Perindopril

Leaflet attached to the packaging: patient information

Perindopril, 2 mg, tablets

Perindopril, 4 mg, tablets

tert-Butylamine perindopril

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Perindopril and what is it used for

The active substance of Perindopril tablets belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).
Perindopril tablets are used:

• to treat high blood pressure (hypertension),
• to treat symptomatic heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs),
• to reduce the risk of heart attacks, such as heart attack, in patients with stable coronary artery disease (a condition in which blood flow to the heart is reduced or blocked) and in patients who have had a heart attack and/or coronary artery bypass grafting, by widening the blood vessels that supply the heart with blood.

2. Important information before taking Perindopril

When not to take Perindopril

• after the third month of pregnancy (it is also recommended to avoid taking Perindopril during early pregnancy - see section "Pregnancy");

Warnings and precautions

Before taking Perindopril, discuss it with your doctor or pharmacist.
It may turn out that Perindopril is not suitable for you, or that you need regular health checks. Therefore, before taking the medicine, inform your doctor about the following conditions:

• reduced or blocked blood flow through the heart (stable coronary artery disease);
• enlargement of the heart muscle or problems with the heart valves;
• narrowing of the artery that supplies blood to the kidneys (renal artery stenosis);
• you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism);
• diabetes;
• kidney, liver, or heart disease;
• dialysis treatment or recent kidney transplant;
• using a low-salt diet, severe vomiting, or diarrhea, or taking diuretics (water pills);
• taking lithium, medicines used to treat mania or depression;
• taking potassium supplements or salt substitutes that contain potassium, or other medicines that may increase potassium levels in the blood, such as heparin;
• you will undergo a procedure to remove cholesterol from the body using a special device (LDL apheresis);
• you will or are undergoing desensitization treatment for bee or wasp stings;
• you have collagen disease, such as systemic lupus erythematosus or scleroderma;
• you are taking immunosuppressive medicines;
• your blood pressure is not well controlled due to your race (this applies especially to black patients);
• you will undergo surgery or general anesthesia;
• you have cerebrovascular disease;
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent transplant rejection and to treat cancer (e.g. sirolimus, everolimus, temsirolimus),
• wildagliptin, a medicine used to treat diabetes.
• angiotensin receptor antagonist (ARB) (also known as sartans - e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
• aliskiren.

Angioedema
Angioedema has been reported in patients treated with ACE inhibitors, including Perindopril.
This reaction may occur at any time during treatment. If you experience such symptoms, stop taking Perindopril and contact your doctor immediately. See also section 4.
If you are pregnant or think you may be pregnant, tell your doctor. Perindopril is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may harm the baby (see section "Pregnancy").

Children and adolescents

Perindopril is not recommended for children and adolescents under 18 years of age.

Perindopril and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or recently, and about any medicines you plan to take.
Do not take medicines available without a prescription without consulting your doctor. This applies especially to:

• cold medicines containing pseudoephedrine or phenylephrine as an active substance;
• analgesics, including acetylsalicylic acid (a substance found in many medicines used to reduce pain and lower fever, as well as to prevent blood clots);
• potassium supplements;
• salt substitutes containing potassium.

Tell your doctor if you are taking any of the following medicines, to ensure that you can safely take Perindopril at the same time:

• other medicines used to treat high blood pressure and/or heart failure, including diuretics (water pills),
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g. trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections; cyclosporine or tacrolimus, an immunosuppressive medicine used to prevent transplant rejection, and heparin, a medicine used to thin the blood to prevent clots),
• potassium-sparing diuretics used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day,
• medicines used to treat irregular heartbeat (procainamide),
• medicines used to treat diabetes (insulin or oral anti-diabetic medicines like wildagliptin),
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),
• medicines used to treat gout (allopurinol),
• non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen, diclofenac, including acetylsalicylic acid used as a pain reliever,
• vasodilators, including nitrates,
• estramustine (used to treat cancer),
• medicines that stimulate certain parts of the nervous system, such as ephedrine, noradrenaline, or adrenaline (sympathomimetics),
• medicines used to treat mania or depression (lithium),
• medicines used to treat mental illnesses, such as depression, anxiety, schizophrenia, or other psychoses (tricyclic antidepressants and antipsychotic medicines),
• gold salts for injection used to treat arthritis (sodium aurothiomalate),
• medicines used to treat diarrhea (racecadotril) or medicines used to prevent transplant rejection (sirolimus, everolimus, temsirolimus, or other mTOR inhibitors). See section "Warnings and precautions".

Your doctor may need to adjust the dose and/or take other precautions:

Taking Perindopril with food, drink, and alcohol

It is recommended to take Perindopril before meals to reduce the effect of food on the medicine's action.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor if you are pregnant or think you may be pregnant. Your doctor will usually advise you to stop taking Perindopril before you become pregnant or as soon as you find out you are pregnant, and will advise you to take a different medicine instead. Do not take Perindopril during early pregnancy and do not take it after the third month of pregnancy, as it may harm the baby.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Perindopril while breastfeeding, especially if you are breastfeeding a newborn or premature baby. Your doctor may advise you to take a different medicine.

Driving and using machines

Perindopril usually does not affect alertness, but some patients may experience dizziness or weakness due to low blood pressure. Therefore, the ability to drive or operate machinery may be impaired.

