NORGALAX Rectal gel (2015)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Norgalax.

2. Qualitative and quantitative composition

Norgalax contains the active ingredient Docusate Sodium 0.12 gin each 10g micro-enema.

3. Pharmaceutical form

Rectal gel.

4.1. Therapeutic indications

For the symptomatic treatment of constipation whenever an enema is required and for the preparation of the colon and rectum for endoscopic examination.

4.2. Posology and method of administration

Adults: use one micro-enema. If required, a second micro-enema may be used on the same or the next day. Children: not recommended for children under 12 years old. Norgalax is to be administered ...

4.3. Contraindications

Haemorrhoids, anal fissures, rectocolitis, anal bleeding, abdominal pain, intestinal obstruction, nausea, vomiting, inflammatory bowel disease, ileus and known hypersensitivity to any of the ingredients. ...

4.4. Special warnings and precautions for use

As with all laxatives, Norgalax should not be administered chronically. Prolonged use can precipitate the onset of an atonic non- functioning colon and hypokalaemia.

4.5. Interaction with other medicinal products and other forms of interaction

Norgalax may increase the resorption of medicines and is not to be used in combination with hepatotoxic agents.

4.6. Pregnancy and lactation

Pregnancy There are no adequate data from the use of docusate enema or oral docusate in pregnant women. Animal studies with oral docusate are insufficient with respect to effects on pregnancy and embryonic ...

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

Gastrointestinal disorders: anal burning, rectal pain, rectal bleeding, diarrhoea Skin disorders: urticaria Hepatic disorders: cases of hepatotoxicity have been reported with oral ...

4.9. Overdose

Overdose will lead to excessive purgation which should be treated symptomatically.

5.1. Pharmacodynamic properties

Docusatesodium is an anionic surfactant and used as a faecal softening agent. It is considered to ease constipation by increasing the penetration of fluid into the faeces thereby causing them to soften. ...

5.2. Pharmacokinetic properties

Norgalax has a local effect in the rectum. Minimal absorption cannot be ruled out even with a rectal application.

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on studies of acute toxicity, repeated dose toxicity and in-vitro genotoxicity. Docusate sodium has been shown to exhibit developmental toxicity ...

6.1. List of excipients

Glycerol Sodium carboxymethylcellulose Purified water

6.2. Incompatibilities

None known.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

A polyethylene tube with fixed applicator and a cap closure, containing 10g of gel in pack sizes of 6 and 100 tubes.

6.6. Special precautions for disposal and other handling

None.

7. Marketing authorization holder

Essential Pharma, 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom

8. Marketing authorization number(s)

PL 41871/0007

9. Date of first authorization / renewal of the authorization

18/01/2005

10. Date of revision of the text

21/09/2015

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