SCIOMIR 2 mg /Ml Injectable Solution
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Інструкція із застосування SOMIR
Зміст інструкції
Sciomir 2mg/ml injectable solution
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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Sciomir is and what it is used for
- 2. What you need to know before you use Sciomir
- 3. How to use Sciomir
- 4. Possible side effects
- 5. How to store Sciomir
- 6. Contents of the pack and other information
1. What is Sciomir and what is it used for
Sciomir contains the active ingredient ticolchicoside. This medicine belongs to the group of
medicines called centrally acting muscle relaxants (i.e., those that act directly on the Central
Nervous System – CNS).
Sciomir is used in the supportive treatment of painful muscle contractions in acute conditions
of the spine in adults and adolescents 16 years of age and older.
2. What you need to know before using Sciomir
Do not use Sciomir
- if you are allergic to ticolchicoside or any of the other ingredients of this medicine (listed in section 6);
- if you are pregnant, suspect you may be pregnant, or are planning a pregnancy (see “Pregnancy, breastfeeding and fertility”);
- if you are breastfeeding (see “Pregnancy, breastfeeding and fertility”);
- if you are a woman of childbearing potential and are not using effective contraceptive measures (during treatment and for up to one month after the end of treatment);
- if you are a man who is not using effective contraceptive measures (during treatment and for up to three months after the end of treatment);
- if you suffer from flaccid paralysis (progressive muscle paralysis) or muscle hypotonia (decreased muscle tone);
- if you have disorders of hemostasis (your body cannot stop bleeding spontaneously);
- if you are being treated with medicines that thin the blood (anticoagulants) (see “Other medicines and Sciomir”);
- if you are a child or adolescent under 16 years of age (see “Children and adolescents”).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Sciomir.
Your doctor will inform you about the need to follow effective contraceptive measures and the
potential risks in case of pregnancy (See “Do not use Sciomir” and “Pregnancy, breastfeeding and
fertility”).
Avoid taking doses of the medicine higher than those recommended or using Sciomir
for long periods of time (see “How to use Sciomir”).
Patients must be informed to discontinue treatment and contact their
doctor if they develop signs and symptoms of liver damage.
The use of the medicine at doses higher than the recommended dose or long-term use must be
avoided.
At the beginning of treatment, you must be carefully informed about the potential risk of
possible pregnancy and the effective contraceptive measures to follow.
Take special care with Sciomir:
- if you suffer from epilepsy or are at risk of seizures, as Sciomir may precipitate epileptic seizures in these patients;
- if you have reduced kidney and/or liver function (renal and/or hepatic insufficiency).
If you observe symptoms that may indicate liver damage during treatment with Sciomir (for
example, loss of appetite, nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice,
itching) you should stop taking / using Sciomir and consult your doctor immediately if
any of these symptoms occur.
If the medicine is administered to you intramuscularly (into the muscle) you should be monitored
due to episodes of vasovagal syncope (temporary loss of consciousness) (see “Possible side
effects”).
Children and adolescents
Do not administer this medicine to children and adolescents under 16 years of age due to safety
concerns (see “Do not use Sciomir”).
Other medicines and Sciomir
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not use Sciomir if you are taking medicines that thin the blood (anticoagulants) (see
“Do not use Sciomir”).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy, breastfeeding and fertility
Do not use this medicine if:
- you are pregnant, suspect you are pregnant, or might become pregnant (See “Do not use Sciomir”).
- you are breastfeeding, as the medicine passes into breast milk (See “Do not use Sciomir”).
- you are a woman of childbearing potential and are not using effective contraceptive measures or you are a man who is not using effective contraceptive measures (see “Do not use Sciomir”)
This medicine can harm the fetus.
Contraception in women and men
Women of childbearing potential must use effective contraceptive measures during treatment with Sciomir and
for 1 month after completion of treatment.
Sciomir and its metabolites can harm the fetus if used by pregnant women. If you
are pregnant or become pregnant during treatment with Sciomir, consult your doctor immediately.
Men must use effective contraceptive measures and be advised not to father children
during the intake of Sciomir and for 3 months after discontinuation of treatment (see "Do not
use Sciomir").
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially “sodium-free”.
Driving and using machines
Studies on the ability to drive vehicles or use machines have not been conducted.
Since the occurrence of drowsiness is a common event, this should be taken into account when
driving vehicles or using machines.
3. How to use Sciomir
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended doseis a maximum of 1 vial (4 mg) every 12 hours (i.e. 8 mg per day). The duration of
treatment should not exceed 5 consecutive days.
Do not exceed the recommended doses and the duration of treatment.
This medicine should not be used for long periods of time (see “Warnings and
precautions”).
Method of administration
Sciomir is administered by intramuscular injection (into the muscle).
Use in children and adolescents
Sciomir should not be used in children and adolescents under 16 years of age due to
safety concerns.
If you use more Sciomir than you should
In case of accidental intake/administration of an excessive dose of Sciomir, immediately inform
your doctor or go to the nearest hospital.
If you forget to use Sciomir
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult 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:
Following intramuscular administration, rare cases of malaise have been reported, sometimes
associated or not with low blood pressure (hypotension) and/or loss of consciousness. The
appearance of a state of agitation or temporary loss of sensory and intellectual abilities
(transient obtundation) after parenteral administration (by injection) has also been rarely
reported. The possible onset of drowsiness is common. Infrequent cases of rash and
skin erythema are known.
Common(may affect up to 1 in 10 people):
- drowsiness
Uncommon(may affect up to 1 in 100 people):
- itching
- allergic skin reactions
Rare(may affect up to 1 in 1,000 people):
- urticaria
- angioedema
- rash (skin eruption)
- skin redness (skin erythema)
- agitation and temporary loss of sensory and intellectual abilities (transient obtundation)
- malaise associated with or without fainting (vasovagal syncope) in the minutes following intramuscular administration).
Very rare(may affect up to 1 in 10,000 people):
- low blood pressure (hypotension) and anaphylactic shock after intramuscular administration
Not known(frequency cannot be estimated from available data):
- seizures
- drug-induced liver damage
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or
nurse. You can also report side effects directly through the national reporting system at
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 Sciomir
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 after “exp”. The
expiry date refers to the last day of that month. The expiry date refers to the
product in intact packaging and 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 Sciomir contains
- The active ingredient is ticolchicoside. Each 2 ml vial contains 4 mg of ticolchicoside.
- The other ingredients are: sodium chloride, water for injections.
Description of the appearance of Sciomir and contents of the pack
Sciomir is presented as an injectable solution.
The pack contains 6 glass vials for a dose of 4mg/2 ml.
Marketing Authorisation Holder
Laboratorio Farmaceutico C.T. S.r.l. – Via Dante Alighieri, 71 – 18038 Sanremo (IM)
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (IM)
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- Країна реєстрації
- Лікарська формаInjectable solution, 2 MG/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 SOMIRЛікарська 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, 4 MG/2 MLДіюча речовина: ТиоколхикозидВиробник: DOMPE' FARMACEUTICI S.P.A.Потрібен рецепт
Аналоги SOMIR в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог SOMIR у Польща
Аналог SOMIR у Україна
Аналог SOMIR у Іспанія
Лікарі онлайн щодо SOMIR
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
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Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
SOMIR потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у SOMIR — Тиоколхикозид. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
SOMIR виробляється компанією LABORATORIO FARMACEUTICO C.T. S.R.L.. 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 SOMIR 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 SOMIR 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, MIOTENS. 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.
