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Folinic acid, folinic acid vs folic acid, antidote, lederfolat tablets

Teofarma srl

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lederfolat tablets, Folinic acid, antidote, folinic acid vs folic acid

Active ingredient:  folinic acid

folinic acid vs folic acid

In contrast to folic acid (which is a synthetic form of folate) folinic acid is one of the forms of folate found naturally in foods. In the body folinic acid can be converted into any of the other active forms of folate.

Active ingredients

  • 6.35 mg calcium folinate-5-water


  • Magnesium stearate
  • Corn starch, pre-gelatinized
  • Cellulose powder
  • carboxymethyl starch, sodium
  • Lactose-1-water
Indication :
  • The preparation belongs to the group of medicines called antidotes (substances that counteract the toxicity of chemotherapy treatment).
  • The medicine is used:
    • to reduce or counteract the toxicity and effects of folic acid antagonists such as methotrexate in chemotherapy or overdose in adults. In chemotherapy, this procedure is commonly known as "calcium folinate rescue"
    • Treatment of folic acid deficiency states of various origins in adults and children (4 - 18 years) that cannot be remedied by dietary measures.
  • Hints
    • With this indication of healing, a vitamin B 12 deficiency should be ruled out through differential diagnosis.
    • In contrast to the first-mentioned area of ​​application, the use of folic acid is sufficient here.
Dosage :
  • Always use the medicine exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure. Please adhere to the application instructions, otherwise the product will not work properly!
  • The dosage and duration of use depend primarily on the type and dosage of methotrexate treatment, the occurrence of symptoms of intoxication and the individual excretion of methotrexate.
  • Therefore, your treating doctor must create an individual dosage regimen for you, which you must adhere to exactly.
  • The tablets are not suitable for patients with gastrointestinal disorders (gastrointestinal disorders, vomiting). Here, the “calcium folinate rescue” must be carried out using an injection solution (iv or im). Therefore, tell your doctor if you suffer from gastrointestinal disorders or vomiting.
  • The following information can help your doctor determine the dosage and duration of use:
    • As a rule, the first dose should be given as IV or IM injection calcium folinate 15 mg (6 - 12 mg/m 2 ) 12 - 24 hours (no later than 24 hours) after the start of the methotrexate infusion. The same dose is administered every 6 hours for the following 72 hours. After several parenteral doses, the oral form can be switched to.
    • 48 hours after starting the methotrexate infusion, the remaining methotrexate level should be measured. If residual methotrexate levels are >0.5 µmol/L, calcium folinate dosages should be adjusted according to the following table:
      • Remaining methotrexate blood level 48 hours after starting methotrexate use: >/= 0.5 µmol/l
        • Calcium folinate, which should also be used every 6 hours for 48 hours or until the methotrexate level is lower than 0.05 µmo1/l: 15 mg/m 2
      • Remaining methotrexate blood level 48 hours after starting methotrexate use: >/= 1.0 µmol/l
        • Calcium folinate, which should also be applied every 6 hours for 48 hours or until the methotrexate level is lower than 0.05 µmo1/l: 100 mg/m 2
      • Remaining methotrexate blood level 48 hours after starting methotrexate use: >/= 2.0 µmol/l
        • Calcium folinate, which should also be used every 6 hours for 48 hours or until the methotrexate level is lower than 0.05 µmo1/l: 200 mg/m 2
  • The medicine as an antidote to the folic acid antagonists trimetrexate, trimethoprim and pyrimethamine:
    • Trimetrexate toxicity (toxicity):
      • For prevention: Calcium folinate should be given daily during treatment with trimetrexate and for 72 hours after the last dose of trimetrexate. Calcium folinate can be given orally, divided into 4 daily doses of 20 mg/m 2 every 6 hours until a total daily dose of 80 mg/m 2 is achieved .
    • Trimethoprim toxicity (toxicity):
      • After discontinuing trimethoprim: administration of calcium folinate 3 - 10 mg/day until normal blood counts are restored.
    • Pyrimethamine toxicity (toxicity):
      • In the case of high-dose therapy with pyrimethamine or long-term treatment with low doses, calcium folinate at 5 to 50 mg/day should be used at the same time, based on the results of the blood count.
  • Treatment of folic acid deficiency:
    • Adults: 5 mg (up to a maximum of 15 mg) folinic acid daily
    • Children 4 - 11 years: 250 µg folinic acid/kg body weight once daily
    • Children 12 - 18 years: 5 mg (up to a maximum of 15 mg) folinic acid daily
    • 1 tablet corresponds to 5 mg folinic acid.


  • If you have used more than you should
    • There are no reports of sequelae in patients who received significantly more than the recommended dose of calcium folinate. However, excessive amounts of calcium folinate may antagonize the chemotherapeutic effect of folic acid antagonists.


  • If you forget to use it
    • If you have used too low a dose of medicine or have completely forgotten to use it, consult your doctor.
      In any case, you should stick to the original treatment plan, i.e. use the correct dose of this preparation at the next time.


  • If you cancel the application
    • Do not interrupt or stop treatment with this medicine without consulting your doctor!


  • If you have any further questions about using the medicine, ask your doctor or pharmacist.
Way :
  • The medicine is to be taken orally. It is used according to your doctor’s individual instructions.
Side effects :
  • Like all medicines, the preparation can have side effects, although not everyone gets them.
  • When evaluating side effects, the following frequency information is used:
    • Very common: more than 1 patient in 10
    • Common: 1 to 10 treated in 100
    • Uncommon: 1 to 10 people treated in 1,000
    • Rare: 1 to 10 people treated in 10,000
    • Very rare: less than 1 person treated in 10,000
    • Not known: Frequency cannot be estimated from the available data.
  • Possible side effects:
    • Psychiatric disorders:
      • Rare: insomnia, restlessness and depression after high doses.
    • Diseases of the gastrointestinal tract (gastrointestinal disorders):
      • Rare: Disorders of the gastrointestinal tract (gastrointestinal disorders) at very high doses (after high doses).
      • If 5-fluorouracil is administered at the same time, high doses of folic acid can lead to severe diarrhea, for example.
    • Neurological disorders:
      • Rare: Increase in seizure frequency in epileptics.
    • Immune system disorders:
      • Very rare: allergic reactions, including hypersensitivity reactions (anaphylactoid reactions) and hives (urticaria), spasm of bronchial smooth muscles (bronchospasm) or anaphylactic shock.
  • If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects that are not specified.
Interactions :
  • When used with other medicines:
    • Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.
    • If calcium folinate is given in conjunction with a folic acid antagonist (e.g. cotrimoxazole, pyrimethamine), the effectiveness of the folic acid antagonist may be reduced or completely eliminated.
    • Calcium folinate can reduce the effects of antiepileptic drugs: phenobarbital, primidone, phenytoin and succinimide, leading to an increase in seizure frequency.
    • The simultaneous use of calcium folinate with 5-fluorouracil has been shown to increase the effectiveness and toxicity of 5-fluorouracil.
Contraindications :
  • The medicine must not be used
    • if you are hypersensitive (allergic) to calcium folinate or any of the other ingredients of this preparation.
    • in the case of dangerous anemia (pernicious anemia) or other vitamin B 12 deficiency conditions.
  • For treatment of pregnant or breast-feeding women with calcium folinate and methotrexate, see the Pregnancy and Breast-feeding category.
Pregnancy and breastfeeding :
  • Before taking/using any medicines, ask your doctor or pharmacist for advice.
  • pregnancy
    • Controlled studies on pregnant women with daily doses of up to 5 mg folic acid have shown no evidence of damage to the embryo or fetus. Folic acid supplementation can reduce the risk of neural tube defects.
    • Since the safety of a higher dosage is not guaranteed, a dosage of more than 5 mg folic acid per day is contraindicated during pregnancy and breastfeeding.
    • During pregnancy, intensive medical advice should be given about the risk of adverse effects to the child associated with methotrexate treatment and treatment should only be started if the benefit outweighs the risk to the fetus. Methotrexate should not be used during pregnancy because there is evidence of a risk of birth defects in humans. In women of childbearing age, existing pregnancy should be safely ruled out before starting methotrexate treatment.
    • Since women should not become pregnant during and for at least 3 months after treatment with methotrexate, effective contraception should be practiced.
    • Since methotrexate can cause genetic damage, men and women must practice effective contraception during and after therapy. If you want to have children, it is recommended that you visit a genetic counseling center before starting therapy, if possible.
  • lactation
    • It is not known whether calcium folinate is excreted in human breast milk. Calcium folinate can be used during breast-feeding if deemed necessary within the therapeutic indications.
    • Breastfeeding should not be carried out during methotrexate treatment as methotrexate passes into breast milk. If calcium folinate is used in conjunction with methotrexate treatment, breast-feeding must be discontinued.
Patient information :
  • Particular caution is required when using the medicine
    • The following describes when you can only use the medicine under certain conditions and with particular caution. Please consult your doctor about this. This also applies if this information previously applied to you.
    • Generally
      • Calcium folinate should only be used with methotrexate under the direct supervision of a doctor experienced in the use of chemotherapy drugs for cancer.
      • Treatment with calcium folinate can mask dangerous anemia or other vitamin B 12 deficiencies and thereby possibly hide them.
      • Epileptics treated with phenobarbital, phenytoin, primidone and succinimides are at risk of increasing seizure frequency. Clinical monitoring is required during use of calcium folinate and after discontinuation. Please consult your treating doctor about this.
    • Children
      • There are no studies on the effectiveness and safety of this preparation in combination with methotrexate. Use in children in this combination is therefore not recommended.
    • Calcium folinate/methotrexate
      • For specific details about reducing methotrexate toxicity, consult your doctor.
      • Excessively high doses of calcium folinate must be avoided as these can reduce the antitumor effectiveness of methotrexate. This is particularly true for tumors of the central nervous system, in which calcium folinate accumulates after repeated courses of treatment.
      • Accidental overdose of a folic acid antagonist such as methotrexate should be treated as a medical emergency. In the event of an accidental overdose, contact your doctor immediately.


  • Ability to drive and use machines:
    • There is no evidence that calcium folinate affects the ability to drive or use machines.