Dicycloverine 10mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Dicycloverine hydrochloride

זמין מ:

A A H Pharmaceuticals Ltd

קוד ATC:

A03AA07

INN (שם בינלאומי):

Dicycloverine hydrochloride

כמות:

10mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 01020000; GTIN: 5025903011026

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
Dicycloverine Hydrochloride
10mg Tablets
20mg Tablets
Dicycloverine hydrochloride
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it
again.
- If you have any further questions, ask your
doctor or pharmacist.
- This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
- If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Dicycloverine Hydrochloride Tablets are
and what they are used for
2. What you need to know before you take
Dicycloverine Hydrochloride Tablets
3. How to take Dicycloverine Hydrochloride
Tablets
4. Possible side effects
5. How to store Dicycloverine Hydrochloride
Tablets
6. Contents of the pack and other information
1. What Dicycloverine Hydrochloride
Tablets are and what they are used for
Dicycloverine Hydrochloride Tablets contains
a medicine called dicycloverine hydrochloride.
This is an antispasmodic, and it relieves, prevents,
or lowers the number of muscle spasms that occur.
It is used to treat cramps, pain in the stomach
or gut (intestine), and stomach or gut (intestine)
problems such as irritable bowel. Muscle spasms
play a part in all of these. Dicycloverine works
by relaxing the muscles in your stomach and gut
(intestine). It stops sudden muscle contractions
(spasms). In doing this, it relieves cramps, pain,
bloating, wind and discomfort.
2. What you need to know before you take
Dicycloverine Hydrochloride Tablets
Do not take Dicycloverine Hydrochloride
Tablets:
- if you are allergic to dicycloverine
hydrochloride or any of the other ingredients
of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Dicycloverine Hydrochloride Tablets if:
- You have painful eye

מאפייני מוצר

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