PERINDOPRIL 4 mg/5 mg Coated Tablet

Зміст інструкції

1. Perindopril and Amlodipine Zentiva 4 mg/5 mg tablets, 4 mg/10 mg tablets, 8 mg/5 mg tablets, 8 mg/10 mg tablets
   1. What is Perindopril and Amlodipine Zentiva and what it is used for
   2. What you need to know before taking Perindopril and Amlodipine Zentiva
   3. How to take Perindopril and Amlodipina Zentiva
   4. Possible side effects
   5. How to store Perindopril and Amlodipina Zentiva
   6. Contents of the pack and other information

Perindopril and Amlodipine Zentiva 4 mg/5 mg tablets, 4 mg/10 mg tablets, 8 mg/5 mg tablets, 8 mg/10 mg tablets

Read this leaflet carefully before you start taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Perindopril and Amlodipine Zentiva and what it is used for

Perindopril and Amlodipine Zentiva contains two active ingredients called perindopril and amlodipine.
Perindopril and Amlodipine Zentiva is prescribed for the treatment of high blood pressure
(hypertension) and for the treatment of stable coronary artery disease (condition in which the blood supply
to the heart is reduced or blocked).
Patients who are already taking perindopril and amlodipine in separate tablets may take instead a tablet of Perindopril and Amlodipine Zentiva which contains both active
ingredients.
Perindopril belongs to a group of medicines called ACE (angiotensin converting
enzyme) inhibitors. Amlodipine belongs to a group of medicines called calcium channel blockers. Together they work by widening and relaxing blood vessels, actions that
result in lowering blood pressure. Blood can flow through the body more
easily and the heart does not have to work so hard.

2. What you need to know before taking Perindopril and Amlodipine Zentiva

Do not take Perindopril and Amlodipine Zentiva

• if you are allergic to perindopril or to any other ACE inhibitor, or to amlodipine or to any other calcium channel blocker, or to any of the other ingredients of this medicine (listed in section 6).
• if you have experienced symptoms such as wheezing, swelling of the face, tongue or throat, severe itching or skin rashes related to a previous treatment with ACE inhibitors or if you or a family member has experienced such symptoms in any other circumstance (a condition called angioedema).
• if you are pregnant for more than three months. (It is best to avoid Perindopril and Amlodipine Zentiva in the early stages of pregnancy - see section “Pregnancy”).
• if you are breastfeeding (see section “Pregnancy and breastfeeding”).
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• if you are undergoing dialysis or any type of blood filtration. Depending on the machine used, therapy with Perindopril and Amlodipine Zentiva may not be suitable for you.
• if you have problems with your kidneys, where the blood flow to the kidneys is reduced (renal artery stenosis).
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a long-term (chronic) type of heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).
• if you suffer from severe low blood pressure (hypotension).
• if you have a narrowing of the aortic heart valve (aortic stenosis) or in case of cardiogenic shock (a condition in which the heart is unable to deliver enough blood to the body).
• if you suffer from heart failure following a heart attack.

Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril and Amlodipine Zentiva.
You should inform your doctor if you have or have had any of the following conditions:

• aortic stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (disease of the heart muscle).
• recent heart attack.
• heart failure.
• severe high blood pressure (hypertensive crisis).
• any other heart problems.
• liver disease.
• kidney problems or if you are undergoing dialysis.
• abnormally increased blood levels of a hormone called aldosterone (primary aldosteronism).
• collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma.
• diabetes.
• if you are following a diet restricted in salt or are using potassium-containing salt substitutes.
• if you are elderly and the dose needs to be increased.
• if you are taking any of the following medicines, this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat):
• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus) and other medicines belonging to the class of mTOR inhibitors.
• Vildagliptin, a medicine used to treat diabetes.
• if you are of black origin as you may have a higher risk of angioedema and this medicine may be less effective in reducing blood pressure compared to patients who are not black.
• if you are taking one of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes;
• aliskiren. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also what is stated under “Do not take Perindopril and Amlodipine Zentiva”.
When you are taking Perindopril and Amlodipine Zentiva, you must also inform your doctor or
medical staff:

• if you are to undergo anesthesia and/or major surgery.
• if you are to undergo LDL apheresis (which involves removing cholesterol from the blood using a machine).
• if you intend to undergo desensitization treatment to reduce the effects of an allergy to bee or wasp stings.
• if you have recently had diarrhea or vomiting, or are dehydrated.

