PERINDOPRIL 2 mg /0.625 Mg Coated Tablet

Зміст інструкції

1. Perindopril and Indapamide TecniGen 2 mg/0.625 mg tablets
   1. What is Perindopril and indapamide Tecnigen 2 mg/0.628 mg and what is it used for
   2. What you need to know before taking Perindopril and Indapamide Tecnigen 2 mg/0.625 mg
   3. How to take Perindopril and Indapamide 2 mg/0.625 mg
   4. Possible side effects
   5. How to store Perindopril and Indapamide 2 mg/0.625 mg
   6. Contents of the pack and other information
2. Perindopril and Indapamide TecniGen 4 mg/1.25 mg tablets
   1. What is Perindopril and Indapamide TecniGen 4 mg/1.25 mg and WHAT IS IT FOR
   2. What you need to know before taking Perindopril and Indapamide Tecnigen 4 mg/1.25 mg
   3. How to take Perindopril and Indapamide TecniGen 4 mg/1.25 mg
   4. Possible side effects
   5. How to store Perindopril e Indapamide TecniGen 4 mg/1.25 mg
   6. Contents of the pack and other information
3. Perindopril and Indapamide TecniGen 8 mg/2.5 mg tablets
   1. What is Perindopril and Indapamide TecniGen 8 mg/2.5 mg and what is it used for
4. Perindopril and Indapamide TecniGen 8 mg/2.5 mg is indicated in patients who are already taking
   1. What you need to know before taking Perindopril and Indapamide Tecnigen 8 mg/2.5 mg
   2. How to take Perindopril and Indapamide TecniGen 8 mg/2.5 mg
   3. Possible side effects
   4. How to store Perindopril and Indapamide TecniGen 8 mg/2.5 mg
   5. Contents of the pack and other information

Perindopril and Indapamide TecniGen 2 mg/0.625 mg tablets

perindopril tert-butylamine and indapamide

Generic medicine

Read this leaflet carefully before 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Perindopril and Indapamide TecniGen 2 mg/0.625 mg is and what it is used for
• 2. What you need to know before you take Perindopril and Indapamide TecniGen 2 mg/0.625 mg
• 3. How to take Perindopril and Indapamide TecniGen 2 mg/0.625 mg
• 4. Possible side effects
• 5. How to store Perindopril and Indapamide TecniGen 2 mg/0.625 mg
• 6. Contents of the pack and other information

1. What is Perindopril and indapamide Tecnigen 2 mg/0.628 mg and what is it used for

What is Perindopril and Indapamide TecniGen 2 mg/0.625 mg
Perindopril and Indapamide TecniGen 2 mg/0.625 mg is a combination of two active ingredients,
perindopril and indapamide.
It is an antihypertensive medicine and is used in the treatment of high blood pressure (hypertension).

What is Perindopril and Indapamide TecniGen 2 mg/0.625 mg used for
Perindopril belongs to a class of drugs called ACE inhibitors. These medicines 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 in that it produces only a slight increase in the amount
of urine produced. Both active ingredients reduce blood pressure and work together to
control blood pressure.

2. What you need to know before taking Perindopril and Indapamide Tecnigen 2 mg/0.625 mg

Do not take Perindopril and Indapamide TecniGen 2 mg/0.625 mg

• if you are allergic to perindopril or to any other ACE inhibitor;
• if you are allergic to indapamide or to any other sulfonamide;
• if you are allergic to 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 following a previous treatment with an ACE inhibitor or if you or a member of your family has presented these symptoms in any other circumstance (a condition called angioedema);
• if you have a severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative brain disease);
• if you have a severe kidney disease or if you are undergoing dialysis;
• if you have low or high levels of potassium in your blood;
• if there is suspicion that you suffer from decompensated heart failure (severe fluid retention, difficulty breathing);
• if you are pregnant for more than three months (it is best to avoid Perindopril and Indapamide TecniGen 2 mg/0.625 mg even in the early stages of pregnancy - see the Pregnancy section);
• if you are breastfeeding.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Perindopril and Indapamide
TecniGen 2 mg/0.625 mg

• if you suffer from aortic stenosis (narrowing of the main blood vessel originating from the heart) or suffer from hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that carries blood to the kidneys);
• if you have any other heart problems or kidney problems;
• if you have liver problems;
• if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus (a particular chronic inflammation) or suffer from 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 following a low-salt diet or use salt substitutes that contain potassium;
• if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with Perindopril and Indapamide TecniGen 2 mg + 0.625 mg should be avoided (see “Other medicines and Perindopril and Indapamide Tecnigen 2 mg/0.625 mg”).
• If you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes.
• 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 what is reported in the section "Do not take Perindopril and Indapamide TecniGen"

