversible on discontinuation, low blood level of sodium, somnolence, fainting, palpitations (awareness of your heartbeat), tachycardia (fast heartbeat), hypoglycaemia (very low blood sugar level) in case of diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions (increased sensitivity of the skin to sun), arthralgia (joint pain), myalgia (muscle pain), chest pain, malaise, oedema peripheral, fever, increased blood urea, increased blood creatinine, fall.

Rare (may affect up to 1 in 1000 people):

Psoriasis worsening, changes in laboratory parameters: increased level of liver enzymes, high level of serum bilirubin, fatigue..

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

Confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose), severe kidney problems, changes in blood values such as a lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets, high level of calcium in the blood, abnormal hepatic function.

Not known (frequency cannot be estimated from the available data):

Abnormal ECG heart tracing, changes in laboratory parameters: low potassium levels, high uric acid levels and high sugar levels in the blood, short sightedness (myopia), vision blurred, decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angleclosure glaucoma). If you suffer from systemic lupus erythematosus (a type of collagen disease), this might get worse, discoloration, numbness and pain in fingers or toes (Raynaud's phe­nomenon).

Concentrated urine (dark in colour), feel or are sick, have muscle cramps, confusion and fits which may be due to inappropriate ADH (anti-diuretic hormone) secretion. If you have these symptoms contact your doctor as soon as possible.

Disorders of the blood, kidney, liver or pancreas and changes in laboratory parameters (blood tests) can occur. Your doctor may need to give you blood tests to monitor your condition.

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.

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 Yellow Card Scheme (Website: ) or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store perindopril/indapamide tablets

Keep out of the sight and reach of children.

Store in the original package to protect from moisture.

When unopened, this medicinal product does not require any special temperature storage conditions.

Once the laminated pouch is opened, blister strips should be stored in the outer box below 30OC.

Any remaining tablets should be discarded two months after opening the pouch.

Do not use this medicine after the expiry date which is stated on the label, blister, pouch and carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. contents of the pack and other informationwhat perindopril/indapamide tablets contains- the active substances are perindopril tert-butylamine and indapamide

• – Each tablet contains 2mg Perindopril tert-butylamine equivalent to 1.669mg perindopril and 0.625mg Indapamide

• – Each tablet contains 4mg Perindopril tert-butylamine equivalent to 3.338mg perindopril and 1.25mg Indapamide

• – The other ingredients are:

What Perindopril/Indapamide Tablets looks like and contents of the pack

Perindopril/In­dapamide 2mg/0.625mg Tablet

White, rod shaped tablets engraved with ‚P‘ and ‚I‘ on either side of the break-line on one side and a break-line on the other side. The tablet can be broken into equal halves.

Perindopril/In­dapamide 4mg/1.25mg Tablet

White rod shaped tablets having ‚PI‘ debossed on one side and plain on the other.

The tablets are packed in PVC / PVdC – Aluminium blisters within a protective aluminium pouch, including a desiccant protecting the tablets from moisture. The desiccant should not be swallowed.

Pack izes

2mg/0.625mg: 20, 30, 90 and 100

4mg/1.25mg: 30, 90 and 100

*Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Glenmark Pharmaceuticals Europe Limited

Laxmi House, 2B Draycott Avenue,

Kenton, Middlesex HA3 0BU,

United Kingdom

Manufacturer (s)

Glenmark Pharmaceuticals S.R.O.

Hvezdova 1716/2b, 140 78 Praha 4,

Czech Republic

Glenmark Pharmaceuticals Europe Limited Building 2, Croxley Green Business Park, Croxley Green, Hertfordshire, WD18 8YA United Kingdom

This medicinal product is authorised in the Member

States of the EEA under the following names:

Italy Perindopril E Indapamide EG 2/0.625mg

and 4/1.25mg

The Netherlands Perindopril tert-butylamine /Indapamide

Glenmark 2/0.625mg and 4/1.25mg Tabletten

Spain Perindopril/In­dapamide Viso

Farmaceutica 2/0.625mg and 4/1.25mg comprimidos

United Kingdom Perindopril/In­dapamide 2 mg/0.625 mg and 4 mg/1.25 mg Tablets

This leaflet was last revised in : 09/2020

180 mm

FONT: Times New Roman

FONT SIZE: 9 pt

DATE: 09–09–2020

VERSION: 04 (UK)

variation no: NL/H/4754/001­002/IB/020