Disipal Tablets

1. Name Of The Medicinal Product

DISIPAL TABLETS

2. Qualitative And Quantitative Composition

Orphenadrine hydrochloride BP 50 mg

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Anti-cholinergic, for the treatment of all forms of Parkinsonism, including drug-induced extrapyramidal symptoms (neuroleptic syndrome).

4.2 Posology And Method Of Administration

For Adults, and the Elderly:

Initially 150 mg daily in divided doses, increasing by 50 mg every two or three days until maximum benefit is obtained. Optimal dosage is usually 250 - 300 mg daily in divided doses in idiopathic and post-encephalitic Parkinsonism, 100 - 300 mg daily in divided doses in the neuroleptic syndrome. Maximal dosage, 400 mg daily in divided doses. The elderly may be more susceptible to side-effects at doses which are clinically optimal.

For children:

A dosage for children has not been established.

4.3 Contraindications

Contraindicated in patients with tardive dyskinesia, glaucoma, or prostatic hypertrophy, untreated urinary retention, gastro-intestinal obstruction, porphyria.

Hypersensitivity to the active substance or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Use with caution in patients with micturition difficulties, in pregnancy and breast feeding, and in the presence of cardiovascular disease and hepatic or renal impairment. Use in caution in the elderly (see 4.2). Avoid abrupt discontinuation of treatment. For some patients, orphenadrine may be a drug of abuse.

Patients with rare hereditary problems of fructose and galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

The colours sunset yellow (E110), tartrazine (E102) and amaranth (E123) may cause allergic reactions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use of other antimuscarinic drugs can lead to an increase in side effects such as dry mouth and urine retention.

4.6 Pregnancy And Lactation

No recommendations; if considered necessary, it should be used with caution, see 4.4.

4.7 Effects On Ability To Drive And Use Machines

Patients must be advised to exercise caution while driving or operating machinery or whilst carrying out other skilled tasks.

4.8 Undesirable Effects

System Organ Class	Common >1/100 <1/10	Uncommon >1/1000 <1/100	Rare >1/10,000 <1/1000
Immune system disorder		Hypersensitivity
Nervous system disorder	Dizziness	Sedation, confusion, nervousness, hallucinations, convulsions, insomnia, euphoria	Memory disturbances
Eye disorders	Accommodation disorders
Cardiac disorders		Tachycardia
Gastrointestinal disorders	Dry mouth, gastrointestinal disturbances
Renal and urinary disorders		Urinary retention

4.9 Overdose

Toxic effects are anti-cholinergic in nature and the treatment is gastric lavage, cholinergics such as carbachol, anticholinesterases such as physostigmine, and general non-specific treatment.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Orphenadrine, which is a congener of diphenhydramine without sharing its soporific effect, is an antimuscarinic agent. It also has weak antihistaminic and local anaesthetic properties.

Orphenadrine is used as the hydrochloride in the symptomatic treatment of Parkinsonism. It is also used to alleviate the extrapyramidal syndrome induced by drugs such as the phenothiazine derivatives, but is of no value in tardive dyskinesia, which may be exacerbated.

5.2 Pharmacokinetic Properties

Orphenadrine is readily absorbed from the gastro-intestinal tract, and very readily absorbed following intramuscular injection. It is rapidly distributed in tissues and most of a dose is metabolised and excreted in the urine along with a small proportion of unchanged drug. A half life of 14 hours has been reported.

5.3 Preclinical Safety Data

No relevant pre-clinical safety data has been generated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose

Sucrose

Acacia

Maize starch

Tribasic calcium phosphate

Stearic acid

Magnesium stearate

Opaseal P-17-0200 (containing IMS, polyvinylacetate phthalate and stearic acid)

Calcium carbonate

Talc

Kaolin

Titanium dioxide

Gelatin

Opalux yellow AS 3026 (containing sucrose, titanium dioxide, tartrazine E102, sunset yellow E110, povidone, amaranth E123 and sodium benzoate E211)

Opaglos 6000 (containing ethanol, shellac, beeswax and yellow carnuba wax)

Black printing ink Opacode black S-1-27794 (containing shellac, IMS, black iron oxide E172, N-butyl alcohol, propylene glycol E1520, isopropyl alcohol)

6.2 Incompatibilities

None

6.3 Shelf Life

Three years

6.4 Special Precautions For Storage

Store at room temperature (15°C - 25°C)

6.5 Nature And Contents Of Container

Amber glass click-lock bottles and/or securitainers and/or plastic lid-seal containers, containing 100, 250, 1,000, or 10,000 tablets.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data

7. Marketing Authorisation Holder

Astellas Pharma Ltd

Lovett House

Lovett Road

Staines

TW18 3AZ

United Kingdom

8. Marketing Authorisation Number(S)

PL 0166/5001R

9. Date Of First Authorisation/Renewal Of The Authorisation

6 May 1987; renewed March 2003.

10. Date Of Revision Of The Text

12^th June 2009

11. Legal Category

POM