Perindopril and indapamide Teva: detailed information

Package leaflet: Information for the user

Perindopril and Indapamide Teva 2.5 mg/0.625 mg film-coated tablets

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Perindopril and Indapamide Teva is and what it is used for
What you need to know before taking Perindopril and Indapamide Teva
How to take Perindopril and Indapamide Teva
Possible side effects
How to store Perindopril and Indapamide Teva
Contents of the pack and other information

1. What Perindopril and Indapamide Teva is and what it is used for

What Perindopril and Indapamide Teva is used for
Perindopril belongs to a class of medicines called ACE inhibitors. This type of medicine dilates blood vessels, helping the heart to pump blood through them.
Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it causes only a slight increase in urine production. Both active substances reduce blood pressure and, together, control hypertension.

2. What you should know before taking Perindopril and Indapamide Teva

Do not take Perindopril and Indapamide Teva

if you are allergic to perindopril, to any other ACE inhibitor, to indapamide, to any other sulfonamide, or to any of the excipients of this medicine (listed in section 6);
if you have previously experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe skin rashes during prior treatment with an ACE inhibitor, or if you or a family member has experienced these symptoms under other circumstances (a condition known as angioedema);
if you have severe liver disease or a condition called hepatic encephalopathy (a degenerative brain disorder);
if you have severe kidney disease or are undergoing dialysis;
if you have low or high blood potassium levels;
if you have untreated decompensated heart failure (severe fluid retention, breathing difficulties);
if you are more than 3 months pregnant (Perindopril and Indapamide Teva is also advised to be avoided during early pregnancy – see section “Pregnancy, breastfeeding and fertility”);
if you are breastfeeding;
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril and Indapamide Teva:

if you are taking any of the following medicines, as the risk of angioedema may be increased:
- racecadotril, a medicine used to treat diarrhoea;
- medicines used to prevent rejection of transplanted organs and to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
- vildagliptin, a medicine used to treat diabetes;
if you have aortic stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys);
if you have any other heart problems or kidney problems;
if you have liver problems;
if you have a collagen vascular disease (a skin disorder), such as systemic lupus erythematosus or scleroderma;
if you have atherosclerosis (hardening of the arteries);
if you have hyperparathyroidism (overactivity of the parathyroid gland);
if you have gout;
if you have diabetes;
if you are on a low-salt diet or use potassium-containing salt substitutes;
if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as their use together with Perindopril and Indapamide Teva should be avoided (see section “Other medicines and Perindopril and Indapamide Teva”);
if you are taking any of the following medicines for high blood pressure:
- an "angiotensin II receptor antagonist" (AIIRA), also known as sartans (e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
- aliskiren;
if you experience vision disturbances or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from a few hours to weeks after taking Perindopril and Indapamide Teva. This condition may lead to permanent vision loss if not treated. If you have previously had allergic reactions to penicillin or sulfonamides, you may be at higher risk of developing this condition.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the section “Do not take Perindopril and Indapamide Teva”.
Inform your doctor if you think you are (or might become) pregnant. Perindopril and Indapamide Teva is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn baby if used during this period (see section “Pregnancy, breastfeeding and fertility”).
While being treated with Perindopril and Indapamide Teva, inform your doctor or medical staff also in the following cases:

if you are scheduled for anaesthesia and/or surgery;
if you have recently had diarrhoea or vomiting or are dehydrated;
if you are undergoing dialysis or LDL apheresis (removal of cholesterol from the blood using a special machine);
if you are about to undergo desensitisation treatment to reduce the effects of an allergy to bee or wasp stings;
if you are scheduled for a medical examination requiring injection of an iodinated contrast agent (a substance that makes organs such as kidneys and stomach visible on X-rays).
Athletes should be aware that Perindopril and Indapamide Teva contains an active substance (indapamide) that may lead to a positive result in doping tests. Perindopril and Indapamide Teva must not be administered to children.

Other medicines and Perindopril and Indapamide Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You must avoid taking Perindopril and Indapamide Teva together with:

lithium (used to treat depression);
potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (e.g. trimethoprim and cotrimoxazole used to treat bacterial infections; ciclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting).

Treatment with Perindopril and Indapamide Teva may be affected by other medicines. Your doctor may need to adjust the dose and/or take additional precautions. These include:

other blood pressure medicines;
your doctor may need to adjust the dose and/or take additional precautions: if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also section “Do not take Perindopril and Indapamide Teva” and “Warnings and precautions”);
medicines used to treat diarrhoea (racecadotril) or medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other drugs belonging to the mTOR inhibitor class). See section “Warnings and precautions”;
procainamide (for treating irregular heartbeat);
allopurinol (used to treat gout);
terfenadine or astemizole (antihistamines used to treat hay fever and allergies);
corticosteroids used to treat various disorders, including severe asthma and rheumatoid arthritis;
immunosuppressants used to treat autoimmune disorders or after surgical transplantation to prevent rejection (e.g. ciclosporin);
anticancer medicines;
intravenous erythromycin (an antibiotic);
halofantrine (used to treat certain types of malaria);
pentamidine (used to treat pneumonia);
injectable gold (used to treat rheumatoid arthritis);
vincamine (used to treat symptomatic cognitive disorders in the elderly, including memory loss);
bepridil (used to treat angina pectoris);
sultopride (used to treat psychosis);
medicines used for heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol);
digoxin and other cardiac glycosides (for treating heart problems);
baclofen (for treating muscle stiffness associated with diseases such as multiple sclerosis);
medicines used to treat diabetes, such as insulin or metformin;
calcium, including calcium supplements;
stimulant laxatives (e.g. senna);
non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high-dose salicylates (e.g. aspirin);
intravenous amphotericin B (to treat serious fungal infections);
medicines used to treat mental disorders, such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics);
tetracosactide (to treat Crohn's disease).

Perindopril and Indapamide Teva with food and drinks
Perindopril and Indapamide Teva should preferably be taken before a meal.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Inform your doctor if you think you are (or might become) pregnant.

Pregnancy
Your doctor will usually advise you to stop taking Perindopril and Indapamide Teva before starting pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine. Perindopril and Indapamide Teva is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if used beyond the third month.

Breastfeeding
Inform your doctor immediately if you are breastfeeding or planning to breastfeed. Perindopril and Indapamide Teva is contraindicated during breastfeeding.
Contact your doctor immediately.

Fertility
The effects of perindopril and indapamide on human fertility are unknown.

Driving and using machines
Perindopril and Indapamide Teva does not affect attention, but some patients may experience side effects such as dizziness or weakness due to low blood pressure. If you experience such effects, your ability to drive or operate machinery may be impaired.

Perindopril and Indapamide Teva contains lactose.
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

Perindopril and Indapamide Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

For athletes: Using this medicine without a medical need constitutes doping and may result in a positive anti-doping test.

3. How to take Perindopril and Indapamide Teva

Take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, consult your doctor or pharmacist. The recommended dose is one tablet once
daily. Your doctor may decide to increase the dose to two tablets daily if your blood pressure is not
well controlled, or may adjust the dose if you have impaired kidney function.
Take the tablet preferably in the morning, before a meal. Swallow the tablet with a glass of water.
The score line is intended to facilitate breaking the tablet for easier swallowing, and is not intended
for dividing the tablet into equal doses.

If you take more Perindopril and Indapamide Teva than you should
If you take too many tablets, contact your doctor or the nearest emergency department immediately.
In case of overdose, the most likely effect is a drop in blood pressure which may cause dizziness or
fainting. If this happens, lying down with your legs raised may help.

If you forget to take Perindopril and Indapamide Teva
It is important that you take this medicine every day, as treatment is most effective when taken regularly.
However, if you forget to take a dose of Perindopril and Indapamide Teva, take the next dose at your
usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Perindopril and Indapamide Teva
Treatment for high blood pressure usually needs to be continued for life; therefore, do not stop taking
this medicine without first consulting your doctor.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you notice any of the following effects, stop taking the medicine
and contact your doctor immediately:

swelling of the face, lips, mouth, tongue or throat, difficulty breathing;
severe dizziness or fainting;
unusually fast or irregular heartbeat.