You must tell your doctor if you suspect (or are planning) a pregnancy. Perindopril and
Indapamide TecniGen 2 mg/0.625 mg should be avoided in early pregnancy, and should not
be taken if you are pregnant for more than three months, as it can cause serious harm to the
baby if taken during that period (see the pregnancy section).
While you are taking Perindopril and Indapamide TecniGen 2 mg/0.625 mg you should also inform
your doctor or medical staff:

• if you need to undergo anesthesia and/or surgery;
• if you have recently suffered from diarrhea or vomiting or are dehydrated;
• if you need to undergo dialysis or LDL apheresis (which consists of removing cholesterol from the blood through a machine);
• if you are going to receive a desensitization treatment to reduce the effects of an allergy to bee or wasp stings;
• if you are going to undergo a diagnostic test that requires the injection of an iodine-containing contrast agent (a substance that makes organs such as the kidneys or stomach visible on an X-ray).

Athletes should be aware that Perindopril and Indapamide TecniGen 2 mg/0.625 mg
contains an active ingredient (indapamide) that may give a positive result in doping tests.

Children
Perindopril and Indapamide TecniGen 2 mg/0.625 mg should not be given to children.

Other medicines and Perindopril and Indapamide TecniGen 2 mg/0.625 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
You should avoid taking Perindopril and Indapamide TecniGen 2 mg/0.625 mg with:

• lithium (used to treat depression);
• potassium-sparing diuretics (spironolactone, triamterene), potassium salts.

Treatment with Perindopril and Indapamide TecniGen 2 mg/0.625 mg may be affected by
other medicines. Make sure to tell your doctor that you are taking any of the following
medicines as special care may be needed.

• other medicines for the treatment of high blood pressure;
• procainamide (for the treatment of irregular heartbeat);
• allopurinol (for the treatment of gout);
• 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 autoimmune disorders following a transplant in order to prevent rejection (e.g. cyclosporine);
• medicines for the treatment of cancer;
• erythromycin given 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 the elderly, including memory loss);
• bepridil (used to treat angina pectoris);
• sultopride (for the treatment of psychosis);
• 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 (for the treatment of muscle stiffness that occurs in conditions such as multiple sclerosis);
• medicines for treating 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 doses of salicylates (e.g. aspirin);
• amphotericin B given by injection (for the treatment of severe fungal infections);
• medicines for treating mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics);
• tetracosactide (for the treatment of Crohn's disease).

Your doctor may need to adjust the dose and/or take other precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see
also what is reported in the section "Do not take Perindopril and Indapamide TecniGen” and "Warnings
and precautions “)

Perindopril and Indapamide TecniGen 2 mg/0.625 mg with food, drinks and alcohol
It is preferable to take Perindopril and Indapamide TecniGen 2 mg/0.625 mg before meals.

Pregnancy, breastfeeding and fertility
If you are pregnant, if you suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you suspect (or are planning) a pregnancy. As a rule, your doctor will advise you to stop taking Perindopril and Indapamide TecniGen 2 mg/0.625 mg
before starting pregnancy or as soon as you become aware of being pregnant, and
will advise you to take another medicine instead of Perindopril and Indapamide TecniGen 2
mg/0.625 mg. Perindopril and Indapamide TecniGen 2 mg/0.625 mg should not be administered
in early pregnancy, and should not be taken if you are pregnant for more than three months
as it can cause serious harm to the baby if used during that period (see the pregnancy section).

Breastfeeding
Talk to your doctor if you are breastfeeding or are planning to start breastfeeding. You should not take
Perindopril and Indapamide TecniGen 2 mg/0.625 mg if you are breastfeeding. Your doctor may choose another
treatment if you intend to breastfeed, especially if your baby is a newborn or was born
prematurely.
Contact your doctor immediately.

Driving and using machines
Perindopril and Indapamide TecniGen 2 mg/0.625 mg usually does not affect reflexes but in
some patients, various reactions such as dizziness or weakness may occur, linked
to lowering blood pressure. If this happens, your ability to drive or operate machinery
may be impaired.

Perindopril and Indapamide TecniGen 2 mg/0.625 mg contains lactose monohydrate (a type of
sugar).
If your doctor has told you that you have an intolerance to some sugars, consult him before taking
this medicine.

3. How to take Perindopril and Indapamide 2 mg/0.625 mg

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet once a day.
The doctor may decide to increase the dose to 2 tablets a day or modify the dosage if
you suffer from renal insufficiency. Take the tablet preferably in the morning and before meals.
Swallow the tablet with a glass of water.
The tablet can be divided into two equal doses.

