Perindopril teva

Package leaflet: Information for the patient

Caution! Keep the leaflet. Information on the immediate packaging in a foreign language.
Perindopril Teva (Perindopril Tosilate Teva)
10 mg, film-coated tablets
Perindoprili tosilas
Perindopril Teva and Perindopril Tosilate Teva are different brand names of the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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

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

Perindopril Teva belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors. These medicines work by dilating blood vessels. This makes it easier for the heart to pump blood.
Perindopril Teva is used:

• for the treatment of high blood pressure (hypertension);
• to reduce the risk of certain cardiovascular events, such as heart attack, in patients with stable ischaemic heart disease (a condition in which blood supply to the heart is reduced or blocked), who have previously had a heart attack and/or undergone a procedure to improve blood supply to the heart by widening the blood vessels.

2. Important information before using Perindopril Teva

When not to use Perindopril Teva

• if the patient is allergic to perindopril, another ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6).
• if the patient previously experienced symptoms during treatment with an ACE inhibitor such as wheezing, facial or tongue swelling, intense itching, or severe skin redness, or if such symptoms occurred in any family member under any circumstances (a condition known as angioedema).
• after the third month of pregnancy. (It is also advisable to avoid using Perindopril Teva during early pregnancy – see section "Pregnancy, breastfeeding and fertility").
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

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• if the patient is undergoing dialysis or another form of blood filtration. Depending on the device used, Perindopril Teva may not be suitable for the patient.
• if the patient has kidney disorders causing reduced blood supply to the kidneys (renal artery stenosis).
• if the patient has taken or is currently using sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, because the risk of angioedema (rapid swelling of tissues beneath the skin, such as in the throat) increases (see section "Warnings and precautions" and "Perindopril Teva and other medicines").

Warnings and precautions
Before starting Perindopril Teva, discuss with your doctor or pharmacist if:

• the patient has aortic valve stenosis (narrowing of the main blood vessel carrying blood from the heart), hypertrophic cardiomyopathy (a heart muscle disease), or renal artery stenosis (narrowing of the blood vessel supplying blood to the kidney),
• the patient has any other heart diseases,
• the patient has liver diseases,
• the patient has kidney diseases or is undergoing dialysis,
• the patient has abnormally high levels of a hormone called aldosterone in the blood (primary hyperaldosteronism),
• the patient has vascular collagen disease, such as systemic lupus erythematosus or scleroderma,
• the patient has diabetes,
• the patient is on a low-salt diet or using salt substitutes containing potassium,
• the patient is to undergo anesthesia and/or surgery,
• LDL apheresis (removal of cholesterol from blood using a special device) is planned,
• desensitization treatment is planned to reduce allergic reactions to bee or wasp stings,
• the patient has recently experienced diarrhea or vomiting, or is dehydrated,
• in patients of black race, there is a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure than in patients of other races,
• the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (Angiotensin Receptor Blockers, ARB) (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if the patient has kidney disorders related to diabetes.
• aliskiren. The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading "When not to use Perindopril Teva".
• if the patient is taking any of the following medicines, the risk of angioedema may increase:
• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to a group called mTOR inhibitors (used to prevent rejection of transplanted organs and in cancer treatment);
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure;
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to a group called gliptins (used to treat diabetes).

Angioedema
In patients treated with ACE inhibitors, including Perindopril Teva, cases of angioedema (a severe allergic reaction; symptoms include swelling of the face, lips, tongue, or
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throat, difficulty swallowing or breathing) have been reported. This reaction may occur at any time during treatment. If such symptoms occur, stop taking Perindopril Teva immediately and contact your doctor without delay. See also section "Possible side effects".
The patient must inform the doctor if she thinks she is (or might be) pregnant. Perindopril Teva is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn child (see section "Pregnancy, breastfeeding and fertility").

