Perindopril Teva Italia: detailed information

Package leaflet: Information for the user

Perindopril Teva Italia 2.5 mg film-coated tablets, 5 mg film-coated tablets, 10 mg film-coated tablets

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

Contents of this leaflet

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

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

Perindopril Teva Italia is an angiotensin-converting enzyme (ACE) inhibitor.
This type of medicine dilates blood vessels, helping the heart pump blood through them.
Perindopril Teva Italia is used for:

treating high blood pressure (hypertension);
[dosages of 2.5 mg and 5 mg] treating heart failure (a condition in which the heart is unable to pump enough blood to meet the body’s needs);
reducing the risk of cardiac events, such as heart attack, in patients with stable coronary artery disease (a condition in which blood flow to the heart is reduced or blocked) who have already had a heart attack and/or undergone surgery to improve blood flow to the heart by widening the blood vessels supplying it.

2. What you need to know before taking Perindopril Teva Italia

Do not take Perindopril Teva Italia

if you are allergic to perindopril, to any other ACE inhibitor, or to any of the other ingredients of this medicine (listed in section 6);
if you are more than three months pregnant. (It is advisable to avoid Perindopril Teva Italia even during early pregnancy – see section 2: Pregnancy, breastfeeding and fertility);
if you have previously experienced symptoms such as wheezing, swelling of the face, tongue or throat, severe itching or serious skin rashes during previous treatment with an ACE inhibitor, or if you or a family member has ever experienced such symptoms under any circumstances (a condition known as angioedema);
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling beneath the skin, for example in the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril Teva Italia if any of the
following apply to you:

if you are taking any of the following medicines, the risk of angioedema may be increased:
racecadotril, a medicine used to treat diarrhoea,
medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus),
vildagliptin, a medicine used to treat diabetes.
if you have aortic stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (a heart muscle disease), or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
if you have any other heart problems,
if you have liver problems,
if you have kidney problems or are undergoing dialysis,
if you suffer from a collagen vascular disease (a connective tissue disorder), such as systemic lupus erythematosus or scleroderma,
if you have diabetes,
if you are on a low-salt diet or use potassium-containing salt substitutes,
if you are due to undergo anaesthesia and/or major surgery,
if you are undergoing LDL-apheresis (removal of cholesterol from the blood using a special machine),
if you are about to undergo desensitisation treatment to reduce the effects of allergy to bee or wasp stings,
if you have recently had diarrhoea or vomiting or are dehydrated,
if your doctor has diagnosed you with an intolerance to certain sugars,
if you are taking any of the following medicines for high blood pressure:
an "angiotensin II receptor antagonist" (AIIRA), also known as sartans (e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes,
aliskiren.

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 Teva Italia".
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Perindopril Teva Italia is not recommended during 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 2: Pregnancy, breastfeeding and fertility).

Children and adolescents
The use of Perindopril Teva Italia in children and adolescents up to 18 years of age is not
recommended.

Other medicines and Perindopril Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Treatment with Perindopril Teva Italia may be affected by other medicines. Your doctor may need to adjust your dose and/or take other precautions. These include:

other medicines for high blood pressure, including diuretics (medicines that increase the amount of urine produced by the kidneys);
your doctor may consider it necessary to adjust the dose and/or take other precautions: if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections "Do not take Perindopril Teva Italia" and "Warnings and precautions");
potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole used to treat bacterial infections; ciclosporin, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting);
lithium for manic disorders or depression;
non-steroidal anti-inflammatory drugs (e.g., ibuprofen) used for pain, or high-dose aspirin;
medicines for diabetes (such as insulin or metformin);
medicines for mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics);
immunosuppressants (medicines that reduce the body's defence mechanisms) used to treat autoimmune disorders or after surgical transplantation (e.g. ciclosporin);
allopurinol (used to treat gout);
procainamide (for treatment of irregular heartbeat);
vasodilators, including nitrates (substances that widen blood vessels);
medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline);
medicines usually used to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors). See section "Warnings and precautions".

Perindopril Teva Italia with food and drink
Perindopril Teva Italia should preferably be taken 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 think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Perindopril Teva Italia before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine instead of Perindopril Teva Italia.
Perindopril Teva Italia is not recommended during 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 after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Perindopril Teva Italia is not recommended for women who are breastfeeding, and your doctor may choose a different treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Fertility
The effects of perindopril on human fertility are unknown.

Driving and using machines
Generally, Perindopril Teva Italia does not affect alertness. However, some patients may experience dizziness or weakness due to low blood pressure. If you experience these effects, your ability to drive or operate machinery may be impaired.

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

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

3. How to take Perindopril Teva Italia

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Swallow the tablet with a glass of water, preferably at the same time each day, in the morning, before a meal. Your doctor will decide the correct dose for you.
The recommended doses are as follows.

High blood pressure: The recommended initial and maintenance dose is 5 mg once daily. After one month of treatment, the dose may be increased to 10 mg once daily, if necessary. The dose of 10 mg daily is the maximum recommended dose for high blood pressure.
If you are 65 years of age or older, the recommended starting dose is 2.5 mg once daily. After one month of treatment, the dose may be increased to 5 mg once daily and then, if necessary, to 10 mg once daily.

[Dosages of 2.5 mg and 5 mg] Heart failure: The recommended initial dose is 2.5 mg once daily. After two weeks, the dose may be increased to 5 mg once daily, which is the maximum recommended dose for heart failure.

