Opiprof 200 mg

Composition ;

Each Film Coated Tablet contains:

Active ingredients:Ibuprofen 200 mg

Inactive ingredients: Microcrystalline cellulose,Lactose Monohydrate,

P.V.P K30,Sodium starch glycolate ,Magnesium Stearate,Hydroxypropylmethyl cellulose, Titanium dioxide,Talc, P.E.G 6000,Ponceu 4,Sunset yellow colour

Dosage form: Film Coated Tablet
CLINICAL PARTICULARS

1– Therapeutic indications

For the relief of mild to moderate pain including rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness and for the relief of the symptoms of cold and influenza.

2- Posology and method of administration

For oral administration and short-term use only.

Adults, the elderly and young persons over 12 years of age:

The minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the product is required for more than 10 days or if the symptoms worsen, the patient should consult a doctor.

1 or 2 tablets to be taken up to three times a day, as required. The tablets should be taken with water.

Leave at least 4 hours between doses and do not take more than 1200mg (6 tablets) in any 24 hour period.

Not to be given to children under 12 years of age.

Category:
Contraindications
Interaction with other medicinal products and other forms of interaction Ibuprofen should not be used in combination with:
Pregnancy and lactation
PHARMACOLOGICAL PROPERTIES
STORAGE INSTRUCTIONS:
PACKAGE

Contraindications

Hypersensitivity to Ibuprofen or any of the constituents in the product. Opiprof is contra-indicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angiodema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or previous peptic ulcer (two or more episodes of proven ulceration or bleeding).History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.Patients with severe hepatic failure, renal failure or heart failure. Use in last trimester of pregnancy.

Interaction with other medicinal products and other forms of interaction Ibuprofen should not be used in combination with:

Aspirin: unless low-dose aspirin (not above 75mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions. Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex-vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use. Other NSAIDs including cyclooxygenase-2 selective inhibitors: as these may increase the risk of adverse effects.
Ibuprofen should be used with caution in combination with:
Corticosteroids
Antihypertensives and diuretics
Anticoagulants
Anti-platelet agents and selective serotonin-reuptake inhibitors (SSRIs)
Lithium
Methotrexate
Ciclosporin
Mifepristone
Tacrolimus
Zidovudine
Quinolone antibiotics

Pregnancy and lactation

Pregnancy: While no teratogenic effects have been demonstrated in animal experiments, use of Opiprof should, if possible, be avoided during the first 6 months of pregnancy. During the 3rd trimester, Opiprof is contraindicated, as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension.The onset of labour may be delayed and duration of labour increased, with increased bleeding tendency in both mother and child. Lactation: In limited studies Ibuprofen appears in the breast milk in very low concentrations and is unlikely to affect the breast-fed infant adversely.

PHARMACOLOGICAL PROPERTIES

1- Pharmacodynamic properties Pharmacotherapeutic group: Propionic acid derivatives. Ibuprofen is a phenylpropionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans, ibuprofen reduces inflammatory pain, swelling and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation. Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release aspirin dosing (81mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex-vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use. 2- Pharmacokinetic properties Ibuprofen is rapidly absorbed following administration and is rapidly distributed throughout the whole body. The excretion is rapid and complete via the kidneys. Maximum plasma concentrations are reached 45 minutes after ingestion if taken on an empty stomach. When taken with food, peak levels are observed after 1 to 2 hours. These times may vary with different dosage forms. The half life of ibuprofen is about 2 hours. In limited studies, ibuprofen appears in the breast milk in very low concentrations. 3- Preclinical safety data No relevant information additional to that already contained elsewhere in the SmPC.

STORAGE INSTRUCTIONS:

Storage at a temp. not exceeding 30 ºC in dry place.

PACKAGE

Carton box contain 1,2 or 3 (Al /transparent PVC) blisters, each of 10 film coated tablets with inner leaflet

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