Cyclizine 50mg/1ml solution for injection ampoules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Cyclizine lactate

Saatavilla:

Advanz Pharma

ATC-koodi:

R06AE03

INN (Kansainvälinen yleisnimi):

Cyclizine lactate

Annos:

50mg/1ml

Lääkemuoto:

Solution for injection

Antoreitti:

Intravenous; Intramuscular

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 04060000; GTIN: 5060337260763

Valmisteyhteenveto

OBJECT 1
CYCLIZINE 50MG TABLETS
Summary of Product Characteristics Updated 10-Apr-2015 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Valoid
1
50 mg Tablets
Cyclizine Hydrochloride 50 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 50 mg of cyclizine hydrochloride.
Excipient with known effect:
Lactose.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
White, biconvex, uncoated tablet, scored; coded T4A.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses
4. Clinical particulars
4.1 Therapeutic indications
Cyclizine Hydrochloride is indicated in adults and in children aged 6
years and over for the prevention
and treatment of nausea and vomiting including:-
• Motion sickness.
• Nausea and vomiting caused by narcotic analgesics and by general
anaesthetics in the post-operative
period.
• Vomiting associated with radiotherapy, especially for breast
cancer since cyclizine does not elevate
prolactin levels.
Cyclizine Hydrochloride may be of value in relieving vomiting and
attacks of vertigo associated with
Menière's disease and other forms of vestibular disturbance.
4.2 Posology and method of administration
Posology
To prevent motion sickness Cyclizine Hydrochloride should be taken
about one to two hours before
departure.
OLDER PEOPLE
There have been no specific studies of Cyclizine Hydrochloride in the
elderly. Experience has indicated
that normal adult dosage is appropriate.
PAEDIATRIC POPULATION
Children less than 6 years of age:
Cyclizine Hydrochloride tablets are not recommended for children less
than 6 years of age.
Children 6 to 12 years of age:
25 mg orally, which may be repeated up to three times a day.
Children over 12 years of age:
50 mg orally, which may be repeated up to three times a day.
Adults
50 mg orally, which may be repeated up to three times a day.
Method of administration:
Oral
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipient