Travel Calm Tablets

Tablets.

For the prevention and relief of travel sickness.

Adults and children over 12 years: One tablet.

Children 7 to 12 years: Half a tablet.

Children 3 to 7 years: Quarter of a tablet.

Not to be taken by children under 3 years.

Elderly: The normal adult dose is still appropriate in the elderly.

The dose should be taken 20 minutes before the journey and may be repeated in 6-8 hours if necessary.

Not more than three doses to be taken in 24 hours.

For oral administration.

Prostatic enlargement, paralytic ileus, pyloric stenosis, closed angle glaucoma.

Should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis and cardiac failure. Should be used with caution by elderly patients and in patients suffering from impaired renal, hepatic or metabolic function.

Warning: May cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.

Not more than three doses to be taken in 24 hours.

Keep all medicines out of the reach of children.

The effects of hyoscine may be enhanced by other drugs with anticholinergic properties, including amantadine, some antihistamines, butyrophenones, phenothiazines and tricyclic antidepressants. Patients should also avoid alcohol. The reduction in gastric motility caused by hyoscine may also affect the absorption of other drugs.

The safety of hyoscine during pregnancy and lactation has not been established, although there is no definite evidence of adverse consequences if taken during early pregnancy. No significant quantities of hyoscine were found in milk when the drug was given to lactating women. Nevertheless, the product should not be used during pregnancy, unless the expected benefit is thought to outweigh any possible risk to the foetus.

Hyoscine may cause drowsiness and dulling of mental alertness and therefore those taking this medication should not take charge of motor vehicles or operate machinery.

Side effects may include drowsiness, dryness of the mouth, thirst, reduced bronchial secretions, mydriasis, loss of accommodation, photophobia, increased intra-ocular pressure, flushing, dry skin, bradycardia followed by tachycardia, with palpitations and arrhythmias, difficulty in micturition, reduction in tone and motility of the gastrointestinal tract leading to constipation. Occasionally vomiting, giddiness and staggering may occur. There have also been occasional reports of confusional states and hallucinations when given to children.

Symptoms of overdosage may include any of the undesirable effects mentioned above under section 4.8 and tachycardia, rapid or stertorous respiration, hyperpyrexia, restlessness, confusion and excitement, hallucinations and delirium. In severe cases, depression of the central nervous system may occur with coma, circulatory and respiratory failure and death.

Treatment consists of emptying the stomach by lavage and aspiration. Charcoal may be used to prevent further absorption. Give a saline purgative, such as sodium sulphate 30g in 250ml of water.

Peripheral anticholinergic effects may be controlled by the administration of the antichlolinesterase, neostigmine. Excitement may be controlled by diazepam. Otherwise treatment should be symptomatic and supportive.

Hyoscine is an anticholinergic agent with central and peripheral actions.

Hyoscine hydrobromide is readily absorbed from the gastrointestinal tract. It Is almost entirely metabolised, probably in the liver. Only a small proportion of an oral dose is excreted unchanged in the urine. Hyoscine crosses the placental barrier and traces may appear in milk.

There are no preclinical data of relevance to the prescriber which are additional to that already included.

Dextrose monohydrate

Purified water

Stearic acid

Magnesium stearate

Not applicable.

36 months.

None.

PVC blister tray heat-sealed to hard temper aluminium foil containing 12 tablets.

Not applicable.

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

PL 00014/5369R

15 June 1990

September 2001