PERINDOPRIL 4 мг/5 мг Коированная таблетка

Содержание инструкции

1. PERINDOPRIL E AMLODIPINA EG STADA 4 mg/5 mg tablets, 4 mg/10 mg tablets, 8 mg/5 mg tablets, 8 mg/10 mg tablets
   1. What is PERINDOPRIL E AMLODIPINA EG STADA and what is it used for
   2. What you need to know before taking PERINDOPRIL E AMLODIPINA EG STADA
   3. How to take PERINDOPRIL E AMLODIPINA EG STADA
   4. Possible side effects
   5. How to store PERINDOPRIL E AMLODIPINA EG STADA
   6. Contents of the pack and other information
2. PERINDOPRIL E AMLODIPINA EG STADA 4 mg/5 mg: tablets of colour from white to almost white,
3. PERINDOPRIL E AMLODIPINA EG STADA 8 mg/5 mg: tablets of colour from white to almost white,

PERINDOPRIL E AMLODIPINA EG STADA 4 mg/5 mg tablets, 4 mg/10 mg tablets, 8 mg/5 mg tablets, 8 mg/10 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine, as 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 E AMLODIPINA EG STADA is and what it is used for
• 2. What you need to know before you take PERINDOPRIL E AMLODIPINA EG STADA
• 3. How to take PERINDOPRIL E AMLODIPINA EG STADA
• 4. Possible side effects
• 5. How to store PERINDOPRIL E AMLODIPINA EG STADA
• 6. Contents of the pack and other information

1. What is PERINDOPRIL E AMLODIPINA EG STADA and what is it used for

PERINDOPRIL E AMLODIPINA EG STADA is prescribed for the treatment of high blood pressure
(hypertension) and/or 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 PERINDOPRIL E AMLODIPINA EG STADA instead, which contains both active
ingredients.
PERINDOPRIL E AMLODIPINA EG STADA is a combination of two active ingredients, perindopril and
amlodipine. Perindopril is an ACE (angiotensin converting enzyme) inhibitor. Amlodipine is a
calcium antagonist (belonging to the class of drugs called dihydropyridines). In combination, they
work by widening and relaxing blood vessels so that it is easier for blood to pass
through them and for the heart to maintain a good level of blood flow.

2. What you need to know before taking PERINDOPRIL E AMLODIPINA EG STADA

DO NOT take PERINDOPRIL E AMLODIPINA EG STADA
if you are allergic to perindopril or to any other ACE inhibitor, to amlodipine or to any other
calcium antagonist, or to any of the other ingredients of this medicine (listed in
section 6),
if you are pregnant for more than 3 months (it is best to avoid PERINDOPRIL E AMLODIPINA EG
STADA even in the early stages of pregnancy – see the section on pregnancy),
if you experience symptoms such as shortness of breath, swelling of the face or tongue, intense itching or severe skin
rashes related to a previous treatment with ACE inhibitors or if you or a family member have
experienced such symptoms in any other circumstance (a condition called angioedema),
if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that
lowers your blood pressure, containing aliskiren,
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 to the body an adequate
amount of blood),
if you suffer from severe low blood pressure (hypotension),
if you suffer from heart failure following a heart attack,
if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of
long-term (chronic) heart failure in adults, as this increases the risk of
angioedema (rapid swelling under the skin in areas such as the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking PERINDOPRIL E AMLODIPINA EG STADA
if you have hypertrophic cardiomyopathy (disease of the heart muscle) or renal artery stenosis
(narrowing of the artery that supplies blood to the kidneys),
if you suffer from heart failure,
if you suffer from a severe increase in blood pressure (hypertensive crisis),
if you suffer from any other heart problem,
if you have liver problems,
if you have kidney problems or are on dialysis,
if you have a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma,
if you have diabetes,
if you are following a diet that restricts salt intake or use potassium-containing salt substitutes (a well-balanced blood potassium level is essential),
if you are elderly and the dosage needs to be increased,
if you are taking any 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 if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may be increased:
• racecadotril, a medicine used to treat diarrhea
• medicines used to prevent rejection of transplanted organs and to treat cancer (such as sirolimus, everolimus, temsirolimus) and other medicines belonging to the class of so-called mTOR inhibitors
• vildagliptin, a medicine used to treat diabetes.

