Perindopril + amlodipine teva pharmaceuticals

Package leaflet: Information for the user

Perindopril + Amlodipine Teva Pharmaceuticals, 5 mg + 5 mg, tablets
Perindopril + Amlodipine Teva Pharmaceuticals, 5 mg + 10 mg, tablets
Perindopril + Amlodipine Teva Pharmaceuticals, 10 mg + 5 mg, tablets
Perindopril + Amlodipine Teva Pharmaceuticals, 10 mg + 10 mg, tablets
Perindoprili tosilas + Amlodipinum
Please 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Perindopril + Amlodipine Teva Pharmaceuticals is and what it is used for
2. Important information before taking Perindopril + Amlodipine Teva Pharmaceuticals
3. How to take Perindopril + Amlodipine Teva Pharmaceuticals
4. Possible side effects
5. How to store Perindopril + Amlodipine Teva Pharmaceuticals
6. Contents of the pack and other information

1. What Perindopril + Amlodipine Teva Pharmaceuticals is and what it is used for

Perindopril + Amlodipine Teva Pharmaceuticals is a combination medicine containing two active substances – perindopril and amlodipine.
Perindopril + Amlodipine Teva Pharmaceuticals, 5 mg + 5 mg, tablets contains 5 mg of perindopril tosylate and 5 mg of amlodipine.
Perindopril + Amlodipine Teva Pharmaceuticals, 5 mg + 10 mg, tablets contains 5 mg of perindopril tosylate and 10 mg of amlodipine.
Perindopril + Amlodipine Teva Pharmaceuticals, 10 mg + 5 mg, tablets contains 10 mg of perindopril tosylate and 5 mg of amlodipine.
Perindopril + Amlodipine Teva Pharmaceuticals, 10 mg + 10 mg, tablets contains 10 mg of perindopril tosylate and 10 mg of amlodipine.
Perindopril is an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine is a calcium antagonist (belonging to a group of medicines called dihydropyridines). Both active substances work by dilating and relaxing blood vessels, which improves blood flow through the vessels and helps the heart pump blood throughout the body.
Perindopril + Amlodipine Teva Pharmaceuticals is indicated for the treatment of high blood pressure (hypertension) and/or stable coronary artery disease (a condition in which blood flow to the heart is reduced or blocked).
Patients previously treated with perindopril and amlodipine as separate tablets may be switched to a single tablet of Perindopril + Amlodipine Teva Pharmaceuticals containing both active substances.

2. Important information before using Perindopril + Amlodipine Teva

Pharmaceuticals
When not to use Perindopril + Amlodipine Teva Pharmaceuticals

• if the patient is allergic to perindopril or other ACE inhibitors, or to amlodipine, or other calcium channel blockers, or to any of the other ingredients of this medicine (listed in section 6),
• if the patient is more than 3 months pregnant (it is also better to avoid using Perindopril + Amlodipine Teva Pharmaceuticals in early pregnancy - see section 2 "Pregnancy and breastfeeding"),
• if the patient previously experienced symptoms during treatment with an ACE inhibitor such as wheezing, facial or tongue swelling, intense itching, or severe skin rash, or if such symptoms occurred in the patient or any family member under any other circumstances (a condition called angioedema),
• if the patient has aortic stenosis (narrowing of the aortic valve; narrowing of the main blood vessel carrying blood from the heart) or cardiogenic shock (a condition in which the heart is unable to deliver sufficient blood to the body),
• if the patient has significantly low blood pressure (hypotension),
• if the patient has heart failure following a heart attack,
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren,
• if the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, because the risk of angioedema (rapid swelling of tissues beneath the skin, such as in the throat) increases.

Warnings and precautions
Before starting treatment with Perindopril + Amlodipine Teva Pharmaceuticals, discuss with your doctor or pharmacist if:

• hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the blood vessel supplying blood to the kidney) is present,
• heart failure is present,
• a significant increase in blood pressure has occurred (hypertensive crisis),
• any other heart diseases are present,
• liver diseases are present,
• kidney diseases are present or if the patient is undergoing dialysis,
• collagenosis (connective tissue disease) such as systemic lupus erythematosus or scleroderma is present,
• the patient has diabetes,
• the patient is on a low-salt diet or uses salt substitutes containing potassium (blood potassium levels need to be balanced),
• dosage adjustment is required in elderly patients,
• the patient is taking any of the following medicines used to treat high blood pressure:
  • an angiotensin II receptor antagonist (AIIRA), also known as a sartan – for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes,
  • aliskiren.
• if the patient is taking any of the following medicines, the risk of angioedema may increase:
  • racecadotril, a medicine used to treat diarrhoea,
  • medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus),
  • vildagliptin, a medicine used to treat diabetes.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section "When not to use Perindopril + Amlodipine Teva Pharmaceuticals".
Inform your doctor if you suspect (or are planning) pregnancy. Use of Perindopril + Amlodipine Teva Pharmaceuticals is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child if used during this period (see section 2 "Pregnancy and breastfeeding").
You should also inform your doctor or medical staff that you are taking Perindopril + Amlodipine Teva Pharmaceuticals if:

• the patient is to undergo general anaesthesia and/or major surgery,
• diarrhoea or vomiting has recently occurred,
• LDL apheresis (removal of cholesterol from the blood using a special device) is planned,
• desensitisation treatment is planned to reduce allergic reactions to bee or wasp stings.

Children and adolescents
Perindopril + Amlodipine Teva Pharmaceuticals is not recommended for use in children and adolescents.
Perindopril + Amlodipine Teva Pharmaceuticals and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Avoid using Perindopril + Amlodipine Teva Pharmaceuticals with:

• lithium (used to treat mania or depression),
• estramustine (used to treat cancer),
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase blood potassium levels (e.g. trimethoprim and co-trimoxazole, used for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).

Your doctor may recommend a dose adjustment and/or additional precautions:
if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to use Perindopril + Amlodipine Teva Pharmaceuticals" and "Warnings and precautions").
Other medicines may affect treatment with Perindopril + Amlodipine Teva Pharmaceuticals. Inform your doctor if you are taking any of the following medicines, as this may require special precautions:

• other medicines used to treat high blood pressure, including diuretics (which increase the amount of urine produced by the kidneys),
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen), taken for pain relief or high doses of acetylsalicylic acid,
• medicines used to treat diabetes (such as insulin),
• medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics, imipramine-type antidepressants, neuroleptics),
• immunosuppressive medicines (which weaken the immune system), used to treat autoimmune diseases or after organ transplantation (e.g. cyclosporine),
• allopurinol (used to treat gout),
• procainamide (used to treat heart rhythm disorders),
• vasodilators, including nitrates,
• ephedrine, noradrenaline, or adrenaline (medicines used to treat low blood pressure, shock, or asthma),
• baclofen or dantrolene (by infusion) used to treat muscle stiffness occurring in conditions such as multiple sclerosis; dantrolene is also used to treat malignant hyperthermia during anaesthesia (symptoms include very high fever and muscle rigidity),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• antiepileptic medicines such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
• itraconazole, ketoconazole (medicines used to treat fungal infections),
• alpha-adrenolytic medicines used to treat enlarged prostate, e.g. prazosin, alfuzosin, doxazosin, tamsulosin, terazosin,
• amifostine (a medicine given to prevent or reduce side effects caused by other medicines or radiotherapy, used in cancer treatment),
• corticosteroids (used to treat various diseases, including severe asthma and rheumatoid arthritis),
• gold salts, particularly when administered intravenously (used to treat symptoms of rheumatoid arthritis),
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in the treatment of HIV),
• simvastatin (used to reduce cholesterol levels),
• medicines most commonly used to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group called mTOR inhibitors). See section "Warnings and precautions",
• tacrolimus (used to control the immune system's response, allowing the body to accept a transplanted organ).

Perindopril + Amlodipine Teva Pharmaceuticals with food and drink
Do not consume grapefruit or grapefruit juice while taking Perindopril + Amlodipine Teva Pharmaceuticals, as it may increase blood levels of the active substance – amlodipine – which could lead to unpredictable intensification of blood pressure-lowering effects.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. Usually, your doctor will recommend stopping treatment with Perindopril + Amlodipine Teva Pharmaceuticals before becoming pregnant or as soon as pregnancy is confirmed, and will prescribe an alternative medicine. Use of Perindopril + Amlodipine Teva Pharmaceuticals 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 used during this period.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human breast milk. Inform your doctor if you are breastfeeding or intend to breastfeed. Use of Perindopril + Amlodipine Teva Pharmaceuticals is not recommended during breastfeeding. Your doctor may choose an alternative medicine if you plan to breastfeed, especially if breastfeeding a newborn or premature infant.
Driving and using machines
Perindopril + Amlodipine Teva Pharmaceuticals may impair the ability to drive and operate machinery. If nausea, dizziness, weakness, fatigue, or headache occur after taking the tablets, do not drive or operate machinery and contact your doctor immediately.
Perindopril + Amlodipine Teva Pharmaceuticals contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Perindopril + Amlodipine Teva Pharmaceuticals contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Perindopril + Amlodipine Teva Pharmaceuticals

This medicine should always be taken as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Swallow the tablet with a glass of water, preferably in the morning, at the same time each day, before a meal. Your doctor will determine the dose appropriate for you. Usually, this is one tablet per day.
Perindopril + Amlodipine Teva Pharmaceuticals is usually prescribed for patients who are already taking perindopril and amlodipine as separate tablets.

