METHADOSE DILUENT, METHADONE DILUENT - summary of medicine characteristics

1. NAME OF THE MEDICINAL PRODUCT

Methadose Diluent

Methadone Diluent

2. Qualitative and Quantitative Composition

There is no active ingredient in the product

Excipient(s) with known effect:

Propyl Hydroxybenzoate (E216) – 1.5mg/5ml

Methyl Hydroxybenzoate (E218) – 6mg/5ml

Propylene Glycol (E1520) – 155.6mg/5ml

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Blue solvent for oral administration.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

For use as a diluent with Methadone Oral Concentrate 10 mg/1ml and 20 mg/1 ml.

4.2. Posology and method of administration

For oral administration only.

Dosage Recommendations:

As required.

4.3. Contraindications

None known.

4.4. Special Warnings and Precautions for Use

Excipients warnings:

Methyl and propyl hydroxybenzoates are contained in this product which may cause allergic reactions (possibly delayed).

Propylene Glycol. This medicine contains 155.6mg propylene glycol in each 5 ml dose.

4.5. Interactions 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 known.

4.8. Undesirable Effects

None known.

4.9. Overdose

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmaco­dynamic Properties

Not applicable.

5.2. Pharmaco­kinetic Properties

Not applicable.

5.3. Pre-clinical Safety Data

None applicable.

6. PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

Propylene Glycol BP

Propyl Hydroxybenzoate BP

Methyl Hydroxybenzoate BP

Patent Blue V (E131)

Purified Water BP

6.2. Incompatibilities

None known.

6.3. Shelf Life

Shelf life – 2 years

Shelf life after first opening container – 3 months.

6.4. Special Precautions for Storage

Store below 25oC but not in a refrigerator.

6.5. Nature and contents of container

Bottle:        Amber (type III) glass bottle

Closure:      HDPE, EPE wadded, tamper evident child resistant closure

Pack Size:    500ml

6.6. Special precautions for disposal and other handling

This product is intended for use as a diluent with Methadone Oral Concentrate 10mg/1ml and 20mg/1ml

7.

MARKETING AUTHORISATION HOLDER

Rosemont Pharmaceuticals Ltd

Rosemont House

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

8. MARKETING AUTHORIZATION NUMBER

PL 00427/0099

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

31 January 1996