Lederfolat tablets, 50 pcs

Areas of application

The medicine belongs to the group of antidotes that counteract the toxicity of chemotherapy treatment.It is used to reduce or counteract the toxicity and effects of folic acid antagonists such as methotrexate in chemotherapy or overdose in adults.This procedure is known in chemotherapy as “calcium folinate rescue”.It is also used to treat folic acid deficiency states of various origins in adults and children between the ages of 4 and 18, which cannot be remedied by dietary measures.

No prescription is required for this product.

Before use, a vitamin B12 deficiency should be ruled out through differential diagnosis.In contrast to use for folic acid deficiency, the use of folic acid is sufficient here.

Active ingredients and ingredients

The medicine contains 6.35 mg of calcium folinate 5-water, which corresponds to 5 mg of folinic acid.In addition, it contains the following excipients: carboxymethyl starch, sodium salt, cellulose powder, lactose 1-water, magnesium stearate and pre-gelatinized corn starch.

Contraindications

The medicine must not be used if you are hypersensitive (allergic) to calcium folinate or any of the other ingredients of the product.It must also not be used in cases of dangerous anemia (pernicious anemia) or other vitamin B12 deficiency conditions.

For treatment of pregnant or breast-feeding women with calcium folinate and methotrexate, see the Pregnancy and Breast-feeding category".

Dosage

The medicine should always be used exactly as your doctor has told you.The dosage and duration of use depend on the type and dosage of methotrexate treatment, the occurrence of symptoms of intoxication and the individual excretion of methotrexate.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 or vomiting.In such cases, “calcium folinate rescue” must be carried out using an injection solution (iv or im).Tell your doctor if you have gastrointestinal upset or vomiting.

The first dose should be given as an IV.or i.m.Injection of 15 mg calcium folinate (6 - 12 mg/m²) should be given 12 - 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 above 0.5 µmol/L, calcium folinate dosages should be adjusted.The exact dosage depends on the remaining methotrexate levels and can be determined by your doctor.

When used as an antidote to the folic acid antagonists trimetrexate, trimethoprim and pyrimethamine, specific dosage regimens apply, determined by your doctor.

To treat folic acid deficiency, the recommended dose for adults and children aged 12 and over is 5 mg (up to a maximum of 15 mg) of folinic acid daily.For children aged 4 to 11 years, the recommended dose is 250 mcg of folinic acid per kg of body weight once daily.One tablet corresponds to 5 mg of folinic acid.

Intake

The medicine is to be taken orally.It is used according to your doctor’s individual instructions.

Patient information

Particular caution is required when using the drug.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 and thereby possibly hide dangerous anemia or other vitamin B12 deficiencies.

Epileptics treated with certain anti-epileptic drugs are at risk of increasing the frequency of seizures.Clinical monitoring is required during use of calcium folinate and after discontinuation.

There are no studies on the effectiveness and safety of the preparation in combination with methotrexate in children.Use in children in this combination is therefore not recommended.

Calcium folinate doses that are too high must be avoided as these can reduce the antitumor effectiveness of methotrexate.Accidental overdose of a folic acid antagonist such as methotrexate should be treated as a medical emergency.

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

Pregnancy and breastfeeding

Before taking/using any medicines, ask your doctor or pharmacist for advice.

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.

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.

Notes

For information about risks and side effects, read the package leaflet and ask your doctor or pharmacy.

Before taking it for the first time, check with your doctor to make sure there is no vitamin B12 deficiency.