Package leaflet: Information for the user

TIOCOLCHICOSIDE EG 4 mg/2 ml solution for intramuscular injection

Equivalent medicine
Please read all of this leaflet carefully before you start 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, 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, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Tiocolchicoside EG 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 using Tiocolchicoside EG

Do not use Tiocolchicoside EG 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 may 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 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).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Tiocolchicoside EG.
If you experience symptoms that may indicate liver damage during treatment with Tiocolchicoside EG (such as loss of appetite, nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice, itching), you must stop using Tiocolchicoside EG and contact your doctor immediately if any of these symptoms occur.
Inform your doctor if you experience any adverse effects during treatment with this medicine, as it may be necessary to reduce the dose.
Use this medicine with caution and inform your doctor if you have epilepsy or are at risk of seizures, as Tiocolchicoside EG could worsen these conditions.
After injection of Tiocolchicoside EG, your doctor should keep you under close observation, as you may experience a temporary loss of consciousness (vasovagal syncope).
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 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 potential risk factor for cancer, may harm the unborn child, and may impair male fertility. Consult your doctor if you have 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 Tiocolchicoside EG" 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 Tiocolchicoside EG
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 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 could become pregnant (see "Do not use Tiocolchicoside EG");
you are breastfeeding, because this medicine passes into breast milk (see "Do not use Tiocolchicoside EG");
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 Tiocolchicoside EG"); This medicine may cause harm to the unborn child.

This medicine may cause problems with male fertility 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 Tiocolchicoside EG and for 1 month after the end of treatment.
Tiocolchicoside EG and its metabolites may cause harm to unborn children if used during pregnancy. If you are pregnant or become pregnant during treatment with Tiocolchicoside EG, seek immediate medical advice.
Men must use effective contraceptive measures and must be advised not to father a child during treatment with Tiocolchicoside EG and for 3 months after stopping treatment (see "Do not use Tiocolchicoside EG").
Driving and using machines
This medicine may cause drowsiness. Therefore, if this occurs, avoid driving or operating machinery.
Tiocolchicoside EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially 'sodium-free'.

3. How to use Tiocolchicoside EG

Use this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine must be administered by injection into a muscle (intramuscular use).
The recommended and maximum dose is 4 mg every 12 hours (i.e. 8 mg per day). The treatment duration is limited to 5 consecutive days.
Do not exceed the recommended doses or the recommended treatment duration.
This medicine must not be used for more than 5 consecutive days (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 Tiocolchicoside EG than you should
If you accidentally use more Tiocolchicoside EG than you should, contact your doctor, pharmacist, or nurse.

If you forget to use Tiocolchicoside EG
Do not use a double dose to make up for the forgotten 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 everyone experiences them.
The following side effects may occur:
Common (may affect up to 1 in 10 people):

drowsiness;
diarrhoea, stomach ache (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 irritation (urticaria);
pain and burning in the throat, chest and stomach (pyrosis);
agitation and transient clouding of consciousness (transient obnubilation).

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 limbs, face, lips, throat and/or tongue (angioedema) and severe allergic reaction (anaphylactic shock);
malaise, with or without transient loss of consciousness (vasovagal syncope), occurring within minutes after intramuscular administration, seizures (see section 2 “Warnings and precautions”);
liver inflammation (cytolytic and cholestatic hepatitis) (see section 2 “Warnings and precautions”);
injection site reactions, including pain, redness, swelling, itching, spots. These reactions may worsen with darkening and death of the skin and underlying tissues surrounding the injection site, eventually healing with scarring; this condition is 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 or pharmacist. You can also report side effects directly via the national reporting system at http://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 Tiocolchicoside EG

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 and to the product in intact packaging and properly stored.
This medicine does not require any special storage conditions.
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 Tiocolchicoside EG 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 Tiocolchicoside EG and contents of the pack
Carton pack containing 6 vials of 2 ml each.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan – Italy
Manufacturer
Esseti Farmaceutici S.r.l. - Via Campobello, 15 - 00071 Pomezia (RM) - Italy