Paxidorm Tablets

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

DIPHENHYDRAMINE HYDROCHLORIDE

Disponible depuis:

Norma Chemicals Limited

Code ATC:

N05CM

DCI (Dénomination commune internationale):

DIPHENHYDRAMINE HYDROCHLORIDE

forme pharmaceutique:

COATED TABLET

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 25 milligram(s)

Type d'ordonnance:

OTC

Domaine thérapeutique:

PSYCHOLEPTICS

Statut de autorisation:

Authorised

Date de l'autorisation:

2006-05-30

Notice patient

PAXIDORM SYRUP AND TABLETS
Diphenhydramine Hydrochloride
_Please read this leaflet carefully before using this _
_medicine. If you have any questions or are not _
_sure about anything, ask your doctor or _
_pharmacist._
EACH TABLET CONTAINS: DIPHENHYDRAMINE HCL 
BP 25MG AS THE ACTIVE INGREDIENT.
_In addition to the above ingredient, the tablets _
_also contain Lactose, Corn Starch, _
_Polyvinylpyrolidone, Magnesium Stearate, _
_Opaseal, Sucrose, Calcium Carbonate, Talc, _
_Acacia, Carnauba Wax, Beeswax, Silicone Fluid _
_and colourings E171 and E127._
EACH 5ML SYRUP CONTAINS: DIPHENHYDRAMINE 
HCL BP 10MG AS THE ACTIVE INGREDIENT.
_In addition to the above ingredient, the syrup _
_also contains Purified Water, Sucrose, Saccharin _
_Sodium, Propylene Glycol, Glycerol, Methyl-. _
_Ethyl-, Propyl Hydroxybenzoate (E218, E214, _
_E216), Butyl Hydroxybenzoate, Flavouring, _
_Colouring (Caramel El50)._
Paxidorm is available in packs of 20 tablets 
and bottles of 150ml syrup.
Diphenhydramine Hydrochloride is an 
antihistamine with sedative properties.
WHAT IS PAXIDORM FOR?
Paxidorm helps relieve temporary 
sleeplessness.
CHECK BEFORE YOU TAKE THIS PRODUCT
You should not use this medicine if you are 
sensitive to any of the ingredients or you 
suffer from porphyria.
You should inform your doctor or pharmacist 
before taking this medicine if any of the 
following apply to you:-
✦
 You are taking any other sleep aids or drugs 
for the relief of anxiety.
✦
 You are pregnant, trying to become 
pregnant or are breast feeding.
✦
 You are suffering from prostatic 
hypertrophy, epilepsy, glaucoma or liver 
disease.
Special Warnings
✦
 Do not take with alcohol.
✦
 Causes drowsiness. Do not drive or operate 
machinery.
✦
 If sleeplessness persists, consult your doctor.
✦
 Do not exceed the stated dose.
✦
 Keep all medicines out of the reach of 
children.
HOW TO TAKE PAXIDORM
Dose: 1 or 2 tablets _OR_ 10ml to 25ml of syrup 
half an hour before reti

Résumé des caractéristiques du produit

Page 1 of 3 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 
Paxidorm Tablets, 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Diphenhydramine Hydrochloride BP 25mg 

3. PHARMACEUTICAL 
FORM 
 Sugar Coated Tablet 

CLINICAL PARTICULARS 

4.1. THERAPEUTIC 
INDICATIONS 
As a short term hypnotic. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 
_ _
Adults: 1 or 2 tablets at bedtime, or after
retiring when sleep is not readily achieved 

Children: Not recommended for children under the age of 16 

Elderly: As for adults, use cautiously, reduce dose if required. 

4.3. CONTRA-INDICATIONS 
Known sensitivity to any of
the ingredients and/or porphyria. _WHEN USED AS A SLEEP AID:_ 
Sedation of children under the age of 16 should only be
under medical direction, 
consequently use as a sedative in this age group is
contra-indicated. 

4.4. 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
Avoid concurrent taking of alcohol 
Use with caution in prostatic hypertrophy, epilepsy, glaucoma and
hepatic disease and CNS 
depression or hypotension in the elderly. Caution should
be exercised in patients with 
urinary retention. 

4.5. 
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF
INTERACTION 
Diphenhydramine may potentiate hypnotics
and anxiolytics. Diphenhydramine and beta-
histamine are antagonistic. 

4.6. 
PREGNANCY AND LACTATION 
Safety in pregnancy and lactation has not been demonstrated 

4.7. 
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 
May cause drowsiness. If affected do not drive
or operate machinery 

4.8. UNDESIRABLE 
EFFECTS 
Page 2 of 3 
Dryness of mouth, dizziness, nausea, difficulty in micturation,
allergic reaction and rarely 
thrombocytopenia. Headache, psychomotor impairment, blurred
vision, gastrointestinal 
disturbances, palpitations, arrhythmias, hypotension,
hypersensitivity (includuding 
broncospasm,