In order of decreasing frequency, the side effects may include the following:

Common side effects (may affect up to 1 in 10 people): headache, dizziness, vertigo, tingling sensations, visual disturbances, tinnitus (ringing or noise in the ears), feeling of lightheadedness due to low blood pressure, cough, shortness of breath, gastrointestinal disorders (nausea, epigastric pain, anorexia, vomiting, abdominal pain, taste disturbances, dry mouth, dyspepsia or indigestion, diarrhea, constipation), allergic reactions (such as skin rashes and itching), muscle cramps, fatigue.
Uncommon side effects (may affect up to 1 in 100 people): mood swings, sleep disturbances, bronchospasm (chest tightness, wheezing and shortness of breath), angioedema (symptoms such as wheezing, swelling of the face or tongue), urticaria, purpura (small red spots on the skin), kidney problems, impotence, sweating.
Rare side effects (may affect up to 1 in 1,000 people): worsening of psoriasis.
Very rare side effects (may affect up to 1 in 10,000 people): confusion, cardiovascular disorders (irregular heartbeat, angina, cardiac arrest), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose), allergic reaction in the small intestine (intestinal angioedema), severe skin reactions such as erythema multiforme. If you suffer from systemic lupus erythematosus (a collagen disease), this may worsen. Cases of photosensitivity reactions (skin changes) after exposure to sunlight or artificial UVA rays have also been reported. Acute renal failure.
Frequency not known (frequency cannot be estimated from the available data):

decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), fainting, abnormal colour, numbness and pain in fingers or toes (Raynaud's phenomenon), potentially life-threatening irregular heartbeat (torsades de pointes), abnormalities in ECG tracing, increased liver enzyme levels.

Blood, kidney, liver or pancreas disorders and changes in laboratory parameters (blood tests) may occur. Your doctor may need to perform some blood tests to monitor your condition.

In case of hepatic impairment (liver problems), there is a risk of developing hepatic encephalopathy (a degenerative brain disorder).

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Perindopril and Indapamide Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the
bottle after "Exp.". The expiry date refers to the last day of that month.
After opening, use within 100 days.
Store the container tightly closed to protect it from moisture. This medicine does not require
any special storage conditions regarding temperature.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines
you no longer use. This will help protect the environment.

6. Package contents and other information

What Perindopril and Indapamide Teva contains

The active substances are perindopril tosilate and indapamide. Each film-coated tablet contains 2.5 mg of perindopril tosilate (equivalent to 1.704 mg of perindopril) and 0.625 mg of indapamide.
The excipients are: monohydrate lactose, maize starch, sodium bicarbonate, pregelatinized starch (maize), povidone, magnesium stearate, polyvinyl alcohol - partially hydrolysed, titanium dioxide E171, macrogol/PEG 3350 and talc.

Description of the appearance of Perindopril and Indapamide Teva and the contents of the pack
Perindopril and Indapamide Teva 2.5 mg/0.625 mg film-coated tablets are white, capsule-shaped, biconvex, film-coated tablets with a score line on one side and smooth on the other.

Tablets are available in packs containing 30, 60, 90, 90 (3x30) or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 – Milan
Italy

Manufacturers
TEVA Pharmaceutical Works Private Limited Company - Pallagi út 13, 4042 Debrecen - Hungary
Teva Operations Sp. z.o.o - ul. Mogilska 80, 31-546 Krakow - Poland
TEVA UK Ltd - Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG - United Kingdom
Pharmachemie B.V. - Swensweg 5, 2031 GA Haarlem - Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names:
Estonia: Indapamide/Perindopril tosilate Teva
France: Perindopril /Indapamide Teva
Hungary: Perindopril-tozilát/Indapamid Teva
Ireland: Indapamide/Perindopril tosilate Teva
Italy: Perindopril e Indapamide Teva
Lithuania: Indapamide/Perindopril tosilate Teva 2,5mg/0,625mg plėvele dengtos tabletės
Indapamide/Perindopril tosilate Teva 5mg/1,25mg plėvele dengtos tabletės
Latvia: Indapamide/Perindopril tosilate Teva 2,5mg/0,625mg apvalkotās tabletes
Indapamide/Perindopril tosilate Teva 5mg/1,25mg apvalkotās tabletes
Netherlands: Perindopril Tosilaat/Indapamide Teva 2,5 mg/0,625 mg
Perindopril Tosilaat/Indapamide Teva 5 mg/1,25 mg
Poland: Perindopril Tosilate/Indapamide Teva
Romania: Hypoprilid 2.5 mg/0.625 mg & 5 mg/1.25 mg comprimate filmate
Slovenia: Perivol Combo

