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TRAVEL CALM TABLETS

Active substance(s): HYOSCINE HYDROBROMIDE / HYOSCINE HYDROBROMIDE / HYOSCINE HYDROBROMIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Travel Calm Tablets

2.

3.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient

mg/tablet

Hyoscine hydrobromide

300 micrograms

PHARMACEUTICAL FORM
Tablets.

4.

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.

Contra-Indications
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.

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 confusional 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.

4.9.

Overdose
Symptoms of overdo sage 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.

5.

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.

Pre-clinical Safety Data
There are no preclinical data of relevance to the prescriber which are
additional to that already included.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Dextrose monohydrate
Purified water
Stearic acid
Magnesium stearate

6.2.

Incompatibilities
Not applicable.

6.3.

Shelf-Life
36 months.

6.4

Special precautions for storage
Do not store above 30oC.

6.5.

Nature and Content of Container
PVC blister tray heat-sealed to hard temper aluminium foil containing 12
tablets.

6.6.

Instructions for Use, Handling and Disposal
Not applicable.

7.

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA

8.

MARKETING AUTHORISATION NUMBER(S)
PL 00014/5369R

9.
DATE OF FIRST AUTHORISATION / RENEWAL OF
AUTHORISATION
15 June 1990

10

DATE OF REVISION OF THE TEXT
20/02/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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