Perindopril + Amlodipine Teva Pharmaceuticals

Leaflet accompanying the packaging: 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

Perindopril tosilate + Amlodipine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Perindopril + Amlodipine Teva Pharmaceuticals and what is it 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 packaging and other information

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

used
Perindopril + Amlodipine Teva Pharmaceuticals is a combination medicine that contains two active substances - perindopril and amlodipine.
Perindopril + Amlodipine Teva Pharmaceuticals, 5 mg + 5 mg, tablets,contain 5 mg of perindopril tosilate and 5 mg of amlodipine.
Perindopril + Amlodipine Teva Pharmaceuticals, 5 mg + 10 mg, tablets,contain 5 mg of perindopril tosilate and 10 mg of amlodipine.
Perindopril + Amlodipine Teva Pharmaceuticals, 10 mg + 5 mg, tablets,contain 10 mg of perindopril tosilate and 5 mg of amlodipine.
Perindopril + Amlodipine Teva Pharmaceuticals, 10 mg + 10 mg, tablets,contain 10 mg of perindopril tosilate and 10 mg of amlodipine.
Perindopril is an angiotensin-converting enzyme inhibitor (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 makes it easier for blood to flow through the vessels and helps the heart pump blood to the whole body.
Perindopril + Amlodipine Teva Pharmaceuticals is indicated for the treatment of high blood pressure (hypertension) and (or) stable coronary heart disease (a condition in which blood flow to the heart is reduced or blocked).
Patients who have previously taken perindopril and amlodipine in separate tablets may receive one tablet of Perindopril + Amlodipine Teva Pharmaceuticals, which contains both active substances.

2. Important information before taking Perindopril + Amlodipine Teva Pharmaceuticals

Pharmaceuticals

When not to take Perindopril + Amlodipine Teva Pharmaceuticals

• if the patient is hypersensitive to perindopril or other ACE inhibitors, or to amlodipine, or to other calcium antagonists or to any of the other ingredients of this medicine (listed in section 6),
• if the patient is pregnant over 3 months (it is also recommended to avoid taking Perindopril + Amlodipine Teva Pharmaceuticals in early pregnancy - see section 2 "Pregnancy and breastfeeding"),
• if the patient has experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rash while taking an ACE inhibitor, or if such symptoms have occurred in the patient or any member of their family in any other circumstances (a condition called angioedema),
• if the patient has a narrowing of the aortic valve (aortic stenosis; narrowing of the main blood vessel carrying blood from the heart) or cardiogenic shock (a condition in which the heart is unable to supply the body with the necessary amount of blood),
• if the patient has significantly low blood pressure (hypotension),
• if the patient has heart failure after 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 a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat) increases.

Warnings and precautions

Before starting treatment with Perindopril + Amlodipine Teva Pharmaceuticals, the patient should discuss the following with their doctor or pharmacist:

• if the patient has hypertrophic cardiomyopathy (a disease of the heart muscle) or narrowing of the renal artery (narrowing of the blood vessel supplying blood to the kidney),
• if the patient has heart failure,
• if the patient has experienced a significant increase in blood pressure (hypertensive crisis),
• if the patient has other heart diseases,
• if the patient has liver diseases,
• if the patient has kidney diseases or is undergoing dialysis,
• if the patient has collagenosis (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma,
• if the patient has diabetes,
• if the patient is on a low-salt diet or is taking salt substitutes containing potassium (it is necessary to adjust the potassium level in the blood),
• if it is necessary to increase the dose in elderly patients,
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g. 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 diarrhea,
• medicines used to prevent the rejection of transplanted organs and to treat cancer (e.g. temsirolimus, sirolimus, everolimus),
• vildagliptin, a medicine used to treat diabetes.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g. potassium) in the blood.
See also the section "When not to take Perindopril + Amlodipine Teva Pharmaceuticals".
The patient should inform their doctor if they suspect (or plan) pregnancy. It is not recommended to take Perindopril + Amlodipine Teva Pharmaceuticals in early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the baby if taken during this period (see section 2 "Pregnancy and breastfeeding").
The patient should also inform their doctor or medical staff if they are taking Perindopril + Amlodipine Teva Pharmaceuticals and:

• are to be given general anesthesia and (or) are to undergo major surgery,
• have recently experienced diarrhea or vomiting,
• are to undergo LDL apheresis (removal of cholesterol from the blood using a special device),
• are to undergo desensitization treatment to reduce allergic reactions to bee stings 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should avoid taking Perindopril + Amlodipine Teva Pharmaceuticals with:

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

The doctor may recommend a dose change and (or) take other precautions:
if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections "When not to take Perindopril + Amlodipine Teva Pharmaceuticals" and "Warnings and precautions").
Taking other medicines may affect treatment with Perindopril + Amlodipine Teva Pharmaceuticals. The patient should tell their doctor if they are taking any of the following medicines, as they may require special precautions:

• other medicines used to treat high blood pressure, including diuretics (which increase the amount of urine excreted by the kidneys),
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen), given to relieve pain or large doses of acetylsalicylic acid,
• medicines used to treat diabetes (such as insulin),
• medicines used to treat mental 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, norepinephrine, or epinephrine (medicines used to treat low blood pressure, shock, or asthma),
• baclofen or dantrolene (given by infusion) used to treat muscle stiffness that occurs in diseases such as multiple sclerosis; dantrolene is also used to treat malignant hyperthermia during anesthesia (symptoms include very high fever and muscle stiffness),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• antiepileptic drugs, such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
• itraconazole, ketoconazole (medicines used to treat fungal infections),
• alpha-adrenergic blockers, used to treat prostate enlargement, e.g. prazosin, alfuzosin, doxazosin, tamsulosin, terazosin,
• amifostine (a medicine given to prevent or reduce the side effects of other medicines or radiation therapy used to treat cancer),
• corticosteroids (used to treat various diseases, including severe asthma and rheumatoid arthritis),
• gold salts, especially given intravenously (used to treat symptoms of rheumatoid arthritis),
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors, used to treat HIV),
• simvastatin (used to lower cholesterol levels),
• medicines commonly used to treat diarrhea (racecadotril) or to prevent the rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See the section "Warnings and precautions",
• tacrolimus (used to control the immune system's response, which allows the body to accept a transplanted organ).

Perindopril + Amlodipine Teva Pharmaceuticals with food and drink

The patient should not consume grapefruits or grapefruit juice while taking Perindopril + Amlodipine Teva Pharmaceuticals, as this may increase the level of the active substance amlodipine in the blood, which may cause unpredictable intensification of the blood pressure-lowering effect.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor if they suspect (or plan) pregnancy. The doctor will usually recommend stopping Perindopril + Amlodipine Teva Pharmaceuticals before becoming pregnant or as soon as the patient finds out they are pregnant, and will recommend a different medicine instead of Perindopril + Amlodipine Teva Pharmaceuticals. It is not recommended to take Perindopril + Amlodipine Teva Pharmaceuticals in early pregnancy and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the baby if taken during this period.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. The patient should inform their doctor if they are breastfeeding or plan to breastfeed. It is not recommended to take Perindopril + Amlodipine Teva Pharmaceuticals while breastfeeding. The doctor may choose a different medicine if the patient plans to breastfeed, especially if breastfeeding a newborn or premature baby.

Driving and using machines

Perindopril + Amlodipine Teva Pharmaceuticals may impair the ability to drive and use machines. If the patient experiences nausea, dizziness, weakness, fatigue, or headache after taking the tablets, they should not drive or operate machines and should contact their doctor immediately.

Perindopril + Amlodipine Teva Pharmaceuticals contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking the medicine.

Perindopril + Amlodipine Teva Pharmaceuticals contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Perindopril + Amlodipine Teva Pharmaceuticals

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The tablet should be swallowed with a glass of water, preferably in the morning, at the same time every day, before meals. The doctor will determine the dose suitable for the patient. It is usually one tablet per day.
Perindopril + Amlodipine Teva Pharmaceuticals is usually recommended for patients who are already taking perindopril and amlodipine in separate tablets.

Taking a higher dose of Perindopril + Amlodipine Teva Pharmaceuticals than recommended

In case of taking too many tablets, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital. The most common symptom of overdose is low blood pressure, which can cause dizziness or fainting.
If such symptoms occur, it may be helpful to lie down with elevated legs.
Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Perindopril + Amlodipine Teva Pharmaceuticals

It is important to take the medicine every day, as regular treatment ensures its effectiveness. However, if a dose of Perindopril + Amlodipine Teva Pharmaceuticals is missed, the next dose should be taken at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Perindopril + Amlodipine Teva Pharmaceuticals

Treatment with Perindopril + Amlodipine Teva Pharmaceuticals usually lasts for life, so the patient should consult their doctor before stopping treatment.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Perindopril + Amlodipine Teva Pharmaceuticals can cause side effects, although not everybody gets them.
If the patient experiences any of the following symptoms, they should stop taking the medicine and immediatelycontact their doctor:
Common side effects (may affect up to 1 in 10 people):

• severe dizziness or fainting due to low blood pressure.

Uncommon side effects (may affect up to 1 in 100 people):

• 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 breathing.

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

• weakness or numbness of the arms or legs, or speech disorders, which may be symptoms of a stroke,
• severe skin reactions, including severe rash, hives, 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) or other allergic reactions,
• abnormally fast or irregular heartbeat, chest pain (angina pectoris), or heart attack,
• pancreatitis, which can cause severe abdominal pain radiating to the back, accompanied by very poor health,
• yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• severe skin reactions, including severe rash, hives, 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, toxic epidermal necrolysis) or other allergic reactions.

The following common side effectshave been reported. If any of the followingsymptoms are troublesomefor the patient or last longer than one week, the patient should contact their doctor.

