Co-prestarium initio

Patient Information Leaflet

Co-Prestarium Initio, 3.5 mg + 2.5 mg, tablets
Co-Prestarium Initio, 7 mg + 5 mg, tablets
Perindoprilum argininum + Amlodipinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, 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, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents:

1. What Co-Prestarium Initio is and what it is used for
2. What you need to know 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 pack and other information

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

Co-Prestarium Initio is a combination medicine containing two active substances:
perindopril and amlodipine. Both of these substances help control high blood pressure.
Perindopril is an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine
is a calcium antagonist belonging 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 helping the heart to pump blood more effectively.
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 previously experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe rash while taking an ACE inhibitor, or if such symptoms occurred in a blood relative under any circumstances (a condition called angioedema);
• if the patient has narrowing of the heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart cannot deliver adequate blood flow to the body);
• if the patient has very low blood pressure (hypotension);
• if the patient has heart failure following a heart attack;
• if the patient is more than 3 months pregnant (it is also better to avoid using Co-Prestarium Initio in early pregnancy – see section “Pregnancy”);
• if the patient has diabetes or impaired kidney function and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient is undergoing dialysis or another form of blood filtration – depending on the equipment used, Co-Prestarium Initio may not be suitable;
• if the patient has kidney problems causing reduced blood supply 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 this increases the risk of angioedema (rapid swelling of tissue under the skin, particularly in the throat area) (see “Warnings and precautions” and “Co-Prestarium Initio with other medicines”).

Warnings and precautions
Before starting Co-Prestarium Initio, discuss with your doctor, pharmacist, or nurse if:

• the patient has hypertrophic cardiomyopathy (a heart muscle disease);
• the patient has heart failure;
• the patient has experienced a significant increase in blood pressure (hypertensive crisis);
• the patient has any other heart conditions;
• the patient has liver disease;
• the patient has kidney disease (including after kidney transplant);
• the patient has abnormally high levels of a hormone called aldosterone in the blood (primary hyperaldosteronism);
• the patient has a collagenosis (connective tissue disease), 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 (appropriate potassium levels in blood are important);
• the patient is elderly and a dose increase is needed;
• the patient is taking any of the following medicines used to treat high blood pressure: an angiotensin II receptor antagonist (AIIRA), also known as a sartan – for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes; or aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also section “When not to take Co-Prestarium Initio”.
• the patient is of Black race – in such cases, there is a higher risk of angioedema, and the medicine may be less effective in lowering blood pressure compared to patients of other races.
• the patient is taking any of the following medicines, as they increase the risk of angioedema: racecadotril (used to treat diarrhoea); sirolimus, everolimus, temsirolimus, and other medicines belonging to a group called mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment); sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure; linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to a group called gliptins (used to treat diabetes).

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including perindopril. This reaction may occur at any time during treatment. If such symptoms occur, stop taking Co-Prestarium Initio immediately and contact your doctor without delay. See also section 4.
The patient must inform the doctor if she thinks she is (or might be) pregnant. Use of Co-Prestarium Initio is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as the medicine may seriously harm the unborn child if used during this period (see section “Pregnancy”).

When taking Co-Prestarium Initio, also inform your doctor or healthcare provider if:

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

Children and adolescents
Co-Prestarium Initio must not be used in children and adolescents.

Co-Prestarium Initio with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Avoid using 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 potassium-containing salt substitutes, and other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent clots, trimethoprim and co-trimoxazole, also known as a combination of trimethoprim and sulfamethoxazole, used to treat infections, and cyclosporine, an immunosuppressant used to prevent organ transplant rejection);
• with aliskiren (used to treat high blood pressure); see also sections “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 intravenous dantrolene (used to treat muscle stiffness in conditions such as multiple sclerosis or to treat malignant hyperthermia that may occur during anaesthesia, characterised by very high fever and muscle rigidity);
• 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”.

Other medicines may affect treatment with Co-Prestarium Initio. Inform your doctor if the patient is taking any of the following medicines, as this may require special precautions:

• other medicines used to treat high blood pressure, including diuretics (medicines that increase urine production by the kidneys);
• medicines most commonly used to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other mTOR inhibitors). See section “Warnings and precautions”.
• non-steroidal anti-inflammatory drugs (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 psychiatric disorders such as depression, anxiety, or schizophrenia (e.g. tricyclic antidepressants, antipsychotics, imipramine-like antidepressants, neuroleptics);
• immunosuppressive medicines (which weaken the body’s immune defences), 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);
• vasodilating medicines, including nitrates;
• ephedrine, noradrenaline, or adrenaline (used to treat low blood pressure, shock, or asthma);
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis);
• certain antibiotics such as rifampicin, erythromycin, clarithromycin (used for bacterial infections);
• antiepileptic medicines such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone;
• itraconazole, ketoconazole (used to treat fungal infections);
• alpha-adrenergic receptor blockers used to treat benign prostatic hyperplasia (e.g. prazosin, alfuzosin, doxazosin, tamsulosin, terazosin);
• amifostine (used to prevent or reduce side effects associated with other cancer medicines or radiotherapy);
• corticosteroids (used to treat various conditions, 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 in HIV treatment);
• potassium-sparing medicines used in heart failure: eplerenone and spironolactone at doses from 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 grapefruit or drink grapefruit juice, as grapefruit and grapefruit juice may increase the concentration of the active substance amlodipine, potentially leading to an unexpected intensification of the blood pressure-lowering effect of Co-Prestarium Initio.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine.

Pregnancy
The patient must inform her doctor if she is pregnant, suspects pregnancy, or is planning to become pregnant. Usually, the doctor will advise stopping Co-Prestarium Initio before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Use of Co-Prestarium Initio is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as the medicine may cause serious harm to the unborn child if used beyond the third month.

Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. Inform your doctor if you are breastfeeding or plan to breastfeed. Use of Co-Prestarium Initio is not recommended in breastfeeding mothers. The doctor may choose an alternative treatment if the patient wishes to breastfeed, especially if the infant is a newborn or was born prematurely.

Driving and operating machinery
Co-Prestarium Initio may affect the ability to drive or operate machinery. If nausea, dizziness, weakness, fatigue, or headache occur, the patient should not drive or operate machinery and should contact their doctor immediately.

Co-Prestarium Initio contains monohydrate lactose
If the patient has been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Co-Prestarium Initio

Co-Prestarium Initio must always be used as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is one tablet of Co-Prestarium Initio 3.5 mg + 2.5 mg once daily.
If the patient has moderate renal impairment, the doctor may initially recommend one tablet of
Co-Prestarium Initio 3.5 mg + 2.5 mg every other day.
Depending on the patient's response to treatment, the doctor may decide to increase the dose after
one month of treatment, if necessary, to 7 mg + 5 mg of Co-Prestarium Initio once daily.
One tablet of Co-Prestarium Initio 7 mg + 5 mg once daily is the maximum recommended dose for
the treatment of high blood pressure.
The tablet should best be taken at the same time each day, in the morning, before a meal.
Do not take a higher dose than prescribed.
Taking more Co-Prestarium Initio than recommended
If too many tablets are taken, contact your doctor immediately or go to the nearest hospital
emergency department. The most common symptom of overdose is low blood pressure, which may
cause dizziness or fainting. In such a case, lying down with legs raised may be helpful.
Breathing difficulties due to excess fluid accumulating in the lungs (pulmonary edema) may occur
within 24 to 48 hours after taking the medication.
Missing a dose of Co-Prestarium Initio
It is important to take the medication every day, as regular use is more effective.
However, if a dose of Co-Prestarium Initio is missed, the next dose should be taken at the usual time.
Do not take a double dose to make up for the missed dose.
Stopping Co-Prestarium Initio
Treatment with Co-Prestarium Initio is usually long-term; therefore, contact your doctor before
discontinuing the tablets.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following potentially serious adverse symptoms,
treatment should be discontinued and medical advice should be sought immediately:

• sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm) (not common – may occur in less than 1 in 100 patients);
• swelling of the eyelids, face or lips (not common – may occur in less than 1 in 100 patients);
• swelling of the tongue and throat, which may cause significant breathing difficulties (angioedema) (not common – may occur in less than 1 in 100 patients);
• severe skin reactions, including severe rash, urticaria, generalized redness of the skin, intense itching (erythema multiforme) (very rare – may occur in less than 1 in 10,000 patients), blistering, peeling and swelling of the skin (exfoliative dermatitis) (very rare – may occur in less than 1 in 10,000 patients), mucosal inflammation (Stevens-Johnson syndrome) (very rare – may occur in less than 1 in 10,000 patients), toxic epidermal necrolysis (frequency not known), or other allergic reactions (not common – may occur in less than 1 in 100 patients);
• severe dizziness or fainting due to low blood pressure (common – may occur in less than 1 in 10 patients);
• weakness of the arms or legs, or difficulty speaking, which may be signs of stroke (very rare – may occur in less than 1 in 10,000 patients);
• heart attack, chest pain (angina pectoris) (very rare – may occur in less than 1 in 10,000 patients), abnormally rapid or irregular heartbeat (common – may occur in less than 1 in 10 patients);
• pancreatitis, which may cause severe upper abdominal pain radiating to the back and severe malaise (very rare – may occur in less than 1 in 10,000 patients);
• yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (very rare – may occur in less than 1 in 10,000 patients).

