Dicycloverine 20mg tablets

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Dicycloverine hydrochloride

থেকে পাওয়া:

Teva UK Ltd

এটিসি কোড:

A03AA07

INN (আন্তর্জাতিক নাম):

Dicycloverine hydrochloride

ডোজ:

20mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 01020000; GTIN: 5017007021117

তথ্য লিফলেট

PVC/PVDC/AL BLISTERS _and PVC/PVdC/PVC _
_(amber)/Al blisters:_
This medicinal product does not require
any special storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.
CONTENTS OF THE PACK AND OTHER
INFORMATION
WHAT DICYCLOVERINE HYDROCHLORIDE TABLETS
CONTAINS
•
The active substance in Dicycloverine
Hydrochloride Tablets is dicycloverine.
Each Dicycloverine Hydrochloride
10 mg Tablet contains 10 mg of
dicycloverine hydrochloride.
Each Dicycloverine Hydrochloride
20 mg Tablet contains 20 mg of
dicycloverine hydrochloride.
•
The other ingredients are lactose
monohydrate; cellulose,
microcrystalline; starch, pregelatinised
(maize); magnesium stearate.
WHAT DICYCLOVERINE HYDROCHLORIDE TABLETS
LOOK LIKE AND CONTENTS OF THE PACK
•
Dicycloverine Hydrochloride 10 mg
Tablets are a round, white, biconvex
tablet, 6 mm in diameter, 3.15 mm in
thickness, marked with A151 on one
side. Available in pack sizes of: 100
tablets.
•
Dicycloverine Hydrochloride 20 mg
Tablets are a round, white, biconvex
tablet, 8 mm in diameter, 3.60 mm in
thickness, marked with A203 on one
side. Available in pack sizes of: 84
tablets.
MARKETING AUTHORISATION HOLDER:
TEVA UK Limited, Eastbourne, BN22 9AG,
United Kingdom
MANUFACTURER:
Actavis Ltd. BLB 016 Bulebel Industrial
Estate, Zejtun ZTN 3000, Malta
THIS LEAFLET WAS LAST REVISED IN 05/2019.
PL 00289/2162 and PL 00289/2163
The following effects may happen:
headache, feeling dizzy, feeling sick, dry
mouth or difficulty in swallowing, blurred
eyesight and hot dry skin.
IF YOU FORGET TO TAKE DICYCLOVERINE
HYDROCHLORIDE TABLETS
If you forget a dose, take it as soon as
you remember it. However, if it is nearly
time for the next dose, skip the missed
dose.
IF YOU STOP TAKING DICYCLOVERINE
HYDROCHLORIDE TABLETS
Keep taking Dicycloverine Hydrochloride
until your doctor tells you to stop. Do not
stop taking Dicycloverine Hydrochloride
just because y

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dicycloverine hydrochloride 20 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg dicycloverine hydrochloride
Excipient with known effect:
Each 20 mg tablet contains lactose monohydrate 129.00 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Each 20 mg tablet is a round, white, biconvex tablet, 8 mm in
diameter,
3.60 mm in thickness, marked with A203 on one 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
Posology
_Adults and children over 12 years _
20 mg dicycloverine hydrochloride three times daily.
Method of administration
Oral use.
The tablets should be taken before or after meals.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
Known idiosyncrasy to dicycloverine hydrochloride.
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.
The tablets contain lactose. Patients with rare hereditary problems of
galactose
intolerance, total 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 fetal abnormalities
if
administered during the first trimester of pregnancy. Since the risk
of
teratog