DulcoEase 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Docusate sodium

Available from:

Sanofi Consumer Healthcare

ATC code:

A06AA02

INN (International Name):

Docusate sodium

Dosage:

100mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01060200; GTIN: 5012917077032 5000283661825

Patient Information leaflet

Package Leaflet:
Information for the user
Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist
has told you.
• Keep this leaflet. You may need to read it
again
• Ask your pharmacist if you need more
information or advice
• 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
• You must talk to a doctor or pharmacist if
you do not feel better or you feel worse
• The full name of your medicine is DulcoEase
100 mg Capsules. In this leaflet the shorter
name DulcoEase is used
What is in this leaflet:
1. What DulcoEase Capsules is and what it is
used for
2. What you need to know before you take
DulcoEase Capsules
3. How to take DulcoEase Capsules
4. Possible side effects
5. How to store DulcoEase Capsules
6. Contents of the pack and other information
1. What DulcoEase Capsules is and what
it is used for
What DulcoEase is
DulcoEase contains the active substance
docusate sodium. This medicine is a laxative.
It belongs to a group of medicines called
‘stool softeners’.
• DulcoEase is used to treat constipation in
adults and children 12 years and over
How DulcoEase works
DulcoEase softens the stools (faeces).
• It does this by increasing the amount of
water within the stools (faeces)
• This makes your bowel movements easier
It helps you when:
• You are constipated
• You have piles
• You have a tear in the lining of your anus
(anal fissure)
What is constipation?
Normal and regular bowel movement is
important for most people. However, what is
‘normal and regular’ varies from person to
person. Some may have a bowel movement
every day, others less often. Whatever it is like
for you, it is best that your bowel movement
has a regular pattern.
• Constipation is an occasional problem for
some people - for others, it may happen
more often
• Cons

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dulcoease 100 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Docusate sodium 100 mg.
Excipients of known effect
Sorbitol
Sunset yellow (E110)
3
PHARMACEUTICAL FORM
Capsule, soft
A two colour (opaque white and opaque yellow) soft, oval, gelatin
capsule
with a clear, colourless liquid fill.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention and treatment of chronic constipation. Prevention of hard,
dry stools and
reduction of straining at stools in the presence of conditions like
haemorrhoids or anal
fissures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children 12 years and above:
Up to maximum of 500 mg should be taken daily in divided doses.
Treatment should be commenced with large doses such as 100 mg three
times
daily, which should be adapted to the treatment response.
Dulcoease is not recommended for use in children under the age of 12
years.
DURATION OF TREATMENT
The patient should be advised to consult a physician when constipation
persists or worsens during treatment or when laxatives are needed for
a long
period of time.
METHOD OF ADMINISTRATION
Oral use. The capsules should be swallowed whole with a glass of
water.
SPECIAL POPULATIONS
No specific dose adjustment is necessary for elderly patients.
4.3
CONTRAINDICATIONS
Dulcoease is contraindicated in patients with:
-
hypersensitivity to docusate or to any of the excipients
-
abdominal pain if not constipation-related
-
nausea and vomiting
-
intestinal obstruction
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Organic disorders should be excluded prior to the administration of
any
laxative.
Each 100 mg capsule contains approximately 19.3 mg of sorbitol,
resulting in
96.5
mg sorbitol per maximum recommended daily dose for adults. Patients
with
hereditary fructose intolerance (HFI) should not take this medicine.
Dulcoease
100
mg
Capsules
contain
E110
sunset
yellow
which
may
cause
allergic reactions.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INT