• Common side effects (may affect up to 1 in 10 people): headache, dizziness of central origin, drowsiness (especially at the beginning of treatment), dizziness of labyrinthine origin, tingling and numbness of the limbs, vision disturbances (including double vision), ringing in the ears (feeling of noise in the ears), palpitations (awareness of heart function), feeling of "emptiness" in the head due to low blood pressure, cough, shortness of breath, nausea, vomiting, abdominal pain, taste disturbances, indigestion or digestive disorders, diarrhea, constipation, allergic reactions (such as skin rash, itching), muscle cramps, feeling of fatigue, weakness, swelling of the ankles (edema).
• Uncommon side effects (may affect up to 1 in 100 people): mood changes, anxiety, depression, insomnia, sleep disorders, tremors, loss of pain sensation, inflammation of the nasal mucosa (nasal congestion or discharge), changes in bowel movements, hair loss, red spots or discoloration of the skin, back pain, muscle or joint pain, chest pain, urinary disorders, increased frequency of urination, especially at night, pain, poor health, dryness of the mucous membranes of the mouth, kidney disorders, impotence, increased sweating, breast enlargement in men, weight gain or loss, increased eosinophil count (a type of white blood cell), severe itching or severe skin rash, blistering, peeling, and swelling of the skin, fever, falls, fainting, rapid heartbeat, inflammation of blood vessels, allergic reactions to light (increased skin sensitivity to sunlight), poor health, abnormal laboratory test results: high potassium levels in the blood (reversible after stopping treatment), low sodium levels, hypoglycemia (very low blood sugar levels) in patients with diabetes, increased levels of urea and creatinine in the blood.
• Rare side effects (may affect up to 1 in 1,000 people): dark urine, nausea or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate secretion of antidiuretic hormone. Disorientation (feeling of confusion), sudden reddening of the face and neck, worsening of psoriasis, decreased or absent urination, abnormal laboratory test results: increased liver enzyme activity, increased bilirubin levels in the blood.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• cardiovascular disorders (angina pectoris and myocardial infarction), eosinophilic pneumonia (a rare form of pneumonia), erythema multiforme (a rash that usually starts with red, itchy spots on the face, arms, or legs), hypersensitivity to light, blood disorders, liver disorders, liver inflammation, jaundice (yellowing of the skin), abdominal bloating (gastritis), nervous system disorders that can cause weakness, tingling, or numbness, increased muscle tone, gum hypertrophy, high blood sugar levels (hyperglycemia), changes in blood test results, such as decreased white blood cell count, red blood cell count, hemoglobin, and platelet count.
• Unknown frequency (frequency cannot be estimated from the available data): cyanosis, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon).
• The following side effects have also been reported by patients taking Perindopril + Amlodipine Teva Pharmaceuticals: disorders combining stiffness, tremors, and (or) movement disorders, tremors, stiffness of posture, mask-like face, slow movements, and shuffling gait.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Perindopril + Amlodipine Teva Pharmaceuticals

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the packaging and label of the bottle after the words "Expiry date:" or "EXP:". The expiry date refers to the last day of the month stated.
There are no special storage temperature requirements.
The container should be kept tightly closed to protect it from light and moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Perindopril + Amlodipine Teva Pharmaceuticals contains

• The active substances of the medicine are perindopril tosilate and amlodipine. One tablet contains 5 mg of perindopril tosilate, which corresponds to 3.4 mg of perindopril, and 6.935 mg of amlodipine besylate, which corresponds to 5 mg of amlodipine. One tablet contains 5 mg of perindopril tosilate, which corresponds to 3.4 mg of perindopril, and 13.87 mg of amlodipine besylate, which corresponds to 10 mg of amlodipine. One tablet contains 10 mg of perindopril tosilate, which corresponds to 6.8 mg of perindopril, and 6.935 mg of amlodipine besylate, which corresponds to 5 mg of amlodipine. One tablet contains 10 mg of perindopril tosilate, which corresponds to 6.8 mg of perindopril, and 13.87 mg of amlodipine besylate, which corresponds to 10 mg of amlodipine.
• The other ingredients are sodium hydrogen carbonate, povidone K30, lactose monohydrate, cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose (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, are white, oval, biconvex tablets, with the inscription "5/5" on one side and smooth on the other.
Perindopril + Amlodipine Teva Pharmaceuticals, 5 mg + 10 mg, are white, square, biconvex tablets, with the inscription "5/10" on one side and smooth on the other.
Perindopril + Amlodipine Teva Pharmaceuticals, 10 mg + 5 mg, are white, round, biconvex tablets, with the inscription "10/5" on one side and smooth on the other.
Perindopril + Amlodipine Teva Pharmaceuticals, 10 mg + 10 mg, are white, round, biconvex tablets, with the inscription "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 authorization holder and manufacturer

Marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53; 00-113 Warsaw
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 Krakow
TEVA PHARMA S.L.U.
C/C, n. 4, Poligono Industrial Malpica
50016 Zaragoza
Spain
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305
74770 Opava-Komarov
Czech Republic

This medicinal product is authorized 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

Date of last revision of the leaflet: July 2022