SOCOMOL Tablet Ref.[115638] Active ingredients: Diclofenac Paracetamol

Posology

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use).

Adults: 1 tablet 2-3 times daily.

If the symptoms are more important by night or in the morning, the tablets should be taken in the evening.

Children: the pharmaceutical form and dosage are not indicated for children.

Method of administration

SOCOMOL Paracetamol 325 mg & Diclofenac Sodium 50 mg Tablets should be swallowed with adrink, preferably while eating.

Elderly patients: the dosage should be reduced and monitoring of biological parameters is recommended.

The daily dose of paracetamol cannot exceed 2 g in the following situations:

Liver failure
Gilbert’s syndrome
Chronic alcoholism

Impaired renal function

The dose should be reduced in terms of the creatinine clearance:

Diclofenac

Symptoms

Diclofenac overdose symptoms include headache, motor agitation, muscular spasm, irritability, ataxia, vertigo sensations, and convulsions especially in small children, epigastric pain, nausea, vomiting, haematemesis, diarrhoea, gastrointestinal ulcer, hepatic function disorders and oliguria.

Therapeutic measure

NSAIDs acute intoxication treatment essentially consists in symptomatic treatment such as:

• As early as possible after (within one hour) ingestion of potentially toxic amount, activated charcoal and gastric lavage should be considered.
• Supportive and symptomatic treatment in case of complications such as hypotonia, renal failure, convulsions, gastrointestinal irritation and respiratory depression.

As NSAIDs are highly bound to plasma proteins and mainly biotransformed, measures for NSAIDs elimination such as accelerated excretion, dialysis or hemoperfusion are ineffective.

Paracetamol

In adults with normal hepatic function, paracetamol toxic dose is 150 mg/kg (in one intake), i.e. around 10 grams for a 70 kg adult.

A risk of liver toxicity exists, in particular in elderly people, young children, in case of liver and kidney failure, chronic alcoholism, chronic malnutrition, enzyme inducing agents and very meagre adults (<50 kg).

It has to be kept in mind that a massive overdose with a glutathione depletion exceeding 70% (which theoretically requires that an adult absorb 15 g paracetamol and a child a dose equal or higher than 150 mg/kg body weight) leads to an increased quantity of reactive metabolite which, as it cannot be detoxified, causes hepatic cytolysis potentially leading to a complete and irreversible necrosis. Paracetamol accumulation due to metabolism impairment has not been observed at therapeutic doses.

Glutathione depletion, which could increase the toxicity risk, does not usually occur.

Symptoms

Early symptoms, that can occur only 12 hours after ingesting a potentially toxic dose, might include: nausea, vomiting, anorexia, abdominal pain and sweating. Clinical and biological proofs of liver disorder can appear later (48 to 72 hours).

As a consequence, in case of any suspicion of paracetamol overdose, the patient should be immediately hospitalized and serum levels should be determined at the earliest from the 4th hour post-ingestion on.

Values exceeding 200 μg/ml at the 4th hour or 50 μg/ml at the 12th hour let suspect a high risk of hepatic necrosis. The usual liver function tests should be performed early and regularly repeated (every 24 hours).

Treatment

The overdose treatment in a specialized environment includes administering at the earliest the N-acetylcysteine antidote.

Early treatment can result in a total functional recovery.

N-acetylcysteine proposed posology: initial dose 150 mg/kg in 30 minutes, then 50 mg/kg in 4 hours and 100 mg/kg during the following 16 hours. A close monitoring of hepatic function is recommended (every 24 hours).

3 years.

Do not store above 30°C.

Store in the original package.

1X10 Tablets.

No special requirements.