If you take more Perindopril and Indapamide TecniGen 2 mg/0.625 mg than you should
If you take too many tablets, contact your doctor or the nearest Emergency Room immediately.
In case of overdose, the most likely effect is a lowering of blood pressure. If you should
experience very low blood pressure (symptoms such as dizziness or weakness), you can be helped
by lying down with your legs raised.

If you forget to take Perindopril and Indapamide TecniGen 2 mg/0.625 mg
It is important to take the medicine every day as regular treatment is more effective.
However, if you forget to take a dose of Perindopril and Indapamide TecniGen 2 mg/0.625
mg, take the next dose at the usual time. Do not take a double dose to make up for the
forgotten dose.

If you stop taking Perindopril and Indapamide TecniGen 2 mg/0.625 mg
Since the treatment of high blood pressure usually lasts for life, you should talk to your
doctor before stopping taking the medicine.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

If any of the following side effects occur, stop taking the medicine immediately and inform your doctor without delay:

• swelling of the face, lips, mouth or throat
• difficulty breathing
• severe dizziness or fainting
• very fast or irregular heartbeat In decreasing order of frequency, side effects may include:

Common (may affect up to 1 in 10 people, but less than 1 in 100)

• headache
• dizziness
• vertigo
• tingling
• vision disturbances
• tinnitus (ringing in the ears)
• dizziness due to low blood pressure
• cough
• shortness of breath
• gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dry mouth, dyspepsia or difficulty digesting, diarrhoea, constipation)
• allergic reactions (such as skin rashes, itching)
• muscle cramps
• feeling tired;

Uncommon (may affect up to 1 in 100 people, but less than 1 in 1000)

• mood changes
• sleep disorders
• bronchospasm (tightening of the chest, wheezing and shortness of breath)
• angioedema (symptoms such as wheezing, swelling of the face or tongue)
• urticaria
• purpura (red spots on the skin)
• kidney problems
• impotence
• sweating

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

• confusion
• cardiovascular disorders (irregular heartbeat, angina, heart attack)
• eosinophilic pneumonia (a rare type of pneumonia)
• rhinitis (blocked or runny nose)
• severe skin manifestations such as erythema multiforme. If you suffer from systemic lupus erythematosus (a type of collagen disease), this may worsen.
• Cases of photosensitivity reactions (change in skin appearance) have been reported after exposure to sunlight or artificial UVA rays.

Not known (frequency cannot be estimated from available data): fainting, potentially life-threatening irregular heartbeat (torsades de pointes), abnormal electrocardiogram, increased levels of liver enzymes.
Blood disorders, kidney, liver or pancreas disorders and changes in laboratory values (blood tests) may occur. Your doctor may need to prescribe blood tests to check your condition.
In case of liver failure (liver disorders), there is a possibility of hepatic encephalopathy (brain degeneration) occurring.
If any of these side effects occur or if you notice any other side effects not listed in this leaflet, tell your doctor, pharmacist or nurse.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. You can also report side effects directly through the national reporting system at

“www.agenziafarmaco.gov.it/it/responsabili”. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Perindopril and Indapamide 2 mg/0.625 mg

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Do not use this medicine after the expiry date which is stated on the blister and the package after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Perindopril and Indapamide TecniGen 2 mg/0.625 mg contains

• The active ingredients are perindopril tert-butylamine and indapamide. Each tablet contains 2 mg of perindopril tert-butylamine and 0.625 mg of indapamide.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Perindopril and Indapamide TecniGen 2 mg/0.625 mg and pack contents
Perindopril and Indapamide TecniGen 2 mg/0.625 mg are capsule-shaped tablets, white in colour,
with a score line on both sides, with “-” imprinted on both sides of the breaking line
and smooth on the opposite side.
The tablets are available in packs containing 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy
Manufacturer

• 1) Atlantic Pharma – Produções Farmacêuticas, S.A. Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal
• 2) West Pharma – Produções de Especialidades Farmacêuticas, S.A. Rua João de Deus, n.º 11, Venda Nova, 2700-486 Amadora, Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Portugal: Perindopril+Indapamida Biofarmoz
Italy: Perindopril e Indapamide TecniGen

Perindopril and Indapamide TecniGen 4 mg/1.25 mg tablets

perindopril tert-butylamine and indapamide
Generic medicine

Read 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Perindopril and Indapamide TecniGen 4 mg/1.25 mg is and what it is used for
• 2. What you need to know before you take Perindopril and Indapamide TecniGen 4 mg/1.25 mg
• 3. How to take Perindopril and Indapamide TecniGen 4 mg/1.25 mg
• 4. Possible side effects
• 5. How to store Perindopril and Indapamide TecniGen 4 mg/1.25 mg
• 6. Contents of the pack and other information

1. What is Perindopril and Indapamide TecniGen 4 mg/1.25 mg and WHAT IS IT FOR

What is Perindopril and Indapamide TecniGen 4 mg/1.25 mg
Perindopril and Indapamide TecniGen 4 mg/1.25 mg is a combination of two active ingredients,
perindopril and indapamide.
It is an antihypertensive medicine and is used in the treatment of high blood pressure (hypertension).

