Dicycloverine 10mg tablets

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Dicycloverine hydrochloride

Boleh didapati daripada:

Advanz Pharma

Kod ATC:

A03AA07

INN (Nama Antarabangsa):

Dicycloverine hydrochloride

Dos:

10mg

Borang farmaseutikal:

Oral tablet

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 01020000; GTIN: 05060055200140

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dicycloverine Hydrochloride 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of Dicycloverine hydrochloride.
Excipient(s) with known effect:
Each tablet contains 67.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off white, circular, flat beveled edge, uncoated tablet
debossed with “S10”
on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Smooth muscle antispasmodic primarily indicated for treatment of
functional
conditions involving smooth muscle spasm of the gastrointestinal
tract.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults: 10-20 mg three times daily before or after meals.
Children (2-12 years): 10 mg three times daily.
Method of administration
Oral
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Products containing dicycloverine 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.
Dicycloverine hydrochloride 10 mg Tablets contains lactose
monohydrate. 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
None stated.
4.6
FERTILITY, PREGNANCY AND LACTATION
Pregnancy:
Epidemiological studies in pregnant women with products containing
dicycloverine
hydrochloride (at doses up to 40 mg/day) have not shown that
dicycloverine
hydrochloride increases the risk of foetal abnormalities if
administered during the
first trimester of pregnancy.
Fertility:
Reproduction studies have been performed in rats and rabbits at dos