Perindopril and indapamide Tecnigen: detailed information

Package leaflet: Information for the user

Perindopril and Indapamide TecniGen 2 mg/0.625 mg tablets

perindopril tert-butylamine and indapamide
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, pharmacist or nurse.
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 effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

What is in this leaflet:

What Perindopril and Indapamide TecniGen 2 mg/0.625 mg is and what it is used for
What you need to know before taking Perindopril and Indapamide TecniGen 2 mg/0.625 mg
How to take Perindopril and Indapamide TecniGen 2 mg/0.625 mg
Possible side effects
How to store Perindopril and Indapamide TecniGen 2 mg/0.625 mg
Contents of the pack and other information

1. What Perindopril and Indapamide TecniGen 2 mg/0.625 mg is and what it is used for

What Perindopril and Indapamide TecniGen 2 mg/0.625 mg is
Perindopril and Indapamide TecniGen 2 mg/0.625 mg 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 TecniGen 2 mg/0.625 mg is used for
Perindopril belongs to a class of medicines called ACE inhibitors. These medicines work by widening blood vessels, making 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 differs from other diuretics in that it causes only a slight increase in the amount of urine produced. Both active substances 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 previously experienced symptoms such as shortness of breath, facial or tongue swelling, severe itching or serious skin rashes during or after treatment with an ACE inhibitor, or if you or a family member has ever had these symptoms under any circumstances (a condition called angioedema);
if you have severe liver disease or suffer from a condition known as hepatic encephalopathy (a degenerative brain disorder);
if you have severe kidney disease or are undergoing dialysis;
if you have low or high levels of potassium in your blood;
if untreated decompensated heart failure is suspected (severe fluid retention, difficulty breathing);
if you are more than three months pregnant (Perindopril and Indapamide TecniGen 2 mg/0.625 mg should also be avoided during early pregnancy – see section "Pregnancy");
if you are breastfeeding;
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine 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 have aortic stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (a heart muscle disorder), or renal artery stenosis (narrowing of the artery supplying blood to the kidneys);
if you have any other heart or kidney problems;
if you have liver problems;
if you suffer from a connective tissue disease (skin disorder) such as systemic lupus erythematosus (a chronic inflammatory condition) or scleroderma;
if you have atherosclerosis (hardening of the arteries);
if you have hyperparathyroidism (overactive parathyroid gland);
if you suffer from gout;
if you have diabetes;
if you are on a low-salt diet or use salt substitutes containing 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 for 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 blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "Do not take Perindopril and Indapamide TecniGen".

You must inform your doctor if you suspect (or are planning) a pregnancy. Perindopril and Indapamide TecniGen 2 mg/0.625 mg should be avoided during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken during this period (see section "Pregnancy").
While taking Perindopril and Indapamide TecniGen 2 mg/0.625 mg, you should also inform your doctor or medical staff:

if you are due to undergo anaesthesia and/or surgery;
if you have recently had diarrhoea or vomiting or are dehydrated;
if you are due to undergo dialysis or LDL apheresis (a procedure to remove cholesterol from the blood using a machine);
if you are about to receive desensitisation treatment to reduce allergic reactions to bee or wasp stings;
if you are about to undergo a diagnostic test requiring injection of an iodinated contrast agent (a substance that makes organs such as the kidneys or stomach visible on X-ray imaging).

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

Children
Perindopril and Indapamide TecniGen 2 mg/0.625 mg must 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 must 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 you tell your doctor if you are taking any of the following medicines, as special care may be needed:

other medicines for high blood pressure;
procainamide (for irregular heartbeat);
allopurinol (for 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 or to prevent transplant rejection (e.g. cyclosporine);
anticancer medicines;
erythromycin administered by injection (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 (for the treatment of psychosis);
medicines for heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol);
digoxin or other cardiac glycosides (for heart problems);
baclofen (to treat muscle stiffness in conditions such as multiple sclerosis);
medicines for 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 administered by injection (for serious fungal infections);
medicines for mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics);
tetracosactide (for the treatment of Crohn's disease).

Your doctor may consider it necessary to adjust your dose and/or take additional precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections "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 a meal.

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

Pregnancy
You must inform your doctor if you suspect (or are planning) a pregnancy. Your doctor will usually advise you to stop taking Perindopril and Indapamide TecniGen 2 mg/0.625 mg before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Perindopril and Indapamide TecniGen 2 mg/0.625 mg must not be taken during early pregnancy and must not be used if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken during this period.

Breastfeeding
Consult your doctor if you are breastfeeding or planning to breastfeed. You must not take Perindopril and Indapamide TecniGen 2 mg/0.625 mg while breastfeeding. Your doctor may choose an alternative 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 it may cause side effects such as dizziness or weakness due to lowered blood pressure. If this occurs, 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 diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.

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

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 increase the dose to two tablets per day or adjust the dosage regimen if you have renal impairment. Take the tablet preferably in the morning and before a meal.
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 hospital emergency department immediately.
In case of overdose, the most likely effect is a drop in blood pressure. If you 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 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 your usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Perindopril and Indapamide TecniGen 2 mg/0.625 mg
Since high blood pressure treatment usually lasts a lifetime, you must speak with your doctor before stopping this medicine.

If you have any further questions about the use of this medicine, consult 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
contact your doctor straight away:

swelling of the face, lips, mouth or throat
difficulty breathing
severe dizziness or fainting
very fast or irregular heartbeat

The following are possible side effects, listed in order of decreasing frequency:

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

headache
dizziness
vertigo
tingling sensations
vision disturbances
tinnitus (ringing or other noises in the ears)
lightheadedness due to low blood pressure
cough
shortness of breath
gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dry mouth, indigestion or difficulty digesting, diarrhoea, constipation)
allergic reactions (such as skin rash, itching)
muscle cramps
feeling of fatigue

Uncommon (may affect up to 1 in 100 people, but more than 1 in 1,000)

mood changes
sleep disorders
bronchospasm (tightness in the chest, gasping and shortness of breath)
angioedema (symptoms such as gasping breath, swelling of the face or tongue)
hives
purpura (small 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 (stuffy or runny nose)
serious skin reactions such as erythema multiforme. If you suffer from systemic lupus erythematosus (a type of collagen disease), this may worsen.
Cases of photosensitivity reactions (skin changes) have been reported after exposure to sunlight or artificial UVA rays.

Not known (frequency cannot be estimated from the available data): fainting, potentially life-threatening irregular heartbeat (torsades de pointes), abnormal electrocardiogram, increased liver enzyme levels.

Blood disorders, or problems affecting the kidneys, liver or pancreas, as well as changes in laboratory test values (blood tests) may occur. Your doctor may need to order blood tests to monitor your condition.
If you have liver impairment (liver problems), there is a possibility that hepatic encephalopathy (a degenerative brain disorder) may develop.

If you experience any of the side effects listed above, or notice any side effects not listed in this leaflet, inform your doctor, pharmacist or nurse.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 above 25°C.
Do not use this medicine after the expiry date stated on the blister and the carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. 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 TecniGen 2 mg/0.625 mg contains

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

Description of the appearance of Perindopril and Indapamide TecniGen 2 mg/0.625 mg and contents of the
pack
Perindopril and Indapamide TecniGen 2 mg/0.625 mg are capsule-shaped, white tablets, with a score line on both sides, marked with “-” on both sides of the break 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

Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal
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 European Economic Area countries under the following
names:
Portugal: Perindopril+Indapamida Biofarmoz
Italy: Perindopril e Indapamide TecniGen

Patient Information Leaflet

Perindopril and Indapamide TecniGen 4 mg/1.25 mg tablets

perindopril tert-butylamine and indapamide
Generic medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Perindopril and Indapamide TecniGen 4 mg/1.25 mg is and what it is used for
What you need to know before taking Perindopril and Indapamide TecniGen 4 mg/1.25 mg
How to take Perindopril and Indapamide TecniGen 4 mg/1.25 mg
Possible side effects
How to store Perindopril and Indapamide TecniGen 4 mg/1.25 mg
Contents in the pack and other information

