PATIENT INFORMATION LEAFLET

Adalgur500 mg/2 mg tablets

Paracetamol / Tiocolchicoside

Read this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask yourdoctororpharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult yourdoctororpharmacist,even if they are not listed in this leaflet. See section 4.

1.What Adalgur is and what it is used for

2.What you need to know before you start taking Adalgur

3.How to take Adalgur

4.Possible side effects

5.Storage of Adalgur

6.Contents of the pack and additional information

Adalguris an association of an analgesic (to reduce pain) and a muscle relaxant.It is used in adults and older adolescents over 16 years old asadjunctive treatmentfor painful muscle contractions. It should be used for acute diseases related to the spinal column.

Do not take Adalgur:

• if you are allergic to paracetamol, tiocolchicoside, or any of the other components of this medication (listed in section 6).
• if you have a severe liver disease.
• in case of paralysis or muscle weakness
• if you have a severe blood disorder called hemolytic anemia
• if you are pregnant, may become pregnant, or think you may be pregnant.
• if you are a fertile woman not using adequate contraceptive methods.
• if you are breastfeeding.

Warnings and precautions

Strictly follow the dose and duration of treatment indicated in section 3. Do not take this medication at high doses or for more than 7 days. This is because one of the products formed in your body when you take tiocolchicoside at high doses can damage some cells (abnormal number of chromosomes). This has been demonstrated in animal studies and laboratory studies. In humans, this type of cell damage is a risk factor for cancer, fetal damage, and male infertility. Consult your doctor if you have any questions.

Your doctor will inform you about all the measures related to effective contraceptive methods and the potential risk of pregnancy.

During treatment with Adalgur, immediately inform your doctor if:

• you have epilepsy or are at risk of seizures, as seizures may occur with the use of this medication.
• you have chronic alcoholism, as you should be careful not to take more than 2 g/day of paracetamol.
• you have liver problems, including Gilbert's syndrome (mild jaundice), or kidney problems,
• you suffer from chronic malnutrition or dehydration
• you have any heart or lung disease or anemia (decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells) or have low levels of a blood enzyme called glucose-6-phosphate dehydrogenase.
• you have asthma or a history of asthma, and/or are sensitive to acetylsalicylic acid.

If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have chronic malnutrition, alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Consuming alcoholic beverages can cause paracetamol to damage the liver.

If the pain persists for more than 3 days or worsens or other symptoms appear, treatment should be interrupted and the doctor consulted.

Children and adolescents

This medication should not be administered to children and adolescents under 16 years of age for safety reasons.

Use of Adalgur with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Other medications and paracetamol

Inform your doctor or pharmacist if you are taking:

• Oral anticoagulants (used for the treatment of thromboembolic diseases)
• Antiepileptics (used for the treatment of seizures)
• Antibiotics (cloranfenicol)
• Oral contraceptives
• Activated charcoal (used for diarrhea or gas treatment)
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Diuretics (used to increase urine elimination)
• Isoniazid (used for the treatment of tuberculosis)
• Lamotrigine (used for the treatment of epilepsy)
• Probenecid (used for the treatment of gout)
• Propranolol (used for the treatment of hypertension, cardiac arrhythmias)
• Rifampicin (used for the treatment of tuberculosis)
• Anticholinergics (used for the relief of spasms or contractions of the intestine and bladder)
• Zidovudine (used for the treatment of HIV infections)
• Colestiramine (used to reduce blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (called metabolic acidosis) that must receive urgent treatment (see section 2)

Do not use with other analgesics (pain-relieving medications) without consulting your doctor.

Interference with analytical tests:

If you are to undergo any analytical test (including blood, urine, skin tests that use allergens, etc.) inform your doctor that you are taking this medication, as it may alter the results of these tests.

Taking Adalgur with food, drinks, and alcohol

Consuming alcohol may increase the liver toxicity of paracetamol.

Pregnancy, breastfeeding, and fertility

Do not take this medication if:

• you are pregnant, may become pregnant, or think you may be pregnant.
• you are a fertile woman not using adequate contraceptive methods.