The following adverse reactions have been reported with the use of Co-Prestarium Initio. If any of these effects are troublesome to the patient, consult a doctor:

• common adverse reactions (may occur in less than 1 in 10 patients): feeling of "emptiness" in the head, cough, swelling (fluid retention).
• not common adverse reactions (may occur in less than 1 in 100 patients): high potassium levels in the blood, which may lead to heart rhythm disturbances (hyperkalaemia), increased blood glucose levels (hyperglycaemia), fatigue.

The following adverse reactions have been reported with perindopril or amlodipine, which were not observed or were observed with higher frequency with Co-Prestarium Initio than with Co-Prestarium Initio. These adverse reactions may also occur with Co-Prestarium Initio. If any of these effects are troublesome to the patient, consult a doctor:

• very common adverse reactions (may occur in at least 1 in 10 patients): swelling (fluid retention).

• common adverse reactions (may occur in less than 1 in 10 patients): headache, drowsiness (especially at the beginning of treatment), taste disturbances, tingling or numbness in the limbs, vertigo-related dizziness, visual disturbances (including double vision), tinnitus (sensation of hearing sounds), palpitations (awareness of heartbeat), sudden redness of the face and neck, shortness of breath, abdominal pain, nausea, vomiting, indigestion or digestive disturbances, changes in bowel rhythm, constipation, diarrhoea, itching, rash, skin redness, pruritus, ankle swelling, muscle cramps, fatigue, weakness.

• not common adverse reactions (may occur in less than 1 in 100 patients): increased number of a certain type of white blood cells (eosinophilia), low sodium levels in the blood (hyponatraemia), low blood glucose levels (hypoglycaemia), mood swings, anxiety, insomnia, depression, sleep disturbances, fainting, pain insensitivity, tremor, vasculitis, inflammation of the nasal mucosa (nasal congestion or discharge), dryness of the oral mucosa, excessive sweating, hair loss, red spots on the skin, skin depigmentation, formation of clusters of blisters on the skin, photosensitivity, back pain, muscle or joint pain, urinary disorders, need to urinate at night, increased frequency of urination, kidney disorders, impotence, discomfort or enlargement of the breasts in men, chest pain, malaise, pain, weight gain or weight loss, increased blood urea levels, increased blood creatinine levels, falls, fever.

• rare adverse reactions (may occur in less than 1 in 1,000 patients): acute kidney failure; symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion): dark urine, nausea or vomiting, muscle cramps, disorientation and seizures; reduced or absent urine output; exacerbation of psoriasis; high bilirubin levels in serum; increased liver enzyme activity.

• very rare adverse reactions (may occur in less than 1 in 10,000 patients): blood-related changes such as decreased numbers of white and red blood cells, decreased haemoglobin concentration, decreased platelet count, increased muscle tension, nerve disorders which may cause weakness, tingling or numbness, eosinophilic pneumonia (a rare type of pneumonia), gum overgrowth, abdominal bloating (gastritis), yellowing of the skin (jaundice).

• frequency not known (cannot be estimated from available data): tremor, muscle rigidity, facial masking, bradykinesia and dragging gait, unsteady gait; cyanosis, numbness and pain in fingers or toes (Raynaud's phenomenon).

If any of these symptoms occur, contact a doctor as soon as possible.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Co-Prestarium Initio

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the word
"EXP" (abbreviation used to describe the expiry date). The expiry date refers to the last day
of the stated month. The word "Lot" on the packaging indicates the batch number.
No special storage instructions apply to this medicinal product.
After first opening the tablet container containing 30 tablets of Co-Prestarium Initio,
the medicine should be used within 30 days.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help
protect the environment.

6. Contents of the pack and other information

What Co-Prestarium Initio contains

• The active substances are: perindopril with 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 with 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 with arginine, and 6.935 mg of amlodipine besylate, equivalent to 5 mg of amlodipine.
• The other ingredients of the tablet are: monohydrate lactose, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silicon dioxide.

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, imprinted with a mark on one side.

Tablets are available in packs containing 30 or 90 tablets (3 tablet containers with 30 tablets each).
The cap of the tablet container contains a desiccant.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Les Laboratoires Servier
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 Przedsiębiorstwo Farmaceutyczne S.A.
Annopol 6B
03-236 Warsaw
Poland
Egis Pharmaceuticals Private Limited Company
H-9900, Körmend
Mátyás király u. 65
Hungary

For further information, contact the representative of the Marketing Authorisation Holder:
Servier Polska Sp. z o.o.
Telephone number: (22) 594 90 00

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria Prestarium Co start, tablets
Cyprus Viacoram, tablets
France Amplival, tablets
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