Perindopril contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The usual dose for high blood pressure is 4 mg of perindopril (1 tablet of 4 mg Perindopril) once a day. If necessary, the dose can be increased to 8 mg of perindopril (2 tablets of 4 mg Perindopril) once a day.
The usual dose for symptomatic heart failure is 2 mg of perindopril (1 tablet of 2 mg Perindopril) once a day; if necessary, the dose can be increased to 4 mg of perindopril (1 tablet of 4 mg Perindopril) once a day.
The usual dose for stable coronary artery disease is 4 mg of perindopril (1 tablet of 4 mg Perindopril) once a day; if necessary, the dose can be increased to 8 mg of perindopril (2 tablets of 4 mg Perindopril) once a day.
Take the tablets with a glass of water, preferably at the same time each day, in the morning, before breakfast.
Depending on the results of the treatment, your doctor will adjust the dosage individually for you.
The dosage may be lower than usual, depending on your doctor's decision: for elderly patients, patients with kidney problems, patients with high blood pressure caused by narrowing of the artery that supplies blood to the kidneys (renal hypertension), patients treated with diuretics (water pills), patients with severe heart failure, and patients treated with vasodilators.
The duration of treatment will be determined by your doctor based on your health condition.
Use in children and adolescents
The efficacy and safety of Perindopril in children have not been established. Therefore, it is not recommended to give it to this age group.
If you feel that the effect of Perindopril is too strong or too weak, ask your doctor or pharmacist.

What to do if you take more Perindopril than you should

If you have taken too many tablets, contact your doctor or pharmacist immediately.
The most likely symptom of overdose is a sudden drop in blood pressure (hypotension). Other symptoms may include: rapid or slow heartbeat, unpleasant feeling of irregular or stronger than usual heartbeat, increased frequency and depth of breathing, dizziness, anxiety, and/or cough.
If you experience a significant drop in blood pressure, lie down, support your legs, so that they are elevated in relation to your body, and put a flat pillow under your head.

What to do if you forget to take Perindopril

It is important to take the medicine every day. However, if you forget to take one dose, simply continue taking the medicine as usual from the next dose. Do not take a double dose to make up for a missed dose. If you miss more than one dose, take the next dose as soon as possible, and then continue taking the medicine as directed.

What to do if you stop taking Perindopril

Stopping treatment may lead to an increase in blood pressure, which may increase the risk of complications related to high blood pressure, especially in the heart, brain, and kidneys.
The condition of patients with heart failure may worsen to the point where hospitalization is necessary. Therefore, if you are considering stopping Perindopril, consult your doctor first.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, stop taking Perindopril and contact your doctor immediately:

as they can 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 rapid 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 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).

If you experience any of the following side effects, tell your doctor:

Common side effects (may affect up to 1 in 10 people):

• headache, dizziness, feeling of spinning (vertigo), feeling of tingling or numbness in the hands or feet (paresthesia),
• vision disturbances,
• ringing, buzzing, hissing, clicking in the ears (tinnitus),
• low blood pressure (hypotension) and symptoms related to hypotension,
• cough, shortness of breath (dyspnoea),
• nausea, vomiting, abdominal pain, taste disturbances, indigestion, diarrhea, and constipation,
• rash, itching,
• muscle cramps,
• weakness.

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

• hypoglycaemia (very low blood sugar),
• high potassium levels in the blood, which may return to normal after stopping treatment,
• low sodium levels,
• mood disturbances, sleep disturbances,
• depression,
• drowsiness, fainting,
• palpitations, tachycardia,
• vasculitis,
• wheezing (bronchospasm),
• dryness of the mucous membranes of the mouth,
• allergic reaction with sudden swelling of the face, neck, lips, mucous membranes, tongue, or throat (with hoarseness or difficulty breathing), possibly also swelling of the hands and feet (angioedema), hives,
• excessive sweating,
• allergic reaction to sunlight (increased skin sensitivity to the sun), pemphigoid (an autoimmune skin disease, its symptoms include large, tense blisters),
• joint pain, muscle pain,
• kidney problems,
• impotence,
• chest pain, poor general condition, peripheral oedema, fever,
• increased levels of urea and creatinine in the blood,
• falls.

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

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

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

• reduced haemoglobin and haematocrit values, thrombocytopenia, leucopenia/neutropenia, agranulocytosis, or pancytopenia. Haemolytic anaemia in patients with a congenital deficiency of glucose-6-phosphate dehydrogenase,
• disorientation,
• arrhythmias, chest pain (angina pectoris), myocardial infarction, and stroke, probably secondary to excessive blood pressure lowering in high-risk patients,
• pulmonary infiltration with eosinophilia (eosinophilic pneumonia), rhinitis,
• pancreatitis,
• hepatitis,
• erythema multiforme.

Frequency not known (frequency cannot be estimated from the 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 not listed in this leaflet, please 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, 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 authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Perindopril

Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Store at a temperature not exceeding 30°C.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Perindopril contains

• The active substance of Perindopril is perindopril tert-butylamine. Perindopril, 2 mg and 4 mg tablets:Each tablet contains 2 mg or 4 mg of perindopril tert-butylamine.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium hydrogen carbonate, anhydrous colloidal silica, magnesium stearate. See section 2 "Perindopril contains lactose".

What Perindopril looks like and contents of the pack

2 mg tablets are white, round, biconvex.
4 mg tablets are white, oval, biconvex with beveled edges and a score line on one side.
The following pack sizes are available:
30, 60, or 90 tablets in blisters, in a cardboard box

Marketing authorisation holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Poland
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information about this medicine, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. +48 22 57 37 500

Date of last revision of the leaflet: