Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Refolinon 15mg tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Calcium folinate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Refolinon contains the active substance leucovorin calcium which is chemically related to a vitamin called folic acid. Refolinon increases the levels of 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.
What you need to know before you take it
e Refolinon Do not take Refolinon if:
- you are allergic (hypersensitive) to leucovorin calcium or any of the other ingredients of this medicine (listed in section 6).
- you have pernicious anaemia or other megaloblastic anaemia where vitamin B12 is deficient. Other medicines and Refolinon Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. 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). Page 1 of 4
Pregnancy, breast-feeding and fertility Pregnancy If you are pregnant, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before you take this medicine. Breast-feeding If you are breast-feeding, speak to your doctor who will advise whether you should use an alternative method of feeding your baby. Driving and using machines Refolinon is not expected to affect your ability to drive or use machines. Refolinon contains lactose Refolinon contains lactose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3.
How to take it
Refolinon Always take this medicine exactly as you 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: 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: 15mg (1 tablet) every 6 hours for 48 hours. Refolinon for leucovorin rescue therapy is usually started 24 hours after the start of methotrexate treatment. Refolinon for megaloblastic anaemia: 15mg (1 tablet) daily until your doctor tells you to stop. 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 medicine, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine 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.
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- 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. 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 at: 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 it
Refolinon Keep this medicine out of the sight and reach of children. Do not use Refolinon after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month. Store below 25 °C. Do not refrigerate or freeze. 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.
Content of the pack and other information
What Refolinon contains The active substance in Refolinon tablets is leucovorin (folinic acid) as the calcium salt. Each tablet contains 15mg of leucovorin. The other ingredients are: microcrystalline cellulose, magnesium stearate and lactose (see section 2 Refolinon contains lactose). What Refolinon looks like and contents of the pack Refolinon tablets are light yellow and are scored and marked CF on one side The tablets are supplied in plastic containers of 30 or 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Pfizer Limited Page 3 of 4
Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom Manufacturer: Orion Corporation Orion Pharma Joensuunkatu 7 FI-24100 Salo Finland Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland
This leaflet was last revised in 05/2020 Ref: RE 8_0
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Frequently asked questions about Refolinon 15mg tablets
How do I take Refolinon 15mg tablets?
Refolinon 15mg tablets comes as tablet containing 15mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Refolinon 15mg tablets?
The active substance in Refolinon 15mg tablets is calcium folinate.
Are there equivalent medicines to Refolinon 15mg tablets?
Medicines with the same active substance, strength and form include: Calcium Folinate 15mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Refolinon 15mg tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Refolinon 15mg tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: calcium folinate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Leucovorin (folinic acid) is the formyl derivative of tetrahydrofolic acid and is an intermediate product of the metabolism of folic acid.
Leucovorin is used in cytotoxic therapy as an antidote to folic acid antagonists such as methotrexate.
Leucovorin is effective in the treatment of megaloblastic anaemia.
4.2. Posology and method of administration
Posology
Although leucovorin calcium may also be available as a solution for injection, leucovorin calcium should not be administered intrathecally.
Adults and children:
Leucovorin rescue: Depending upon the dose of methotrexate administered, dosage regimens of leucovorin calcium vary. Up to 120 mg leucovorin calcium are generally given, usually in divided doses over 12-24 hours by intramuscular injection, bolus intravenous injection or intravenous infusion in normal saline. This is followed by 12-15 mg intramuscularly or 15 mg orally every 6 hours for 48 hours. Rescue therapy is usually started 24 hours after the commencement of methotrexate administration.
If overdosage of methotrexate is suspected, the dose of leucovorin calcium should be equal to or greater than the dose of methotrexate and should be administered within one hour of the methotrexate administration.
Megaloblastic anaemia (folate deficiency): 15 mg (one tablet) leucovorin per day.
Method of administration
To be given orally.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1..
Pernicious anaemia or other megaloblastic anaemia where vitamin B12 is deficient.
4.4. Special warnings and precautions for use
Calcium folinate should only be used with methotrexate and 5-fluorouracil by clinicians experienced in the use of cancer chemotherapeutic agents.
Refolinon contains lactose.
Patients with rare hereditary problems of galacatose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
Leucovorin should not be given simultaneously with a folic acid antagonist, for the purpose of reducing or preventing clinical toxicity, as the therapeutic effect of the antagonist may be nullified.
Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin, as well as primidone and increase the frequency of seizures.
Concurrent administration of chloramphenicol and folic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folic acid.
Calcium folinate may enhance the toxicity of fluorouracil.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate and well-controlled clinical studies conducted in pregnant or breast feeding women. No formal animal reproductive toxicity studies with calcium folinate have been conducted. There are no indications that folic acid induces harmful effects if administered during pregnancy. During pregnancy, methotrexate should only be administered on strict indications, where the benefits of the drug to the mother should be weighed against possible hazards to the foetus. Should treatment with methotrexate or other folate antagonists take place despite pregnancy or lactation, there are no limitations as to the use of calcium folinate to diminish toxicity or counteract the effects.
5-fluorouracil use is generally contraindicated during pregnancy and contraindicated during breastfeeding; this applies also to the combined use of calcium folinate with 5-fluorouracil.
Please refer to the SPC for methotrexate, other folate antagonists (and 5-fluorouracil) containing medicinal products.
Breast-feeding
It is not known whether calcium folinate is excreted into human breast milk. Calcium folinate can be used during breast feeding when considered necessary according to the therapeutic indications.
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Adverse reactions to leucovorin calcium are rare, but following intravenous and intramuscular administration occasional pyrexial reactions have been reported.
The most common dose-limiting adverse reaction occurring in patients receiving combination of calcium folinate and 5-fluorouracil are stomatitis and diarrhoea. In addition, haematological adverse reactions, such as leucocytopenia and thrombocytopenia, may occur. These adverse reactions are dose-dependent and their occurrence can usually be decreased by reducing the dosage of cytotoxic drugs. These adverse reactions can be controlled by close monitoring of haematological values, e.g. blood leucocyte and thrombocyte levels, and serum electrolyte (e.g. Na, K, Ca) and creatinine levels.
Anaphylactoid and urticaria allergic reactions have also been reported with the use of leucovorin.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
4.9. Overdose
There have been no reported sequelae in patients who have received significantly more calcium folinate then the recommended dosage. However, excessive amounts of calcium folinate may nullify the chemotherapeutic effect of folic acid antagonists.
Should overdosage of the combination of 5-fluorouracil and calcium folinate occur, the overdosage instructions for 5-FU should be followed.
💬 Ask about this leaflet
Ask anything about Refolinon 15mg tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.