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

Perindopril Teva and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Other medicines may affect treatment with Perindopril Teva. Your doctor may need to adjust the dose and/or take additional precautions if you are taking any of the following medicines simultaneously:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (ARB), aliskiren (see also information under "When not to use Perindopril Teva" and "Warnings and precautions"), or diuretics (medicines that increase urine production by the kidneys);
• potassium-sparing medicines (e.g. triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, and other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent clots; trimethoprim and co-trimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at doses from 12.5 mg to 50 mg per day;
• lithium salts used to treat mania or depression;
• non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. ibuprofen) used for pain relief, or high-dose aspirin or large doses of acetylsalicylic acid, a substance found in many medicines used for pain and fever relief, and also to prevent blood clots;
• medicines used to treat diabetes (such as insulin or metformin);
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis);
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics);
• immunosuppressive medicines (medicines that suppress the body's immune defenses) used to treat immune system disorders or after organ transplantation (e.g. cyclosporine, tacrolimus);
• estramustine (used to treat cancer);
• medicines most commonly used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to a group called mTOR inhibitors). See section "Warnings and precautions";
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to use Perindopril Teva" and "Warnings and precautions";
• allopurinol (used to treat gout);
• procainamide (used to treat heart rhythm disorders);
• vasodilating medicines, including nitrates;
• medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline, or adrenaline);

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• gold salts, particularly when administered intravenously (used to treat symptoms of rheumatoid arthritis).

Perindopril Teva with food and drink
Perindopril Teva should be taken in the morning before a meal.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The patient must inform her doctor if she thinks she is pregnant (or plans to become pregnant). Usually, the doctor will recommend an alternative medicine instead of Perindopril Teva, as use of Perindopril Teva during early pregnancy is not recommended. However, it must not be used after the third month of pregnancy, as it may cause severe harm to the unborn child.

Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Perindopril Teva is not recommended during breastfeeding. For women who are breastfeeding, the doctor may recommend another medicine, especially if the breastfed infant is a newborn or premature.

Fertility
The effect of perindopril on human fertility is unknown.

Driving and using machines
While taking Perindopril Teva, some patients may experience dizziness or fatigue associated with low blood pressure. In such cases, the ability to drive or operate machinery may be impaired.

Perindopril Teva contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Perindopril Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Perindopril Teva

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
The tablets should be taken with a glass of water, preferably at the same time each day, in the morning, before a meal. Your doctor will determine the appropriate dose for you.
Usual doses of Perindopril Teva:
Hypertension: the recommended starting and maintenance dose is 5 mg once daily. After one month, your doctor may increase the dose to 10 mg once daily, if necessary. A dose of 10 mg once daily is the maximum recommended dose for the treatment of hypertension.
In patients aged 65 years and older, the recommended starting dose is 2.5 mg once daily. After one month, your doctor may increase the dose to 5 mg once daily or, if necessary, to 10 mg once daily.
Stable ischaemic heart disease: the recommended starting dose is 5 mg once daily. After two weeks, your doctor may increase the dose to 10 mg once daily, which is the maximum recommended dose for this indication.
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In patients aged 65 years and older, the recommended starting dose is 2.5 mg once daily. After one week, your doctor may increase the dose to 5 mg once daily, and after another week to 10 mg once daily.
Use in children and adolescents
Perindopril Teva is not recommended for use in children and adolescents.
Taking more Perindopril Teva than recommended
If you take too many tablets, contact your doctor immediately or go to the nearest emergency department. The most common symptom of overdose is low blood pressure, with symptoms such as dizziness or fainting. If this occurs, lying down with your legs raised may be helpful.
Missing a dose of Perindopril Teva
It is important to take this medicine regularly, as this ensures the best effect. If you miss a dose of Perindopril Teva, take the next dose at your usual time. Do not take a double dose to make up for a missed dose.
Stopping Perindopril Teva
Treatment with Perindopril Teva is long-term, so you should consult your doctor before stopping the medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You must stop taking this medicine and contact your doctor immediately if any of the following adverse effects occur, as they may be serious:

• swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema; see section 2 "Warnings and precautions") (uncommon – may occur in up to 1 in 100 patients),
• severe dizziness or fainting caused by low blood pressure (common – may occur in up to 1 in 10 patients),
• extremely rapid or irregular heartbeat, chest pain (angina) or heart attack (very rare – may occur in up to 1 in 10,000 patients);
• muscle weakness in arms or legs, or difficulty speaking, which may be signs of stroke (very rare – may occur in up to 1 in 10,000 patients);
• sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm; uncommon – may occur in up to 1 in 100 patients);
• pancreatitis, which may cause severe upper abdominal pain radiating to the back and severe malaise (very rare – may occur in up to 1 in 10,000 patients), yellowing of the skin or eyes (jaundice), which may indicate liver inflammation (very rare – may occur in up to 1 in 10,000 patients);
• skin rash, often starting with red, itchy spots on the face, arms or legs (erythema multiforme; very rare – may occur in up to 1 in 10,000 patients).

You should inform your doctor if any of the following adverse effects occur:

Adverse effects grouped by decreasing frequency of occurrence:
Common (may affect up to 1 in 10 patients):

• headache,
• dizziness,
• vestibular dizziness (vertigo),
• tingling and numbness,
• visual disturbances,
• tinnitus (sensation of hearing sounds),
• cough,
• shortness of breath,
• gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion or difficulty digesting, diarrhoea, constipation),
• allergic reactions (such as rashes, itching),
• muscle cramps,
• feeling of weakness.

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

• mood swings,
• sleep disturbances,
• depression,
• dry mouth,
• intense itching or severe skin rashes,
• kidney function disorders,
• impotence,
• excessive sweating,
• increased eosinophil count (a type of white blood cell),
• drowsiness,
• fainting,
• palpitations,
• tachycardia,
• vasculitis (inflammation of blood vessels),
• photosensitivity reaction (increased skin sensitivity to sunlight),
• joint pain,
• muscle pain,
• chest pain,
• malaise,
• peripheral oedema,
• fever,
• falls,
• abnormal laboratory test results: high blood potassium levels (transient and resolve after discontinuation of treatment), low blood sodium levels, hypoglycaemia (very low blood sugar levels) in diabetic patients, increased blood urea levels, increased blood creatinine levels.

Rare (may affect up to 1 in 1,000 patients):

• dark urine, nausea or vomiting, muscle cramps, disorientation and seizures. These may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion),
• sudden redness of the face and neck,
• worsening of psoriasis,
• decreased or absent urine output, acute kidney failure,
• abnormal laboratory test results: increased liver enzyme activity, high serum bilirubin levels.

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

• disorientation,
• eosinophilic pneumonia (a rare type of lung inflammation),
• rhinitis (stuffy or runny nose),
• blood count abnormalities such as reduced number of white blood cells and red blood cells, reduced haemoglobin concentration, reduced platelet count.

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

• bluish discoloration, numbness and pain in fingers or toes (Raynaud's phenomenon).

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Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Perindopril Teva

Keep the medicine out of the sight and reach of children.
After opening, use within 100 days.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store in a tightly closed container to protect from moisture and light. There are no special storage temperature requirements.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Perindopril Teva contains

• The active substance is perindopril tert-butylamine salt (perindopril tosilate). Each coated tablet contains 6.816 mg of perindopril (equivalent to 10 mg of perindopril tosilate).
• Other ingredients are: monohydrate lactose, corn starch, sodium hydrogen carbonate, pregelatinized corn starch, povidone K 30, magnesium stearate.
  Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, indigo carmine, aluminium lake (E 132), brilliant blue, aluminium lake (E 133), yellow iron oxide (E 172), quinoline yellow, aluminium lake (E 104).

What Perindopril Teva looks like and contents of the pack
Perindopril Teva 10 mg, coated tablets are green, round, biconvex, film-coated tablets with a diameter of approximately 8 mm, imprinted with the number "10" on one side and the letter "T" on the other.
The tablets are available in packs containing 30 film-coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Ireland, the country of export:
Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands

Manufacturer:
Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Teva Operations Poland Sp. z o.o., Mogilska 80, 31-546 Kraków, Poland

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Irish Marketing Authorisation Number, country of export: PA0749/168/003
Parallel Import Licence Number: 417/19

This medicinal product is authorised in the Member States of the European Economic Area (EEA) under the following names:
Belgium: Perindopril Teva
Bulgaria: Zaprinel
Estonia: Perindopril Teva
Greece: Perindopril Teva Pharma
France: Perindopril Tosilate Teva
Hungary: Perindopril-tozilát Teva
Ireland: Perindopril Tosilate Teva
Italy: Perindopril Teva Italia
Lithuania: Perindopril Teva
Latvia: Perindopril Teva
The Netherlands: Perindopril tosilaat 10mg Teva
Poland: Perindopril Teva
Portugal: Perindopril Rytulop
Romania: Perindopril tosilat Teva
Slovenia: Perivol 10 mg filmsko obložene tablete