PARACETAMOL PENSA PHARMA 1g TABLETS
How to use PARACETAMOL PENSA PHARMA 1g 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
Patient Information Leaflet
Paracetamol Pensa Pharma 1g Film-Coated Tablets EFG
Read this leaflet carefully before starting to take 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 or pharmacist.
- This medicine has been prescribed to you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Contents of the Leaflet
- What is Paracetamol Pensa Pharma and what is it used for
- What you need to know before taking Paracetamol Pensa Pharma
- How to take Paracetamol Pensa Pharma
- Possible side effects
- Storage of Paracetamol Pensa Pharma
- Package contents and additional information
1. What is Paracetamol Pensa Pharma and what is it used for
Paracetamol is an effective medicine for reducing pain and fever (analgesic and antipyretic).
Paracetamol is used for the relief of mild to moderate pain and/or fever in adults.
2. What you need to know before taking Paracetamol Pensa Pharma
Do not take Paracetamol Pensa Pharma
- If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine:
- If you have kidney disease.
- If you have heart or lung disease.
- If you have liver problems or are taking medication that affects liver function.
- If you have anemia (reduced red blood cells, which can cause pale and yellowish skin, weakness, and difficulty breathing).
- If you regularly consume excessive alcohol. In chronic alcoholics, you should not take more than 2 grams of paracetamol in 24 hours.
- If you are being treated with medication for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be reduced and hepatotoxicity increased, especially with high doses of paracetamol.
- If you are taking other medicines that contain paracetamol, as this may cause liver damage.
- If you are asthmatic and sensitive to acetylsalicylic acid (aspirin).
Do not use paracetamol habitually for a long time, as prolonged exposure can cause liver damage. Consult your doctor or pharmacist if you intend to take paracetamol for an extended period.
Do not use paracetamol without talking to your doctor if you have alcohol problems or liver problems. Do not use Paracetamol Pensa Pharma with alcohol. The effect of alcohol is not increased by taking Paracetamol Pensa Pharma.
Do not take more paracetamol than recommended in section 3 of this leaflet. Higher doses do not increase the pain-reducing effect but may cause serious liver damage. Symptoms of liver damage usually appear after a few days. Therefore, it is essential to contact your doctor as soon as possible if you have taken more than the recommended dose.
Children and adolescents
Do not use in children and adolescents under 18 years of age.
Other medicines and Paracetamol Pensa Pharma
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Do not takeany other medicine that contains paracetamol.
Paracetamol may affect or be affected by other medicines. Tell your doctor or pharmacist if you are taking any of the following medicines:
- Metoclopramide or domperidone (medicines used to prevent nausea and vomiting).
- Colestyramine (medicines used to lower cholesterol levels in the blood). Paracetamol should be taken at least 1 hour before or after this medicine.
- Warfarin or other medicines used to prevent blood clots, in case you need to take an analgesic daily for a prolonged period.
- Medicines used to increase urine production (diuretics such as furosemide).
- Probenecid (medicines used to treat gout).
- Substances that reduce liver enzymes, e.g., rifampicin (used to treat infections) and medicines used to treat epilepsy, such as barbiturates, phenytoin, carbamazepine, and primidone.
- Lamotrigine (medicine used to treat epilepsy), as paracetamol may reduce its efficacy.
- Propranolol (medicines used to treat high blood pressure and heart rhythm disorders).
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disorders (metabolic acidosis with high anion gap) that requires urgent treatment and may occur particularly in cases of severe kidney failure, sepsis, malnutrition, chronic alcoholism, and when using the maximum daily doses of paracetamol.
Paracetamol may alter some laboratory test results, such as blood sugar or uric acid tests.
Taking Paracetamol Pensa Pharma with food and alcohol
Using paracetamol in patients who regularly consume alcohol (3 or more alcoholic drinks per day) may cause liver damage.
Taking this medicine with food does not affect its efficacy.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
If necessary, Paracetamol Pensa Pharma 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.
