MIOREXIL 4 мг Инъекционный раствор
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Инструкция по применению MIOREXIL
Содержание инструкции
MIOREXIL 4 mg injectable solution for intramuscular use
Tiocolchicoside
Generic 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 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 experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What MIOREXIL is and what it is used for
- 2. What you need to know before you use MIOREXIL
- 3. How to use MIOREXIL
- 4. Possible side effects
- 5. How to store MIOREXIL
- 6. Contents of the pack and other information
1. What is MIOREXIL and what is it used for
This medicine is a muscle relaxant. It is used in adults and adolescents aged 16 years and over as supportive treatment for painful muscle contractures. It must be used for acute conditions related to the spine.
2. What you need to know before you use MIOREXIL
Do not use MIOREXIL if:
- you are allergic to tiocolchicoside or any of the other ingredients of this medicine (listed in section 6);
- you are in a condition characterised by loss of voluntary muscle movement (flaccid paralysis);
- you suffer from muscle weakness (muscle hypotonia);
- you are pregnant, suspect you may be pregnant, or might become pregnant (see “Pregnancy, breastfeeding and fertility”);
- you are breastfeeding (see “Pregnancy, breastfeeding and fertility”);
- you are a woman of childbearing potential who is not using effective contraception (during treatment and for one month after stopping treatment);
- you are a man who is not using effective contraceptive measures (during treatment and for three months after stopping treatment).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using MIOREXIL.
Use this medicine with caution and tell your doctor if you suffer from epilepsy or are at risk of seizures, as MIOREXIL may worsen these conditions.
You must inform your doctor if you experience epileptic seizures.
After administration of MIOREXIL, your doctor will need to monitor you carefully as transient loss of consciousness may occur.
During therapy with this medicine, cases of liver inflammation (cytolytic and cholestatic hepatitis) have been reported; some of these cases have proven fatal (fulminant hepatitis) when the product was administered together with other medicines used to relieve pain (non-steroidal anti-inflammatory drugs NSAIDs, paracetamol). If you observe symptoms that may indicate liver damage during treatment with MIOREXIL (for example, loss of appetite, nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice, itching), you should stop taking MIOREXIL and consult your doctor immediately if any of these symptoms appear.
Strictly adhere to the doses and duration of treatment as reported in section 3. Do not use this medicine at higher doses or for more than 5 days. This is because one of the substances that forms in the body when you take tiocolchicoside at high doses 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 cellular damage is a risk factor for cancer, damages the unborn child, and alters male fertility. Talk to your doctor if you have further questions.
The doctor will inform you about the need for effective contraception and the potential risks in case of pregnancy (see “Do not use Miorexil” and “Pregnancy, breastfeeding and fertility”).
Children and adolescents
Do not administer this medicine to children and adolescents under 16 years of age due to safety concerns.
Other medicines and MIOREXIL
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
No interactions with other medicines are known.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor, pharmacist or nurse for advice before using this medicine.
Do not use this medicine if:
- you are pregnant, suspect you may be pregnant, or might become pregnant (see “Do not use Miorexil”);
- you are breastfeeding, because this medicine passes into breast milk (See “Do not use Miorexil”);
- 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 Miorexil”). 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 Miorexil and for 1 month after the end of treatment.
Miorexil and its metabolites can cause harm to unborn children if used by pregnant women.
If you are pregnant or become pregnant during treatment with Miorexil, ask your doctor for advice immediately.
Men must use effective contraceptive measures and be advised not to father a child during treatment with Miorexil and for 3 months after stopping treatment (see “Do not use Miorexil”).
Driving and using machines
This medicine can cause drowsiness. Therefore, if this happens to you, avoid driving vehicles or using machines.
Important information about certain excipients (sodium)
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is practically ‘sodium-free’.
3. How to use MIOREXIL
Use this medicine following the instructions of your doctor, pharmacist or
nurse exactly. If you have any doubts, ask your doctor, pharmacist or nurse.
Use this medicine, respecting all precautions to maintain sterility.
This medicine must be administered by an injection into a muscle (intramuscular use).
Open the vials along the dotted line and insert the needle of the syringe inside the vial.
Introduce the solution into the syringe and inject into a muscle.
The recommended and maximum dose is4 mg every 12 hours (i.e. 8 mg per day).
The duration of treatment is limited to 5 consecutive days.
Do not exceed the recommended doses and the duration of treatment.
This medicine should not be used for long-term treatment (see section 2 “Warnings and
precautions”).
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 MIOREXIL than you should
If you accidentally use more MIOREXIL than you should, contact your doctor, pharmacist or nurse.
If you forget to use MIOREXIL
Do not use a double dose to make up for a missed dose.
If you have any doubts about using this 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.
The following side effects may occur:
Common(may affect up to 1 in 10 people)
- drowsiness;
- diarrhoea, 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 rash (urticaria);
- agitation, temporary loss of sensory and intellectual abilities (transient clouding of consciousness);
- heartburn (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)
- swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing or swallowing (angioedema), severe allergic reactions, sudden allergic reaction, potentially life-threatening (anaphylactic shock);
- illness associated with or without transient loss of consciousness (vasovagal syncope) following administration, convulsions (See section “Warnings and precautions”);
- liver inflammation (hepatitis, including cytolytic and cholestatic hepatitis) (See section “Warnings and precautions”);
- reactions at the injection site, including pain at the injection site, redness, swelling, hard lump, sores and bruising. This can contribute to the 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 MIOREXIL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after “Expiry”. The
expiry date refers to the last day of that month and the product in intact packaging and
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 that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What MIOREXIL contains
- The active ingredient is ticolchicoside. Each vial contains 4 mg of ticolchicoside.
- The other ingredients are sodium chloride and water for injectable preparations.
Description of the appearance of MIOREXIL and contents of the pack
Pack of 6 vials of 2 ml.
Marketing Authorisation Holder
SPA - Società Prodotti Antibiotici S.p.A. - Via Biella, 8 - 20143 Milan – Italy
Manufacturer
ESSETI Farmaceutici S.r.l. - Via Campobello, 15 - 00071 Pomezia (RM) – Italy.
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- Страна регистрации
- Форма выпускаInjectable solution, 4 MG
- 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 MIOREXILФорма выпуска: Injectable solution, 4 MG/2 MLДействующее вещество: ТиоколхикозидПроизводитель: S.F. GROUP S.R.L.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
Аналоги MIOREXIL в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог MIOREXIL в Польша
Аналог MIOREXIL в Украина
Аналог MIOREXIL в Испания
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Часто задаваемые вопросы
MIOREXIL требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество MIOREXIL — Тиоколхикозид. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
MIOREXIL производится компанией SPA SOCIETA' PRODOTTI ANTIBIOTICI S.P.A.. 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 MIOREXIL 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 MIOREXIL 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 DEKONTRIL, MIOTENS, MUSKOFLEX. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
