Orphenadrine Hydrochloride 50mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
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
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.
7 MARKETING AUTHORISATION HOLDER
Teva UK Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG
8 MARKETING AUTHORISATION NUMBER(S)
PL 00289/0771
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18 September 1998
10 DATE OF REVISION OF THE TEXT
08/07/2016