Calcium folinate Sandoz

Package leaflet: Information for the patient

Calcium Folinate Sandoz 15 mg tablets

Generic medicine
Please read all of this leaflet carefully before you start 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, because it may be harmful.
• If any of the side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Calcium Folinate Sandoz is and what it is used for
2. What you need to know before taking Calcium Folinate Sandoz
3. How to take Calcium Folinate Sandoz
4. Possible side effects
5. How to store Calcium Folinate Sandoz
6. Contents of the pack and other information

1. What Calcio Folinato Sandoz is and what it is used for

Calcio Folinato Sandoz contains the active substance calcium folinate, which belongs to a group of medicines called "rescue agents for cytotoxic therapy".
Calcio Folinato Sandoz is used:

• in cases of overdose of certain substances that antagonize folic acid, and to reduce the harmful effects of certain antitumour medicines (aminopterins and methotrexate).
• to treat certain types of anaemia caused by low levels of folic acid.

2. What you should know before taking Calcio Folinato Sandoz

Do not take Calcio Folinato Sandoz

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from certain types of anaemia (a condition in which red blood cell levels are low), such as pernicious anaemia or other forms of megaloblastic anaemia due to vitamin B12 deficiency, unless taken concomitantly with vitamin B12. Calcio Folinato Sandoz must not be used for these types of anaemia because it may cause an apparent improvement in the disease, masking the progression of damage to the central nervous system.

Warnings and precautions
Talk to your doctor or pharmacist before taking Calcio Folinato Sandoz.
Use this medicine in combination with methotrexate (an anticancer medicine) only under the direct supervision of a physician experienced in the use of drugs for cancer treatment.
Talk to your doctor before taking Calcio Folinato Sandoz if you think any of the following conditions apply to you:

• you are undergoing cancer treatment with one of the following medicines: hydroxyurea, cytarabine, mercaptopurine, thioguanine. These medicines may cause the formation in the blood of red blood cells larger than normal (a condition known as "macrocytosis"). This condition must not be treated with Calcio Folinato Sandoz;
• you have epilepsy and are being treated with one of the following medicines: phenobarbital, phenytoin, primidone, succinimides. Combination with Calcio Folinato Sandoz may increase the frequency of epileptic seizures. Your doctor will monitor you frequently and may adjust the dosage of your antiepileptic medicine during and after discontinuation of Calcio Folinato Sandoz (see section "Other medicines and Calcio Folinato Sandoz");
• you are being treated for cancer with one of the medicines belonging to the class called fluoropyrimidines, especially if the cancer has spread to the central nervous system. Treatment with Calcio Folinato Sandoz together with these medicines may, although rarely, cause seizures and syncope (see section "Other medicines and Calcio Folinato Sandoz");
• you have been treated with excessive doses of anticancer medicines that interfere with the detoxifying action of folic acid. Calcio Folinato Sandoz must be administered within 1 hour after the anticancer medicine, as after 4 hours this medicine becomes ineffective.
• If you suffer from pernicious anaemia or other megaloblastic anaemias due to vitamin B12 deficiency, your doctor will prescribe Calcio Folinato Sandoz only in combination with vitamin B12.

Laboratory tests
If your condition requires treatment with Calcio Folinato Sandoz in combination with methotrexate, your doctor may consider it necessary to perform frequent blood and urine tests.

Other medicines and Calcio Folinato Sandoz
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

Calcio Folinato Sandoz may reduce the effectiveness of the following medicines:

• medicines such as methotrexate, co-trimoxazole, and pyrimethamine. Calcium folinate, the active ingredient in Calcio Folinato Sandoz, may reduce the effectiveness of these medicines, even neutralizing them completely (see section "If you take more Calcio Folinato Sandoz than you should");
• medicines used to treat epilepsy such as phenobarbital, primidone, phenytoin, succinimides. Calcium folinate may reduce the effectiveness of these medicines, resulting in an increased frequency of epileptic seizures.

Calcio Folinato Sandoz may increase certain adverse effects caused by treatment with the following medicines:

• medicines belonging to a class called fluoropyrimidines (see section "Warnings and precautions").

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
This medicine may be used during pregnancy. Your doctor will advise you on the most appropriate dose for you and your condition.

Breastfeeding
Calcium folinate passes into breast milk. Since its effect on the infant is unknown, consult your doctor before taking this medicine if you are breastfeeding.

Driving and using machines
It is not known whether Calcio Folinato Sandoz affects the ability to drive or use machinery. If in doubt, consult your doctor.

This medicine contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Calcio Folinato Sandoz

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
To reduce harmful effects after certain anti-cancer treatments:
Take the medicine within 6–24 hours after methotrexate infusion. Your doctor will determine the most
appropriate dosage for you.
In case of accidental overdose of methotrexate, the medicine should be taken within the first hour, in doses
equal to or higher than those of methotrexate, since administration at later times is less effective.
For the treatment of anaemia due to low folic acid levels:
Take one tablet daily (15 mg) for 10–15 days.
If you take more Calcio Folinato Sandoz than you should
If you accidentally ingest or take an excessive dose of Calcio Folinato Sandoz, inform your doctor immediately
or go to the nearest hospital.
Excessive doses of calcium folinate may reduce the effectiveness of certain anticancer medicines, even
neutralizing them completely (see section “Other medicines and Calcio Folinato Sandoz”).
If you forget to take Calcio Folinato Sandoz
Do not take a double dose to make up for the forgotten tablet.
If you have any questions 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 gets them.
Contact your doctor immediately if you experience any of the following side effects because they may be
serious, and your doctor may decide to stop treatment with Calcio Folinato Sandoz:

• Severe skin allergic reactions with rashes, redness, peeling and/or blistering (e.g. Stevens-Johnson Syndrome, toxic epidermal necrolysis). These reactions may sometimes be fatal;
• severe allergic reaction (anaphylactic shock); you may experience sudden itching (urticaria), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing and breathing), and you may feel like fainting. This is a serious side effect and urgent medical treatment may be required (very rare side effect: may affect up to 1 in 10,000 people).

The following side effects may also occur:
Very rare (may affect up to 1 in 10,000 people):

• allergic reaction, urticaria

Rare (may affect up to 1 in 1,000 people):

• increased frequency of epileptic seizures in patients with epilepsy;
• convulsions;
• depression;
• agitation;
• gastrointestinal disturbances;
• difficulty sleeping (insomnia);
• sudden and transient loss of consciousness (syncope).

Not known (frequency cannot be estimated from the available data):

• fever;
• inflammation of the lip skin, manifesting as cracks, swelling and small ulcers starting from the corners or edges and spreading to the lips (cheilitis);
• low blood pressure (arterial hypotension);
• rapid heartbeat (tachycardia).

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

5. How to store Calcio Folinato Sandoz

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

6. Package contents and other information

What Calcio Folinato Sandoz contains

• The active substance is: calcium folinate pentahydrate. One tablet contains 19.1 mg of calcium folinate pentahydrate (equivalent to 15 mg of folinic acid).
• The other components are:
• magnesium stearate
• lactose monohydrate
• maize starch

Description of the appearance of Calcio Folinato Sandoz and package contents
Calcio Folinato Sandoz tablets are packaged in blisters, with a pack size of 10 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz S.p.A.
Largo U. Boccioni, 1
21040 Origgio (VA) - Italy
Manufacturer
ABC Farmaceutici S.p.A.
Via Cantone Moretti, 29
Località San Bernardo
10090 Ivrea (TO) - Italy