CALTHEK 500 mg Tablets

Contents of the leaflet

1. Introduction
2. What is Calthek and what is it used for
3. What you need to know before taking Calthek
4. How to take Calthek
5. Possible side effects
6. Conservation of Calthek
7. Contents of the packaging and additional information

Introduction

Package Leaflet: Information for the Patient

Calthek500 mg Tablets

Readthe entire package leaflet carefully before starting to take this medication,as it contains important information for you.

• Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.
• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days.

Contentsof the Package Leaflet

1. What is Calthek and what is it used for
2. What you need to know before taking Calthek
3. How to take Calthek
4. Possible side effects

5 Conservation of Calthek

1. Contents of the packaging and additional information

1. What is Calthek and what is it used for

Paracetamol is effective in reducing pain and fever.

It is indicated for the symptomatic relief of occasional pain of mild to moderate intensity and febrile states in adults and children over 10 years old (body weight over 33 kg).

2. What you need to know before taking Calthek

Do not takeCalthek

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

Paracetamol should be used with special caution in the following situations:

Do not take more medication than recommended in section 3.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paracetamol.

• if you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic beverages per day);
• if you have kidney problems;
• if you have a deficiency of glucose-6-phosphate dehydrogenase;
• if you have anorexia, bulimia, cachexia, or chronic malnutrition;
• if you suffer from dehydration or hypovolemia;
• if you are taking a medication to treat epilepsy, you should consult your doctor before taking this medication, as when used at the same time, it decreases the effectiveness and increases the hepatotoxicity of paracetamol, especially in treatments with high doses of paracetamol (see below in this section)
• if you have Gilbert's disease (also known as Meulengracht's disease);
• if you have heart, respiratory, or anemia failure; in these situations, administration should be carried out under surveillance and only for short periods;
• if you have asthma and are sensitive to acetylsalicylic acid;
• Paracetamol may cause severe skin reactions, such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of severe skin reactions and the use of the medication should be discontinued at the first sign of skin rash or any other sign of hypersensitivity.
• The total dose of paracetamol should not exceed 3 g per day.
• The simultaneous use of this medication with other medications that contain paracetamol, such as flu and cold medications, should be avoided, as high doses can cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor. If an overdose occurs, seek medical attention immediately (see "If you take more than you should").
• Chronic alcoholics should be careful not to take more than 2 grams of paracetamol in 24 hours.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, the clinical situation should be evaluated by your doctor. This medication should not be used for self-medication of high fever (over 39°C), fever that lasts more than 3 days, or recurrent fever, unless indicated by your doctor, as these situations may require medical evaluation and treatment.

The administration of paracetamol doses higher than recommended implies a very serious risk of liver injury. Medications that contain paracetamol should not be taken for more than a few days or in high doses unless indicated by your doctor.

Prolonged use of analgesics or inadequate use of high doses can cause headaches, which should not be treated with higher doses of the medication.

During treatment with Calthek, inform your doctor immediately if:

If you have serious illnesses, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Other medications andCalthek

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

In particular, if you are using any of the following medications, it may be necessary to modify the dose of one of them or interrupt treatment:

• Medications to prevent blood clot formation: oral anticoagulants (acenocoumarol, warfarin).
• Medications to treat epilepsy: antiepileptic medications (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications to treat tuberculosis: (isoniazid, rifampicin)
• Medications to treat depression and seizures: barbiturics (used as hypnotics, sedatives, and anticonvulsants).
• Medications to reduce cholesterol levels in the blood: (cholestyramine)
• Medications to increase urine elimination (loop diuretics such as those in the furosemide group).
• Medications used to treat gout (probenecid and sulfinpyrazone).
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications for the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.
• Salicylamide, a medication to treat fever and pain, may prolong the elimination half-life of paracetamol
• Zidovudine (used in the treatment of HIV infections).

Inform your doctor or pharmacist if you are taking:

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomalies (metabolic acidosis with high anion imbalance) that should be treated urgently.

Interference with analytical tests:

If you are going to have any analytical tests (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the results. Paracetamol may alter the values of analytical determinations of uric acid and glucose.

TakingCalthekwith food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, ... per day) may cause liver damage.

Taking this medication with food does not affect its efficacy.

