Package leaflet: Information for the user

Folidar 15 mg tablets

calcium folinate
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Folidar is and what it is used for
What you need to know before taking Folidar
How to take Folidar
Possible side effects
How to store Folidar
Contents of the pack and other information

1. What Folidar is and what it is used for

Folidar contains the active substance calcium folinate, which belongs to the category
of antianaemic medicinal products.
This medicine is indicated in all forms of anaemia (insufficient number of
red blood cells) due to deficiency of Vitamin B caused by increased demand, reduced
utilisation, or inadequate dietary intake of Vitamin B.
Folidar is also used to counteract the undesirable effects induced by two
anticancer medicines (aminopterin and methotrexate).

2. What you should know before taking Folidar

Do not take Folidar

if you are allergic to calcium folinate or to any of the other ingredients of this medicine (listed in section 6).
if you have anaemia caused by vitamin B₁₂ deficiency, such as pernicious anaemia (the immune system attacks the body's red blood cells) or megaloblastic anaemia (red blood cells are larger than normal); in these cases, Folidar may be administered only in combination with vitamin B₁₂ (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Folidar.
If you have pernicious anaemia or other megaloblastic anaemias due to vitamin B₁₂ deficiency, your doctor will prescribe Folidar only in combination with vitamin B₁₂. Otherwise, blood test results may improve, while progressive neurological problems could occur.
Therefore, treatment must be monitored through blood tests.
When treating adverse effects caused by folic acid antagonists (anti-cancer chemotherapy drugs) administered at conventional doses, administration of Folidar should preferably occur within 1 hour. Administration after 4 hours is generally ineffective.
The medicine must be administered carefully to avoid the risk of allergic reactions or adverse effects.

Other medicines and Folidar
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The active substance in this medicine antagonizes the effects of antifolates (medicines used in anti-cancer chemotherapy that inhibit folic acid functions) (see “Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Folates (such as the active ingredient in this medicine) are vitamin compounds that are normal components of the human body. At recommended doses, they have no harmful effects on the mother or the foetus.

Driving and using machines
FOLIDAR does not impair the ability to drive vehicles or operate machinery.

3. How to take Folidar

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Take the medicine orally.
The recommended doses are:

Treatment of folate deficiency anemia (vitamin B deficiency)
Initial dose: 15 mg for 10–15 days.
If a favorable response occurs, your doctor will instruct you to reduce the dose by half and continue treatment until blood tests normalize and clinical symptoms disappear.

Management of adverse effects from conventional doses of methotrexate
15 mg every 6 hours for 4 doses.
In the treatment of adverse effects caused by folic acid antagonists (medicines used in antitumor chemotherapy) administered at conventional doses, Folidar should preferably be administered within 1 hour. Administration after a period of 4 hours is generally ineffective.

If you take more Folidar than you should
To date, no signs of overdose have been observed in humans.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone experiences them.
Side effects reported following administration of the medicine:
Frequency not known (frequency cannot be estimated from the available data):
Administration of the medicine may be followed by general hypersensitivity reactions including:

fever,
urticaria,
low blood pressure (arterial hypotension),
rapid heartbeat (tachycardia),
contraction of the muscles lining the airways, causing breathing difficulties (bronchospasm),
anaphylactic shock.

Reporting of side effects
If you experience any side effect, including those not listed in
this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Folidar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Folidar contains

The active substance is: calcium folinate pentahydrate. One tablet contains 19.06 mg of calcium folinate pentahydrate (equivalent to 15 mg of folinic acid).
The other components are: magnesium stearate, microcrystalline cellulose, maize starch, dibasic calcium phosphate.

Description of the appearance of Folidar and contents of the pack
Carton box with lithographed packaging containing 1 blister of 30 tablets of 15 mg
Marketing Authorization Holder
ITALFARMACO S.p.A. - V.le F. Testi, 330 - Milan
Manufacturer
Officina Farmaceutica Italfarmaco S.p.A. - V.le F. Testi, 330 - Milan