Perindopril and amlodipine Doc Generici

Patient Information Leaflet: Information for the User

PERINDOPRIL and AMLODIPINE DOC Generics 4 mg/5 mg tablets, 4 mg/10 mg tablets, 8 mg/5 mg tablets, 8 mg/10 mg tablets

Read this entire leaflet carefully before 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

PERINDOPRIL and AMLODIPINA DOC Generici contains two active substances: 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 (a condition in which blood flow to the heart is reduced or blocked).
Patients who are already taking perindopril and amlodipine as separate tablets may instead take a single tablet of PERINDOPRIL and AMLODIPINA DOC Generici, which contains both active substances.

2. What you need to know before taking PERINDOPRIL and AMLODIPINE DOC Generics

Do not take PERINDOPRIL and AMLODIPINE DOC Generics

• if you are allergic to perindopril or any other ACE inhibitor, or to amlodipine or any other calcium antagonist, or to any of the other ingredients of this medicine (listed in section 6)
• if you have previously experienced symptoms such as shortness of breath, swelling of the face or tongue, intense itching, or severe skin rashes during treatment with ACE inhibitors, or if you or a family member have ever had such symptoms under any circumstances (a condition called angioedema)
• if you are more than three months pregnant (it is also advisable to avoid PERINDOPRIL and AMLODIPINE DOC Generics in early pregnancy – see section “Pregnancy”)
• if you have cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body) or aortic stenosis (a narrowing of the main blood vessel leaving the heart)
• if you have very low blood pressure (severe hypotension)
• if you have heart failure (the heart is unable to pump blood effectively, causing shortness of breath or peripheral swelling of legs, ankles, or feet) following a heart attack
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat)

Warnings and precautions
Talk to your doctor or pharmacist before taking PERINDOPRIL and AMLODIPINE DOC Generics

• if you have a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma
• if you have hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys)
• if you have other heart problems
• if you have cerebrovascular disorders
• if you have kidney problems or are on dialysis
• if you have liver problems
• if you are on a low-salt diet or use potassium-containing salt substitutes (maintaining a well-balanced blood potassium level is essential)
• if you have diabetes
• if you are elderly and your dose needs to be increased
• if you are taking any of the following medicines for high blood pressure:
  • an "angiotensin II receptor antagonist" (AIIRA), also known as sartans (e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes
  • aliskiren
• if you are taking any of the following medicines, as the risk of angioedema may be increased:
  • Racecadotril, a medicine used to treat diarrhoea
  • Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus)
  • Vildagliptin, a medicine used to treat diabetes

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the section "Do not take PERINDOPRIL and AMLODIPINE DOC Generics".
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). PERINDOPRIL and AMLODIPINE DOC Generics is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child (see section “Pregnancy”).
PERINDOPRIL and AMLODIPINE DOC Generics may be less effective in lowering blood pressure in patients of black origin.
Contact your doctor or pharmacist if you develop a persistent dry cough.
When taking PERINDOPRIL and AMLODIPINE DOC Generics, you should also inform your doctor or medical staff if:

• you are scheduled to undergo LDL apheresis (blood purification to remove cholesterol using a machine)
• you are undergoing desensitization treatment to reduce allergic reactions to bee or wasp stings
• you have recently had diarrhoea or vomiting (a state of illness)
• you are due to undergo general anaesthesia and/or major surgery

Children and adolescents
PERINDOPRIL and AMLODIPINE DOC Generics is not recommended for use in children and adolescents.

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

• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting)
• lithium (used to treat mania or depression)
• estramustine (used in cancer therapy)
• tacrolimus (used to control the body’s immune response, allowing acceptance of a transplanted organ)

Your doctor may consider it necessary to adjust your dose and/or take additional precautions:
if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take PERINDOPRIL and AMLODIPINE DOC Generics” and “Warnings and precautions”).
Treatment with PERINDOPRIL and AMLODIPINE DOC Generics may be affected by the use of other medicines. Inform your doctor if you are taking any of the following medicines, as special attention may be required:

• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief, or high doses of acetylsalicylic acid
• medicines for diabetes (such as insulin, metformin, or vildagliptin)
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in HIV treatment)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• itraconazole, ketoconazole (medicines used to treat fungal infections)
• verapamil, diltiazem (heart medicines)
• St. John’s wort (Hypericum perforatum)
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis)
• other blood pressure medicines, including diuretics (medicines that increase urine production by the kidneys)
• ephedrine, noradrenaline, or adrenaline (medicines used to treat low blood pressure, shock, or asthma)
• gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis)
• bisoprolol, carvedilol, and metoprolol (beta-blockers used in heart failure)
• vasodilators, including nitrates (substances that dilate blood vessels)
• corticosteroids (used to treat various conditions including severe asthma and rheumatoid arthritis)
• alpha-blockers used to treat benign prostatic hyperplasia, such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin
• amifostine (used to prevent or reduce side effects caused by other medicines or radiotherapy in cancer treatment)
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics, anaesthetics)
• simvastatin (a medicine to lower cholesterol)
• immunosuppressants (medicines that suppress the body’s immune defences) used to treat autoimmune disorders
• allopurinol (for treatment of gout)
• procainamide (for treatment of irregular heartbeat)
• racecadotril (for treatment of diarrhoea)
• medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other mTOR inhibitors). See section “Warnings and precautions”.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Pregnancy
Your doctor will normally advise you to stop taking PERINDOPRIL and AMLODIPINE DOC Generics before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
PERINDOPRIL and AMLODIPINE DOC Generics is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken beyond the third month of pregnancy.
Breast-feeding
It has been shown that amlodipine passes into breast milk in small amounts. Inform your doctor if you are breast-feeding or about to start breast-feeding. PERINDOPRIL and AMLODIPINE DOC Generics is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby is newborn or was born prematurely.

