PERINDOPRIL 4 mg/5 mg Tabletki

Treść ulotki

1. What is Perindopril and Amlodipine Mylan Pharma and what is it used for
2. What you need to know before taking Perindopril and Amlodipine Mylan Pharma
3. How to take Perindopril and Amlodipina Mylan Pharma
4. Possible side effects
5. How to store Perindopril and Amlodipina Mylan Pharma
6. Package Contents and Other Information

Perindopril and Amlodipine Mylan Pharma 4 mg/5 mg tablets
Perindopril and Amlodipine Mylan Pharma 4 mg/10 mg tablets
Perindopril and Amlodipine Mylan Pharma 8 mg/5 mg tablets
Perindopril and Amlodipine Mylan Pharma 8 mg/10 mg tablets
perindopril tert-butylamine / amlodipine besylate

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 they have the same symptoms as you, as it may 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 Mylan Pharma is and what it is used for
• 2. What you need to know before you take Perindopril and Amlodipine Mylan Pharma
• 3. How to take Perindopril and Amlodipine Mylan Pharma
• 4. Possible side effects
• 5. How to store Perindopril and Amlodipine Mylan Pharma
• 6. Contents of the pack and other information

1. What is Perindopril and Amlodipine Mylan Pharma and what is it used for

Perindopril and Amlodipine Mylan Pharma 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 instead a single tablet of Perindopril and Amlodipine Mylan Pharma which contains both active substances.
Perindopril and Amlodipine Mylan Pharma 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 the blood vessels so that it is easier
for blood to pass through and for the heart to maintain a good level of blood flow.

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

Do not take Perindopril and Amlodipine Mylan Pharma

• if you are allergic to perindopril or to any other ACE inhibitor, 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 are pregnant for more than 3 months (it is best to avoid Perindopril and Amlodipine Mylan Pharma even in the early stages of pregnancy - see the section on pregnancy),
• if you have experienced symptoms such as wheezing, 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 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 enough blood to the body),
• if you suffer from severe low blood pressure (hypotension), if you suffer from heart failure following a heart attack,
• if you are undergoing dialysis or any type of blood filtration. Depending on the machine used, therapy with Perindopril and Amlodipine Mylan Pharma may not be suitable for you,
• if you have kidney problems, for which 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 type of long-term (chronic) heart failure in adults, as it increases the risk of angioedema (rapid swelling under the skin in an area such as the throat). Warnings and precautionsTalk to your doctor or pharmacist before taking Perindopril and Amlodipine Mylan Pharma if you have any of the following conditions:
• if you have hypertrophic cardiomyopathy (heart muscle disease) 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 abnormally elevated levels of a hormone called aldosterone in your blood (primary aldosteronism),
• if you have a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma, diabetes,
• if you are following a diet that limits salt intake or use potassium-containing salt substitutes (a well-balanced blood potassium level is essential),
• if you are elderly and the dosage may need 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 suffer from 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 the information in the section “Do not take Perindopril and Amlodipine Mylan Pharma”.
• if you are taking any of the following medicines, the risk of angioedema is increased: ‐ racecadotril (used to treat diarrhea), ‐ sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors (used to prevent organ rejection after transplantation), ‐ sacubitril (available as a fixed-dose combination with valsartan) used to treat long-term heart failure, ‐ linagliptin, saxagliptin, sitagliptin, vildagliptin and other medicines belonging to the class of pharmaceuticals known as gliptins (used for the treatment of diabetes).
• are of black ethnic origin, as you may have a higher risk of angioedema and this medicine may be less effective in reducing blood pressure compared to patients of non-black ethnicity.

Angioedema
In patients treated with ACE inhibitors, including perindopril/amlodipine, angioedema has been reported
(a serious allergic reaction with swelling of the face, lips, tongue or throat with
difficulty swallowing or breathing) and rarely intestinal angioedema (stomach pain with or without
nausea). This can occur at any time during treatment. If you develop such symptoms,
you should stop taking Perindopril and Amlodipine Mylan Pharma and consult
your doctor immediately. See also section 4.
You should inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant).
Perindopril and Amlodipine Mylan Pharma is not recommended in early pregnancy and should 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”).
When taking Perindopril and Amlodipine Mylan Pharma, tell your doctor or medical staff if:

• you need to undergo general anesthesia and/or major surgery,
• you have recently suffered from diarrhea or vomiting (state of discomfort),
• you need to undergo LDL apheresis (blood purification from cholesterol using a machine),
• you need to have desensitization treatment to reduce the effects of an allergy to bee or wasp stings. Children and adolescentsThe use of Perindopril and Amlodipine Mylan Pharma is not recommended in children and adolescents. Other medicines and Perindopril and Amlodipine Mylan Pharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
You should avoid taking Perindopril and Amlodipine Mylan Pharma with:

• lithium (used to treat mania or depression),
• estramustine (used in cancer therapy),
• potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in the blood (e.g. trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ rejection; and heparin, a medicine used to thin the blood to prevent blood clots),
• potassium-sparing drugs used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day. The treatment with Perindopril and Amlodipine Mylan Pharma may be affected by taking other medicines. Your doctor may need to adjust 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:
• medicines used mostly to treat diarrhea (racecadotril) or to prevent organ rejection (sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors). See the section “Warnings and precautions”,
• other medicines for the treatment of high blood pressure, including angiotensin II receptor blockers (AIIRA), aliskiren (see also the information in the sections “Do not take Perindopril and Amlodipine Mylan Pharma” and “Special care with Perindopril and Amlodipine Mylan Pharma”) or diuretics (medicines that increase the amount of urine produced by the kidneys),
• sacubitril/valsartan (used to treat long-term heart failure). See the sections “Do not take Perindopril and Amlodipine Mylan Pharma” and “Warnings and precautions”,
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or high doses of aspirin,
• medicines for the treatment of diabetes (such as insulin),
• medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia etc. (e.g. tricyclic antidepressants, antipsychotics, imipramine-like antidepressants, neuroleptics),
• immunosuppressants (medicines that can reduce the body's defense mechanism) used for the treatment of autoimmune disorders or following an organ transplant (e.g.

cyclosporine, tacrolimus),

• trimethoprim and cotrimoxazole (for the treatment of infections),
• allopurinol (for the treatment of gout),
• procainamide (for the treatment of irregular heartbeat),
• vasodilators, including nitrates (products that dilate blood vessels),
• heparin (medicine used to thin the blood),
• ephedrine, noradrenaline 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 stiffness),
• some antibiotics such as rifampicin, erythromycin, clarithromycin (for bacterial infections),
• Hypericum perforatum(St John's wort, a herbal medicine used to treat depression),
• simvastatin (medicine to lower cholesterol),
• 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 prostate enlargement (benign 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 and Amlodipine Mylan Pharma with food and drink
Grapefruit and grapefruit juice should not be consumed by people who are
taking Perindopril and Amlodipine Mylan Pharma. This is because grapefruit and grapefruit juice can cause an increase in the levels of the active ingredient amlodipine in the blood, which
can cause an unpredictable increase in the blood pressure lowering effect of
Perindopril and Amlodipine Mylan Pharma.

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
You should 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 and Amlodipine Mylan Pharma before becoming pregnant or as soon as pregnancy is confirmed
and will prescribe another medicine to use instead of Perindopril and Amlodipine Mylan
Pharma. Perindopril and Amlodipine Mylan Pharma is not recommended in early pregnancy and
should 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
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Perindopril and
Amlodipine Mylan Pharma 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.
Amlodipine has been shown to pass into breast milk in small amounts.

Driving and using machines
Perindopril and Amlodipine Mylan Pharma may affect your ability to drive and operate
machinery. If the tablets make you feel unwell, dizzy, weak or tired, or if they
cause headache, do not drive or operate machinery and contact your doctor immediately.
Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.

3. How to take Perindopril and Amlodipina Mylan Pharma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Take the tablet 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 and Amlodipina Mylan Pharma will be prescribed to patients who are already taking perindopril and amlodipine in separate tablets.

Use in children and adolescents
Use in children and adolescents is not recommended.

If you take more Perindopril and Amlodipina Mylan Pharma than you should
If you have taken an excessive amount of tablets, go immediately to the nearest emergency room or consult your doctor immediately. The most likely effect in case of 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 it.

If you forget to take Perindopril and Amlodipina Mylan Pharma
It is important to take the medicine every day as regular treatment is more effective. If, however, you forget to take a dose of Perindopril and Amlodipina Mylan Pharma, 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 Mylan Pharma
Since treatment with Perindopril and Amlodipina Mylan Pharma is usually lifelong, talk to your doctor before stopping taking the tablets. 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.
If you notice any of the following side effects, stop taking the medicine immediately and
immediatelyinform your doctor:

• sudden wheezing, chest pain, shortness of breath 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 rash, hives, skin redness 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 or chest pain,
• inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of severe malaise.

The following common side effects have been reported. Contact your doctorif these effects cause you problems or if they last for more than one week.
Very common side effects (may affect more than 1 in 10 people):

• edema (fluid retention). 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.
• dizziness due to a drop in blood pressure, cough, shortness of breath, nausea (feeling unwell), vomiting (feeling sick), abdominal pain, altered sense of taste, dyspepsia or digestive difficulties, changes in bowel habits, diarrhea, constipation, allergic reactions (such as skin rashes, itching), muscle cramps, fatigue, weakness, swollen ankles (peripheral edema). Other possible side effects Uncommon: (may affect up to 1 in 100 people)
• rhinitis (nasal congestion or runny nose),
• excess of eosinophils (a type of white blood cells),
• angioedema (symptoms such as wheezing, swelling of the face or tongue),
• hypoglycemia (very low blood sugar) in diabetic patients,
• high potassium levels in the blood, reversible upon discontinuation,
• mood swings, anxiety, depression, insomnia, sleep disorders,
• dry mouth,
• tremor, fainting, loss of pain sensation,
• irregular heartbeat, tachycardia,
• vasculitis (inflammation of blood vessels),
• blistering of the skin, increased sweating, photosensitivity reaction (increased sensitivity of the skin to the sun),
• bronchospasm (tightness of the chest, wheezing and shortness of breath),
• hair loss, red spots on the skin, abnormal skin color,
• back pain, arthralgia (joint pain), myalgia (muscle pain), chest pain,
• kidney problems, urination disorders, increased need to urinate at night, increased frequency of urination, pain,
• impotence, discomfort or enlargement of the breasts in men,
• feeling unwell,
• fever,
• weight gain or loss,
• increased sweating,
• alteration of laboratory test results, low sodium levels, increased urea in the blood and increased creatinine in the blood.
• falls.