What is Perindopril and Indapamide TecniGen 4 mg/1.25 mg for
Perindopril belongs to a class of drugs called ACE inhibitors. These medicines 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 in that it produces only a slight increase in the amount
of urine produced. Both active ingredients lower blood pressure and work together to
control blood pressure.

2. What you need to know before taking Perindopril and Indapamide Tecnigen 4 mg/1.25 mg

Do not take Perindopril and Indapamide TecniGen 4 mg/1.25 mg

• if you are allergic to perindopril or to any other ACE inhibitor;
• if you are allergic to indapamide or to any other sulfonamide;
• if you are allergic to 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 following a previous treatment with an ACE inhibitor or if you or a member of your family has presented these symptoms in any other circumstance (a condition called angioedema);
• if you have a severe liver disease or suffer from a condition called hepatic encephalopathy (brain disease);
• if you have a severe kidney disease or if you are undergoing dialysis;
• if you have low or high levels of potassium in your blood;
• if there is suspicion that you suffer from decompensated heart failure (severe fluid retention, difficulty breathing);
• if you are pregnant for more than three months (it is better to avoid Perindopril and Indapamide TecniGen 4 mg/1.25 mg even in the early stages of pregnancy - see the section Pregnancy);
• if you are breastfeeding.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Perindopril and Indapamide
TecniGen 4 mg/1.25 mg

• if you suffer from aortic stenosis (narrowing of the main blood vessel originating from the heart) or suffer from hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that carries blood to the kidneys);
• if you have any other heart problems or kidney problems;
• if you have liver problems;
• if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus (a particular chronic inflammation) or suffer from 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 following a low-salt diet or use salt substitutes that contain potassium;
• if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with Perindopril and Indapamide TecniGen 4 mg/1.25 mg must be avoided (see “Other medicines and Perindopril and Indapamide TecniGen 4 mg/1.25 mg”).
• If you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes.
• 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 what is reported under the heading "Do not take Perindopril and Indapamide TecniGen".

You must tell your doctor if you suspect (or are planning) a pregnancy. Perindopril and
Indapamide TecniGen 4 mg/1.25 mg should be avoided in early pregnancy, and should not
be taken if you are pregnant for more than three months, as it can cause serious harm to the
baby if taken during that period (see the section pregnancy).
While you are taking Perindopril and Indapamide TecniGen 4 mg/1.25 mg you should also inform your
doctor or medical staff:

• if you are going to have anesthesia and/or surgery;
• if you have recently suffered from diarrhea or vomiting or are dehydrated;
• if you are going to undergo dialysis or LDL apheresis (which involves removing cholesterol from the blood through a machine);
• if you are going to receive a desensitization treatment to reduce the effects of an allergy to bee or wasp stings;
• if you are going to undergo a diagnostic test that requires the injection of an iodine-containing contrast agent (a substance that makes organs such as the kidneys or stomach visible on an X-ray).

Athletes should be aware that Perindopril and Indapamide TecniGen 4 mg/1.25 mg
contains an active ingredient (indapamide) that may give a positive result in doping tests.

Children
Perindopril and Indapamide TecniGen 4 mg/1.25 mg should not be given to children.

Other medicines and Perindopril and Indapamide TecniGen 4 mg/1.25 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
You should avoid taking Perindopril and Indapamide TecniGen 4 mg/1.25 mg with:

• lithium (used to treat depression);
• potassium-sparing diuretics (spironolactone, triamterene), potassium salts.

The treatment with Perindopril and Indapamide TecniGen 4 mg/1.25 mg may be affected by
other medicines. Make sure to tell your doctor that you are taking any of the following
medicines as special care may be needed.

