Co-prestarium

Package leaflet: Information for the patient

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
Perindoprilum argininum + Amlodipinum
Please read this leaflet carefully before taking this medicine, as 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Co-Prestarium is and what it is used for
2. What you need to know 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 Co-Prestarium is and what it is 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 as separate tablets may instead take a single
Co-Prestarium tablet containing both active substances.
Co-Prestarium is a combination medicine containing two active substances: perindopril and
amlodipine.
Perindopril is an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine is a
calcium antagonist (belonging to a class 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 pump blood more effectively.

2. Important information before using Co-Prestarium

When not to use Co-Prestarium:

• 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 is more than 3 months pregnant (it is also better to avoid using Co-Prestarium in early pregnancy – see Pregnancy section);
• if the patient previously experienced symptoms such as wheezing, facial or tongue swelling, severe itching, or intense rashes while taking an ACE inhibitor, or if such symptoms occurred in a blood relative under any circumstances (a condition known as angioedema);
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient has aortic valve stenosis (narrowing of the aortic valve) or is in cardiogenic shock (a condition in which the heart is unable to deliver sufficient blood 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 undergoing dialysis or another form of blood filtration. Depending on the device used, Co-Prestarium may not be suitable for the patient;
• if the patient has kidney disorders that reduce blood supply to the kidneys (renal artery stenosis);
• if the patient has taken or is currently taking a medicine containing sacubitril and valsartan, used to treat heart failure, because this increases the risk of angioedema (rapid swelling of tissues under the skin, particularly in the throat area) (see "Warnings and precautions" and "Co-Prestarium with other medicines").

Warnings and precautions
Before starting treatment with Co-Prestarium, discuss with your doctor, pharmacist, or nurse if the patient has any of the following conditions:

• hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the blood vessel supplying blood to the kidney);
• heart failure;
• severe high blood pressure (hypertensive crisis);
• any other heart diseases;
• liver diseases;
• kidney diseases or undergoing dialysis;
• abnormally high levels of the hormone aldosterone in the blood (primary hyperaldosteronism);
• vascular collagenoses (connective tissue diseases), such as systemic lupus erythematosus or scleroderma;
• diabetes;
• following a low-sodium diet or using salt substitutes containing potassium (blood potassium levels should be monitored);
• need for dose adjustment in elderly patients;
• if 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,
  • aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also the section "When not to use Co-Prestarium".
• if the patient is taking any of the following medicines, because this increases the risk of angioedema:
  • racecadotril (used to treat diarrhoea);
  • sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of drugs known as 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 the group of drugs called gliptins (used to treat diabetes);
• if the patient is of Black race – in such cases, there may be a higher risk of angioedema, and the medicine may be less effective in lowering blood pressure compared to patients of other races.

Angioedema
Angioedema (a serious 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 Co-Prestarium. This reaction may occur at any time during treatment. If such symptoms occur, stop taking Co-Prestarium immediately and contact your doctor without delay. See also section 4.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Use of Co-Prestarium is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if used during this period (see Pregnancy section).
When taking Co-Prestarium, you should also inform your doctor or healthcare provider if:

• the patient is to undergo general 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 is not recommended for use in children and adolescents.

Co-Prestarium 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:

• with lithium (used to treat mania or depression);
• with estramustine (used to treat cancer);
• with potassium-sparing medicines (triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes, or 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 cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• with potassium-sparing medicines used in heart failure treatment: eplerenone and spironolactone at doses of 12.5 mg to 50 mg per day.

Other medicines may affect treatment with Co-Prestarium. Your doctor may recommend a dose adjustment and/or additional precautions. Inform your doctor if the patient is taking any of the following medicines, as this may require special care:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRAs), aliskiren (see also sections "When not to use Co-Prestarium" and "Warnings and precautions") or 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 so-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 use Co-Prestarium" and "Warnings and precautions".
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) used to relieve pain, or high doses of acetylsalicylic acid, a substance found in many medicines used for pain, fever, and prevention of blood clots;
• medicines used to treat diabetes (such as insulin);
• medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics, imipramine-type antidepressants, neuroleptics);
• immunosuppressive medicines (weakening the body's immune defenses), used to treat autoimmune diseases or after organ transplantation (e.g. cyclosporine, tacrolimus);
• trimethoprim and cotrimoxazole (used to treat infections);
• allopurinol (used to treat gout);
• procainamide (used to treat heart rhythm disorders);
• vasodilating medicines, including nitrates;
• ephedrine, noradrenaline, or adrenaline (medicines used to treat low blood pressure, shock, or asthma);
• baclofen or dantrolene (by infusion), used to treat muscle stiffness in conditions such as multiple sclerosis; dantrolene is also used to treat malignant hyperthermia occurring during anaesthesia (symptoms include very high fever and muscle rigidity);
• 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 blood cholesterol);
• 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 benign prostatic hyperplasia (enlarged prostate), such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin;
• amifostine (used to prevent or reduce side effects associated with other cancer treatments or radiotherapy);
• corticosteroids (used to treat various conditions, including severe asthma and rheumatoid arthritis);
• gold salts, especially when administered by injection (used to treat symptoms of rheumatoid arthritis);
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in the treatment of HIV infection).