Package leaflet: information for the user

Perindopril and Indapamide Teva 5 mg/1.25 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Perindopril and Indapamide Teva is and what it is used for
What you need to know before taking Perindopril and Indapamide Teva
How to take Perindopril and Indapamide Teva
Possible side effects
How to store Perindopril and Indapamide Teva
Contents of the pack and other information

1. What Perindopril and Indapamide Teva is and what it is used for

What Perindopril and Indapamide Teva is
Perindopril and Indapamide Teva is a combination of two active substances, perindopril and indapamide. It is an antihypertensive medicine used to treat high blood pressure (hypertension).
What Perindopril and Indapamide Teva is used for
Perindopril belongs to a class of medicines called ACE inhibitors. This type of medicine dilates blood vessels, helping the 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 in that it causes only a slight increase in urine production. Both active substances reduce blood pressure, and together they control hypertension.

2. What you need to know before taking Perindopril and Indapamide Teva

Do not take Perindopril and Indapamide Teva

if you are allergic to perindopril, to any other ACE inhibitor, to indapamide, to any other sulfonamide, or to any of the excipients of this medicine (listed in section 6);
if you have previously experienced symptoms such as wheezing, facial or tongue swelling, severe itching, or serious skin rashes during treatment with an ACE inhibitor, or if you or a family member has experienced these symptoms under other circumstances (a condition known as angioedema);
if you have severe liver disease or a condition called hepatic encephalopathy (a degenerative brain disorder);
if you have severe kidney disease or are undergoing dialysis;
if you have low or high blood potassium levels;
if you have suspected untreated decompensated heart failure (severe fluid retention, breathing difficulties);
if you are more than 3 months pregnant (Perindopril and Indapamide Teva is also advised to be avoided in early pregnancy – see section “Pregnancy, breastfeeding and fertility”);
if you are breastfeeding;
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling beneath the skin, for example in the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril and Indapamide Teva:

if you are taking any of the following medicines, as the risk of angioedema may be increased:
- racecadotril, a medicine used to treat diarrhoea,
- medicines used to prevent rejection of transplanted organs and to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
- vildagliptin, a medicine used to treat diabetes.
if you have aortic stenosis (narrowing of the main blood vessel leaving the heart), hypertrophic cardiomyopathy (a heart muscle disease), or renal artery stenosis (narrowing of the artery supplying blood to the kidneys);
if you have any other heart problems or kidney issues;
if you have liver problems;
if you suffer from a collagen vascular disease (a skin disorder), such as systemic lupus erythematosus or scleroderma;
if you have atherosclerosis (hardening of the arteries);
if you have hyperparathyroidism (overactivity of the parathyroid gland);
if you have gout;
if you have diabetes;
if you are on a low-salt diet or use potassium-containing salt substitutes;
if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as their use together with Perindopril and Indapamide Teva should be avoided (see section “Other medicines and Perindopril and Indapamide Teva”);
if you are taking any of the following medicines for high blood pressure:
- an "angiotensin II receptor antagonist" (AIIRA), also known as sartans (e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
- aliskiren;
if you experience vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to weeks after starting Perindopril and Indapamide Teva. This condition may lead to permanent vision loss if untreated. If you have previously had allergic reactions to penicillin or sulfonamides, you may be at higher risk of developing this condition.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the section “Do not take Perindopril and Indapamide Teva”.
Inform your doctor if you think you are (or might become) pregnant. Perindopril and Indapamide Teva is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may cause severe harm to the fetus if used during this period (see section “Pregnacy, breastfeeding and fertility”).
During treatment with Perindopril and Indapamide Teva, inform your doctor or medical staff if:

you are due to undergo anaesthesia and/or surgery;
you have recently had diarrhoea or vomiting, or are dehydrated;
you are undergoing dialysis or LDL apheresis (removal of cholesterol from the blood using a special machine);
you are about to undergo desensitisation treatment to reduce the effects of an allergy to bee or wasp stings;
you are scheduled for a medical examination requiring injection of an iodinated contrast agent (a substance used to make organs such as the kidneys and stomach visible on X-rays).

