CALTHEK FORTE 1 g TABLETS

2. What you need to know before taking Calthek Forte

Do not takeCalthek Forte

• 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 medication than recommended in section 3. How to take Calthek Forte.
• The simultaneous use of this medication with other medications containing paracetamol, such as flu medications, should be avoided, as high doses can lead to liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.

Consult your doctor or pharmacist before starting to take Calthek Forte.

• If you have kidney or liver disease.
• If you habitually consume alcohol (3 or more alcoholic beverages per day). In this case, you may need to take a lower dose of paracetamol and limit its use to shorter periods, as your liver may be affected. Chronic alcoholics should not take more than 2g of paracetamol in 24 hours.
• If you suffer from dehydration or chronic malnutrition caused, for example, by alcohol abuse, anorexia, or inadequate diet.
• If you have hemolytic anemia (caused by abnormal breakdown of red blood cells)
• If you have glucose-6-phosphate dehydrogenase deficiency (enzyme deficiency).
• If you are asthmatic and sensitive to acetylsalicylic acid.
• If you are taking other medications that affect the liver.
• If you are taking other medications that contain paracetamol, as this could cause serious liver damage.
• If you frequently take pain medications for long periods, as prolonged use can lead to more severe and frequent headaches. In these cases, consult your doctor, but do not increase the dose of analgesic.

The sudden interruption of long-term treatments with high doses of analgesics can produce withdrawal symptoms, such as headache, muscle pain, nervousness, or fatigue, which usually disappear within a few days. If you do not notice improvement, consult your doctor.

Taking higher doses than recommended may cause serious liver damage. Therefore, do not exceed the maximum daily dose indicated in section 3. How to take Calthek Forte. See also the section "If you take more Calthek Forte than you should".

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, you should consult your doctor and reassess the clinical situation.

Children and Adolescents

In children under 15 years of age, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.

During treatment with Calthek Forte, immediately inform your doctor if:

If you have serious illnesses, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (a blood and fluid anomaly) 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.

Taking Calthek Forte with other medications

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

Paracetamol may interact with the following medications:

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications to treat epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications to treat tuberculosis: (isoniazid, rifampicin)
• Medications to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood (cholestyramine)
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• Medications used to treat gout (probenecid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): propranolol.

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

As a general rule for any medication, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medication. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Inform your doctor or pharmacist if you are taking:

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

Interference with analytical tests:

If you are going to undergo any analytical test (including blood tests, urine tests, 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 Calthek Forte with food, drinks, and alcohol

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

Taking this medication with food does not affect its efficacy.

Pregnancy, Breastfeeding, and Fertility

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

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

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 Forte

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

The tablets are administered orally with the help of a glass of liquid, preferably water.

The tablets are scored, which allows them to be broken in half to facilitate swallowing.

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 these disappear, treatment should be suspended. 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 interrupted and your doctor consulted.

The recommended dose is:

Adults and adolescents over 15 years: the usual dose is 1 tablet (1g of paracetamol) 3 times a day. The doses should be spaced at least 4 hours apart. No more than 3 tablets (3g) should be taken in 24 hours.

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 between each dose of 8 hours. They should not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

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

Take a maximum of 500 milligrams per dose.

Due to the dose, 1 gram of paracetamol, the medication is not indicated for this group of patients.

Elderly patients: should consult their doctor.

Use in Children and Adolescents

Do not use in adolescents and children under 15 years.

If you think the action of this medication is too strong or too weak, inform your doctor or pharmacist.

When lower doses of paracetamol are required per dose, other paracetamol presentations that adapt to the required dosing should be used.

If you take more Calthek Forte than 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 immediately to a medical center, even if you do not notice symptoms, as they often do not appear 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 overdose is more effective if started within 4 hours of ingestion of the medication.

Patients being treated with barbiturates or suffering from chronic alcoholism may be more susceptible to the toxicity of a paracetamol overdose.

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

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

4. Possible Side Effects

Like all medications, Calthek Forte can cause side effects, although not everyone will experience them.

Rare side effects (may affect up to 1 in 1,000 patients):

• Blood platelet disorders (coagulation disorders), disorders of blood cell formation in the bone marrow
• Allergic reactions (hypersensitivity)
• Depression, confusion, hallucination
• Tremor, headache
• Abnormal vision
• Edema (abnormal accumulation of fluid under the skin)
• Abdominal pain, stomach or intestinal bleeding, diarrhea, nausea, vomiting
• Abnormal liver function, liver failure, jaundice (with symptoms such as yellowing of the skin and eyes), liver cell death (necrosis)
• Skin rash, itching, sweating, urticaria, red spots on the skin, angioedema with symptoms such as swelling of the face, lips, throat, or tongue
• Dizziness, general malaise, fever, sedation, interaction with other medications
• Overdose and poisoning

Very rare side effects (may affect up to 1 in 10,000 patients):

• Blood disorders (reduction in the number of platelets, white blood cells, and neutrophils in the blood, hemolytic anemia)
• Low blood sugar levels
• Liver toxicity (liver damage)
• Cloudy urine and kidney disorders
• Severe allergic reactions that require treatment interruption

Side effects of unknown frequency (cannot be estimated from available data):

Necrolysis (potentially fatal skin disorder), erythema multiforme (allergic reaction or skin infection), Stevens-Johnson syndrome (potentially fatal severe skin disorder), fluid accumulation in the larynx, anaphylactic shock (severe allergic reaction), anemia (reduction in red blood cells), liver alteration and hepatitis (liver inflammation), kidney disorders (severe kidney failure, blood in urine, inability to urinate), stomach and intestine disorders, vertigo.

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Calthek Forte

No special storage conditions are required.

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

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 disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your 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. Package Contents and Additional Information

Calthek Forte Composition

• The active ingredient is paracetamol.
• The other ingredients are: pregelatinized cornstarch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable magnesium stearate.

Product Appearance and Package Contents

Oblong tablets, white in color, and scored on one side, packaged in blisters.

This medication is available in packages of 10 tablets.

Marketing Authorization Holder

Apotheke Laboratorios, S.L.

Paseo de la Castellana 40, 8th floor

28046 - Madrid

Spain

Manufacturer

Toll Manufacturing Services, S.A.

c/ Aragoneses 2, 28108 Alcobendas

Madrid

or

Ferrer Internacional, S.A.

c/ Joan Buscalla, 1-9

08173 Sant Cugat del Vallès (Barcelona) Spain

or

Pharmaloop, S.L.

c/ Bolivia 15, Pol. Ind. Azque

28806 Alcalá de Henares (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/