Strialisin

Package leaflet: Information for the patient

STRIALISIN 4 mg/2 ml injectable solution

Tiocolchicoside
Please read this leaflet carefully before using this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What STRIALISIN is and what it is used for
2. What you need to know before taking STRIALISIN
3. How to take STRIALISIN
4. Possible side effects
5. How to store STRIALISIN
6. Contents of the pack and other information

1. What STRIALISIN is and what it is used for

This medicinal product is a muscle relaxant. It is used in adults and adolescents
from the age of 16 onwards as an adjunctive treatment for painful muscle spasms. It should be
used for acute conditions related to the spine.

2. What you need to know before taking STRIALISIN

Do not take Strialisin if:

• you are allergic to tiocolchicoside or to any of the excipients of this medicine (listed in section 6)
• you are pregnant, suspect you may be pregnant, or could become pregnant (see "Pregnancy, breastfeeding and fertility")
• you are breastfeeding (see "Fertility, pregnancy and breastfeeding")
• you are a woman of childbearing age who is not using an effective contraceptive method (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)
• you have progressive paralysis affecting the muscles, characterized by weakness and loss of muscle tone (flaccid paralysis)
• you have reduced muscle tone caused by nervous system or muscular disorders (muscular hypotonia).

Warnings and precautions
Talk to your doctor or pharmacist before taking Strialisin.
If you experience symptoms that may indicate liver damage during treatment with Strialisin
(for example, loss of appetite, nausea, vomiting, abdominal pain, fatigue, dark urine,
jaundice, itching), you must stop taking/using Strialisin and consult your
doctor immediately if any of these symptoms occur.
In particular, inform your doctor:

• If you suffer from seizures (involuntary and uncontrolled muscle movements) or epilepsy (a nervous system disorder characterized by loss of consciousness and violent convulsive muscle movements). The use of Strialisin may worsen epileptic seizures (episodes characterized by sudden loss of consciousness and collapse, with or without convulsions).
• If you experience any of the following symptoms: epileptic seizures

Strictly follow the dosage and duration of treatment indicated in section 3.
You must not use this medicine at higher doses or for longer than 5 days. This is because one of the
substances formed in the body after taking tiocolchicoside at high doses may
cause damage to certain cells (abnormal number of chromosomes). This has been demonstrated in
animal studies and laboratory studies. In humans, this type of cellular damage is a
risk factor for cancer, can harm the unborn child, and may impair male fertility.
Consult your doctor if you have any further questions.
Your doctor will inform you about all necessary measures regarding effective contraception and the potential risks in case of pregnancy (see "Do not use Strialisin" 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 Strialisin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy, breastfeeding and fertility
Do not take this medicine if:

• you are pregnant, suspect you may be pregnant, or could become pregnant (see "Do not use Strialisin");
• you are breastfeeding, because this medicine passes into breast milk (see "Do not use Strialisin");
• you are a woman of childbearing age who is not using an effective contraceptive method or a man who is not using effective contraceptive measures (see "Do not use Strialisin"). Indeed, this medicine may harm the unborn child.

This medicine may cause male fertility problems due to potential damage to sperm cells (abnormal number of chromosomes). This is based on laboratory studies (see section 2 "Warnings and precautions").

Contraception in women and men
Women who are able to become pregnant must use an effective contraceptive method during treatment with Strialisin and for 1 month after the end of treatment.
Strialisin and its metabolites may harm the unborn child if used during pregnancy. If you are pregnant or become pregnant while taking Strialisin, consult your doctor immediately.
Men must use effective contraceptive measures and must be advised not to father a child during treatment with Strialisin and for 3 months after stopping treatment (see "Do not use Strialisin").

Driving and using machines
Taking Strialisin may affect your ability to drive or operate machinery due to the possible occurrence of drowsiness.

Strialisin 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 take STRIALISIN

Take this medicine exactly as your doctor or
pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
The recommended and maximum dose is 4 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 or the recommended duration of treatment.
This medicine must not be used for long-term treatment (see section 2 "Warnings and precautions").
Instructions for use:

• Open the vial along the dotted line
• Draw up the contents of the vial into a sterile syringe
• Inject the solution directly into the muscle tissue.

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 take more Strialisin than you should
If you accidentally take more Strialisin than you should, contact your doctor, pharmacist, or nurse.
If you forget to take Strialisin
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use 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 adverse reactions may occur during treatment with Strialisin:

Common (may affect up to 1 in 10 people):

• drowsiness
• diarrhoea, stomach ache (gastralgia)

Uncommon (may affect up to 1 in 100 people):

• pruritus*
• nausea, vomiting
• skin irritations causing redness of the skin (allergic skin reactions)

Rare (may affect up to 1 in 1,000 people):

• urticaria*
• restlessness and temporary loss of sensory and mental functions (transient obnubilation)
• heartburn (pyrosis)

Very rare (may affect up to 1 in 10,000 people):

• low blood pressure (hypotension)*

Not known (frequency cannot be estimated from the available data):

• swelling of the skin, mucosa and submucosal tissues (angioedema) and anaphylactic shock*
• severe allergic reactions
• malaise, with or without loss of consciousness within minutes after intramuscular administration (vasovagal syncope or common fainting), seizures (see section 2)
• cytolytic hepatitis (with destruction of liver cells and increased liver enzymes in the blood) and cholestatic hepatitis (with obstruction of the bile ducts)
• inflammation of the liver (hepatitis) (see section 2)

* effects due to hypersensitivity reactions

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address:
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 STRIALISIN

This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Strialisin contains

• The active substance is tiocolchicoside. Each 2 ml vial contains 4 mg of tiocolchicoside.
• The other components are: sodium chloride (see section 2. Strialisin contains sodium) and water for injections.

Description of the appearance of Strialisin and package contents
Strialisin is a solution for injection administered intramuscularly.
The solution is supplied in 2 ml vials. The available pack sizes are:

• Carton containing 6 vials
• Carton containing 10 vials

Marketing Authorization Holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo, 15 - Milan, Italy
Manufacturer
Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.
Via Morolense 87
03013 – Ferentino (FR)
Italy