PATIENT INFORMATION LEAFLET

Calthek 650 mg Tablets

paracetamol

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

- Keep this leaflet, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

- You should consult a doctor if your symptoms worsen or do not improve after 3 days with fever or 5 days with pain.

Paracetamol is effective in reducing pain and fever.

This medication is used for symptomatic relief of occasional mild to moderate pain, such as headache, toothache, muscle pain (muscle spasms) or back pain (lumbago) and in febrile states in adults and adolescents over 15 years old.

Do not take Calthek

• If you are allergic to paracetamol or any of the other components of this medication (listed in section 6).

Warnings and precautions

Do not take more than the recommended dose in the section 3. How to take Calthek.Calthek.

Concomitant use of this medication with other medications containing paracetamol, such as cold and flu medications, may lead to liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.

If you have liver, kidney, heart, or lung disease, or anemia (decreased hemoglobin levels in the blood, with or without decreased red blood cells), consult your doctor before taking this medication.

When taking medication for epilepsy, consult your doctor before taking this medication, as concomitant use may decrease its effectiveness and increase the risk of liver damage, especially with high doses of paracetamol.

Chronic alcoholics should be cautious not to take more than 3 tablets of 650 mg of paracetamol in 24 hours.

Patients with asthma who are sensitive to acetylsalicylic acid should consult their doctor before taking this medication.

If the pain persists for more than 5 days, fever for more than 3 days, or if the pain or fever worsens or new symptoms appear, consult your doctor and reevaluate the clinical situation.

Inform your doctor immediately during treatment with Calthek:

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 malnutrition, chronic 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, somnolence, feeling unwell (nausea), and vomiting.

Calthek interactions with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

Paracetamol may interact with the following medications:

• Blood clot prevention medication: Oral anticoagulants (acenocoumarol, warfarin)
• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications for treating tuberculosis: (isoniazid, rifampicin)
• Medications for treating depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications used to lower cholesterol levels in the blood: (colestiramine)
• Medications used to increase urine elimination (diuretics such as furosemide)
• Medications used to treat gout (probencid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): Propranolol.

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

Inform your doctor or pharmacist if you are taking:

Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (metabolic acidosis) that requires urgent treatment (see section 2).

As a general rule, it is recommended to inform your doctor or pharmacist if you are taking any other medication. In the case of anticoagulant oral treatment, Calthek may be administered occasionally as the preferred analgesic.

Interference with analytical tests:

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

Calthek with food and beverages:

The taking of this medication with food does not affect its efficacy.

Use in children and adolescents:

Do not use in children or adolescents under 15 years old.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Paracetamol may be used during pregnancy if necessary. Use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medication more frequently.

Small amounts of paracetamol may appear in breast milk, so it is recommended to consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

The influence of paracetamol on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medication should be taken orally.

According to your preference, the tablets can be swallowed whole or broken in half with the help of a liquid, preferably water. The groove is only used to break the tablet if it is difficult to swallow it whole.

Always use the lower dose that is effective.

It should be avoided to use high daily doses of paracetamol for prolonged periods of time as it increases the risk of suffering adverse effects such as liver damage.

The administration of this medication is subject to the appearance of pain or fever. As these disappear, treatment should be suspended.

If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, treatment should be interrupted and your doctor consulted.

The recommended dose is:

Adults and adolescents over 15 years with a body weight of over 50 kg:take 1 tablet every 4 or 6 hours as needed. Do not take more than 3 tablets in 24 hours, divided into 3 doses.

Patients with liver disease:before taking this medication, they must consult their doctor. They should take the amount of medication prescribed by their doctor with a minimum interval of 8 hours between each dose. Do not take more than 3 tablets in 24 hours, divided into 3 doses.

Patients with kidney disease:before taking this medication, they must consult their doctor.

Patients with severe or moderate disease may take a maximum of 500 mg of paracetamol per dose. Due to the content of paracetamol, this medication should not be used in these patients.

Older patients:they should consult their doctor.

Use in children and adolescents::

Do not use in children (under 12 years) or adolescents with a body weight of less than 50 kg. There are other formulations that allow for appropriate dosing in this group of patients.

If it is estimated that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take moreCalthekthan you should:

You should consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you have ingested an overdose, go immediately to a medical center even if you do not notice the symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe intoxication.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

The treatment of overdose is more effective if it is initiated within 4 hours of medication ingestion.

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

If you forgot to takeCalthek:

Do not take a double dose to compensate for the missed doses. Simply take the missed dose when you remember, taking the next doses with the indicated interval (at least 4 hours).

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

Rare adverse effects that may occur (in up to 1 in 1,000 people), are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects that may occur (in up to 1 in 10,000 people) are:

Kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

Severe skin reactions have been reported very rarely.

Unknown frequency (cannot be estimated from available data):

A serious disease that can make the blood more acidic (designated metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Paracetamol can damage the liver when taken in high doses or prolonged treatment.

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through 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.

This medication does not require special storage conditions.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

“Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE 1 point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.1

Composition ofCalthek

The active principle is paracetamol. Each tablet contains 650 mg of paracetamol.

The other components are: maize pregelatinized starch, stearic acid, povidone, crospovidone, microcrystalline cellulose and plant-derived magnesium stearate.

Appearance ofCalthekand content of the packaging

Oblong, white, scored tablets, packaged in PVC/PVDC-Aluminium blisters.

This medicine is available in packs of 20 tablets.

Holder of the marketing authorization

Apotheke Laboratorios, S.L.

Paseo de la Castellana 40, 8th

28046 - Madrid

Spain

Responsible for manufacturing

Toll Manufacturing Services S.L

c/ Aragoneses, 2. 28108 Alcobendas (Madrid)

Spain

or

Farmalider S.A.

c/ Aragoneses, 2. 28108 Alcobendas (Madrid)

Spain

Revision date of thisleaflet:March 2025

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