Athletes should be aware that Perindopril and Indapamide Teva contains an active substance (indapamide) that may lead to a positive result in doping tests. Perindopril and Indapamide Teva must not be administered to children.

Other medicines and Perindopril and Indapamide Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

You must avoid taking Perindopril and Indapamide Teva together with:

lithium (used to treat depression);
potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (e.g. trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting).

Treatment with Perindopril and Indapamide Teva may be influenced by other medicines. Your doctor may need to adjust your dose and/or take additional precautions. These include:

other medicines for high blood pressure;
if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take Perindopril and Indapamide Teva” and “Warnings and precautions”);
medicines used to treat diarrhoea (racecadotril) or commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other mTOR inhibitors). See section “Warnings and precautions”;
procainamide (for irregular heartbeat);
allopurinol (used to treat gout);
terfenadine or astemizole (antihistamines for hay fever and allergies);
corticosteroids used to treat various disorders, including severe asthma and rheumatoid arthritis;
immunosuppressants used to treat autoimmune disorders or after organ transplantation to prevent rejection (e.g. cyclosporine);
anticancer medicines;
injectable erythromycin (an antibiotic);
halofantrine (used to treat certain types of malaria);
pentamidine (used to treat pneumonia);
injectable gold (used to treat rheumatoid arthritis);
vincamine (used to treat symptomatic cognitive disorders in the elderly, including memory loss);
bepridil (used to treat angina pectoris);
sultopride (used to treat psychosis);
medicines used for heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol);
digoxin and other cardiac glycosides (for heart problems);
baclofen (for muscle stiffness associated with conditions such as multiple sclerosis);
medicines used to treat diabetes, such as insulin or metformin;
calcium, including calcium supplements;
stimulant laxatives (e.g. senna);
non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high-dose salicylates (e.g. aspirin);
injectable amphotericin B (for treating serious fungal infections);
medicines used to treat mental disorders, such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics);
tetracosactide (for treating Crohn's disease).

Perindopril and Indapamide Teva with food and drink
Perindopril and Indapamide Teva should preferably be taken before a meal.

Pregnancy
Your doctor will usually advise you to stop taking Perindopril and Indapamide Teva before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Perindopril and Indapamide Teva is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may cause severe harm to the fetus if used beyond the third month.

Fertility
The effects of perindopril and indapamide on human fertility are unknown.

Perindopril and Indapamide Teva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Perindopril and Indapamide Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

3. How to take Perindopril and Indapamide Teva

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist. The recommended dose is one tablet once
daily. Your doctor may decide to adjust the dosage if you have renal impairment.
Take the tablet preferably in the morning before a meal. Swallow the tablet with a
glass of water.
The tablet may be divided into equal doses.
If you take more Perindopril and Indapamide Teva than you should
If you take too many tablets, contact your doctor or the nearest emergency department immediately. In
case of overdose, the most likely effect is a drop in blood pressure which may cause dizziness or fainting. If
this occurs, lying down with your legs raised may help.
If you forget to take Perindopril and Indapamide Teva
It is important that you take this medicine every day, as treatment is most effective when taken regularly. However, if you forget to take a dose of Perindopril and
Indapamide Teva, take the next dose at your usual time. Do not take a double dose to
make up for the missed dose.
If you stop taking Perindopril and Indapamide Teva
Treatment for hypertension is usually continued for life; therefore, consult your doctor before stopping
the medication.
If you have any questions about 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 everyone experiences them.
If you notice any of the following effects, stop taking the medicine and contact your doctor immediately:

swelling of the face, lips, mouth, tongue or throat, difficulty breathing;
severe dizziness or fainting;
unusually fast or irregular heartbeat.

The following side effects may occur, listed in order of decreasing frequency.