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 the information in section “DO NOT take PERINDOPRIL E AMLODIPINA EG STADA”.
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). PERINDOPRIL E AMLODIPINA EG STADA is not recommended in the early stages of
pregnancy and must not be taken if you are pregnant for more than 3 months as it can cause
serious harm to the baby if taken during this period (see the section “Pregnancy”).
If you are taking PERINDOPRIL E AMLODIPINA EG STADA, inform your doctor or medical staff:
if you are going to have general anesthesia and/or major surgery,
if you have recently had diarrhea or vomiting (feeling unwell),
if you are going to undergo LDL apheresis (blood purification from cholesterol using a
machine),
if you are going to have desensitization treatment to reduce the effects of an allergy to bee or wasp stings.

Children and adolescents
The use of PERINDOPRIL E AMLODIPINA EG STADA is not recommended in children and
adolescents.

Other medicines and PERINDOPRIL E AMLODIPINA EG STADA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take PERINDOPRIL E AMLODIPINA EG STADA with sacubitril/valsartan, a medicine used to
treat a type of long-term (chronic) heart failure in adults. See section 2 “DO NOT
take PERINDOPRIL E AMLODIPINA EG STADA”.
You must not take PERINDOPRIL E AMLODIPINA EG STADA with:
lithium (used to treat mania or depression),
estramustine (used in cancer therapy),
potassium-sparing diuretics (spironolactone, triamterene), potassium supplements (including salt substitutes
containing potassium) and other medicines that may increase the amount of potassium in
the blood (such as trimethoprim and co-trimoxazole also known as trimethoprim/sulfamethoxazole 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 the formation of clots).
Treatment with PERINDOPRIL E AMLODIPINA EG STADA may be affected by taking
other medicines. Your doctor may need to change the dose and/or take other precautions.
Tell your doctor if you are taking any of the following medicines as special care may be needed:
other medicines for the treatment of high blood pressure, including an angiotensin II receptor blocker (AIIRA), aliskiren (see also the information in sections "DO NOT
take PERINDOPRIL E AMLODIPINA EG STADA" and "Warnings and precautions") or diuretics (medicines
that increase the amount of urine produced by the kidneys),
medicines, mostly used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs
and for cancer (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called
mTOR inhibitors). See the section “Warnings and precautions”,
non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or high doses of acetylsalicylic acid,
medicines for the treatment of diabetes (such as insulin, vildagliptin),
medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia etc. (e.g.
tricyclic antidepressants, antipsychotics, antidepressants similar to imipramine, neuroleptics),
immunosuppressants (medicines that can suppress the body's defense mechanism) used for
the treatment of autoimmune disorders or following an organ transplant,
allopurinol (for the treatment of gout),
procainamide (for the treatment of irregular heartbeat),
vasodilators, including nitrates (products that dilate blood vessels),
ephedrine, norepinephrine or adrenaline (drugs used to treat low blood pressure, shock or asthma),
baclofen or dantrolene (for infusion) both used in the treatment of muscle stiffness that occurs in diseases such as multiple sclerosis; dantrolene is also used in the treatment of malignant hyperthermia during anesthesia (whose symptoms consist of very high fever and muscle rigidity),
some antibiotics such as rifampicin, erythromycin, clarithromycin,
antiepileptic drugs such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
itraconazole, ketoconazole (drugs used in the treatment of fungal infections),
alpha-blockers used for the treatment of prostatic hyperplasia such as prazosin, alfuzosin, doxazosin,
tamsulosin, terazosin,
amifostine (used in the prevention or reduction of side effects caused by other drugs or
radiotherapy for cancer treatment),
corticosteroids (used in the treatment of various conditions including severe asthma and rheumatoid arthritis),
gold salts, especially with intravenous administration (used in the treatment of symptoms of rheumatoid arthritis),
ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV).

PERINDOPRIL E AMLODIPINA EG STADA with food and drink
PERINDOPRIL E AMLODIPINA EG STADA should be taken before a meal.
Grapefruit and grapefruit juice should not be consumed by people who are taking
PERINDOPRIL E AMLODIPINA EG STADA. This is because grapefruit and grapefruit juice can
cause an increase in the levels of the active substance amlodipine in the blood, which can cause an unpredictable increase in the blood pressure-lowering effect of PERINDOPRIL E AMLODIPINA EG
STADA.

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

Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop treatment with PERINDOPRIL E
AMLODIPINA EG STADA before starting pregnancy or as soon as pregnancy is confirmed and will
prescribe another medicine to use instead of PERINDOPRIL E AMLODIPINA EG STADA.
PERINDOPRIL E AMLODIPINA EG STADA is not recommended in the early stages of pregnancy and must not
be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken
after the third month of pregnancy.

