PARACETAMOL TEVA GROUP 500 mg TABLETS
How to use PARACETAMOL TEVA GROUP 500 mg TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Paracetamol Teva Group 500 mg Tablets EFG
Read the 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, pharmacist, or nurse.
This medication can be purchased without a prescription. Nevertheless, to obtain the best results, it should be used with caution.
- 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, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
- You should consult your doctor if your fever worsens or persists after 3 days of treatment or if your pain lasts for more than 5 days.
Contents of the Package Leaflet
- What is Paracetamol Teva Group and what is it used for
- What you need to know before taking Paracetamol Teva Group
- How to take Paracetamol Teva Group
- Possible side effects
- Storage of Paracetamol Teva Group
- Package Contents and Additional Information
1. What is Paracetamol Teva Group and what is it used for
Paracetamol belongs to the group of medications called analgesics and antipyretics.
Paracetamol is used to treat mild to moderate pain and febrile states in adults and children over 12 years old (or with a body weight over 40 kg).
2. What you need to know before taking Paracetamol Teva Group
Do not take Paracetamol Teva Group:
If you are allergic (hypersensitive) to paracetamol or to any of the other components of this medication (listed in section 6).
Be cautious when taking Paracetamol Teva Group:
- Do not take more medication than recommended in section 3. How to take Paracetamol Teva Group.
- Avoid simultaneous use of this medication with other medications containing paracetamol, such as flu and cold medications, as high doses can cause liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.
- In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medication.
- If you have liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood), you should consult your doctor before taking this medication.
- When being treated with medication for epilepsy, consult your doctor before taking this medication, as the efficacy of paracetamol may be reduced and hepatotoxicity increased when used together, especially with high doses of paracetamol.
- In chronic alcoholics, be cautious not to take more than 4 tablets of 500 mg or 2 grams of paracetamol per day.
- If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsens or other symptoms appear, consult your doctor and reassess the clinical situation.
- In children under 10 years old, consult your doctor or pharmacist, as there are other presentations with doses suitable for this group of patients.
During treatment with paracetamol, inform your doctor immediately if:
- You have severe illnesses, 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 taking flucloxacillin (an antibiotic). A severe 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. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.
Other medications and Paracetamol Teva Group:
Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.
Paracetamol may interact with the following medications:
- Medications 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: barbiturics (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
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).
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, paracetamol may be administered occasionally as the analgesic of choice.
Interference with analytical tests:
If you are going to undergo any analytical test (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.
Taking Paracetamol Teva Group with food, drinks, and alcohol
The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages per day: beer, wine, liquor...) may cause liver damage.
Taking this medication with food does not affect its efficacy.
Pregnancy and Breastfeeding
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.
In case of necessity, Paracetamol Teva Group 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.
Small amounts of paracetamol may appear in breast milk; therefore, 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.
This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially "sodium-free".
3. How to take Paracetamol Teva Group
Follow these instructions unless your doctor has given you different instructions. Remember to take your medication. Paracetamol should be taken orally.
The normal dose is:
Adults and children over 12 years old, or with a body weight over 40 kg:
Take 1 tablet every 4-6 hours, as needed, up to a maximum of 6 tablets per day. Do not take more than 3 grams of paracetamol in 24 hours. The doses should be spaced at least 4 hours apart.
Avoid using high daily doses of paracetamol for prolonged periods, as this increases the risk of adverse effects such as liver damage.
If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsens or other symptoms appear, you should stop treatment and consult your doctor.
Children: It is necessary to respect the dosages defined according to weight. The child's age in relation to weight is provided for informational purposes.
The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.
Children between 33 and 40 kg: 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.
Children between 41 and 50 kg: 1 tablet per dose, every 4-6 hours, up to a maximum of 6 tablets per day.
Patients with liver disease: Before taking this medication, they must consult their doctor.
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 grams or 4 tablets of 500 mg of paracetamol in 24 hours.
Patients with kidney disease: Before taking this medication, they must consult their doctor. Take a maximum of 500 mg per dose.
Elderly patients: They should consult their doctor.
Use in children and adolescents:
Do not use in children under 12 years old.
If the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist.
When a dose lower than 500 mg of paracetamol per dose is required, other presentations of paracetamol that adapt to the required dosage should be used.
If you take more Paracetamol Teva Group than you should:
You should consult 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 should go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.
Treatment of overdose is more effective if started within 4 hours after ingestion of the medication.
Patients being treated with barbiturics or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.
If you forget to take Paracetamol Teva Group:
Do not take a double dose to make up for forgotten doses; simply take the forgotten dose when you remember, taking the next doses with the indicated interval (at least 4 hours).
4. Possible side effects
Like all medications, this medication can cause side effects, although not everyone will experience them.
Rare side effects that may occur (in up to 1 in 1,000 people) are: discomfort, low blood pressure (hypotension), and increased transaminase levels in the blood.
Very rare side effects that may occur (in up to 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.
Paracetamol may cause liver damage when taken in high doses or for prolonged periods.
Unknown side effects (cannot be estimated from available data): A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).
Reporting side effects
If you experience any side effects, consult your doctor or pharmacist, even if they are 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 Paracetamol Teva Group
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 disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection 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. Package Contents and Additional Information
Composition of Paracetamol Teva Group:
The active ingredient is paracetamol. Each tablet contains 500 mg of paracetamol.
The other components are: potato starch glycolate (Type A), purified water, pregelatinized corn starch, povidone K30 (E1201), stearic acid (E570), and crospovidone (E1202).
Appearance of the product and package contents:
Paracetamol Teva Group is presented in oral tablets.
The tablets are biconvex, white, and round in shape.
The packaging is 20 tablets, packaged in PVC/PVDC/Aluminum blisters.
Marketing authorization holder and manufacturer:
Marketing authorization holder
Teva B.V.,
Swensweg 5,
2031GA Haarlem,
Netherlands
Manufacturer:
SAG Manufacturing S.L.U.
Crta. N-I, Km 36,
San Agustín de Guadalix,
28750 Madrid
Spain
or
Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain
You can request more information about this medication by contacting the local representative of the marketing authorization holder:
Teva Pharma, S.L.U.
C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,
Alcobendas, 28108, Madrid (Spain)
Date of the last revision of this package leaflet: January 2025
Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
- Country of registration
- Active substance
- Prescription requiredNo
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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