Co-prestarium Initio

Leaflet accompanying the packaging: patient information

Co-Prestarium Initio, 3.5 mg + 2.5 mg, tablets

Co-Prestarium Initio, 7 mg + 5 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 their symptoms 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 Initio and what is it used for
• 2. Important information before taking Co-Prestarium Initio
• 3. How to take Co-Prestarium Initio
• 4. Possible side effects
• 5. How to store Co-Prestarium Initio
• 6. Contents of the packaging and other information

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

Co-Prestarium Initio is a combination preparation containing two active substances: perindopril and amlodipine. Both of these substances help control high blood pressure. Perindopril is an angiotensin-converting enzyme inhibitor (ACE inhibitor). Amlodipine is a calcium antagonist, belonging to a group of drugs called dihydropyridines. Together, these drugs work by dilating and relaxing blood vessels, making it easier for blood to flow through them and for the heart to maintain normal blood flow. Co-Prestarium Initio is used to treat high blood pressure (hypertension) in adults.

2. Important information before taking Co-Prestarium Initio

When not to take Co-Prestarium Initio

• if the patient is allergic to perindopril or another ACE inhibitor, to amlodipine or other calcium antagonists, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe kidney problems;
• if the patient has previously experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe rash when taking an ACE inhibitor, or if such symptoms have occurred in a related person under any other circumstances (a condition called angioedema);
• if the patient has a narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body);
• if the patient has very low blood pressure (hypotension);
• if the patient has heart failure after a heart attack;
• if the patient is pregnant over 3 months (it is also recommended to avoid taking Co-Prestarium Initio in early pregnancy - see "Pregnancy");
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient is undergoing dialysis or blood filtration by another method - depending on the device used, Co-Prestarium Initio may not be suitable for the patient;
• if the patient has kidney problems that reduce blood flow to the kidneys (renal artery stenosis);
• if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan, used to treat heart failure, as the risk of angioedema (rapid swelling of tissues under the skin in the throat area) increases (see "Warnings and precautions" and "Co-Prestarium Initio and other medicines").

Warnings and precautions

Before starting to take Co-Prestarium Initio, the patient should discuss it with their doctor, pharmacist, or nurse if:

• the patient has hypertrophic cardiomyopathy (a disease of the heart muscle);
• the patient has heart failure;
• the patient has experienced a significant increase in blood pressure (hypertensive crisis);
• the patient has any other heart problems;
• the patient has liver disease;
• the patient has kidney disease (including after kidney transplantation);
• the patient has an abnormally high level of a hormone called aldosterone in the blood (primary hyperaldosteronism);
• the patient has collagenosis (a disease of connective tissue), such as systemic lupus erythematosus or scleroderma;
• the patient has diabetes;
• the patient is on a low-salt diet or uses salt substitutes containing potassium (it is essential to have the right potassium level in the blood);
• the patient is elderly and needs to increase the dose;
• 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 - e.g., valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes; or 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 Initio".
• the patient is black - in this case, there is a higher risk of angioedema, and the medicine may be less effective in lowering blood pressure than in patients of other races.
• the patient is taking any of the following medicines, as the risk of angioedema increases: racecadotril (used to treat diarrhea); sirolimus, everolimus, temsirolimus, and other medicines belonging to a group of medicines called mTOR inhibitors (used to prevent transplant rejection 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 a group of medicines also called gliptins (used to treat diabetes).

Angioedema has been reported in patients treated with ACE inhibitors, including perindopril. This reaction can occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Co-Prestarium Initio and contact their doctor immediately. See also section 4. The patient must tell their doctor if they think they are (or may be) pregnant. It is not recommended to take Co-Prestarium Initio in early pregnancy, and it should not be taken if the patient is pregnant over 3 months, as the medicine may seriously harm the baby if taken during this period (see "Pregnancy"). When taking Co-Prestarium Initio, the patient should also inform their doctor or medical staff if:

• they are to be given anesthesia and/or surgery;
• they have recently had 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 or wasp stings.

