Refolinon 15mg Tablets
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PATIENT INFORMATION LEAFLET
Refolinon®
leucovorin calcium
Read all of this leaflet carefully before you start taking this medicine.
• 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 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.
In this leaflet:
1. What Refolinon is and what it is used for
2. Before you take Refolinon
3. How to take Refolinon
4. Possible side effects
5. How to store Refolinon
6. Further information
1. What Refolinon is and what it is used for
Refolinon contains leucovorin calcium which is chemically related to a vitamin called folic acid. Refolinon increases the levels of a folic acid in your body. Methotrexate (a medicine used to treat cancer) can lower your body's levels of folic acid. Refolinon is used to reverse this and help to maintain folic acid levels. This is known as ‘leucovorin rescue'.
Refolinon is also used to treat a form of anaemia (megaloblastic) which results from low levels of folic acid.
You should ask your doctor if you are unsure why you have been given Refolinon.
2. Before you take Refolinon
Do not take Refolinon if:
• you are allergic (hypersensitive) to leucovorin calcium or any of the other ingredients of Refolinon.
Take special care with Refolinon
• Tell your doctor before taking Refolinon if you currently have, or have had anaemia that needed treatment.
Taking other medicines
Some medicines can affect the way Refolinon works, or Refolinon itself can reduce the effectiveness of other medicines taken at the same time.
• The effectiveness of Refolinon can be reduced by chloramphenicol (an antibiotic).
• Refolinon can reduce the effectiveness of drugs used to treat epilepsy (phenobarbital, phenytoin or primidone) and lead to more frequent seizures (fits).
• Refolinon may increase the side effects of fluorouracil (used to treat cancer).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and Breast-feeding
If you are pregnant, planning to get pregnant or are breast-feeding, tell your doctor before you take Refolinon.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Refolinon is not expected to affect your ability to drive or use machines.
Important information about some of the ingredients of Refolinon
Refolinon contains lactose, a type of sugar. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Refolinon
Always take Refolinon exactly as your doctor has told you. You should check with your doctor or pharmacist if you are still not sure.
The usual dose in adults and children is as follows:
Refolinon for Leucovorin rescue: 15mg (1 tablet) every 6 hours for 48 hours. Refolinon for Megaloblastic anaemia:
15mg (1 tablet) daily until your doctor tells you to stop.
The tablets should be swallowed with a glass of water.
It is important to take your medicine at the right times. Refolinon for Leucovorin rescue therapy is usually started 24 hours after the start of methotrexate treatment.
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If you take more Refolinon than you should
If you accidentally take too much Refolinon contact your doctor. Side effects with Refolinon are rare, since it is similar to a naturally occurring vitamin.
If you forget to take Refolinon
If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a missed dose.
If you stop taking Refolinon
Do not stop taking Refolinon unless your doctor tells you to. If you suddenly stop taking this medicine your condition may return.
If you have any further questions on how to take this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Refolinon can cause side effects, although not everybody gets them.
Tell your doctor immediately if
you experience any of the following symptoms after taking this medicine. Although they are very rare, these symptoms can be serious.
• sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
If Refolinon is given with another drug called fluorouracil (to treat cancer) the following side effects have been reported:
• decreased white blood cell count or low platelets in the blood. Symptoms may include bruising, nose bleeds
or rash. Your doctor will take regular blood tests to check these.
• sore and inflamed mouth (stomatitis) and/or diarrhoea.
If you have received Refolinon by injection, prior to receiving the tablets, you can also get a high temperature.
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. How to store Refolinon
Keep your tablets out of the reach and sight of children.
Do not use Refolinon after the expiry date which is stamped on the pack after EXP. The expiry date refers to the last day of that month.
Store your Refolinon Tablets below 25°C. Do not refrigerate or freeze them.
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 Refolinon contains
The active substance in Refolinon tablets is 15mg of leucovorin (folinic acid) as the calcium salt.
The other ingredients are: Avicel PH101, magnesium stearate and lactose.
What Refolinon looks like and contents of the pack
Refolinon tablets are yellow in colour and are scored and marked CF on one side
The tablets are supplied in plastic containers of 30 or 100 tablets.
Marketing Authorisation Holder
Pfizer Ltd., Ramsgate Road,
Sandwich, Kent CT13 9NJ, UK.
Manufacturer:
Orion Corporation, PO Box 425, SF20101, Turku, Finland.
Company Contact Address:
For further information on your medicine please contact Medical Information at the following address: Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK. Telephone: 01304 616161.
This leaflet was last revised in 08/2015. RE 6_0 UK
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