Skip to Content

DIMENHYDRINATE BP 50MG TABLETS

Active substance(s): DIMENHYDRINATE

View full screen / Print PDF » Download PDF ⇩
Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Dimenhydrinate

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Dimenhydrinate BP 50.00 mg

3

PHARMACEUTICAL FORM
Tablet

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:
For motion sickness it is usually given in doses of 50 mg three times daily, the first
dose for preventing motion sickness being taken about 30 minutes before the journey.
For other 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:
2 to 6 years - 12.5 to 25 mg two to three times daily. Not more than 75 mg should be
given in any 24 hours. Do not exceed the stated dose.
7 to 12 years - 25 to 50 mg two to three times daily. Not more than 150 mg should be
given in any 24 hours. Do not exceed the stated dose.

Elderly:
Same as adult dose.
Route of administration: Oral.

4.3

Contraindications
Sensitivity to Dimenhydrinate or any of the other ingredients of the tablet.
In patients with porphyria.
Children under 2 years old.

4.4

Special warnings and precautions for use
Dimenhydrinate should be used with caution in patients with


epilepsy



prostatic hypertrophy or urinary retention



glaucoma



hepatic diseases



pyloroduodenal obstruction

In patients with renal impairment, a reduction in the dose of any antihistamine (e.g.
dimenhydrinate) may be necessary.
Use in children under 6 years old should only be under professional advise.
Diphenhyramine should not be taken with cough and cold medicines in children aged
2-6 years old.
Children and the elderly are more susceptible to the side effects.
It has been suggested that Dimenhydrinate could mask warning symptoms of damage
caused by ototoxic drugs such as the amino-glycoside antibiotics.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction
Dimenhydrinate will interact with anticholinergic, anti-depressant (tricyclic and
MAOIs) and anti-parkinsonian drugs such as Trihexyphenidyl, increasing the
anticholinergic side effects, dry mouth, urine retention, confusion, etc.
The effects of Betahistine may be antagonized.
Sedating antihistamines may enhance the sedative effects of CNS depressants
including alcohol, other sedating antihistamines, barbiturates, hypnotics, opiods,
anxiolytic sedatives and antipsychotics.
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).
Dimenhydrinate is excreted in breast milk to such an extent that effects on the
suckling child are likely if therapeutic doses of Dimenhydrinate are administered to
breast-feeding women.

4.7

Effects on ability to drive and use machines
Patients undergoing treatment with Dimenhydrmnate 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 inco-ordination. 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. These include bronchospasm, angioedema, rashes and
photosensitivity.

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-chiorotheophylline.
Dimenhydrmnate 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 ‘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
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose
Povidone
Sodium Starch Glycollate
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 chioramphenicol
succinate.

6.3

6.4

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 packs.

Special precautions for storage
Keep container well closed. Protect from light. Store below 25ºC.

6.5

Nature and contents of container
High density polystyrene containers with polythene lids and/or polypropylene
containers
with polyproylene or polythene lids: 100 and 500
PVC/Aluminium foil packs: 30

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 33414/0040

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/02/2009

10

DATE OF REVISION OF THE TEXT

17/02/2009

Expand view ⇕

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.

Hide