• other medicines for the treatment of high blood pressure;
• procainamide (for the treatment of irregular heartbeat);
• allopurinol (for the treatment of gout);
• terfenadine or astemizole (antihistamines for hay fever or allergies);
• corticosteroids used to treat various conditions, including severe asthma and rheumatoid arthritis;
• immunosuppressants used to treat autoimmune disorders following a transplant in order to prevent rejection (e.g. cyclosporine);
• medicines for the treatment of cancer;
• erythromycin given 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 the elderly, including memory loss);
• bepridil (used to treat angina pectoris);
• sultopride (for the treatment of psychosis);
• 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 (for the treatment of muscle stiffness that occurs in conditions such as multiple sclerosis);
• medicines for treating 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 doses of salicylates (e.g. aspirin);
• amphotericin B given by injection (for the treatment of severe fungal infections);
• medicines for treating mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics);
• tetracosactide (for the treatment of Crohn's disease).

Your doctor may need to adjust the dose and/or take other precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also
what is reported under the heading "Do not take Perindopril and Indapamide TecniGen” and
"Warnings and precautions “)

Perindopril and Indapamide TecniGen 4 mg/1.25 mg with food, drinks and alcohol
It is preferable to take Perindopril and Indapamide TecniGen 4 mg/1.25 mg before meals.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you suspect (or are planning) a pregnancy. As a rule, your doctor will
advise you to stop taking Perindopril and Indapamide TecniGen 4 mg/1.25 mg
before starting pregnancy or as soon as you find out you are pregnant and will advise you to take
another medicine instead of Perindopril and Indapamide TecniGen 4
mg/1.25 mg. Perindopril and Indapamide TecniGen 4 mg/1.25 mg should not be administered
in early pregnancy, and should not be taken if you are pregnant for more than three months
as it can cause serious harm to the baby if used during that period (see the section pregnancy).

Breastfeeding
Talk to your doctor if you are breastfeeding or planning to start breastfeeding. You should not take
Perindopril and Indapamide TecniGen 2 mg/0.625 if you are breastfeeding. Your doctor may choose
another treatment if you intend to breastfeed, especially if your baby is a newborn or was born
prematurely.
Contact your doctor immediately.

Driving and operating machinery
Perindopril and Indapamide TecniGen 4 mg/1.25 mg usually does not affect reflexes but in
some patients various reactions such as dizziness or weakness, related to
lowering blood pressure may occur. If this happens, your ability to drive or operate machinery
may be impaired.

Perindopril and Indapamide TecniGen 4 mg/1.25 mg contains lactose monohydrate (a type of
sugar).
If your doctor has told you that you have an intolerance to some sugars, consult him before taking
this medicine.

3. How to take Perindopril and Indapamide TecniGen 4 mg/1.25 mg

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet once a day.
The doctor may decide to increase the dose to 2 tablets a day or modify the dosage if
you suffer from renal insufficiency. Take the tablet preferably in the morning and before meals.
Swallow the tablet with a glass of water.
The tablet can be divided into two equal doses.

If you take more Perindopril and Indapamide TecniGen 4 mg/1.25 mg than you should
If you take too many tablets, contact your doctor or the nearest Emergency Room immediately.
In case of overdose, the most likely effect is a lowering of blood pressure. If you should
experience very low blood pressure (symptoms such as dizziness or weakness), lying down with your legs raised may help.

If you forget to take Perindopril and Indapamide TecniGen 4 mg/1.25 mg
It is important to take the medicine every day as regular treatment is more effective.
However, if you forget to take a dose of Perindopril and Indapamide TecniGen 4 mg/1.25 mg,
take the next dose at the usual time. Do not take a double dose to make up for the
forgotten dose.

If you stop taking Perindopril and Indapamide TecniGen 4 mg/1.25 mg
As treatment for high blood pressure usually lasts for life, you should talk to your
doctor before stopping taking the medicine.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

If any of the following side effects occur, stop taking the medicine immediately and tell your doctor:

• swelling of the face, lips, mouth or throat
• difficulty breathing
• severe dizziness or fainting
• very fast or irregular heartbeat In decreasing order of frequency, side effects may include:

Common (may affect up to 1 in 10 people, but less than 1 in 100)

• headache
• dizziness
• vertigo
• tingling
• vision disturbances
• tinnitus (ringing in the ears)
• dizziness due to low blood pressure
• cough
• shortness of breath
• gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dry mouth, dyspepsia or difficulty digesting, diarrhoea, constipation)
• allergic reactions (such as skin rashes, itching)
• muscle cramps
• feeling tired;

Uncommon (may affect up to 1 in 100 people, but less than 1 in 1000)

• mood changes
• sleep disorders
• bronchospasm (tightening of the chest, wheezing and shortness of breath)
• angioedema (symptoms such as wheezing, swelling of the face or tongue)
• urticaria
• purpura (red spots on the skin)
• kidney problems
• impotence
• sweating

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

• confusion
• cardiovascular disorders (irregular heartbeat, angina, heart attack)
• eosinophilic pneumonia (a rare type of pneumonia)
• rhinitis (blocked or runny nose)
• severe skin manifestations such as erythema multiforme. If you suffer from systemic lupus erythematosus (a type of collagen disease), this may worsen.
• Cases of photosensitivity reactions (change in skin appearance) have been reported after exposure to sunlight or artificial UVA rays.

