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ORPHENADRINE HYDROCHLORIDE 50MG/5ML ORAL SOLUTION

Active substance(s): ORPHENADRINE HYDROCHLORIDE

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Patient Information Leaflet
Uncommon (affect more than 1 in 1000 people)
n Constipation
n Greater sensitivity to things around you or feeling nervous
n Feeling light-headed and an unusual feeling of excitement (elation)
n Difficulty sleeping or feeling tired.
Rare (affect more than 1 in 10,000 people)
n Forgetting things more than usual.
If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Orphenadrine Oral Solution
Keep out of the reach and sight of children.
Do not store above 25°C and keep out of direct sunlight.
n Do not use after the expiry date (month, year) which is stated on the label and carton
(exp: month, year)
n The expiry date refers to the last day of that month
n Do not use Orphenadrine Oral Solution if you notice that the appearance or smell of
your medicine has changed. Talk to your pharmacist
n Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment
n
n

6. Further information
What Orphenadrine Oral Solution contains
n The active ingredient is orphenadrine hydrochloride.
n The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate
(E216), propylene glycol (E1520), liquid maltitol (E965), sorbitol solution (E420),
saccharin sodium, blackcurrant flavour (containing propylene glycol and ethanol),
aniseed flavour, citric acid (E330), sodium citrate (E331) and purified water.
What Orphenadrine Oral Solution looks like and contents of the pack
An almost colourless liquid with an odour of blackcurrant.
It comes in a brown glass bottle holding 150ml of solution.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11
9XE, UK.
This leaflet was last revised in 11/2009.

OSP SPC (04/09)

Orphenadrine 50mg/5ml Oral Solution
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.
n 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

344

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:
n You are allergic (hypersensitive) to orphenadrine or any of the ingredients
in this liquid (see section 6: Further information)
n You have an enlarged prostate gland, particularly if you are an elderly man
n You have problems with your movement and speech
n You have porphyria. This is a red blood cell problem that is passed through
families
n 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 above apply to you. If you are not sure, talk to
your doctor or pharmacist before taking orphenadrine.
Take special care with Orphenadrine Oral Solution
Before you take orphenadrine tell your doctor if:
n You have unusual fast heart beats, high blood pressure or heart problems
n You have kidney or liver problems
n You are an older person
n You suffer from involuntary movements of the face or body (tardive dyskinesia).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist
before taking orphenadrine.
Continued overleaf

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines. This includes medicines you buy without a prescription, including herbal
medicines. This is because orphenadrine can affect the way some other medicines work.
Also some medicines can affect the way orphenadrine works.
Tell your doctor if you are taking any of these medicines
n Painkillers such as dextropropoxyphene
n Anti-histamines - used for allergies
n Disopyramide - used for irregular heartbeats
n Medicines used for depression
n Medicines used for mental problems called ‘psychoses’ (such as

chlorpromazine and thioridazine)
n Medicines used for Parkinson’s disease (such as amantadine - which

can also be used to treat viral infections)
n Medicines used for stomach pain – “antispasmodics” (such as atropine

sulphate, dicycloverine hydrochloride and propantheline bromide).
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, planning to become
pregnant or are breast-feeding.
Driving and using machines
While taking this medicine you may feel light-headed, your eyesight can become blurry or
you could get an unusual feeling of excitement (elation). If this happens, you should not
drive a car or use any tools or machines.
Important information about what is in Orphenadrine Oral Solution
This medicine contains:
n Methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This
allergy may happen some time after starting the medicine
n Liquid maltitol and liquid sorbitol. If your doctor has told you that you cannot tolerate
some sugars, see your doctor before taking this medicine
n Ethanol (alcohol). This product contains small amounts of alcohol, less than 100mg per
dose.

3. How to take Orphenadrine Oral Solution
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask
the doctor or pharmacist if you are not sure.
Taking this medicine
n This medicine contains 50mg of orphenadrine hydrochloride in each 5ml
n Take this medicine by mouth.
Adults
The usual doses for adults are given below:
Parkinsonism
n A total daily dose of 100mg to 400mg each day
n This total daily dose can be split into two or three smaller doses to be taken through
the day
n At the start of treatment you may be asked to take 150mg each day
n This total daily dose may be increased by 50mg every two to three days
The increases should be continued until your symptoms are under control.





Parkinsonism that happens after having encephalitis (brain infection) or where the
cause is unknown
n 250mg to 300mg each day
n This can be split into two or three smaller doses to be taken through the day.

OSP SPC (04/09)





Parkinsonism that happens when your arteries harden
n 100mg to 150mg each day
n This can be split into two or three smaller doses to be taken through the day.

Parkinsonism that is caused by other medicines
n 150mg to 300mg each day
n This can be split into two or three smaller doses to be taken through the day.
Children
This medicine is not usually given to children.
Elderly
If you are an older person you may be more sensitive to the
medicine. The chances of you getting side effects are increased.
If you take more Orphenadrine Oral Solution than you should
Talk to a doctor or go to a hospital straight away. Take the medicine
pack with you so the doctor knows what you have taken. The following effects may
happen: excitement, confusion, being delirious, unusually fast heart beats, pupils
become larger, difficulty in passing urine, fits and coma.
If you forget to take Orphenadrine Oral Solution
Do not take a double dose (two doses at the same time) to make up for forgotten
doses. Skip the missed dose, then go on as before.
If you stop taking Orphenadrine Oral Solution
Keep taking orphenadrine until your doctor tells you to stop. Do not stop taking your
medicine suddenly.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, orphenadrine can cause side effects, although not everybody gets
them.
If you notice any of the following side effects, STOP taking the medicine and see a
doctor immediately:
n any kind of skin rash, flaking skin, boils or sore lips and mouth
n sudden wheezing, fluttering or tightness of the chest or collapse
This may mean that you are having an allergic reaction to orphenadrine.
If you get any of the following side effects, see your doctor as soon as possible:
Common (affect more than 1 in 100 people)
n Blurred vision and dizziness.
Uncommon (affect more than 1 in 1000 people)
n Fast heart beats
n Difficulty in managing your movements
n Difficulty in passing urine
n Hallucinations
n Feeling confused
n Fits.
Tell your doctor if you get any of these side effects:
Common (affect more than 1 in 100 people)
n Dry mouth
n Feeling sick (nausea) and stomach upset
n Feeling restless.

Continued overleaf

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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