Package leaflet: Information for the user

[Product name] 500 mg + 2 mg Tablet Paracetamol + Thiocolchicoside

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet 1. What [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information

1. What [Product name] is and what it is used for

This medicine is a muscle relaxant. It is used in adults and adolescents from 16 years old as an adjunctive treatment for painful muscle contractions. It is used for spine-related acute episodes.

2. What you need to know before you take [Product name]

Do not take [Product name]: - if you are allergic to paracetamol, thiocolchicoside or any of the other ingredients of this medicine (listed in section 6). - if you are pregnant, if you may be pregnant or think you may be pregnant; - if you are a woman of childbearing potential who does not use contraceptive methods; - if you are breast-feeding; - if you suffer from severe liver disease; - if you suffer from flaccid paralysis or muscular hypotonia; - if you have a kidney disorder.

Warnings and precautions Talk to your doctor or pharmacist before taking [Product name].

Concomitant treatment with drugs that have potentially hepatotoxic action should be avoided. Do not associate with alcoholic beverages intake.

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Respect strictly the doses and duration of treatment detailed in section 3. You should not use this product at a higher dose or for longer than 7 days. This is because one of the products that forms in your body when taking thiocolchicoside at high doses may cause damage to some cells (abnormal number of chromosomes). This has been proven in animal studies and laboratory studies. In humans, this type of cell damage is a risk factor for cancer, fetal lesions and fertility problems in men. Talk to your doctor if you have further questions.

The doctor will tell you about all the measures related to effective contraception and the potential risk of a pregnancy.

If you notice any symptoms that may indicate liver damage during treatment with [Product name] (e.g. loss of appetite, nausea, vomiting, abdominal discomfort, fatigue, dark urine, jaundice, pruritus), you should stop taking [Product name] and seek immediate medical advice.

You should tell your doctor if you experience any of the following symptoms: Convulsion.

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

Other medicines and [Product name] Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

[Product name] may increase the toxicity of chloramphenicol. [Product name] may potentiate the effect of anticoagulants.

The simultaneous administration of [Product name] with aspirin, salicylates or non-steroidal anti- inflammatory drugs is not recommended. Simultaneous use of diflunisal with [Product name] increases the risk of hepatotoxicity. The expected analgesic response of this drug is altered by the administration of barbiturates. The effect of [Product name] is inhibited by the administration of colestipol, cholestyramine and estrogens. Isoniazid enhances the hepatotoxic capacity of [Product name].

[Product name] may cause increase in the following laboratory values: transaminases, alkaline phosphatase, ammonia, creatinine, lactate dehydrogenase and urea. [Product name] may cause interference in the determination of glucose and uric acid in the blood, and of metadrenaline and uric acid in urine.

Pregnancy, breast-feeding and fertility

Do not take this medicine if: - you are pregnant, if you may be pregnant or think you may be pregnant; - you are a woman of childbearing potential who does not use contraceptive methods. This is because this medicine may cause damage to the fetus.

Do not take this medicine if you are breast-feeding. This is because the medicine passes into breast milk.

This medicine may cause fertility problems in men due to potential damage to sperm (abnormal chromosome numbers). This is based on laboratory studies (see section 2 "Warnings and Precautions").

Driving and using machines There are no data regarding the effect of [Product name] on the ability to drive or use machines. Clinical studies have concluded that thiocolchicoside has no effect on psychomotor function. However,

2 there were some cases of drowsiness, which should be taken into account when driving or operating machinery.

[Product name] contains sodium. This medicinal product contains less than 1 mmol (23 mg) of sodium per dose, ie it is practically "sodium-free".

3. How to take [Product name]

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 1 to 2 tablets, 3 or 4 times a day. The duration of treatment is limited to 7 consecutive days.

The tablets should be taken whole with water. Do not exceed 8 tablets / 24 hours.

Do not exceed the recommended dosages and duration of treatment. This medicinal product must 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 due to safety concerns.

If you take more [Product name] than you should If you accidentally take more [Product name] than you should, talk to your doctor, pharmacist or nurse.

In case of overdose you may experience nausea, vomiting, anorexia, abdominal pain, diarrhea. If an overdose (more than 6 g of paracetamol in one intake, equivalent to 12 tablets in adults or more than 100 mg / kg in children) has been taken, you should go to the hospital even if there are no symptoms, as these usually begin to manifest on the third day after ingestion of the overdose.

The treatment includes: Gastric lavage or induction of vomiting. Oral administration of activated charcoal; Hemodialysis; Administration of acetylcysteine in appropriate doses.

If you forget to take [Product name] Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you stop taking [Product name] If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

Adverse effects are generally uncommon but they may be important in some cases, particularly those related to paracetamol.

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Hepatotoxicity at high doses or prolonged treatment.

Rare side effects: angioedema, allergic skin reactions, blood disorders (thrombocytopenia, pancytopenia, neutropenia, agranulocytosis and haemolytic anemia), drowsiness, nausea, vomiting, pancreatitis, fever, hypoglycaemia, jaundice, gastralgia and diarrhea.

Very rare side effects: severe allergic reactions such as pruritus and urticaria. At a not known frequency, inflammation of the liver (hepatitis) and convulsions may occur (see section 2).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store [Product name]

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 which is stated on the carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What [Product name] contains

- The active substance are paracetamol (500 mg) and thiocolchicoside (2 mg). - The other ingredients are: maize starch, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate and talc.

What [Product name] looks like and contents of the pack The tablets are yellowish, round, with a score line on one side. [Product name] is available in packs of 30 and 60 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder [To be completed nationally]

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

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Portugal

This medicinal product is authorised in the Member States under the following names:

RMS: Portugal: Paracetamol + Tiocolquicosido Azevedos

CMS: Italy: Descontran

This leaflet was last revised in 10/2019

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