Driving and using machines
PERINDOPRIL and AMLODIPINE DOC Generics may affect your ability to drive or use machinery. If the tablets cause you to feel unwell, dizzy, weak or tired, or give you headaches, do not drive or operate machinery and contact your doctor immediately.

PERINDOPRIL and AMLODIPINE DOC Generics 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 AMLODIPINE DOC Generics

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The recommended dose is one tablet daily.
Take the tablet preferably in the morning, before a meal. Swallow the tablet with a glass of water. Your doctor will determine the appropriate dose for you.
PERINDOPRIL and AMLODIPINE DOC Generics is generally prescribed for patients who are already taking perindopril and amlodipine as 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 unsure about which dose to take.

If you take more PERINDOPRIL and AMLODIPINE DOC Generics than you should
If you have taken too many tablets, go immediately to the nearest emergency room or contact your doctor. The most likely effect of an overdose is low blood pressure, which may cause dizziness or weakness. In such cases, lying down with your legs raised may be helpful.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop within 24–48 hours after ingestion.

If you forget to take PERINDOPRIL and AMLODIPINE DOC Generics
It is important to take the medicine every day, as regular treatment is more effective. If, however, you forget a dose of PERINDOPRIL and AMLODIPINE DOC Generics, take the next dose as usual. Do not take a double dose to make up for the missed dose.

If you stop taking PERINDOPRIL and AMLODIPINE DOC Generics
Since treatment with PERINDOPRIL and AMLODIPINE DOC Generics is usually lifelong, speak with your doctor before stopping this medicine.

If you have any questions about the use of this medicine, consult 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 may also occur in the intestine and cause stomach pain (with or without nausea and vomiting). You should know that patients with black skin have a higher risk of experiencing these types of reactions (uncommon – may affect up to 1 in 100 people)
• Unusually fast heartbeat (common – may affect up to 1 in 10 people) or irregular heartbeat (uncommon – may affect up to 1 in 100 people)
• Sudden onset of shortness of breath, tightness in the chest, difficulty breathing (bronchospasm) (uncommon – may affect up to 1 in 100 people)
• Sudden appearance of a rash, often starting 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, widespread redness of the skin, intense itching, blisters, peeling and swelling of the skin, inflammation of 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 from the available data)
• Abnormal colour, numbness and pain in fingers or toes (Raynaud's phenomenon) (frequency not known – frequency cannot be estimated from the 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
• sensation of noise in the ear (tinnitus)
• flushing (feeling of warmth or cold on the face)
• shortness of breath, cough
• abdominal pain, nausea (feeling unwell), vomiting (feeling sick), heartburn or difficulty digesting food, changes in bowel habits, altered taste, diarrhoea, constipation
• allergic reactions (such as skin rashes, itching)
• muscle cramps
• swelling of legs or ankles (oedema)
• feeling of tiredness or weakness

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 weight loss
• depression, mood changes, drowsiness, sleep disturbances
• tremor, loss of sensitivity to pain
• inflammation of blood vessels in the skin
• temporary loss of consciousness
• blocked or runny nose
• dry mouth
• hair loss, red or discoloured skin patches, increased sweating
• formation of clusters of blisters on the skin (bullous pemphigoid)
• increased sensitivity of the skin to sunlight
• back pain, muscle or joint pain
• increased need to urinate, especially at night, kidney problems
• impotence, breast enlargement in men
• chest pain, pain, feeling of general malaise
• fever
• changes in blood tests, very low blood sugar levels in diabetic patients, low sodium levels, high potassium levels, increased levels of blood urea nitrogen and serum creatinine (indicative of impaired kidney function)
• falls

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

• confusion, increased liver function test values (indicative of liver damage), including increased bilirubin in the blood (which may, in severe cases, cause yellowing of the skin and eyes), dark-coloured urine, feeling unwell (nausea) or illness (vomiting), muscle cramps, confusion and seizures. These symptoms may be due to a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion), reduced or absent urine output, acute kidney failure (symptoms may include lower back pain 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 condition called peripheral neuropathy causing 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 peeling of the skin over large areas of the body, which may cause itching or pain (exfoliative dermatitis)
• blood, pancreas, stomach or liver disorders

Not known (frequency cannot be estimated from the available data)

• tremor, rigid posture, expressionless face, slowed movements, shuffling and unbalanced gait

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 AMLODIPINE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via 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 AMLODIPINE DOC Generici contains

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

Description of the appearance of PERINDOPRIL and AMLODIPINE DOC Generici and pack contents

The tablets of PERINDOPRIL and AMLODIPINE DOC Generici 4 mg/5 mg are white to off-white, oval, biconvex, 5 mm x 9 mm, with "4/5" engraved on one side.
The tablets of PERINDOPRIL and AMLODIPINE DOC Generici 4 mg/10 mg are white to off-white, rectangular, biconvex, 8 mm in size, with "4/10" engraved on one side.
The tablets of PERINDOPRIL and AMLODIPINE DOC Generici 8 mg/5 mg are white to off-white, triangular, biconvex, 9 mm in height, with "8/5" engraved on one side.
The tablets of PERINDOPRIL and AMLODIPINE DOC Generici 8 mg/10 mg are white to off-white, round, biconvex, 9 mm in diameter, with "8/10" engraved on one side.
Blister packs (Al/Al): 30 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici Srl, Via Turati 40, 20121 Milano, Italy

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