Angioedema
Angioedema (a serious
allergic reaction with swelling of the face, lips, tongue or throat with difficulty
swallowing or breathing) has been reported in patients treated with ACE inhibitors, including perindopril. This can occur at any time during treatment. If
you develop such symptoms, you should stop taking Perindopril and Amlodipine Zentiva and consult
a doctor immediately. See also section 4.
You should inform your doctor if you are pregnant (or
planning a pregnancy).
Perindopril and Amlodipine Zentiva is not recommended in the early stages of pregnancy and should not be
taken if you are pregnant for more than three months, as it can cause serious harm to the
baby if taken during this period (see section “Pregnancy”).

Children and adolescents
There is no experience with the use of Perindopril and Amlodipine Zentiva in children (under
18
years of age). Therefore Perindopril and Amlodipine Zentiva should not be given to children and
adolescents.

Other medicines and Perindopril and Amlodipine Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Your doctor may need to change your dose and/or take other
precautions.
Perindopril and Amlodipine Zentiva can influence or be influenced by other medicines, such as for
example:

• Other medicines for high blood pressure, including diuretics (medicines that increase the amount of urine produced by the kidneys).
• An angiotensin II receptor blocker (ARB) or aliskiren (see also information provided under “Do not take Perindopril and Amlodipine Zentiva” and “Warnings and precautions”).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that may increase the amount of potassium in your blood (such as trimethoprim and co-trimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent blood clots).
• Potassium-sparing medicines used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day.
• Sacubitril/valsartan - used to treat a long-term (chronic) type of heart failure in adults (see also information under “Do not take Perindopril and Amlodipine Zentiva”).
• Lithium (a medicine for mental health problems).
• Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen for pain relief or high doses of acetylsalicylic acid.
• Medicines for the treatment of diabetes (such as insulin, vildagliptin or metformin).
• Baclofen (used for the treatment of muscle stiffness in diseases such as multiple sclerosis).
• Medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia etc (e.g. tricyclic antidepressants, antipsychotics).
• Immunosuppressants (medicines that suppress the body's defense mechanism), used for the treatment of autoimmune diseases or to allow your body to accept a transplanted organ (e.g. tacrolimus).
• Estramustine (used in the treatment of cancer).
• Allopurinol (for the treatment of gout).
• Procainamide (for the treatment of irregular heartbeat).
• Vasodilators including nitrates (products that dilate blood vessels).
• Medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline).
• Gold salts, especially with intravenous administration (used to treat the symptoms of rheumatoid arthritis).
• Ketoconazole, itraconazole (antifungal medicines).
• Ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV).
• Rifampicin, erythromycin, clarithromycin (antibiotics - for infections caused by bacteria).
• Hypericum perforatum (St John's wort).
• Verapamil, diltiazem (heart medicines).
• Dantrolene (infusion for the treatment of severe abnormalities of body temperature).
• Simvastatin (a medicine that lowers cholesterol).
• Medicines used mainly for the treatment of diarrhea (racecadotril) and other medicines that belong to the class of neprilysin (NEP) inhibitors or medicines used to prevent rejection following organ transplantation (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors). See section "Warnings and precautions".

Perindopril and Amlodipine Zentiva with food, drinks and alcohol
Grapefruit and grapefruit juice should not be consumed by people taking
Perindopril and Amlodipine Zentiva. This is because grapefruit and grapefruit juice can lead to
an increase in blood levels of the active ingredient amlodipine, which can cause an unpredictable increase
in the blood pressure lowering effect of Perindopril and Amlodipine
Zentiva.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.

Pregnancy
Tell your doctor if you think you may be pregnant (or are planning a pregnancy). Usually your doctor will
advise you to stop taking Perindopril and Amlodipine Zentiva
before starting a pregnancy or as soon as you find out you are pregnant
and will advise you to take another medicine instead of Perindopril and Amlodipine Zentiva.
Perindopril and Amlodipine Zentiva is not recommended in the early stages of pregnancy, and should not be
taken if you are pregnant for more than three months, as it can cause serious harm to the
baby if taken after the third month of pregnancy.

Breastfeeding
Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or
are about to start breastfeeding, you should tell your doctor before taking Perindopril and Amlodipine
Zentiva.
Perindopril and Amlodipine Zentiva is not recommended for mothers who are breastfeeding, and your
doctor may choose another treatment for you if you wish to breastfeed, especially if your
baby is newly born or premature.

Driving and using machines
Perindopril and Amlodipine Zentiva can affect your ability to drive or operate
machinery. If the tablets make you feel unwell, dizzy or tired, or give you a headache, do not drive or
operate machinery and contact your doctor immediately.