Co-Prestarium with food and drink
Co-Prestarium should be taken before a meal.
While taking Co-Prestarium, do not drink grapefruit juice or eat grapefruits, as grapefruit and grapefruit juice may increase the concentration of the active substance amlodipine, which could lead to unpredictable intensification of the blood pressure-lowering effect of Co-Prestarium.

Pregnancy, breastfeeding and fertility
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 using this medicine.

Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Your doctor will usually recommend stopping Co-Prestarium before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Use of Co-Prestarium is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if used during this period.

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 is not recommended during breastfeeding. Your doctor may recommend an alternative medicine if you wish to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines
Co-Prestarium may affect the ability to drive or operate machinery. If the patient experiences nausea, dizziness, weakness, fatigue, or headache after taking the medicine, driving and operating machinery should be avoided and the patient should contact their doctor immediately.

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

3. How to take Co-Prestarium

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
The tablet should be swallowed with a glass of water, preferably at the same time each day, in the morning before
a meal. Your doctor will determine the appropriate dose for you. The usual recommended dose is one tablet
per day.
Co-Prestarium is generally recommended for patients already being treated with perindopril and amlodipine
in separate tablets.
Use in children and adolescents
Co-Prestarium is not recommended for use in children and adolescents.
Taking more Co-Prestarium than prescribed
If you take too many tablets, seek immediate medical attention at the nearest hospital emergency department
or contact your doctor. The most common symptom of overdose is low blood pressure, which may cause
dizziness or fainting.
In such a case, lying down with raised legs may help.
Breathlessness due to fluid accumulation in the lungs (pulmonary edema) may occur up to 24–48 hours
after taking the medicine.
If you miss a dose of Co-Prestarium
It is important to take the medicine every day, as regular use is most effective.
However, if you miss a dose of Co-Prestarium, take the next dose at your usual time.
Do not take a double dose to make up for the missed dose.
Stopping Co-Prestarium treatment
Treatment with Co-Prestarium is usually long-term; therefore, you should consult your doctor before
discontinuing the tablets.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse symptoms occur, stop taking the medicine immediately and contact your doctor without delay:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue or throat, causing significant breathing difficulties;
• severe skin reactions, including severe rash, urticaria, redness of the entire skin surface, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions;
• severe dizziness or fainting;
• heart attack, abnormally rapid or irregular heartbeat, or chest pain;
• pancreatitis, which may cause severe upper abdominal pain radiating to the back and severe malaise.

The following very common and common adverse effects have been reported. If any of these adverse effects are troublesome to the patient, or if they persist for more than one week, contact your doctor.

• Very common adverse effects (may affect at least 1 in 10 patients): oedema (fluid retention).
• Common adverse effects (may affect less than 1 in 10 patients): headache, central dizziness, drowsiness (especially at the beginning of treatment), labyrinthine dizziness, sensation of numbness or tingling in the limbs, visual disturbances (including double vision), tinnitus (perception of ringing or other sounds), palpitations (awareness of heartbeat), sudden flushing of the face and neck, sensation of "emptiness" in the head due to low blood pressure, cough, shortness of breath, nausea, vomiting, abdominal pain, taste disturbances, indigestion or digestive disturbances, changes in bowel habits, diarrhoea, constipation, allergic reactions (such as skin rashes, itching), muscle cramps, fatigue, weakness, swelling around the ankles (peripheral oedema).

Other reported adverse effects are listed below. If any of these adverse symptoms worsen, or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.

