Calthek 500 mg tablets

Package Leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Calthek 500 mg tablets

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

• Follow exactly the instructions for taking this medicine as described in this leaflet or as advised 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 3 days.

Contents of the leaflet

1. What Calthek is and what it is used for
2. What you need to know before taking Calthek
3. How to take Calthek
4. Possible side effects
5. Storage of Calthek
6. Contents of the pack and other information

1. What Calthek is and what it is used for

Paracetamol is effective in reducing pain and fever.

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

2. What you need to know before taking Febredol

Do not take Calthek

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

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

Do not take more medicine than the recommended dose stated in section 3.

Warnings and precautions

Talk to your doctor or pharmacist before taking paracetamol.

• if you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic drinks per day);
• if you have kidney problems;
• if you have glucose-6-phosphate dehydrogenase deficiency;
• if you have anorexia, bulimia, cachexia, or chronic malnutrition;
• if you are dehydrated or have hypovolemia;
• if you are taking a medicine to treat epilepsy, you must consult your doctor before taking this medicine, as concomitant use may reduce effectiveness and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol treatments (see below in this section);
• if you have Gilbert's disease (also known as Meulengracht's disease);
• if you have heart failure, respiratory failure, or anemia; in these cases, administration should be under medical supervision and only for short periods;
• if you have asthma and are sensitive to acetylsalicylic acid;
• Paracetamol may cause serious 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 serious skin reactions, and the medicine should be discontinued at the first sign of skin rash or any other sign of hypersensitivity.
• The total daily dose of paracetamol must not exceed 3 g.
• Concomitant use of this medicine with other medicines containing paracetamol, such as cold and flu remedies, should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor. If an overdose occurs, seek immediate medical attention (see "If you take more than you should").
• Chronic alcoholics should be careful not to exceed 2 grams of paracetamol in 24 hours.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, your condition should be evaluated by your doctor. This medicine should not be used for self-treatment of high fever (over 39°C), fever lasting more than 3 days, or recurrent fever, unless directed by your doctor, as these conditions may require medical evaluation and treatment.

Taking paracetamol doses higher than recommended poses a serious risk of severe liver injury. Medicines containing paracetamol should not be taken for longer than a few days or in high doses unless directed by your doctor.

Prolonged use of analgesics or inappropriate use of high doses may cause headaches, which should not be treated with higher doses of the medicine.

During treatment with Calthek, inform your doctor immediately if:

You have serious conditions such as severe renal failure 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 condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Other medicines and Calthek

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, if you are taking any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medicines to treat epilepsy: antiepileptic drugs (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines to treat tuberculosis: (isoniazid, rifampicin).
• Medicines to treat depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower blood cholesterol levels: (cholestyramine).
• Medicines to increase urine output (loop diuretics such as those in the furosemide group).
• Medicines used to treat gout: (probenecid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines for treating high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.
• Salicylamide, a medicine used 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 abnormalities (metabolic acidosis with high anion gap) that requires urgent treatment.

Interference with laboratory tests:

If you are scheduled for any laboratory tests (including blood and urine tests, etc.), inform your doctor that you are taking this medicine, as it may affect test results. Paracetamol may alter the analytical values of uric acid and glucose.

Taking Calthek with food, drinks, and alcohol

Using paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

Taking this medicine with food does not affect its effectiveness.

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 medicine.

IMPORTANT FOR WOMEN
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be supervised by your doctor.

Pregnancy and breastfeeding

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

Breastfeeding

Consult your doctor or pharmacist before taking this medicine.

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

Fertility

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

Driving and using machines:

The effect of paracetamol on the ability to drive and use machines is none or negligible.

3. How to take Calthek

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 15 years of age (body weight above 50 kg):

1 tablet every 4–6 hours.

Doses must 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 of age (body weight above 33 kg):

It is necessary to follow the dosages defined according to body weight. The child's age is provided for informational purposes only.

-Children weighing between 33 kg and 40 kg: 1 tablet 3 or 4 times daily. Doses must be spaced at least 4 hours apart.

Maximum dosage: 4 tablets per day.

-Weighing between 41 and 50 kg: 1 tablet 3 or 4 times daily. Doses must be spaced at least 4 hours apart.

Maximum dosage: 5 tablets per day.

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

Patients with liver disease: consult your doctor before taking this medicine.

They must take the amount of medicine prescribed by their doctor, with a minimum interval of 8 hours between doses.

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

In chronic alcoholics, the daily dose must not exceed 2 g.

Patients with kidney disease: consult your doctor before taking this medicine.

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

This medicine is taken orally.

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

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

Always use the lowest dose that is effective.

Prolonged use of high daily doses of paracetamol should be avoided, as this increases the risk of adverse effects such as liver damage.

Administration of this medicine should be limited to periods when pain or fever are present. As these symptoms subside, treatment should be discontinued.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, treatment must be stopped and a doctor consulted.

If you take more Calthek than you should

You must 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 medicine and the amount ingested.

If you have taken an overdose, you must go quickly to a medical center even if there are no symptoms, as symptoms often do not appear until 3 days after the overdose has been ingested, even in cases of severe poisoning.

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

Treatment of overdose is most effective if started within 4 hours of taking the medicine.

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

If you forget to take Calthek

Do not take a double dose to make up for missed doses. If you forget to take a dose, take the missed dose as soon as you remember, taking the following doses at the recommended intervals (at least 4 hours apart).

If you stop treatment with Calthek

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

The following adverse effects have been reported:

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

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

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

• kidney disorders,
• cloudy urine,
• allergic dermatitis (skin rash),
• jaundice (yellowing of the skin),
• blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia),
• hypoglycaemia (low blood sugar levels).
• Very rarely, cases of serious skin reactions have been reported.

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

A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Paracetamol may cause liver damage when taken at high doses or during 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Calthek

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Calthek

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

Appearance of the product and contents of the container

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

Calthek is available in packs of 20 tablets 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 most recent revision of this leaflet: March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/