Perindopril and Amlodipine Zentiva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially
“sodium-free”.

3. How to take Perindopril and Amlodipina Zentiva

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The doctor decides the appropriate dose for you. Perindopril and Amlodipina Zentiva is usually
prescribed to patients who are already taking perindopril and amlodipine in separate tablets.
The recommended dose of Perindopril and Amlodipina Zentiva 4 mg / 5 mg is 1 or 2 tablets per
day.
The recommended dose of Perindopril and Amlodipina Zentiva 4 mg / 10 mg, 8 mg / 5 mg and 8 mg / 10
mg is 1 tablet per day.
Swallow the tablets with a glass of water, preferably at the same time each day, in the
morning and before a meal.

If you take more Perindopril and Amlodipina Zentiva than you should
Taking too many tablets can cause a dangerous lowering of blood pressure. You may experience dizziness, lightheadedness, fainting or weakness. If the
drop in blood pressure is severe enough, shock may occur.
The skin may become cool and clammy and you may lose consciousness. If you take too many tablets
of Perindopril and Amlodipina Zentiva, seek immediate medical help.

If you forget to take Perindopril and Amlodipina Zentiva
If you forget to take a tablet, completely skip that dose. Take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

If you stop taking Perindopril and Amlodipina Zentiva
The doctor will advise you how long to take the medicine. Your condition may
return, if you stop using the medicine prematurely. Therefore, do not stop taking
Perindopril and Amlodipina Zentiva without first talking to your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Seek immediatemedical attention if any of the following side effects occur after
taking this medicine:

• Swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (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).
• Heart attack, unusually fast or irregular heartbeat, chest pain (angina) (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 possible 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).
• Severe skin reactions, including intense rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions (very rare - may affect up to 1 in 10,000 people).
• Inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of severe discomfort (very rare - may affect up to 1 in 10,000 people).
• Yellowing of the skin or eyes (jaundice), which may be a sign of hepatitis (very rare - may affect up to 1 in 10,000 people).
• Rash, which often starts with itchy red spots on the face, arms or legs (erythema multiforme) (very rare - may affect up to 1 in 10,000 people).

Since Perindopril and Amlodipina Zentiva is a combination of two active ingredients, the side effects
that have been reported are related to both the use of perindopril and amlodipine.

Side effects related to the use of perindopril
Common(may affect up to 1 in 10 people):

• Headache, dizziness, vertigo.
• Tingling.
• Vision disturbances.
• Ringing in the ears (tinnitus).
• Feeling lightheaded due to low blood pressure.
• Cough.
• Shortness of breath.
• Feeling unwell (nausea), vomiting.
• Abdominal pain.
• Alterations of taste.
• Indigestion or difficulty digesting.
• Diarrhea, constipation.
• Rash, itching.
• Muscle cramps.
• Feeling of weakness.

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

• Mood changes.
• Sleep disorders.
• Depression
• Dry mouth.
• Kidney problems.
• Impotence.
• Sweating.
• Excess of eosinophils (a type of white blood cells).
• Drowsiness.
• Fainting.
• Palpitations.
• Tachycardia.
• Vasculitis (inflammation of the blood vessels).
• Photosensitivity reactions (increased sensitivity of the skin to the sun).
• Joint pain.
• Muscle pain.
• Chest pain.
• Feeling unwell.
• Peripheral edema.
• Fever.
• Falls.
• Changes in laboratory parameters: high level of potassium in the blood reversible upon discontinuation of the medicine, low level of sodium, hypoglycemia (very low blood sugar) in diabetic patients, increased plasma urea and increased plasma creatinine.

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

• Dark urine, feeling unwell (nausea) or feeling sick (vomiting), muscle cramps, confusion and convulsions. These symptoms may be due to a condition called SIADH (syndrome of inappropriate secretion of antidiuretic hormone).
• Flushing.
• Worsening of psoriasis.
• Reduced or absent urine production
• Acute renal failure
• Changes in laboratory parameters: increased levels of liver enzymes, elevated serum bilirubin.

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

• Confusion.
• Eosinophilic pneumonia (a rare type of pneumonia).
• Stuffy or runny nose (rhinitis).
• Changes in blood values, such as a lower number of white and red blood cells, decreased hemoglobin, lower number of platelets.

Not known (frequency cannot be estimated based on available data):
Abnormal color, numbness and pain in the fingers of the hands and feet (Raynaud's phenomenon).

