Tiocolis

Package Leaflet: Information for the User

Tiocolis, 4 mg, tablets

Tiocolis, 8 mg, tablets

Thiocolchicoside

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Tiocolis and what is it used for
• 2. Important information before taking Tiocolis
• 3. How to take Tiocolis
• 4. Possible side effects
• 5. How to store Tiocolis
• 6. Package contents and other information

1. What is Tiocolis and what is it used for

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

2. Important information before taking Tiocolis

When not to take Tiocolis:

• if you are allergic to thiocolchicoside or any of the other ingredients of this medicine (listed in section 6),
• if you are pregnant, may become pregnant, or think you may be pregnant,
• if you are of childbearing age and do not use contraception,
• if you are breastfeeding.

Warnings and precautions

Before starting treatment with Tiocolis, discuss it with your doctor:

• if you have epilepsy or are at increased risk of seizures. If a seizure occurs, treatment should be discontinued.

During treatment with Tiocolis, inform your doctor:

• if you experience diarrhea; in such cases, a dose reduction may be necessary;
• if you experience abdominal pain, nausea, or vomiting.

Strictly follow the dosing and duration of treatment specified in section 3.
The medicine should not be taken in a higher dose or for longer than 7 days, as one of the products formed in the body during the use of high doses of thiocolchicoside may cause damage to some cells (abnormal chromosome number). This has been shown in animal studies and laboratory tests. In humans, this type of cell damage is a risk factor for cancer, harmful effects on the unborn child, and impaired fertility in men.
In case of any further doubts, consult a doctor.
Your doctor will inform you about all measures related to effective contraception and potential risks during pregnancy.

Children and adolescents

Do not give this medicine to children and adolescents under 16 years of age, for safety reasons.

Tiocolis and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy, breastfeeding, and fertility

Do not take this medicine if:

• you are pregnant, may become pregnant, or think you may be pregnant,
• you are of childbearing age and do not use contraception. This medicine may harm the unborn child. Do not take this medicine 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 tests (see section 2 "Warnings and precautions").

Driving and using machines

The medicine usually does not affect the ability to drive and use machines.
However, single cases of drowsiness have been observed, which may be increased when consuming alcoholic beverages and medicines containing alcohol. You should not drive if the medicine affects your ability to drive. Do not use any tools or machines if taking the medicine affects your ability to operate them.

Tiocolis contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Tiocolis

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask 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 dose and 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 and adolescents under 16 years of age, for safety reasons.

Method of administration

Swallow the tablets with water.
The medicine can be taken with or without food.

Overdose of Tiocolis

In case of accidental overdose of Tiocolis, consult a doctor, pharmacist, or nurse.

Missed dose of Tiocolis

Do not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects (between 1 and 10 patients in 10,000):

• Blisters
• Abdominal pain, diarrhea, nausea, and vomiting

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

• Allergic reactions - hives, Quincke's edema (which can be life-threatening if localized in the throat or larynx)
• Itching, redness, papular rash
• Drowsiness

Frequency not known:

• Anaphylactic shock
• Seizures or recurrence of seizures in patients with epilepsy

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Tiocolis

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

6. Package contents 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.

• The other ingredients are: lactose monohydrate, microcrystalline cellulose type 101, microcrystalline cellulose type 102, povidone (type K30), colloidal anhydrous silica, crospovidone (type A), magnesium stearate

What Tiocolis looks like and contents of the pack

Round, biconvex tablets, yellow in color.
Tiocolis tablets are packaged in PVC/PVDC/Aluminum blisters, placed in a cardboard box.
Available packs:
Tiocolis, 4mg: 10, 14, 20, 28 or 30 tablets
Tiocolis, 8 mg: 14, 20, 28 or 30 tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Phone: +48 61 66 51 500
biofarm@biofarm.pl
Date of last revision of the leaflet:04.05.2020