- Approval Id
- 50e80ad4e0694ce8
- Drug Approval Emc Name
- Boots Travel Calm Tablets
- Drug Name
- Boots Travel Calm Tablets
- Company Address
- 1 Thane Road West, Beeston, Nottingham, NG2 3AA
- Company Telephone
- +44 (0)1159 595 165
- Legal Category
- Pharmacy
- Authorisation Holder
- The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
- Authorisation Number
- PL 00014/5369R
- Authorisation Date
- 15 June 1990
- Instruction Authorisation Holder
- The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
- Instruction Authorisation Number
- PL 00014/5369R
- Instruction Authorisation Date
- 15 June 1990
- Instruction Composition
- | | |
| --- | --- |
| Active ingredient Hyoscine hydrobromide Excipient(s) with known effect Glucose | micrograms/tablet 300 mg/tablet 276.7 |
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Tablets.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the prevention and relief of travel sickness.4.2 Posology and method of administration
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.4.3 Contraindications
Prostatic enlargement, paralytic ileus, pyloric stenosis, closed angle glaucoma.4.4 Special warnings and precautions for use
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.
There have been rare reports of an increase in frequency of seizures in epileptic patients.
Not more than three doses to be taken in 24 hours.
Keep all medicines out of the reach of children.
This medicine contains dextrose monohydrate, also known as glucose. Patients with rare glucose-galactose malabsorption should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction
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.4.6 Pregnancy and lactation
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.4.7 Effects on ability to drive and use machines
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.4.8 Undesirable effects
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 confused states and hallucinations when given to children.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or by searching for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
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.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Hyoscine is an anticholinergic agent with central and peripheral actions.5.2 Pharmacokinetic properties
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.5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Dextrose monohydrate
Purified water
Stearic acid
Magnesium stearate6.2 Incompatibilities
Not applicable.6.3 Shelf life
36 months.6.4 Special precautions for storage
Do not store above 30° C.6.5 Nature and contents of container
PVC blister tray heat-sealed to hard temper aluminium foil containing 12 tablets.6.6 Special precautions for disposal and other handling
Not applicable.
- Instruction Content
- ## Composition
| | |
| --- | --- |
| Active ingredient Hyoscine hydrobromide Excipient(s) with known effect Glucose | micrograms/tablet 300 mg/tablet 276.7 |
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Tablets.
## Clinical Particulars
4.1 Therapeutic indications
For the prevention and relief of travel sickness.4.2 Posology and method of administration
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.4.3 Contraindications
Prostatic enlargement, paralytic ileus, pyloric stenosis, closed angle glaucoma.4.4 Special warnings and precautions for use
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.
There have been rare reports of an increase in frequency of seizures in epileptic patients.
Not more than three doses to be taken in 24 hours.
Keep all medicines out of the reach of children.
This medicine contains dextrose monohydrate, also known as glucose. Patients with rare glucose-galactose malabsorption should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction
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.4.6 Pregnancy and lactation
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.4.7 Effects on ability to drive and use machines
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.4.8 Undesirable effects
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 confused states and hallucinations when given to children.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or by searching for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
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.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Hyoscine is an anticholinergic agent with central and peripheral actions.5.2 Pharmacokinetic properties
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.5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
## Pharmaceutical Particulars
6.1 List of excipients
Dextrose monohydrate
Purified water
Stearic acid
Magnesium stearate6.2 Incompatibilities
Not applicable.6.3 Shelf life
36 months.6.4 Special precautions for storage
Do not store above 30° C.6.5 Nature and contents of container
PVC blister tray heat-sealed to hard temper aluminium foil containing 12 tablets.6.6 Special precautions for disposal and other handling
Not applicable.
- Company Detail Path
- /organization/the-boots-company-plc
