Thiozone is used to relieve painful muscle contractionsin adults and children above 16 years of age & it could be useful in following conditions.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the recommended dose.

Do not take paracetamol for more than three days without consulting a doctor.

Do not take with any other paracetamol-containing products.

If symptoms persist, consult a doctor.

Keep out of reach of children.

Immediate medical advice should be sought in the event of an overdose even if you feel well, because of the risk of delayed, serious liver damage.

In patients with epilepsy or at risk of seizures, it is recommended to assess benefit-risk of Thiocolchicoside and strengthen clinical monitoring. The occurrence of seizures requires stopping the treatment.

Not recommended for children under 16 years of age.

A clear association of drug use and birth defects, miscarriage, or adverse maternal or fetal outcomes has not been shown with human use of paracetamol; animal studies have demonstrated adverse events at clinically relevant doses.

Thiocolchicoside has shown teratogenicity effects in animal studies but clinically there is no enough current data that shows deformation effects when when administered during pregnancy.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding. Since it passes into the mother’s milk, the use of thiocolchicoside is contraindicated during breastfeeding.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin an other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Drug interaction associated with thiocolchicoside are simillar to those whith other NSAIDs.

Do not use this medicine if you are allergic to Paracetamol. Ask a doctor or pharmacist if it is safe for you to take Paracetamol if you have liver disease, kidney disease or a history of alcoholism.

Do not use this medicine if you are; allergic to Thiocolchicoside or any excipient in the formulation, women of childbearing age who are not using effective contraception, pregnant or breastfeeding.

Overdose of paracetamol often shows no symptom within the first 24 hours after the overdose. In some cases there may be mild nausea and vomiting, severe cases may lead to jaundice, confusion and unconsciousness. Researchers show that the threshold for liver damage to start from a single paracetamol overdose is 15gms. Activated charcoal is used if the overdose has been taken within an hour and treatment with N-acetylcysteine may be used within or up to 24 hours after ingestion of paracetamol.

No specific information available on overdose with Thiocolchicoside. Contact your doctor immediately if an overdose with this medicine is suspected. Give symptomatic and supportive treatment.

Paracetamol is an effective analgesic and antipyretic agent, but has only weak antiinflamatory properties. Its mechanism of action is not fully understood. It has been suggested that it may act predominantly by inhibiting prostaglandin synthesis in the CNS and to a lesser extent through a peripheral action by blocking plain impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitize pain preceptors to mechanical or chemical stimulation. Paracetamol probably produces an antipyretic action by a central action effect on the hypothalmic heat-regulating centre to produce peripheral or chemical stimulation. Paracetamol probably produces an antipyretic action by a central action effect on the hypothalmic heat-regulating centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus. The drug has no effect on the cardiovascular and respiratory systems, and unlike salicylates it does not cause gastric irritation or bleeding.

This compound has been shown to inhibit the binding of [3h] GABA (g-amino butyric acid) or [3H] strychnine of cerebrocortical or spinal cord membranes. [3H] TCC was also displaced in a concentration-dependent manner by GABA or by several agonists or antagonists of the type A receptor for GABA (GABAAR). TCC has been thought to act as a GABAAR agonist that induces depression of the central nervous system, in turn, myorelaxation. Moreover, TCC possesses a molecular structure simillar to that of colchicine, a plant alkaloid that binds to tubulin and induces the depolymerization of microtubules, disrupts axonal transport, and inhibits mitosis.

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentration occurring about 30 minutes to 2 hours after ingestion. It is metabolized in the liver (90=95%) and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1 to 4 hours. Plasma protein binding is negligible at usual therapeutic concetraions but increases with increasing concetrations.

A minor hydroxylated metabolite (N-acetyl-p-benzoquineimine) which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate the following paracetamol overdosage and cause liver damage. The time to peak plasma concentration of paracetamol is 0.5 to 2 hours, the time to peak effect 1 to 3 hours and the duration of action 3 to 4 hours.

Following oral administration, thiocolchicoside is well absorbed from the gastrointestinal tract. It shows its effect in 1-2 hours after oral administration and peak plasma level is achieved in about 0.7 hours and elimination half-life is about 2.5-5 hours. Its effect is continued for 24 hours.

Special precaution for storage

Store below 30 degrees celcius, Protected from light & moisture.

Keep the medicine out of reach of children.

Mfg. Lic No. :MNB/07/509

Manufactured for and marketed by

Zuvan Limited

PO BOX 236-00623, Nairobi, Kenya

regulatory.pmt@zunpharma.com