Skip to Content

ORPHENADRINE HYDROCHLORIDE 50 MG TABLETS

Active substance(s): ORPHENADRINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Disipal 50mg Tablets
(orphenadrine hydrochloride)
Read all of this leaflet carefully before you start taking
this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
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.
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.
The name of your medicine is Disipal ® 50mg Tablets but will
be referred to as Disipal Tablets throughout this leaflet.
In
1.
2.
3.
4.
5.
6.

this leaflet:
What Disipal Tablets are and what they are used for
Before you take Disipal Tablets
How to take Disipal Tablets
Possible side effects
How to store Disipal Tablets
Further information

1. WHAT DISIPAL TABLETS ARE AND WHAT THEY ARE
USED FOR
The active ingredient in Disipal Tablets belongs to the group
of medicines called anticholinergic agents. Disipal Tablets
are used in the treatment of all forms of Parkinson’s disease,
a condition which can cause uncontrollable trembling of the
hands, and other difficulties of movement, for example in
standing or walking. Anticholinergic agents are also used
when other medicines have caused these problems.
2. BEFORE YOU TAKE DISIPAL TABLETS
Do not take Disipal Tablets. Tell your doctor if you:
are allergic (hypersensitive) to orphenadrine or any of
the other ingredients of Disipal Tablets (see list in section
6 ‘Further information’)
have increased pressure in the eye (glaucoma).
have an enlarged prostate.
are unable to pass water for any reason.
have a blockage in your digestive system or any
stomach disorders.
suffer from a rare inherited disease where the
breakdown of haemoglobin (a pigment in the red blood
cells) is affected (porphyria).
suffer from involuntary movements of the face or body
(tardive dyskinesia). Your doctor will take this into
consideration before prescribing the tablets for you.

suffer from a rare hereditary problem of fructose and
galactose intolerance, Lapp lactase deficiency,
glucose-galactose malabsorption or sucrase-isomaltase
insufficiency.
Disipal Tablets should not be given to children.
Take special care with Disipal Tablets
Tell your doctor if you:
suffer from heart disease
suffer from liver disorders
suffer from kidney disorders
have difficulties passing water
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
If you are taking other anticholinergic agents at the same
time as Disipal Tablets, this can lead to an increase in dry
mouth and difficulties in passing water. Your doctor or
pharmacist will be able to advise you whether any of the
medicines you are taking fall into this category.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine. Do not use Disipal Tablets during pregnancy or if
you are breast-feeding, unless clearly necessary.
Driving and using machines
Do not drive or use any tools or machines if you feel dizzy or
have blurred vision whilst taking Disipal Tablets.
Important information about some of the ingredients of
Disipal Tablets
This medicine contains sucrose. If you have been told by
your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicine. The colours
tartrazine (E102), sunset yellow (E110) and amaranth (E123)
used in the sugar coat may cause allergic reactions (see
section 6 for the list of ingredients).
3. HOW TO TAKE DISIPAL TABLETS
Always take Disipal Tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if you
are not sure.
Dosage
The usual dose for adults and the elderly is three tablets daily
in divided doses. Your doctor may increase this dose, if
necessary, by one tablet every two to three days up to a
maximum of eight tablets in a day. Usually you will need
long term treatment with Disipal Tablets.
Use in children
Disipal Tablets should not be given to children.

If you take more Disipal Tablets than you should
Taking more Disipal Tablets than have been prescribed could
be dangerous. If you, or anyone else, should accidentally
take more tablets than prescribed, you must phone your
doctor or go to a hospital casualty department immediately.
If you forget to take Disipal Tablets
Take the forgotten dose as soon as you remember. If it is
time for your next dose skip the dose you missed and just
continue to follow the dosing schedule as usual. Do not take
a double dose to make up for a forgotten one.
If you stop taking Disipal Tablets
If you are to stop taking Disipal Tablets then your doctor will
make sure that the dose is gradually reduced over a number
of days. You should not stop taking the tablets unless you
have been told to do so by your doctor. If you have any
further questions on the use of this product, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Disipal Tablets can cause side effects,
although not everybody gets them. If you are elderly you may
be more likely to get side effects.
Uncommon (fewer than 1 in 100 patients)
allergic reactions may occur while on treatment with Disipal
Tablets. Signs of allergy include: rash – wheezing –
breathlessness - swollen eyelids - face or lips and in extreme
cases collapse. If you get any of these symptoms soon after
taking Disipal Tablets, do not take any more. Tell a doctor
immediately and take the packaging and this leaflet with you.