Common side effects (may affect up to 1 in 10 people): headache, dizziness, vertigo, tingling sensations, visual disturbances, tinnitus (ringing in the ears), feeling of lightheadedness due to low blood pressure, cough, shortness of breath, gastrointestinal disorders (nausea, epigastric pain, loss of appetite, vomiting, abdominal pain, taste disturbances, dry mouth, dyspepsia or indigestion, diarrhoea, constipation), allergic reactions (such as skin rashes and itching), muscle cramps, fatigue.
Uncommon side effects (may affect up to 1 in 100 people): mood swings, sleep disorders, bronchospasm (chest tightness, wheezing and shortness of breath), angioedema (symptoms such as wheezing, swelling of the face or tongue), urticaria, purpura (small red spots on the skin), kidney problems, impotence, sweating.
Rare side effects (may affect up to 1 in 1,000 people): worsening of psoriasis.
Very rare side effects (may affect up to 1 in 10,000 people): confusion, cardiovascular disorders (irregular heartbeat, angina, cardiac arrest), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose), allergic reaction in the small intestine (intestinal angioedema), severe skin reactions such as erythema multiforme. If you suffer from systemic lupus erythematosus (a collagen disease), this may worsen. Cases of photosensitivity reactions (skin changes) after exposure to sunlight or artificial UVA rays have also been reported. Acute kidney failure.
Frequency not known (frequency cannot be estimated from the available data): decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), fainting, abnormal colour, numbness and pain in fingers or toes (Raynaud's phenomenon), potentially life-threatening irregular heartbeat (torsades de pointes), abnormalities in ECG tracing, increased levels of liver enzymes.

Blood, kidney, liver or pancreas disorders and changes in laboratory parameters (blood tests) may occur. Your doctor may need to perform blood tests to monitor your condition.

In case of liver impairment (liver problems), there is a risk of developing hepatic encephalopathy (a degenerative brain disorder).

Reporting of side effects

5. How to store Perindopril and Indapamide Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the bottle after "Exp.". The expiry date refers to the last day of that month.
After opening, use within 100 days.
Store the container tightly closed to protect it from moisture. This medicine does not require any special storage conditions regarding temperature.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Perindopril and Indapamide Teva contains

The active substances are perindopril tosylate and indapamide. Each film-coated tablet contains 5 mg of perindopril tosylate (equivalent to 3.408 mg of perindopril) and 1.25 mg of indapamide.
The excipients are: monohydrate lactose, maize starch, sodium bicarbonate, pregelatinized starch (maize), povidone, magnesium stearate, polyvinyl alcohol – partially hydrolysed, titanium dioxide E171, macrogol/PEG 3350 and talc.

Description of the appearance of Perindopril and Indapamide Teva and pack contents
Perindopril and Indapamide Teva 5 mg/1.25 mg film-coated tablets are white, capsule-shaped, biconvex, film-coated tablets marked with “P” and “I” and a break line on one side, and smooth on the other. The tablets are available in packs containing 30, 60, 90, 90 (3x30) or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 – Milan
Italy

Manufacturers
TEVA Pharmaceutical Works Private Limited - Company Pallagi út 13, 4042 Debrecen - Hungary
Teva Operations Sp. z.o.o - ul. Mogilska 80, 31-546 Krakow - Poland
TEVA UK Ltd - Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG - United Kingdom
Pharmachemie B.V. - Swensweg 5, 2031 GA Haarlem - Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names:

Bulgaria: Perindopril/Indapamide Teva
Estonia: Indapamide/Perindopril tosilate Teva
France: Perindopril/Indapamide Teva
Hungary: Perindopril-tozilát/Indapamid Teva
Ireland: Indapamide/Perindopril tosilate Teva
Italy: Perindopril e Indapamide Teva
Lithuania: Indapamide/Perindopril tosilate Teva 2,5mg/0,625mg plėvele dengtos tabletės
Indapamide/Perindopril tosilate Teva 5mg/1,25mg plėvele dengtos tabletės
Latvia: Indapamide/Perindopril tosilate Teva 2,5mg/0,625mg apvalkotās tabletes
Indapamide/Perindopril tosilate Teva 5mg/1,25mg apvalkotās tabletes
Netherlands: Perindopril Tosilaat/Indapamide Teva 2,5 mg/0,625 mg
Perindopril Tosilaat/Indapamide Teva 5 mg/1,25 mg
Poland: Perindopril Tosilate/Indapamide Teva
Romania: Hypoprilid 2.5 mg/0.625 mg & 5 mg/1.25 mg comprimate filmate
Slovenia: Perivol Combo