1. What Perindopril and Indapamide TecniGen 4 mg/1.25 mg Is and What It Is Used For

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

What Perindopril and Indapamide TecniGen 4 mg/1.25 mg Is Used For
Perindopril belongs to a class of medicines called ACE inhibitors. These medicines work by widening blood vessels, making 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 differs from other diuretics in that it causes only a slight increase in the amount of urine produced. Both active substances 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 previously experienced symptoms such as shortness of breath, facial or tongue swelling, severe itching or severe skin rash during treatment with an ACE inhibitor, or if you or a family member has ever had these symptoms under any circumstances (a condition called angioedema);
if you have severe liver disease or suffer from 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 levels of potassium in your blood;
if untreated decompensated heart failure is suspected (severe fluid retention, difficulty breathing);
if you are more than three months pregnant (Perindopril and Indapamide TecniGen 4 mg/1.25 mg should also be avoided during early pregnancy – see section Pregnancy);
if you are breastfeeding;
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine 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 have aortic stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (a heart muscle disorder), or renal artery stenosis (narrowing of the artery supplying blood to the kidneys);
if you have any other heart or kidney problems;
if you have liver problems;
if you suffer from a collagen disease (skin disorder) such as systemic lupus erythematosus (a chronic inflammatory condition) or scleroderma;
if you have atherosclerosis (hardening of the arteries);
if you have hyperparathyroidism (overactive parathyroid gland);
if you suffer from gout;
if you have diabetes;
if you are on a low-salt diet or use salt substitutes containing 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 have kidney problems related to diabetes;
aliskiren.
Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section "Do not take Perindopril and Indapamide TecniGen".

You must inform your doctor if you suspect (or are planning) a pregnancy. Perindopril and Indapamide TecniGen 4 mg/1.25 mg should be avoided during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken during this period (see section Pregnancy).
While taking Perindopril and Indapamide TecniGen 4 mg/1.25 mg, you should also inform your doctor or medical staff:

if you are due to undergo anaesthesia and/or surgery;
if you have recently had diarrhoea or vomiting or are dehydrated;
if you are due to undergo dialysis or LDL apheresis (a procedure to remove cholesterol from the blood using a machine);
if you are about to receive desensitisation treatment to reduce the effects of allergy to bee or wasp stings;
if you are about to undergo a diagnostic test requiring injection of an iodinated contrast agent (a substance that makes organs such as kidneys or stomach visible on X-ray).

Athletes should be aware that Perindopril and Indapamide TecniGen 4 mg/1.25 mg contains an active substance (indapamide) that may lead to a positive result in anti-doping tests.
Children
Perindopril and Indapamide TecniGen 4 mg/1.25 mg must 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 must avoid taking Perindopril and Indapamide TecniGen 4 mg/1.25 mg with:

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

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

other medicines for treating high blood pressure;
procainamide (for treating irregular heartbeat);
allopurinol (for treating 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 or to prevent organ transplant rejection (e.g. cyclosporine);
medicines for treating cancer;
erythromycin administered by injection (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 (for treating psychosis);
medicines used for heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol);
digoxin or other cardiac glycosides (for treating heart problems);
baclofen (to treat muscle stiffness occurring 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 administered by injection (to treat serious fungal infections);
medicines for treating mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics);
tetracosactide (to treat Crohn's disease).

Your doctor may consider it necessary to adjust the dose and/or take additional precautions if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections "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 a meal.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you suspect (or are planning) a pregnancy. Your doctor will usually advise you to stop taking Perindopril and Indapamide TecniGen 4 mg/1.25 mg before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Perindopril and Indapamide TecniGen 4 mg/1.25 mg must not be taken during early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to the unborn child if taken during this period.
Breastfeeding
Talk to your doctor if you are breastfeeding or planning to breastfeed. You must not take Perindopril and Indapamide TecniGen 2 mg/0.625 if you are breastfeeding. Your doctor may choose an alternative 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 4 mg/1.25 mg usually does not affect reflexes, but in some patients side effects such as dizziness or weakness may occur due to lowered blood pressure. 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 certain sugars, consult him/her before taking this medicine.

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

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, 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 or adjust the dosing regimen if
you have renal impairment. Take the tablet preferably in the morning and before a meal.
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 department immediately.
In case of overdose, the most likely effect is low blood pressure. If you 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 your usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Perindopril and Indapamide TecniGen 4 mg/1.25 mg
Since high blood pressure treatment usually lasts a lifetime, you must speak with your doctor before stopping 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 will experience them.
If you experience any of the following side effects, stop taking the medicine immediately and
contact your doctor straight away:

swelling of the face, lips, mouth or throat
difficulty breathing
severe dizziness or fainting
very fast or irregular heartbeat

In order of decreasing frequency, possible side effects include:

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

headache
dizziness
vertigo
tingling sensations
visual disturbances
tinnitus (ringing or other noises in the ears)
drowsiness due to low blood pressure
cough
shortness of breath
gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, dry mouth, dyspepsia or difficulty digesting, diarrhoea, constipation)
allergic reactions (such as skin rash, itching)
muscle cramps
feeling of fatigue

Uncommon (may affect up to 1 in 100 people but more than 1 in 1,000)

mood changes
sleep disorders
bronchospasm (chest tightness, laboured and short breathing)
angioedema (symptoms such as laboured breathing, swelling of the face or tongue)
urticaria
purpura (small 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 (stuffy or runny nose)
severe skin reactions such as erythema multiforme. If you suffer from systemic lupus erythematosus (a type of collagen disease), this may worsen.
Cases of photosensitivity reactions (skin changes) have been reported after exposure to sunlight or artificial UVA radiation.

