OPILON 40 MG TABLETS

Active substance: MOXISYLYTE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

OPILON® 40mg TABLETS
Moxisylyte hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
• Please 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 you suffer from any of the side effects which get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Opilon Tablets are and what are they used for
2. Before you take Opilon Tablets
3. How to take Opilon Tablets
4. Possible side effects
5. How to store Opilon Tablets
6. Further information

1. WHAT OPILON TABLETS ARE AND WHAT THEY ARE USED FOR
Opilon tablets contain the active ingredient moxisylyte hydrochloride (equivalent
to 40mg of moxisylyte).
Opilon tablets are a “vasodilator” which works by widening the blood vessels and
improving blood circulation. It is used for the short-term control of Raynaud’s
Phenomenon. This is a condition where the fingers and toes become discoloured
and is triggered by responses to cold, or emotional distress. Opilon tablets help by
improving blood circulation to the extremities.

2. BEFORE YOU TAKE OPILON TABLETS
Do not take Opilon Tablets if you have:
• an allergy to moxisylyte or any of the other ingredients of Opilon tablets (see
Section 6, and also end of Section 2)
• liver disease
These tablets are not intended for children under 18 years.
Take special care with Opilon tablets
You should consult your doctor before taking Opilon tablets if any of the following
applies to you:
• diabetes
• high blood pressure
• taking tricyclic antidepressants
• are over 65 years of age
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.
In particular, tell your doctor or pharmacist if you are taking any of the following
medicines, because Opilon tablets may interact with them:
• antihypertensives (to reduce high blood pressure): Opilon tablets may increase
their effect.
• antidiabetic medicines (to treat diabetes): your insulin requirement may be
reduced.
• tricyclic antidepressants (to treat panic and anxiety disorders and some types of
pain): this may increase the blood pressure lowering effects of Opilon tablets.
If you are not sure which medicines you are already taking, please ask your doctor
or pharmacist.
Pregnancy and breast-feeding
Opilon tablets are not recommended for use if you are pregnant, think you
might be pregnant or are planning to become pregnant, as its safety has not been
established.
Do not breast-feed if you are taking Opilon tablets.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There are no known effects of taking Opilon tablets on driving or using machines.
Important information about some of the ingredients of Opilon Tablets
Lactose is an ingredient in Opilon tablets – if you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor before taking this
product.
The film coating of Opilon tablets contains the colouring agent ponceau red
(E124) which may cause an allergic reaction and propylene glycol which may cause
alcohol-like symptoms.

3. HOW TO TAKE OPILON TABLETS
Always take Opilon tablets exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
The dosage of Opilon tablets varies from person to person and depends on your
condition.
Your doctor will tell you how many tablets to take and for how long you should take
them.
Swallow the tablets whole with some water.
Try to take the tablets at the same time every day.
If there is no improvement within two weeks of starting Opilon tablets, your doctor
will probably stop your treatment.

Adults:
The usual starting dose is one 40mg tablet four times a day. Your doctor may
increase your dose to two tablets four times a day if your initial response is poor. If
you are exposed to the cold during the daytime, one tablet should be administered
every three hours during the period when symptoms are most likely to occur.
Elderly (over 65 years):
The dosage is the same as stated for adults, but the elderly should take special care
when taking Opilon tablets.
Children:
Opilon tablets are not recommended for use in children under 18 years old.
If you forget to take Opilon Tablets
If you forget to take your tablets, take your next dose as soon as you remember
unless it is time for your next dose. Do not take two doses at the same time to make
up for a forgotten individual dose. If in doubt about what you should do, please
contact your doctor or pharmacist.
If you take more Opilon Tablets than you should
If you accidentally take more tablets than you should, or you suspect that a child
has swallowed the tablets, contact your doctor straight away or go to your nearest
hospital casualty department immediately. Take this leaflet and the pack of tablets
along with you, if you can.
In excessive overdosage, you may experience a drop in blood pressure; you may
need to lie down until your blood pressure is back to normal.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Opilon tablets can cause side effects, although not everybody
gets them.
Stop taking Opilon tablets and seek immediate medical attention if you experience
the following:
• jaundice (yellowing of the skin and eyes). This side effect is rare and may
indicate that Opilon tablets have affected your liver.
Other side effects that have been reported are:
• mild nausea (feeling sick),
• diarrhoea,
• headache,
• flushing of the face,
• giddiness ( a feeling of dizziness or spinning),
• rash.
If any of these side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor.

5. HOW TO STORE OPILON TABLETS
Keep out of the reach and sight of children.
Keep the tablets in the original pack and store below 30°C.
Do not use Opilon tablets after the expiry date which is stated on the carton after
‘Expiry:’ and on blister 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 Opilon Tablets contain
The active substance in each tablet is: moxisylyte hydrochloride 45.22mg
(equivalent to moxisylyte 40mg).
The other ingredients in the tablet are: lactose, maize starch, microcrystalline
cellulose, magnesium stearate and silicon dioxide.
The tablet coating contains: hypromellose (E464), propylene glycol, titanium
dioxide (E171), quinoline yellow (E104), ponceau 4R (E124) and indigo carmine
(E132).
(see also end of Section 2 “Further information about some of the other ingredients of
Opilon Tablets”).
What Opilon Tablets look like and contents of the pack
Opilon tablets are small, round, unmarked, pale yellow film-coated tablets.
The tablets are supplied blister packs containing 112 tablets.
Marketing Authorisation Holder
Archimedes Pharma UK Limited
250 South Oak Way
Green Park
Reading
RG2 6UG
UK
Manufacturer
Recipharm Limited
Vale of Bardsley
Ashton-under-Lyne
Lancashire
OL7 9RR
UK
This leaflet was last approved in
10/2011


OPITAB40-PILUK11

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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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