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TRAVLESE

Active substance(s): DIMENHYDRINATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
TRAVLESE

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Dimenhydrinate 50 mg

3

PHARMACEUTICAL FORM
Tablet
White biconvex tablets, one face scored.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Dimenhydrinate is used mainly as an anti-emetic in the prevention and
treatment of motion sickness; irradiation sickness, postoperative vomiting,
drug-induced nausea and vomiting, and the symptomatic treatment of nausea
and vertigo due to Meniere's disease and other labyrinthine disturbances.

4.2

Posology and method of administration
Adults:
It is usually given in doses of 50 mg thrice daily, the first dose for preventing
motion sickness being taken about 30 minutes before the journey. For
treatment, 4-hourly administration may be required. Doses of 100 mg may be
required but a daily total of 300 mg should not usually be exceeded.
Children:

1 to 6 years - 12.5 to 25 mg two or three times daily
7 to 12 years - 25 to 50 mg two or three times daily
Elderly: Same as adult dose.
Route of administration: Oral.

4.3

Contraindications
Sensitivity to Dimenhydrinate or any of the other ingredients of the tablet.

4.4

Special warnings and precautions for use
Dimenhydrinate should be used with caution in epilepsy, prostatic
hypertrophy, glaucoma and hepatic diseases.
It has been suggested that Dimenhydrinate could mask warning symptoms of
damage caused by ototoxic drugs such as the amino-glycoside antibiotics.

4.5

Interaction with other medicinal products and other forms of interaction
Dimenhydrinate will interact with anticholinergic and anti-parkinsonian drugs
such as Benzhexol, increasing the anticholinergic side effects, dry mouth,
urine retention, confusion, etc. Patients should be warned not to take alcohol
while under treatment with drugs affecting the Central Nervous System, in
particular anti-histamines such as Dimenhydrinate.
Because of the potentiating threat of Dimenhydrinate on the action of the
Central Nervous System depressants it is important that the dose of
Neperidine, Morphine or other narcotic analgesics and of barbiturates be
reduced by ¼ or ½ when used concomitantly.

4.6

Pregnancy and lactation
Dimenhydrinate should not be used in pregnancy unless the physician considers
it is essential. There was a significant incidence of cleft palate and clefts with
other defects in children whose mothers have taken diphenhydramine (a
component of Dimenhydrinate).

4.7

Effects on ability to drive and use machines
Patients undergoing treatment with Dimenhydrinate should not take charge of
vehicles, other means of transport or machinery where loss of attention may
lead to accidents because Dimenhydrinate may cause drowsiness and dulling
of mental alertness.

4.8

Undesirable effects
Adverse effects with Dimenhydrinate may vary in incidence and severity from
patient to patient. The most common effect is sedation which may vary from
slight drowsiness to deep sleep. The drug may be associated with inability to
concentrate, lassitude, dizziness, hypotension, muscular weakness and
uncoordination. When they do occur the sedative effects may diminish after a
few days.
Rare with Dimenhydrinate are gastro-intestinal side effects.
Dimenhydrinate may very rarely produce headache, blurred vision, tinnitus,
elation or depression, irritability, nightmares, anorexia, difficulty in
micturition, dryness in the mouth, tightness in the chest, tingling, heaviness
and weakness of the hands.
Although cardio-vascular side effects are rare, minor increases in blood
pressure and occasional mild hypotension have been reported. Leucopenia
and rarely agranulocytosis, jaundice and extra-pyramidal reactions have also
been reported. Occasionally hypersensitivity reactions have followed its uses
by both mouth or topical application.

4.9

Overdose
In the case of severe overdosage, the stomach should be emptied by gastric
lavage. Emetics should not be used.
The patient should be kept quiet, particularly in the case of children, to
minimise the excitation which occurs. Convulsions may be controlled with
Diazepam preferably given intravenously. Since Dimenhydrinate is rapidly
metabolised with only traces being recoverable in the urine, diuresis is of little,
if any, value.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Dimenhydrinate is the salt produced by interaction of the antihistimanic base
diphenhydramine with the acidic compound 8-chlorotheophylline.
Dimenhydrinate markedly depresses labyrinthine function.
Because of the receptors with which it interacts, Dimenhydrinate is described as
an H1-antagonist or the blocker of histamine and belongs to the Theanolamine
group.
The mode of action is a result of the binding with high affinity to H1-receptors in
the brain. It is not, however, clear whether the anti-motion sickness activity of
Dimenhydrinate is related to its ability to block muscarinic receptors.

5.2

Pharmacokinetic properties
Dimenhydrinate is well absorbed from the gastro-intestinal tract after oral
dosing with extensive first-pass effect. The drug is metabolised in the liver
and excreted usually as metabolites in the urine. The drug is highly bound to
plasma proteins and is widely distributed in the body. Following oral
administration, the effects develop in about 30 minutes and are maximal
within 1-2 hours and last for 3-6 hours.

5.3

Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose
Povidone
Sodium starch glycollate (Type A)
Magnesium stearate

6.2

Incompatibilities
Dimenhydrinate caused precipitation when mixed with solutions of
Tetracycline Hydrochloride in dextrose injections and when mixed with
Novobiocin Sodium in sodium chloride solution.
Substances which were incompatible with solutions of Dimenhydrinate
included phenothiazine derivatives, reserpine, methoxamine hydrochloride,
pentobarbitone sodium, thiamylal sodium, nicotinic acid, pyridoxine
hydrochloride, and certain antibiotic solutions such as chloramphenicol
succinate.

6.3

Shelf life
36 months: High density polystyrene containers with polythene lids and/or
polypropylene containers with polypropylene or polythene lids.
24 months: PVC/Aluminium foil strips.

6.4

Special precautions for storage
Containers : Do not store above 25°C. Keep the container tightly closed. Store
in the original
container.
Strips : Do not store above 25°C. Store in the original package. Keep container
in the outer
carton.

6.5

Nature and contents of container
High density polystyrene containers with polythene lids and/or polypropylene
containers with
polypropylene or polythene lids.
Packs of 100 and 500 tablets.
Strips. 250 micron rigid PVC (pharmaceutical grade)/20 micron hard-tempered
aluminium foil coated on the dull side with 6-7 gsm heat seal lacquer and printed
on the bright side.
Packs of 30 tablets.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited
11 Boumpoulinas Street,
3rd floor, 1060 Nicosia
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 33414/0039

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/03/2009

10

DATE OF REVISION OF THE TEXT
16/03/2009

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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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