Bienadol analgesic for pain and headache antipyretic

Bienadol Tablets
Analgesic for pain and headache- antipyretic

Composition :

Each tablet contains:
Active ingredients:
Paracetamol                                  500 mg
Caffeine anhydrous                     65 mg
Inactive ingredients:
Lactose, pregelatinized starch, magnesium stearate, talc, sodium starch glycolate, PVP k25 .

Pharmaceutical form :

Tablets

Pharmacological action :

Bienadol has antipyretic and mild analgesic actions.
This action based on containing Paracetamol (which inhibits Prostaglandin synthesis, and additional ingredient (caffeine) which enhances the therapeutic effect of Parae eta mol . It also has less irritant effect to the stomach and dosen’t affect platelet function.
Its analgesic action: is related to an elevation of the pain threshold.
Its antipyretic action: is due to direct action on the hypothalamic heat regulating center to block the effects of endogenous pyrogen, resulting in increased heat dissipation through sweating and vasodilatation.

Pharmacokinetics :

-Paracetamol is rapidly and completely absorbed after oral administration. Paracetamol crosses the placenta.
– The mean plasma Paracetamol half-life after a therapeutic dose is about 2.3 hr. in healthy adults with a range of 1.5 – 3 hr.
– Paracetamol is metabolized in the liver, and the clearance of it is reduced and the half-life increased following a hepatotoxic overdose.

Indications :

-Temporary relieves pains due to: Headache ,Common cold ,Arthritis ,Toothache ,Sinusitis ,Premenstrual and menstrualcramps ,Neuralgia ,Rheumatic and
muscular pain ,Backache and Migraine.
– Antipyretic .

Dosage and administration :

Adults and children 12 years of age and over:
Take 2 tablets every 6 hours, not more than 8 tablets daily.
Children under 12 years of age: not recommended.

Contraindication :

– Known sensitivity to components of the drug.

Side effects :

– Skin reactions have been reported rarely.

Drug interactions :

antacids :- delayed and decreased absorption of paracetamol .
anticoagulants :- may potentiate effects of these drugs.
anticonvulscents , isoniazid: may increase risk of hepatotoxicity .
phenothiazines :- may result in hypothermia so monitor patient temp.

Pregnancy and lactation :

Paracetamol and caffeine cross the placenta so consult your physician due to its minimum limitation use.
Both are excreted in low concentration into breast milk but no adverse effects in nursing infants were reported so consult your
physician although there evidence of the safety of paracetamol in pregnancy and lactation, medical advice should be taken before using this product.

Precautions and warnings :

Alcohol warnings: use cautiously in patients with history of chronic alcohol abuse because hepatotoxicity has occurred after therapeutic doses.

Caffeine warnings :

limit the use of caffeine containing medicines, food or beverages while taking Bienadol because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally rapid heart beat. Use cautiously in patients with hepatic diseases. d0 not administer The drug with food because it delays and decreases its absorpiton .
In massive over dosage exceeding 10 gm : Bienadol may cause liver damage; early symptoms are nausea, vomiting and general malaise.{ overdose should be promptly treated by gastric lavage followed by intravenous N-acetylcysteine or methionine without waiting for the results of plasma paracetamol level.
d0 not take other paracetamol containing medications at the same time. Used with caution in cases of liver damage or kidney damage.
d0 not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a physican .

Package and storage :

Carton box contains ( 1 – 2 – 3 – 10 PVC I AL strips, each strip contains 10 tablets )+ pamphlet.
store at temperatuer not exceeding 30·C, in a dry place and protect from light.

Patient,s instructions :

-Keep the medicaments out of reach of children.
-Use under medical supervision of the physician.

Manufactured by :

EI- NILE Co. for Pharmaceuticals and Chemical Industries Cairo A.R.E.

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