• Uncommon adverse effects (may affect less than 1 in 100 patients): mood swings, anxiety, depression, insomnia, sleep disturbances, tremor, fainting, loss of pain sensation, cardiac arrhythmias, nasal mucosal inflammation (nasal congestion or rhinitis), hair loss, red skin spots, skin discoloration, back pain, joint pain, muscle pain, chest pain, urinary disturbances, nocturia (urge to urinate at night), increased frequency of urination, pain, malaise, bronchospasm (feeling of tightness in the chest, wheezing and shortness of breath), dryness of the oral mucosa, angioedema (symptoms such as wheezing, swelling of the face or tongue), formation of blister clusters on the skin, kidney disorders, impotence, excessive sweating, increased eosinophil count (a type of white blood cell), discomfort or enlargement of the breasts in men, weight gain or weight loss, tachycardia (rapid heartbeat), vasculitis (inflammation of blood vessels), photosensitivity reactions (increased skin sensitivity to sunlight), fever, falls, changes in laboratory test results: high blood potassium levels (which resolve after discontinuation of treatment), low sodium levels, hypoglycaemia (very low blood sugar levels) in diabetic patients, increased blood urea levels, increased blood creatinine levels.
• Rare adverse effects (may affect less than 1 in 1,000 patients): acute kidney failure; symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion): dark-coloured urine, nausea or vomiting, muscle cramps, confusion and seizures; reduced or absent urine output; exacerbation of psoriasis; changes in laboratory test results: increased liver enzyme activity, high serum bilirubin levels.
• Very rare adverse effects (may affect less than 1 in 10,000 patients): cardiovascular disorders (angina pectoris, myocardial infarction and stroke), eosinophilic pneumonia (a rare type of lung inflammation), swelling of the eyelids, face or lips, swelling of the tongue and throat causing significant breathing difficulties, severe skin reactions including severe skin rash, urticaria, redness of the entire skin surface, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome), erythema multiforme (skin rash, often beginning with red, itchy spots on the face, arms or legs), photosensitivity, changes in blood parameters such as reduced white and red blood cell counts, decreased haemoglobin concentration, reduced platelet count, blood disorders, pancreatitis which may cause severe upper abdominal pain radiating to the back and severe malaise, liver function disorders, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity which may affect certain test results, abdominal distension (dyspepsia), nerve disorders causing weakness, tingling or numbness, increased muscle tone, gum swelling, increased blood sugar levels (hyperglycaemia).
• 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 your doctor as soon as possible.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can also 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Co-Prestarium

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.
Keep the container tightly closed to protect from moisture. Store in the original packaging.
No special temperature storage requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such 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.
  Co-Prestarium 5 mg + 5 mg: one tablet contains 5 mg of perindopril arginine complex and 5 mg of amlodipine.
  Co-Prestarium 10 mg + 5 mg: one tablet contains 10 mg of perindopril arginine complex and 5 mg of amlodipine.
  Co-Prestarium 5 mg + 10 mg: one tablet contains 5 mg of perindopril arginine complex and 10 mg of amlodipine.
  Co-Prestarium 10 mg + 10 mg: one tablet contains 10 mg of perindopril arginine complex and 10 mg of amlodipine.

• Other ingredients are: lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica.

What Co-Prestarium looks like and contents of the pack
Co-Prestarium 5 mg + 5 mg are white, elongated tablets measuring 8.5 mm in length and 4.5 mm in width,
with the imprint “5/5” on one side and the imprint “ ” on the other side.

Co-Prestarium 10 mg + 5 mg are white, triangular tablets measuring 9.5 mm x 8.8 mm x 8.8 mm,
with the imprint “10/5” on one side and the imprint “ ” on the other side.

Co-Prestarium 5 mg + 10 mg are white, square tablets measuring 8 mm in length and 8 mm in width,
with the imprint “5/10” on one side and the imprint “ ” on the other side.

Co-Prestarium 10 mg + 10 mg are white, round tablets with a diameter of 8.5 mm,
with the imprint “10/10” on one side and the imprint “ ” on the other side.

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

Marketing Authorisation Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy
France
Servier (Ireland) Industries Ltd
Gorey Road - Arklow – Co. Wicklow
Ireland
Anpharm Przedsiębiorstwo Farmaceutyczne S.A.
Annopol 6B
03-236 Warszawa
Poland

For further information, contact the local 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 European Economic Area countries 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
Poland Co-Prestarium
Portugal COVERAM
Romania PRESTANCE
Slovakia PRESTANCE
Slovenia PRESTANCE