Coffepirine Tabletki od bulu gvovi

Package Leaflet: Information for the Patient

COFFEPIRINE Pain Relief Tablets, 450 mg + 50 mg, tablets

Acetylsalicylic acid + Caffeine

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 leaflet or as directed 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 any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days in adults or 1 day in adolescents over 12 years, there is no improvement or the patient feels worse, consult a doctor.

Table of Contents of the Leaflet:

• 1. What is Coffepirine Pain Relief Tablets and what is it used for
• 2. Important information before taking Coffepirine Pain Relief Tablets
• 3. How to take Coffepirine Pain Relief Tablets
• 4. Possible side effects
• 5. How to store Coffepirine Pain Relief Tablets
• 6. Contents of the pack and other information

1. What is Coffepirine Pain Relief Tablets and what is it used for

Coffepirine Pain Relief Tablets contain two active substances: acetylsalicylic acid with analgesic, antipyretic, and anti-inflammatory effects, and caffeine, which acts on the brain's vasomotor center, causing vasoconstriction of blood vessels, thereby reducing blood flow through brain tissue. It also stimulates the respiratory center.
Coffepirine Pain Relief Tablets are used to treat pains of various origins with mild to moderate intensity (e.g., headaches, rheumatic, muscle, neuralgic, toothache).

2. Important information before taking Coffepirine Pain Relief Tablets

When not to take Coffepirine Pain Relief Tablets:

• during pregnancy and breastfeeding;
• if the patient is allergic to acetylsalicylic acid, caffeine, or any of the other ingredients of this medicine (listed in section 6) or to salicylates;
• in case of stomach or duodenal ulcer, gastrointestinal bleeding, hemorrhagic diathesis, gout, severe kidney or liver dysfunction;
• in children under 12 years of age;
• in patients who have had asthma attacks, induced by the administration of salicylates or substances with similar effects, especially non-steroidal anti-inflammatory drugs;
• concomitantly with methotrexate in doses of 15 mg per week or higher, and similarly with other medicines containing acetylsalicylic acid on the day the patient receives a dose of methotrexate;
• in severe heart failure;
• to combat pain after coronary artery bypass grafting.

Warnings and precautions

Should be used with caution in:

• patients with hypersensitivity to non-steroidal anti-inflammatory and anti-rheumatic drugs or other allergizing substances and with allergic diseases (asthma, hay fever, with nasal polyps);
• patients taking anticoagulant medications;
• patients who have had stomach ulcers or gastrointestinal bleeding;
• patients with glucose-6-phosphate dehydrogenase deficiency;
• patients with hyperthyroidism;
• patients with hypertension;
• patients with epilepsy;
• patients before surgical procedures;
• patients with liver and/or kidney function disorders;
• women using intrauterine contraceptive devices or during heavy menstrual bleeding.

The medicine may have a negative effect on female fertility (see below).
Taking such medicines as Coffepirine Pain Relief Tablets may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not take higher doses or for longer than recommended.
In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, increased cholesterol levels, smoking), consult a doctor or pharmacist.
Consult a doctor, even if the above warnings refer to past situations.

Children

The medicine should not be used in children and adolescents under 12 years of age.
Due to the possibility of Reye's syndrome - a rare but serious disease causing liver and brain damage, the medicine may be used in viral infections with or without fever only on the doctor's prescription.

Coffepirine Pain Relief Tablets and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as medicines you plan to take, especially if you are taking:

• methotrexate in doses of 15 mg per week or higher - concomitant use of Coffepirine Pain Relief Tablets is contraindicated;
• methotrexate in doses less than 15 mg per week - increased risk of toxic effects of methotrexate on the bone marrow;
• ticlopidine - concomitant use increases the risk of bleeding; if there is a need for concomitant administration of medicines containing acetylsalicylic acid and ticlopidine, bleeding time tests should be performed;
• medicines that increase uric acid excretion - the effectiveness of diuretics, e.g., spironolactone and furosemide, and blood pressure-lowering medicines may be reduced when used concomitantly with acetylsalicylic acid;
• furosemide - acetylsalicylic acid enhances the harmful effect of this medicine on the ears;
• glucocorticosteroids - during systemic use of these medicines, the salicylate concentration in the blood decreases. After discontinuation of steroids, there is a risk of salicylate overdose. The dose of salicylates should be determined separately during concomitant administration with steroid medicines and after their discontinuation;
• fluoroquinolone antibiotics - concomitant use of the medicine with fluoroquinolone derivatives (e.g., ciprofloxacin) may cause accumulation of caffeine in the body;
• cimetidine or disulfiram - slow down caffeine metabolism;
• oral contraceptives - slow down caffeine metabolism;
• barbiturates - accelerate caffeine metabolism;
• isoprenaline - caffeine may enhance its effect;
• oral antidiabetic medicines from the sulfonylurea group - acetylsalicylic acid enhances their effect;
• medicines that reduce blood clotting, including coumarin derivatives - acetylsalicylic acid enhances their effect;
• certain antibiotics - acetylsalicylic acid enhances their effect;
• other non-steroidal anti-inflammatory medicines - concomitant use with acetylsalicylic acid increases the risk of damage to the gastrointestinal mucosa and kidney damage;
• sedatives and hypnotics - caffeine reduces their effect;
• medicines that cause rapid heart rate, e.g., from the sympathomimetic group, thyroxine - caffeine enhances their effect. Concomitant use of ibuprofen may inhibit the effect of low-dose acetylsalicylic acid in preventing clot formation.