Breastfeeding
It has been shown that amlodipine, one of the two active ingredients of PERINDOPRIL E AMLODIPINA EG
STADA, passes into breast milk in small amounts. Tell your doctor if you are breastfeeding or intend to
breastfeed your baby. PERINDOPRIL E AMLODIPINA EG STADA is not recommended for mothers
who are breastfeeding. If you wish to continue breastfeeding your baby, your doctor may decide
to prescribe an alternative treatment.

Driving and using machines
PERINDOPRIL E AMLODIPINA EG STADA can affect your ability to drive and use
machines. If the tablets make you feel unwell, dizzy, weak or tired, or give you
headache, do not drive or use machines and contact your doctor immediately.

PERINDOPRIL E AMLODIPINA EG STADA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take PERINDOPRIL E AMLODIPINA EG STADA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist. The recommended dose is one tablet a day.
Take the tablet by swallowing it with a glass of water, preferably every day at the same time, in the
morning before a meal. The doctor will decide the appropriate dose for you. Usually the dose will be one
tablet a day.
Generally, PERINDOPRIL E AMLODIPINA EG STADA will be prescribed to patients who are already taking
perindopril and amlodipine in separate tablets.

If you take more PERINDOPRIL E AMLODIPINA EG STADA than you should
If you have taken an excessive amount of tablets, go immediately to the nearest emergency room or
consult your doctor. The most likely effect of an overdose is a lowering of blood
pressure which may cause dizziness or fainting. In this case, it may be helpful to lie down with your legs
raised.
Excess fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath which may
develop up to 24-48 hours after taking the medicine.

If you forget to take PERINDOPRIL E AMLODIPINA EG STADA
It is important to take the medicine every day as regular treatment is more effective. However, if you
forget to take a dose of PERINDOPRIL E AMLODIPINA EG STADA, 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 E AMLODIPINA EG STADA
Since treatment with PERINDOPRIL E AMLODIPINA EG STADA is usually lifelong, talk to your
doctor before stopping taking the tablets.
If you have any further questions on 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 everybody gets them.
If you experience any of the following side effects, stop taking the medicine immediately and inform

immediatelyyour doctor:
sudden onset of shortness of breath, chest pain, wheezing or difficulty breathing,
swelling of the eyelids, face or lips,
swelling of the tongue and throat which can cause significant difficulty breathing,
severe skin reactions, including intense skin rash, urticaria, redness of the skin all over the
body, severe itching, blistering, peeling and swelling of the skin,
inflammation of the mucous membranes (Stevens Johnson syndrome, toxic epidermal necrolysis) or
other allergic reactions,
severe dizziness or fainting,
heart attack, unusually fast or irregular heartbeat,
inflammation of the pancreas which can cause severe abdominal and back pain accompanied by
a feeling of severe malaise.
The following common side effectshave been reported. Tell your doctorif these effects cause you
problems or if they last for more than one week.
Common side effects(may affect up to 1 in 10 people):
Headache.
Dizziness.
Drowsiness (especially at the beginning of treatment).
Vertigo.
Numbness or tingling in the limbs.
Vision disorders (including double vision).
Tinnitus (ringing in the ears).
Palpitations (awareness of your heartbeat).
Flushing
Feeling lightheaded due to a drop in blood pressure.
Cough.
Shortness of breath.
Nausea (feeling sick), vomiting (being sick).
Abdominal pain.
Changes in taste sensation.
Indigestion or digestive difficulties.
Diarrhoea.
Constipation.
Allergic reactions (such as skin rashes, itching).
Muscle cramps.
Fatigue.
Weakness.
Swollen ankles (oedema).
Other side effects that have been reported are included in the following list. If any of the
side effects gets worse, or if you notice any side effect not listed in this
leaflet, inform your doctor or pharmacist.

Uncommon side effects(may affect up to 1 in 100 people):
Changes in mood.
Anxiety.
Depression.
Insomnia, sleep disorders.
Tremor.
Fainting.
Loss of pain sensation.
Rhinitis (nasal congestion or runny nose).
Altered bowel habits.
Hair loss.
Red spots on the skin, skin discoloration.
Back pain, muscle or joint pain, chest pain.
Urinary disorders, need to urinate at night, frequent urination.
Pain.
Feeling unwell.
Bronchospasm (feeling of tightness in the chest, wheezing and shortness of breath).
Dry mouth.
Angioedema (symptoms such as wheezing, swelling of the face or tongue).
Kidney problems.
Impotence.
Excessive sweating.
Discomfort or enlargement of the breasts in men.
Weight gain or loss.

