Package leaflet: Information for the user

Tiocolchicoside Mylan Generics 4 mg/2 ml solution for intramuscular injection

tiocolchicoside
Generic 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 give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Tiocolchicoside Mylan Generics is and what it is used for

This medicine is a muscle relaxant.
Tiocolchicoside Mylan Generics is used in adults and adolescents over 16 years of age to help treat painful muscle spasms. It should be used for acute conditions related to the spine.

2. What you need to know before using Tiocolchicoside Mylan Generics

Do not use Tiocolchicoside Mylan Generics 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 muscle control and movement (flaccid paralysis);
you suffer from muscle weakness (muscular hypotonia);
you are pregnant, may become pregnant, or suspect you might be 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).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Tiocolchicoside Mylan Generics.
If you experience symptoms that may indicate liver damage during treatment with Tiocolchicoside Mylan Generics (e.g. loss of appetite, nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice, itching), you must stop using Tiocolchicoside Mylan Generics and consult your doctor immediately.
Use this medicine with caution and inform your doctor if you have seizures or are at risk of seizures, as Tiocolchicoside Mylan Generics could worsen these conditions.
After receiving an injection of Tiocolchicoside Mylan Generics, your doctor should closely monitor you, as temporary loss of consciousness (vasovagal syncope) may occur.
Cases of liver inflammation (cytolytic and cholestatic hepatitis) have been reported during treatment with this medicine; some of these cases were fatal (fulminant hepatitis), particularly when Tiocolchicoside Mylan Generics was administered together with other pain-relieving medicines (NSAIDs, paracetamol).
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 after taking 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 potential risk factor for cancer and could harm the fetus and impair male fertility. Consult your doctor if you have further questions.
Your doctor will advise you on the need for an effective contraceptive method and the potential risks in case of pregnancy (see "Do not use Tiocolchicoside Mylan Generics" and "Pregnancy, breastfeeding and fertility").

Children and adolescents
Do not administer this medicine to children and adolescents under 16 years of age.

Other medicines and Tiocolchicoside Mylan Generics
Inform your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines.
No disturbances (interactions) are known when this medicine is used together with other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor, pharmacist or nurse before using this medicine.

Pregnancy
Do not use this medicine if you are pregnant, may become pregnant, or suspect you might be pregnant (see "Do not use Tiocolchicoside Mylan Generics").

Breastfeeding
Do not use Tiocolchicoside Mylan Generics if you are breastfeeding, as this medicine passes into breast milk (see "Do not use Tiocolchicoside Mylan Generics").

Fertility
Do not use Tiocolchicoside Mylan Generics if 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 Mylan Generics").
This medicine may harm the unborn child.

Contraception in women and men
Women who are able to become pregnant must use an effective contraceptive method during treatment with Tiocolchicoside Mylan Generics and for 1 month after treatment ends.
Tiocolchicoside Mylan Generics and its metabolites may cause harm to the unborn child if used during pregnancy. If you are pregnant or become pregnant during treatment with Tiocolchicoside Mylan Generics, seek medical advice immediately.
Men must use effective contraceptive measures and be advised not to father a child during treatment with Tiocolchicoside Mylan Generics and for 3 months after stopping treatment (see "Do not use Tiocolchicoside Mylan Generics").

Driving and using machines
This medicine may cause drowsiness. Therefore, avoid driving or operating machinery while using this medicine.

Tiocolchicoside Mylan Generics 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 Tiocolchicoside Mylan Generics

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 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 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.
If you use more Tiocolchicoside Mylan Generics than you should
If you accidentally use more Tiocolchicoside Mylan Generics than you should, contact your doctor, pharmacist, or nurse.
If you forget to use Tiocolchicoside Mylan Generics
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 pain (gastralgia).

Uncommon (may affect up to 1 in 100 people)

itching;
nausea, vomiting;
skin allergic reactions.

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

skin irritations (urticaria);
agitation and clouding of senses and consciousness (transient obnubilation);
pain and burning in the throat, chest and stomach (pyrosis).

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

lowering of blood pressure (hypotension).

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

swelling of the limbs, face, lips, throat and/or tongue which may cause difficulty in breathing and swallowing (angioedema), severe allergic reactions (anaphylactic shock);
malaise which may be associated with loss of consciousness (vasovagal syncope) in the minutes following administration, seizures (see section 2 “Warnings and precautions”);
inflammation of the liver (hepatitis) (see section 2 “Warnings and precautions”);
injection site reactions including pain at injection site, redness, swelling, hard nodule, ulcers, bruising, itching and spots. This may lead 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 or pharmacist. You can also report side effects directly via 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 Tiocolchicoside Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the vial after "Exp.". The expiry date refers to the last day of that month and applies to the product in intact packaging and properly stored.
This medicine does not require any special storage conditions.
Do not dispose of 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 Tiocolchicoside Mylan Generics contains

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

Description of the appearance of Tiocolchicoside Mylan Generics and contents of the pack
Carton pack containing 6 vials of 2 ml.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
ESSETI Farmaceutici S.r.l., Via Campobello 15, 00071 Pomezia (Roma)