Not known (frequency cannot be estimated from available data): fainting, potentially life-threatening irregular heartbeat (torsades de pointes), abnormal electrocardiogram, increased levels of liver enzymes.
Blood, kidney, liver or pancreas disorders and changes in laboratory values (blood tests) may occur. Your doctor may need to prescribe blood tests to check your condition.
In case of liver failure (liver disorders), there is a possibility of hepatic encephalopathy (brain degeneration) occurring.
If any of these side effects occur, or if you notice any other side effects not listed in this leaflet, tell your doctor, pharmacist or nurse.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. You can also report side effects directly through the national reporting system at

“www.agenziafarmaco.gov.it/it/responsabili”. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Perindopril e Indapamide TecniGen 4 mg/1.25 mg

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the blister and the outer packaging after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What contains Perindopril and Indapamide TecniGen 4 mg/1.25 mg

• The active ingredients are perindopril tert-butylamine and indapamide. Each tablet contains 4 mg of perindopril tert-butylamine and 1.25 mg of indapamide.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Perindopril and Indapamide TecniGen 4 mg/1.25 mg and pack contents
Perindopril and Indapamide TecniGen 4 mg/1.25 mg are capsule-shaped tablets, white in colour,
with a notch on both sides, imprinted with “+” on both sides of the notch
and smooth on the opposite side.
The tablets are available in packs containing 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy
Manufacturer

• 1) Atlantic Pharma – Produções Farmacêuticas, S.A. Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal
• 2) West Pharma – Produções de Especialidades Farmacêuticas, S.A. Rua João de Deus, n.º 11, Venda Nova, 2700-486 Amadora, Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Portugal: Perindopril+Indapamida Biofarmoz
Italy: Perindopril e Indapamide TecniGen

Perindopril and Indapamide TecniGen 8 mg/2.5 mg tablets

perindopril tert-butylamine and indapamide
Generic medicine

Read 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Perindopril and Indapamide TecniGen 8 mg/2.5 mg is and what it is used for
• 2. What you need to know before you take Perindopril and Indapamide TecniGen 8 mg/2.5 mg
• 3. How to take Perindopril and Indapamide TecniGen 8 mg/2.5 mg
• 4. Possible side effects
• 5. How to store Perindopril and Indapamide TecniGen 8 mg/2.5 mg
• 6. Contents of the pack and other information

1. What is Perindopril and Indapamide TecniGen 8 mg/2.5 mg and what is it used for

What is Perindopril and Indapamide TecniGen 8 mg/2.5 mg
Perindopril and Indapamide TecniGen 8 mg/2.5 mg is a combination of two active ingredients,
perindopril and indapamide.
It is an antihypertensive medicine and is used in the treatment of high blood pressure (hypertension).

Perindopril and Indapamide TecniGen 8 mg/2.5 mg is indicated in patients who are already taking

tablets of perindopril 8 mg and indapamide 2.5 mg separately. These patients can therefore
take a single tablet of Perindopril and Indapamide TecniGen 8 mg/2.5 mg which contains
both active ingredients.

What is Perindopril and Indapamide TecniGen 8 mg/2.5 mg used for
Perindopril belongs to a class of drugs called ACE inhibitors. These medicines 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 in that it produces only a slight increase in the amount of
urine produced. Both active ingredients reduce blood pressure and work together to
control blood pressure.

2. What you need to know before taking Perindopril and Indapamide Tecnigen 8 mg/2.5 mg

Do not take Perindopril and Indapamide TecniGen 8 mg/2.5 mg

• if you are allergic to perindopril or to any other ACE inhibitor;
• if you are allergic to indapamide or to any other sulfonamide;
• if you are allergic to 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 following a previous treatment with an ACE inhibitor or if you or a family member has presented these symptoms in any other circumstance (a condition called angioedema);
• if you have a severe liver disease or suffer from a condition called hepatic encephalopathy (brain disease);
• if you have a kidney disease or if you are undergoing dialysis;
• if you have low or high levels of potassium in your blood;
• if there is suspicion that you suffer from decompensated heart failure (severe fluid retention, difficulty breathing);
• if you are pregnant for more than three months (it is best to avoid Perindopril and Indapamide TecniGen 8 mg/2.5 mg even in the early stages of pregnancy - see the Pregnancy section);
• if you are breastfeeding.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Perindopril and Indapamide
TecniGen 8 mg/2.5 mg

