Patient information leaflet

What active substances and auxiliary materials does the preparation contain?

Active substance:
250 mg paracetamol per tablet

Auxiliary materials:
Polyvidone, pregelatinised starch, stearic acid

Appearance:
Tablet: white and long with a bisecting line on each side of the tablet

Packaging:
10 tablets in a transparent blister foil and box

Pack size:
10 tablets

Registration category
Over-the-counter medicinal product

Marketing authorisation holder:
Béres Házipatika Kft.
1037 Budapest, Mikoviny u. 2-4.

Manufacturer:
Béres Gyógyszergyár Zrt.
5005 Szolnok, Nagysándor József u. 39.

1. What type of medicine is Béres Febrilin© 250 mg tablet and what diseases can it be applied for?

To reduce fever and ease mild and moderate pains (headache, toothache, muscle and joint pain, neuralgia, inflammation-associated pain, pain caused by cold, fever).

2. Important notes before taking Béres Febrilin© 250 mg tablet

Do not apply the preparation in the case of:

allergy to any of the active substances or auxiliary materials of the preparation,
severe liver and kidney disorders,
innate glucose-6-phosphate dehydrogenase deficiency,
chronic alcoholism.

Can be applied based on individual medical judgement in the cases of:

mild liver or kidney disorders,
Gilbert disease.

Application of the tablet with dishes/drinks:
Simultaneous alcohol consumption increases the risk of liver damage.

Pregnancy, lactation:
If possible, pregnant women should not use the preparation in the first 3 months and the last 6 weeks of their pregnancy and during lactation. The preparation can be taken exclusively based on medical judgement in other periods.

The effects of the preparation on driving capabilities and capabilities of the operation of machines:
No effects of the preparation are known that would influence these capabilities.

Other medicines taken during the treatment:

Béres Febrilin© 250 mg tablet can be taken based on individual medical judgement in the following cases:

with preparations causing liver enzyme induction (e.g. fenobarbital, cyclooxigenase enzyme inhibitor medicinal products, phenytoin, carbamazepine, rifampicin), owing to the possibility of the accumulation of toxic paracetamol metabolites;
with chloramphenicol, the degradation time of which might lengthen, its toxicity may increase,
with anticoagulants, prothrombin-time may lengthen;
with doxorubicin, the risk of liver damage may increase;
with metoclopramide, which increases paracetamol absorption,
preparations retarding the stomach’s evacuation (e.g.: propantheline)

3. How to apply Béres Febrilin© 250 mg tablet?

For children for maximum 5 days:

a single dose for children aged 4-6 years is 125-250 mg (1/2 or 1 250 mg tablet), maximum 4 times a day,
a single dose for children aged 6-9 years is 250-500 mg (1-2 250 mg tablets), maximum 4 times a day,
a single dose for children aged 9-14 years is 500 mg (2 250 mg tablets), maximum 4 times a day.

The maximum daily dose is 2000 mg, wait minimum 4 hours between taking the doses.

The preparation is to be taken with at least half a decilitre liquid (e.g. water, tea, fruit juice, etc.). Medical supervision is required when administered for children for more than 3 days.

If more tablets were taken than prescribed:
See the doctor or the emergency department of the nearest hospital. The symptoms of overdose can even be lethal, arising 24-48 hours after administration.

If a dose was missed:
Do not take a double dose the next time, because the omitted quantity cannot be supplied this way, but there would be a risk of overdose. Continue the treatment as prescribed!

Side effects arising when the treatment is discontinued:
If a pain relief medicine is applied for a long time, in a high dose or not as prescribed, as well as the sudden discontinuing of its administration may cause headaches, fatigue, muscle pains, irritability and vegetative symptoms. Do not take any pain relief until these symptoms spontaneously cease within a few days and see your doctor.

4. Possible side effects

Allergic phenomena (skin rashes, itching, sweating fits, nausea, low blood pressure, shock) may very rarely occur while taking the preparation. In this case, stop taking the preparation! In a high dose, mainly when applied for a long time, it is toxic, and in a very high dose a lethal liver damage may result, the early symptoms of which are the loss of appetite, nausea, vomiting, sweating, general weakness, malaise.

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-9591/01
Patient information leaflet approval date:
April 28, 2006.