Frequency not known (cannot be estimated from the available data): fainting, potentially life-threatening irregular heartbeat (torsade de pointes), abnormal electrocardiogram, increased levels of liver enzymes.
Blood disorders, as well as adverse effects on the kidneys, liver or pancreas, and changes in laboratory test values (blood tests) may occur. Your doctor may need to prescribe blood tests to monitor your condition.
In case of hepatic impairment (liver problems), there is a possibility that hepatic encephalopathy (a degenerative brain disorder) may develop.

If you experience any of the side effects, or notice any side effects not listed in this leaflet, inform your doctor, pharmacist or nurse.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at “www.agenziafarmaco.gov.it/it/responsabili”. By reporting side effects, you help provide more information on the safety of this medicine.

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

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the blister and carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Perindopril and Indapamide TecniGen 4 mg/1.25 mg contains

The active substances 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, monohydrate lactose, anhydrous colloidal silicon dioxide, and magnesium stearate.

Description of the appearance of Perindopril and Indapamide TecniGen 4 mg/1.25 mg and contents of the
pack
Perindopril and Indapamide TecniGen 4 mg/1.25 mg are capsule-shaped white tablets, with a breakline on both sides, marked with “+” on both sides of the breakline 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
Manufacturers

Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal
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 European Economic Area Member States under the
following names:
Portugal: Perindopril+Indapamida Biofarmoz
Italy: Perindopril e Indapamide TecniGen
Package leaflet: Information for the user

Perindopril and Indapamide TecniGen 8 mg/2.5 mg tablets

perindopril tert-butylamine and indapamide
Generic medicine
Please read this leaflet carefully before 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Perindopril and Indapamide TecniGen 8 mg/2.5 mg is and what it is used for
What you need to know before taking Perindopril and Indapamide TecniGen 8 mg/2.5 mg
How to take Perindopril and Indapamide TecniGen 8 mg/2.5 mg
Possible side effects
How to store Perindopril and Indapamide TecniGen 8 mg/2.5 mg
Contents of the pack and other information

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

What Perindopril and Indapamide TecniGen 8 mg/2.5 mg is
Perindopril and Indapamide TecniGen 8 mg/2.5 mg is a combination of two active substances,
perindopril and indapamide.
It is an antihypertensive medicine used to treat high blood pressure (hypertension).
Perindopril and Indapamide TecniGen 8 mg/2.5 mg is indicated for patients who are already taking
separate tablets of perindopril 8 mg and indapamide 2.5 mg. Such patients can thus switch to a single tablet of Perindopril and Indapamide TecniGen 8 mg/2.5 mg containing both active substances.
What Perindopril and Indapamide TecniGen 8 mg/2.5 mg is used for
Perindopril belongs to a class of medicines called ACE inhibitors. These medicines work by widening blood vessels, making 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 differs from other diuretics in that it causes only a slight increase in urine production. Both active substances lower 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 previously experienced symptoms such as shortness of breath, swelling of the face or tongue, severe itching or serious skin rashes after treatment with an ACE inhibitor, or if you or a family member has ever had these symptoms under any circumstances (a condition called angioedema);
if you have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative brain disease);
if you have kidney disease or are undergoing dialysis;
if you have low or high levels of potassium in your blood;
if untreated decompensated heart failure is suspected (severe fluid retention, difficulty breathing);
if you are more than three months pregnant (it is better to avoid Perindopril and Indapamide TecniGen 8 mg/2.5 mg even in early pregnancy – see section Pregnancy);
if you are breastfeeding;
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine 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 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;
if you have liver problems;
if you suffer from a connective tissue disease (skin disease) such as systemic lupus erythematosus (a specific 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 on a low-salt diet or use salt substitutes containing 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 levels of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section “Do not take Perindopril and Indapamide TecniGen”.

You must inform 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 must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section Pregnancy).
While taking Perindopril and Indapamide TecniGen 8 mg/2.5 mg, you should also inform your doctor or medical staff:

if you are due to undergo anaesthesia and/or surgery;
if you have recently had diarrhoea or vomiting or are dehydrated;
if you are due to undergo dialysis or LDL apheresis (a procedure to remove cholesterol from the blood using a machine);
if you are about to receive desensitisation treatment to reduce the effects of an allergy to bee or wasp stings;
if you are about to undergo a diagnostic test requiring injection of an iodinated contrast agent (a substance that makes organs such as kidneys or stomach visible on X-ray).

