Package leaflet: Information for the user

MIOREXIL 4 mg solution for intramuscular injection

Tiocolchicoside
Generic medicine
Please read all of this leaflet carefully before you use 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, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What MIOREXIL is and what it is used for
What you need to know before using MIOREXIL
How to use MIOREXIL
Possible side effects
How to store MIOREXIL
Contents of the pack and other information

1. What MIOREXIL is and what it is used for

This medicine 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 using MIOREXIL

Do not use MIOREXIL if:

you are allergic to tiocolchicoside or to any of the other ingredients of this medicine (listed in section 6);
you have a condition characterized by loss of voluntary muscle movement (flaccid paralysis);
you suffer from muscle weakness (muscular hypotonia);
you are pregnant, suspect you might be pregnant, or could 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 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).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using MIOREXIL.
Use this medicine with caution and inform your doctor if you have epilepsy or are at risk of seizures,
as MIOREXIL may worsen these conditions.
You must inform your doctor if epileptic seizures occur.
After administration of MIOREXIL, your doctor should keep you under close observation, as transient loss of consciousness may occur.
During treatment with this medicine, cases of liver inflammation (cytolytic and cholestatic hepatitis) have been reported; some of these cases have been fatal (fulminant hepatitis), particularly when the product was administered together with other medicines used to relieve pain (non-steroidal anti-inflammatory drugs [NSAIDs], paracetamol). If you notice symptoms that may indicate liver damage during treatment with MIOREXIL (e.g., loss of appetite, nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice, itching), you must stop taking MIOREXIL and consult your doctor immediately if any of these symptoms appear.
Strictly follow the dosage and duration of treatment indicated in section 3. Do not use this medicine at higher doses or for longer than 5 days. This is because one of the substances formed in the body when taking high doses of tiocolchicoside 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, may harm the unborn child, and may impair male fertility. Consult your doctor if you have any further questions.
Your doctor will inform you about the need for an effective contraceptive method 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
Inform 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 might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
Do not use this medicine if:

you are pregnant, suspect you might be pregnant, or could 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 an effective contraceptive method, or a man who is not using effective contraceptive measures (see "Do not use MIOREXIL"). This medicine may harm the unborn child.

Contraception in women and men
Women who are capable of becoming pregnant must use an effective contraceptive method during treatment with Miorexil and for 1 month after the end of treatment.
Miorexil and its metabolites may cause harm to the unborn child if used during pregnancy.
If you become pregnant while taking Miorexil, seek immediate medical advice.
Men must use effective contraceptive measures and must 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 use of machines
This medicine may cause drowsiness. Therefore, if this occurs, avoid driving vehicles or operating machinery.

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 exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
Use this medicine, taking all necessary precautions to maintain sterility.
This medicine must be administered by injection into a muscle (intramuscular use).
Open the vials along the dotted line and insert the needle of the syringe into the vial.
Draw the solution into the syringe and inject it into a muscle.
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”).

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 forgotten dose.
If you have any questions 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:

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 functions (transient mental confusion);
stomach burning (pyrosis).

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

low blood pressure (hypotension).

Frequency not known (frequency cannot be estimated from the available data)

swelling of the face, lips, mouth, tongue or throat which may cause breathing and swallowing difficulties (angioedema), severe allergic reactions, sudden potentially fatal allergic reaction (anaphylactic shock);
malaise, with or without transient loss of consciousness (vasovagal syncope) following administration, seizures (See section “Warnings and precautions”);
liver inflammation (hepatitis, including cytolytic and cholestatic hepatitis) (See section “Warnings and precautions”);
injection site reactions, including pain at injection site, redness, swelling, hard nodule, sores and bruising. These may contribute to darkening and death of the skin and underlying tissues surrounding the injection site, healing with scarring, also known as Nicolau syndrome.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via 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 stated on the packaging after "Expiry".
The expiry date refers to the last day of that month and applies to the product in its original, unopened packaging stored under proper conditions.
This medicine does not require any special storage conditions.
Do not dispose of any medicines 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 MIOREXIL contains

The active substance is tiocolchicoside. Each 2 ml vial contains 4 mg of tiocolchicoside.
The other components are sodium chloride and water for injections.

Description of the appearance of MIOREXIL and contents of the pack
Carton pack containing 6 vials of 2 ml each.
Marketing Authorization 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