CITOFOLIN 15 мг Таблетка
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Инструкция по применению KITOFOLIN
Содержание инструкции
CITOFOLIN 15 mg tablets
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 or pharmacist.
- 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 or pharmacist. See section 4.
Contents of this leaflet
- 1. What CITOFOLIN is and what it is used for
- 2. What you need to know before you take CITOFOLIN
- 3. How to take CITOFOLIN
- 4. Possible side effects
- 5. How to store CITOFOLIN
- 6. Contents of the pack and other information
1. What CITOFOLIN is and what it is used for
CITOFOLIN contains the active ingredient calcium folinate.
The general therapeutic indication of CITOFOLIN is the treatment of folate deficiency states.
CITOFOLIN is therefore indicated in all anemic conditions due to folate deficiency due to increased
demand, reduced utilization and/or insufficient dietary intake of folates.
In addition, calcium folinate is useful as an antidote to treat excessive doses of folic acid antagonists and to counteract the undesirable effects induced by antitumor drugs such as
aminopterin or methotrexate.
2. What you need to know before taking CITOFOLIN
Do not take CITOFOLIN
- if you are allergic to calcium folinate or to any of the other ingredients of this medicine (listed in section 6).
- If you suffer from a type of anemia characterized by vitamin B12 deficiency. CITOFOLIN should not be used for this type of anemia because it can 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 CITOFOLIN if you think that any of the following
conditions apply to you:
- you are undergoing treatment for cancer 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
CITOFOLIN;
- you suffer from epilepsy and are taking one of the following medicines: phenobarbital, phenytoin, primidone, succinimide. The association with CITOFOLIN can cause an increase in the frequency of epileptic seizures. Your doctor will subject you to frequent checks and may modify the dosage of the anti-epilepsy medicine during and after discontinuation of CITOFOLIN (see section Other medicines and CITOFOLIN);
- you are being treated for cancer with one of the medicines that belong to the fluoropyrimidine category, especially if the cancer has spread to the central nervous system. Treatment with CITOFOLIN together with these medicines can cause, although rarely, convulsions and syncope (see section Other medicines and CITOFOLIN);
- you have been treated with excessive doses of anticancer medicines that prevent the detoxifying action of folic acid. CITOFOLIN must be used within 1 hour of the administration of the anticancer drugs, because after a period of 4 hours this medicine is ineffective.
CITOFOLIN should not be administered for the treatment of pernicious anemia or other
megaloblastic anemias due to vitamin B12 deficiency unless in association with it; otherwise
remission of hematological signs may occur, while neurological manifestations
remain progressive. Therapy should therefore be conducted under hematological control.
The administration of CITOFOLIN must be carried out with caution in order to avoid the
risk of allergic reactions and undesirable effects.
Other medicines and CITOFOLIN
Tell your doctor if you are taking, have recently taken or might take any other
medicines. CITOFOLIN can reduce the effectiveness of the following medicines:
- medicines such as methotrexate, cotrimoxazole and pyrimethamine. Calcium folinate, the active ingredient of CITOFOLIN, can reduce the effectiveness of these medicines up to completely neutralizing them;
- medicines for the treatment of epilepsy such as phenobarbital, primidone, phenytoin, succinimide. Calcium folinate can decrease the effectiveness of these medicines, resulting in an increased frequency of epileptic seizures.
- CITOFOLIN can increase some undesirable effects caused by the treatment of medicines belonging to the fluoropyrimidine category (see section Warnings and precautions).
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor for advice before taking this medicine.
Driving and operating machinery
It is not known whether CITOFOLIN alters the ability to drive or operate machinery. If you have doubts
consult your doctor.
CITOFOLIN 15 mg tablets contains lactose.
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.
3. How to take CITOFOLIN
Use in the therapy of folate deficiency anemias: the recommended dose of CITOFOLIN for
oral administration may be indicated in one tablet (equivalent to 15 mg of folinic acid) per day or on
alternate days as prescribed by a doctor. The dosages to be used will be defined by the doctor based on
the hematological picture. Treatment with CITOFOLIN should be prolonged until complete
remission of the clinical signs of folate deficiency and normalization of the hematological picture.
Use of calcium folinate in the context of particular antineoplastic chemotherapy protocols with
high doses of methotrexate: based on the most recent findings, to improve the therapeutic index
of methotrexateat high doses, calcium folinate is used in a sequential treatment as
an antidote (calcium folinate "rescue"). In this way, it has been possible to record better control of the
tumor pathology, without significant increases in toxicity.
The therapeutic protocol provides for the use of calcium folinate:
- parenterally, in the first phase corresponding to competitive antidotism.
- orally, in the second phase in which the biochemical-metabolic component comes into play predominantly.
Currently, however, dosage schemes are not precisely defined. Since
calcium folinate is an antagonist of methotrexate, their concomitant administration can only
be carried out when, in individual cases, a specific
therapeutic protocol has been defined.
