Package leaflet: Information for the patient

DECONTRIL 4 mg/2 ml injectable solution for intramuscular use

tiocolchicoside
equivalent medicine
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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What DECONTRIL is and what it is used for

DECONTRIL contains the active substance tiocolchicoside and belongs to the group of centrally-acting muscle relaxants.
DECONTRIL is used as an adjunctive treatment for painful muscle spasms associated with acute spinal disorders in adults and adolescents over 16 years of age.

2. What you need to know before using DECONTRIL

Do not use DECONTRIL

if you are allergic to tiocolchicoside or to any of the other ingredients of this medicine (listed in section 6)
if you are pregnant, suspect you may be pregnant, or could become pregnant (see "Pregnancy, breastfeeding and fertility")
if you are breastfeeding (see "Pregnancy, breastfeeding and fertility")
if you are a woman of childbearing age who is not using an effective contraceptive method (during treatment and for one month after stopping treatment)
if you are a man who is not using effective contraceptive measures (during treatment and for three months after stopping treatment)
if you have a condition characterized by loss of muscle control and movement (flaccid paralysis)
if you suffer from muscle weakness (muscle hypotonia)
if the patient is a child or adolescent under 16 years of age.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using DECONTRIL.
Strictly follow the dosage and duration of treatment indicated in section 3. Do not use this medicine at higher doses. Do not use this medicine for more than 5 days.
This is because one of the substances formed in the body after taking tiocolchicoside could 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 may be a potential risk factor for cancer, spontaneous abortion, fetal harm, and impaired male fertility. Consult your doctor if you have any further questions.
Your doctor will inform you about the potential risk of pregnancy and the need to use effective contraception (see "Do not use DECONTRIL" and "Pregnancy, breastfeeding and fertility").
Stop taking DECONTRIL and contact your doctor immediately if, during treatment, you experience any of the following symptoms, which may indicate liver damage: loss of appetite, nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice, itching.
If you develop diarrhoea during treatment with DECONTRIL, consult your doctor, who will decide whether to reduce the dose.
After intramuscular administration, you may experience episodes of malaise, sometimes associated with hypotension and/or loss of consciousness; therefore, your doctor should monitor you after the injection.
Use this medicine with caution and inform your doctor if you have a history of epileptic seizures or are at risk of seizures, as DECONTRIL could worsen these conditions.
Children and adolescents
Do not administer this medicine to children and adolescents under 16 years of age due to safety concerns.
Other medicines and DECONTRIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No disturbances (interactions) are known when this medicine is taken 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 or pharmacist before taking this medicine.
Do not use this medicine if:

you are pregnant, suspect you may be pregnant, or could become pregnant (see "Do not use DECONTRIL");
you are breastfeeding, as the medicine passes into breast milk (see "Do not use DECONTRIL").
you are a woman of childbearing age not using an effective contraceptive method, or a man not using effective contraceptive measures (see "Do not use DECONTRIL"). 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 DECONTRIL and for 1 month after stopping treatment. DECONTRIL and its metabolites may harm the unborn child if used during pregnancy. If you are pregnant or become pregnant during treatment with DECONTRIL, seek immediate advice from your doctor.
Men must use effective contraceptive measures and should be advised not to father a child during treatment with DECONTRIL and for 3 months after stopping treatment (see "Do not use DECONTRIL").
Fertility
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"). Consult your doctor if you have further questions.
Driving and using machines
This medicine may cause drowsiness. Therefore, avoid driving or operating machinery while taking this medicine.
DECONTRIL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially 'sodium-free'.

3. How to use DECONTRIL

Use 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 an injection into a muscle (intramuscular use).
The recommended and maximum dose is 4 mg (one vial) every 12 hours (i.e. 8 mg per day).
This medicine must not be used for more than 5 consecutive days (see section 2 "Warnings and precautions").
Do not exceed the recommended doses or the recommended duration of treatment.
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 DECONTRIL than you should
If you are accidentally given more DECONTRIL than you should, contact your doctor, pharmacist, or nurse.
If you forget to use DECONTRIL
Do not use a double dose to make up for a 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;
allergic skin reactions.

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

skin irritations (urticaria);
temporary loss of sensory and intellectual functions (transient mental confusion), agitation;
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).

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

malaise, sometimes with or without hypotension and/or loss of consciousness in the minutes following administration;
seizures (see section 2 “Warnings and precautions”);
inflammation of the liver (hepatitis) (see section 2 “Warnings and precautions”);
swelling of the limbs, face, lips, throat and/or tongue (angioedema), severe allergic reactions (anaphylactic shock);
reactions at the injection site, including pain at the injection site, redness, swelling, hard nodule, ulcers 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 effects, 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store DECONTRIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the product in its original, unopened packaging, 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 DECONTRIL 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 DECONTRIL and package contents
Injectable solution for intramuscular use.
Pack containing 6 vials of 4 mg/2 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. Group S.r.l., Via Tiburtina 1143, 156, - Rome – Italy
Manufacturer
ESSETI FARMACEUTICI SRL, Via Campobello, 15 - 00040 Pomezia - Rome