• if you suffer from aortic stenosis (narrowing of the main blood vessel originating from the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that carries blood to the kidneys);
• if you have any other heart problems;
• if you have liver problems;
• if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus (a particular chronic inflammation) 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 following a low-salt diet or use salt substitutes that contain potassium;
• if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with Perindopril and Indapamide TecniGen 8 mg/2.5 mg should be avoided (see “Other medicines and Perindopril and Indapamide TecniGen 8 mg/2.5 mg”).
• If you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• 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 what is stated in the section "Do not take Perindopril and Indapamide TecniGen"

You must tell your doctor if you suspect (or are planning) a pregnancy. Perindopril and
Indapamide TecniGen 8 mg/2.5 mg should be avoided in early pregnancy, and should not
be taken if you are pregnant for more than three months, as it can cause serious harm to the
baby if taken during that period (see the pregnancy section).
While you are taking Perindopril and Indapamide TecniGen 8 mg/2.5 mg you should also inform your
doctor or medical staff:

• if you need to undergo anesthesia and/or surgery;
• if you have recently suffered from diarrhea or vomiting or are dehydrated;
• if you need to undergo dialysis or LDL apheresis (which consists of removing cholesterol from the blood through a machine);
• if you are about to receive a desensitization treatment to reduce the effects of an allergy to bee or wasp stings;
• if you are about to undergo a diagnostic test that requires the injection of an iodine-containing contrast agent (a substance that makes organs such as the kidneys or stomach visible on an X-ray).

Athletes should be aware that Perindopril and Indapamide TecniGen 8 mg/2.5 mg contains
an active ingredient (indapamide) that may give a positive result in doping tests.

Children
Perindopril and Indapamide TecniGen 8 mg/2.5 mg should not be given to children.

Other medicines and Perindopril and Indapamide TecniGen 8 mg/2.5 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
You should avoid taking Perindopril and Indapamide TecniGen 8 mg/2.5 mg with:

• lithium (used to treat depression);
• potassium-sparing diuretics (spironolactone, triamterene), potassium salts.

Treatment with Perindopril and Indapamide TecniGen 8 mg/2.5 mg can be affected by other
medicines. Make sure to tell your doctor that you are taking any of the following medicines as
particular care may be needed.

• other medicines for the treatment of high blood pressure;
• procainamide (for the treatment of irregular heartbeat);
• allopurinol (for the treatment of gout);
• terfenadine or astemizole (antihistamines for hay fever or allergies);
• corticosteroids used to treat various conditions, including severe asthma and rheumatoid arthritis;
• immunosuppressants used to treat autoimmune disorders following a transplant in order to prevent rejection (e.g. cyclosporine);
• medicines for the treatment of cancer;
• erythromycin given 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 the elderly, including memory loss);
• bepridil (used to treat angina pectoris);
• sultopride (for the treatment of psychosis)
• 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 (for treating muscle stiffness that occurs in conditions such as multiple sclerosis);
• medicines for treating 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 doses of salicylates (e.g. aspirin);
• amphotericin B given by injection (for treating severe fungal infections);
• medicines for treating mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics);
• tetracosactide (for treating Crohn's disease).

Your doctor may need to adjust the dose and/or take other precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also
what is stated in the section "Do not take Perindopril and Indapamide TecniGen” and "Warnings
and precautions “)

Perindopril and Indapamide TecniGen 8 mg/2.5 mg with food, drinks and alcohol
It is preferable to take Perindopril and Indapamide TecniGen 8 mg/2.5 mg before meals.

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant, if you suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk.

Pregnancy
You must tell your doctor if you suspect (or are planning) a pregnancy. Usually your doctor will
advise you to stop taking Perindopril and Indapamide TecniGen 8 mg/2.5 mg before
starting pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Perindopril and Indapamide TecniGen 8
mg/2.5 mg. Perindopril and Indapamide TecniGen 8 mg/2.5 mg should not be given
in early pregnancy, and should not be taken if you are pregnant for more than three months
as it can cause serious harm to the baby if used during that period (see the pregnancy section).

Breastfeeding
Talk to your doctor if you are breastfeeding or planning to start breastfeeding. You should not take
Perindopril and Indapamide TecniGen 2 mg/0.625 if you are breastfeeding. Your doctor may choose another
treatment if you intend to breastfeed, especially if your baby is a newborn or was born
prematurely.
Contact your doctor immediately.

