MIOTENS 4 mg /2 Ml Injectable Solution
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Інструкція із застосування MIOTENS
Зміст інструкції
Miotens 4 mg/2 ml injectable solution for intramuscular use
tiocolchicoside
Read this leaflet carefully before you 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 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 Miotens is and what it is used for
- 2. What you need to know before you use Miotens
- 3. How to use Miotens
- 4. Possible side effects
- 5. How to store Miotens
- 6. Contents of the pack and other information
1. What is Miotens and what is it used for
Miotens is a centrally acting muscle relaxant (it acts directly on the Central Nervous System – CNS) that contains the active ingredient ticolchicoside.
This medicine is used intramuscularly for the adjuvant treatment of painful muscle contractures in acute spinal diseases, in adults and adolescents starting from 16 years of age.
2. What you need to know before you use Miotens
Do not use Miotens
- if you are allergic to ticolchicoside or to any of the other ingredients of this medicine (listed in section 6);
- if you suffer from flaccid paralysis (progressive paralysis involving the muscles) or muscle hypotonia (reduced muscle tone);
- if you are pregnant, if you suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding (see subsection “Pregnancy, breastfeeding and fertility”);
- if you are a woman of childbearing potential who is not using effective contraceptive methods (during treatment and for one month after stopping treatment);
- if you are a man who is not using effective contraceptive measures (during treatment and for three months after stopping treatment).
Warnings andprecautions
Talk to your doctor or pharmacist before using Miotens.
Before starting treatment with Miotens, your doctor or pharmacist will inform you about the potential risks to a possible pregnancy and the effective contraceptive measures to follow.
Ticolchicoside (the active ingredient of Miotens) can precipitate epileptic seizures in patients with epilepsy or those at risk of convulsions. You must inform your doctor if you experience any of the following symptoms: seizures.
If you experience undesirable effects, consult your doctor, as it is necessary to reduce the dose of the medicine (see Section 4 “Possible side effects”).
Strictly adhere to the doses and duration of treatment reported in section 3 “How to use Miotens”.
Do not use doses higher than those recommended and do not use Miotens for long periods of time.
If you observe symptoms that may indicate liver damage during treatment with Miotens (for example, loss of appetite, nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice, itching), you should stop using Miotens and consult your doctor immediately if any of these symptoms occur.
Special warnings
Preclinical studies have shown that one of the metabolites of ticolchicoside (SL59.0955) induced aneuploidy (alteration of the number of chromosomes in dividing cells) at concentrations close to human exposure observed with doses of 8 mg twice daily orally. Aneuploidy is considered a risk factor for teratogenicity (the ability to cause malformations or abnormal fetal development), embryo/fetal toxicity, spontaneous abortion, alteration of male fertility, and a potential risk factor for cancer. As a precaution, the use of the medicine at doses higher than the recommended dose or long-term use should be avoided (see section 3 “How to use Miotens”).
Children and adolescents
Miotens should not be administered to children and adolescents under 16 years of age due to safety concerns (see “Use in children and adolescents”).
Other medicines and Miotens
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 are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor, pharmacist or nurse for advice before using this medicine.
Pregnancy
Data relating to the use of ticolchicoside in pregnant women are limited. Therefore, the potential risks to the embryo and fetus are unknown. Animal studies have shown teratogenic effects. Miotens is contraindicated during pregnancy (see section 2 “What you need to know before you use Miotens”).
Breastfeeding
The use of ticolchicoside is contraindicated during breastfeeding as it is excreted in breast milk (see section 2 “What you need to know before you use Miotens”).
Fertility
In a fertility study conducted on rats, no alteration of fertility was observed at doses up to 12 mg/kg, i.e. at dose levels that do not induce any clinical effects. Ticolchicoside and its metabolites exert aneugenic activity (which induces aneuploidy, i.e. an alteration in the number of chromosomes, compared to normal) at different concentration levels, which is a risk factor for alteration of human fertility. If you are a woman of childbearing potential who is not using effective contraception or a man who is not using effective contraceptive measures (see section 2 “What you need to know before you use Miotens”).
Contraception in women and men
Women who are able to become pregnant must use an effective contraceptive method during the intake of Miotens and for 1 month after the end of treatment. Miotens and its metabolites can harm unborn children if used by pregnant women. If you are pregnant or become pregnant during treatment with Miotens, ask your doctor for advice immediately.
Men must use effective contraceptive measures and be advised not to father a child during treatment with Miotens and for 3 months after stopping treatment (see section 2 “What you need to know before you use Miotens”).