Antidote in case of methotrexate overdose: calcium folinate, a specific antidote for
methotrexate, allows neutralizing the toxic effects exerted by the antimetabolite methotrexate
on the hematopoietic system and on the mucous membranes of the digestive tract. In its role as an antidote, calcium
folinate is used at different dosages depending on the effect to be achieved.
In cases of accidental overdose, to obtain a competitive effect, calcium
folinate is recommended for intravenous infusion (up to 100 mg within the first 12 hours); to obtain a
biochemical-metabolic effect, calcium folinate is recommended intramuscularly or intravenously or orally (15 mg every 6 hours for 4 doses).
In cases of adverse effects from conventional doses of methotrexate, calcium folinate is recommended
intramuscularly or intravenously or orally (15 mg every 6 hours for 4 doses).
In cases of accidental administration, calcium folinate should be taken at doses equal to or
greater than those of methotrexatewithin the first hour, as administration at later times is less effective.
The administration of calcium folinate must be carried out with caution in order to avoid the
risk of allergic reactions and side effects.
If you take more CITOFOLIN than you should
If you take more CITOFOLIN than recommended, contact your doctor immediately.
No toxic effects from overdose have been reported so far for CITOFOLIN even for doses much
higher than the therapeutic ones.
However, excessive amounts of calcium folinate may cancel out the chemotherapeutic effects of
folic acid antagonists.
4. Possible side effects
Contact your doctor immediately if you experience the following side effects because they may
be serious and your doctor may decide to stop treatment with CITOFOLIN:
- Stevens-Johnson syndrome, a serious acute hypersensitivity reaction of the skin and mucous membranes in various areas of the body, with the formation of areas of necrosis and peeling. This reaction can sometimes be fatal;
- Toxic Epidermal Necrolysis, a serious acute hypersensitivity reaction, with almost total necrosis of the skin and mucous membranes. This reaction can be fatal;
- Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Uncommon (affects up to 1 in 100 people):
- fever
Rare (affects up to 1 in 1000 people):
- increased frequency of seizures in patients with epilepsy (convulsions)
- sudden and transient loss of consciousness (syncope)
- depression
- agitation
- gastrointestinal disorders
- difficulty sleeping (insomnia)
Very rare (affects up to 1 in 10,000 people):
- Serious allergic reactions (anaphylactoid/anaphylactic reactions, including shock) that can manifest with a skin rash and sudden itching (urticaria), swelling of the hands, feet, ankles, face, lips, mouth or throat (which can cause difficulty swallowing or breathing), and a feeling of fainting. This is a serious side effect that requires urgent medical attention.
Side effects with unknown frequency(frequency cannot be estimated on the basis of the
available data):
- inflammation of the skin of the lips manifested by cracks, swelling and small ulcers starting from the corners or edge and extending onto the lips (cheilitis);
- kidney problems caused by calcium-ceftriaxone deposits. Pain may occur when urinating, or the amount of urine produced may decrease.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store CITOFOLIN
Keep this medicine out of sight and reach of children.
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. This date applies to the product in
intact packaging, correctly stored.
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 CITOFOLIN contains
- The active ingredient is calcium folinate. The tablets contain 16.2 mg of anhydrous calcium folinate (equivalent to 15 mg of folinic acid).
- The other ingredients are: lactose monohydrate, talc, magnesium stearate, microcrystalline cellulose.
Description of the appearance of CITOFOLIN and contents of the pack
Box containing a PVC/PP/Al blister with 10 tablets of 15 mg
Marketing Authorisation Holder
SUBSTIPHARM 24 rue Erlanger, 75016 Paris - France
Distributor for sale
SUBSTIPHARM S.r.l. Via Felice Casati, 20 – 20124 Milano
Manufacturers
Patheon Italia S.p.A. - 20900 Monza
Alternatively
Doppel Farmaceutici S.r.l.
Via Volturno, 48
Quinto De’ Stampi 20089 Rozzano (MI)
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- Страна регистрации
- Форма выпускаTablet, 15 MG
- Код АТХV03AF03
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги KITOFOLINФорма выпуска: Hard capsule, 15 MGДействующее вещество: Кальция фолинатПроизводитель: LANOVA FARMACEUTICI S.R.L.Отпускается по рецептуФорма выпуска: Tablet, 15 MGДействующее вещество: Кальция фолинатПроизводитель: SANDOZ S.P.A.Отпускается по рецептуФорма выпуска: Tablet, 15 MGДействующее вещество: Кальция фолинатПроизводитель: FAR.G.IM. S.R.L.Отпускается по рецепту
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Действующее вещество KITOFOLIN — Кальция фолинат. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
KITOFOLIN производится компанией SUBSTIPHARM. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения KITOFOLIN с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
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Другие лекарства с тем же действующим веществом (Кальция фолинат) включают KALKIFOLIN, KALKIO FOLINATO SANDOTS, SANIFOLIN. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
