Biocarbon Tablets 250mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CHARCOAL, ACTIVATED

Available from:

F. TRENKA Chem.-pharmazeutische Fabrik Ges.m.b.H. Goldeggasse 5, 1040 Vienna, Austria

ATC code:

A07BA01

INN (International Name):

CHARCOAL, ACTIVATED 250 mg

Pharmaceutical form:

TABLET

Composition:

CHARCOAL, ACTIVATED 250 mg

Prescription type:

OTC

Therapeutic area:

ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS

Authorization status:

Authorised

Authorization date:

2005-11-17

Patient Information leaflet

Package leaflet: Information for the user
BIOCARBON® tablets
Activated charcoal (medicinal charcoal)
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
Always use 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 after 3 days.
What is in this leaflet
1.
What BIOCARBON is and what it is used for
2.
What
you
need
to
know
before
you
take
BIOCARBON
3.
How to take BIOCARBON
4.
Possible side effects
5.
How to store BIOCARBON
6.
Contents of the pack and other information
1.
What BIOCARBON is and what it is used for
BIOCARBON tablets contain high-quality activated
charcoal which is produced by carbonisation of
vegetable materials. Due to its large surface it is
highly adsorbent.
BIOCARBON tablets are used in case of diarrhoea,
especially when travelling in countries with high
hygienic risk. Medicinal charcoal is evacuated in a
natural way together with the adsorbed toxic agents.
2.
What
you
need
to
know
before
you
take
BIOCARBON
Do not take BIOCARBON:
–
if you are allergic to medicinal charcoal or any of
the other ingredients of this medicine (listed in
section 6).
–
In case of heavy constipation and suspected
intestinal obstruction
Take special care with BIOCARBON
–
In case of disposition to gastrointestinal bleedings
(in case of stomach ulcers, duodenum ulcers,
inflammatory
intestinal
diseases).
After
using BIOCARBON tablets, the stool may
be black coloured, a harmless phenomenon.
Stool should be observed several days after
having stopped taking BIOCARBON. If dark
colouring of the stool persists, you should
consult a doctor to exclude the possibility
of g

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BIOCARBON tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 250 mg carbo activatus (activated charcoal).
Excipients:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Round black tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adsorption therapy in case of acute diarrhoea, especially when
travelling in countries with low
hygienic standard.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_Adults, children from 2 years of age and adolescents:_
3 times daily 3-4 tablets.
Method of administration:
The tablets can be taken chewed or unchewed with some liquid. Infants
take the tablets possibly
well mashed with viscous or pasty food, preferably without milk or
sugar.
Duration of administration:
BIOCARBON tablets should be used until action of the bowel is normal
again.
If, after approx. 3 days, treatment is not successful, other
therapeutic or diagnostic measures must
be taken.
4.3
CONTRAINDICATIONS
BIOCARBON tablets should not be taken in case of hypersensitivity to
the active substance or to
any of the excipients, in case of gastrointestinal obstruction and
suspected ileus.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
After using BIOCARBON tablets, the stool may be black coloured, a
harmless phenomenon.
2
However, in case of known disposition to bleeding in the
gastrointestinal tract (gastric or duodenal
ulcer, inflammatory intestinal diseases) stool should be monitored for
some days after discontinuing
use of this medicinal product in order to exclude tarry stool which
might be due to bleeding.
If the patient suffers from abdominal or intestinal pain and in case
of febrile diarrhoea further
examination should be carried out.
Keep out of the reach and sight of children!
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Medicinal charcoal may reduce the effect of other orally administered
medicinal products. So,
BIOCARBON should not be used together with