FREMEDOL PAIN
FREMEDOL PAIN
Active ingredients:
Paracetamol 500 mg, ibuprofen 200 mg.
Dosage form: Tablet.
Packaging: Box of 10 blisters x 10 tablets.
Expiry date: 36 months.
Posology
For short term-use only.
Before Fremedol Pain is taken, the patient should first try ibuprofen or paracetamol for pain relief in accordance with the product instructions, for the first day of treatment.
If the pain has not been relieved by ibuprofen or paracetamol during the first day of treatment, then the next day Fremedol Pain can be taken.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section Special warnings and precautions for use).
The patient should consult a doctor if the symptoms persist or worsen or if the product is required for more than 3 days.
Adults: One tablet to be taken up to three times per day with water. Leave at least six hours between doses.
If the one tablet dose does not control symptoms, a maximum of two tablets may be taken up to three times a day. Leave at least six hours between doses.
Do not take more than six tablets of Fremedol Pain (3000mg Paracetamol, 1200mg Ibuprofen) in any 24 hour period.
To minimise side effects, it is recommended that patients take Fremedol Pain with food.
Elderly: No special dosage modifications are required (see section Special warnings and precautions for use).
The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used for the shortest possible duration. The patient should be monitored regularly for gastrointestinal bleeding during NSAID therapy.
Not for use by children under 18 years.
Administration
For oral administration.
Should be taken with meal.
INDICATIONS
For the temporary relief of mild to moderate pain which has not been relieved by ibuprofen or paracetamol individually such as migraine, headache, backache, period pain, dental pain, rheumatic and muscular pain, cold and flu symptoms, sore throat and fever.
CONTRAINDICATIONS
This product is contraindicated:
- In patients with a known hypersensitivity to ibuprofen, paracetamol or any other excipients in the product.
- In concomitant use with other Paracetamol-containing products – increased risk of serious adverse effects (see Section Interactions).
- In patients with a history of hypersensitivity reactions (e.g. bronchospasm, angioedema, asthma, rhinitis, or urticaria) associated with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
- In patients with active, or a history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
- In patients with a history of, or an existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs (see Section Special warnings and precautions for use).
- Patients with defects in coagulation.
- In patients with severe hepatic failure, severe renal failure or severe heart failure (NYHA Class IV) (see Section Special warnings and precautions for use).
- In concomitant use with other NSAID containing products, including cyclo-oxygenase-2 (COX-2) specific inhibitors and doses of acetylsalicylic acid above 75 mg daily – increased risk of adverse reactions (see Section Interactions).
- During the last trimester of pregnancy due to risk of premature closure of the foetal ductus arteriosus with possible pulmonary hypertension (see Section Pregnant and breast-feeding women).