This is because this medication can damage the fetus.

Do not take this medication if you are breastfeeding. This is because the medication is excreted in breast milk.

This medication may cause male infertility problems, due to potential damage to sperm (abnormal number of chromosomes). These data are based on laboratory studies (see section 2 "Warnings and precautions").

Driving and operating machinery

You may feel drowsy with this medication, so it is recommended that you do not drive or operate machinery until you check that this medication does not affect you.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Adults and adolescents over 16 years old:

The recommended dose is 1 or 2 tablets per dose. Doses may be repeated 2 to 4 times a day.

The maximum recommended unit dose is 2 tablets per dose and the minimum interval between each administration is 6 hours.

The recommended and maximum dose of tiocolchicósido is 4 mg every 6 hours (i.e., 16 mg per day). The treatment duration is limited to 7 consecutive days.

Do not exceed the recommended dose or treatment duration.

This medication should not be used as prolonged treatment (see section 2 “Warnings and precautions”).

If the pain persists for more than 3 days, or if the pain worsens or other symptoms appear, you should consult your doctor.

Use in children and adolescents

This medication should not be administered to children and adolescents under 16 years old for safety reasons.

Patients with liver or kidney disease:Before taking the medication, they should consult their doctor.

Patients of advanced age: they should consult their doctor.

If you take more Adalgurthan you should

If you accidentally take more Adalgur than you should, consult your doctor or pharmacist immediately or go to the nearest hospital, bringing the remaining tablets with you to inform the doctor. You can also call theToxicological Information Service. Phone:91 562 04 20

If you have taken an overdose, you should go to a medical center immediately, even if you do not have symptoms, as symptoms often do not appear until three days after taking the overdose, even in cases of severe intoxication. The symptoms of an overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the medication.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forgot to takeAdalgur

Do not take a double dose to compensate for the missed doses. If you forgot to take a dose of Adalgur when it was due, take it as soon as you remember and then wait the indicated time between doses (at least 4 to 6 hours, depending on the dose) to take the next one.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Rare Adverse Effects (may affect up to 1 in 1,000 patients)

• Discomfort
• Agitation, dizziness
• Skin allergic reactions
• Increased levels of liver transaminases (liver enzymes),
• Stomach pain or burning, diarrhea, nausea, vomiting
• Hypotension (decreased blood pressure).

Very Rare Adverse Effects (may affect up to 1 in 10,000 patients)

• Allergic reactions (hypersensitivity) ranging from a simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a severe type of allergic reaction). In this case, treatment should be discontinued immediately and a doctor consulted.
• Drowsiness
• Hepatotoxicity (liver toxicity) and jaundice (yellow discoloration of skin and mucous membranes).
• Hypoglycemia (reduced blood glucose levels).
• Thrombocytopenia (reduced platelet count in blood), agranulocytosis, leucopenia, neutropenia (alterations in white blood cells), hemolytic anemia (reduced red blood cell count).
• Purulent urine, kidney adverse effects.
• Severe skin reactions have been rarely reported.

Unknown Frequency (cannot be estimated from available data): A severe disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it ispossibleadverse effects not listed in this prospectus.You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight andreach of children.

No special storage conditions are required

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or inthe trash. Disposeof the packaging and unused medications at the SIGREcollection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Adalgur tablets

• The active principles are paracetamol and tiocolchicoside. Each tablet contains 500 mg of paracetamol and 2 mg of tiocolchicoside.
• The other components are: cornstarch, sodium carboxymethylstarch from potato, magnesium stearate (E572), hydroxypropylcellulose (E463), talc (E553b).

Appearance of the product and contents of the packaging

Adalgur are round, flat, yellowish tablets, scored on one face.The score is only for breaking the tablet if it is difficult to swallow whole,but not for dividing it into equal doses.

It is presented in packs of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Teofarma S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene (PV) - Italy

Date of the last review of this leaflet:February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.