Taking more Perindopril + Amlodipine Teva Pharmaceuticals than prescribed
If you take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department. The most common symptom of overdose is low blood pressure, which may cause dizziness or fainting.
If such symptoms occur, lying down with your legs raised may be helpful.
Breathlessness due to fluid accumulation in the lungs (pulmonary oedema) may occur up to 24–48 hours after taking the medicine.

Missing a dose of Perindopril + Amlodipine Teva Pharmaceuticals
It is important to take the medicine every day, as regular use ensures effectiveness. If you miss a dose of Perindopril + Amlodipine Teva Pharmaceuticals, take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

Stopping Perindopril + Amlodipine Teva Pharmaceuticals
Treatment with Perindopril + Amlodipine Teva Pharmaceuticals usually continues for life; therefore, you should consult your doctor before stopping the medicine.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur in the patient, treatment must be stopped immediately and medical advice must be sought without delay:

Common adverse reactions (may occur in less than 1 in 10 patients):

• severe dizziness or fainting due to low blood pressure.

Uncommon adverse reactions (may occur in less than 1 in 100 patients):

• sudden wheezing, chest pain, shortness of breath or difficulty breathing,
• swelling of the eyelids, face or lips,
• swelling of the lips, tongue and throat causing difficulty in breathing.

Very rare adverse reactions (may occur in less than 1 in 10,000 patients):

• weakness of arms or legs, or speech disturbances, which may be signs of stroke,
• severe skin reactions including severe skin rash, urticaria, redness of the entire skin surface, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome), or other allergic reactions,
• abnormally fast or irregular heartbeat, chest pain (angina pectoris) or heart attack,
• pancreatitis, which may cause severe upper abdominal pain radiating to the back, accompanied by general malaise,
• yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• severe skin reactions including severe rash, urticaria, redness of the entire skin surface, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions.

The following common adverse reactions have been reported. If any of the following symptoms are troublesome to the patient or persist for more than one week, the patient should contact a doctor.

• Common adverse reactions (may occur in less than 1 in 10 patients): headache, central dizziness, drowsiness (especially at the beginning of treatment), labyrinthine dizziness, tingling and numbness of limbs, visual disturbances (including double vision), tinnitus (sensation of noise in the ears), palpitations (awareness of heartbeat), sudden flushing (especially of the face), sensation of "emptiness" in the head due to low blood pressure, cough, shortness of breath, nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or digestive disturbances, diarrhoea, constipation, allergic reactions (such as skin rash, itching), muscle cramps, feeling of fatigue, weakness, swelling of the ankles (oedema).

• Uncommon adverse reactions (may occur in less than 1 in 100 patients): mood changes, anxiety, depression, insomnia, sleep disturbances, tremor, loss of pain sensation, nasal mucosal inflammation (nasal congestion or discharge), changes in bowel frequency, hair loss, red spots or skin discoloration, back, muscle or joint pain, chest pain, urinary disturbances, increased frequency of urination, especially at night, pain, malaise, dryness of the oral mucosa, kidney disorders, impotence, increased sweating, breast enlargement in men, weight gain or weight loss, increased eosinophil count (a type of white blood cell), intense itching or severe skin rashes, clusters of blisters on the skin, fever, falls, fainting, rapid heartbeat, vasculitis (inflammation of blood vessels), photosensitivity reactions (increased skin sensitivity to sunlight), malaise, abnormal laboratory test results: high blood potassium levels (reversible upon discontinuation of treatment), low sodium levels, hypoglycaemia (very low blood sugar levels) in diabetic patients, increased blood urea and creatinine levels.

• Rare adverse reactions (may occur in less than 1 in 1,000 patients): dark urine, nausea or vomiting, muscle cramps, confusion and seizures. These may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion). Confusion (feeling disoriented), sudden flushing of the face and neck, worsening of psoriasis, reduced or absent urine output, abnormal laboratory test results: increased liver enzyme activity, increased serum bilirubin levels.

