CALCIO 15 mg Tabletka
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Jak stosować KALKIO FOLINATO SANDOTS
Treść ulotki
Calcio Folinato Sandoz 15 mg tablets
Generic medicine
Read 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 pass it on to others, even if their symptoms are the same as yours, as it could 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 Calcio Folinato Sandoz is and what it is used for
- 2. What you need to know before you take Calcio Folinato Sandoz
- 3. How to take Calcio Folinato Sandoz
- 4. Possible side effects
- 5. How to store Calcio Folinato Sandoz
- 6. Contents of the pack and other information
1. What is Calcio Folinato Sandoz and what is it used for
Calcio Folinato Sandoz contains the active ingredient calcium folinate, which belongs to a group of medicines
called “detoxifying substances for cytostatic treatments”.
Calcio Folinato Sandoz is used:
- in case of excessive doses of substances that counteract folic acid and to reduce the harmful effects of some anti-cancer medicines (aminopterine and methotrexate).
- to treat some types of anemia due to low levels of folic acid.
2. What you need to know before taking Calcio Folinato Sandoz
Do not take Calcio Folinato Sandoz
- if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).
- if you suffer from certain forms of anemia (a condition in which the levels of red blood cells are low) such as pernicious anemia or other forms of megaloblastic anemias due to vitamin B12 deficiency, unless in association with the intake of the same vitamin B12. Calcio Folinato Sandoz should not be used for this type of anemia because it can cause an apparent improvement of the disease, hiding 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 association with methotrexate (an anti-cancer medicine) only under the direct
supervision of a doctor experienced in the use of drugs for the treatment of tumors.
Talk to your doctor beforetaking Calcio Folinato Sandoz if you think that any of the following conditions apply to you:
- you are undergoing treatment for a tumor with one of the following medicines: hydroxycarbamide,
cytarabine, mercaptopurine, thioguanine. These medicines can cause the formation of
red blood cells with a diameter larger than normal in the blood (a condition known as “macrocytosis”). This
condition should not be treated with Calcio Folinato Sandoz;
- you suffer from epilepsy and are taking one of the following medicines: phenobarbital, phenytoin, primidone, succinimide. The association with Calcio Folinato Sandoz may cause an increase in the frequency of epileptic seizures. Your doctor may subject you to frequent checks and may modify the dosage of the medicine against epilepsy during and after discontinuation of Calcio Folinato Sandoz (see section Other medicines and Calcio Folinato Sandoz);
- you are being treated for a tumor with one of the medicines that belong to the category called fluoropyrimidines, especially if the tumor has spread to the central nervous system. Treatment with Calcio Folinato Sandoz together with these medicines can cause, although rarely, convulsions and syncope (see section Other medicines and Calcio Folinato Sandoz);
- you have been treated with excessive doses of anti-cancer medicines that prevent the detoxifying action of folic acid. Calcio Folinato Sandoz must be used within 1 hour of the administration of the anti-cancer drugs, because after a period of 4 hours this medicine is ineffective
- If you suffer from pernicious anemia or other megaloblastic anemias when Vitamin B12 is deficient, your doctor will prescribe Calcio Folinato Sandoz only in association with Vitamin B12. Laboratory testsIf your condition requires treatment with Calcio Folinato Sandoz in association with methotrexate, your doctor may deem it necessary to subject you to frequent blood and urine tests. Other medicines and Calcio Folinato SandozTell your doctor if you are taking, have recently taken or might take any other medicine.
Calcio Folinato Sandoz may reduce the effectiveness of the following medicines:
- medicines such as methotrexate, cotrimoxazole and pyrimethamine. Calcium folinate, the active ingredient of Calcio Folinato Sandoz, may reduce the effectiveness of these medicines up to neutralizing them completely (see section “If you take more Calcio Folinato Sandoz than you should”);
- medicines for the treatment of epilepsy such as phenobarbital, primidone, phenytoin, succinimide. Calcium folinate may decrease the effectiveness of these medicines, resulting in an increased frequency of epileptic seizures.
Calcio Folinato Sandoz may increase some undesirable effects caused by the treatment of the following medicines:
- medicines belonging to a category called fluoropyrimidines (see section “Warnings and precautions”).
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The medicine can 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. Because its effect on the baby is unknown, ask your
doctor before taking this medicine if you are breastfeeding with breast milk.
Driving and using machines
It is not known whether Calcio Folinato Sandoz alters the ability to drive vehicles or use machines. If you have doubts, consult
your doctor.
This medicine contains lactose.
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this
medicine.
3. How to take Calcio Folinato Sandoz
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
To reduce the harmful effects after certain cancer treatments:
Take the medicine within 6-24 hours after the methotrexate infusion. The doctor will determine the most
suitable dosage for you.
In the case of accidental intake of excessive doses of methotrexate, the medicine must be taken within
the first hour in equal or higher doses than those of methotrexate because its administration at
later times is less effective
For the treatment of anemia due to low folic acid levels
Take one tablet a day (15 mg) for 10-15 days.
If you take more Calcio Folinato Sandoz than you should
In case of accidental ingestion/intake of an excessive dose of Calcio Folinato Sandoz, immediately inform
your doctor or go to the nearest hospital.
Excessive doses of calcium folinate may reduce the effectiveness of some anticancer drugs up to
completely neutralizing them (see the paragraph “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 missed tablet.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediatelyif you experience the following side effects as they may be seriousand 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 can sometimes be fatal;
- severe allergic reaction (anaphylactic shock); it is possible to experience sudden itching (urticaria), swelling of the hands, feet, ankles, face, lips, mouth or throat (which can cause difficulty swallowing and breathing), and you may feel like you are going to faint. This is a serious side effect and urgent medical attention may be needed (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 seizures in patients with epilepsy;
- convulsions;
- depression;
- agitation;
- gastrointestinal disorders;
- difficulty sleeping (insomnia);
- sudden and transient loss of consciousness (syncope).
Not known (frequency cannot be estimated based on available data):
- fever;
- inflammation of the skin of the lips that manifests with cracks, swelling and small ulcerations starting from the corners or edge and extending onto the lips (cheilitis).
- low blood pressure (hypotension),
- fast heartbeat (tachycardia),
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system 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 does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the pack 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 Calcio Folinato Sandoz contains
- The active ingredient is: calcium folinate pentahydrate. One tablet contains 19.1 mg of calcium folinate pentahydrate (equivalent to 15 mg of folinic acid).
- The other ingredients are:
- magnesium stearate
- lactose monohydrate
- corn starch
Description of the appearance of Calcio Folinato Sandoz and contents of the pack
Calcio Folinato Sandoz tablets are packaged in blisters, in packs 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
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- Kraj rejestracji
- Postać farmaceutycznaTablet, 15 MG
- Kod ATCV03AF03
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki KALKIO FOLINATO SANDOTSPostać farmaceutyczna: Hard capsule, 15 MGSubstancja czynna: calcium folinateProducent: LANOVA FARMACEUTICI S.R.L.Wymaga receptyPostać farmaceutyczna: Tablet, 15 MGSubstancja czynna: calcium folinateProducent: SUBSTIPHARMWymaga receptyPostać farmaceutyczna: Tablet, 15 MGSubstancja czynna: calcium folinateProducent: FAR.G.IM. S.R.L.Wymaga recepty
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KALKIO FOLINATO SANDOTS wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w KALKIO FOLINATO SANDOTS jest calcium folinate. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
KALKIO FOLINATO SANDOTS jest produkowany przez SANDOZ S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie KALKIO FOLINATO SANDOTS jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić KALKIO FOLINATO SANDOTS w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (calcium folinate) to m.in. KALKIFOLIN, KITOFOLIN, SANIFOLIN. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