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

• 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 antidiuretic hormone secretion). If you develop these symptoms, contact your doctor as soon as possible.
• acute kidney failure,
• reduced or absent urine,
• confusional state,
• worsening of psoriasis,
• changes in laboratory parameters: increased levels of liver enzymes, high levels of serum bilirubin. Very rare: (may affect up to 1 in 10,000):
• changes in blood values, such as a reduction in white and red blood cells, decreased hemoglobin, reduced platelets in the blood, blood disorders,
• excess sugar in the blood (hyperglycemia),
• swelling of the eyelids, face or lips, swelling of the tongue and throat, which causes great difficulty breathing,
• cardiovascular disorders (angina, heart attack and stroke),
• eosinophilic pneumonia (a rare type of pneumonia),
• inflamed 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 affect some medical tests, abdominal swelling (gastritis), gum swelling,
• severe skin reactions including intense rash, hives, skin redness all over the body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome), erythema multiforme (a rash that often starts with itchy red spots on the face, arms or legs), sensitivity to light,
• increased muscle tension,
• nerve disorders that can cause weakness, tingling or numbness.

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

• tremors, rigid posture, face like a mask, slow and shuffling movements, unsteady gait,
• alteration of color, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon).

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 Mylan Pharma

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 package and on the blister after the
wording “Exp.”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light and moisture.
For the 4 mg/10 mg dosage
Do not store at a temperature above 25°C.
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. Package Contents and Other Information

What Perindopril and Amlodipina Mylan Pharma Contains
The active ingredients are perindopril tert-butylamine and amlodipine besilate.
Each 4 mg/5 mg tablet contains 4 mg of perindopril tert-butylamine (equivalent to 3.338 mg
of perindopril) and 5 mg of amlodipine (equivalent to 6.94 mg of amlodipine besilate).
Each 4 mg/10 mg tablet contains 4 mg of perindopril tert-butylamine (equivalent to 3.338 mg
of perindopril) and 10 mg of amlodipine (equivalent to 13.88 mg of amlodipine besilate).
Each 8 mg/5 mg tablet contains 8 mg of perindopril tert-butylamine (equivalent to 6.676 mg
of perindopril) and 5 mg of amlodipine (equivalent to 6.94 mg of amlodipine besilate).
Each 8 mg/10 mg tablet contains 8 mg of perindopril tert-butylamine (equivalent to 6.676 mg
of perindopril) and 10 mg of amlodipine (equivalent to 13.88 mg of amlodipine besilate).
The other ingredients are:
Sodium starch glycolate, (see section 2 “sodium content”), dibeenate glycerol, calcium
hydrogen phosphate, trehalose dihydrate, microcrystalline cellulose, magnesium oxide, crospovidone type
A, magnesium stearate.

Description of the appearance of Perindopril and Amlodipina Mylan Pharma and package contents
Perindopril and Amlodipina Mylan Pharma 4 mg/5 mg are tablets of colour from white to off-white,
oval, biconvex, with imprinted 4/5 on one side.
Perindopril and Amlodipina Mylan Pharma 4 mg/10 mg are tablets of colour from white to
off-white, rectangular, biconvex, with imprinted 4/10 on one side.
Perindopril and Amlodipina Mylan Pharma 8 mg/5 mg are tablets of colour from white to
off-white, triangular, biconvex, with imprinted 8/5 on one side.
Perindopril and Amlodipina Mylan Pharma 8 mg/10 mg are tablets of colour from white to
off-white, round, biconvex, with imprinted 8/10 on one side.
The tablets of Perindopril and Amlodipina Mylan Pharma are available in blisters of 10, 30, 90 or
120 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Italy

Manufacturer
Actavis Ltd.
BLB 015-016, Bulebel Industrial Estate,
Zejtun ZTN 3000,
MALTA

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
France PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE VIATRIS 4 mg/5 mg, comprimé
PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE VIATRIS 4 mg/10 mg, comprimé
PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE VIATRIS 8 mg/5 mg, comprimé
PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE VIATRIS 8 mg/10 mg, comprimé
Italy
Portugal
Perindopril e Amlodipina Mylan Pharma
Perindopril + Amlodipina Mylan