• Very rare adverse reactions (may occur in less than 1 in 10,000 patients): cardiovascular disorders (angina pectoris and stroke), eosinophilic pneumonia (a rare form of lung inflammation), erythema multiforme (a rash which usually starts with red, itchy spots on the face, arms or legs), photosensitivity, blood disorders, liver function disorders, hepatitis, yellowing of the skin (jaundice), abdominal distension (gastritis), nerve disorders which may cause weakness, tingling or numbness, increased muscle tension, gum swelling, high blood sugar levels (hyperglycaemia), changes in blood parameters such as decreased white and red blood cell counts, decreased haemoglobin and platelet count.

• Frequency not known (frequency cannot be estimated from available data): bruising, numbness and pain in fingers or toes (Raynaud's phenomenon).

• The following adverse reactions have also been reported in patients taking Perindopril + Amlodipine Teva Pharmaceuticals: disorders involving rigidity, tremor and/or movement disorders, tremors, postural stiffness, facial masking, slowed movements and shuffling gait.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Perindopril + Amlodipine Teva Pharmaceuticals

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and bottle label after "Expiry date (EXP):" or "EXP:". The expiry date refers to the last day of the stated month.
No special temperature storage conditions apply.
Store the container tightly closed to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Package and Other Information

What Perindopril + Amlodipine Teva Pharmaceuticals Contains

• The active substances are: perindopril tert-butylamine salt (perindopril tosilate) and amlodipine. One tablet contains 5 mg of perindopril tosilate, equivalent to 3.4 mg of perindopril, and 6.935 mg of amlodipine besylate, equivalent to 5 mg of amlodipine. One tablet contains 5 mg of perindopril tosilate, equivalent to 3.4 mg of perindopril, and 13.87 mg of amlodipine besylate, equivalent to 10 mg of amlodipine. One tablet contains 10 mg of perindopril tosilate, equivalent to 6.8 mg of perindopril, and 6.935 mg of amlodipine besylate, equivalent to 5 mg of amlodipine. One tablet contains 10 mg of perindopril tosilate, equivalent to 6.8 mg of perindopril, and 13.87 mg of amlodipine besylate, equivalent to 10 mg of amlodipine.
• Other ingredients: sodium hydrogen carbonate, povidone K30, lactose monohydrate, maize starch, microcrystalline cellulose, sodium carboxymethyl starch (Type A), magnesium stearate, and calcium hydrogen phosphate.

What Perindopril + Amlodipine Teva Pharmaceuticals Looks Like and Contents of the Pack
Perindopril + Amlodipine Teva Pharmaceuticals, 5 mg + 5 mg, white, oval, biconvex tablets, embossed with "5/5" on one side and smooth on the other.
Perindopril + Amlodipine Teva Pharmaceuticals, 5 mg + 10 mg, white, square, biconvex tablets, embossed with "5/10" on one side and smooth on the other.
Perindopril + Amlodipine Teva Pharmaceuticals, 10 mg + 5 mg, white, round, biconvex tablets, embossed with "10/5" on one side and smooth on the other.
Perindopril + Amlodipine Teva Pharmaceuticals, 10 mg + 10 mg, white, round, biconvex tablets, embossed with "10/10" on one side and smooth on the other.
Perindopril + Amlodipine Teva Pharmaceuticals is available in packs containing:
5 mg + 5 mg: 10, 30, 50, 60, 90, 100 or 120 (2x60) tablets.
5 mg + 10 mg, 10 mg + 5 mg, 10 mg + 10 mg: 30, 50, 60, 90, 100 or 120 (2x60) tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53; 00-113 Warszawa
tel.: (22) 345 93 00

Manufacturer:
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13
4042 Debrecen
Hungary
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
TEVA PHARMA S.L.U.
C/C, n. 4, Poligono Industrial Malpica
50016 Zaragoza
Spain
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305
74770 Opava-Komarov
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Peramteva tablets
Bulgaria: Zaprinel A tablets
Croatia: Articel-Am tablets
Czech Republic: Perindopril tosilate/amlodipine Teva tablets
Estonia: Perindopril/Amlodipine Teva
Ireland: Perindopril tosilate/Amlodipine Teva Tablets
Italy: PERINDOPRIL E AMLODIPINA TEVA
Latvia: Perindopril/Amlodipine Teva tablets
Netherlands: Perindopril tosilaat/Amlodipine Teva tablets
Poland: Perindopril + Amlodipine Teva Pharmaceuticals
Portugal: Perindopril + Amlodipina refta
Slovenia: Perodilam tablets