Opilon 40 Mg Tablets
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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
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.
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 TABLETS
Keep out of the sight and reach 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
Galabank Business Park
Galashiels
TD1 1QH
United Kingdom
Manufacturer
Recipharm Limited Vale of Bardsley Ashton-under-Lyne Lancashire OL79RR United Kingdom
This leaflet was last revised in April 2015.
LFT-OPI-GB-001
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YELLOWDOT DESIGN |
Artwork Technical Specifications |
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DESCRIPTION: |
Opilon tablets UK PIL |
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PRODUCT No.: |
LFT-OPI-GB-001 |
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INTERNAL CODE No.: | |
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CUTTERGUIDE REF.: | |
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VERSION No.: |
2 |
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DATE: |
14/04/2015 |
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YELLOWDOT REF: | |
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REASON FOR CHANGE: |
Change address to GalabankBusiness Park... |
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SIZE: |
420mm high x 148mm wide |
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COLOURS: |
Black |
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TEXT SIZE: |
10pt |
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LEADING: |
11pt (3.8mm) |
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FONTS: |
ITC New Baskerville, Times |