Paracetamol Ratio 1 g tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Paracetamol ratio 1 g tablets EFG
Read the entire 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 or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Paracetamol ratio is and what it is used for
- What you need to know before taking Paracetamol ratio
- How to take Paracetamol ratio
- Possible adverse effects
- How to store Paracetamol ratio
- Contents of the pack and other information
1. What Paracetamol ratio is and what it is used for
Paracetamol ratio belongs to a group of medicines called analgesics and antipyretics.
This medicine is used for the symptomatic treatment of mild to moderate pain and for fever in adults and adolescents aged 12 years and older.
2. What you need to know before taking Paracetamol ratio
Do not take Paracetamol ratio:
- If you are allergic (hypersensitive) to paracetamol or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol ratio
- Do not take more than the recommended dose.
- 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 if you have anaemia (reduced haemoglobin levels in the blood, with or without a reduction in red blood cells), you should consult your doctor before taking this medicine.
- In chronic alcoholics, caution should be taken not to exceed 2 g/day of paracetamol.
During treatment with paracetamol, inform your doctor immediately if:
- You have serious illnesses 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 known as 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 breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.
Use of Paracetamol ratio with other medicines:
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Paracetamol may interact with the following medicines:
- Oral anticoagulants (used to treat thromboembolic disorders)
- Antiepileptics (used to treat epileptic seizures)
- Diuretics (used to increase urine elimination)
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disorder (called metabolic acidosis) that requires urgent treatment (see section 2)
- Isoniazid (used to treat tuberculosis)
- Lamotrigine (used to treat epilepsy)
- Probenecid (used to treat gout)
- Propranolol (used to treat hypertension, cardiac arrhythmias)
- Rifampicin (used to treat tuberculosis)
- Colestyramine (used to lower blood cholesterol levels)
Do not use with other analgesics (medicines that reduce 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 another medicine. In patients taking oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.
Interference with laboratory tests:
If you are due to have any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter the results of these tests.
Taking Paracetamol ratio with food, drinks and alcohol:
The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day, such as beer, wine, spirits, etc.) may cause liver damage.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
If necessary, Paracetamol may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor or midwife if pain or fever does not improve or if you need to take the medicine more frequently.
Pregnancy
If you are pregnant or think you might be, consult your doctor before taking this medicine. Taking medicines during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.
Epidemiological studies in pregnant women have not shown adverse effects from the use of paracetamol at recommended doses, but patients should still follow their doctor's advice regarding its use.
Breastfeeding
Consult your doctor or pharmacist before using any medicine.
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 operate machinery is none or negligible.
3. How to take Paracetamol ratio
Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
This medicine is taken orally. Depending on your preference, the tablets may be taken whole or split in half with water, milk, or fruit juice.
The tablet may be divided into equal doses.
Adults and adolescents over 15 years of age:
The recommended dose is half or 1 tablet (500 mg–1 g of paracetamol), according to requirements.
Doses should be spaced at least 4 hours apart.
Do not take more than 4 tablets (4 g) in 24 hours.
Paediatric population:
Adolescents over 12 years of age (>42 kg): The recommended dose is half a tablet (500 mg of paracetamol) three times daily. Doses should be spaced at least 4 hours apart. The daily dose must not exceed 2 and a half tablets (2.5 g of paracetamol).
Children (under 12 years of age): Due to the paracetamol dose, this medicine is not suitable for use in children.
Patients with liver disease:
Before taking this medicine, you must consult your doctor. You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between each dose. Do not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.
Patients with kidney disease:
Before taking this medicine, you must consult your doctor.
In cases of moderate or severe renal insufficiency, take a maximum of half a tablet (500 mg) per dose.
Elderly patients:
Your doctor will indicate the most appropriate treatment for you.
This medicine is not suitable for use in children or adolescents under 15 years of age.
If you take more Paracetamol ratio than you should
If you have taken more paracetamol than you should or have accidentally ingested the entire contents of the package, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested.
If an overdose has occurred, you must go immediately to a medical centre even if there are no symptoms, as symptoms often do not appear until three days after the overdose, even in cases of severe poisoning. Symptoms of overdose may include dizziness, vomiting, anorexia, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Liver and kidney damage may subsequently develop. Severe overdoses may result in death.
Treatment for overdose is most effective if started within 4 hours of taking the medicine.
Patients undergoing treatment with barbiturates or those suffering from chronic alcoholism may be more susceptible to paracetamol overdose.
If you forget to take Paracetamol ratio
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 will experience them.
The adverse effects observed are described below according to their frequency of occurrence:
Rare adverse effects (may affect up to 1 in 1,000 people), very rare adverse effects (may affect up to 1 in 10,000 people), not known (cannot be estimated from available data).
The following adverse effects have been observed:
General disorders and administration site conditions
Rare: Malaise
Immune system disorders
Not known: Allergic reactions (hypersensitivity) ranging from simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a type of severe allergic reaction).
Hepatobiliary disorders
Rare: Increased levels of hepatic transaminases (liver enzymes).
Very rare: Hepatotoxicity (liver toxicity) and jaundice (yellowing of the skin and mucous membranes).
Not known: Liver damage
Metabolism and nutrition disorders
Very rare: Hypoglycemia (reduced blood glucose levels).
Not known: A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).
Blood and lymphatic system disorders
Very rare: Leukopenia, neutropenia (decrease in white blood cells), hemolytic anemia (decrease in red blood cells).
Not known: Thrombocytopenia (reduction in blood platelets), agranulocytosis
Vascular disorders
Rare: Hypotension (decrease in blood pressure).
Renal and urinary disorders
Very rare: Sterile pyuria (cloudy urine), adverse renal effects.
Skin and subcutaneous tissue disorders
Not known: Exanthema
Severe skin reactions have been reported in very rare cases (medications inducing Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP)).
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 may 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 Paracetamol ratio
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 carton (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 unused medicines and their containers at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the container and additional information
Composition of Paracetamol ratio
The active substance is paracetamol. Each tablet contains 1 g of paracetamol.
The other components are: pregelatinized maize starch, stearic acid, povidone K-30, crospovidone, microcrystalline cellulose and vegetable magnesium stearate.
Appearance of the product and contents of the container
Paracetamol ratio are white, oblong, scored tablets.
They are packaged in aluminum-PVC-PVDC blisters in packs of 20 and 40 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
Teva Pharma, S.L.U.
C/ Anabel Segura 11, Edificio Albatros B,
1st floor, Alcobendas,
28108 Madrid (Spain)
Manufacturer:
Toll Manufacturing Services S.L
C/ Aragoneses, 2. 28108 Alcobendas (Madrid)
Spain
or
Pharmex Advanced Laboratories, S.L Pol. Ind. Los Mochos. Polígono 8 - Parcela 20. Crta. A-431,
Km 19 (Almodóvar del Río) -14720
Spain
or
SAG MANUFACTURING S.L.U.
Carretera Nacional I, Km. 36
28750 San Agustín de Guadalix,
Spain
This summary of product characteristics was approved in 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/”