Side effects related to the use of amlodipine
Very common(may affect more than 1 in 10 people):

• Swelling (edema).

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

• Headache, dizziness, drowsiness (especially at the beginning of treatment).
• Awareness of your heartbeat (palpitations), flushing.
• Abdominal pain, feeling unwell (nausea).
• Altered bowel habits, diarrhea, constipation, indigestion.
• Fatigue, weakness.
• Swelling of the ankles, muscle cramps.
• Visual disturbances, double vision.

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

• Mood changes, anxiety, depression, insomnia.
• Tremor, taste abnormalities, fainting.
• Feeling of numbness or tingling in the limbs, loss of sensation of pain.
• Ringing in the ears (tinnitus).
• Low blood pressure.
• Stuffy or runny nose (rhinitis).
• Cough.
• Dry mouth, vomiting (feeling sick).
• Hair loss, increased sweating, itching, red spots on the skin, discoloration of the skin.
• Problems with urination, increased need to urinate at night, increased number of urinations.
• Inability to get an erection; discomfort or enlargement of the breasts in men.
• Pain, feeling unwell.
• Joint or muscle pain, back pain.
• Weight gain or loss.

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

• Confusion.

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

• Decreased number of white blood cells, decreased platelets in the blood which can lead to unusual bruising or easy bleeding (damage to red blood cells).
• Excess sugar in the blood (hyperglycemia).
• A nerve disease that can cause muscle weakness, tingling or numbness.
• Swelling of the gums.
• Inflammation of the stomach (gastritis).
• Abnormal liver function, increased liver enzymes which can lead to alteration of some medical tests.
• Increased muscle tension.
• Inflammation of the blood vessels, often with a rash.
• Sensitivity to light.

Not known(frequency cannot be estimated based on available data):

• tremor, rigid posture, mask-like face, slow and clumsy movements, unbalanced gait.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Perindopril and Amlodipina Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton/blister after EXP.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C. Store in the original packaging to
protect the medicine from light and moisture..
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What containsPerindopril e Amlodipina Zentiva
The active ingredients are perindopril erbumine and amlodipine besilate.
Perindopril e Amlodipina Zentiva 4 mg/5 mg: Each tablet contains 4 mg of perindopril
erbumine equivalent to 3.338 mg perindopril and 5 mg of amlodipine (as besilate).
Perindopril e Amlodipina Zentiva 4 mg/10 mg: Each tablet contains 4 mg of perindopril
erbumine equivalent to 3.338 mg perindopril and 10 mg of amlodipine (as besilate).
Perindopril e Amlodipina Zentiva 8 mg/5 mg: Each tablet contains 8 mg of perindopril
erbumine equivalent to 6.676 mg perindopril and 5 mg of amlodipine (as besilate).
Perindopril e Amlodipina Zentiva 8 mg/10 mg: Each tablet contains 8 mg of perindopril
erbumine equivalent to 6.676 mg perindopril and 10 mg of amlodipine (as besilate).
The other ingredients are microcrystalline cellulose, dihydrated calcium hydrogen phosphate, croscarmellose
sodium, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Perindopril e Amlodipina Zentiva and contents of the pack
Perindopril e Amlodipina Zentiva 4 mg/5 mg: tablets of colour from white to almost white,
round, with imprinted 4/5 on one side.
Perindopril e Amlodipina Zentiva 4 mg/10 mg: tablets of colour from white to almost white,
round, with imprinted 4/10 on one side.
Perindopril e Amlodipina Zentiva 8 mg/5 mg: tablets of colour from white to almost white,
round, with imprinted 8/5 on one side.
Perindopril e Amlodipina Zentiva 8 mg/10 mg: tablets of colour from white to almost white,
round, with imprinted 8/10 on one side.
Packs:
Perindopril e Amlodipina Zentiva 4 mg/5 mg: 10, 15, 30, 90 tablets.
Perindopril e Amlodipina Zentiva 4 mg/10 mg, 8 mg/5 mg 8 mg/10 mg: 30, 90 tablets.
It is possible that not all packs are marketed.

Marketing Authorisation Holder
Zentiva Italia S.r.l.
Viale L. Bodio, 37/B
20158 Milano

Manufacturer
ZENTIVA, k.s.
U Kabelovny 130,
Dolní Měcholupy
102 37 Praha 10
Czech Republic

UAB “Oriola Vilnius”
Laisvės pr. 75
06144 Vilnius
Lithuania

This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:
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