TRAVLESE - summary of medicine 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 % or ^ 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.

5.1 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.

6.1

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

7   MARKETING AUTHORISATION HOLDER

8 MARKETING AUTHORISATION NUMBER(S)

PL 33414/0039

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

16/03/2009