Perindopril Teva

Leaflet accompanying the packaging: patient information

Perindopril Teva, 10 mg, coated tablets

Perindopril tosilate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• Consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Perindopril Teva belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). The action of these medicines is to widen the blood vessels, making it easier for the heart to pump blood.
Perindopril Teva is used:

• to treat high blood pressure(hypertension);
• to reduce the risk of certain heart events, such as heart attack in patients with stable coronary artery disease(a disease where the heart's blood supply is reduced or blocked), who have had a heart attack and/or have undergone a procedure to improve blood flow to the heart.

2. Important information before taking Perindopril Teva

When not to take Perindopril Teva

• if you are allergic to perindopril, another ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had symptoms such as wheezing, swelling of the face or tongue, intense itching, or severe skin redness when taking an ACE inhibitor, or if such symptoms have occurred in a family member in any other circumstances (a condition called angioedema).
• after the third month of pregnancy. (It is also recommended to avoid taking Perindopril Teva during early pregnancy - see the section "Pregnancy, breastfeeding, and fertility").
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.
• if you are undergoing dialysis or blood filtration by another method. Depending on the device used, Perindopril Teva may not be suitable for you.
• if you have kidney problems that reduce blood flow to the kidneys (renal artery stenosis).
• if you have taken or are currently taking sacubitril with valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of

angioedema (rapid swelling of tissues under the skin, such as the throat) is increased (see "Warnings and precautions" and "Perindopril Teva with other medicines").

Warnings and precautions

Before starting Perindopril Teva, discuss it with your doctor or pharmacist:

• if you have a narrowing of the aortic valve (narrowing of the main blood vessel carrying blood from the heart) or hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the blood vessel supplying the kidney),
• if you have any other heart disease,
• if you have liver disease,
• if you have kidney disease or are undergoing dialysis,
• if you have an abnormally high level of a hormone called aldosterone in your blood
• (primary aldosteronism),
• if you have a collagen vascular disease (a skin disease), 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 going to have anesthesia and/or surgery,
• if you are going to have an LDL apheresis procedure (removal of cholesterol from the blood using a special device),
• if you are going to have desensitization treatment to reduce allergic reactions to bee or wasp stings,
• if you have recently had diarrhea or vomiting, or are dehydrated,
• in black patients, there is a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure than in patients of other races,
• if you are taking any of the following medicines for high blood pressure:
• an angiotensin receptor blocker (ARB) (also known as a sartan - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals. See also the information under the heading "When not to take Perindopril Teva".
• if you are 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 the group of medicines called mTOR inhibitors (used to prevent rejection of transplanted organs and to treat cancer);
• 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 the group of medicines called gliptins (used to treat diabetes).

Angioedema
In patients treated with ACE inhibitors, including Perindopril Teva, angioedema (a severe allergic reaction; symptoms include swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing) has been reported. This reaction can occur at any time during treatment. If you experience such symptoms, stop taking Perindopril Teva and contact your doctor immediately. See also the section "Possible side effects".
If you are pregnant or think you may be pregnant, tell your doctor. Perindopril Teva is not recommended during early pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby (see the 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 with other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Taking other medicines may affect your treatment with Perindopril Teva. Your doctor may need to change the dose and/or take other precautions when taking such medicines as:

• other medicines used to treat high blood pressure, including an angiotensin receptor blocker (ARB), aliskiren (see also the information under the heading "When not to take 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, other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent blood clots; trimethoprim and cotrimoxazole, 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 in doses from 12.5 mg to 50 mg per day;
• lithium salts used to treat mania or depression;
• non-steroidal anti-inflammatory medicines (NSAIDs) (e.g., ibuprofen) used as painkillers or high doses of aspirin or large doses of acetylsalicylic acid, a substance found in many medicines, used as a painkiller and antipyretic, as well as 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 system) used to treat immune system disorders or after organ transplantation (e.g., cyclosporine, tacrolimus);
• estramustine (used to treat cancer);
• medicines commonly used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See the section "Warnings and precautions";
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See the sections "When not to take 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, especially when given 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 think you may be pregnant, or if you are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Tell your doctor if you think you are pregnant (or plan to become pregnant). In general, your doctor will advise you to take a different medicine instead of Perindopril Teva, as taking Perindopril Teva during early pregnancy is not recommended. However, you should not take it after the third month of pregnancy, as it may cause serious harm to the baby.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Perindopril Teva while breastfeeding. For breastfeeding women, your doctor may prescribe a different medicine, especially if the baby is a newborn or premature.
Fertility
The effect of perindopril on human fertility is not known.

Driving and using machines

While taking Perindopril Teva, some patients may experience dizziness or fatigue related 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 told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Perindopril Teva contains sodium.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Perindopril Teva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablets with a glass of water, preferably at the same time each day, in the morning, before breakfast. Your doctor will decide on the appropriate dose for you.
The usual doses of Perindopril Teva are:
Hypertension:the recommended initial and maintenance dose is 5 mg per day. After one month, your doctor may increase the dose to 10 mg per day if necessary. The dose of 10 mg per day is the maximum recommended dose for the treatment of hypertension.
In patients over 65 years of age, the recommended initial dose is 2.5 mg per day. After one month, your doctor may increase the dose to 5 mg per day or, if necessary, to 10 mg per day.
Stable coronary artery disease:the recommended initial dose is 5 mg per day. After two weeks, your doctor may increase the dose to 10 mg per day, which is the maximum recommended dose for this indication.
In patients over 65 years of age, the recommended initial dose is 2.5 mg per day. After one week, your doctor may increase the dose to 5 mg per day, and after another week to 10 mg per day.

