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Drug information

Glycerol

OTC
Read time: 1 mins
Last updated: 03 Dec 2014
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Summary of product characteristics


1. Name of the medicinal product

Glycerin Suppositories BP 1g Infants' Size


2. Qualitative and quantitative composition

Glycerol BP 70% w/w


3. Pharmaceutical form

Suppositories.


4.1. Therapeutic indications

For the relief of occasional constipation.


4.2. Posology and method of administration

Route of administration:

 Rectal.

Dose:

 One suppository.

Dosage schedule:

 As required.

The suppository should be dipped in water before insertion.The suppositories are defined as infants' size, therefore there is no adults' or children's use recommendation.


4.3. Contraindications

Contraindicated in patients with known hypersensitivity to glycerol.


4.4. Special warnings and precautions for use

Keep all medicines away from children.Not to be swallowed. Suppositories must not be taken by mouth. Consult your doctor before use.


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

None known.


4.6. Fertility, pregnancy and lactation

Not applicable.


4.7. Effects on ability to drive and use machines

None.


4.8. Undesirable effects

Gastrointestinal Disorders: May cause irritation and occasionally abdominal cramps.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.


4.9. Overdose

Glycerol has a mildly laxative action, however, if the product is accidentally swallowed it is unlikely to cause such effects and it is unlikely that active measures will be required. Accidental ingestion of a large number of suppositories may cause headache, nausea and vomiting; less frequently diarrhoea, thirst, dizziness, mental confusion and cardiac arrhythmias can occur.


5.1. Pharmacodynamic properties

Glycerol by the rectal route promotes peristalsis and evacuation of the lower bowel by virtue of its irritant action.


5.2. Pharmacokinetic properties

No information available.


5.3. Preclinical safety data

None.


6.1. List of excipients

Gelatin Purified Water


6.2. Incompatibilities

None known.


6.3. Shelf life

18 months unopened.


6.4. Special precautions for storage

Store below 25°C in a dry place.


6.5. Nature and contents of container

12's: Sealed, PVC/PE laminate inside a cardboard carton.


6.6. Special precautions for disposal and other handling

None.


7. Marketing authorisation holder

Thornton & Ross Ltd.Linthwaite LaboratoriesHuddersfieldHD7 5QH.


8. Marketing authorisation number(s)

PL 00240/6100R


9. Date of first authorisation/renewal of the authorisation

1st August 1986 / 22nd April 1993, 9th September 1998


10. Date of revision of the text

26/11/2014

4.1 Therapeutic indications

For the relief of occasional constipation.

4.2 Posology and method of administration

Route of administration:

 Rectal.

Dose:

 One suppository.

Dosage schedule:

 As required.

The suppository should be dipped in water before insertion.The suppositories are defined as infants' size, therefore there is no adults' or children's use recommendation.

4.3 Contraindications

Contraindicated in patients with known hypersensitivity to glycerol.

4.4 Special warnings and precautions for use

Keep all medicines away from children.Not to be swallowed. Suppositories must not be taken by mouth. Consult your doctor before use.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

Not applicable.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Gastrointestinal Disorders: May cause irritation and occasionally abdominal cramps.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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The drug SPC information (indications, contra-indications, interactions, etc), has been developed in collaboration with eMC (www.medicines.org.uk/emc/). Medthority offers the whole library of SPC documents from eMC.

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Drug Licencing

Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).