Rare side effects(may affect up to 1 in 1000 people):
Confusional state.
Worsening of psoriasis.
Increased liver function values (indicative of liver damage) including increased
bilirubin in the blood (which can, in severe cases, cause yellowing of the skin and eyes).
Dark urine, feeling sick (nausea) or feeling unwell (vomiting), muscle cramps,
confusion and convulsions. These symptoms may be due to a condition called
SIADH (inappropriate secretion of the antidiuretic hormone).
Reduced or absent urine production.
Acute kidney failure.

Very rare side effects(may affect up to 1 in 10,000 people):
Cardiovascular disorders (irregular heartbeat, angina, heart attack and stroke).
Eosinophilic pneumonia (a rare type of pneumonia).
Swelling of the eyelids, face or lips, swelling of the tongue and throat causing severe
breathing problems.
Severe skin reactions including intense rash, urticaria, 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), erythema multiforme (a skin rash that often starts with itchy red spots
on the face, arms or legs).
Sensitivity to light.
Blood disorders.
Inflammation of the pancreas which can cause severe abdominal and back pain accompanied by
a feeling of severe malaise.
Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice),
increased liver enzymes which can lead to changes in some clinical tests.
Swollen abdomen (gastritis).
A nerve disorder that can cause weakness, tingling or numbness.
Increased muscle tension.
Vasculitis (inflammation of blood vessels).
Swollen gums.
High blood sugar levels (hyperglycaemia).

Frequency not known(cannot be estimated from the available data):
Abnormal colour, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon).
The following side effects have also been reported by patients treated with PERINDOPRIL AND
AMLODIPINE EG STADA:
hypoglycaemia (severe lowering of blood sugar levels), disorders related to stiffness,
tremor, and/or movement disorders.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any side effects not listed in this
leaflet. 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 E AMLODIPINA EG STADA

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 label, on the packaging or on the
bottle after the wording “EXP.” The expiry date refers to the last day of that month.
Blister pack (Al/Al): Store in the original packaging to protect the medicine from light and
humidity.
Package with HDPE bottle: do not store at a temperature above 30°C. Store in the
original packaging to protect the medicine from light and humidity. Use within 3 months of
first opening.
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 PERINDOPRIL E AMLODIPINA EG STADA contains
The active ingredients are perindopril tert-butylamine and amlodipine.
Each tablet contains 4 mg of perindopril tert-butylamine and 5 mg of amlodipine.
Each tablet contains 4 mg of perindopril tert-butylamine and 10 mg of amlodipine.
Each tablet contains 8 mg of perindopril tert-butylamine and 5 mg of amlodipine.
Each tablet contains 8 mg of perindopril tert-butylamine and 10 mg of amlodipine.
The other ingredients are sodium carboxymethyl starch (Type A), dibeenate glycerol, dibasic calcium phosphate, trehalose dihydrate, microcrystalline cellulose, light magnesium oxide, crospovidone,
magnesium stearate.

Description of the appearance of PERINDOPRIL E AMLODIPINA EG STADA and contents of the
pack

PERINDOPRIL E AMLODIPINA EG STADA 4 mg/5 mg: tablets of colour from white to almost white,

oval, biconvex, 5 mm x 9 mm, with 4|5 imprinted on one side and smooth on the other side.
PERINDOPRIL E AMLODIPINA EG STADA 4 mg/10 mg: tablets of colour from white to almost white,
rectangular, biconvex, 8 mm x 8 mm, with 4|10 imprinted on one side and smooth on the other side.

PERINDOPRIL E AMLODIPINA EG STADA 8 mg/5 mg: tablets of colour from white to almost white,

triangular, biconvex, with side of 9 mm and with 8|5 imprinted on one side and smooth on the other side.
PERINDOPRIL E AMLODIPINA EG STADA 8 mg/10 mg: tablets of colour from white to almost white,
round, biconvex, with diameter of 9 mm and with 8|10 imprinted on one side and smooth on the other side.

Pack sizes:
Blister pack (Al/Al): 10, 30, 60, 90 tablets.
Tablet container: 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6 - 20136 Milan

Manufacturer
Actavis Ltd., BLB016, Bulebel Industrial Estate Zejtun ZTN 3000 – Malta
STADA Arzneimittel AG, Stadastrasse 2-18 Bad Vilbel 61118 – Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
FR Perindopril tert-butylamine /Amlodipine EG 4 mg/5 mg, 4 mg/10 mg, 8 mg/5 mg, 8 mg/10 mg,
comprimé
IT PERINDOPRIL E AMLODIPINA EG STADA
SK Perindamlostad 4 mg/5 mg, 4 mg/10 mg, 8 mg/5 mg, 8 mg/10 mg, tablets