ORPHENADRINE HYDROCHLORIDE 50 MG TABLETS - summary of medicine characteristics

Orphenadrine Hydrochloride 50mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 50 mg of orphenadrine hydrochloride.

Excipients with known effect

This product contains lactose, sucrose, and sunset yellow (E110)

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet

Yellow, sugar-coated, round tablet with convex faces, coded 5X1 on one side and plain on the reverse.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Anticholinergic agent used to treat all forms of Parkinsonism including drug-induced (neuroleptic syndrome) extrapyramidal symptoms.

4.2 Posology and method of administration

ADULTS and ELDERLY: Initially 150mg per day in divided doses, if necessary increasing by 50mg every two or three days until maximal benefit is obtained.

Optimal doses are usually as follows:

Idiopathic and post encephalitic Parkinsonism

– 250 to 300 mg daily in divided doses.

Neuroleptic syndrome            - 100 to 300 mg daily in divided doses.

Maximal dose is 400mg daily in divided doses.

The elderly may be more susceptible to side effect at doses which are clinically optimal.

Paediatric population

A suitable dose has not been established.

Method of administration

To be taken orally.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Patients with glaucoma, prostatic hypertrophy and tardive dyskinesia.

4.4 Special warnings and precautions for use

Use with caution in patients with micturition difficulties, in pregnancy, in the presence of cardiovascular disease and hepatic or renal impairment. Do not discontinue treatment abruptly. It is potentially liable to abuse because of its mood altering effects e.g. euphoria.

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

Patients with rare hereditary problems of fructose intolerance or sucrase-isomaltase insufficiency should not take this medicine.

Contains Azo colouring agent – sunset yellow (E110) which may cause allergic reactions.

4.5 Interaction with other medicinal products and other forms of interaction Side effects may be increased with concomitant use of; amantidine, antidepressants, antihistamines, disopyramide and phenothiazines (dry mouth, urine retention, confusional states, etc).

Orphenadrine causes decreased absorption of ketoconazole and antagonises the action of metoclopramide.

4.6 Pregnancy and lactation

There is inadequate evidence of the safety of orphenadrine in human pregnancy but it has been in wide use for many years without apparent ill consequence, animal studies having shown no hazard. Its use in pregnancy is only advisable if no safer alternative strategy exists.

4.7 Effects on ability to drive and use machines

Orphenadrine can cause disturbances of visual accommodation which may result in an impaired ability to drive and use machines.

4.8 Undesirable effects

List of adverse reactions

The frequencies of adverse events are ranked according to the following: very common (> 1/100 to < 1/10), uncommon (> 1/1,000 to < 1/100), rare (> 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).

Immune system disorders

Not known:    hypersensitivity

Psychiatric disorders

Not known:    euphoria, insomnia

Nervous system disorders

Not known:    dizziness, nervousness

Eye disorders

Not known:    disturbance of visual accommodation

Cardiac disorders

Not known:    tachycardia

Gastrointestinal disorders

Not known:    dry mouth, gastrointestinal disturbances

Renal and urinary disorders

Not known: micturition difficulties

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

The toxic effects of overdose are anticholinergic in nature.

Treatment is by gastric lavage and usual general treatment with cholinergics, (e.g. Carbachol), anticholinesterases (e.g. physostigmine) and general nonspecific treatment.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: M03B C51 Ethers, chemically close to antihistamines.

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

a) General characteristics: Orphenadrine is readily absorbed from the gastrointestinal tract, rapidly distributed to tissues. It is metabolised and excreted in the urine along with a small portion of unchaged drug.

b) Characteristics in patients: The half-life of orphenadrine is reported as 14 hours.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablets contain:

Lactose

Maize starch

Stearic acid (E570)

Talc (E553b)

Light kaolin (E559)

Coating contains:

Sucrose

Opadry-Oy-28–0200

Quinoline yellow (E104)

Sunset yellow (E110)

Titanium dioxide (E171)

Sodium benzoate (E211)

Carnauba wax (E903)

Beeswax (E901).

Printing ink (Opacode Black S-1–17823) contains:

Shellac

Black Iron Oxide (E172)

Propylene Glycol (E1520)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Protect from moisture and heat.

6.5 Nature and contents of container

Polypropylene ‚Securitainer‘ either with or without polythene ‚Jayfilla‘ and fitted with a polythene lid.

Containers of 50; 100; 250; 1,000 and 10,000 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal Not applicable.

Teva UK Limited Ridings Point Whistler Drive Castleford WF10 5HX United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 00289/0771

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

18 September 1998