Dicycloverine 10mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Dicycloverine hydrochloride

Disponibil de la:

Phoenix Healthcare Distribution Ltd

Codul ATC:

A03AA07

INN (nume internaţional):

Dicycloverine hydrochloride

Dozare:

10mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 01020000

Prospect

731884
1065013426
PACKAGE LEAFLET: INFORMATION FOR THE USER
DICYCLOVERINE HYDROCHLORIDE
10MG TABLETS
TAKING THIS MEDICINE
• If you have any further questions, ask your doctor
or pharmacist
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if
their symptoms are the same as yours
please tell your doctor or pharmacist
1.
What Dicycloverine hydrochloride Tablets are and
what they are used for
2.
Before you take Dicycloverine hydrochloride Tablets
3.
How to take Dicycloverine hydrochloride Tablets
5.
How to store Dicycloverine hydrochloride Tablets
6.
Further information
1.
WHAT DICYCLOVERINE HYDROCHLORIDE
TABLETS ARE AND WHAT THEY ARE USED FOR
WHAT DICYCLOVERINE HYDROCHLORIDE TABLETS ARE
Dicycloverine hydrochloride Tablets contain a medicine
called dicycloverine hydrochloride. This belongs to a
group of medicines called antispasmodics.
WHAT DICYCLOVERINE HYDROCHLORIDE TABLETS ARE USED FOR
• Cramps
• Pain in the stomach or intestine (gut)
• Stomach or intestine (gut) problems - such as
irritable bowel.
HOW DICYCLOVERINE HYDROCHLORIDE TABLETS WORK
Dicycloverine hydrochloride Tablets work 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. BEFORE YOU TAKE DICYCLOVERINE HYDROCHLORIDE TABLETS
DO NOT TAKE DICYCLOVERINE HYDROCHLORIDE
TABLETS IF:
×
Y
ou are allergic (hypersensitive) to dicycloverine
hydrochloride or any of the other ingredients in
Dicycloverine hydrochloride Tablets (see Section 6:
Further information)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
Do not take this medicine if any of the above apply to
you. If you are not sure, talk to your doctor or pharmacist
before taking Dicycloverine hydrochloride Tablets.
TAKE SPECIAL CARE WITH DICYCLOVERINE
HYDROCHLORIDE TABLETS. CHECK WITH YOUR DOCTOR OR
PHARMACIST BEFORE TAKING YOUR MEDICINE IF:
 You

Caracteristicilor produsului

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