1.    NAME OF THE MEDICINAL PRODUCT

Methadose Diluent Methadone Diluent

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

There is no active ingredient in the product.

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

This product contains parahydroxybenzoates. These may cause allergic reactions (possibly delayed).

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

None known.

4.6.    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 25^oC 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.    Instruction for Use, Handling and Disposal

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

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

10 DATE OF REVISION OF THE TEXT

11/09/2013