PERINDOPRIL TEVA

Package leaflet: Information for the patient

Perindopril Teva, 10 mg, film-coated tablets
Perindopril tosylate
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.
• Please contact your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Perindopril Teva is and what it is used for
2. Before you take 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 called angiotensin-converting enzyme (ACE) inhibitors. These medicines work by widening blood vessels. This makes it easier for the heart to pump blood.
Perindopril Teva is used:

• to treat 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 the 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 while taking an ACE inhibitor such as wheezing, facial or tongue swelling, intense itching, or severe skin redness, or if such symptoms occurred in any family members under any circumstances (a condition called 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 problems and is being treated with a blood pressure-lowering medicine containing aliskiren.
• 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 treatment with Perindopril Teva, discuss the following with your doctor or pharmacist:

• if you have 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),
• if you have any other heart conditions,
• if you have liver diseases,
• if you have kidney diseases or are undergoing dialysis,
• if you have abnormally high levels of a hormone called aldosterone in your blood (primary hyperaldosteronism),
• if you have a blood vessel disorder such as systemic lupus erythematosus or scleroderma,
• if you have diabetes,
• if you are on a low-salt diet or using salt substitutes containing potassium,
• if you are due to undergo anaesthesia and/or surgery,
• if LDL apheresis (removal of cholesterol from the blood using a special device) is planned,
• if desensitisation treatment is planned to reduce allergic reactions to bee or wasp stings,
• if you have recently experienced diarrhoea or vomiting, or if you are dehydrated,
• patients of Black race have a higher risk of developing angioedema, and this medicine may be less effective in lowering blood pressure compared to patients of other races,
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (ARB) (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren. Your 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 you are taking any of the following medicines, the risk of angioedema may increase:
• racecadotril (used to treat diarrhoea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of drugs 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 in the treatment of chronic heart failure;
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group of drugs called gliptins (used in the treatment of diabetes).

Angioedema

Angioedema (a severe allergic reaction; symptoms include swelling of the face, lips, tongue or throat, difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Perindopril Teva. This reaction may occur at any time during treatment. If you experience such symptoms, stop taking Perindopril Teva immediately and contact your doctor without delay. See also section “Possible side effects”.

Pregnant women must inform their doctor if they think they are (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

Perindopril Teva should not be used in children and adolescents under 18 years of age.

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 your dose and/or take other precautions if you are taking any of the following:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (ARBs), 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 in heart failure treatment: eplerenone and spironolactone at doses of 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, as well as for preventing blood clots;
• medicines used to treat diabetes (such as insulin or metformin);
• baclofen (used to treat muscle stiffness in conditions 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 defences) used to treat immune system disorders or after organ transplantation (e.g. cyclosporine, tacrolimus);
• estramustine (used in the treatment of cancer);
• medicines most commonly used to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the group called mTOR inhibitors). See section “Warnings and precautions”;
• a combination medicine containing sacubitril and valsartan (used in the treatment of 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);
• vasodilators, including nitrates;
• medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline or adrenaline);
• 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you think you are pregnant (or plan to become pregnant). Your doctor will usually advise switching to another medicine instead of Perindopril Teva, as its use during early pregnancy is not recommended. 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. Your doctor may recommend alternative medicines, 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 tiredness due to low blood pressure. In such cases, the ability to drive or operate machinery may be impaired.

Perindopril Teva contains lactose.

If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

Perindopril Teva contains sodium.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it 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 in doubt, 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 initial 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 initial 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 initial 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.
In patients aged 65 years and older, the recommended initial 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.
If you forget to take Perindopril Teva
It is important to take this medicine regularly, as this ensures the best effect. However, 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 reactions

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

• swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema; see section 2 "Warnings and precautions") (not very common – 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),
• very rapid or irregular heartbeat, chest pain (angina) or heart attack (very rare – may occur in up to 1 in 10,000 patients);
• weakness or loss of muscle strength 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; not very common – may occur in up to 1 in 100 patients);
• pancreatitis, which may cause severe abdominal pain radiating to the back and general malaise (very rare – may occur in up to 1 in 10,000 patients), yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (very rare – may occur in up to 1 in 10,000 patients);
• rash, often beginning 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 reactions occur:

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

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

Not very common (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 number of eosinophils (a type of white blood cell),
• drowsiness,
• fainting,
• palpitations,
• tachycardia,
• vasculitis,
• 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 resolving after discontinuation of treatment, low 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, confusion 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,
• reduced or absent urine output, acute renal failure,
• abnormal laboratory test results: increased liver enzyme activity, high serum bilirubin levels;

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

• confusion,
• eosinophilic pneumonia (a rare type of lung inflammation),
• rhinitis (stuffy or runny nose),
• blood count changes such as reduced number of white and red blood cells, reduced haemoglobin levels, reduced platelet count;

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Perindopril Teva

Keep this medicine out of sight and reach of children.
After opening, use within 100 days.
Do not use this medicine after the expiry date stated on the cardboard box and bottle after
"Expiry date (EXP):" or "EXP:". The batch number on the packaging is indicated after the abbreviation
"Lot". The expiry date refers to the last day of the stated month.
Store in a tightly closed container to protect from moisture and light.
No special temperature storage requirements.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Perindopril Teva contains

• The active substance is perindopril tosylate. Each coated tablet contains 6.816 mg of perindopril (equivalent to 10 mg of perindopril tosylate).
• Other ingredients are: lactose monohydrate, corn starch, sodium hydrogen carbonate, pregelatinized corn starch, povidone K30, magnesium stearate, 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, marked with the number "10" on one side and the letter "T" on the other side.
Tablets are available in packs containing 30, 60, 90, 90 (3x30), 100 or 120 (2x60) coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Tel.: (22) 345 93 00

Manufacturers:
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.
ul. Mogilska 80
31-546 Kraków
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