Paracetamol 500mg Biogaran 16 capsules

. WHAT IS PARACETAMOL BIOGARAN 500 mg, capsule AND WHAT IS IT USED FOR?

Pharmacotherapeutic class

ANTALGIC

ANTIPYRETIC

(N. Central nervous system)

Therapeutic indications

This medicine contains paracetamol.

It is indicated in cases of pain and/or fever such as headaches, flu-like conditions, toothache, aches and pains, painful periods.

This presentation is reserved for adults and children from 27 kg (approximately 8 to 15 years).

For children weighing less than 27 kg, there are other presentations of paracetamol: ask your doctor or pharmacist for advice.

2. WHAT DO YOU NEED TO KNOW BEFORE TAKING PARACETAMOL BIOGARAN 500 mg, capsule?

List of information needed before taking the medicine

Not applicable.

Contraindications

Never take PARACETAMOL BIOGARAN 500 mg, capsule in the following cases:

• - Known allergy to paracetamol.
• - Severe liver disease.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Precautions for use; special warnings

Be careful with PARACETAMOL BIOGARAN 500 mg, capsule:

Special Warnings

In case of overdose or if you take too much by mistake, consult your doctor immediately.

Tablets and capsules should not be taken by children under 6 years of age as they may swallow the wrong way and choke.

Precautions for use

• - If the pain persists for more than 5 days or the fever for more than 3 days, or in case of insufficient efficiency or any other sign, do not continue the treatment without the advice of your doctor.
• - In case of serious liver or kidney disease, it is necessary to consult your doctor before taking paracetamol.

IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Interactions with other medicines

Taking or using other medicines

Report taking this medication if your doctor orders a uric acid or blood sugar test.

Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Interactions with food and drink

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and lactation

Paracetamol, under normal conditions of use, can be used during pregnancy and when breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Sportsmen

Not applicable.

Effects on ability to drive and use machines

Not applicable.

List of excipients with a known effect

Not applicable.

3. HOW DO I TAKE PARACETAMOL BIOGARAN 500 mg, capsule?

Instructions for proper use

Not applicable.

Dosage, Method and/or route of administration, Frequency of administration and Duration of treatment

Dosage:

This presentation is for adults and children weighing 27 kg or more (approximately 8 to 15 years of age)

• - For adults and children weighing more than 50 kg (from about 15 years of age), the maximum recommended daily dosage is 3000 mg of paracetamol per day, i.e. 6 capsules per day.
  The usual dosage is 1 capsule of 500 mg, to be repeated if necessary after a minimum of 4 hours, without exceeding 6 capsules per day.
  In case of more intense pain or fever, 2 capsules of 500 mg, to be repeated if necessary after a minimum of 4 hours, without exceeding 6 capsules per day.
• - Inchildren:
  The dosage of paracetamol depends on the child's weight; the ages are given for information purposes.
  If you do not know the child's weight, you should weighhim or her in order to give the most appropriate dose.
  Paracetamol is available in many dosages, allowing treatment to be adapted to the weight of each child.
  The recommended daily dose of paracetamol is about 60 mg/kg/day, divided into 4 or 6 doses, i.e. about 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.
  The usual dosage is

o For children weighing between 27 and 40 kg (approximately 8 to 13 years of age), the dosage is 1 capsule at 500 mg per dose, repeated if necessary after 6 hours, not to exceed 4 capsules per day.For children weighing between 41 and 50 kg (about 12 to 15 years old), the dosage is 1 capsule of 500 mg per dose, to be repeated if necessary after 4 hours, without exceeding 6 capsules per day.

IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

How to take it

Take by mouth.

The capsules should be swallowed unopened with a drink (e.g. water, milk, fruit juice).

It is not advisable to take the tablet or capsule in children under 6 years of age as they may swallow it wrongly and choke. Use another form.

Frequency of administration

Systematic administration avoids oscillations of pain or fever.

In children, they should be regularly spaced, including at night, preferably 6 hours apart, and at least 4 hours apart.

In adults, they should be at least 4 hours apart.

In cases of severe kidney disease (severe renal failure), the interval between doses should be at least 8 hours.

Symptoms and instructions in case of overdose

If you have taken more PARACETAMOL BIOGARAN 500 mg, capsule than you should have:

In case of overdose or accidental poisoning, seek urgent medical attention.

Instructions in case of missed dose(s)

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects

Like all medicines, PARACETAMOL BIOGARAN 500 mg, capsule is likely to have side effects, although not everyone is susceptible:

• - In some rare cases, a skin rash or allergic reaction may occur. You should immediately stop the treatment and inform your doctor.
• - Exceptionally, biological changes requiring a blood test may have been observed: abnormally low levels of certain blood elements (platelets) which may result in nose or gum bleeding. In this case, consult a doctor.

If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.

5. HOW TO USE PARACETAMOL BIOGARAN 500 mg, capsule

Keep out of the reach and sight of children.

Expiry date

Do not use PARACETAMOL BIOGARAN 500 mg, capsule after the expiry date stated on the box.

Storage conditions

Store at a temperature not exceeding 30°C.

If necessary, warnings against certain visible signs of deterioration

Do not dispose of the medicine in the sewage system or in your household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.

6. ADDITIONAL INFORMATION

Complete list of active ingredients and excipients

What does PARACETAMOL BIOGARAN 500 mg, capsule contain?

The active substance is:

Paracetamol .................................................................................................................................... 500 mg

For one capsule.

The other ingredients are:

Cross-linked sodium carboxymethylcellulose, colloidal anhydrous silica, talc, sodium laurilsulphate.

Capsule shell composition: patent blue, erythrosine, quinoline yellow, titanium dioxide, gelatine.

Pharmaceutical form and content

What is PARACETAMOL BIOGARAN 500 mg, capsule and what does it contain?

This medicine is in capsule form. Box of 16.

Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different

Holder

BIOGARAN

15, boulevard Charles de Gaulle

92700 COLOMBES