Children and adolescents

Co-Prestarium Initio should not be taken by children and adolescents.

Co-Prestarium Initio 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 Initio:

• with lithium (used to treat mania or depression);
• with estramustine (used to treat cancer);
• with potassium-sparing medicines (e.g., 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 clotting, trimethoprim, and cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat infections, and cyclosporine, an immunosuppressive medicine used to prevent transplant rejection);
• with aliskiren (used to treat high blood pressure), see also subsections "When not to take Co-Prestarium Initio" and "Warnings and precautions";
• with angiotensin II receptor antagonists (used to treat high blood pressure), e.g., valsartan, telmisartan, irbesartan;
• with dantrolene (injection), used to treat muscle stiffness occurring in diseases such as multiple sclerosis or to treat malignant hyperthermia that may occur during anesthesia (symptoms include very high fever and muscle stiffness);
• with a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Co-Prestarium Initio" and "Warnings and precautions".

Taking other medicines may affect treatment with Co-Prestarium Initio. 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 diuretics (medicines that increase the amount of urine produced by the kidneys);
• medicines commonly used to treat diarrhea (racecadotril) or to prevent transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to a group of medicines called mTOR inhibitors). See "Warnings and precautions".
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen) used to relieve pain or high doses of acetylsalicylic acid;
• medicines used to treat diabetes (such as insulin, gliptins);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotics, antidepressants similar to imipramine, neuroleptics);
• immunosuppressive medicines (which weaken the body's defense mechanisms), used to treat autoimmune diseases or after organ transplantation (e.g., cyclosporine, tacrolimus);
• 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, used to treat muscle stiffness occurring in diseases such as multiple sclerosis;
• certain antibiotics, such as rifampicin, erythromycin, clarithromycin (used to treat bacterial infections);
• antiepileptic medicines, such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone;
• itraconazole, ketoconazole (medicines used to treat fungal infections);
• medicines that block alpha-adrenergic receptors, used to treat prostate enlargement (prostate), such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin;
• amifostine (used to prevent or reduce side effects associated with the use of other medicines or radiation therapy in cancer treatment);
• corticosteroids (used to treat various diseases, including severe asthma and rheumatoid arthritis);
• gold salts, especially when given intravenously (used to treat symptoms of rheumatoid arthritis);
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day;
• Hypericum perforatum(St. John's Wort, used to treat depression).

Co-Prestarium Initio with food and drink

See section 3. Patients taking Co-Prestarium Initio should not eat grapefruits or drink grapefruit juice, as grapefruits and grapefruit juice may lead to increased levels of the active substance amlodipine, which may cause unexpected intensification of the blood pressure-lowering effect of Co-Prestarium Initio.

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 must tell their doctor about pregnancy, suspected pregnancy, or planned pregnancy. Usually, the doctor will recommend stopping Co-Prestarium Initio 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 Initio. It is not recommended to take Co-Prestarium Initio in early pregnancy, and it should not be taken if the patient is pregnant over 3 months, as the medicine may cause serious harm to the baby if taken after the third month of pregnancy.

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 Initio in breastfeeding mothers, and the doctor may choose a different treatment if the patient wants to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines

Co-Prestarium Initio may affect the ability to drive or use machines. If the patient experiences nausea, dizziness, weakness, fatigue, or headache, they should not drive or use machines and should contact their doctor immediately.

Co-Prestarium Initio contains lactose monohydrate

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

3. How to take Co-Prestarium Initio

Co-Prestarium Initio should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. The recommended dose is one tablet of Co-Prestarium Initio 3.5 mg + 2.5 mg, once a day. If the patient has moderate kidney problems, the doctor may recommend one tablet of Co-Prestarium Initio 3.5 mg + 2.5 mg every other day at the start of treatment. Depending on the patient's response to treatment, the doctor may decide to increase the dose after one month of treatment to 7 mg + 5 mg of Co-Prestarium Initio, once a day, if necessary. One tablet of Co-Prestarium Initio 7 mg + 5 mg, once a day, is the maximum recommended dose for the treatment of high blood pressure. The tablet is best taken daily at the same time, in the morning, before a meal. The patient should not take more than the prescribed dose.

