Orphenadrine 50mg/5ml oral solution sugar free

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Orphenadrine hydrochloride

Tillgänglig från:

Rosemont Pharmaceuticals Ltd

ATC-kod:

N04AB02

INN (International namn):

Orphenadrine hydrochloride

Dos:

10mg/1ml

Läkemedelsform:

Oral solution

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 04090200; GTIN: 5016119060892

Bipacksedel

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
n
Keep this leaflet. You may need to read it again.
n
If you have any further questions, ask your doctor or pharmacist.
n
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.
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If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What is Orphenadrine Oral Solution and what is it used for
2. Before you take Orphenadrine Oral Solution
3. How to take Orphenadrine Oral Solution
4. Possible side effects
5. How to store Orphenadrine Oral Solution
6. Further information
1. WHAT IS ORPHENADRINE ORAL SOLUTION AND WHAT IS IT USED FOR
The name of your medicine is Orphenadrine 50mg/5ml Oral Solution
(called
orphenadrine in this leaflet). It contains orphenadrine hydrochloride.
This belongs to
a group of medicines called anticholinergics.
Orphenadrine can be used for the symptoms of Parkinsonism (usually
slow
movement, muscle stiffness and shaking fingers). These symptoms can be
caused by
Parkinson’s Disease, but there are other causes as well.
2. BEFORE YOU TAKE ORPHENADRINE ORAL SOLUTION
DO NOT TAKE ORPHENADRINE ORAL SOLUTION AND TELL YOUR DOCTOR IF:
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You are allergic (hypersensitive) to orphenadrine or any of the
ingredients
in this liquid (see section 6: Further information)
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You have an enlarged prostate gland, particularly if you are an
elderly man
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You have problems with your movement and speech
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You have porphyria. This is a red blood cell problem that is passed
through
families
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You have difficulty passing water (urine)
n
You have stomach problems including a paralysed bowel. The signs
include
swollen and tender stomach (abdomen), feeling and being sick but with
no wind
n
You have glaucoma (increased pressure in the eye)
n
You are at risk of getting a very high temperature. This can happen if
you have
malaria.
Do not take this medicine if any of the

Produktens egenskaper

OBJECT 1
ORPHENADRINE HYDROCHLORIDE 50MG/5ML ORAL
SOLUTION
Summary of Product Characteristics Updated 06-Aug-2013 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Orphenadrine Hydrochloride 50mg/5ml Oral Solution
2. Qualitative and quantitative composition
Orphenadrine hydrochloride 50mg/5ml
3. Pharmaceutical form
Oral Solution
4. Clinical particulars
4.1 Therapeutic indications
Anticholinergic, for the treatment of all forms of Parkinsonism,
including drug induced (neuroleptic
syndrome)
4.2 Posology and method of administration
ADULTS AND THE ELDERLY:
Initially, 150mg daily in divided doses, increasing by 50mg every two
or three days until maximum
benefit is obtained. Optimal dosage is usually 250mg to 300mg daily in
divided doses in idiopathic and
post-encephalitic Parkinsonism; 100mg to 150mg daily in divided doses
in arteriosclerotic parkinsonism;
and 150mg to 300mg daily in divided doses in the neuroleptic syndrome.
Maximal dosage is 400mg daily in divided doses. The elderly may be
more susceptible to side effects at
doses which are clinically optimal.
Children:
Not recommended for use in children.
4.3 Contraindications
Hypersensitivity to orphenadrine or to any of the Excipients.
In patients with prostatic hypertrophy, tardive dyskinesia, porphyria,
urinary retention and must also be
used with caution in elderly men.
Also in patients with paralytic ileus or pyloric stenosis, where use
may lead to obstruction.
Do not use in patients with glaucoma or too narrow an angle between
iris and cornea, as it may raise
intra-ocular pressure. Not indicated for use in patients at risk of
developing hyperpyrexia.
4.4 Special warnings and precautions for use
Use with caution in the elderly (see Section 4.2).
When used alone or with analgesics, pain or skeletal muscle spasms
have been reported.
Use with caution in conditions characterised by tachycardia.
Anti-muscarinic agents, such as
orphenadrine, should be used with caution in patients with
pre-existing tachycardia (e.g. in heart failure,
thyrotoxicos