Driving and operating machinery
Perindopril and Indapamide TecniGen 8 mg/2.5 mg usually does not affect reflexes but in some
patients may experience various reactions such as dizziness or weakness, related to
lowering blood pressure. If this happens, your ability to drive or operate machinery
may be impaired.

Perindopril and Indapamide TecniGen 8 mg/2.5 mg contains lactose monohydrate (a type of
sugar).
If your doctor has told you that you have an intolerance to some sugars, consult him before taking
this medicine.

3. How to take Perindopril and Indapamide TecniGen 8 mg/2.5 mg

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet a day.
Take the tablet preferably in the morning and before meals.
Swallow the tablet with a glass of water.
The tablet can be divided into two equal doses.

If you take more Perindopril and Indapamide TecniGen 8 mg/2.5 mg than you should
If you take too many tablets, contact your doctor or the nearest Emergency Room immediately.
In case of overdose, the most likely effect is a lowering of blood pressure. If you should
experience very low blood pressure (symptoms such as dizziness or weakness), lying down with your legs raised may help.

If you forget to take Perindopril and Indapamide TecniGen 8 mg/2.5 mg
It is important to take the medicine every day as a regular treatment is more effective.
However, if you forget to take a dose of Perindopril and Indapamide TecniGen 8 mg/2.5 mg,
take the next dose at the usual time. Do not take a double dose to make up for the
forgotten dose.

If you stop taking Perindopril and Indapamide TecniGen 8 mg/2.5 mg
Since treatment for high blood pressure usually lasts for life, you should talk to your
doctor before stopping taking the medicine.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

If you experience any of the following side effects, stop taking the medicine immediately and inform your doctor immediately:

• swelling of the face, lips, mouth or throat
• difficulty breathing
• severe dizziness or fainting
• very fast or irregular heartbeat In decreasing order of frequency, side effects may include:

Common (may affect up to 1 in 10 people, but less than 1 in 100)

• headache
• dizziness
• vertigo
• tingling
• vision disturbances
• tinnitus (ringing in the ears)
• dizziness due to low blood pressure
• cough
• shortness of breath
• gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dry mouth, dyspepsia or difficulty digesting, diarrhoea, constipation)
• allergic reactions (such as skin rashes, itching)
• muscle cramps
• feeling tired;

Uncommon (may affect up to 1 in 100 people, but less than 1 in 1000)

• mood changes
• sleep disorders
• bronchospasm (tightness of the chest, wheezing and shortness of breath)
• angioedema (symptoms such as wheezing, swelling of the face or tongue)
• urticaria
• purpura (red spots on the skin)
• kidney problems
• impotence
• sweating

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

• confusion
• cardiovascular disorders (irregular heartbeat, angina, heart attack)
• eosinophilic pneumonia (a rare type of pneumonia)
• rhinitis (blocked or runny nose)
• severe skin manifestations such as erythema multiforme. If you suffer from systemic lupus erythematosus (a type of collagen disease), this may worsen.
• Cases of photosensitivity reactions (change in skin appearance) have been reported after exposure to the sun or artificial UVA rays.

Not known (frequency cannot be estimated from available data): fainting, potentially life-threatening irregular heartbeat (torsades de pointes), abnormal electrocardiogram, increased levels of liver enzymes.
Blood disorders, kidney, liver or pancreas disorders and changes in laboratory values (blood tests) may occur. Your doctor may need to prescribe you blood tests to check your condition.
In case of liver failure (liver disorders), there is a possibility of hepatic encephalopathy (degenerative brain disease).
If you experience any of these side effects, or if you notice any other side effect not listed in this leaflet, tell your doctor, pharmacist or nurse.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. You can also report side effects directly through the national reporting system at

“www.agenziafarmaco.gov.it/it/responsabili”. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Perindopril and Indapamide TecniGen 8 mg/2.5 mg

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and the package after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Perindopril and Indapamide TecniGen 8 mg/2.5 mg contains

• The active ingredients are perindopril tert-butylamine and indapamide. Each tablet contains 8 mg of perindopril tert-butylamine and 2.5 mg of indapamide.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Perindopril and Indapamide TecniGen 8 mg/2.5 mg and pack contents
Perindopril and Indapamide TecniGen 8 mg/2.5 mg are tablets of colour from white to almost white, round, with a score line on one side.
The tablets are available in packs containing 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy
Manufacturer

• 1) Atlantic Pharma – Produções Farmacêuticas, S.A. Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal
• 2) West Pharma – Produções de Especialidades Farmacêuticas, S.A. Rua João de Deus, n.º 11, Venda Nova, 2700-486 Amadora, Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following denominations:
Portugal: Perindopril+Indapamida Biofarmoz
Italy: Perindopril e Indapamide TecniGen