Leather folate tablets, 100 pcs

Active ingredients / ingredients / ingredients

The preparation contains 6.35 mg calcium folinate 5-water and 5 mg folinic acid.The following excipients are also included: carboxymethyl starch, sodium salt, cellulose powder, lactose 1-water, magnesium stearate and pre-gelatinized corn starch.

Area of application

This medicine belongs to the group of antidotes that counteract the toxicity of chemotherapy treatments.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 process is also known 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.

It is important to rule out a vitamin B12 deficiency through differential diagnosis.In contrast to the treatment of folic acid deficiency states, the use of folic acid is sufficient when used to combat the toxicity of folic acid antagonists.

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 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

Always use the medicine 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 (gastrointestinal disorders, 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.

As a rule, the first dose should be given as an IV.or i.m.Injection of calcium folinate 15 mg (6 - 12 mg/m²) should be given 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 applied every 6 hours for 48 hours or until the methotrexate level is lower than 0.05 µmol/l: 15 mg/m².

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 µmol/l: 100 mg/m².

Remaining methotrexate blood level 48 hours after starting methotrexate use: >= 2.0 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 µmol/l: 200 mg/m².

The medicine as an antidote to the folic acid antagonists trimetrexate, trimethoprim and pyrimethamine:

Trimetrexate 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/m² every 6 hours until a total daily dose of 80 mg/m² is reached.

Trimethoprim toxicity (toxicity): After discontinuation of trimethoprim, calcium folinate 3 - 10 mg/day should be given until normal blood counts are restored.

Pyrimethamine toxicity (toxicity): In case of high-dose therapy with pyrimethamine or prolonged 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 KG 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 use more than you should: There have been no reports of adverse effects 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 the 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 the next time.

If you stop using: 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.

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 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.

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

For specific details about reducing methotrexate toxicity, consult your doctor.Calcium folinate doses that are too high 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.

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

Pregnancy

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.

Breast-feeding: 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.

Other

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