DISIPAL TABLETS 50MG

Active substance: ORPHENADRINE HYDROCHLORIDE

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Braille:
disipal

disipal

Tablets
(Orphenadrine hydrochloride)

50 mg

250 tablets

Astellas Pharma Ltd.,
Chertsey, Surrey,
KT16 0RS, UK.

POM

Each tablet contains 50 mg
orphenadrine hydrochloride. Also
includes tartrazine (E102), sunset
yellow (E110), amaranth (E123),
sodium benzoate (E211), lactose
and sucrose
See leaflet for further information
Swallow the tablets as directed by
your doctor
Store at room temperature 0
(15°-25°C)
KEEP OUT OF THE REACH AND
SIGHT OF CHILDREN
PL 0166/5001
51724201

138636

PMS 116 C
PMS 431 C
Black
Keyline

EXP:

®

Lot:

Disipal

Braille

Disipal

®

Tablets
(Orphenadrine hydrochloride)

50 mg

250 tablets

Each tablet contains 50 mg
orphenadrine hydrochloride.
Also includes tartrazine
(E102), sunset yellow (E110),
amaranth (E123), sodium
benzoate (E211), lactose and
sucrose
See leaflet for further
information
Swallow the tablets as
directed by your doctor
Store at room temperature
(15°-25°C)
KEEP OUT OF THE REACH
AND SIGHT OF CHILDREN

disipal

Astellas Pharma Ltd.,
Chertsey, Surrey,
KT16 0RS, UK.

1

POM

PL 0166/5001
51724201

and sodium benzoate E211.
What Disipal Tablets look like and contents of the pack
Disipal Tablets are yellow, round and sugar coated.
Tablets come in amber glass bottles and/or securitainers and/
or plastic containers, containing 100, 250, 1,000, or 10,000
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Astellas Pharma Ltd., 2000 Hillswood Drive,
Chertsey, Surrey, KT16 0RS, UK.
Manufacturer
Astellas Pharma Europe B.V., Sylviusweg 62,
2333 BE Leiden, The Netherlands.
This leaflet was last approved in
January 2013.

138636

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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.
6.0FURTHER INFORMATION
What Disipal Tablets contain
•0  he active ingredient is orphenadrine hydrochloride.
T
Each tablet contains 50 mg orphenadrine hydrochloride.
The other ingredients are lactose, sucrose, acacia,
maize starch, tribasic calcium phosphate, stearic acid,
magnesium stearate, calcium carbonate, talc, kaolin,
titanium dioxide, gelatine, IMS, polyvinylacetate phthalate,
ethanol, shellac, beeswax, yellow carnuba wax, tartrazine
E102, sunset yellow E110, povidone, amaranth E123, 0

Read all of this leaflet carefully before you start taking
this medicine.
•0 Keep this leaflet. You may need to read it again.
•0 f you have any further questions, ask your doctor or
I
pharmacist.
•0  his medicine has been prescribed for you. Do not pass
T
it on to others. It may harm them, even if their symptoms
are the same as yours.
•0 f any of the side effects gets serious, or if you notice
I
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

In this leaflet:
1.0What Disipal Tablets are and what they are used for
2.0Before you take Disipal Tablets
3.0How to take Disipal Tablets
4.0Possible side effects
5.0How to store Disipal Tablets
6.0Further information
1.0 HAT DISIPAL TABLETS ARE AND WHAT THEY ARE
W
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.

•0 dizziness
•0 difficulty in seeing clearly
Uncommon (fewer than 1 in 100 patients)
•0 rapid heart beat
•0  hanges of mood such as highly elevated mood,
c
confusion, sleepiness, hallucinations, difficulty in
sleeping, nervousness, seizure (fits)
•0 difficulty in passing water
Rare (fewer than 1 in 1000 patients)
•0 memory disturbance
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.
5.0HOW TO STORE DISIPAL TABLETS
Keep out of the reach and sight of children.
Keep the tablets at normal room temperature (15°C - 25°C).

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your doctor or pharmacist.
4.0POSSIBLE 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)
•0 dry mouth, stomach upsets

2.0BEFORE YOU TAKE DISIPAL TABLETS
Do not take Disipal Tablets. Tell your doctor if you:
•0  re allergic (hypersensitive) to orphenadrine or any
a
of the other ingredients of Disipal Tablets. (see list in
section 6 ‘Further information’)
•0 have increased pressure in the eye (glaucoma).
•0 have an enlarged prostate.
•0 are unable to pass water for any reason.
•0  ave a blockage in your digestive system or any
h
stomach disorders.
•0  uffer from a rare inherited disease where the break­
s
down of haemoglobin (a pigment in the red blood cells)
is affected (porphyria).
•0  uffer from involuntary movements of the face or
s
body (tardive dyskinesia). Your doctor will take this into
consideration before prescribing the tablets for you.

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•0  uffer from a rare hereditary problem of fructose
s
and ga­actose intolerance, Lapp lactase deficiency,
l
glucose-galac­ ose malabsorption or sucrase-isomaltase
t
insufficiency.
Disipal Tablets should not be given to children.
Take special care with Disipal Tablets
Tell your doctor if you:
•0 suffer from heart disease
•0 suffer from liver disorders
•0 suffer from kidney disorders
•0 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

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

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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).
3.0HOW 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.

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Disipal Tablets
®

(Orphenadrine hydrochloride)

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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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