Carbalax suppositories

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Sodium dihydrogen phosphate anhydrous; Sodium bicarbonate

Mevcut itibaren:

Forest Laboratories UK Ltd

ATC kodu:

A06AG20

INN (International Adı):

Sodium dihydrogen phosphate anhydrous; Sodium bicarbonate

Doz:

1.69gram ; 1.08gram

Farmasötik formu:

Suppository

Uygulama yolu:

Rectal

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 01060400

Bilgilendirme broşürü

103/L/e/2
1
PATIENT INFORMATION LEAFLET
CARBALAX
TM SUPPOSITORIES
Carbalax Suppositories are used to treat constipation, including
constipation caused by prolonged bedrest or
the effect of medicines. They are also sued to evacuate the bowels
before childbirth, operations or diagnostic
procedures and to ease bowel movements after operations or in any
condition where staining may be painful.
Carbalax suppositories effervesce on contact with the rectal mucosa
and this encourages evacuation.
Carbalax are suitable for adults and children over 12 years of age. Do
not administer to younger children.
There are certain bowel conditions where treatment of constipation
with Carbalax Suppositories may not be
suitable. You should discuss this with your doctor or pharmacist if
you are not sure.
Administer one suppository 30 minutes before evacuation is required.
Remove from packaging and moisten
with water before insertion into the rectum. Do not lubricate with
oil.
There are not normally any problems following the use of Carbalax
Suppositories. If you notice anything
unusual tell your doctor or pharmacist.
If anyone accidentally swallows Carbalax Suppositories contact a
doctor or pharmacist.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects
not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
Each Suppository contains: Sodium Bicarbonate Ph.Eur. 1.08g
And anhydrous Sodium Acid Phosphate 1.3g
in an inert Polyethylene Glycol base.
12 suppositories.
Keep out of reach of children.
Do not remove from packaging until needed.
Do not use after expiry date.
Store below 25°C in a dry place.
For rectal use only
Manufactured by: Forest Laboratories UK Limited, Bourne Road, Bexley,
Kent, DA5 1NX, United Kingdom
Chemidex Pharma Limited
Chemidex House
Egham Business Village
Crabtree Roa

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
CARBALAX SUPPOSITORIES
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains:
Sodium acid phosphate anhydrous
(equivalent to Sodium Acid Phosphate Ph.Eur. 1.69g)
1.30g
Sodium Bicarbonate Ph.Eur.
1.08g
3
PHARMACEUTICAL FORM
Suppository for rectal administration
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic simple constipation. Constipation due to prolonged bed-rest or
to drugs.
Bowel evacuation before childbirth, surgery, sigmoidoscopy,
radiological
examination and post-operatively. To avoid discomfort associated with
straining. To
regularise bowel movement and keep stools to normal consistency in
local anal
conditions such as haemorrhoids, fissures and fistulae.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and the Elderly:
Administer one suppository 30 minutes before evacuation is required.
Children under 12:
Not recommended.
4.3
CONTRAINDICATIONS
Conditions where any bowel medication for the relief of constipation
is contra-
indicated.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The suppository should be moistened with water, not lubricated with
oil before
insertion.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6
PREGNANCY AND LACTATION
No restriction.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8
UNDESIRABLE EFFECTS
Side effects are unlikely.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal product is
important. It allows continued monitoring of the benefit/risk balance
of the medicinal
product. Healthcare professionals are asked to report any suspected
adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9
OVERDOSE
Overdose has not been reported.
5
PHARMACOLOGICAL PROPERTIES
5.1
PHARMACODYNAMIC PROPERTIES
Carbalax Suppositories function by a physical induction of reflex
bowel evacuation
caused when carbon dioxide is liberated when the suppository contacts
m