Laxolyne for occasional use as a stimulant laxative for the treatment of constipation

For rectal use.

Dosage:

Adults: 1 - 2 adult suppositories per day.

As with all laxatives, the suppositories should not be used on a continuous daily basis for long periods. If you need laxatives every day you should see your doctor.

Infants and Children

Not recommended

The product is intended for occasional use only. Prolonged or excessive use of the product is not recommended as this may cause diarrhoea. Use of this product may interfere with glucose control in diabetic patients. If symptoms persist consult a doctor.

None stated.

No evidence of harmful effects available. However, it is best avoided during the first trimester of pregnancy. It may be used during breast feeding.

None stated

Use of the product may occasionally cause abdominal cramps. Glycerin can cause irritation when given rectally.

To report any side effect(s):

The National Pharmacovigilance and Drug Safety Center (NPC)

Fax: +966-11-205-7662

Call NPC at +966-11-2038222, Exts: 2317-2356-2340

Reporting Hotline: 19999

E-mail: npc.drug@sfda.gov.sa

Website: www.sfda.gov.sa/npc

Overdosage via rectal route is unlikely. However, if ingested treat symptomatically.

ATC code A06AX01

Glycerin is commonly classified as an osmotic laxative but may act additionally or alternatively by promoting peristalsis and evacuation of the lower bowel by virtue of a mild irritant effect. Glycerin suppositories possess also lubricating and faecal softening actions.

Glycerin following rectal administration is poorly absorbed.

There are no preclinical data of relevance to the prescriber.

None stated

Store below 30ºC, protected from heat.

5 Suppositories in an Al-PE blister, 2 blisters packed in a printed carton along with a leaflet.

Wash hands before opening individual packaging. The suppository is shaped for rectal insertion; ensure the tip of the suppository is inserted first. The tip should be moistened with a little cold water to aid insertion.