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DISIPAL 50MG TABLETS

Active substance(s): ORPHENADRINE HYDROCHLORIDE / ORPHENADRINE HYDROCHLORIDE

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Disipal ® 50mg Tablets

Ref: 0245/021214/1/F

(orphenadrine hydrochloride)
Patient Information Leaflet
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.
Your medicine is called Disipal 50mg Tablets but will
be referred to as Disipal Tablets throughout this
Patient Information Leaflet.
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
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 lactose and 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.
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

How to store Disipal Tablets

5



KEEP THIS MEDICINE OUT OF THE SIGHT
AND REACH OF CHILDREN.
Do not store above 25°C
Do not take your tablets out of the blister strip
until it is time to take your dose.
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 that 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 to protect the
environment.






6

Further Information

What Disipal contains
Each tablet contains 50mg of orphenadrine
hydrochloride as the active ingredient.
Your medicine also contains the following inactive
ingredients: Lactose, sucrose, acacia, potato starch,
stearic acid, talc, titanium dioxide, gelatin, polyvinyl
acetate, shellac and bees wax.
What Disipal looks like and contents of the pack
They are small white sugar coated tablets.
Disipal Tablets are available in plastic containers of
50 or 100 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by NP Gerolymatos
AEBE, Attiki, Greece and are procured from within
the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.
Disipal is a registered trademark of Yamanouchi
Europe B.V.

POM PL 15184/0245
Leaflet revision date: 02/12/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

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.

Ref: 0245/021214/1/B

Ref: 0245/021214/2/F

Orphenadrine Hydrochloride 50mg Tablets
Patient Information Leaflet
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.



Your medicine is called Orphenadrine Hydrochloride
50mg Tablets but will be referred to as
Orphenadrine Hydrochloride Tablets throughout this
Patient Information Leaflet.

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

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
sucrase-isomaltase insufficiency.

Orphenadrine Hydrochloride Tablets should not
be given to children.

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 lactose and 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 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,
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.

5







How to store Orphenadrine Hydrochloride
Tablets
KEEP THIS MEDICINE OUT OF THE SIGHT
AND REACH OF CHILDREN.
Do not store above 25°C
Do not take your tablets out of the blister strip
until it is time to take your dose.
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
that 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 to protect the
environment.

6 Further Information
What Orphenadrine Hydrochloride contains
Each tablet contains 50mg of orphenadrine
hydrochloride as the active ingredient.
Your medicine also contains the following inactive
ingredients: Lactose, sucrose, acacia, potato starch,
stearic acid, talc, titanium dioxide, gelatin, polyvinyl
acetate, shellac and bees wax.
What Orphenadrine Hydrochloride looks like and
contents of the pack
They are small white sugar coated tablets.
Orphenadrine Hydrochloride Tablets are available in
plastic containers of 50 or 100 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by NP Gerolymatos
AEBE, Attiki, Greece and are procured from within
the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.

POM PL 15184/0245
Leaflet revision date: 02/12/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: 0245/021214/2/B

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.

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