Stable coronary artery disease: The recommended initial dose is 5 mg once daily. After two weeks, the dose may be increased to 10 mg once daily, which is the maximum recommended dose for this indication.
If you are 65 years of age or older, the recommended starting dose is 2.5 mg once daily. After one week of treatment, the dose may be increased to 5 mg once daily and, after another week, to 10 mg once daily.

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

If you forget to take Perindopril Teva Italia
It is important to take this medicine every day, as treatment is most effective when taken regularly. However, if you forget to take a dose of Perindopril Teva Italia, simply 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 Teva Italia
Since treatment with Perindopril Teva Italia is generally intended to continue for life, you must consult your doctor before stopping the medicine.

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

4. Possible side effects

Like all medicines, Perindopril Teva Italia may cause side effects, although not everyone gets them.
If you notice any of the following symptoms, stop taking the medicine and contact your doctor immediately:

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

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

Common (may affect up to 1 in 10 people): headache, dizziness, vertigo, tingling, visual disturbances, tinnitus (sensation of noise in the ears), feeling of dizziness due to low blood pressure, cough, shortness of breath, gastrointestinal disorders (nausea, vomiting, abdominal pain, altered taste, dyspepsia or digestive difficulties, diarrhoea, constipation), allergic reactions (such as skin rashes and itching), muscle cramps, fatigue.
Uncommon (may affect up to 1 in 100 people): mood swings, sleep disorders, bronchospasm (chest tightness, wheezing and shortness of breath), dry mouth, angioedema (symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rashes), kidney problems, impotence, sweating.
Rare (may affect up to 1 in 1,000 people): worsening of psoriasis.
Very rare (may affect up to 1 in 10,000 people): confusion, cardiovascular disorders (irregular heartbeat, angina, heart attack and stroke), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose), erythema multiforme, blood disorders, pancreas or liver disorders.
Frequency not known (frequency cannot be estimated from the available data): abnormal colour, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon).
In diabetic patients, episodes of hypoglycaemia (very low blood sugar levels) may occur.
Cases of vasculitis (inflammation of blood vessels) have been reported.

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

5. How to store Perindopril Teva Italia

Keep this medicine out of the sight and reach of children.
After opening, use within 100 days.
Do not use this medicine after the expiry date which is stated on the carton and container after
"Exp".
The expiry date refers to the last day of that month.
Store the container tightly closed to protect it from light and moisture.
This medicine does not require any special storage temperature.
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 Teva Italia contains

The active substance is perindopril tosylate. Each film-coated tablet contains 1.704 mg of perindopril (equivalent to 2.5 mg of perindopril tosylate), or 3.408 mg of perindopril (equivalent to 5 mg of perindopril tosylate), or 6.816 mg of perindopril (equivalent to 10 mg of perindopril tosylate).
The other components are monohydrate lactose, maize starch, sodium hydrogen carbonate, pregelatinized starch, povidone K30, magnesium stearate, poly(vinyl alcohol) - partially hydrolyzed, titanium dioxide E171, macrogol 3350, talc; and for the 5 mg and 10 mg tablets, indigo carmine E132, brilliant blue FCF E133, iron oxide yellow E172 and quinoline yellow E104.

Description of the appearance of Perindopril Teva Italia and package contents
Perindopril Teva Italia 2.5 mg tablets are white, round, biconvex, film-coated tablets, approximately 5 mm in diameter, marked with "T" on one side and smooth on the other.
Perindopril Teva Italia 5 mg tablets are light green, capsule-shaped, biconvex, film-coated tablets, approximately 4 mm wide and 8 mm long, marked with "T" on one side and smooth on the other, with score lines on both edges.
Perindopril Teva Italia 10 mg tablets are green, round, biconvex, film-coated tablets, approximately 8 mm in diameter, marked with "10" on one side and "T" on the other.
5 mg – Tablets are available in packs of 10, 30, 60, 90, 90 (3 x 30) or 100 film-coated tablets.
2.5 mg and 10 mg – Tablets are available in containers of 30, 60, 90, 90 (3 x 30) or 100 film-coated tablets.

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

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

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Perindopril Teva 2.5 mg filmomhulde tabletten, comprimés pelliculés, Filmtabletten
Perindopril Teva 5 mg filmomhulde tabletten, comprimés pelliculés, Filmtabletten
Perindopril Teva 10 mg filmomhulde tabletten, comprimés pelliculés, Filmtabletten
Bulgaria: Zaprinel
France: Perindopril Tosilate Teva
Hungary: Perindopril-tozilát Teva
Ireland: Perindopril Tosilate Teva
Italy: Perindopril Teva Italia
Lithuania: Perindopril Teva 2.5 mg/5 mg/10 mg plėvele dengtos tabletės
Latvia: Perindopril Teva 2.5/5/10 mg apvalkotās tabletes
Netherlands: Perindopril tosilaat 2.5 mg/5 mg/10 mg Teva
Poland: Perindopril Teva
Portugal: Perindopril Teva comprimido revestido por película
Romania: Perindopril tosilat Teva 2.5 mg comprimate filmate
Perindopril tosilat Teva 5 mg comprimate filmate
Perindopril tosilat Teva 10 mg comprimate filmate
Slovenia: Perivol 2.5 mg filmsko obložene tablete
Perivol 5 mg filmsko obložene tablete
Perivol 10 mg filmsko obložene tablete