Winofen

Ibuprofen.

Active Ingredient: Each 5 ml contains Ibuprofen 100 mg.
Excipients/Inactive Ingredients: Preservatives: Methyl Hydroxybenzoate 0.1% w/v, Propyl Hydroxybenzoate 0.01% w/v, Sodium Benzoate 0.1% w/v.

Pharmacology: Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) of propionic acid derivative. It exhibits analgesic, anti-inflammatory and antipyretic activities and is effective in the relief of inflammation, pain and fever. It is thought that the anti-inflammatory effect of Ibuprofen is produced to a degree by inhibiting the production of prostaglandins. Analgesic and antipyretic activity have been shown with Ibuprofen in animal and human studies, providing symptomatic relief of pain and inflammation in conditions such as musculoskeletal and joint disorders, rheumatoid arthritis and allied conditions.
Following oral administration of Ibuprofen suspension in febrile children, plasma concentration-time curves (AUCs) increase with increasing single Ibuprofen doses up to 10 mg/kg. It appears that the pharmacokinetics of Ibuprofen is not affected by age, in children 2 to 11 years of age. In children, the antipyretic effect of Ibuprofen suspension begins 1 hour after oral administration and peaks within 2 to 4 hours. The antipyretic effect of single Ibuprofen suspension doses of 5 or 10 mg/kg may last up to 6 or 8 hours respectively.

Winofen Suspension is indicated for its analgesic and anti-inflammatory effects in the treatment of juvenile rheumatoid arthritis and soft-tissue injuries such as sprains and strains. It is also indicated for its analgesic effect in the relief of mild to moderate pain such as dental pain and for symptomatic relief of headache.
Winofen Suspension is indicated in short-term use for the treatment of pyrexia in children over one year of age.

The daily dosage for children is based on 20 mg/kg body weight in divided doses: Children 8 to 12 years: Give 10 ml (200 mg) 3 to 4 times a day.
Children 3 to 7 years: Give 5 ml (100 mg) 3 to 4 times a day.
Children 1 to 2 years: Give 2.5 ml (50 mg) 3 to 4 times a day.
In juvenile rheumatoid arthritis, up to 40 mg/kg of body weight daily in divided doses may be taken.
Not recommended for children weighing less than 7 kg.
For oral use only.
Do not exceed the recommended dose unless advised by a doctor. Do not exceed 4 doses in 24 hours.
Take it together with a glass of water. Take with food and a glass of milk to minimize stomach upset.
For short-term use only.
Shake well before use.
After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used.

Symptoms: Ibuprofen is less toxic in acute overdose if compared to either Aspirin or Paracetamol. Depression of the central nervous system and the respiratory system may occur as a result of overdosage. Nausea, vomiting, stomach pain, tinnitus, headache, confusion, drowsiness, coma and unsteadiness may also occur.
Treatments: There is no specific antidote for overdose with Ibuprofen. Gastric lavage or induced vomiting in the conscious patient may be performed if not more than an hour has elapsed since ingestion. As Ibuprofen is acidic and is excreted in the urine, alkalinisation of the urine may promote more rapid excretion. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption of Ibuprofen.

Patients with known hypersensitivity to Ibuprofen.
Patients with hypersensitivity (eg. asthma, rhinitis or urticaria) to Aspirin or other NSAIDs.
Patients with active gastrointestinal bleeding and/or peptic ulcerations.
Not recommended for babies under 1 year.

RISK OF GI ULCERATION, BLEEDING AND PERFORATION WITH NSAID: Serious GI toxicity such as bleeding, ulceration and perforation can occur at any time, with or without warning symptoms, in patients treated with NSAID therapy. Although minor upper GI problems (e.g. dyspepsia) are common, usually developing early in therapy, prescribers should remain alert for ulceration and bleeding in patients treated with NSAIDs even in the absence of previous GI tract symptoms. Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Patients with prior history of serious GI events and other risk factors associated with peptic ulcer disease (e.g alcoholism, smoking, and corticosteroid therapy) are at increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleeding less than other individuals and account for most spontaneous reports for fatal GI events.

Cardiovascular Thrombotic Events: Observational studies have indicated that non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events, principally myocardial infarction, which may increase with dose or duration of use. Patients with cardiovascular disease or cardiovascular risk of an adverse cardiovascular event in patients taking NSAID, especially in those with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration. There is no consistent evidence that the concurrent use of aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAID use.
Hypertension: NSAIDs may lead to the onset of new hypertension or worsen pre-existing hypertension and patients taking anti-hypertensive with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing NSAIDS to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and at regular intervals thereafter.
Heart Failure: Fluid retention and oedema have been observed in some patients taking NSAIDs, caution is advised in patients with fluid retention or heart failure.
Gastrointestinal Events: All NSAIDs can cause gastrointestinal discomfort and rarely serious, potentially fatal gastrointestinal effects such as ulcers, bleeding and perforation which may increase with dose or duration of use, but can occur at any time without warning. Caution is advised in patients with risk factors for gastrointestinal events e.g. the elderly, those with a history of serious gastrointestinal events, smoking and alcoholism. When gastrointestinal bleeding or ulcerations occur in patients receiving NSAIDs, the drug should be withdrawn immediately. Doctors should warn the patient about signs and symptoms of serious gastrointestinal toxicity. The concurrent use of aspirin and NSAIDs also increases the risk of serious gastrointestinal adverse events.
Severe Skin Reactions: NSAIDs may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), which can be fatal and occur without warning. These serious adverse events are idiosyncratic and are independent of dose or duration of use. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of skin rash or any other sign of hypersensitivity.
Caution should be taken when giving to patients with asthma or have ever suffered from asthma particularly those with aspirin-sensitive asthma.
If the existing symptoms persist for more than 3 days, consult a doctor.
Patients with impaired liver or kidney functions should take the medication with caution.
Ibuprofen should be administered with caution to patients with cardiac impairment.
Caution should be taken when giving to patients with a history of gastrointestinal bleeding or peptic ulcerations.

Category C: NSAIDs inhibit prostaglandin synthesis and, when given during the latter part of pregnancy, may cause closure of the foetal ductus arteriosus, foetal renal impairment, inhibition of platelet aggregation and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Children under 12 years are not likely to become pregnant.
Ibuprofen appears in breast milk in very low concentrations and is not recommended for lactating women. Children under 12 years are not likely to breastfeed.

Gastrointestinal: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis and gastrointestinal haemorrhage have been reported following ibuprofen administration. Less frequently, gastritis, duodenal ulcer, gastric ulcer and gastrointestinal perforation have been observed.
Hypersensitivity: Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a) Non-specific allergic reaction and anaphylaxis, (b) Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) Assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Cardiovascular: Oedema has been reported in association with ibuprofen treatment.
Other adverse events reported less commonly and for which causality has not necessarily been established include: Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.
Hepatic: Abnormal liver function, hepatitis and jaundice.
Neurological & special senses: Visual disturbances, optic neuritis, headaches, paraesthesia, depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.
Haematological: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.
Dermatological: Photosensitivity.

Care should be taken in patients treated with any of the following drugs as interactions have been reported in some patients: Antihypertensives: Reduced antihypertensive effect.
Diuretics: Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels.
Lithium: Decreased elimination of lithium.
Methotrexate: Decreased elimination of methotrexate.
Cyclosporin: Increased risk of nephrotoxicity with NSAIDs.
Mifepristone: NSAIDs should not be used for 8 - 12 days after mifepristone administration as NSAIDs can reduce the effects of mifepristone.
Other analgesics: Avoid concomitant use of two or more NSAIDs.
Corticosteroids: Increased risk of gastrointestinal bleeding.
Anticoagulants: Enhanced anticoagulant effect.
Quinolone antibiotics: Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Store below 30°C. Protect from light. Keep cap tightly closed.
Shelf Life: 3 years from the date of manufacture.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

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