OKITASK Film-coated tablet Ref.[50400] Active ingredients: Ketoprofen

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Dompé Farmaceutici S.p.A., Via San Martino 12-12/a, 20122 Milano, Italy

4.1. Therapeutic indications

Okitask 25 mg Film-Coated Tablets is recommended in the symptomatic treatment of acute mild to moderate pain such as rheumatic and muscular pain, headache, toothache, menstrual pain, and for pain and fever associated with common cold and flu symptoms.

Okitask 25 mg Film-Coated Tablets is indicated in adults aged 18 years and over.

4.2. Posology and method of administration

Posology

Indication Age group Dose Duration
Symptomatic relief of pain and
fever
Adults aged 18 years and over1 tablet as a single dose
repeated 2 to 3 times a
day as needed.*
The minimum effective dose
should be used for the
shortest time necessary to
relieve symptoms (see
section 4.4).

* Leave at least 4 hours between doses.

For short term use only.

Consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

Do not take more than 3 film coated tablets in any 24 hour period.

Elderly

Ketoprofen Lysine Salt should be used with caution in the elderly.

For elderly patients a dose of 1 tablet a day is recommended.

Paediatrics

Ketoprofen should not be used in children and adolescents under the age of 18 years.

Method of administration

Oral use only.

Swallow the tablet whole with a glass of water, if necessary.

4.9. Overdose

Symptoms

The UK National Poisons Information Service considers 10 mg/kg Sprintafen as a toxic dose. In most instances of overdose the symptoms observed are usually limited to lethargy, drowsiness, abdominal pain, nausea, vomiting, which are generally reversible with supportive care. Respiratory depression, coma or convulsions have occurred following large Sprintafen overdoses. GI bleeding, hypotension, hypertension, or acute renal failure may occur but are rare.

Treatment measures

There are no specific antidotes for Sprintafen Lysine Salt overdose. Management should occur at a specialised centre, with symptomatic and supportive treatment instituted. It should include maintenance of airway patency, monitoring of cardiac and vital signs, treatment to compensate for dehydration, monitoring of urinary excretion and correction of acidosis. Considered oral administration of active charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. Frequent or prolonged convulsions should be treated with intravenous diazepam.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store in the original packaging in order to protect against light and moisture.

6.5. Nature and contents of container

Opaque, Al/PA/Al/PVC blister in the following pack sizes: 8, 10, 15, 16, 20 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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