Use in children and adolescents

Perindopril Teva should not be used in children and adolescents.

Taking a higher dose of Perindopril Teva than recommended

If you have taken too many tablets, contact your doctor or go to the nearest emergency department immediately. The most common symptom of overdose is low blood pressure, with symptoms such as dizziness or fainting. If this happens, lying down with your legs raised may help.

Missing a dose of Perindopril Teva

It is important to take your medicine regularly for it to work best. However, if you miss a dose of Perindopril Teva, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Perindopril Teva treatment

Treatment with Perindopril Teva is long-term, so before stopping this medicine, consult your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Perindopril Teva can cause side effects, although not everybody gets them.

Stop taking this medicine and contact your doctor immediately if you experience any of the following serious side effects:

which may be serious:

• swelling of the face, lips, mouth, tongue, or throat, difficulty breathing (angioedema; see section 2 "Warnings and precautions") (uncommon - may affect up to 1 in 100 people),
• severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people),
• very fast or irregular heartbeat, chest pain (angina pectoris), or heart attack (very rare - may affect up to 1 in 10,000 people);
• weakness of the arms or legs, or difficulty speaking, which may be a sign of a stroke (very rare - may affect up to 1 in 10,000 people);
• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm; uncommon - may affect up to 1 in 100 people);
• pancreatitis, which can cause severe abdominal pain and very poor general condition (very rare - may affect up to 1 in 10,000 people), yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (very rare - may affect up to 1 in 10,000 people);
• rash, often starting with the appearance of red, itchy patches on the face, arms, or legs (erythema multiforme; very rare - may affect up to 1 in 10,000 people).

Tell your doctor if you experience any of the following side effects:

side effects:
Side effects, grouped by frequency of occurrence:
Common (may affect up to 1 in 10 people):

• headache,
• dizziness,
• vertigo,
• tingling or numbness,
• vision disturbances,
• tinnitus (a feeling of hearing sounds),
• cough,
• shortness of breath,
• gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion or difficulty digesting, diarrhea, constipation),
• allergic reactions (such as rashes, itching),
• muscle cramps,
• feeling of weakness;

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

• mood changes,
• sleep disturbances,
• depression,
• dry mouth,
• intense itching or severe skin rashes,
• kidney problems,
• impotence,
• excessive sweating,
• increased eosinophil count (a type of white blood cell),
• drowsiness,
• fainting,
• palpitations,
• tachycardia,
• vasculitis,
• photosensitivity reaction (increased skin sensitivity to sunlight),
• joint pain,
• muscle pain,
• chest pain,
• poor general condition,
• peripheral edema,
• fever,
• falls,
• abnormal laboratory test results: high potassium levels in the blood, transient after stopping treatment, low sodium levels, hypoglycemia (very low blood sugar levels) in diabetic patients, increased urea levels in the blood, increased creatinine levels in the blood;

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

• dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion),
• sudden flushing of the face and neck,
• exacerbation of psoriasis,
• reduced or absent urine production, acute kidney failure,
• abnormal laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood;

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

• disorientation,
• eosinophilic pneumonia (a rare type of pneumonia),
• nasal congestion (stuffy or runny nose),
• blood test abnormalities, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin levels, decreased platelet count;

Frequency not known (cannot be estimated from available data):

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

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Perindopril Teva

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 stated on the carton and bottle after the "EXP" or "EXP:" label. The batch number is stated on the packaging after the "Lot" abbreviation. The expiry date refers to the last day of the month stated.
Store in a tightly closed container to protect from moisture and light. There are no special storage temperature requirements.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Perindopril Teva contains

• The active substance is perindopril tosilate. Each coated tablet contains 6.816 mg of perindopril (equivalent to 10 mg of perindopril tosilate).
• The other ingredients are: lactose monohydrate, cornstarch, sodium bicarbonate, maize starch, povidone K30, magnesium stearate, polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol 3350, talc, and indigo carmine aluminum lake (E 132), brilliant blue aluminum lake (E 133), yellow iron oxide (E 172), quinoline yellow aluminum lake (E 104).

What Perindopril Teva looks like and contents of the pack

Perindopril Teva 10 mg coated tablets are green, round, biconvex, coated tablets with a diameter of about 8 mm, with the number "10" embossed on one side and the letter "T" on the other side.
The tablets are available in packs of 30, 60, 90, 90 (3x30), 100, or 120 (2x60) coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
To obtain more detailed information on this medicine, contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Tel.: (22) 345 93 00

Manufacturer:

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

This medicinal product is authorized 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
Netherlands: Perindopril tosilaat 10mg Teva
Poland:
Perindopril Teva
Portugal: Perindopril Rytulop
Romania:
Perindopril tosilat Teva
Slovenia: Perivol 10 mg filmsko obložene tablete

Date of last revision of the leaflet: June 2022