Orphenadrine 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Orphenadrine hydrochloride

Available from:

DE Pharmaceuticals

ATC code:

N04AB02

INN (International Name):

Orphenadrine hydrochloride

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090200

Patient Information leaflet

If you have any further questions on the
use of this product, ask your doctor or
pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
If the following happens, stop taking the
tablets and tell your doctor immediately
or go to the casualty department at your
nearest hospital:
•
an allergic reaction (swelling of the lips,
face or neck leading to severe difficulty
in breathing; skin rash or hives).
This is a very serious but rare side effect.
You may need urgent medical attention or
hospitalisation.
The following side effects have been
reported:
Not Known: frequency cannot be
estimated from the available data
• dry mouth
• blurred vision
• difficulty in passing water
• stomach problems
• dizziness.
• fast heart rate
• nervousness
• an abnormal feeling of well-being
• difficulty sleeping.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety of
this medicine.
HOW TO STORE ORPHENADRINE
KEEP THIS MEDICINE OUT OF THE SIGHT AND
REACH OF CHILDREN. Store away from
moisture and heat. Do not use this
medicine after the expiry date which is
stated on the carton. The expiry date
refers to the last day of that month. Do
not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.
FURTHER INFORMATION
WHAT ORPHENADRINE TABLETS CONTAIN:
• The active substance is orphenadrine
hydrochloride 50 mg.
• The other ingredients are lactose,
maize starch, talc (E553b), light kaolin
(E559) and stearic acid (E570). The
tablet coating contains: sucrose,
opadry-oy-28-0200, quinoline yellow
(E104), sunset yellow (E110), titanium
dioxide (E171), sodium benz

Summary of Product characteristics

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 in