NOTENSYL SYRUP

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

DICYCLOMINE HYDROCHLORIDE

Commercializzato da:

CTS CHEMICAL INDUSTRIES LTD

Codice ATC:

A03AA07

Forma farmaceutica:

SYRUP

Composizione:

DICYCLOMINE HYDROCHLORIDE 10 MG / 5 ML

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

CTS CHEMICAL INDUSTRIES LTD

Gruppo terapeutico:

DICYCLOVERINE

Area terapeutica:

DICYCLOVERINE

Indicazioni terapeutiche:

Adjunctive therapy in irritable bowel syndrome, neurogenic bowel disturbance.

Data dell'autorizzazione:

2010-02-28

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Notensyl Tablets
Notensyl Syrup
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Notensyl contains Dicyclomine hydrochloride 10mg
Each 5ml of Notensyl Syrup contain Dicyclomine hydrochloride 10mg
3. PHARMACEUTICAL FORM
Tablets , syrup
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adjunctive therapy in irritable bowel syndrome, neurogenic bowel
disturbance
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral
_tablets _
_Adolescents and Adults (above 12 years): 10-20mg three times daily
before or after meals. _
_Children (2-12 years):_ 10mg three times daily.
syrup
Adults
5-10 ml (10 - 20mg) three times daily before or after meals.
Children (2-12 years):
5ml (10mg) three times daily.
Children (6 months - 2 years)
2.5 ml (5mg) three or four times daily, 15 minutes before feeds. Do
not exceed a daily dose of
40mg.
4.3 CONTRAINDICATIONS
Tablets and syrup
•
Known idiosyncrasy to dicyclomine hydrochloride.
syrup
•
Infant under 6 months of age
•
Patients with rare heredity problems of fructose intolerance, glucose
galactose
malabsorption or sucrase-isomaltase insufficiency should not take this
medicine
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Products containing dicyclomine hydrochloride should be used with
caution in any patient with or
suspected of having glaucoma or prostatic hypertrophy.
Use with care in patients with hiatus hernia associated with reflux
oesophagitis because
anticholinergic drugs may aggravate the condition.
There are reports of infants, 3 months of age and under, administered
dicyclomine hydrochloride
syrup who have evidenced respiratory symptoms (breathing difficulty,
shortness of breath,
breathlessness, respiratory collapse, apnoea) as well as seizures,
syncope, asphyxia, pulse rate
fluctuations, muscular hypotonia and coma. The above symptoms have
occurred within minutes
of ingestion and lasted 20-30 minutes. The symptoms were reported in
association with
dicyclomine hydrochloride syru