PERINDOPRIL 4 mg/5 mg Coated Tablet

Зміст інструкції

1. PERINDOPRIL and AMLODIPINA DOC Generici 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 AMLODIPINA DOC Generici and what is it used for
   2. What you need to know before taking PERINDOPRIL and AMLODIPINA DOC Generici
2. PERINDOPRIL and AMLODIPINA DOC Generici are not recommended for use in children and
   1. How to take PERINDOPRIL and AMLODIPINA DOC Generici
   2. Possible side effects
   3. How to store PERINDOPRIL and AMLODIPINA DOC Generici
   4. Contents of the pack and other information

PERINDOPRIL and AMLODIPINA DOC Generici 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 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 and AMLODIPINA DOC Generici is and what it is used for
• 2. What you need to know before you take PERINDOPRIL and AMLODIPINA DOC Generici
• 3. How to take PERINDOPRIL and AMLODIPINA DOC Generici
• 4. Possible side effects
• 5. How to store PERINDOPRIL and AMLODIPINA DOC Generici
• 6. Contents of the pack and other information

1. What is PERINDOPRIL and AMLODIPINA DOC Generici and what is it used for

PERINDOPRIL and AMLODIPINA DOC Generici contains two active ingredients: perindopril tert-butylamine and
amlodipine. Perindopril belongs to a class of medicines called ACE inhibitors (angiotensin converting enzyme
inhibitors). Amlodipine belongs to a class of medicines called calcium antagonists.
PERINDOPRIL and AMLODIPINA DOC Generici 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 tablet of
PERINDOPRIL and AMLODIPINA DOC Generici, which contains both active ingredients.

2. What you need to know before taking PERINDOPRIL and AMLODIPINA DOC Generici

Do not take PERINDOPRIL and AMLODIPINA DOC Generici

• 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 or tongue, intense itching or severe skin rashes with 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 are pregnant for more than three months (it is best to avoid PERINDOPRIL and AMLODIPINA DOC Generici even in the early stages of pregnancy - see the section “Pregnancy”)
• if you have cardiogenic shock (a condition in which the heart is unable to deliver enough blood to the body) or aortic stenosis (a narrowing of the main blood vessel exiting the heart)
• if you have very low blood pressure (severe hypotension)
• if you suffer from heart failure (the heart is unable to pump blood adequately and this causes shortness of breath or swelling of the legs, ankles or feet) following a heart attack
• 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 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 and AMLODIPINA DOC Generici

• if you have a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma
• if you have hypertrophic cardiomyopathy (disease of the heart muscle) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys)
• if you suffer from other heart problems
• if you have cerebrovascular problems
• if you have kidney problems or are on dialysis
• if you have liver problems
• 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 have diabetes
• if you are elderly and the dose needs to be increased
• if you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes
• aliskiren
• if you are taking any of the following medicines, the risk of angioedema may be increased.
• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

The doctor may check your kidney function, blood pressure, and the amount of electrolytes (such as potassium) in your blood at regular intervals.
See also what is stated in the section "Do not take PERINDOPRIL and AMLODIPINA DOC Generici".
You should inform your doctor if you think you may be pregnant (or if there is a possibility of starting a pregnancy). PERINDOPRIL and AMLODIPINA DOC Generici is not recommended in the early stages of pregnancy, and must 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”).
PERINDOPRIL and AMLODIPINA DOC Generici may be less effective in lowering blood pressure in patients with black skin.
Contact your doctor or pharmacist if you develop a dry cough that persists for a long time.
When taking PERINDOPRIL and AMLODIPINA DOC Generici, you should also inform your doctor or medical staff if:

• 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
• you have recently had diarrhea or vomiting (feeling unwell)
• you need to undergo general anesthesia and/or major surgery

Children and adolescents

PERINDOPRIL and AMLODIPINA DOC Generici are not recommended for use in children and

adolescents.