5. HOW TO STORE DISIPAL TABLETS
Keep out of the sight and reach of children
Store at room temperature (15°C-25°C).
Do not take your tablets after the expiry date which is
stated on the carton/blister label after ‘Exp’. The expiry
date refers to the last day of that month.
Remember if your doctor tells you to stop taking this
medicine; return any unused tablets to your pharmacist
for safe disposal. Only keep this medicine if your doctor
tells you to.
Medicines should not be disposed of via waste water or
house hold waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.
If your tablet becomes discoloured or show any sings of
deterioration, seek the advice of your pharmacist.
6. FURTHER INFORMATION
What Disipal Tablets contain
Each tablet contains 50mg orphenadrine hydrochloride.
Other ingredients are microcrystalline cellulose, maize starch
granulated, stearic acid, magnesium stearate, silicon dioxide.
Excipients for sugar-coating are shellac, acacia, talc,
beta-carotene E160a, sucrose.
What Disipal Tablets look like and contents of the pack
Disipal are round, yellow, sugar coated tablets with no
markings.
Tablets come in blister pack.
Dispal Tablets are available in packs of 50 tablets.

Other possible side effects:
Common (fewer than 1 in 10 patients)
dry mouth, stomach upsets
dizziness
difficulty in seeing clearly

Manufactured by: Mipharm S.p.A,, Via B.Quaranta,
12-20141, Milan, Italy.

Uncommon (fewer than 1 in 100 patients)
rapid heart beat
changes of mood such as highly elevated mood,
confusion, sleepiness, hallucinations, difficulty in
sleeping, nervousness, seizure (fits)
difficulty in passing water

Disipal® 50mg Tablets

Rare (fewer than 1 in 1000 patients)
memory disturbance
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. 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.

Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
POM

PL No: 18799/2162
Leaflet date: 16.06.2015
Disipal is the registered trademark of Astellas group of
companies.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Orphenadrine hydrochloride 50mg Tablets
Read all of this leaflet carefully before you start taking
this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
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.
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.
The name of your medicine is Orphenadrine hydrochloride
50mg Tablets but will be referred to as Orphenadrine
throughout this leaflet.
In this leaflet:
1. What Orphenadrine Tablets are and what they are used
for
2. Before you take Orphenadrine Tablets
3. How to take Orphenadrine Tablets
4. Possible side effects
5. How to store Orphenadrine Tablets
6. Further information
1. WHAT ORPHENADRINE TABLETS ARE AND WHAT
THEY ARE USED FOR
The active ingredient in Orphenadrine Tablets belongs to the
group of medicines called anticholinergic agents.
Orphenadrine Tablets are used in the treatment of all forms
of Parkinson’s disease, a condition which can cause
uncontrollable trembling of the hands, and other difficulties of
movement, for example in standing or walking.
Anticholinergic agents are also used when other medicines
have caused these problems.
2. BEFORE YOU TAKE ORPHENADRINE TABLETS
Do not take Orphenadrine Tablets. Tell your doctor if
you:
are allergic (hypersensitive) to orphenadrine or any of
the other ingredients of Orphenadrine Tablets (see list in
section 6 ‘Further information’)
have increased pressure in the eye (glaucoma).
have an enlarged prostate.
are unable to pass water for any reason.
have a blockage in your digestive system or any
stomach disorders.
suffer from a rare inherited disease where the
breakdown of haemoglobin (a pigment in the red blood
cells) is affected (porphyria).
suffer from involuntary movements of the face or body
(tardive dyskinesia). Your doctor will take this into
consideration before prescribing the tablets for you.

suffer from a rare hereditary problem of fructose and
galactose intolerance, Lapp lactase deficiency,
glucose-galactose malabsorption or sucrase-isomaltase
insufficiency.
Orphenadrine Tablets should not be given to children.
Take special care with Orphenadrine Tablets
Tell your doctor if you:
suffer from heart disease
suffer from liver disorders
suffer from kidney disorders
have difficulties passing water
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
If you are taking other anticholinergic agents at the same
time as Orphenadrine Tablets, this can lead to an increase in
dry mouth and difficulties in passing water. Your doctor or
pharmacist will be able to advise you whether any of the
medicines you are taking fall into this category.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine. Do not use Orphenadrine Tablets during
pregnancy or if you are breast-feeding, unless clearly
necessary.
Driving and using machines
Do not drive or use any tools or machines if you feel dizzy or
have blurred vision whilst taking Orphenadrine Tablets.
Important information about some of the ingredients of
Orphenadrine Tablets
This medicine contains sucrose. If you have been told by
your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicine. The colours
tartrazine (E102), sunset yellow (E110) and amaranth (E123)
used in the sugar coat may cause allergic reactions (see
section 6 for the list of ingredients).
3. HOW TO TAKE ORPHENADRINE TABLETS
Always take Orphenadrine Tablets exactly as your doctor has
told you. You should check with your doctor or pharmacist if
you are not sure.
Dosage
The usual dose for adults and the elderly is three tablets daily
in divided doses. Your doctor may increase this dose, if
necessary, by one tablet every two to three days up to a
maximum of eight tablets in a day. Usually you will need
long term treatment with Orphenadrine Tablets.
Use in children
Orphenadrine Tablets should not be given to children.

If you take more Orphenadrine Tablets than you should
Taking more Orphenadrine Tablets than have been
prescribed could be dangerous. If you, or anyone else,
should accidentally take more tablets than prescribed, you
must phone your doctor or go to a hospital casualty
department immediately.
If you forget to take Orphenadrine Tablets
Take the forgotten dose as soon as you remember. If it is
time for your next dose skip the dose you missed and just
continue to follow the dosing schedule as usual. Do not take
a double dose to make up for a forgotten one.
If you stop taking Orphenadrine Tablets
If you are to stop taking Orphenadrine Tablets then your
doctor will make sure that the dose is gradually reduced over
a number of days. You should not stop taking the tablets
unless you have been told to do so by your doctor. If you
have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Orphenadrine Tablets can cause side
effects, although not everybody gets them. If you are elderly
you may be more likely to get side effects.

5. HOW TO STORE ORPHENADRINE TABLETS
Keep out of the sight and reach of children
Store at room temperature (15°C-25°C).
Do not take your tablets after the expiry date which is
stated on the carton/blister label after ‘Exp’. The expiry
date refers to the last day of that month.
Remember if your doctor tells you to stop taking this
medicine; return any unused tablets to your pharmacist
for safe disposal. Only keep this medicine if your doctor
tells you to.
Medicines should not be disposed of via waste water or
house hold waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.
If your tablet becomes discoloured or show any sings of
deterioration, seek the advice of your pharmacist.
6. FURTHER INFORMATION
What Orphenadrine Tablets contain
Each tablet contains 50mg orphenadrine hydrochloride.
Other ingredients are microcrystalline cellulose, maize starch
granulated, stearic acid, magnesium stearate, silicon dioxide.
Excipients for sugar-coating are shellac, acacia, talc,
beta-carotene E160a, sucrose.

Uncommon (fewer than 1 in 100 patients)
allergic reactions may occur while on treatment with
Orphenadrine Tablets. Signs of allergy include: rash –
wheezing – breathlessness - swollen eyelids - face or lips
and in extreme cases collapse. If you get any of these
symptoms soon after taking Orphenadrine Tablets, do not
take any more. Tell a doctor immediately and take the
packaging and this leaflet with you.

What Orphenadrine Tablets look like and contents of the
pack
Orphenadrine are round, yellow, sugar coated tablets with no
markings.
Tablets come in blister pack.
Orphenadrine Tablets are available in packs of 50 tablets.

Other possible side effects:
Common (fewer than 1 in 10 patients)
dry mouth, stomach upsets
dizziness
difficulty in seeing clearly

Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Uncommon (fewer than 1 in 100 patients)
rapid heart beat
changes of mood such as highly elevated mood,
confusion, sleepiness, hallucinations, difficulty in
sleeping, nervousness, seizure (fits)
difficulty in passing water
Rare (fewer than 1 in 1000 patients)
memory disturbance
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. 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.

Manufactured by: Mipharm S.p.A,, Via B.Quaranta,
12-20141, Milan, Italy.

Orphenadrine 50mg Tablets
PL No: 18799/2162
Leaflet date: 16.06.2015

POM

Expand view ⇕

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.

Hide