SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Glycerin Suppositories BP 4g Adult Size Superdrug Glycerine Constipation Relief Suppositories Boots Constipation Relief Suppositories Sainsburys Constipation Relief Suppositories Tesco Constipation Relief Suppositories

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Glycerol 70% w/w

3    PHARMACEUTICAL FORM

Suppository

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of occasional constipation.

4.2    Posology and method of administration

Rectal

Recommended Doses and Dosage Schedules

One suppository as required.

The suppository should be dipped in water before insertion.

The suppositories are defined as adult size, therefore there is no children’s use recommendation.

They are suitable for use by the elderly, dose and dosage schedule as above.

4.3    Contraindications

Contra-indicated in patients with known hypersensitivity to glycerol. Adults suppositories are not suitable for use by children and infants.

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.

4.5 Interaction with other medicinal products and other forms of interaction

None known

4.6    Fertility, pregnancy and lactation

All medicines should be avoided if possible during pregnancy and lactation. Use only under a doctor’s instruction in these conditions.

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 needed. 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    PHARMACOLOGICAL PROPERTIES

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 has been found on the pharmacokinetics of glycerol administered rectally.

5.3    Preclinical safety data

No data of relevance, which is additional to that included on other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Gelatin

Purified Water

6.2    Incompatibilities

None known

6.3    Shelf life

PVC/PE laminate inside a cardboard carton: 18 months PVC/PVDC/PE laminate inside a cardboard carton: 36 months

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.

12’s: Sealed, PVC/PVDC/PE laminate inside a cardboard carton 24’s: 2 x 12 sealed, PVC/PVDC/PE laminates inside a cardboard carton Not all pack sizes may be marketed.

6.6    Special precautions for disposal

None

7    MARKETING AUTHORISATION HOLDER

L.C.M. LTD.

Linthwaite Laboratories Huddersfield West Yorkshire HD75QH

8    MARKETING AUTHORISATION NUMBER(S)

PL 12965/0015

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23/07/1993

10 DATE OF REVISION OF THE TEXT

02/01/2015