Patient Information Leaflet: Information for the User

Tyomol 500 mg + 2 mg tablets

Paracetamol + Tiocolchicoside
Equivalent medicine
Please read this leaflet carefully before taking 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Tyomol is and what it is used for
What you need to know before taking Tyomol
How to take Tyomol
Possible side effects
How to store Tyomol
Contents of the pack and other information

1. What Tyomol is and what it is used for

This medicine 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 for acute episodes related to the spine.

2. What you need to know before taking Tyomol

Do not take Tyomol:

if you are allergic to paracetamol, 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;
if you are a woman of childbearing age who is not using contraceptive methods;
if you are breastfeeding;
if you have severe liver disease;
if you have flaccid paralysis or muscle hypotonia;
if you have renal disorder.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tyomol.
Concomitant treatment with medicines that may have hepatotoxic effects should be avoided.
Do not consume alcoholic beverages during treatment.
Strictly follow the dosage and duration of treatment indicated in section 3. Do not take this medicine at higher doses or for longer than 7 days. This is because one of the substances formed in the body when taking high doses of tiocolchicoside 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 possible risk factor for cancer, fetal abnormalities, and male fertility problems. Consult your doctor if you have any further questions.
Your doctor will inform you about effective contraceptive measures and the potential risk of pregnancy.
If you experience symptoms that may indicate liver damage during treatment with Tyomol (for example, loss of appetite, nausea, vomiting, abdominal discomfort, fatigue, dark urine, jaundice, itching), stop taking Tyomol and consult your doctor immediately.
Contact your doctor immediately if you experience any of the following symptoms: seizures.

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

Other medicines and Tyomol
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tyomol may increase the toxicity of chloramphenicol. Tyomol may enhance the effect of anticoagulants.
Concomitant administration of Tyomol with aspirin, salicylates, or non-steroidal anti-inflammatory drugs is not recommended. Simultaneous use of diflunisal and Tyomol increases the risk of hepatotoxicity. The expected analgesic response of this medicine may be altered by the administration of barbiturates.
The effect of Tyomol is inhibited by colestipol, colestyramine, and estrogens.
Isoniazid increases the hepatotoxic potential of Tyomol.
Inform your doctor or pharmacist if you are taking:

flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (metabolic acidosis with high anion gap) that requires urgent treatment and may occur particularly in cases of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and when maximum daily doses of paracetamol are used.

Tyomol may cause an increase in the following laboratory parameters: transaminases, alkaline phosphatase, ammonia, lactate dehydrogenase, and urea. Tyomol may interfere with the measurement of glucose and uric acid in blood, and metanephrine and uric acid in urine.

Pregnancy, breastfeeding, and fertility
Do not take this medicine if:

you are pregnant, suspect you may be pregnant, or could become pregnant;
you are a woman of childbearing age who is not using contraceptive methods. This is because this medicine may cause harm to the fetus.

Do not take this medicine if you are breastfeeding.
This is because the medicine passes into breast milk.
The medicine may cause male fertility problems due to potential damage to sperm (abnormal number of chromosomes). This is based on laboratory studies (see section 2 “Warnings and precautions”).

Driving and using machines
There are no data available on the effect of Tyomol on the ability to drive or use machines.
Clinical studies have shown that tiocolchicoside has no effect on psychomotor function. However, since cases of somnolence have been reported, this should be taken into account when driving or operating machinery.

Tyomol contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per dose and is therefore essentially "sodium-free".

3. How to take Tyomol

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 or 2 tablets, 3 or 4 times a day. The treatment duration is limited
to 7 consecutive days.
The tablets should be swallowed whole with water. Do not exceed 8 tablets in 24 hours.
Do not exceed the recommended doses or treatment duration.
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 take more Tyomol than you should
If you accidentally take more Tyomol than you should, contact your doctor, pharmacist, or
nurse.
In case of overdose, you may experience nausea, vomiting, anorexia, abdominal pain, or diarrhoea.
If an excessive dose has been taken (more than 6 grams of paracetamol in a single administration,
corresponding to 12 tablets in adults, or more than 100 mg/kg in children), you must go to
the nearest hospital even if no symptoms are present, as symptoms typically begin to appear
within the first three days after the excessive dose.
Treatment includes:
Gastric lavage or induction of vomiting;
Oral administration of activated charcoal;
Haemodialysis;
Administration of appropriate doses of acetylcysteine.
If you forget to take Tyomol
Do not take a double dose to make up for the forgotten dose.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.
If you stop treatment with Tyomol
If you have 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 everyone experiences them.
Side effects are generally uncommon but may be significant in some cases, particularly those related to paracetamol.
Hepatotoxicity at high doses or with prolonged treatment.
Rare side effects: angioedema, skin allergic reactions, blood disorders (thrombocytopenia, pancytopenia, neutropenia, agranulocytosis and haemolytic anaemia), drowsiness, nausea, vomiting, pancreatitis, fever, hypoglycaemia, jaundice, gastralgia and diarrhoea.
Very rare side effects: severe allergic reactions such as itching and urticaria.
With unknown frequency, liver inflammation (hepatitis) and seizures may occur (see section 2).
If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tyomol

This medicine does not require any special storage conditions.
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 last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Tyomol contains

The active substances are paracetamol (500 mg) and tiocolchicoside (2 mg).
The other components are: maize starch, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate and talc.

Description of the appearance of Tyomol and package contents
The tablets are round, yellowish in colour, with a break line on one side.
Tyomol is available in packs of 30 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
BRUNO FARMACEUTICI S.p.A.
Via delle Ande 15
00144 Rome
Italy

Manufacturer
Sofarimex – Indústria Química e Farmacêutica, S.A.
Avenida das Indústrias, Alto do Colaride, Agualva
2735-213 Cacém
Portugal

This medicinal product is authorised in Member States under the following names:
RMS:
Portugal: Paracetamol + Tiocolchicoside Azevedos
CMS:
Italy: Tyomol