PARACETAMOL ALTER 650 mg TABLETS
How to use PARACETAMOL ALTER 650 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 Patient
Paracetamol Alter 650 mg Tablets EFG
Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.
- Keep this package leaflet, as you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, as it may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
Contents of the Package Leaflet
- What is Paracetamol Alter and what is it used for
- What you need to know before taking Paracetamol Alter
- How to take Paracetamol Alter
- Possible side effects
- Storage of Paracetamol Alter
- Contents of the pack and further information
1. What is Paracetamol Alter and what is it used for
Paracetamol belongs to a group of medicines called analgesics and antipyretics.
This medicine is used for the symptomatic treatment of mild or moderate pain and fever in adults and adolescents from 15 years of age and weighing over 50 kg.
2. What you need to know before taking Paracetamol Alter
Do not take Paracetamol Alter
- If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol Alter.
- Do not take more than the recommended dose in section 3. How to take Paracetamol Alter.
- Avoid taking this medicine at the same time as other medicines that contain paracetamol, such as flu and cold medicines, as high doses can lead to liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
- Chronic alcoholics should be cautious not to take more than 2 grams of paracetamol in 24 hours.
- Patient with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medicine.
- When being treated with certain medicines for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be decreased and hepatotoxicity increased, especially with high doses of paracetamol.
- Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
- If you have severe diseases, such as severe renal 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 (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 breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.
Children and adolescents
This medicine should not be used in children under 15 years of age or weighing less than 50 kg.
Other medicines and Paracetamol Alter
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
In particular, if you are taking any of the following medicines, it may be necessary to modify the dose of some of them or interrupt treatment:
- Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
- Medicines for treating epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
- Medicines for treating tuberculosis (isoniazid, rifampicin)
- Medicines for treating depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
- Medicines to lower cholesterol levels in the blood (cholestyramine)
- Medicines used to increase urine elimination (loop diuretics such as furosemide)
- Medicines used to treat gout (probenecid and sulfinpyrazone)
- Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
- Medicines used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.
Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis) that must be treated urgently (see section 2).
Interference with laboratory tests
If you are going to have any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter the results.
Taking Paracetamol Alter with food, drinks, and alcohol
The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, etc. per day) may cause liver damage.
Taking this medicine with food does not affect its efficacy.
Pregnancy and breastfeeding
Pregnancy
Consult your doctor or pharmacist before taking any medicine.
IMPORTANT FOR WOMEN If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. Taking medicines during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor. |
In case of necessity, paracetamol 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 medicine more frequently.
Breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medicine.
Driving and using machines
The influence of paracetamol on the ability to drive and use machines is negligible or non-existent.
3. How to take Paracetamol Alter
Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
The recommended dose is:
Adults and adolescents over 15 years of age (weight > 50 kg): take 1 tablet every 4-6 hours as needed.
Do not take more than 4 grams (6 tablets) in 24 hours.
Patient with liver disease: before taking this medicine, you must consult your doctor. They should take the amount of medicine prescribed by their doctor with a minimum interval of 8 hours between each intake.
Do not take more than 3 tablets in 24 hours, divided into 3 intakes.
Chronic alcoholics: should be cautious not to take more than 2 grams of paracetamol in 24 hours.
Patient with kidney disease: before taking this medicine, they must consult their doctor.
Take a maximum of 500 milligrams per intake. Due to the dose, 650 milligrams of paracetamol, the medicine is not indicated for this group of patients.
This medicine is taken orally.
The tablets should be swallowed whole or broken in half with the help of a glass of liquid, preferably water.
The tablets are scored. The tablet can be divided into equal doses.
Always use the lowest effective dose.
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 medicine is subject to the appearance of pain or fever. As these disappear, treatment should be discontinued.
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.
If you take more Paracetamol Alter than you should
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. Symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and pancreatitis (inflammation of the pancreas).
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, even in cases of severe poisoning.
Treatment of overdose is more effective if started within 4 hours of ingestion of the medicine.
Patient treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.
If you forget to take Paracetamol Alter
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 between intakes (at least 4 hours).
If you stop taking Paracetamol Alter
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare side effects that may occur (between 1 and 10 in every 10,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.
Very rare side effects that may occur (in less than 1 in every 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.
Frequency not known (cannot be estimated from the available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).
Paracetamol can damage the liver when taken in high doses or in prolonged treatments.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Paracetamol Alter
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. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.
6. Contents of the pack and further information
Composition of Paracetamol Alter
- The active substance is paracetamol. Each tablet contains 650 mg of paracetamol.
- The other ingredients are: pregelatinized maize starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and magnesium stearate.
Appearance of the product and pack contents
Paracetamol Alter is presented in the form of oral tablets, in packs of 40 tablets. The tablets are oblong, biconvex, white, and scored, allowing them to be divided into equal doses.
Marketing authorization holder
Laboratorios Alter S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain
Manufacturer
Toll Manufacturing Services S.L.
C/ Aragoneses 2
28108 Alcobendas, Madrid
Spain
or
Farmalider, S.A.
C/ Aragoneses 2
28108 Alcobendas, Madrid
Spain
or
Pharmex Advanced Laboratories, S.L.
Ctra. A-431, Km. 19
14720 Almodóvar del Río, Córdoba
Spain
Date of last revision of this package leaflet:February 2025
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.
- Country of registration
- Average pharmacy price1.31 EUR
- Active substance
- Prescription requiredYes
- 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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