Other medicines and PERINDOPRIL and AMLODIPINA DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take PERINDOPRIL and AMLODIPINA DOC Generici with sacubitril/valsartan, a medicine used
to treat heart failure in adults. See paragraph “Do not take PERINDOPRIL and
AMLODIPINA DOC Generici”.
Avoid taking PERINDOPRIL and AMLODIPINA DOC Generici with:

• potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that could increase the amount of potassium in your blood (such as trimethoprim and co-trimoxazole for treating infections caused by bacteria; ciclosporin, a medicine that suppresses the immune system used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent the formation of clots)
• lithium (used for the treatment of mania or depression)
• estramustine (used in cancer therapy)
• tacrolimus (used to control the body's immune response, allowing your body to accept a transplanted organ)

Your doctor may need to adjust your dose and/or take other precautions:
if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what
is stated under “Do not take PERINDOPRIL and AMLODIPINA DOC Generici” and “Warnings and
precautions”).
Treatment with PERINDOPRIL and AMLODIPINA DOC Generici may be affected by taking
other medicines. Tell your doctor if you are taking any of the following medicines as special
attention may be needed:

• 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, metformin or vildagliptin)
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used for the treatment of HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• itraconazole, ketoconazole (drugs used in the treatment of fungal infections)
• verapamil, diltiazem (heart medicines)
• St John's wort (hypericum perforatum)
• baclofen used in the treatment of muscle stiffness in diseases such as multiple sclerosis
• other medicines for high blood pressure, including diuretics (medicines that increase the amount of urine produced by the kidneys)
• ephedrine, noradrenaline or adrenaline (drugs used for the treatment of low blood pressure, shock or asthma)
• gold salts, especially with intravenous administration (used in the treatment of the symptoms of rheumatoid arthritis)
• bisoprolol, carvedilol and metoprolol (beta-blockers used in heart failure)
• vasodilators, including nitrates (products that dilate blood vessels)
• corticosteroids (used in the treatment of various conditions including severe asthma and rheumatoid arthritis)
• 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 medicines or radiotherapy in the treatment of cancer)
• medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics, anesthetics)
• simvastatin (medicine to reduce cholesterol)
• immunosuppressants (medicines capable of depressing the body's defense mechanism) used for the treatment of autoimmune disorders
• allopurinol (for the treatment of gout)
• procainamide (for the treatment of irregular heartbeat)
• racecadotril (for the treatment of diarrhea)
• drugs usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See paragraph “Warnings and precautions”.

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

Pregnancy
As a general rule, your doctor will advise you to stop taking PERINDOPRIL and AMLODIPINA DOC
Generici before starting a pregnancy or as soon as you find out that you are pregnant
and will advise you to take another medicine instead of PERINDOPRIL and AMLODIPINA DOC Generici.
PERINDOPRIL and AMLODIPINA DOC Generici is not recommended in the early stages of pregnancy, and must 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. Tell your doctor if you are
breastfeeding or are about to start breastfeeding. PERINDOPRIL and AMLODIPINA DOC Generici 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 was born prematurely.

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

PERINDOPRIL and AMLODIPINA DOC Generici 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 and AMLODIPINA DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. The recommended dose is one tablet a day.
Take the tablet preferably in the morning, before meals. Swallow the tablet with a glass of
water. The doctor will decide the appropriate dose for you. Generally, PERINDOPRIL and AMLODIPINA
DOC Generici will be prescribed to patients who are already taking perindopril and amlodipine in separate
tablets.
If you are taking another tablet containing perindopril, you should know that the dosage may be expressed
differently even if the amount of perindopril is the same. Always check with your doctor if you are
not sure which dose to use.

If you take more PERINDOPRIL and AMLODIPINA DOC Generici than you should
If you have taken too many 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 weakness. 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 DOC Generici
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 and AMLODIPINA DOC Generici, take the next
dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking PERINDOPRIL and AMLODIPINA DOC Generici
Since treatment with PERINDOPRIL and AMLODIPINA DOC Generici is usually lifelong, talk to your
doctor before stopping taking this medicine.
If you have any questions 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 everybody gets them.
If you experience any of the following side effects, stop taking the medicine immediately and inform your
doctor straight away:

• Severe dizziness or fainting (common, may affect up to 1 in 10 people)
• Symptoms of an allergic reaction such as swelling of the face, lips, mouth, tongue or throat, difficulty breathing. These allergic reactions can also occur at the intestinal level and cause stomach pain (with or without nausea and vomiting). You should be aware that people of Black skin are at higher risk of experiencing this type of reaction (uncommon - may affect up to 1 in 100 people)
• Unusually fast (common - may affect up to 1 in 10 people) or irregular (uncommon - may affect up to 1 in 100 people) heartbeat
• Sudden onset of shortness of breath, feeling of tightness in the chest, wheezing (bronchospasm) (uncommon - may affect up to 1 in 100 people)
• Skin rash that 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)
• Severe skin reactions including severe rashes, hives, redness of the skin all over the body, intense itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) (very rare - may affect up to 1 in 10,000 people)
• Toxic epidermal necrolysis (frequency not known - frequency cannot be estimated based on available data)
• Abnormal color, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon) (frequency not known - frequency cannot be estimated based on available data)

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

• drowsiness, dizziness, headache, tingling, sensation of spinning (vertigo)
• vision disturbances
• ringing in the ears (tinnitus)
• flushing (feeling of warmth or cold on the face)
• shortness of breath, cough
• abdominal pain, nausea (feeling unwell), vomiting (feeling unwell), heartburn or difficulty digesting food, changes in bowel habits, altered taste, diarrhea, constipation
• allergic reactions (such as skin rashes, itching)
• muscle cramps
• swelling of the legs or ankles (edema)
• feeling tired or weak

Uncommon (may affect up to 1 in 100 people)

• excessive number of a type of white blood cells, called eosinophils
• itchy skin rash (urticaria)
• weight gain or loss
• depression, mood changes, drowsiness, sleep disorders
• tremor, loss of sensitivity to pain
• inflammation of the blood vessels in the skin
• temporary loss of consciousness
• blocked or runny nose
• dry mouth
• hair loss, red or discolored skin patches, increased sweating
• formation of clusters of blisters on the skin (pemphigoid)
• increased sensitivity of the skin to the sun
• back pain, muscle pain or joint pain
• increased need to urinate, especially at night, kidney problems
• impotence, breast enlargement in men
• chest pain, pain, feeling unwell
• fever
• changes in blood tests, very low blood sugar levels in diabetic patients, low sodium levels, high potassium levels, increased levels of urea and creatinine in the serum (indicative of impaired kidney function)
• falls

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

• confusion, 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 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), reduced or absent urine, acute kidney failure (symptoms may include pain in the lower back and reduced amount of urine produced)

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

• high blood sugar levels
• abnormal increase in muscle tension
• a disease called peripheral neuropathy that causes loss of sensation, pain, inability to control muscles
• cardiovascular disorders (angina, heart attack and stroke)
• a rare type of pneumonia (eosinophilic pneumonia)
• swelling of the gums
• redness and scaling of the skin over large areas of the body, which can cause itching or pain (exfoliative dermatitis)
• disorders of the blood, pancreas, stomach or liver

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

• tremor, rigid posture, expressionless face, slowing of movements and unsteady and 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 DOC Generici

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 Exp. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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 and AMLODIPINA DOC Generici contains

• The active ingredients are perindopril tert-butylamine and amlodipine. One tablet contains 4 mg of perindopril tert-butylamine, corresponding to 3.3 mg of perindopril and 5 mg of amlodipine corresponding to 6.9 mg of amlodipine besylate. One tablet contains 4 mg of perindopril tert-butylamine, corresponding to 3.3 mg of perindopril and 10 mg of amlodipine corresponding to 13.9 mg of amlodipine besilate. One tablet contains 8 mg of perindopril tert-butylamine, corresponding to 6.7 mg of perindopril and 5 mg of amlodipine corresponding to 6.9 mg of amlodipine besilate. One tablet contains 8 mg of perindopril tert-butylamine, corresponding to 6.7 mg of perindopril and 10 mg of amlodipine corresponding to 13.9 mg of amlodipine besilate.
• The other ingredients are: sodium starch glycolate (type A), dibeenate glycerol, anhydrous calcium hydrogen phosphate, trehalose dihydrate, microcrystalline cellulose, magnesium oxide, crospovidone, magnesium stearate

Description of the appearance of PERINDOPRIL and AMLODIPINA DOC Generici and contents of the pack
The tablets of PERINDOPRIL and AMLODIPINA DOC Generici 4 mg/5 mg are from white to off-white in colour, oval, biconvex, 5 mm x 9 mm and with 4/5 on one side.
The tablets of PERINDOPRIL and AMLODIPINA DOC Generici 4 mg/10 mg are from white to off-white in colour, rectangular, biconvex, 8 mm on a side and with 4/10 inscribed on one side
The tablets of PERINDOPRIL and AMLODIPINA DOC Generici 8 mg/5 mg are from white to off-white in colour, triangular, biconvex, 9 mm in height and with 8/5 on one side.
The tablets of PERINDOPRIL and AMLODIPINA DOC Generici 8 mg/10 mg are from white to off-white in colour, round, biconvex, 9 mm and with 8/10 on one side
Blister packs (Al/Al): 30 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici Srl, Via Turati 40, 20121 Milano

Manufacturer
Actavis Ltd.
BLB016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta