Tiocolchicoside Doc Generici

Package leaflet: Information for the user

TIOCOLCHICOSIDE DOC Generici

4 mg/2 ml injectable solution for intramuscular use
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, because 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:

1. What TIOCOLCHICOSIDE DOC Generici is and what it is used for
2. What you need to know before using TIOCOLCHICOSIDE DOC Generici
3. How to use TIOCOLCHICOSIDE DOC Generici
4. Possible side effects
5. How to store TIOCOLCHICOSIDE DOC Generici
6. Contents of the pack and other information

1. What TIOCOLCHICOSIDE DOC Generici 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 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 DOC Generici

Do not use TIOCOLCHICOSIDE DOC Generici if:

• you are allergic to thiocolchicoside 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, may become pregnant, or suspect you are 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 DOC Generici.
Use this medicine with caution and inform your doctor if you have epilepsy or are at risk of seizures,
as TIOCOLCHICOSIDE DOC Generici could worsen these conditions.
You must inform your doctor if you experience symptoms of epileptic seizures.
After administration of TIOCOLCHICOSIDE DOC Generici, your doctor should keep you under close
monitoring, 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 may be very severe and life-threatening (fulminant hepatitis), particularly when this medicine has been administered together with other anti-inflammatory and pain-relieving medicines (non-steroidal anti-inflammatory drugs, paracetamol).
If you notice symptoms that may indicate liver damage during treatment with
TIOCOLCHICOSIDE DOC Generici (e.g., loss of appetite, nausea, vomiting, abdominal pain,
fatigue, dark urine, jaundice, itching), you must stop using TIOCOLCHICOSIDE DOC Generici and
consult your doctor immediately if any of these symptoms occur.
Inform your doctor if you experience any adverse reaction during treatment with this medicine, as
it may be necessary to reduce the dose.
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 thiocolchicoside 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, may harm the unborn child, and may 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 on the potential risks in case of pregnancy (see "Do not use TIOCOLCHICOSIDE DOC Generici" 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 DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
No interaction studies with other medicines have been conducted.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
Do not use this medicine if:

• you are pregnant, may become pregnant, or suspect you are pregnant (see "Do not use TIOCOLCHICOSIDE DOC Generici");
• you are breastfeeding, because this medicine passes into breast milk (see "Do not use TIOCOLCHICOSIDE DOC Generici");
• 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 DOC Generici"). This medicine may cause harm to the unborn child.

Do not take this medicine if you are breastfeeding, as the medicine passes into breast milk. The medicine
may affect 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 DOC Generici and for 1 month after the end of treatment.
TIOCOLCHICOSIDE DOC Generici and its metabolites may cause harm to unborn children if used
during pregnancy. If you are pregnant or become pregnant during treatment with
TIOCOLCHICOSIDE DOC Generici, seek immediate medical advice.
Men must use effective contraceptive measures and should be advised not to father a child during
treatment with TIOCOLCHICOSIDE DOC Generici and for 3 months after stopping treatment
(see "Do not use TIOCOLCHICOSIDE DOC Generici").
Driving and use of machines
This medicine may cause drowsiness. Therefore, if this occurs, avoid driving or operating machinery.
TIOCOLCHICOSIDE DOC Generici 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 DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
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 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 TIOCOLCHICOSIDE DOC Generici than you should
If you accidentally use more TIOCOLCHICOSIDE DOC Generici than you should, contact your doctor,
pharmacist, or nurse.
If you forget to use TIOCOLCHICOSIDE DOC Generici
Do not use a double dose to make up for a forgotten 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:

Common (may affect more than 1 in 10 people)

• drowsiness;
• diarrhoea, stomach pain.

Uncommon (may affect up to 1 in 10 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;
• stomach burning (pyrosis).

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

• drop in blood pressure (hypotension).

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

• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing and swallowing (angioedema), severe allergic reaction; sudden potentially fatal allergic reaction (anaphylactic shock);
• malaise, with or without transient loss of consciousness (vasovagal syncope) following administration, seizures (see section 2 "Warnings and precautions");
• liver inflammation (hepatitis, including cytolytic and cholestatic hepatitis) (see section 2 "Warnings and precautions").

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 DOC Generici

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.
The expiry date applies to the product in its original, unopened packaging and properly stored.
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 DOC Generici contains

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

Description of the appearance of TIOCOLCHICOSIDE DOC Generici and contents of the pack
Pack containing 6 vials for the 4 mg/2 ml dose.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 – 20121 Milan – Italy.
Manufacturer
Esseti Farmaceutici S.r.l. - Via Campobello 15 - 00071 Pomezia (Rome) – Italy.