Athletes should be aware that Perindopril and Indapamide TecniGen 8 mg/2.5 mg contains an active substance (indapamide) that may lead to a positive result in doping tests.
Children
Perindopril and Indapamide TecniGen 8 mg/2.5 mg must 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 must 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 may be affected by other medicines. Make sure you tell your doctor if you are taking any of the following medicines, as special care may be needed:

other medicines for treating high blood pressure;
procainamide (for treating irregular heartbeat);
allopurinol (for treating 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 or following organ transplantation to prevent rejection (e.g. cyclosporine);
medicines for treating cancer;
erythromycin administered by injection (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 (for treating psychosis);
medicines used for heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol);
digoxin or other cardiac glycosides (for treating heart problems);
baclofen (to treat muscle stiffness occurring 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 administered by injection (to treat severe fungal infections);
medicines for treating mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics);
tetracosactide (to treat Crohn's disease).

Your doctor may consider it necessary to adjust your dose and/or take other precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “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 a meal.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you suspect (or are planning) a pregnancy. Your doctor will usually advise you to stop taking Perindopril and Indapamide TecniGen 8 mg/2.5 mg before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Perindopril and Indapamide TecniGen 8 mg/2.5 mg must not be taken during early pregnancy and must not be used if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period.
Breastfeeding
Talk to your doctor if you are breastfeeding or planning to breastfeed. You must not take Perindopril and Indapamide TecniGen 8 mg/2.5 mg while breastfeeding. Your doctor may choose an alternative 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 8 mg/2.5 mg usually does not affect reflexes, but in some patients, side effects such as dizziness or weakness related to low blood pressure may occur. 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 certain sugars, consult him/her before taking this medicine.

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

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet daily.
Take the tablet preferably in the morning and before a meal.
Swallow the tablet with a glass of water.
The tablet may 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 department immediately.
In case of overdose, the most likely effect is low blood pressure. If you 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 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 your 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 must speak to your doctor before stopping 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 everyone gets them.
If you experience any of the following side effects, stop taking the medicine immediately and
contact your doctor without delay:

swelling of the face, lips, mouth or throat
difficulty breathing
severe dizziness or fainting
very fast or irregular heartbeat

In order of decreasing frequency, side effects may include:

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

headache
dizziness
vertigo
tingling sensations
visual disturbances
tinnitus (ringing or other noise in the ears)
lightheadedness due to low blood pressure
cough
shortness of breath
gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, dry mouth, dyspepsia or difficulty digesting, diarrhoea, constipation)
allergic reactions (such as skin rash, itching)
muscle cramps
feeling of fatigue

Uncommon (may affect up to 1 in 100 people but more than 1 in 1,000)

mood changes
sleep disturbances
bronchospasm (tightness of the chest, 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

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 (stuffy or runny nose)
severe skin reactions such as erythema multiforme. If you suffer from systemic lupus erythematosus (a type of collagen disease), this may worsen.
Cases of photosensitivity reactions (skin changes) have been reported after exposure to sunlight or artificial UVA radiation.

Not known (frequency cannot be estimated from the available data): fainting, potentially life-threatening irregular heartbeat (torsade de pointes), abnormal electrocardiogram, increased liver enzyme levels.
Blood disorders, or problems affecting the kidneys, liver or pancreas, as well as changes in laboratory test values (blood tests) may occur. Your doctor may need to order blood tests to monitor your condition.
In case of liver impairment (liver problems), there is a possibility of developing hepatic encephalopathy (a degenerative brain disorder).
If you experience any side effect, or notice any unlisted side effect not mentioned in this leaflet, inform your doctor, pharmacist or nurse.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the website “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 special storage conditions.
Do not use this medicine after the expiry date stated on the blister and carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. 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 TecniGen 8 mg/2.5 mg contains

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

Description of the appearance of Perindopril and Indapamide TecniGen 8 mg/2.5 mg and contents of the
pack
Perindopril and Indapamide TecniGen 8 mg/2.5 mg are white to almost white, round tablets 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

Manufacturers

Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal
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 European Economic Area member states under the following names:
Portugal: Perindopril+Indapamida Biofarmoz
Italy: Perindopril e Indapamide TecniGen