Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Rupan femme is indicated for the relief of migraine, headaches, backache, dental pain, neuralgia and dysmenorrheal as well as rheumatic pain and myalgia.
Rupan femme relieves pain and reduces inflammation and fever being efficacious in headaches and other types of pain as well as in alleviating cold and flu symptoms.
For oral administration and short-term use only.
The tablets should be swallowed whole, without been chewed, with a glass of water.
During short-term use, if symptoms persist or worsen the patient should be advised to consult a doctor.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). If in adults the product is required for more than 10 days, or if the symptoms worsen the patient should consult a doctor.
Initial dose is 400mg (one tablet); if necessary, another 400mg ibuprofen (one tablet) can be taken every four-six hours.
Do not exceed 1200mg (three tablets) daily.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
In children and/or in adolescents (age range: ≥12 years to <18 years): If in children and in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
Not for use by children under 12 years of age.
In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.
Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.
Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.
5 years.
This medicinal product does not require any special temperature storage conditions.
Tablets are packed in combination blisters of polyvinylchloride film and aluminium foil and in PVC securitainers.
Blisters: packs of 10, 20, 30 or 100 tablets are available.
PVC securitainers: packs of 100, 500 and 1000 tablets are available.
Not all pack sizes may be marketed.
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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