Taking a higher dose of Co-Prestarium Initio than recommended

If the patient has taken too many tablets, they should contact their doctor or go to the emergency department of the nearest hospital immediately. The most common symptom of overdose is low blood pressure, which can cause dizziness or fainting. In such cases, it may be helpful to lie down with elevated legs. 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 Initio

It is essential to take the medicine every day, as regular treatment is more effective. However, if the patient misses a dose of Co-Prestarium Initio, 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 treatment with Co-Prestarium Initio

Treatment with Co-Prestarium Initio 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 or pharmacist.

4. Possible side effects

Like all medicines, Co-Prestarium Initio can cause side effects, although not everybody gets them.

If the patient experiences any of the following potentially serious side effects, they should stop taking the medicine and contact their doctor immediately:

• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm) (uncommon - may affect up to 1 in 100 people);
• swelling of the eyelids, face, or lips (uncommon - may affect up to 1 in 100 people);
• swelling of the tongue and throat, which can cause significant difficulty breathing (angioedema) (uncommon - may affect up to 1 in 100 people);
• severe skin reactions, including severe rash, hives, redness of the skin all over the body, intense itching (erythema multiforme) (rare - may affect up to 1 in 10,000 people), blistering, peeling, and swelling of the skin (exfoliative dermatitis) (rare - may affect up to 1 in 10,000 people), inflammation of the mucous membranes (Stevens-Johnson syndrome) (rare - may affect up to 1 in 10,000 people), toxic epidermal necrolysis (frequency not known) or other allergic reactions (uncommon - may affect up to 1 in 100 people);
• severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people);
• weakness or numbness in the arms or legs, or difficulty speaking, which can be a sign of a stroke (very rare - may affect up to 1 in 10,000 people);
• heart attack, chest pain (angina pectoris) (very rare - may affect up to 1 in 10,000 people), abnormal or very fast heart rhythm (common - may affect up to 1 in 10 people);
• inflammation of the pancreas, which can cause severe abdominal pain and very poor health (very rare - may affect up to 1 in 10,000 people);
• yellowing of the skin or eyes (jaundice), which can be a sign of liver inflammation (very rare - may affect up to 1 in 10,000 people).

If the patient experiences any of the following side effects, they should tell their doctor:

• common side effects (may affect up to 1 in 10 people): feeling of "emptiness" in the head, cough, swelling (fluid retention).
• uncommon side effects (may affect up to 1 in 100 people): high levels of potassium in the blood, which can cause heart rhythm disturbances (hyperkalemia), high blood sugar levels (hyperglycemia), fatigue.

After taking perindopril or amlodipine, the following side effects have been reported, which were not observed after taking Co-Prestarium Initio or were observed more frequently after taking Co-Prestarium Initio. These side effects may also occur after taking Co-Prestarium Initio. If any of these side effects are troublesome for the patient, they should tell their doctor:

