Dozile

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Doxylamine succinate 25mg;  

Disponibil de la:

Wilson Foods Limited

INN (nume internaţional):

Doxylamine succinate 25 mg

Dozare:

25 mg

Forma farmaceutică:

Liquid filled capsule

Compoziție:

Active: Doxylamine succinate 25mg   Excipient: Amaranth Butylated hydroxyanisole Gelatin Macrogol 400 Patent blue V Propylene glycol Purified water Sorbitol

Unități în pachet:

Blister pack, 10 capsules

Clasă:

Restricted

Tip de prescriptie medicala:

Restricted

Produs de:

Corden Pharma Bergamo SpA

Indicații terapeutice:

Temporary use in the relief of insomnia

Rezumat produs:

Package - Contents - Shelf Life: Blister pack, - 10 capsules - 24 months from date of manufacture stored at or below 25°C

Data de autorizare:

1994-06-15

Prospect

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INFORMATION FOR
CONSUMERS
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Consumer Medicine
Information
DOZILE
®
Doxylamine succinate 25mg capsules
What is in this leaflet
Please read this leaflet carefully before you start taking DOZILE. This leaflet answers some common
questions about DOZILE. It does not contain all the available information.
It does not take the place of talking to your pharmacist or doctor.
All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking
DOZILE against the benefits they expect it will have for you.
Use DOZILE as instructed and follow the advice given in this leaflet.
If you have any concerns about taking this medicine, ask your pharmacist or doctor.
Keep this leaflet with the medicine. You may need to read it again.
What DOZILE is used for
DOZILE is used to help in the temporary relief of sleeplessness. If you have trouble falling asleep, your
doctor or pharmacist will advise you if DOZILE may help.
Ask your doctor or pharmacist if you have any questions about why DOZILE has been recommended
for you.
How DOZILE works
DOZILE capsules contain doxylamine succinate. Doxylamine succinate is a type of antihistamine called
an ethanolamine derivative antihistamine. It has a sedating effect.
Before taking DOZILE
Before taking DOZILE
When you must not take it
Do not take DOZILE if:
you have an allergy to doxylamine succinate, other ethanolamine derivative antihistamines or any
of the ingredients listed at the end of this leaflet. If you are not sure if you have such an allergy to
DOZILE, check with your pharmacist or doctor.
the expiry date (EXP) printed on the pack has passed. If you take this medicine after the
expiry date

Caracteristicilor produsului

NEW ZEALAND DATASHEET
1 PRODUCT NAME
DOZILE 25 mg capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Doxylamine Succinate 25 mg Capsules
3 PHARMACEUTICAL FORM
Liquid filled soft gel capsules, purple, containing 25 mg doxylamine
succinate.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Temporary use in the relief of insomnia.
4.2 Dose and method of administration
Adults: 1 capsule 30 minutes before retiring, or as directed by a
pharmacist or physician.
Maximum stated dose should not be exceeded.
Dozile is recommended for occasional use only i.e. for periods of no
longer than a week at a
time. If sleeplessness persists, consult your doctor.
Note: Dozile is not recommended for children under 12 years of age.
4.3 Contraindications
Hypersensitivity to doxylamine, other ethanolamine derivative
antihistamines or to any other
ingredient in the product.
4.4 Special warnings and precautions for use
Caution should be used if taken with alcohol. Due to the
anticholinergic properties of
antihistamines,
caution
should be
used when Dozile is
taken concurrently
with other
medications. (See section 4.5)
Caution should be taken by those with narrow angle or open-angle
glaucoma, urinary
retention,
prostate
enlargement,
pyloroduodenal
obstruction,
epilepsy
or
severe
cardiovascular disorders.
Doxylamine may suppress positive skin test results.
USE IN CHILDREN
Dozile is not recommended for children under 12 years of age. The
safety and efficacy of
doxylamine as a night time sleep aid in children younger than 12 years
of age have not been
established. In addition, children may be more prone than adults to
experience paradoxical
CNS stimulation rather than sedation when antihistamines are used as
night time sleep aids.
USE IN THE ELDERLY
The elderly may be more sensitive to the effects of the usual adult
dose.
4.5 Interaction with other medicines and other forms of interaction
Dozile produces an additive effect when administered with other CNS
depressants such as
opioid analgesics, neuroleptics, alcohol, hypnotics and
psychotherape