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OPILON 40 MG TABLETS

Active substance(s): MOXISYLYTE HYDROCHLORIDE / MOXISYLYTE HYDROCHLORIDE

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Package Leaflet: Information for the user

OPILON® 40 mg Tablets
Moxisylyte hydrochloride
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• 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 only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Opilon is and what it is used for
2. What you need to know before you take Opilon
3. How to take Opilon
4. Possible side effects
5. How to store Opilon
6. Contents of the pack and other information

1. What Opilon is and what it is used for
Opilon tablets contain the active ingredient moxisylyte hydrochloride
(equivalent to 40 mg of moxisylyte).
Opilon is a “vasodilator” which works by widening the blood vessels and
improving blood circulation.
Opilon is used for the short-term control of Raynaud’s Phenomenon in
adults. This is a condition where the fingers and toes become discoloured
and is triggered by responses to cold, or emotional distress. Opilon helps by
improving blood circulation to the extremities.

2. What you need to know before you take Opilon
Do not take Opilon :
• if you are allergic to moxisylyte or any of the other ingredients of this
medicine (listed in section 6)
• if you have liver disease
Warnings and precautions
Talk to your doctor or pharmacist before taking Opilon if any of the following
applies to you:
• diabetes
• high blood pressure
• taking tricyclic antidepressants
• are over 65 years of age
Children and adolescents
This medicine is not intended for children under 18 years.
Other medicines and Opilon
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the
following medicines, because Opilon may interact with them:
• antihypertensives (to reduce high blood pressure): Opilon 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.
If you are not sure which medicines you are already taking, please ask your
doctor or pharmacist.
Pregnancy and breast-feeding
Opilon is 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There are no known effects of taking Opilon on driving or using machines.
Opilon contains Lactose and Ponceau Red (E124)
This product contains lactose – if you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this
medicinal product.
The film coating of Opilon tablets contains the colouring agent ponceau red
(E124) – may cause allergic reactions.

3. How to take Opilon
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose 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, your doctor
will probably stop your treatment.
Adults:
The usual starting dose is one 40 mg 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.

Use in children and adolescents:
Opilon is not recommended for use in children under 18 years old.
If you take more Opilon 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 forget to take Opilon
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 a double dose to
make up for a forgotten dose. If in doubt about what you should do, please
contact your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking Opilon 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 the medicine has 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
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 Opilon
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the carton
after ‘EXP:’ and on blister after ‘Exp:’. 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.

6. Contents of the pack and other information
What Opilon contains
The active substance is moxisylyte hydrochloride, each tablet contains
45.22 mg (equivalent to moxisylyte 40 mg).
The other ingredients in the tablet core 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).
(please see end of section 2 “Opilon contains” for further information on
some of the ingredients).
What Opilon looks like and contents of the pack
Opilon tablets are small, round, unmarked, pale yellow film-coated tablets.
The tablets are supplied in blister packs containing 112 tablets.
Marketing Authorisation Holder
Archimedes Pharma UK Limited
Galabank Business Park
Galashiels
TD1 1QH
United Kingdom
Manufacturer
Recipharm Limited
Vale of Bardsley
Ashton-under-Lyne
Lancashire
OL7 9RR
United Kingdom
This leaflet was last revised in June 2017.

LFT-OPI-GB-002

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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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