• 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, drowsiness (especially at the start of treatment), taste disturbance, numbness or tingling in the limbs, dizziness of inner ear origin, vision disturbances (including double vision), ringing in the ears (tinnitus), palpitations (feeling of heartbeat), sudden reddening of the face and neck, shortness of breath, abdominal pain, nausea, vomiting, indigestion or digestive disturbances, changes in bowel movements, constipation, diarrhea, itching, rash, redness of the skin, itching, swelling of the ankle area, muscle cramps, fatigue, weakness.
• uncommon side effects (may affect up to 1 in 100 people): increased white blood cell count, low sodium levels in the blood (hyponatremia), low blood sugar levels (hypoglycemia), mood changes, anxiety, insomnia, depression, sleep disturbances, fainting, loss of sensation, tremor, inflammation of blood vessels, inflammation of the nasal mucosa (nasal congestion or runny nose), dryness of the mucous membranes of the mouth, increased sweating, hair loss, red spots on the skin, skin discoloration, formation of blisters on the skin, increased sensitivity to light, back pain, muscle or joint pain, urinary disturbances, need to urinate at night, increased frequency of urination, kidney problems, impotence, discomfort or enlargement of the breasts in men, chest pain, poor health, pain, weight gain or loss, increased levels of urea or creatinine in the blood, falls, fever.
• rare side effects (may affect up to 1 in 1,000 people): acute kidney failure; symptoms of a condition called SIADH (inappropriate secretion of antidiuretic hormone): dark urine, nausea or vomiting, muscle cramps, disorientation, and seizures; decreased or absent urine production; worsening of psoriasis; high levels of bilirubin in the blood; increased activity of liver enzymes.
• very rare side effects (may affect up to 1 in 10,000 people): changes in blood, such as decreased white or red blood cell count, decreased hemoglobin levels, decreased platelet count, increased muscle tension, nerve disorders that can cause weakness, numbness, or tingling, eosinophilic pneumonia (a rare type of pneumonia), gum hypertrophy (gum overgrowth), abdominal distension (gastritis), jaundice (yellowing of the skin);
• frequency not known (cannot be estimated from the available data): tremor, stiffness, mask-like face, slow movements and dragging of the feet, cyanosis, numbness, and pain in the fingers or toes (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 Drug Safety Monitoring of the 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Co-Prestarium Initio

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 specified month. The "Lot" on the packaging indicates the batch number of the medicine. There are no special precautions for storing the medicinal product. After opening the tablet container containing 30 tablets of Co-Prestarium Initio, it should be used within 30 days. 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 Initio contains

• The active substances of Co-Prestarium Initio are: perindopril arginine and amlodipine besylate. Co-Prestarium Initio, 3.5 mg + 2.5 mg: one tablet contains 2.378 mg of perindopril, equivalent to 3.5 mg of perindopril arginine, and 3.4675 mg of amlodipine besylate, equivalent to 2.5 mg of amlodipine. Co-Prestarium Initio, 7 mg + 5 mg: one tablet contains 4.756 mg of perindopril, equivalent to 7 mg of perindopril arginine, and 6.935 mg of amlodipine besylate, equivalent to 5 mg of amlodipine.
• The other ingredients of the tablet are: lactose monohydrate, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica.

What Co-Prestarium Initio looks like and contents of the pack

Co-Prestarium Initio, 3.5 mg + 2.5 mg, are white, round tablets with a diameter of 5 mm. Co-Prestarium Initio, 7 mg + 5 mg, are white, round tablets with a diameter of 6 mm, with an embossed mark on one side. The tablets are available in packs of 30 or 90 (3 containers of 30 tablets each). The cap of the tablet container contains a desiccant. Not all pack sizes may be marketed.

Marketing authorization holder

Servier Laboratories, 50, rue Carnot, 92284 Suresnes cedex, France

Manufacturer

Servier (Ireland) Industries Ltd, Gorey Road, Arklow - Co. Wicklow, Ireland; Les Laboratoires Servier Industrie, 905 route de Saran, 45520 Gidy, France; Anpharm Pharmaceutical Company S.A., ul. Annopol 6B, 03-236 Warsaw, Poland; Egis Pharmaceuticals Private Limited Company, H-9900, Körmend, Mátyás király u. 65, Hungary

Phone: (22) 594 90 00

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

Cyprus

Viacoram, tablets

France

Amplival, tablet

Germany

Viacoram, tablets

Greece

Coveram initio, tablets

Ireland

Viacoram, tablets

Latvia

Viacoram, tablets

Lithuania

Viacoram, tablets

Poland

Co-Prestarium Initio

Slovakia

Prestance Initio, tablets

Spain

Viacoram, tablets

Date of last revision of the leaflet: 01/2025