Children and adolescents

Paracetamol should not be used in children under 10 years of age or weighing less than 33 kg.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before taking this medication

IMPORTANT FOR WOMENIf you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Taking medications during pregnancy can be dangerous for the embryo or fetus and should be controlled by your doctor.

Pregnancy and breastfeeding

If necessary, Paracetamol can be used during pregnancy. You should 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.

Breastfeeding

Consult your doctor or pharmacist before taking this medication.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medication.

Fertility

No harmful effects on fertility are known with the normal use of paracetamol

Driving and using machines:

The influence of paracetamol on the ability to drive and use machines is nil or insignificant.

3. How to take Calthek

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

The recommended dose is:

Adults andadolescents over 15 years old (body weight over 50 kg):

1 tablet every 4-6 hours.

The doses should be spaced at least 4 hours apart.

Maximum dosage: Do not exceed 3 g of paracetamol (6 tablets) in 24 hours.

Children and adolescents over 10 years old (body weight over 33 kg)

It is necessary to respect the dosages defined according to weight. The child's age is given for informational purposes.

-Children between 33 kg and 40 kg in weight: 1 tablet 3 or 4 times a day. The doses should be spaced at least 4 hours apart.

Maximum dosage: 4 tablets per day.

-Between 41 and 50 kg in weight: 1 tablet 3 or 4 times a day. The doses should be spaced at least 4 hours apart.

Maximum dosage: 5 tablets per day.

Paracetamol should not be used in children under 10 years of age or weighing less than 33 kg.

Patient with liver disease: consult your doctor before taking this medication.

They should take the prescribed amount of medication with a minimum interval of 8 hours between each dose.

They should not take more than 2 g (4 tablets) in 24 hours. The doses should be spaced at least 4 hours apart.

In chronic alcoholics, the dose should not exceed 2 g per day.

Patient with kidney disease: Consult your doctor before taking this medication.

Patients with moderate to severe renal disease should take a maximum of 500 mg of paracetamol per dose, every 6-8 hours.

This medication is taken orally.

The tablets should be swallowed with the help of a glass of liquid, preferably water.

The tablets are scored, which allows them to be divided in half. The tablet can be divided into equal doses.

Always use the lowest effective dose.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of adverse effects such as liver damage increases.

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

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

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 (telephone 91 562 04 20), indicating the medication and the amount ingested.

If you have ingested an overdose, you should go quickly to a medical center even if you have no symptoms, as they often do not manifest until 3 days after ingestion of the overdose, even in cases of severe poisoning.

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

Treatment of the overdose is more effective if started within 4 hours after ingestion of the medication.

Patient taking barbiturics or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to takeCalthek

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, take the forgotten dose as soon as you remember, taking the following doses with the indicated separation between doses (at least 4 hours).

If you stop treatment withCalthek

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

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone experiences them.

The following side effects have been reported:

Rare: may affect up to 1 in 1,000 people.

• discomfort
• low blood pressure (hypotension)
• increased levels of transaminases in the blood.

Very rare: may affect up to 1 in 10,000 people

• kidney disease,
• cloudy urine,
• allergic dermatitis (skin rash),
• jaundice (yellowing of the skin),
• blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia),
• hypoglycemia (low blood sugar level).
• Very rarely, cases of severe skin reactions have been reported.

Frequency not known (cannot be estimated from available data):

A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with serious disease using paracetamol (see section 2).

Paracetamol may damage the liver when taken in high doses or in prolonged treatments.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Calthek

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

Composition ofCalthek

• The active ingredient is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other components (excipients) are pregelatinized cornstarch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and contents of the packaging

The tablets are oblong, biconvex, white, and scored, approximately 18 mm long and 8 mm wide.

Calthek is presented in packages of 20 tablets packaged in PVC/PVDC-Aluminum blisters.

Marketing authorization holder

Apotheke Laboratorios, S.L.

Paseo de la Castellana 40, 8th floor

28046 – Madrid, Spain

Manufacturer:

Toll Manufacturing Services, S.L.

c/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

or

Pharmex Advanced Laboratories S.L.

Ctra. A-431 Km.

Almodóvar del Río, 19

14720 Córdoba

Spain

or

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the last revision of this package leaflet: March 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/