Folinoral 25 mg, 14 capsules, available at our organic pharmacy. Share your feedback on usage instructions and dosage with our partner; reviews are verified after your purchase.
Folinoral 25 mg is a medication whose active ingredient is calcium folinate. It belongs to the pharmacotherapeutic class of detoxification agents for cytostatic therapy.
Folinic acid is the reduced form offolic acid. In the body, it acts as an essential cofactor for thymidylate synthase, a key enzyme involved in DNA synthesis. It acts as a specific biochemical antagonist of antifolic agents.
This medication is primarily indicated for:
This treatment is intended for adults and children, provided that the specific dosages appropriate for age and therapeutic context are followed.
Administration is exclusively oral. The dosage varies strictly according to the indication and the associated treatment.
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Folinoral 25 mg is a calcium folinate-based detoxifying medication used to prevent or correct hematological and cellular toxicities induced by antifolate therapies (methotrexate, pyrimethamine, etc.). It acts as a cofactor in DNA synthesis, thereby protecting healthy cells against certain chemotherapy agents. Its oral administration is governed by specific protocols depending on the dose of the associated cytotoxic agent. Close medical monitoring is recommended, particularly regarding kidney function and drug interactions.
Folinic acid is the reduced (tetrahydrogenated) form of folic acid, which allows it to act directly as an enzymatic cofactor without requiring conversion by dihydrofolate reductase, an enzyme inhibited by certain chemotherapy drugs.
Yes, this is one of its main indications for preventing methotrexate toxicity; however, it should generally not be administered simultaneously, unless a specific protocol calls for it, as it is a methotrexate antagonist.
Adhering to the dosing intervals (often every 6 hours in rescue regimens) is crucial for the effectiveness of detoxification. If a dose is missed or the capsule is vomited, immediate medical advice is necessary.
Folinic acid is considered non-toxic. The body uses the necessary amount and eliminates the excess; no cases of overdose have been observed, even with very high doses.
No, Folinoral 25 mg contains lactose as an excipient with a known effect. Its use is therefore not recommended for people with galactose intolerance or lactase deficiency.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on : 08/07/2021
FOLINORAL 25 mg, capsule
Calcium folinate
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is FOLINORAL 25 mg, capsule and what is it used for?
2. What do I need to know before taking FOLINORAL 25 mg, capsule?
3. How do I take FOLINORAL 25 mg, capsule?
4. What are the possible side effects?
5. How should FOLINORAL 25 mg capsule be stored?
6. Package contents and other information.
1. WHAT IS FOLINORAL 25 mg, capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: DETOXIFYING DRUGS FOR CYTOSTATIC TREATMENT - ATC code: V03AF03 (V: Miscellaneous).
This drug is a derivative of a vitamin from the B vitamin group. It is used with the following drugs: trimethoprim, salazopyrine, pyrimethamine, trimetrexate and methotrexate.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING FOLINORAL 25 mg, capsule?
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
Never take FOLINORAL 25 mg, capsule:
- if you are allergic (hypersensitive) to calcium folinate or to any of the other ingredients of this medicine, as listed in section 6.
Calcium folinate should not be used to treat pernicious anaemia or other anaemias due to vitamin B12 deficiency.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Talk to your doctor or pharmacist before taking FOLINORAL 25 mg, capsule.
This medicine is not recommended for patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Tell your doctor if you have renal insufficiency.
In the event of vomiting, it is essential to inform your doctor so that he/she can prescribe this medicine in its injectable form.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Other medicines and FOLINORAL 25 mg, capsule
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
FOLINORAL 25 mg, capsule with food and drink
Not applicable.
Pregnancy and breast-feeding
This medicine should be used with caution during pregnancy and while breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and use of machinery
Not applicable.
FOLINORAL 25 mg, capsule contains lactose.
3. HOW DO I TAKE FOLINORAL 25 mg, capsule?
Dosage
Dosage varies according to indication.
It is strictly individual. Follow your doctor's recommendations.
Method and route of administration
Take by mouth.
If you have taken more FOLINORAL 25 mg, capsule than prescribed
Not applicable.
If you forget to take FOLINORAL 25 mg, capsule
Not applicable.
If you stop taking FOLINORAL 25 mg, capsule
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
- Very rarely: urticaria, angioedema, anaphylactic shock.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: www.signalement-sante.gouv.fr
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE FOLINORAL 25 mg, capsule?
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the box.
No special storage precautions.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What FOLINORAL 25 mg capsule contains
- The active substance is :
Calcium folinate.......................................................................................................... 27.012 mg
Quantity corresponding to folinic acid......................................................................... 25,000 mg
For one capsule.
- The other components are :
Lactose monohydrate, glycerol palmitostearate.
Capsule shell composition: gelatin, yellow iron oxide, titanium dioxide.
What FOLINORAL 25 mg capsule is and what it contains
This medicine comes in capsule form. Boxes of 14, 28, 56 capsules.
Marketing authorization holder
THERABEL LUCIEN PHARMA
18 RUE CAMILLE PELLETAN
92300 LEVALLOIS-PERRET
Marketing authorization holder
CENTER SPECIALITES PHARMACEUTIQUES
76-78 AVENUE DU MIDI
63800 COURNON-D'AUVERGNE
FRANCE
SKYEPHARMA PRODUCTION SAS
ZONE INDUSTRIELLE CHESNES OUEST,
55 RUE DU MONTMURIER,
38070 SAINT-QUENTIN-FALLAVIER
FRANCE
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Not applicable.
Detailed information on this drug is available on the ANSM (France) website.
This medicine contains folinic acid, a substance derived from folic acid (vitamin B9). Certain cytotoxic drugs can alter the action of folic acid, causing megaloblastic anemia or bone marrow failure. Supplementation with folinic acid reduces the toxicity of these drugs.
Prices do not include dispensing fees.
| p capsule | p capsule | |
| Folinic acid | 5 mg | 25 mg |
When this drug is taken to prevent the toxic effects of methotrexate, it should generally not be taken at the same time; if in doubt, ask your doctor for advice.
If vomiting occurs after taking this drug (vomiting due to methotrexate), folinic acid must be administered by injection.
Tell your doctor if you are taking phenobarbital, primidone or phenytoin.
This medicine contains a substance presumed safe for use during pregnancy and breast-feeding.
However, drugs associated with folinic acid are contraindicated during pregnancy (drugs containing trimethoprim, pyrimethamine, sulfasalazine, methotrexate).
This medicine may be taken with or without meals.
Correction of megaloblastic anemias induced by trimethoprim or salazopyrin:
Prevention and correction of pyrimethamine-induced megaloblastic anemias:
Prevention of toxic accidents due to trimetrexate or methotrexate: doses vary according to the doses of trimetrexate or methotrexate administered.
The reimbursement rate for this medication depends on the indication for which it is prescribed.
Chemical name for vitamin B9, normally present in the diet and in the body in the form of folate. Folic acid plays an important role in cell renewal and the production of red blood cells. Insufficient folic acid intake can have serious consequences, particularly in childhood and adolescence (anemia) or during pregnancy (fetal malformations).
A particular type of anemia, due to a deficiency of folic acid (vitamin B9), which results in a drop in the number of red blood cells and an increase in their size. It differs from the more common iron-deficiency anemias, which result in a decrease in red blood cell size.
Damage to the bone marrow, which becomes incapable of producing blood cells (red blood cells, white blood cells, platelets).
See also: bone marrow failure.
A substance essential for growth and proper functioning of the body. Vitamin requirements are normally covered by a varied diet. In developed countries, only vitamin D deficiency in young children or elderly people with little exposure to sunlight justifies systematic supplementation. Intake in excess of requirements, particularly through medication, can lead to overdosage and various disorders (mainly vitamins A and D).
See article: Vitamins.
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