Co-prestarium

Leaflet accompanying the packaging: patient information

Co-Prestarium, 5 mg + 5 mg, tablets

Co-Prestarium, 10 mg + 5 mg, tablets

Co-Prestarium, 5 mg + 10 mg, tablets

Co-Prestarium, 10 mg + 10 mg, tablets

Perindopril arginine + Amlodipine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. 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, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Co-Prestarium and what is it used for
• 2. Important information before taking Co-Prestarium
• 3. How to take Co-Prestarium
• 4. Possible side effects
• 5. How to store Co-Prestarium
• 6. Contents of the pack and other information

1. What is Co-Prestarium and what is it used for

Co-Prestarium is used to treat high blood pressure (hypertension) and (or) stable coronary artery disease (a condition in which blood flow to the heart is reduced or blocked).
Patient already taking perindopril and amlodipine in separate tablets may instead take one Co-Prestarium tablet, which contains both active ingredients.
Co-Prestarium is a combination medicine that contains two active substances: perindopril and amlodipine.
Perindopril is an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine is a calcium antagonist (which belongs to a group of medicines called dihydropyridines). Together, these medicines work by widening and relaxing blood vessels, making it easier for blood to flow through them and for the heart to maintain a normal blood flow.

2. Important information before taking Co-Prestarium

When not to take Co-Prestarium:

in the past, or if such symptoms have occurred in a relative in any other circumstances (a condition called angioedema);

Warnings and precautions

Before taking Co-Prestarium, discuss with your doctor, pharmacist, or nurse if you have any of the following conditions:

• hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the blood vessel that supplies blood to the kidney);
• heart failure;
• severe high blood pressure (hypertensive crisis);
• any other heart disease;
• liver disease;
• kidney disease or dialysis;
• you have an abnormally high level of a hormone called aldosterone in your blood (primary aldosteronism);
• collagen vascular disease (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma;
• diabetes;
• taking a low-sodium diet or using potassium-sparing diuretics (e.g., triamterene, amiloride) or potassium supplements, or other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent blood clots; trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections);
• need to increase the dose in elderly patients;
• if you are 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 you have kidney problems related to diabetes,
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium). See also subsection "When not to take Co-Prestarium" and "Warnings and precautions".
• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors (used to prevent rejection of a transplanted organ and to treat cancer);
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure;
• linagliptin, saxagliptin, sitagliptin, wildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes);

Angioedema
Angioedema has been reported in patients treated with ACE inhibitors, including Co-Prestarium. This reaction may occur at any time during treatment. If you experience such symptoms, stop taking Co-Prestarium and contact your doctor immediately. See also section 4.
You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Co-Prestarium is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the baby (see section Pregnancy).
When taking Co-Prestarium, you should also inform your doctor or healthcare professional if:

• you are to undergo general anesthesia and (or) surgery;
• you have recently had diarrhea or vomiting;
• you are to undergo LDL apheresis (removal of cholesterol from the blood using a special device);
• you are to undergo desensitization treatment to reduce allergic reactions to bee stings or wasp stings.

Children and adolescents

Co-Prestarium is not recommended for children and adolescents.

Co-Prestarium with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Do not take Co-Prestarium:

• with lithium (used to treat mania or depression);
• with estramustine (used to treat cancer);
• with potassium-sparing diuretics (triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, or other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent blood clots; trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections);
• with potassium-sparing diuretics used to treat heart failure: eplerenone and spironolactone at doses of 12.5 mg to 50 mg per day.

Taking other medicines may affect your treatment with Co-Prestarium. Your doctor may need to change the dose or take other precautions. Tell your doctor if you are taking any of the following medicines, as they may require special precautions:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRA), aliskiren (see also subsections "When not to take Co-Prestarium" and "Warnings and precautions"), or diuretics (medicines that increase urine production);
• medicines commonly used to treat diarrhea (racecadotril) or to prevent rejection of a transplanted organ (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See section "Warnings and precautions".
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Co-Prestarium" and "Warnings and precautions".
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen) used to relieve pain or high doses of acetylsalicylic acid, a substance found in many medicines, used to relieve pain and reduce fever, as well as to prevent blood clots;
• medicines used to treat diabetes (such as insulin);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotics, imipramine-type antidepressants, neuroleptics);
• immunosuppressants (medicines that weaken the body's defense mechanisms), used to treat autoimmune diseases or after organ transplantation (e.g., cyclosporine, tacrolimus);
• trimethoprim and cotrimoxazole (used to treat bacterial infections);
• 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 (used to treat muscle stiffness in diseases such as multiple sclerosis; dantrolene is also used to treat malignant hyperthermia that occurs during anesthesia);
• certain antibiotics, such as rifampicin, erythromycin, clarithromycin (used to treat bacterial infections);
• Hypericum perforatum(St. John's Wort, used to treat depression);
• simvastatin (a medicine that lowers cholesterol levels in the blood);
• antiepileptic medicines, such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone;
• itraconazole, ketoconazole (medicines used to treat fungal infections);
• alpha-adrenergic receptor antagonists - medicines used to treat prostate enlargement (prostate), such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin;
• amifostine (used to prevent or reduce the side effects of other medicines or radiation therapy for cancer);
• corticosteroids (used to treat various diseases, including severe asthma and rheumatoid arthritis);
• gold salts, especially those given by injection (used to treat symptoms of rheumatoid arthritis);
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infection).

Co-Prestarium with food and drink

Co-Prestarium should be taken before a meal.
Do not drink grapefruit juice or eat grapefruits while taking Co-Prestarium, as grapefruits and grapefruit juice may increase the levels of the active substance amlodipine, which may lead to unpredictable increases in the blood pressure-lowering effect of Co-Prestarium.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Co-Prestarium before you become pregnant or as soon as you find out you are pregnant, and will advise you to take a different medicine instead of Co-Prestarium. Co-Prestarium is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the baby.
Breastfeeding
It has been shown that small amounts of amlodipine pass into breast milk. Tell your doctor if you are breastfeeding or about to start breastfeeding. Co-Prestarium is not recommended during breastfeeding. Your doctor may recommend a different medicine if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Co-Prestarium may affect your ability to drive or use machines. If you experience dizziness, drowsiness, weakness, fatigue, or headache after taking the medicine, do not drive or use machines and contact your doctor immediately.

Co-Prestarium contains lactose monohydrate

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Co-Prestarium

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablet with a glass of water, preferably at the same time each day, in the morning, before breakfast. Your doctor will determine the appropriate dose for you. The recommended dose is one tablet per day.
Co-Prestarium is usually recommended for patients already taking perindopril and amlodipine in separate tablets.

Use in children and adolescents

Co-Prestarium is not recommended for children and adolescents.

Overdose of Co-Prestarium

If you have taken too many tablets, contact the emergency department of the nearest hospital or your doctor immediately. The most common symptom of overdose is low blood pressure, which can cause dizziness or fainting. In this case, lying down with your legs raised may help.
Up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missed dose of Co-Prestarium

It is important to take the medicine every day, as regular treatment is most effective.
If you miss a dose of Co-Prestarium, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Co-Prestarium

Treatment with Co-Prestarium is usually long-term, so before stopping the tablets, contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Co-Prestarium can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking the medicine and contact your doctor immediately:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue or throat, which can cause severe difficulty breathing;
• severe skin reactions, including severe rash, hives, redness of the skin 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, very fast or irregular heartbeat, or chest pain;
• pancreatitis, which can cause severe abdominal pain, radiating to the back, and very poor general condition.

The following side effects have been reported. If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Very common side effects (may affect more than 1 in 10 people): swelling (fluid retention).
• Common side effects (may affect up to 1 in 10 people): headache, dizziness, drowsiness (especially at the start of treatment), vertigo, feeling of numbness or tingling in the limbs, visual disturbances (including double vision), ringing in the ears (feeling of hearing sounds), palpitations (feeling of heartbeat), sudden redness of the face and neck, 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, changes in bowel movements, diarrhea, constipation, allergic reactions (such as skin rash, itching), muscle cramps, fatigue, weakness, swelling of the ankles (peripheral edema).

Other side effects that have been reported include:

• Uncommon side effects (may affect up to 1 in 100 people): mood changes, anxiety, depression, insomnia, sleep disturbances, tremors, fainting, loss of sensation, irregular heartbeat, inflammation of the nasal mucosa (nasal congestion or runny nose), hair loss, red spots on the skin, skin discoloration, back pain, joint pain, muscle pain, chest pain, urinary disorders, nocturia (need to urinate at night), increased urination, pain, poor general condition, bronchospasm (feeling of constriction in the chest, wheezing, and shortness of breath), dry mouth, angioedema (symptoms such as wheezing, swelling of the face or tongue), blistering of the skin, kidney problems, impotence, increased sweating, increased eosinophil count (a type of white blood cell), breast tenderness or enlargement in men, weight gain or loss, fast heartbeat (tachycardia), vasculitis (inflammation of blood vessels), sensitivity to light (increased sensitivity of the skin to sunlight), fever, falls, changes in laboratory test results: high potassium levels in the blood, low sodium levels, hypoglycemia (very low blood sugar levels) in patients with diabetes, increased urea levels in the blood, increased creatinine levels in the blood.
• Rare side effects (may affect up to 1 in 1,000 people): acute kidney failure; symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion): dark urine, nausea or vomiting, muscle cramps, confusion, and seizures; decreased or absent urination; worsening of psoriasis; changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood.
• Very rare side effects (may affect up to 1 in 10,000 people): cardiovascular disorders (angina pectoris, heart attack, and stroke), eosinophilic pneumonia (a rare type of pneumonia), swelling of the eyelids, face, or lips, swelling of the tongue and throat, which can cause severe difficulty breathing, severe skin reactions, including severe rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome), erythema multiforme (a skin rash that often starts with the appearance of red, itchy patches on the face, arms, or legs), sensitivity to light, changes in blood test results, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin levels, decreased platelet count, blood disorders, pancreatitis, which can cause severe abdominal pain, radiating to the back, and very poor general condition, liver disorders, liver inflammation, jaundice (yellowing of the skin), increased liver enzyme activity, which may affect some laboratory test results, abdominal bloating (gastritis), nerve disorders, which can cause weakness, numbness, or tingling, increased muscle tone, gum hypertrophy, increased blood sugar levels (hyperglycemia).
• Frequency not known (cannot be estimated from the available data): tremors, stiffness, mask-like face, slow movements and shuffling gait, cyanosis, numbness, and pain in the fingers or toes (Raynaud's phenomenon).

If you experience any of these symptoms, contact your doctor as soon as possible.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder.

5. How to store Co-Prestarium

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 packaging after "EXP" (the expiry date stated is the last day of the month). The packaging is labeled with the batch number.
Store the container tightly closed to protect from moisture. Store in the original packaging. There are no special storage instructions for this medicine.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Co-Prestarium contains

• The active substances are perindopril and amlodipine besylate. Co-Prestarium 5 mg + 5 mg: one tablet contains 5 mg of perindopril arginine and 5 mg of amlodipine. Co-Prestarium 10 mg + 5 mg: one tablet contains 10 mg of perindopril arginine and 5 mg of amlodipine. Co-Prestarium 5 mg + 10 mg: one tablet contains 5 mg of perindopril arginine and 10 mg of amlodipine. Co-Prestarium 10 mg + 10 mg: one tablet contains 10 mg of perindopril arginine and 10 mg of amlodipine.
• The other ingredients are lactose monohydrate, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica.

What Co-Prestarium looks like and contents of the pack

Co-Prestarium 5 mg + 5 mg is a white, oblong tablet, 8.5 mm long and 4.5 mm wide, with "5/5" engraved on one side and a symbol on the other side.

Co-Prestarium 10 mg + 5 mg is a white, triangular tablet, 9.5 mm x 8.8 mm x 8.8 mm, with "10/5" engraved on one side and a symbol on the other side.

Co-Prestarium 5 mg + 10 mg is a white, square tablet, 8 mm x 8 mm, with "5/10" engraved on one side and a symbol on the other side.

Co-Prestarium 10 mg + 10 mg is a white, round tablet, 8.5 mm in diameter, with "10/10" engraved on one side and a symbol on the other side.

The tablets are available in boxes of 30, 60, or 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Servier Laboratories
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer

Servier Industrie
905 route de Saran
45520 Gidy
France
Servier (Ireland) Industries Ltd
Gorey Road - Arklow – Co. Wicklow
Ireland
Anpharm Pharmaceutical Company S.A.
Annopol 6B
03-236 Warsaw
Poland
To obtain further information, contact the marketing authorization holder's representative:
Servier Polska Sp. z o.o.
Phone: (22) 594 90 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium
COVERAM
Bulgaria
PRESTARIUM-CO
Cyprus
COVERAM
Czech Republic
PRESTANCE
Estonia
COVERAM
Finland
COVERAM
France
COVERAM
Greece
COVERAM
Ireland
ACERYCAL
Italy
COVERLAM
Latvia
PRESTERAM
Lithuania
PRESTERAM
Luxembourg
COVERAM
Malta
COVERAM
Netherlands
COVERAM arg
Poland
Co-Prestarium
Portugal
COVERAM
Romania
PRESTANCE
Slovakia
PRESTANCE
Slovenia
PRESTANCE

Date of last revision of the leaflet: