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DISIPAL 50 MG TABLETS

Active substance(s): ORPHENADRINE HYDROCHLORIDE

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Package Leaflet: Information for the user

Disipal® 50 mg tablets
(orphenadrine hydrochloride)
Your medicine is called Disipal 50 mg tablets but throughout this
leaflet will be referred to as Disipal 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.

In this leaflet:
1. What Disipal Tablets are and what they are used for
2. Before you take Disipal Tablets
3. How to take Disipal Tablets
4. Possible side effects
5. How to store Disipal Tablets
6. 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 sucrose-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 breastfeeding, 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. 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.
Other possible side effects:
Common (fewer than 1 in 10 patients)
• dry mouth, stomach upsets
• dizziness
• difficulty in seeing clearly
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 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,
website: www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of this medicine.
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 use Disipal Tablets after the expiry date which is stated on
the label after EXP.The expiry date refers to the last day of the
month.
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 protect the environment.
6. FURTHER INFORMATION
What Disipal Tablets contain
the active ingredient is orphenadrine hydrochloride. Each coated
tablet contains 50 mg orphenadrine hydrochloride.
The other ingredients are microgranular cellulose, maize starch
microgranular, stearic acid, magnesium stearate, amorphous silica.
Ingredients used in the tablet coating are shellac, acacia, talc, betacarotene E160a, sucrose.



What Disipal Tablets look like and contents of the pack
Disipal Tablets are round, yellow, coated tablets with no markings.
Disipal Tablets come in packs of 50, 100 and 250 tablets.
Product Licence holder: Ecosse Pharmaceuticals Limited
3 Young Place, East Kilbride G75 0TD.
Manufacturer
Mipharm S.p.A.,
Via B. Quaranta,
12-20141,
Milano.
Re-packaged by: Munro Wholesale Medical Supplies Limited, 3
Young Place, East Kilbride G75 0TD.
Procured within the EU.
PL 19065/0441 Disipal 50 mg Tablets
POM
This leaflet was revised 08/10/2014
E0441-1
Disipal® is a registered trademark of Astellas Pharma Europe B.V

Package Leaflet: Information for the user

Orphenadrine Hydrochloride 50 mg tablets
Your medicine is called Orphenadrine Hydrochloride 50 mg tablets
but throughout this leaflet will be referred to as Orphenadrine
Hydrochloride 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.
In this leaflet:
1. What Orphenadrine Hydrochloride Tablets are and what they are
used for
2. Before you take Orphenadrine Hydrochloride Tablets
3. How to take Orphenadrine Hydrochloride Tablets
4. Possible side effects
5. How to store Orphenadrine Hydrochloride Tablets
6. Further information





1. WHAT ORPHENADRINE HYDROCHLORIDE TABLETS ARE
AND WHAT THEY ARE USED FOR
The active ingredient in Orphenadrine Hydrochloride Tablets
belongs to the group of medicines called anticholinergic agents.
Orphenadrine Hydrochloride 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 HYDROCHLORIDE
TABLETS
Do not take Orphenadrine Hydrochloride Tablets. Tell your
doctor if you:







are allergic (hypersensitive) to orphenadrine or any of the
other ingredients of Orphenadrine Hydrochloride 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 sucrose-isomaltase insufficiency.
Orphenadrine Hydrochloride tablets should not be given to
children.
Take special care with Orphenadrine Hydrochloride 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 Hydrochloride 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 Hydrochloride 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 Hydrochloride Tablets.
Important information about some of the ingredients of
Orphenadrine Hydrochloride 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. See section 6 for the list of ingredients.
3. HOW TO TAKE ORPHENADRINE HYDROCHLORIDE
TABLETS
Always take Orphenadrine Hydrochloride 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 Hydrochloride Tablets.
Use in children
Orphenadrine Hydrochloride Tablets should not be given to
children.
If you take more Orphenadrine Hydrochloride Tablets than you
should
Taking more Orphenadrine Hydrochloride 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 Hydrochloride 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 Hydrochloride Tablets
If you are to stop taking Orphenadrine Hydrochloride 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 Hydrochloride 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 Orphenadrine
Hydrochloride 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 Hydrochloride Tablets, do not take any more. Tell a
doctor immediately and take the packaging and this leaflet with you.
Other possible side effects:
Common (fewer than 1 in 10 patients)
• dry mouth, stomach upsets
• dizziness
• difficulty in seeing clearly
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 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,
website: www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of this medicine.
5. HOW TO STORE ORPHENADRINE HYDROCHLORIDE
TABLETS
Keep out of the sight and reach of children
Store at room temperature (15°C – 25°C).
Do not use Orphenadrine Hydrochloride Tablets after the expiry date
which is stated on the label after EXP.The expiry date refers to the
last day of the month.
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 protect the environment.
6. FURTHER INFORMATION
What Orphenadrine Hydrochloride Tablets contain
the active ingredient is orphenadrine hydrochloride. Each coated
tablet contains 50 mg orphenadrine hydrochloride.
The other ingredients are microgranular cellulose, maize starch
microgranular, stearic acid, magnesium stearate, amorphous silica.
Ingredients used in the tablet coating are shellac, acacia, talc, betacarotene E160a, sucrose.



What Orphenadrine Hydrochloride Tablets look like and
contents of the pack
Orphenadrine Hydrochloride Tablets are round, yellow, coated
tablets with no markings.
Orphenadrine Hydrochloride Tablets come in packs of 50, 100 and
250 tablets.
Product Licence holder: Ecosse Pharmaceuticals Limited
3 Young Place, East Kilbride G75 0TD.
Manufacturer
Mipharm S.p.A.,
Via B. Quaranta,
12-20141,
Milano.
Re-packaged by: Munro Wholesale Medical Supplies Limited, 3
Young Place, East Kilbride G75 0TD.
Procured within the EU.
PL 19065/0441 Orphenadrine Hydrochloride 50 mg Tablets
This leaflet was revised 08/10/2014
POM
E0441(O)-1

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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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