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

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.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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 side effects not listed in this leaflet, they should tell their 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 packaging 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).
Patients 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:

or if such symptoms have occurred in a related person in any other circumstances (a condition called angioedema);

Warnings and precautions

Before starting to take Co-Prestarium, the patient should discuss it with their doctor, pharmacist, or nurse if they 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;
• significant increase in blood pressure (hypertensive crisis);
• any other heart disease;
• liver disease;
• kidney disease or dialysis;
• the patient has an abnormally high level of a hormone called aldosterone in their 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 salt substitutes containing potassium (it is necessary to monitor potassium levels in the blood);
• the need to increase the dose in elderly patients;
• 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. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the subsection "When not to take Co-Prestarium".
• 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
Patients treated with ACE inhibitors, including Co-Prestarium, have reported angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing). This reaction can occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Co-Prestarium and contact their doctor immediately. See also section 4.
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Co-Prestarium in early pregnancy, and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the fetus (see section Pregnancy).
When taking Co-Prestarium, the patient should also inform their doctor or medical staff if:

• they are to undergo general anesthesia and (or) surgery;
• they have recently experienced diarrhea or vomiting;
• they are to undergo LDL apheresis (removal of cholesterol from the blood using a special device);
• they 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 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 Co-Prestarium:

• with lithium (used to treat mania or depression);
• with estramustine (used to treat cancer);
• with potassium-sparing medicines (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 a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• with potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in a dose of 12.5 mg to 50 mg per day.

Taking other medicines may affect treatment with Co-Prestarium. The doctor may recommend changing the dose and (or) taking other precautions. The patient should tell their doctor if they are taking any of the following medicines, as it may require special caution:

• 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 the amount of urine produced by the kidneys);
• 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 as a pain reliever and antipyretic, 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);
• immunosuppressive medicines (which 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 in cancer treatment);
• 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 (so-called protease inhibitors used to treat HIV infection).

Co-Prestarium with food and drink

Co-Prestarium should be taken before a meal.
While taking Co-Prestarium, the patient should not drink grapefruit juice or eat grapefruits, as grapefruits and grapefruit juice can cause an increase in the level of the active substance amlodipine, which may result in unpredictable intensification of the blood pressure-lowering effect of Co-Prestarium.

Pregnancy, breastfeeding, and fertility

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 tell their doctor about pregnancy, suspected pregnancy, or planned pregnancy. Usually, the doctor will recommend stopping Co-Prestarium before becoming pregnant or as soon as the patient finds out they are pregnant, and will recommend taking a different medicine instead of Co-Prestarium. It is not recommended to take Co-Prestarium in early pregnancy, and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the fetus.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. The patient should tell their doctor if they are breastfeeding or start breastfeeding. It is not recommended to take Co-Prestarium while breastfeeding. The doctor may recommend taking a different medicine if the patient wants to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

Co-Prestarium may affect the patient's ability to drive or operate machines. If the patient experiences nausea, dizziness, weakness, fatigue, or headache after taking the medicine, they should not drive or operate machines and should contact their doctor immediately.

Co-Prestarium contains lactose monohydrate

If the patient has been told that they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Co-Prestarium

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The tablet should be swallowed with a glass of water, preferably at the same time every day, in the morning, before a meal. The doctor will determine the appropriate dose for the patient. The recommended dose is usually one tablet per day.
Co-Prestarium is usually recommended for patients who are 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 the patient has taken too many tablets, they should immediately go to the emergency department of the nearest hospital or contact their doctor. The most common symptom of overdose is low blood pressure, which can cause dizziness or fainting. In such a situation, lying down with elevated legs 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.

Missing a dose of Co-Prestarium

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

Stopping Co-Prestarium treatment

Treatment with Co-Prestarium is usually long-term, so before stopping the tablets, the patient should contact their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Co-Prestarium can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they should stop taking the medicine and contact their 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 significant 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, too 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 very common and common side effects have been reported. If any of these side effects are troublesome for the patient, or if they last for more than a week, they should contact their doctor.

• Very common side effects (may affect at least 1 in 10 people): swelling (fluid retention).
• Common side effects (may affect up to 1 in 10 people): headache, dizziness of central origin, drowsiness (especially at the start of treatment), dizziness of labyrinthine origin, feeling of numbness or tingling in the limbs, vision disturbances (including double vision), ringing in the ears (feeling of hearing sounds), palpitations (feeling of heartbeat), sudden reddening 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 rashes, itching), muscle cramps, fatigue, weakness, swelling of the ankles (peripheral edema).

Other side effects that have been reported are listed below. If any of these side effects worsen or if the patient experiences any side effects not listed in the leaflet, they should tell their doctor or pharmacist.

• Uncommon side effects (may affect up to 1 in 100 people): mood changes, anxiety, depression, insomnia, sleep disturbances, tremors, fainting, loss of pain 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 frequency of urination, pain, poor general condition, bronchospasm (feeling of constriction in the chest, wheezing, and shortness of breath), dryness of the mucous membranes of the mouth, angioedema (symptoms such as wheezing, swelling of the face or tongue), blistering of the skin, kidney disorders, impotence, increased sweating, increased eosinophil count (a type of white blood cell), breast tenderness or enlargement in men, weight gain or loss, tachycardia (fast heartbeat), 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, disorientation, and seizures; reduced or absent urine production; 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 significant 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 parameters, such as decreased white blood cell count and 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, hepatitis, jaundice (yellowing of the skin), increased liver enzyme activity, which may affect some laboratory test results, abdominal bloating (gastritis), nervous system 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 of the hands or feet (Raynaud's phenomenon).

If the patient experiences any of these symptoms, they should contact their doctor as soon as possible.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
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 Co-Prestarium

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the words "EXP" (abbreviation used to describe the expiry date). The expiry date refers to the last day of the month stated.
The word "Lot" on the packaging means the batch number of the medicine.
Store the container tightly closed to protect from moisture. Store in the original packaging. There are no special recommendations for the storage temperature of the medicine.
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 Co-Prestarium contains

• The active substances of the medicine 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 of the tablet 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 the inscription "5/5" on one side and a logo 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 the inscription "10/5" on one side and a logo on the other side.
Co-Prestarium 5 mg + 10 mg is a white, square tablet, 8 mm x 8 mm, with the inscription "5/10" on one side and a logo on the other side.
Co-Prestarium 10 mg + 10 mg is a white, round tablet, 8.5 mm in diameter, with the inscription "10/10" on one side and a logo on the other side.
The tablets are available in boxes containing 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 Laboratories Industry
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 detailed information, the patient should contact the representative of the marketing authorization holder:
Servier Poland 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: