Kopirina - tabletki od bulu gvovi

Package Leaflet: Information for the Patient

K –
Acetylsalicylic Acid+ Caffeine
400 mg + 50 mg, tablets

Read the Leaflet Carefully Before Using the Medication, as it Contains

Important Information for the Patient.
This medication should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.

Table of Contents of the Leaflet

• 1. What is K – and what is it used for
• 2. Important Information Before Using K –
• 3. How to Use K –
• 4. Possible Side Effects
• 5. How to Store K –
• 6. Package Contents and Other Information

1. What is K – and What is it Used For

The medication contains two active substances: acetylsalicylic acid with analgesic, antipyretic, and anti-inflammatory effects. It is believed that caffeine enhances the effect of acetylsalicylic acid in headaches and that caffeine, when taken orally with painkillers, reduces fatigue and fluid retention associated with menstruation.
The medication is used for mild to moderate pain, such as headaches, muscle aches, menstrual cramps, and fever.

2. Important Information Before Using K –

When Not to Use K –

• if the patient is allergic to the active substances, other salicylates, other nonsteroidal anti-inflammatory drugs, or any of the other ingredients of this medication (listed in section 6);
• if the patient has: severe liver, kidney, or heart disorders; severe uncontrolled hypertension; active peptic ulcer disease; gastrointestinal bleeding; hemorrhagic diathesis (a general tendency to bleed).
• if the patient has a history of asthma attacks triggered by salicylates or substances with similar effects, particularly nonsteroidal anti-inflammatory drugs;
• during pregnancy and breastfeeding;
• if the patient is taking methotrexate in doses of 15 mg per week or higher;
• in children under 12 years of age, during viral infections due to the risk of Reye's syndrome;
• at least 5 days before surgery.

Warnings and Precautions

K – should be used with caution and only under medical supervision in cases of:

• asthma, chronic respiratory diseases, hay fever, nasal polyps, or allergic reactions;
• blood coagulation disorders (due to vitamin K deficiency);
• anemia (red blood cell deficiency);
• high blood pressure;
• heart disorders;
• gout (a disease related to increased uric acid levels in the blood);
• liver and kidney disorders;
• concomitant use of anticoagulant medications;
• history of peptic ulcer disease or gastrointestinal bleeding;
• glucose-6-phosphate dehydrogenase deficiency (an enzyme involved in red blood cell metabolism).

Concomitant use of K – with alcohol increases the risk of gastrointestinal bleeding.
Long-term use of painkillers, especially those containing multiple active substances, may lead to permanent kidney damage.
Acetylsalicylic acid may hinder fertility. If a patient plans to become pregnant or is having trouble becoming pregnant, they should inform their doctor.

K – and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
K – should not be used with the following medications:

• methotrexate (used in cancer, rheumatic diseases, psoriasis);
• coumarin derivatives, heparin, ticlopidine (anticoagulant medications);
• other nonsteroidal anti-inflammatory drugs (used to combat fever, pain, inflammation);
• glucocorticosteroids, except for hydrocortisone (used, among others, in inflammatory conditions, allergies);
• digoxin (used in heart failure);
• medications used in diabetes;
• valproic acid (used in epilepsy);
• sympathomimetics (used, for example, in asthma, colds, glaucoma, hypertension);
• thyroxine (used in hypothyroidism);
• substances with effects similar to ephedrine (used in hypotension, inflammatory conditions of mucous membranes);
• barbiturate derivatives (used, among others, as sedatives);
• benzbromarone, probenecid (used in gout);
• diuretics (e.g., spironolactone, furosemide - used in hypertension);
• angiotensin-converting enzyme inhibitors (used in hypertension);
• antihistamines (used in allergies);
• theophylline (used in asthma);
• cimetidine (used in peptic ulcer disease);
• quinolone derivatives (used in bacterial infections);
• disulfiram (used in alcoholism);
• oral contraceptives.

K – should also not be used with alcohol or tobacco.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult a doctor or pharmacist before using this medication.
In the event of pregnancy during long-term use of the medication, the doctor should be informed.

Driving and Operating Machinery

The medication does not affect the ability to drive or operate machinery.

3. How to Use K –

This medication should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.
In case of doubts, a doctor or pharmacist should be consulted.
Usually, the recommended dose of K – is:
Adults: 1 to 2 tablets up to 3 times a day
Children over 12 years of age: ½ to 1 tablet 3 times a day
Tablets should be swallowed with a large amount of water.

Using a Higher Than Recommended Dose of K –

In case of taking a higher dose than recommended, a doctor or pharmacist should be consulted immediately.

Missing a Dose of K –

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

Stopping the Use of K –

The medication is not intended for long-term use. In case of any further doubts related to the use of this medication, a doctor or pharmacist should be consulted.

4. Possible Side Effects

Like all medications, K – can cause side effects, although not everybody gets them.
The following may occur:

• stomach and abdominal pain, heartburn, nausea, vomiting, indigestion, inflammation, and bleeding from the gastrointestinal tract (symptoms of bleeding include coffee ground vomiting, black stools, and the risk of bleeding increases with higher doses), peptic ulcer disease, perforation (perforation of the gastrointestinal tract wall), gastrointestinal disorders;
• transient liver function disorders;
• headache with long-term use;
• dizziness and tinnitus, usually after taking a higher dose than recommended;
• increased risk of bleeding, hemorrhages (postoperative, nasal, gum, urogenital), hematomas, prolonged bleeding time, platelet deficiency. The consequence of bleeding may be anemia.
• brain hemorrhage (especially in patients with uncontrolled high blood pressure and/or concomitantly using other anticoagulant medications); transient increase in blood pressure;
• after long-term use of high doses of acetylsalicylic acid, kidney damage has been reported;
• allergic reactions: asthma, mild to moderate skin reactions (e.g., rash, urticaria), respiratory disorders, heart rhythm disorders, edema, and very rarely severe allergic reactions, including anaphylactic shock (may include facial and eyelid edema, tongue and larynx edema with narrowing of the airways, breathing difficulties, shortness of breath up to asthma attacks, increased heart rate, sudden drop in blood pressure; if any of these symptoms occur, immediate medical attention should be sought);
• insomnia, restlessness;
• palpitations, increased heart rate.

Reporting Side Effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medication.

5. How to Store K –

Store at a temperature below 25°C.
Keep out of sight and reach of children.
Do not use this medication after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.

6. Package Contents and Other Information

What K – Contains

• The active substances of the medication are: acetylsalicylic acid and caffeine.
• Other ingredients of the medication include potato starch.

What K – Looks Like and What the Package Contains

Blister pack of PP film or Aluminum/PVC in a cardboard box.
6 pieces (1 blister of 6 pieces)
12 pieces (2 blisters of 6 pieces or 1 blister of 12 pieces)

Marketing Authorization Holder

MEDICOFARMA S.A.Sopharma Warszawa Sp. z o.o.
Al. Jerozolimskie 1136ul. Sokołowska 9 lok. 19
02-30501-142 Warsaw
Phone: 22 613 39 30

Manufacturer

Medicofarma S.A.
Tarnobrzeska 13
26-613 Radom
“MARCMED” Sp.z o.o.
ul. Zamenhofa 29-31
20-435 Lublin
Date of Last Update of the Leaflet:08/2021