Package leaflet: Information for the user

Tiocolis, 4 mg, tablets
Tiocolis, 8 mg, tablets
Thiocolchicoside
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Tiocolis is and what it is used for
Important information before taking Tiocolis
How to take Tiocolis
Possible side effects
How to store Tiocolis
Contents of the pack and other information

1. What Tiocolis is and what it is used for

Tiocolis is a muscle relaxant. It is used in adults and adolescents aged 16 years and older, as an adjunctive treatment for painful muscle spasms. It is used in acute conditions related to the spine.

2. Important information before using Tiocolis

When not to use Tiocolis:

if the patient is allergic to thiocolchicoside or any of the other ingredients of this medicine (listed in section 6),
if the patient is pregnant, may become pregnant, or suspects she might be pregnant,
if the patient is of childbearing age and is not using contraception,
if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Tiocolis, discuss the following with your doctor:

if the patient has epilepsy or belongs to a group at increased risk of seizures. If a seizure occurs, treatment must be discontinued.

During treatment with Tiocolis, inform your doctor:

if the patient develops diarrhoea; in such a case, dose reduction may be necessary;
if the patient experiences abdominal pain, nausea, or vomiting.

Strictly follow the dosage and duration of treatment specified in section 3.
Do not use this medicine in higher doses or for longer than 7 days, as one of the substances formed in the body during high-dose thiocolchicoside treatment may cause damage to certain cells (abnormal chromosome number). This has been demonstrated in animal studies and laboratory investigations. In humans, this type of cell damage is a risk factor for cancer, harm to the unborn child, and impaired fertility in men.
If you have any further doubts, consult your doctor.
Your doctor will advise you on all measures regarding effective contraception and the potential risks to pregnancy.

Children and adolescents
Do not give this medicine to children or adolescents under 16 years of age due to safety concerns.

Tiocolis with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding and effects on fertility
Do not use this medicine if:

the patient is pregnant, may become pregnant, or suspects she might be pregnant,
the patient is of childbearing age and is not using contraception.

This medicine may harm the unborn child. Do not use during breastfeeding, as it passes into breast milk.
This medicine may cause fertility problems in men due to potential damage to sperm cells (abnormal chromosome number). This is based on laboratory studies (see section 2 "Warnings and precautions").

Driving and operating machinery
This medicine usually does not affect the ability to drive or operate machinery.
However, isolated cases of drowsiness have been observed, which may be increased when consuming alcoholic beverages or medicines containing alcohol. The patient should not drive if the medicine affects their ability to do so. Do not use any tools or machinery if taking this medicine impairs your ability to operate them.

Tiocolis contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Tiocolis
Always take this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dosage
The recommended and maximum dose is 8 mg every 12 hours (i.e. 16 mg per day). The duration of treatment is limited to 7 consecutive days.
Do not exceed the recommended dosage or duration of treatment.
This medicine should not be used for long-term treatment (see section 2 "Warnings and precautions").

Use in children and adolescents
Do not give this medicine to children or adolescents under 16 years of age due to safety concerns.

Method of administration
Tablets should be taken with water.
This medicine can be taken with or without food.

Taking more Tiocolis than recommended
If more than the recommended dose of Tiocolis is taken by accident, consult your doctor, pharmacist, or nurse immediately.

Missing a dose of Tiocolis
Do not take a double dose to make up for a missed dose.
If you have any further 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.

Uncommon side effects (in 1 to 10 patients out of 10,000):

Vesicular rash
Upper abdominal pain, diarrhoea, nausea, and vomiting

Very rare side effects (less than 1 patient in 10,000):

Allergic reactions – urticaria, Quincke's oedema (angioedema may be life-threatening if located in the throat or larynx)
Itching, erythema, maculopapular rash
Drowsiness

Frequency not known:

Anaphylactic shock
Seizures or recurrence of seizures in patients with epilepsy

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the Marketing Authorisation Holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Tiocolis
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information
What Tiocolis contains

The active substance is thiocolchicoside.

Tiocolis, 4 mg:
One tablet contains 4 mg of thiocolchicoside.
Tiocolis, 8 mg:
One tablet contains 8 mg of thiocolchicoside.

Other ingredients are: Monohydrate lactose, microcrystalline cellulose type 101, microcrystalline cellulose type 102, povidone (type K30), anhydrous colloidal silica, crospovidone (type A), magnesium stearate.

What Tiocolis looks like and contents of the pack
Yellow, round, biconvex tablets.
Tiocolis tablets are packed in PVC/PVDC/Aluminium blisters, placed in a cardboard box.
Available pack sizes:
Tiocolis, 4 mg: 10, 14, 20, 28 or 30 tablets
Tiocolis, 8 mg: 14, 20, 28 or 30 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Tel. +48 61 66 51 500
[email protected]