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ORPHENADRINE HYDROCHLORIDE 50MG TABLETS

Active substance(s): ORPHENADRINE HYDROCHLORIDE

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REG0069304

Version 1.10

Approved

What Orphenadrine is and what
it is used for

What you need to know before
you take orphenadrine

3

How to take Orphenadrine

Children
Orphenadrine is not recommended for
use in children.

Adults and the elderly
The starting dose is one tablet taken three
times a day. Your doctor may increase the
dose depending on your response and
particular condition, up to a maximum of
eight tablets per day.

The usual dose is:

The tablets should be swallowed
preferably with a drink of water.

Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.

(Main)

Pharma code 278

Page 1 of 2

Other medicines and Orphenadrine
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Talk to your doctor if you are taking any of
the following:

If you stop taking Orphenadrine
Do not stop taking your medicine without
talking to your doctor first even if you feel
better. It is important that you continue to
take your tablets without stopping
suddenly or you may become unwell.

If you take more Orphenadrine than you
should
If you (or someone else) swallow a lot of
the tablets all together, or if you think a
child has swallowed any of the tablets,
contact your nearest hospital casualty
department or your doctor immediately.
An overdose is likely to cause dry mouth,
Warnings and precautions
blurred vision, difficulty urinating,
Talk to your doctor or pharmacist before
stomach problems and dizziness. Please
taking Orphenadrine:
take this leaflet, any remaining tablets
• if you have difficulties passing urine
• if you have heart, blood vessel or blood and the container with you to the hospital
or doctor so that they know which tablets
circulation problems
were consumed.
• if you have liver or kidney problems
• if you are pregnant or planning on
If you forget to take Orphenadrine
becoming pregnant.
If you forget to take a tablet, take one as
• if you have been told by your doctor that soon as you remember, unless it is nearly
you have an intolerance to some sugars time to take the next one. Do not take a
There is the potential for Orphenadrine to double dose to make up for a forgotten
dose. Take the remaining dose at the
be abused because it may cause an
correct time.
abnormal feeling of well-being.

Do not take Orphenadrine if you:
• are allergic to orphenadrine
hydrochloride or any of the other
ingredients of this medicine (listed in
section 6).
• have glaucoma (loss of vision due to
abnormally high pressure in the eye)
• have an enlarged prostate causing
difficulty passing urine
• have tardive dyskinesia (uncontrollable
movements of mouth, tongue and
limbs).

2

Orphenadrine is used to:
• help in the control of Parkinsonism
(symptoms of tremor, stiffness and
shuffling)
• treat related Parkinson-like side effects
of other drugs.

Orphenadrine belongs to a group of
drugs called antimuscarinic agents.

1

Length:
Width:

Dimensions:
323 mm
160 mm

Colours Used:

231-30-55229-D LEA ORPHENADRINE 50MG TAB TUK
• amantadine (treatment for
Parkinsonism)
• antidepressants
• antihistamines (allergy treatments)
PACKAGE LEAFLET: INFORMATION
• disopyramide (treatment for abnormal
FOR THE USER
heart rhythm)
Read all of this leaflet carefully before you • ketoconazole (antifungal treatment)
start taking this medicine because it
• metoclopramide (treatment for feeling
contains important information for you.
or/and being sick)
• Keep this leaflet. You may need to read • phenothiazines (tranquillisers).
it again.
Pregnancy
and breast-feeding
• If you have any further questions, ask
If you are pregnant, planning to become
your doctor or pharmacist.
pregnant or breast-feeding, ask your
• This medicine has been prescribed for
you only. Do not pass it on to others. It doctor or pharmacist for advice before
taking this medicine.
may harm them, even if their signs of
illness are the same as yours.
Driving and using machines
• If you get any side effects, talk to your
Orphenadrine may cause blurred vision, if
doctor or pharmacist. This includes any affected do not drive or operate machinery.
possible side effects not listed in this
Orphenadrine contains lactose, sucrose
leaflet. See section 4.
and sunset yellow (E110)
What is in this leaflet:
Patients who are intolerant to lactose and
1. What Orphenadrine is and what it is
sucrose should note that Orphenadrine
used for
Tablets contain a small amount of lactose
2. What you need to know before you take and sucrose. If you have been told by
Orphenadrine
your doctor that you have an intolerance
3. How to take Orphenadrine
to some sugars, contact your doctor
4. Possible side effects
before taking this medicinal product.
5. How to store Orphenadrine
Please note that Orphenadrine Tablets
6. Contents of the pack and other
contain sunset yellow (E110), which can
information
cause allergic reactions.

ORPHENADRINE
HYDROCHLORIDE
50 mg TABLETS

PAGE 1: FRONT FACE (INSIDE OF REEL)

TEVA UK Ref:

Top of page cut-off to middle of registration mark: 44 mm.

Version:

3
01 June 2016

CUTTER

BLACK

POSSIBLE SIDE EFFECTS

Marketing Authorisation Holder and
Manufacturer:
Marketing Authorisation holder and
company responsible for manufacture:
TEVA UK Limited, Eastbourne, BN22 9AG.

• Orphenadrine Tablets come in pack sizes
of: 50, 100, 250, 1000, 10000.
Not all pack sizes may be marketed.

How to store Orphenadrine

FURTHER INFORMATION

What Orphenadrine Tablets look like and
contents of the pack:
• Orphenadrine Tablets are yellow,
sugar-coated, round tablets with convex
faces. They are printed 5X1 on one side
and plain on the reverse.

What Orphenadrine Tablets contain:
• The active substance is orphenadrine
hydrochloride 50 mg.
• The other ingredients are lactose,
maize starch, talc (E553b), light kaolin
(E559) and stearic acid (E570). The
tablet coating contains: sucrose,
opadry-oy-28-0200, quinoline yellow
(E104), sunset yellow (E110), titanium
dioxide (E171), sodium benzoate
(E211), carnauba wax (E903) and
beeswax (E901). The printing ink
contains: shellac, black iron oxide
(E172) and propylene glycol (E1520).

6

Keep this medicine out of the sight and
reach of children. Store away from
moisture and heat. Do not use this
medicine after the expiry date which is
stated on the carton. The expiry date
refers to the last day of that month. Do
not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

5

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 at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety of
this medicine.

Not Known: frequency cannot be
estimated from the available data
• dry mouth
• blurred vision
• difficulty in passing water
• stomach problems
• dizziness.
• fast heart rate
• nervousness
• an abnormal feeling of well-being
• difficulty sleeping.

The following side effects have been
reported:

This is a very serious but rare side effect.
You may need urgent medical attention or
hospitalisation.

PM 20555
55229-D

This leaflet was last revised: May 2016
If the following happens, stop taking the
tablets and tell your doctor immediately
PL 00289/0771
or go to the casualty department at your
nearest hospital:
• an allergic reaction (swelling of the lips,
face or neck leading to severe difficulty
in breathing; skin rash or hives).

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.

4

If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

PANTONE® GREEN C

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
mockup-pil-uk-pl-00289-0771-orphenadrine-hydrochloride-50mg-tablets

APPROVALS
Signed by
Divya Jain

REG0069304

Meaning of Signature
Regulatory Affairs Approval

Version 1.10

Approved

Server Date
04-Jul-2016 12:21:44 PM

Page 2 of 2

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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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