Driving and using machines
This medicine can cause drowsiness (see Section 4 “Possible side effects”).
Miotens contains 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 Miotens
Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
The recommended doseis 1 vial (4 mg) every 12 hours. The maximum daily dose is 2 vials (8 mg).
The duration of treatment should not exceed 5 consecutive days.
Warning:Do not exceed the recommended doses. Use Miotens only for short periods of treatment (see the
sub-paragraph “Warnings and precautions”).
Method of administration of the injectable solution:
- open the vial along the dotted line;
- introduce the solution from each vial into the syringe and inject the contents intramuscularly.
Use in children and adolescents
Miotens should not be used in children and adolescents under 16 years of age due to
safety concerns (see the sub-paragraph “Children and adolescents”).
If you use more Miotens than you should
No cases of overdose have been reported.
In case of accidental intake of an excessive dose of Miotens, immediately inform your doctor or
go to the nearest hospital.
If you forget to use Miotens
Do not use a double dose to make up for a missed dose.
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.
The following side effects, with frequency not known (cannot be estimated from the available data),
are important and require immediate medical attention if they occur. Stop treatment
with this medicine and seek immediate medical adviceif you experience the following symptoms:
- difficulty breathing or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema);
- severe allergic reactions. Skin irritation, difficulty breathing, nausea, vomiting or diarrhoea, dizziness or loss of consciousness: these can be symptoms of a severe allergic reaction (anaphylactic shock);
Common(may affect up to 1 in 10 people)
- Drowsiness;
- diarrhoea;
- gastralgia (stomach pain).
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)
- agitation;
- transient confusion (temporary loss of sensory and intellectual abilities);
- urticaria (skin allergic reaction characterized by raised patches and itching);
- pyrosis (burning sensation in the stomach).
Very rare(may affect up to 1 in 10,000 people)
- hypotension (low blood pressure);
Frequency not known(the frequency cannot be estimated from the available data)
- swelling of the limbs, face, lips, throat and/or tongue (angioedema), severe allergic reactions (anaphylactic shock);
- discomfort associated or not with vasovagal syncope (fainting) within minutes of intramuscular administration, convulsions (see section 2);
- liver inflammation (hepatitis) (see section 2);
- reactions at the injection site, including pain, redness, swelling, itching, spots. These reactions may worsen with blackening and death of the skin and underlying tissues surrounding the injection site, which then heal with scarring, this condition is also known as Nicolau syndrome.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 Miotens
This medicine does not require any particular storage conditions.
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. The expiry date indicated refers 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 that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Miotens contains
- The active ingredient is ticolchicoside. Each 2 ml vial contains 4 mg of ticolchicoside.
- The other ingredients are: sodium chloride, monobasic sodium phosphate monohydrate, disodium phosphate dodecahydrate, water for injections.
Description of the appearance of Miotens and contents of the pack
Miotens is presented as an injectable solution for intramuscular use.
The pack contains 6 glass vials of 2 ml.
Marketing Authorisation Holder
Dompé farmaceutici S.p.A. - Via San Martino 12 - 20122 Milan
Manufacturers
Abiogen Pharma S.p.A. – via Meucci 36 – 56014 Ospedaletto (PI)
Alfasigma S.p.A. – Via Enrico Fermi, 1 - Alanno (PE)
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- Країна реєстрації
- Лікарська формаInjectable solution, 4 MG/2 ML
- Код АТХM03BX05
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до MIOTENSЛікарська форма: Injectable solution, 4 MG/2 MLДіюча речовина: ТиоколхикозидВиробник: S.F. GROUP S.R.L.Потрібен рецептЛікарська форма: Injectable solution, 4 MGДіюча речовина: ТиоколхикозидВиробник: SPA SOCIETA' PRODOTTI ANTIBIOTICI S.P.A.Потрібен рецептЛікарська форма: Injectable solution, 2 MG/MLДіюча речовина: ТиоколхикозидВиробник: EPIFARMA S.R.LПотрібен рецепт
Аналоги MIOTENS в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог MIOTENS у Польща
Аналог MIOTENS у Україна
Аналог MIOTENS у Іспанія
Лікарі онлайн щодо MIOTENS
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Заповніть форму за 2 хвилини
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Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
MIOTENS потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у MIOTENS — Тиоколхикозид. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
MIOTENS виробляється компанією DOMPE' FARMACEUTICI S.P.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування MIOTENS з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати MIOTENS у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (Тиоколхикозид) включають DEKONTRIL, MIOREXIL, MUSKOFLEX. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
