Perindopril Teva

Leaflet accompanying the packaging: patient information

Perindopril Teva, 5 mg, film-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.
• If you experience any side effects, including any possible side effects not listed in the 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 treat heart failure(a condition where the heart is not able to pump enough blood to meet the body's needs);
• to reduce the risk of certain heart events, such as heart attack in patients with stable coronary artery disease(a condition where the blood supply to the heart is reduced or blocked), who have had a heart attack and/or have had a procedure to improve blood supply 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 rash when taking an ACE inhibitor, or if you have had such symptoms 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 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 using a method other than hemofiltration and low-flux dialysis.
• if you have kidney problems that reduce blood flow to the kidneys (renal artery stenosis).
• if you have taken or are currently taking sacubitril/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 in the throat) is increased (see sections "Warnings and precautions" and "Perindopril Teva and other medicines").

Warnings and precautions

Before taking Perindopril Teva, discuss with your doctor or pharmacist:

• if you have 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 increased level of a hormone called aldosterone in your blood (primary aldosteronism),
• if you have a connective tissue 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 LDL apheresis (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 used to treat high blood pressure:
• angiotensin receptor blockers (ARBs) (also known as sartans - 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" and "Warnings and precautions".
• if you are taking any of the following medicines, the risk of angioedema may be increased:
• 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 section "Possible side effects".
If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You must tell your doctor if you think you are pregnant (or might become pregnant). Normally, your doctor will advise you to take a different medicine instead of Perindopril Teva, as taking Perindopril Teva in early pregnancy is not recommended. However, you must not take it after the third month of pregnancy, as it may cause serious harm to your baby (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 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 certain medicines, such as:

• other medicines used to treat high blood pressure, including angiotensin receptor blockers (ARBs), 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 clotting; 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 at doses of 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 for pain relief or high doses of aspirin or large doses of acetylsalicylic acid, a substance found in many medicines, used for pain relief and 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 section "Warnings and precautions";
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Perindopril Teva" and "Warnings and precautions";
• allopurinol (used to treat gout);
• procainamide (used to treat irregular heart rhythms);
• vasodilators, including nitrates;
• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, norepinephrine, 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 breakfast.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You must tell your doctor if you think you are pregnant (or might become pregnant). Normally, your doctor will advise you to take a different medicine instead of Perindopril Teva, as taking Perindopril Teva in early pregnancy is not recommended. However, you must not take it after the third month of pregnancy, as it may cause serious harm to your baby (see section "Pregnancy, breastfeeding, and fertility").
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. Perindopril Teva is not recommended during breastfeeding. In breastfeeding women, the doctor may prescribe a different medicine, especially if the baby is a newborn or premature.
Fertility
The effect of perindopril on fertility in humans 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.
Take the tablets with a glass of water, preferably at the same time each day, in the morning, before breakfast. Your doctor will decide the appropriate dose for you.
The usual doses of Perindopril Teva are:
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. The dose of 10 mg once daily is the maximum recommended dose for the treatment of hypertension.
In patients aged 65 and over, 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.
Heart failure:the recommended initial dose is 2.5 mg once daily. After two weeks, your doctor may increase the dose to 5 mg once daily, which is the maximum recommended dose for the treatment of heart failure.
Stable coronary artery 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 and over, 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 under 18 years of age.
The tablet can be divided into equal doses.

If you take more Perindopril Teva than you should

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.

If you forget to take Perindopril Teva

It is important to take your medicine regularly, as its effect is best when taken regularly. 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 treatment with Perindopril Teva

Treatment with Perindopril Teva is long-term, so before stopping treatment, 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 Perindopril Teva 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 health (very rare - may affect up to 1 in 10,000 people), jaundice (yellowing of the skin or eyes), which can 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::
Common (may affect up to 1 in 10 people):

• headache,
• dizziness,
• vertigo,
• tingling or numbness,
• vision disturbances,
• tinnitus (ringing in the ears),
• cough,
• shortness of breath,
• gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion, or difficulty digesting, diarrhea, constipation),
• allergic reactions (such as rashes, itching),
• muscle cramps,
• feeling weak;

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

• mood changes,
• sleep disturbances,
• depression,
• dry mouth,
• intense itching or severe skin rashes,
• formation of blisters on the skin,
• kidney problems,
• impotence,
• increased 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,
• general feeling of being unwell,
• peripheral edema,
• fever,
• falls,
• abnormal laboratory test results: high potassium levels in the blood, transient and disappearing after treatment discontinuation, low sodium levels, hypoglycemia (very low blood sugar) 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 secretion of antidiuretic hormone),
• 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 changes, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin level, decreased platelet count;

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

• 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 the leaflet, tell your doctor or pharmacist. You can also report side effects 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
You can also report side effects 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 blister after "EXP:". The batch number is stated on the packaging after "Lot". The expiry date refers to the last day of the month stated.
Store in a tightly closed container, protected from moisture and light. There are no special storage instructions regarding temperature.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Perindopril Teva contains

• The active substance is perindopril tosilate. Each film-coated tablet contains 3.408 mg of perindopril (equivalent to 5 mg of perindopril tosilate).
• The other ingredients are: lactose monohydrate, cornstarch, sodium hydrogen carbonate, cornstarch glycolate, 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 5 mg film-coated tablets are light green, biconvex, film-coated tablets in the shape of a capsule, approximately 4 mm wide and 8 mm long, with the letter "T" embossed on one side, smooth on the other side, with dividing lines on both edges.
The tablets are available in packs of 30, 60, 90, 90 (3x30), 100, or 120 (2x60) film-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
For further information about this medicine, please contact the local 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 Krakow

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 2.5mg/5mg Teva
Poland:
Perindopril Teva
Portugal: Perindopril Rytulop
Romania: Perindopril tosilat Teva
Slovenia: Perivol 2,5 mg filmsko obložene tablete
Perivol 5 mg filmsko obložene tablete

Date of last revision of the leaflet: June 2022