DECONTRIL 4 mg /2 Ml Инъекционный Раствор
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Инструкция по применению DEKONTRIL
Содержание инструкции
DECONTRIL 4 mg/2 ml injectable solution for intramuscular use
tiocolchicoside
equivalent medicine
Read this leaflet carefully before using 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What DECONTRIL is and what it is used for
- 2. What you need to know before you take DECONTRIL
- 3. How to take DECONTRIL
- 4. Possible side effects
- 5. How to store DECONTRIL
- 6. Contents of the pack and other information
1. What is DECONTRIL and what is it used for
DECONTRIL contains the active ingredient tiocolchicoside and belongs to the group of muscle relaxants (muscle
relaxant) with central action.
DECONTRIL is used for the adjuvant treatment of painful muscle contractures in
acute conditions related to the spine in adults and adolescents over 16 years of age.
2. What you need to know before you use DECONTRIL
Do not use DECONTRIL
- if you are allergic to tiocolchicoside or to any of the other ingredients of this medicine (listed in section 6)
- if you are pregnant, suspect you may be pregnant, or might become pregnant (see “Pregnancy, breastfeeding and fertility”)
- if you are breastfeeding (see “Pregnancy, breastfeeding and fertility”)
- if you are a woman of childbearing potential who is not using effective contraception (during treatment and for one month after stopping treatment)
- if you are a man who is not using effective contraception (during treatment and for three months after stopping treatment)
- if you are in a condition characterized by loss of control and movement of the muscles (flaccid paralysis)
- if you suffer from muscle weakness (muscle hypotonia)
- if the patient is a child or adolescent under 16 years of age.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using DECONTRIL.
Strictly follow the doses and duration of treatment as reported in section 3. Do not use this
medicine at higher doses. Do not use this medicine for more than 5 days.
This is because one of the substances that forms in the body when you take tiocolchicoside could cause
damage to some cells (abnormal number of chromosomes). This has been demonstrated in animal studies and in laboratory
studies. In humans, this type of cell damage is a possible risk factor for
cancer, for spontaneous abortion, could damage the fetus and alter male fertility. Talk to your
doctor if you have further questions.
The doctor will inform you about the potential risk to a possible pregnancy and about the effective contraceptive
measures to follow (see “Do not use DECONTRIL” and “Pregnancy, breastfeeding and fertility”).
Stop taking DECONTRIL and consult your doctor immediately if, during treatment,
you experience any of these symptoms that may indicate liver damage: loss of appetite, nausea,
vomiting, abdominal pain, fatigue, dark urine, jaundice, itching.
If you experience diarrhea during treatment with DECONTRIL, consult your doctor, who will determine whether to reduce
the dose.
After intramuscular administration, you may experience episodes of malaise, sometimes associated or not
with hypotension and/or loss of consciousness, therefore the doctor must monitor you after the injection.
Use this medicine with caution and inform your doctor if you suffer from epileptic seizures or if you are at risk of
convulsions, as DECONTRIL may worsen these conditions.
Children and adolescents
Do not administer this medicine to children and adolescents under 16 years of age due to safety concerns.
Other medicines and DECONTRIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
No interactions are known when this medicine is combined with other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be 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.
Do not use this medicine if:
- you are pregnant, suspect you may be pregnant, or might become pregnant (see “Do not use DECONTRIL”);
- you are breastfeeding as the medicine passes into breast milk (see “Do not use DECONTRIL”).
- you are a woman of childbearing potential who is not using effective contraception or a man who is not using effective contraceptive measures (see “Do not use DECONTRIL”). This medicine can cause harm to the fetus.
Contraception in women and men
Women who are able to become pregnant must use effective contraception
during the intake of DECONTRIL and for 1 month after the end of treatment. DECONTRIL and its
metabolites can cause harm to unborn children if used by pregnant women. If you are pregnant
or become pregnant during treatment with DECONTRIL, ask your doctor for advice immediately.
Men must use effective contraceptive measures and be advised not to father a child during
treatment with DECONTRIL and for 3 months after stopping treatment (see “Do not use
DECONTRIL”).
Fertility
This medicine may cause problems with male fertility due to potential damage to sperm cells
(abnormal number of chromosomes). This is based on laboratory studies (see section 2
“Warnings and precautions”). Talk to your doctor if you have further questions.
Driving and using machines
This medicine can cause drowsiness. Therefore, avoid driving vehicles or using
machinery while taking this medicine.
DECONTRIL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.
3. How to use DECONTRIL
Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
This medicine must be administered via an injection into a muscle (intramuscular use).
The recommended and maximum dose is 4 mg (one vial) every 12 hours (i.e. 8 mg per day).
This medicine should not be used for more than 5 consecutive days (see section 2
“Warnings and precautions”).
Do not exceed the recommended doses and the duration of treatment.
Use in children and adolescents
Do not administer this medicine to children and adolescents under 16 years of age due to
safety concerns.
If you use more DECONTRIL than you should
If you are accidentally administered more DECONTRIL than you should, contact your doctor, your
pharmacist or your nurse.
If you forget to use DECONTRIL
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, contact your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Common(may affect up to 1 in 10 people)
- drowsiness;
- diarrhea, stomach pain (gastralgia).
Uncommon(may affect up to 1 in 100 people)
- itching;
- nausea, vomiting;
- allergic skin reactions.
Rare(may affect up to 1 in 1,000 people)
- skin irritation (urticaria);
- temporary loss of sensory and intellectual abilities (transient clouding of consciousness), agitation;
- pain and burning in the throat, chest and stomach (pyrosis).
Very rare(may affect up to 1 in 10,000 people)
- low blood pressure (hypotension).
Frequency not known(the frequency cannot be estimated from the available data)
- feeling unwell, sometimes associated or not with hypotension and/or loss of consciousness within minutes of administration;
- convulsions (see section 2 “Warnings and precautions”);
- liver inflammation (hepatitis) (see section 2 “Warnings and precautions”);
- swelling of the limbs, face, lips, throat and/or tongue (angioedema), severe allergic reactions (anaphylactic shock).
- reactions at the injection site, including pain at the injection site, redness, swelling, hard lump, sores and bruising. This can contribute to darkening and death of the skin and underlying tissues surrounding the injection site, which heal with scarring, also known as Nicolau syndrome.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store DECONTRIL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the product in intact packaging, correctly stored.
This medicine does not require any particular storage conditions.
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 DECONTRIL contains
- The active ingredient is ticolchicoside. Each vial contains 4 mg of ticolchicoside.
- The other ingredients are: sodium chloride; water for injections.
Description of the appearance of DECONTRIL and contents of the pack
Injectable solution for intramuscular use.
Pack of 6 vials for a dose of 4 mg/2 ml.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
S.F. Group S.r.l., Via Tiburtina 1143, 00156, - Roma –Italy
Manufacturer
ESSETI FARMACEUTICI SRL, Via Campobello, 15 - 00040 Pomezia - Roma
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- Страна регистрации
- Форма выпускаInjectable solution, 4 MG/2 ML
- Код АТХM03BX05
- 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 DEKONTRILФорма выпуска: Injectable solution, 4 MGДействующее вещество: ТиоколхикозидПроизводитель: SPA SOCIETA' PRODOTTI ANTIBIOTICI S.P.A.Отпускается по рецептуФорма выпуска: Injectable solution, 4 MG/2 MLДействующее вещество: ТиоколхикозидПроизводитель: DOMPE' FARMACEUTICI S.P.A.Отпускается по рецептуФорма выпуска: Injectable solution, 2 MG/MLДействующее вещество: ТиоколхикозидПроизводитель: EPIFARMA S.R.LОтпускается по рецепту
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Аналог DEKONTRIL в Испания
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Часто задаваемые вопросы
DEKONTRIL требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество DEKONTRIL — Тиоколхикозид. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
DEKONTRIL производится компанией S.F. GROUP S.R.L.. 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 DEKONTRIL с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить DEKONTRIL в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Тиоколхикозид) включают MIOREXIL, MIOTENS, MUSKOFLEX. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
