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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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. Contents of the pack 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 spinal conditions.

2. Important information before taking Tiocolis

When not to take 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 they may 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, the patient should discuss it with their doctor:

• if the patient has epilepsy or is at increased risk of seizures. In case of a seizure, treatment should be discontinued.

During treatment with Tiocolis, the patient should inform their doctor:

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

The patient should strictly follow the dosing and treatment duration 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, the patient should consult their doctor.
The doctor will inform the patient about all measures related to effective contraception and potential pregnancy risks.

Children and adolescents

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

Tiocolis and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

Do not take this medicine if:

• the patient is pregnant, may become pregnant, or suspects they may be pregnant,
• the patient is of childbearing age and is not using 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 or operate machines.
However, single cases of drowsiness have been observed, which may be increased when consuming alcoholic beverages and medicines containing alcohol. The patient should not drive if the medicine affects their ability to drive. Do not use any tools or machines if taking the medicine affects their ability to operate them.

Tiocolis contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Tiocolis

This medicine should always be taken as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

Recommended dosage

The recommended and maximum dose is 8 mg every 12 hours (i.e., 16 mg per day). The treatment duration is limited to 7 consecutive days.
Do not exceed the recommended dosage and treatment duration.
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

Tablets should be taken with water.
The medicine can be taken with or without food.

Taking a higher dose of Tiocolis than recommended.

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

Missing a 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, Tiocolis can cause side effects, although not everybody gets them.

Rare side effects (affecting 1 to 10 patients in 10,000):

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

Very rare side effects (affecting 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 any side effects occur, including any side effects not listed in the leaflet, the patient should inform their 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

The medicine should be stored out of 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tiocolis contains

• The active substance of the medicine is thiocolchicoside.

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

• Other ingredients of the medicine 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, 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 authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Phone: +48 61 66 51 500
[email protected]
Date of last revision of the leaflet:04.05.2020