Although small amounts of paracetamol are excreted in breast milk, no adverse effects have been reported in breastfed infants. Paracetamol can be used during breastfeeding.
Driving and using machines
The influence of paracetamol on the ability to drive and use machines is negligible.
Paracetamol Pensa Pharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; it is essentially "sodium-free".
3. How to take Paracetamol Pensa Pharma
Follow the administration instructions of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
The recommended dose is:
Adults:
The recommended dose is 1 tablet every 6-8 hours as needed. Do not take more than 3 tablets (3000 mg) per day.
Patient with kidney or liver impairment:
In patients with kidney or liver impairment, the dose should be reduced or the dosing interval prolonged.
In patients with severe kidney impairment, the dosing interval for paracetamol should be at least 8 hours between each dose.
Consult your doctor if you are unsure.
The tablet can be divided into equal doses. Always use the lowest effective dose.
Do not use in combination with other medicines that contain paracetamol.
Do not exceed the recommended dose.
Avoid using paracetamol for extended periods, as this increases the risk of adverse effects such as liver damage. Consult your doctor or pharmacist if you intend to take paracetamol for an extended period.
The administration of this medicine is subject to the appearance of pain or fever. As these symptoms 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, you should discontinue treatment and consult your doctor.
If you think the effect of paracetamol is too strong or too weak, tell your doctor or pharmacist.
If you take more Paracetamol Pensa Pharma than you should
If you have taken more paracetamol than you should, consult your doctor or pharmacist immediately.
There may be a risk of liver damage, even if you feel well. To prevent liver damage, it is essential that your doctor starts treatment as soon as possible (preferably within 10-12 hours after taking the medicine).
Symptoms of overdose may include nausea, vomiting, anorexia, sweating, and feeling unwell, yellowing of the skin and eyes (jaundice), and abdominal pain. In this case, you should go to a medical center immediately.
Patient taking barbiturates or chronic alcoholics may be more susceptible to paracetamol toxicity.
In case of overdose or accidental ingestion, go to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.
If you forget to take Paracetamol Pensa Pharma
Do not take a double dose to make up for forgotten doses.
If you have any other questions about 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.
This medicine may cause the following side effects:
Rare (may affect up to 1 in 1,000 people): discomfort, low blood pressure, and increased levels of transaminases in the blood.
Very rare (may affect up to 1 in 10,000 people): kidney disease, cloudy urine, allergic dermatitis, jaundice, blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia), and hypoglycemia. Very rare cases of severe skin reactions have been reported.
Paracetamol may cause liver damage when taken in high doses or for prolonged periods.
Reporting side effects
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Paracetamol Pensa Pharma
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.
This medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.
6. Package contents and additional information
Composition of Paracetamol Pensa Pharma
- The active ingredient is paracetamol.
- The other ingredients (excipients) are: sodium carboxymethyl starch type A (potato), purified water, pregelatinized corn starch, povidone (E-1201), stearic acid (E-570), and crospovidone (E-1202).
Appearance of the product and package contents:
Paracetamol Pensa Pharma are oval, biconvex, white film-coated tablets with a functional score line on one side and marked with PC on the other side, 21.0 ± 0.5 mm in length.
The tablet can be divided into equal doses.
Paracetamol Pensa Pharma is available in packages of 16, 18, 20, and 40 tablets.
Available only on prescription.
Not all pack sizes may be marketed.
Marketing authorization holder:
Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain
Manufacturer:
Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain
O
SAG Manufacturing S.L.U.
Crta. N-I, Km 36
San Agustin de Guadalix,
28750 Madrid
Spain
This medicine is authorized in the Member States of the European Economic Area under the following names:
Spain: Paracetamol Pensa Pharma 1g film-coated tablets EFG
Portugal: Paracetamol Lumec 1000 mg film-coated tablets
Italy: Paracetamolo Pensa Pharma 1000 mg, compresse
Date of the last revision of this leaflet:06/2022
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 price1.9 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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