Dioctyl 100mg capsules

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Docusate sodium

Tilgjengelig fra:

Teofarma S.r.l.

ATC-kode:

A06AA02

INN (International Name):

Docusate sodium

Dosering :

100mg

Legemiddelform:

Oral capsule

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 01060200; GTIN: 5015366000262 5015366000279

Informasjon til brukeren

Read the package leaflet before use.
For the prevention and treatment of
constipation
Dose: ADULTS AND ELDERLY - Up to five
capsules per day. The capsules should be
swallowed whole with a glass of water.
CHILDREN - Not recommended.
See the package leaflet for further
information.
Each capsule contains 100 mg docusate
sodium.
If laxatives are needed every day, or if you
have persistent stomach pain, talk to your
doctor.
Keep out of the sight and reach of children.
DIOCTYL
®
MG CAPSULES
100
Docusate sodium Oral use
P
PL 00039/0737
Do not store above 25°C.
Store in the original package
in order to protect from
moisture
LOT:
EXP:
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 have 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 if you do not feel
better or if you feel worse.
WHAT IS IN THIS LEAFLET:
1. What Dioctyl is and what it is used for
2.
What you need to know before you take Dioctyl
3. How to take Dioctyl
4. Possible side effects
5. How to store Dioctyl
6. Contents of the pack and other information.
1. WHAT DIOCTYL IS AND WHAT IT IS USED FOR
Dioctyl contains the active substance docusate
sodium, it is one of a group of medicines called
“laxatives”. They are usually taken to prevent and
treat constipation that has lasted for a long time.
It may also be taken during certain types of
stomach
X-rays, or to help you go to the toilet
if you have piles (haemorrhoids).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIOCTYL
BANLB003-12
Docusate sodium Oral use
For the prevention and treatment of constipation.
Dose: ADULTS AND ELDERLY - Up to five
capsules per day. The capsules should be
swallow

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dioctyl 100 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Docusate sodium 100 mg.
Excipients with known effect: sorbitol and sunset yellow (E110)
For the full list of excipients, see section 6.1.
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
a)
To prevent and treat chronic constipation.
(i)
to soften hard, dry stools in order to ease defaecation and reduce
straining at
stool; and
(ii)
in the presence of haemorrhoids and anal fissure, to prevent hard, dry
stools
and reduce straining.
b)
As an adjunct in abdominal radiological procedures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS:
Up to 500 mg should be taken daily in divided doses. Treatment should
be
commenced with large doses, which should be decreased as the condition
of the
patient improves.
_For use with barium meals:_
400 mg to be taken with the meal.
ELDERLY:
As for adults.
PAEDIATRIC POPULATION:
The safety and efficacy of Dioctyl in children aged 0 to 11 years have
not yet been
established. No data are available
.
METHOD OF ADMINISTRATION
For oral use.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Dioctyl should not be administered when abdominal pain, nausea,
vomiting or
intestinal obstruction is present.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Organic disorders should be excluded prior to the administration of
any laxative.
The treatment of constipation with any medicinal product is only
adjuvant to a healthy
lifestyle and diet, for example:
•
increased intake of fluids and dietary fibre.
•
advice on appropriate physical activity
If laxatives are needed every day, or if there is persistent abdominal
pain, consult your
doctor.
Excipients
_Fructose intolerance: _
This product contains sorbitol. Patients with rare hereditary problems
of fru