Proficar

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

PROFICAR 75 mg, enteric-coated tablets
Acetylsalicylic acid

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

This medicine should always be taken exactly as described in the patient information leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after a few days there is no improvement or you feel worse, consult a doctor.

Table of contents of the leaflet

• 1. What is Proficar and what is it used for
• 2. Important information before taking Proficar
• 3. How to take Proficar
• 4. Possible side effects
• 5. How to store Proficar
• 6. Package contents and other information

1. What is Proficar and what is it used for

The active substance of Proficar, acetylsalicylic acid, inhibits platelet aggregation. The medicine's form - enteric-coated tablet, releasing the active substance in the intestine, protects the stomach lining from irritation.
Proficar is indicated for use in:
inhibiting platelet aggregation:

• in coronary heart disease,
• in recent myocardial infarction or suspected recent myocardial infarction,
• in preventing thromboembolic complications after coronary artery bypass grafting (CABG), after percutaneous transluminal coronary angioplasty (PTCA),
• in preventing transient ischemic attacks (TIA) and ischemic stroke in patients with TIA,
• in preventing the first myocardial infarction in patients with multiple risk factors,
• in preventing deep vein thrombosis in patients who are immobilized for a long time, e.g. after major surgical procedures as a supplement to other preventive methods.

If after a few days there is no improvement or you feel worse, consult a doctor.

2. Important information before taking Proficar

When not to take Proficar

• if the patient is hypersensitive to acetylsalicylic acid, other salicylates, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has a bleeding disorder,
• if the patient has active gastric or duodenal ulcer disease,
• if the patient has severe renal, hepatic, or heart failure,
• if the patient has had asthma attacks in the past after taking salicylates or substances with similar effects, especially non-steroidal anti-inflammatory drugs,
• in patients taking methotrexate at doses of 15 mg per week or higher,
• in women in the third trimester of pregnancy,
• in children under 12 years of age with viral infections due to the risk of Reye's syndrome - a rare but serious disease causing liver and brain damage.

Warnings and precautions

Before starting to take Proficar, consult a doctor or pharmacist.
Particular caution should be exercised when taking Proficar in patients:

• with hypersensitivity to non-steroidal anti-inflammatory and anti-rheumatic drugs or other allergenic substances,
• in the first and second trimester of pregnancy,
• during breastfeeding,
• taking anticoagulant medications,
• taking ibuprofen,
• with impaired liver or kidney function,
• with a history of gastric or gastrointestinal bleeding,
• with glucose-6-phosphate dehydrogenase deficiency. Acetylsalicylic acid may cause bronchospasm and trigger asthma attacks or other hypersensitivity reactions. Risk factors include: asthma, chronic respiratory diseases, hay fever with nasal polyps. This warning also applies to patients showing allergic reactions (e.g. skin reactions, itching, hives) to other substances. Acetylsalicylic acid, due to its anti-aggregatory effect, may lead to prolonged bleeding time during or after surgical procedures (including minor procedures, e.g. tooth extraction). Acetylsalicylic acid, even in small doses, reduces uric acid excretion. In patients with reduced uric acid excretion, the medicine may cause a gout attack.

Children and adolescents

Proficar should not be used in children under 12 years of age with viral infections due to the risk of Reye's syndrome.

Proficar and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Medicines contraindicated for concomitant use with acetylsalicylic acid:

• methotrexate at doses of 15 mg per week or higher Increased toxic effect of methotrexate on the bone marrow (decreased renal clearance of methotrexate during concomitant use with anti-inflammatory drugs - including acetylsalicylic acid - and displacement of methotrexate from protein binding). Interactions requiring special caution:
• methotrexate at doses less than 15 mg per week Increased toxic effect of methotrexate on the bone marrow (decreased renal clearance of methotrexate during concomitant use with anti-inflammatory drugs - including acetylsalicylic acid - and displacement of methotrexate from protein binding).
• ibuprofen Concomitant use of ibuprofen antagonizes the irreversible inhibition of platelet aggregation by acetylsalicylic acid. In patients with increased risk of cardiovascular events, treatment with ibuprofen may reduce the cardioprotective effect of acetylsalicylic acid.
• metamizol

Concomitant use of metamizol with acetylsalicylic acid may reduce the inhibitory effect of acetylsalicylic acid on platelet aggregation. Therefore, metamizol should be used with caution in patients taking acetylsalicylic acid in low doses for protective cardiovascular effects.

• anticoagulant medications, e.g. coumarin derivatives, heparin Concomitant use of acetylsalicylic acid with anticoagulant medications may increase the anticoagulant effect: increased risk of prolonged bleeding time and bleeding, resulting from displacement of anticoagulant medications from their protein binding and the anti-aggregatory properties of acetylsalicylic acid.
• other non-steroidal anti-inflammatory drugs, including salicylates in high doses (≥ 3 g/day) Concomitant use of non-steroidal anti-inflammatory drugs with acetylsalicylic acid increases the risk of gastric and duodenal ulcer disease and gastrointestinal bleeding, as well as kidney damage, due to the synergistic effect of these medicines.
• medicines that increase uric acid excretion, e.g. benzbromarone, probenecid Acetylsalicylic acid used concomitantly with medicines that increase uric acid excretion reduces the effect of medicines used to treat gout (competition in uric acid excretion through renal tubules).
• digoxin Concomitant use of acetylsalicylic acid with digoxin increases digoxin serum levels, resulting from decreased renal excretion of digoxin.
• antidiabetic medicines, e.g. insulin, sulfonylurea derivatives Due to their hypoglycemic properties and displacement of sulfonylurea derivatives from protein binding, acetylsalicylic acid increases the effect of antidiabetic medicines.
• thrombolytic or other antiplatelet aggregation medicines, e.g. ticlopidine, used concomitantly with acetylsalicylic acid may increase the risk of prolonged bleeding time and bleeding.
• diuretic medicines used concomitantly with acetylsalicylic acid at doses of 3 g per day and higher - reduced diuretic effect through sodium and water retention in the body due to decreased glomerular filtration caused by reduced prostaglandin synthesis in the kidneys. Acetylsalicylic acid may increase the ototoxic effect of furosemide.
• systemic glucocorticoids, except for hydrocortisone used as replacement therapy in Addison's disease, used concomitantly with acetylsalicylic acid - increased risk of gastric and duodenal ulcer disease and gastrointestinal bleeding, as well as reduced salicylate serum levels during corticosteroid therapy and increased risk of salicylate overdose after discontinuation of glucocorticoids.
• angiotensin-converting enzyme (ACE) inhibitors used concomitantly with acetylsalicylic acid at doses of 3 g per day and higher - reduced antihypertensive effect through decreased glomerular filtration, resulting from inhibition of prostaglandin production, which has a vasodilatory effect on blood vessels.
• valproic acid Acetylsalicylic acid increases the toxicity of valproic acid by displacing it from protein binding. Valproic acid increases the anti-aggregatory effect of acetylsalicylic acid due to the synergistic anti-aggregatory effect of both medicines.
• alcohol Alcohol may increase the risk of gastrointestinal adverse effects, such as mucosal damage or bleeding.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.
The medicine can be used in the first and second trimester of pregnancy only if necessary, after careful consideration of the risk-to-benefit ratio.
Taking acetylsalicylic acid in doses higher than 300 mg per day in the third trimester of pregnancy leads to premature closure of the fetal ductus arteriosus and inhibition of uterine contractions. Both in the mother and the child, an increased tendency to bleeding has been observed.
Taking acetylsalicylic acid in doses higher than 300 mg per day during the perinatal period may - especially in preterm infants - lead to intracranial hemorrhages.
Taking acetylsalicylic acid in the third trimester of pregnancy is contraindicated.
Acetylsalicylic acid and its metabolites pass into breast milk in small amounts. Since, to date, no adverse effects have been observed in infants breastfed by mothers taking salicylates for a short period, breastfeeding does not usually need to be discontinued. However, in the case of regular intake of high doses of acetylsalicylic acid, breastfeeding should be discontinued beforehand.

Driving and using machines

The medicine has no effect on the ability to drive vehicles or operate machinery.

3. How to take Proficar

This medicine should always be taken exactly as described in the patient information leaflet or as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Recommended dose
Initial single dose - 150 mg per day.
Maintenance dose - 75 mg per day.
Tablets should be swallowed whole, not chewed.

