SANIFOLIN 15 мг Таблетки

Содержание инструкции

1. SANIFOLIN powder for injectable solution
   1. What is SANIFOLIN and what is it used for
   2. What you need to know before using SANIFOLIN
   3. How to use SANIFOLIN
   4. Possible side effects
   5. How to store SANIFOLIN
   6. Contents of the pack and other information
2. SANIFOLIN tablets
   1. What is SANIFOLIN and what is it used for
   2. What you need to know before taking SANIFOLIN
   3. How to take SANIFOLIN
   4. Possible side effects
   5. How to store SANIFOLIN
   6. Contents of the pack and other information

SANIFOLIN powder for injectable solution

Calcium folinate

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What SANIFOLIN is and what it is used for
• 2. What you need to know before you use SANIFOLIN
• 3. How to use SANIFOLIN
• 4. Possible side effects
• 5. How to store SANIFOLIN
• 6. Contents of the pack and other information

1. What is SANIFOLIN and what is it used for

SANIFOLIN contains the active ingredient calcium folinate, which is a folic acid supplement, a
vitamin important for the production of DNA, proteins and red blood cells.
This medicine is indicated:

• as an antidote in case of taking high doses of medicines that prevent the absorption of folic acid (folic acid antagonists);
• to reduce the toxic effects of medicines used for the treatment of some diseases of the immune system and tumors, such as aminopterin and methotrexate;
• in the treatment of the reduction of the number of red blood cells in the blood caused by a deficiency of folic acid (folate deficiency anemias) which may be due to an increased demand for this vitamin, reduced utilization or insufficient intake with the diet.

2. What you need to know before using SANIFOLIN

Do not use SANIFOLIN

• if you are allergic to calcium folinate or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from severe blood disorders caused by a vitamin B deficiency (pernicious anemia, megaloblastic anemias) and do not associate vitamin B therapy with SANIFOLIN treatment (See section “Warnings and precautions”). Warnings and precautionsConsult your doctor, pharmacist or nurse before using SANIFOLIN. If you suffer from severe blood disorders caused by vitamin B deficiency (pernicious anemia, megaloblastic anemias), your doctor will prescribe SANIFOLIN only in association with vitamin B. Otherwise, improvements may occur in blood tests, while progressive problems with the nervous system may occur. Therapy should therefore be conducted under blood test control (hematological control) (See section “Do not use SANIFOLIN”). If SANIFOLIN is to be administered to you for the treatment of overdose from medicines that prevent the absorption of folic acid (folic acid antagonists), the medicine should be administered within 1 hour, because after 4 hours it is no longer effective. This medicine will be administered to you with particular caution to avoid allergic reactions or other undesirable effects.

Other medicines and SANIFOLIN
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take
any other medicine.
Use this medicine with caution and inform your doctor if you are undergoing therapy with certain medicines used for the
treatment of tumors such as fluoropyrimidines, methotrexate and other antifolates (See section
“What SANIFOLIN is and what it is used for”).
5-fluorouracil must not be mixed with SANIFOLIN in the same injection or intravenous infusion

SANIFOLIN with food and drink
No interactions with food and drinks are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor, pharmacist or nurse for advice before using this medicine.
SANIFOLIN can improve or normalize megaloblastic anemia in pregnancy due to
increased folate requirements. If you are breastfeeding, this medicine should be
administered to you with great caution.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles and operate machinery.

SANIFOLIN contains para-hydroxybenzoates and sodium
This medicine contains para-hydroxybenzoates, which can cause allergic reactions (including
delayed ones) and, exceptionally, bronchospasm.
SANIFOLIN contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is practically ‘sodium-free’.

3. How to use SANIFOLIN

Use this medicine following exactly the instructions of your doctor, pharmacist or
nurse. If you have any doubts, ask your doctor, pharmacist or nurse.
Method of administration
This medicine will be administered to you via an injection into a vein or muscle (infusion,
intravenous, intramuscular) especially if you are undergoing therapy with medicines for the treatment of tumors
(chemotherapy with folic acid antagonists) and if you experience vomiting.
The powder contained in the vial can be dissolved, respecting the rules of sterility (asepsis), in 5 ml of
water for injectable preparations or in physiological solution if SANIFOLIN is to be
administered via slow infusion. The solution thus obtained can be stored at a
temperature not exceeding 8°C for a maximum duration of 12 hours.

Treatment of overdose of medicines that prevent the absorption of folic acid
In case of overdose of methotrexate (folic acid antagonist), SANIFOLIN neutralizes the
toxic effects of this medicine on the bone marrow (myelosuppression), on the blood (hematopoietic
system) and on the mucous membranes of the stomach and intestines (digestive system).
SANIFOLIN must be administered within 1 hour of taking methotrexate at the same dose
or at doses higher than those of methotrexate, because after 4 hours it is no longer effective. In these cases, the
recommended dose is 100 mg of calcium folinate for intravenous (endovenous) injection within 12 hours or 15 mg
every 6 hours for 4 doses per day, via intramuscular or intravenous (endovenous) injection.

Treatment of bowel cancer, together with other medicines
In the treatment of colorectal cancer, in association with other medicines (fluoropyrimidines), the
dose of calcium folinate will be established by the doctor based on the anticancer therapies. Usually, the
recommended dose is 200 mg/m per day for 5 consecutive days via slow infusion every 4
weeks or 500 mg/m per week for 6 weeks, followed by 2 weeks of interval

Treatment of reduced number of red blood cells in the blood (megaloblastic anemia)
due to a deficiency of folic acid
The recommended dose is 10 mg per day for 10-15 days.
If necessary, the doctor will reduce the dose and continue the treatment until the normalization of
blood test results (hematological picture) and the disappearance of the symptoms of the disease.

If you use more SANIFOLIN than you should
No cases of overdose are known.
In case of accidental ingestion/intake of an excessive dose of SANIFOLIN, immediately warn
your doctor or go to the nearest hospital.

If you forget to use SANIFOLIN
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of the medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With reference to the authorised therapeutic indications, the following side effects have been reported:

• Very rare:may affect up to 1 in 10,000 people
• Severe allergic reactions - may experience a sudden itchy rash (urticaria), swelling of the hands, feet, ankles, lips, mouth or throat (which may cause difficulty swallowing or breathing), and feel like you are about to faint. This is a serious side effect. You may need urgent medical attention.
• Uncommon:may affect up to 1 in 100 people
• Fever.
• Rare:may affect up to 1 in 1,000 people
• An increase in seizures (fits) in patients with epilepsy
• Depression
• Agitation
• Problems with the digestive system
• Difficulty sleeping (insomnia)

If you are taking Calcio Folinato in combination with anti-cancer medicines containing fluoropyrimidines,
you are more likely to experience the following side effects related to these other medicines:

• Very common:may affect more than 1 in 10 people
• Nausea
• Vomiting
• Severe diarrhoea
• Dehydration caused by diarrhoea
• Inflammation of the wall of the intestine and mouth (life-threatening conditions have occurred)
• Decrease in the number of blood cells (including life-threatening conditions)
• Common
• Redness and swelling of the palms of the hands or soles of the feet that may cause the skin to peel (hand-foot syndrome or palmo-plantar erythrodysesthesia)
• Not known:frequency cannot be estimated from available data
• Increase in ammonia levels in the blood

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at 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 SANIFOLIN

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

6. Contents of the pack and other information

What SANIFOLIN contains

• The active ingredient is calcium folinate. Each vial contains 63.51 mg of calcium folinate (equivalent to 50 mg of folic acid, equal to 25 mg of levofolinic acid).
• The other ingredients are: methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium chloride. Description of the appearance of SANIFOLIN and contents of the packVial containing lyophilized powder for injectable solution. Marketing Authorisation HolderFAR.G.IM. S.p.A. - Via Cervignano, 29 - - 95129 Catania - Italy ManufacturersProduction stages: manufacturing, packaging and controls except for pyrogen and biological toxicity control BIOLOGICI ITALIA LABORATOIRES S.r.l. - Via F. Serpero 2 - 20060 Masate (MI) - Italy Production stages: pyrogen and toxicity control EUROFINS BIOLAB S.r.l. - Via Bruno Buozzi 2 - 20090 Vimodrone (MI) - Italy

SANIFOLIN tablets

Calcium folinate

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is SANIFOLIN and what is it used for

SANIFOLIN contains the active ingredient calcium folinate, which is a folic acid supplement, a
vitamin important for the production of DNA, proteins and red blood cells.
This medicine is indicated:

• as an antidote in case of taking high doses of medicines that prevent the absorption of folic acid (folic acid antagonists);
• to reduce the toxic effects of medicines used for the treatment of some diseases of the immune system and tumors, such as aminopterin and methotrexate;
• in the treatment of the reduction of the number of red blood cells in the blood caused by a deficiency of folic acid (folate deficiency anemias) which may be due to an increased demand for this vitamin, reduced utilization or insufficient intake with food.

2. What you need to know before taking SANIFOLIN

Do not take SANIFOLIN

• if you are allergic to calcium folinate or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from severe blood disorders caused by a vitamin B deficiency (pernicious anemia, megaloblastic anemias) and do not associate vitamin B therapy with SANIFOLIN treatment (See section “Warnings and precautions”).

Warnings and precautions
Consult your doctor or pharmacist before taking SANIFOLIN.
If you suffer from severe blood disorders caused by vitamin B deficiency (pernicious anemia,
megaloblastic anemias), your doctor will prescribe SANIFOLIN only in association with vitamin B
Otherwise, improvements may occur in blood tests, while progressive problems may occur
to the nervous system. Therapy should therefore be conducted under control
of blood tests (hematological control) (See section “Do not take SANIFOLIN”).
If you need to take SANIFOLIN for the treatment of overdose from medicines that prevent
folic acid absorption (folic acid antagonists), take the medicine within 1 hour,
because after 4 hours it is no longer effective.
Take this medicine with particular caution to avoid allergic reactions or other adverse
effects.

Other medicines and SANIFOLIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Take this medicine with caution and inform your doctor if you are being treated with some medicines used
for the treatment of tumors such as fluoropyrimidines, methotrexate and other antifolates (See the
section “What SANIFOLIN is and what it is used for”).

SANIFOLIN with food and drink
No interactions with food and drink are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
SANIFOLIN can improve or normalize megaloblastic anemia in pregnancy due to
increased folate requirements.
If you are breastfeeding, take this medicine with great caution.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles and operate machinery.

3. How to take SANIFOLIN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Take the tablet whole, with a glass of water.

Treatment of overdose of medicines that prevent the absorption of folic acid
In case of overdose of methotrexate (folic acid antagonist), SANIFOLIN neutralizes the
toxic effects of this medicine on the bone marrow (myelosuppression), on the blood (hematopoietic
system) and on the mucous membranes of the stomach and intestines (digestive system).
Take SANIFOLIN within 1 hour of taking methotrexate at the same dose or at higher doses than
methotrexate, because after 4 hours it is no longer effective. In these cases, the recommended dose is
15 mg every 6 hours for 4 doses a day.

Treatment of reduced number of red blood cells in the blood (megaloblastic anemia)
due to a deficiency of folic acid
The recommended dose is 1 tablet a day for 10-15 days.
If necessary, the doctor will reduce the dose and will continue the treatment until the normalization of the
results of blood tests (hematological picture) and the disappearance of the symptoms of the disease.

If you take more SANIFOLIN than you should
No cases of overdose are known.
In case of accidental ingestion/taking of an excessive dose of SANIFOLIN, immediately inform
your doctor or go to the nearest hospital.

If you forget to take SANIFOLIN
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Frequency not known(frequency cannot be estimated from available data):

• allergic reactions (allergic sensitization) which manifest with symptoms such as:
• fever;
• skin irritation (urticaria);
• low blood pressure (arterial hypotension);
• increased heart rate (tachycardia);
• breathing problems (bronchospasm);
• severe allergic reaction, potentially fatal (anaphylactic shock).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at 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 SANIFOLIN

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

6. Contents of the pack and other information

What SANIFOLIN contains

• The active ingredient is calcium folinate pentahydrate. Each tablet contains 19.06 mg of calcium folinate pentahydrate (equivalent to 15 mg of folinic acid, equal to 7.5 mg of levofolinic acid).
• The other ingredients are: microcrystalline cellulose, polyvinylpyrrolidone, magnesium stearate.

Description of the appearance of SANIFOLIN and contents of the pack
Pack of 10 tablets.

Marketing Authorisation Holder
FAR.G.IM. S.p.A. – Via Cervignano, 29 - – 95129 Catania – Italy

Manufacturers
RAFARM SA Thesi Pousi-Xatzi Agiou Louka, Paiania Attiki, TK 19002 – Greece

Production stages: all stages
Pb Beltracchini Srl Via S.Erasmo 6 - 20027 Rescaldina (MI)

Secondary packaging