Germoloids Suppositories & Ointment Duo Pack

1. Name Of The Medicinal Product

Germoloids Suppositories & Ointment Duo Pack

2. Qualitative And Quantitative Composition

Suppositories Ointment

Zinc Oxide 283.5 mg 6.6% w/w

Lidocaine Hydrochloride 13.2 mg 0.7% w/w

For excipients, see section 6.1.

3. Pharmaceutical Form

Suppository for rectal administration.

Ointment for topical administration.

4. Clinical Particulars

4.1 Therapeutic Indications

The symptomatic relief of pain, swelling, irritation and itching associated with haemorrhoids and pruritus ani.

4.2 Posology And Method Of Administration

Adults and children aged 12 years and over:

Suppositories:

One suppository to be inserted into the rectum on retiring at night and in the morning, preferably after a bowel movement. If necessary the suppository may be used at any time during the day with a minimum of three to four hours between suppositories. Do not use more than four suppositories in any 24-hour period.

Ointment:

Apply to the affected area at least twice a day with a minimum of three to four hours between applications. Further applications can be made at any time of day and are particularly recommended after a bowel movement. Do not use more than four times in any 24-hour period.

Children under 12:

Only as directed by a doctor.

The elderly:

The normal adult dose may be used.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Persons who continually suffer from haemorrhoids, have severe haemorrhoids or experience excessive bleeding, are advised to consult a doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is a lack of definitive evidence of safety of the product in human pregnancy and lactation. However, lidocaine hydrochloride and zinc oxide have been in wide use for many years without apparent ill consequence. It is not necessary to contraindicate this product in pregnancy and lactation provided caution is exercised and the directions for use are followed. However, as with all medicines, the advice of a doctor should be sought.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Very rarely increased irritation may occur at the site of application when using the suppositories or the ointment.

Very rarely burning sensations may occur at the site of application when using the ointment. Rarely rashes may occur.

4.9 Overdose

It is very unlikely that overdosage would occur from these pharmaceutical forms. Symptoms of lidocaine overdosage would be unlikely to occur even after rectal insertion of large quantities.

Normally there should be no systemic adverse effects, but at worst CNS and cardiovascular effects are possible. Treatment would be symptomatic after withdrawal of the product.

In the case of accidental oral ingestion, the advice of a doctor should be sought.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Zinc oxide has astringent, antiseptic, soothing and protectant properties.

Lidocaine hydrochloride has a local anaesthetic action.

The suppository and ointment bases have lubricant and emollient properties.

5.2 Pharmacokinetic Properties

The product has a local action with minimal risk of systemic effects. Lidocaine has a fast onset and intermediate duration of action. It is partially absorbed but plasma levels will be low, in view of the concentration of lidocaine in the product. It undergoes de-ethylation in the liver, where clearance approaches the rate of hepatic flow.

5.3 Preclinical Safety Data

Preclinical safety data on the active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Suppository:

Hard fat

Methyl salicylate

Glyceryl tristearate

Ointment:

Yellow soft paraffin

Wool fat

Methyl salicylate

Propylene glycol

Menthol crystals

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25^oC.

6.5 Nature And Contents Of Container

Suppository:

Preformed PVC/polyethylene laminate moulds. Strips of suppositories are packed in a boxboard carton. Six suppositories per strip, two strips per carton.

Ointment:

a) Flexible aluminium tubes, internally lacquered, fitted with a polypropylene cap contained in a boxboard carton.

b) Aluminium laminate tube consisting of 150µm Polyethylene /5µm polyacrylate outer layer, 30µm alumininum and an inner layer of 30µm polyacrylate / 60µm polyethylene, fitted with a HD polyethylene shoulder, an aluminium/surlyn tamper evident seal, HD polypropylene cap.

Pack size: Each carton contains 12 suppositories and 15ml ointment.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data

7. Marketing Authorisation Holder

Bayer plc,

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

United Kingdom

Trading as Bayer plc, Consumer Care Division.

8. Marketing Authorisation Number(S)

PL 0010/0277

9. Date Of First Authorisation/Renewal Of The Authorisation

25^th July 2006

10. Date Of Revision Of The Text

16^th June 2005