Coffepirine Pain Relief Tablets with food, drink, or alcohol

See section 3 of the leaflet.
Note! Alcohol increases the risk of stomach mucosa irritation and gastrointestinal 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.
Taking Coffepirine Pain Relief Tablets during pregnancy and breastfeeding is contraindicated.
This medicine belongs to a group of medicines that may have a negative effect on female fertility. This effect is temporary and disappears after the end of therapy.

Driving and using machines

Coffepirine Pain Relief Tablets have no influence or insignificant influence on the ability to drive and use machines.

3. How to take Coffepirine Pain Relief Tablets

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Adults and adolescents over 12 years
Usually, 1 tablet (450 mg of acetylsalicylic acid and 50 mg of caffeine) is taken, if necessary, from 2 to 6 times a day, but not more often than every 4 hours.
Do not take more than 6 tablets (corresponding to 2700 mg of acetylsalicylic acid and 300 mg of caffeine) in 24 hours.
The medicine should not be used without consulting a doctor for more than 3 days in adults and for more than 1 day in adolescents over 12 years.
In adolescents over 12 years, use with caution due to the content of caffeine.
Method of administration
Do not take on an empty stomach. Swallow the tablet with a large amount of liquid.

Use in children and adolescents

Do not use in children and adolescents under 12 years of age.
If you feel that the effect of the medicine is too strong or too weak, consult a doctor.

Overdose of Coffepirine Pain Relief Tablets

Symptoms of overdose usually occur within 2 hours.
After an overdose, the following may occur: hand tremors, diarrhea, drowsiness, tinnitus, headaches and dizziness, disorientation, rapid breathing, acid-base balance disorders, and metabolic acidosis, vomiting, and abdominal pain, elevated body temperature, decreased prothrombin levels, seizures. In case of severe overdose, the following may occur: hyperventilation (rapid and deep breathing), respiratory disorders, fever, metabolic acidosis, coma.
Symptoms of caffeine overdose are central nervous system disorders, i.e., anxiety, agitation, racing thoughts, insomnia, seizures, palpitations, abdominal pain, diarrhea, nausea, and vomiting.
Procedure after overdose
The patient should be taken to the hospital immediately.
The procedure depends on the amount of the dose taken, the stage, and clinical symptoms. Measures should be taken to reduce the absorption of the active substance: gastric lavage, administration of activated carbon, and monitoring of acid-base balance.
If kidney function is preserved, alkaline diuresis can be used until a urine pH of 7.5-8 is achieved; in case of severe poisoning, forced alkaline diuresis, hemodialysis, or peritoneal dialysis should be considered.
Fluids should be supplemented, and general symptomatic treatment should be provided.

Missed dose of Coffepirine Pain Relief Tablets

Do not take a double dose 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.
The frequency of side effects of Coffepirine Pain Relief Tablets depends on the dose of the medicine, the patient's condition, and sensitivity, as well as concomitant treatment.
The frequency of side effects is unknown (frequency cannot be estimated from available data).
Stop taking the medicine and consult a doctor immediately if you experience any of the following:

• coffee grounds vomiting, black, tarry stools,
• sudden severe abdominal pain,
• hives, rash, heart rhythm disorders, nasal mucosa inflammation, facial, eyelid, laryngeal edema, shortness of breath,
• bleeding,
• oliguria or anuria and edema. In rare cases, after long-term use of high doses of acetylsalicylic acid, renal papillary necrosis and interstitial nephritis have been reported
• myocardial infarction: chest pain, shortness of breath, nausea, sweating,
• stroke; taking some NSAIDs (especially long-term and in high doses) may be associated with a small increased risk of arterial thrombosis (e.g., myocardial infarction or stroke), see Warnings and precautions in section 2.

Other side effects:
Blood and lymphatic system disorders
prolonged bleeding time, prothrombin time, thrombocytopenia (reduced platelet count).
Immune system disorders
asthma, angioedema.
Nervous system disorders
dizziness, tinnitus; caffeine contained in the medicinal product may cause insomnia, restlessness.
Long-term use of acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Cardiac disorders
Caffeine may cause heart rhythm disorders.
Unknown frequency: edema, hypertension, and heart failure.
Gastrointestinal disorders
abdominal pain, heartburn, nausea, vomiting; occult gastrointestinal bleeding, which may cause iron deficiency anemia; stomach and duodenal ulcers.
Hepatobiliary disorders
Rarely, liver function disorders (increased aminotransferase activity) have been observed.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 Coffepirine Pain Relief Tablets

Store in a temperature below 25°C.
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.
The expiry date refers to the last day of the month.
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. Contents of the pack and other information

What Coffepirine Pain Relief Tablets contain

• The active substances of the medicine are acetylsalicylic acid and caffeine.
• The excipients are potato starch and talc.

What Coffepirine Pain Relief Tablets look like and contents of the pack

Coffepirine Pain Relief Tablets are white, round, flat on both sides or convex, with the inscription "from headache" on one side and an equal-armed cross on the other.
The pack contains:
6, 8, 12, 18 tablets in PVC/Aluminum or cellulose film and polyethylene-coated paper blisters in cardboard boxes
or 20, 50 tablets in PVC/Aluminum blisters in cardboard boxes
Not all pack sizes may be marketed.

Marketing authorization holder

Sopharma Warszawa Sp. z o. o.
Al. Jerozolimskie 136
02-305 Warsaw

Manufacturer

Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom

Date of last revision of the leaflet: