SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Norit

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Activated Charcoal 200mg

3    PHARMACEUTICAL FORM

Capsules

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Anti-diarrhoea, indigestion, flatulence.

4.2 Posology and method of administration

For Adults and Children over 8 years: Diarrhoea: 3-4 capsules 3 times a day Indigestion: 1-2 capsules 3 times a day. Flatulence: 3 capsules after meal.

For Children 2-8 years:

Half the adult dosage:

For babies and infants under 2 years: Seek medical advice.

For the elderly:

The normal adult dose is appropriate.

The capsules should be taken with water.

4.3 Contraindications

Total gastrointestinal obstruction, suspected ileus. Acute abdominal pain and ulcerative colitis.

4.4 Special warnings and precautions for use

1. Consult a doctor if symptoms persist or recur.

2. Treatment with Norit can cause blackening of the faeces.

4.5 Interaction with other medicinal products and other forms of interaction

Treatment with Norit can lead to reduced absorption of the following medicaments: cardiac glycosides oral contraceptives, anticoagulants and anti epileptics. Norit should not be taken within two hours of any of the above.

4.6 Fertility, pregnancy and lactation

There are no controlled clinical data regarding animal or human studies available but Norit has been taken by pregnant women for 70 years without any reported ill effects. If in doubt consult your doctor.

4.7    Effects on ability to drive and use machines

None stated.

4.8    Undesirable effects

None stated.

4.9    Overdose

None stated

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Activated charcoal absorbs various substances in the gastro intestinal tract whether gaseous or liquid.

5.2    Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

None stated.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Gelatine, titanium dioxide (E171) and black iron oxide (E172)

6.2    Incompatibilities

None

6.3    Shelf life

5 years

6.4    Special precautions for storage

Keep in a dry place, keep out of the reach of children.

6.5 Nature and contents of container

The capsules are packed in a PVC/Aluminium strips of 9 capsules. One pack contains 3 strips.

6.6 Special precautions for disposal

None

7    MARKETING AUTHORISATION HOLDER

Norit N.V.

Nijverheidsweg Noord 72-74 3812 PM Amersfoort The Netherlands

8    MARKETING AUTHORISATION NUMBER(S)

PL 04714/0001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

18/02/2009

10 DATE OF REVISION OF THE TEXT

18/02/2009