Calthek 650 mg tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Calthek 650 mg tablets
paracetamol
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed 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 adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 3 days of fever or 5 days of pain.
Leaflet contents:
- What Calthek is and what it is used for
- What you need to know before taking Calthek
- How to take Calthek
- Possible side effects
- How to store Calthek
- 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.
This medicine is used for the symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, muscle pain (muscle spasms), or back pain (lumbago), and in febrile conditions in adults and adolescents over 15 years of age.
2. What you need to know before starting to take Calthek
Do not take Calthek
- If you are allergic to paracetamol or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Do not take more than the recommended dose stated in section 3, "How to take Calthek."
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 you have liver, kidney, heart, or lung disease, or suffer from anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), you should consult your doctor before taking this medicine.
If you are being treated with medication for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially when high doses of paracetamol are used.
In chronic alcoholics, caution should be taken not to exceed 3 tablets of 650 mg paracetamol in 24 hours.
Asthmatic patients who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, you should consult your doctor and reassess the clinical situation.
During treatment with Calthek, inform your doctor immediately:
If you have serious conditions such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from 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 over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.
Interaction of Calthek with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Paracetamol may interact with the following medicines:
- Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
- Medicines for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
- Medicines for tuberculosis: (isoniazid, rifampicin)
- Medicines for depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
- Medicines to lower blood cholesterol levels: (cholestyramine)
- Medicines used to increase urine elimination (loop diuretics such as furosemide)
- Medicines used in the treatment of gout (probenecid and sulfinpyrazone)
- Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
- Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.
Do not use together with other analgesics (medicines that relieve pain) without consulting your doctor.
Inform your doctor or pharmacist if you are taking:
Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).
As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are being treated with another medicine. In patients treated with oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.
Interference with diagnostic tests:
If you are scheduled to undergo any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.
Calthek with food and drink:
The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day: beer, wine, liquor, etc.) may cause liver damage. |
Taking this medicine with food does not affect its efficacy.
Use in children and adolescents:
Do not use in children or adolescents under 15 years of age.
Pregnancy and breastfeeding
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.
Paracetamol may be used during pregnancy if necessary. You should use the lowest possible dose that relieves pain or fever and take it for the shortest possible time. Contact your doctor if pain or fever do not improve, or if you need to take the medicine more frequently.
Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.
Driving and using machines
The influence 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 provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
Depending on your preference, the tablets may be taken whole or split in half, with a glass of liquid, preferably water. The score line is intended solely for splitting the tablet if you have difficulty swallowing it whole.
Always use the lowest effective dose.
The prolonged use of high daily doses of paracetamol should be avoided, as this increases the risk of adverse effects such as liver damage.
This medicine should only be administered when pain or fever occurs. 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, discontinue treatment and consult your doctor.
Recommended dose:
Adults and adolescents over 15 years of age weighing more than 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: must consult their doctor before taking this medicine. They should take the amount prescribed by their doctor, with a minimum interval of 8 hours between doses. Do not take more than 3 tablets in 24 hours, divided into 3 doses.
Patients with kidney disease: must consult their doctor before taking this medicine.
Patients with moderate or severe liver disease may take a maximum of 500 mg of paracetamol per dose. Due to its paracetamol content, this medicine should not be used in these patients.
Elderly patients: must consult their doctor.
Use in children and adolescents:
Do not use in children (under 12 years of age) or adolescents weighing less than 50 kg. Other formulations are available that allow appropriate dosing for this patient group.
If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
If you take more Calthek than you should:
Contact 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 immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose, 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 for 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. Simply take the missed dose as soon as you remember, then take the following doses at the recommended intervals (at least 4 hours apart).
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody gets them.
Rare adverse effects (occurring in up to 1 in 1,000 people) are: malaise, drop in blood pressure (hypotension), and increased blood transaminase levels.
Very rare adverse effects (occurring in up to 1 in 10,000 people) are:
Kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).
Very rare cases of severe 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 use 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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Calthek
This medicine does not require special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.
“Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point**1 at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.”
6. Contents of the pack and other information
Composition of Calthek
The active substance is paracetamol. Each tablet contains 650 mg of paracetamol.
The other components are: pregelatinized corn starch, stearic acid, povidone, crospovidone, microcrystalline cellulose and vegetable magnesium stearate.
Appearance of Calthek and contents of the pack
White, oblong, film-coated tablets, scored on one side, packed in PVC/PVDC-Aluminum blisters.
This medicine is available in packs of 20 tablets.
Marketing Authorization Holder
Apotheke Laboratorios, S.L.
Paseo de la Castellana 40, 8th floor
28046 - Madrid
Spain
Manufacturer
Toll Manufacturing Services S.L
Calle Aragoneses, 2. 28108 Alcobendas (Madrid)
Spain
or
Farmalider S.A.
Calle Aragoneses, 2. 28108 Alcobendas (Madrid)
Spain
Date of the most recent review of this leaflet: March 2025
“Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”