Patient information leaflet

What active substances and auxiliary materials does the preparation contain?

Active substances:
500 mg paracetamol, 300 mg propyphenazone, 75 mg caffeine per film-coated tablet.

Auxiliary materials:

Core: water-free colloid silicon dioxide, talc, magnesium stearate, type-A carboxymethyl starch sodium, dicalcium phosphate anhydrate, microcrystalline cellulose, povidone.
Coating: Patent Blue V (E 131), quinoline yellow (E 104), titanium dioxide (E171), macrogol stearate, microcrystalline cellulose, hypromellose, carnauba wax.

Packaging: 10 film-coated tablets in a transparent PVC/Alu blister and a box.
Marketing authorisation holder: Béres Házipatika Kft., 1037 Budapest, Mikoviny u. 2-4. Manufacturer: Béres Gyógyszergyár Zrt., 1037 Budapest, Mikoviny u. 2-4.

1. What diseases is Béres Trinell Pro© film-coated tablet for and how does it take effect?

What is the preparation recommended for?
The preparation is recommended for relieving mild and moderate pains like menstruation pains, headaches, migraines, toothaches, rheumatic pains, postoperative pains, as well as cold-related pains and to reduce fever.

2. Important notes before taking Béres Trinell Pro© film-coated tablet

When should you avoid taking this preparation?
If you are hypersensitive to medicines containing phenylbutazone, acetyl salicylic acid, pyrazolone or similar compounds (phenazone, propyphenazone, aminophenazone, metamizole) or to any compound of the preparation. Do not take in the cases of hereditary glucose-6-phosphate dehydrogenase deficiency, severe liver or kidney disorders, porphyrin metabolism disorder (porphyria) and excessive or chronic alcohol consumption, as well as below 12 years of age.

What do you need to know before taking it?
Do not take the medicine in higher doses than recommended and longer than 1 week without medical instructions. If you have a fever or you are in pain for more than 3 days, see your doctor! If you have asthma, if you are hypersensitive to pain relief or antirheumatic preparations, if you have other diseases or allergies, if you take anticoagulants, consult your doctor before taking Béres Trinell Pro© film-coated tablet. Do not drink alcohol while taking this medicine.

Can children take this preparation?
Children below 12 years of age cannot take this film-coated tablet.

Can you take the preparation with other medicines?
Preparations taken simultaneously may influence each others’ effects. Consult your doctor if you also take sleeping pills, preparations influencing the emptying of the stomach, chloramphenicol, metoclopramide, antiallergic preparations, anticoagulants or oral contraceptives.

What do you need to consider during pregnancy and lactation?
If you have any questions before taking a medicine consult your doctor or pharmacist. Pregnant women should not take this preparation in the first 3 months and the last 6 weeks of their pregnancy. At other times, consult your doctor before taking this medicine! Do not take this preparation during nursing.

3. How to apply Béres Trinell Pro© film-coated tablet?

What is the recommended dose?
Depending on the intensity of pain, its single dose for adults is 1 film-coated tablet. If necessary, the single dose can be repeated 3 times within 24 hours. The daily maximum dose is 4 film-coated tablets.

How and when should you take the preparation?
If you are in pain, take the preparation whole with abundant liquid (e.g. water, tea, fruit juice, etc.).

How long can you take the preparation?
If your complaints persist even with the recommended daily maximum dose for a long time (more than 3 days) contact your doctor!

What else should you make sure during the application of the preparation?
If you keep the tablet in your mouth without water, or if you swallow it this way, it may discolour your tongue and the mucous membrane of the mouth, which phenomenon is harmless and do not influence the efficacy of the medicine.

4. Possible side effects
If you perceive any of the side effects listed below, stop taking the medicine and contact your doctor!
Hypersensitivity reactions (hives, itching) might rarely occur when taking the preparation. Very rarely those who are sensitive to it, respiratory system related (difficulty in breathing, asthma) and circulatory system related problems may arise.

Overdosing:
The prolonged application of large doses may cause severe, irreversible liver damage and renal function deterioration. The symptoms of paracetamol overdose: nausea, vomiting, loss of appetite, malaise, abdominal pains. Overdose may cause hepatic coma leading to death. Symptoms of caffeine overdose: excitation, shaking, ringing in the ears, heart rate problems.
Urgently seek medical help in the case of an overdose!

5. Storage
Store it below 25^oC.
The medicine is to be stored out of reach of children! Do not take the medicine after its expiry date printed on the packaging.

OGYI-T-9400/02
Patient information leaflet approval date: April 28, 2006.

For risks and side effects, please read the patient information leaflet or consult your doctor, pharmacist!

For risks and side effects, please read the patient information leaflet or consult your doctor, pharmacist!