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Biolax Tablets

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Document: spc-doc_PL 33414-0016 change

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Bisacodyl Tablets BP 5mg

Biolax Tablets 5mg

Numark Constipation Relief Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Bisacodyl BP 5.00 mg

3    PHARMACEUTICAL FORM

Enteric sugar-coated tablets.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For human medicinal use.

GSL packs will state:

Short term relief of constipation.

P packs will state:

Constipation either chronic or recent onset. Bowel clearance before surgery, labour or radiological investigation.

4.2    Posology and method of administration

GSL packs will state:

Constipation:

Adults (including the elderly) and children over 10 years: 1 to 2 tablets at night.

Children under 10 years: Consult your doctor.

P packs will state:

Constipation:

Adults (including the elderly) and children over 10 years: 1 to 2 tablets at night.

Children under 6 years: Consult your doctor.

In preparation for radiological investigation:

Adults and children over 10 years: 2 tablets on each of the 2 nights before the investigation.

Route of administration: oral

4.3 Contraindications

Conditions where any laxative is contraindicated. BIOLAX should not be used in intestinal obstruction. Hypersensitivity to Bisacodyl or to the constituents listed. Do not use in conjunction with suppositories.

4.4    Special warnings and precautions for use

The tablets should not be crushed or chewed but swallowed whole. Antacids should not be given within one hour of taking the tablets.

Prolonged use may precipitate the onset of an atonic non-functioning colon.

Prolonged and excessive use may lead to fluid and electrolyte imbalance and hypokalaemia.

Intestinal loss of fluids may promote dehydration. Symptoms may include thirst and oliguria.

Laxatives do not help in long-term weight loss.

This product should not be used on a continuous daily basis for long periods. If laxatives are needed every day, then the cause of constipation should be investigated.

4.5    Interaction with other medicinal products and other forms of interaction

None known.

4.6    Pregnancy and lactation

Do not use unless there are compelling reasons.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

May cause griping and abdominal cramp; these can be minimised by dosing adjustment.

4.9 Overdose

Gastric lavage should be performed where appropriate. Adequate hydration must be maintained and the serum potassium should be measured. Antispasmodics may be of some value. Particular care about fluid balance should be taken in the elderly and young.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Bisacodyl is a stimulant laxative that increases intestinal motility. The product resulting from the hydrolysis of Bisacodyl is responsible for its laxative effect.

5.2 Pharmacokinetic properties

After oral administration a small amount is absorbed from the gastrointestinal tract and excreted in the urine as the glucuronide. About 3% of the glucuronide appears in the bile after about 10 hours but Bisacodyl is mainly excreted in the faeces.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose, maize starch, magnesium stearate, pregelatinised maize starch, cellulose acetate phthalate, diethylphthalate, sucrose, povidone, talc, titanium dioxide, dispersed yellow (E104), methanol, dichloromethane, purified water.

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months for containers and blister packs.

6.4 Special precautions for storage

Store below 25°C in a dry place.

6.5 Nature and contents of container

High-density polystyrene with Polythene lids and/or polypropylene containers with polypropylene or Polythene lids and polyurethane/Polythene inserts.

Pack sizes: 8, 10, 28, 30,50, 56, 60, 84, 100, 250, 500 and 1000.

25 micron PVC glass-clear/bluish rigid PVC (Pharmaceutical grade).

20 micron hard-tempered aluminium foil coated on the dull side with 6-7 gsm heat seal lacquer and printed on the bright side.

Pack sizes: 8, 10, 20, 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000.

6.6 Special precautions for disposal

No special instructions.

7    MARKETING AUTHORISATION HOLDER

Chelonia Healthcare Limited 11 Boumpoulinas Street,

3rd floor, 1060 Nicosia Cyprus

8    MARKETING AUTHORISATION NUMBER(S)

PL 33414/0016

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

28/11/2008

10    DATE OF REVISION OF THE TEXT

19/05/2015