INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
BESENOL NC (tablets)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

BESENOL NC (tablets)

COMPOSITION:
Each tablet contains: paracetamol 450 mg and orphenadrine citrate 35 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic combination.

PHARMACOLOGICAL ACTION:
BESENOL NC has analgesic, antipyretic and skeletal muscle relaxant properties.

INDICATIONS:
Generalised pain and the relief of muscle spasm associated with acute painful musculo-skeletal conditions.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
Severe liver function impairment.
Prostatic enlargement, achalasia, bladder neck obstruction, glaucoma, myasthenia gravis, peptic ulcer or stenosing and pyloric or duodenal obstruction.
Safety in pregnancy and lactation has not been established.
Patients with porphyria.

WARNINGS:
Dosages in excess of those recommended may cause severe liver damage.
Patients suffering from liver or kidney disease should takeBESENOL NC under medical supervision.
Caution is recommended in patients on other central nervous systemdepression-producing medication as well as patients on anticholinergics or medication with anticholinergic properties.
Use with caution in patients with cardiac disease or arrhythmias, especially tachycardia.
Do not use continuously for more than 10 days without consulting a doctor.

Contains paracetamol - read the package insert

DOSAGE AND DIRECTIONS FOR USE:
Adults:         2 tablets 3 times a day. Do not exceed the recommended dosage.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol:
Haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis have been reported. Pancreatitis, skin rashes and other allergic reactions occur occasionally. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions.
Orphenadrine Citrate:
Dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition as well as reduction in the tone of motility of the gastro-intestinal tract leading to constipation. Occasionally vomiting, confusion, giddiness and staggering may occur.
Drug Interactions
Orphenadrine may increase central nervous system depression if taken concurrently with alcohol or central nervous system depressants. Anticholinergic effects may be intensified if orphenadrine is taken concurrently with anticholinergics or medication with anticholinergic effects.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

In the event of overdosage or suspected overdose and notwithstanding the fact that the person may have no signs or symptoms, the nearest doctor, hospital or Poison Control Centre must be contacted immediately.

Paracetamol:
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported. Symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may become manifest on the second day, (or later) initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death. Cerebral oedema and non-specific myocardial depression have also occurred.
In the event of overdosage consult your doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible.
Prompt treatment is essential. Any patient who has ingested 7,5 g of paracetamol in the preceding 4 hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or methionine may be necessary. If decided upon, acetylcysteine should be administered IV as soon as possible, preferably within 8 hours of overdosage.
IV: An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours and then 100 mg/kg in
1000 mL over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally: 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses. Acetylcysteine is effective if administered within 8 hours of overdosage.
Orphenadrine Citrate:
Toxic doses cause tachycardia, rapid respiration, hyperpyrexia and central nervous system stimulation marked by restlessness, confusion, excitement, paranoid and psychotic reactions, hallucinations and delirium, and occasionally seizures or convulsions. A rash may appear on the face or upper trunk. In severe intoxication, central stimulation may give way to central nervous system depression, coma, circulatory and respiratory failure, and death.
Treatment is symptomatic and supportive. Institution of haemodialysis or peritoneal dialysis may be of some benefit if the serum concentration exceeds 4 mcg per 4 mL.

IDENTIFICATION:
White, circular, biconvex tablets with a breakbar on one face.

PRESENTATION:
Cartons containing 20 blister packed tablets.
Securitainers of 50 and 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
32/2.8/0605

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston
Private Bag X69
Bryanston
2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 1997

New addition to this site: April 2004
Source: Pharmaceutical Industry
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