Overdose of Proficar

Overdose in elderly people and small children (taking higher doses than recommended or accidental poisoning) requires special attention, as it may lead to death in these patient groups.
Symptoms:
Mild overdose: uncontrolled hand tremors, especially in elderly patients, diarrhea, abdominal pain, drowsiness, rapid and deep breathing, nausea, vomiting, tinnitus, feeling of hearing loss, headaches, dizziness; these symptoms may resolve after dose reduction. Severe overdose: initially hyperventilation, then shallow breathing and difficulty breathing, fever, ketonuria, respiratory alkalosis, metabolic acidosis, coma, cardiogenic shock, respiratory failure, severe hypoglycemia, blood in urine, seizures, hallucinations, ketonuria, proteinuria, hypokalemia.
Procedure after overdose:
The patient should be taken to the hospital immediately. The procedure depends on the dose taken, stage, and clinical symptoms. Measures should be taken to reduce the absorption of the active substance: gastric lavage, administration of activated charcoal, and monitoring of acid-base balance (it is necessary to monitor the following blood parameters: pH, pCO2, bicarbonate levels, potassium levels). If kidney function is preserved, alkaline diuresis can be used until a urine pH of 7.5-8 is achieved; in the case of salicylate serum levels above 500 mg/l (3.6 mmol/l) in adults or 300 mg/l (2.2 mmol/l) in children, the possibility of forced alkaline diuresis should be considered. Infusions containing NaHCO3, KCl, and diuretics should be used.
In cases of severe poisoning, hemodialysis or peritoneal dialysis can be used. Fluids should be supplemented, and general symptomatic treatment should be provided.

Missed dose of Proficar

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Gastrointestinal disorders:
Symptoms of indigestion (heartburn, nausea, vomiting), abdominal pain, rarely inflammatory conditions of the stomach and intestines; gastric and duodenal ulcer disease very rarely leading to bleeding and perforation with corresponding laboratory and clinical symptoms.
Liver and biliary disorders:
Rarely, transient liver function disorders with increased liver enzyme activity have been reported.
Nervous system disorders:
Dizziness and tinnitus, usually symptoms of overdose.
Blood and lymphatic system disorders:
Increased risk of bleeding, prolonged bleeding time, prothrombin time, thrombocytopenia (reduced platelet count). Bleeding such as: perioperative bleeding, hematomas, nosebleeds, bleeding from the urinary and genital tracts, gum bleeding. Rarely or very rarely, severe bleeding such as: gastrointestinal bleeding, cerebral hemorrhage (especially in patients with uncontrolled hypertension and/or concomitant use of bleeding-inhibiting medicines), which in individual cases may be life-threatening.
Bleeding may lead to acute or chronic anemia due to bleeding and/or iron deficiency anemia (e.g. due to hidden microbleeding) with corresponding laboratory and clinical symptoms, such as: asthenia, pallor, hypoperfusion (reduced blood flow).
Renal and urinary disorders:
Rarely, after long-term use of high doses of acetylsalicylic acid, renal papillary necrosis and interstitial nephritis have occurred.
Immune system disorders:
Hypersensitivity reactions with corresponding laboratory and clinical symptoms, including: asthma, skin reactions, rash, urticaria, edema, itching, cardiorespiratory disorders. Very rarely, severe reactions, including anaphylactic shock.
Long-term use of medicines containing acetylsalicylic acid may cause headache, which worsens with subsequent doses.
Long-term use of painkillers, especially those containing multiple active substances, may lead to severe kidney damage and kidney failure.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C,
02-222 Warsaw,
phone: 22 49-21-301,
fax: 22 49-21-309,
e-mail: ndl@urpl.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 Proficar

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Proficar contains

• The active substance is acetylsalicylic acid
• The other ingredients are: corn starch, microcrystalline cellulose, talc. Coating ingredients: methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate, povidone, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What Proficar looks like and contents of the pack

Enteric-coated tablets, yellow, with a uniform surface.
Packaging: aluminum foil blisters, PVC/Al or PE tablet containers with a PE cap, in a cardboard box. Single packaging contains 30 or 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of last revision of the leaflet: