Biofen Extra, 400 mg/325mg, 20 film-coated tablets, Biofarm

Indications:

Biofen Extra 400 mg/325mg contains paracetamol and ibuprofen.
Paracetamol works by stopping pain signals from reaching the brain. It also works to reduce fever.
Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (or NSAIDs). It relieves pain and reduces inflammation (swelling, redness, or pain).

Biofen Extra 400 mg/325mg is used for the temporary relief of pain associated with:
• Headache
• Menstrual pain
• Migraine
• Back pain
• Toothache
• Muscle pain
• Cold and flu symptoms
• Sore throat
• Fever

This medicine should only be used on the advice of a doctor in cases of indications that are not suitable for self-treatment, namely in arthritis, rheumatism, tendonitis, after surgery.

Ask your doctor or pharmacist if you have any questions about this medicine.
You should talk to a doctor if you do not feel better or if you feel unwell after 3 days.

Contraindications:

Do not use Biofen Extra 400 mg/325mg:
- If you are allergic to the active substance(s) or any of the other ingredients of this medicine.

Precautions:

Pregnancy, lactation and fertility:
Do not use this medicine during the last three months of pregnancy. Take special care if you are in the first 6 months of pregnancy.
This medicine may affect female fertility and is not recommended for women planning to become pregnant.

Driving and using machines:
Be careful when driving or using machinery until you know how Biofen Extra 400 mg/325mg affects you.
Biofen Extra 400 mg/325mg contains lactose monohydrate.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Method of administration:

Always use this medicine exactly as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.

Biofen Extra 400 mg/325mg is intended for oral administration and for a short period of time.
It is recommended to use the lowest effective dose for the shortest period necessary to control symptoms.
Patients should consult a doctor if symptoms do not improve or worsen for more than 3 days.
Adults
The recommended dose is 1 film-coated tablet 1-3 times a day, administered at intervals of at least 6 hours.
The maximum dose of Biofen Extra 400 mg/325mg is 3 film-coated tablets (1200 mg ibuprofen, 975 mg paracetamol) in 24 hours.
The film-coated tablets are swallowed whole with a glass of water, preferably after a meal.
Children and adolescents
It is not indicated for children and adolescents under 18 years of age.
elderly
No dosage adjustment is necessary, unless there is renal insufficiency, hepatic insufficiency or a history of gastrointestinal bleeding after taking nonsteroidal anti-inflammatory drugs; in this case, dosages should be individualized.

If you have any further questions on this medicine, ask your doctor, pharmacist or nurse.

Composition:

- The active substances are ibuprofen and paracetamol. Each film-coated tablet contains 400 mg ibuprofen and 325 mg paracetamol.
- The other ingredients are: core-corn starch, Povidone K 30, microcrystalline cellulose pH 101, colloidal anhydrous silica, talc, magnesium stearate, sodium starch glycolate (type A); film-AquaPolish D white 011.14 (hypromellose, lactose monohydrate, talc, glycerol, titanium dioxide (E 171)).

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Presentation:

20 film-coated tablets