Paracetamol Tevagen 1000 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Paracetamol Tevagen 1000 mg tablets EFG
paracetamol
Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.
Contents of this leaflet
- What Paracetamol Tevagen is and what it is used for
- What you need to know before taking Paracetamol Tevagen
- How to take Paracetamol Tevagen
- Possible side effects
- How to store Paracetamol Tevagen
- Contents of the pack and other information
1. What Paracetamol Tevagen is and what it is used for
Paracetamol belongs to a group of medicines called analgesics and antipyretics.
It is indicated for the treatment of pain and fever symptoms.
2. What you need to know before taking Paracetamol Tevagen
Do not take Paracetamol Tevagen
- If you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol Tevagen.
- Do not take more than the recommended dose stated in section 3. How to take Paracetamol Galenicum Health.
- In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
- If you have kidney, liver, heart, or lung disease, or have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.
- If you are being treated with medications for epilepsy, consult your doctor before taking this medicine, as when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially with high-dose paracetamol treatments.
- In chronic alcoholics, caution should be taken not to exceed 2 g 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, consult your doctor and reassess the clinical situation.
- In children under 15 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.
During treatment with paracetamol, 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 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.
Other medicines and Paracetamol Tevagen
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.
Paracetamol may interact with the following medicines:
- Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
- Medicines to treat epilepsy: Antiepileptics (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 used to increase urine elimination (loop diuretics such as those in the furosemide group)
- Medicines used in the treatment of gout (probenecid and sulfinpyrazone)
- Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
- Medicines used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.
Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).
Do not use with other analgesics (medicines that relieve pain) without consulting your doctor.
As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking any other medicine. In cases of treatment with oral anticoagulants, paracetamol may occasionally be administered as the analgesic of choice.
Interference with laboratory tests
If you are scheduled to undergo any laboratory tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking/using this medicine, as it may alter the results of these tests.
Taking Paracetamol Tevagen with food, drinks, and alcohol
The use of paracetamol in patients who regularly 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 efficacy.
Pregnancy, breastfeeding, and fertility
Consult your doctor or pharmacist before using any medicine.
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before taking this medicine.
The use of medicines during pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.
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 effect of paracetamol on the ability to drive and use machines is negligible or none.
Paracetamol Tevagen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; thus, it is essentially "sodium-free".
3. How to take Paracetamol Tevagen
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Paracetamol should be taken orally.
The recommended dose is:
Adults and children over 15 years of age: The usual dose is 1 tablet (1000 mg paracetamol) 3 times a day. Doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 g) in 24 hours.
Patients with liver disease: You must consult your doctor before taking this medicine. You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses.
Do not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.
Patients with kidney disease: You must consult your doctor before taking this medicine. Take a maximum of 500 milligrams per dose.
Due to the dosage (1000 mg of paracetamol), this formulation is not indicated for this group of patients.
Elderly patients: You should consult your doctor.
Use in children: Do not use in children under 15 years of age.
If you feel that the effect of Paracetamol Tevagen is too strong or too weak, inform your doctor or pharmacist. When doses lower than 1000 milligrams of paracetamol per dose are required, other paracetamol formulations appropriate for the required dosage should be used.
If you take more Paracetamol Tevagen than you should:
You should contact your doctor or pharmacist immediately.
Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
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 has been ingested, even in cases of severe poisoning.
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.
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 forget to take Paracetamol Tevagen:
Do not take a double dose to make up for missed doses. Simply take the missed dose as soon as you remember, and then take the following doses at the recommended intervals (at least 4 hours apart).
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Rare adverse effects (occurring in between 1 and 10 out of every 10,000 people) are: malaise, drop in blood pressure (hypotension), and increased blood transaminase levels.
Very rare adverse effects (occurring in fewer than 1 out of every 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.
Paracetamol may damage the liver when taken at high doses or over prolonged periods.
Adverse effects not known (frequency cannot be estimated from available data): A serious condition that may make the blood more acidic (called metabolic acidosis) in patients with serious illness who use paracetamol (see section 2).
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 can 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 Paracetamol Tevagen
Keep this medicine out of the 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 is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Paracetamol Tevagen:
Each tablet contains 1000 mg of paracetamol as the active substance.
The other components (excipients) are sodium carboxymethylstarch type A (derived from potato), purified water, pregelatinized starch (derived from maize), povidone K30 (E1201), stearic acid (E570) and crospovidone (E1202).
Appearance of the product and contents of the pack:
Paracetamol Tevagen is presented as tablets for oral administration.
The tablets are oblong, biconvex, white in colour, with a score on one side and marked "PC" on the other side.
Pack sizes of 20 and 40 tablets and hospital pack of 500 tablets, packed in PVC/PVdC/Aluminium blisters.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
Teva B.V.,
Swensweg 5,
2031GA Haarlem,
The Netherlands
Manufacturer
SAG Manufacturing S.L.U
Crta. N-I, Km 36,
San Agustín de Guadalix,
28750 Madrid
Spain
o
Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain
You can request further information about this medicine by contacting the local representative of the marketing authorization holder:
Teva Pharma, S.L.U.
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,
Alcobendas, 28108, Madrid (Spain)
Date of the most recent review of this leaflet: January 2025
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/