Leaflet: information for the user

Paracetamol ratio 650 mg tablets EFG

1. What is Paracetamol ratio and what it is used for

2. What you need to know before starting to take Paracetamol ratio

3. How to take Paracetamol ratio

4. Possible side effects

5. Storage of Paracetamol ratio

6. Contents of the pack and additional information

Paracetamol ratio belongs to a group of medications called analgesics and antipyretics.

This medication is used for the symptomatic treatment of mild or moderate pain and in febrile states.

Do not take Paracetamol ratio

• If you are allergic to paracetamol or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paracetamol ratio

• Do not take more than the recommended dose.
• Avoid using this medication with other medications that contain paracetamol, such as cold and flu medications, as high doses may cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• If you have asthma and are sensitive to acetylsalicylic acid, consult your doctor before taking this medication.
• If you have kidney, liver, heart, or lung disease, or have anemia (a decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells), consult your doctor before taking this medication.
• In chronic alcoholics, be careful not to take more than 2 g/day of

paracetamol.

Inform your doctor immediately if you experience any of the following during treatment with paracetamol:

• If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Interference with analytical tests:

Inform your doctor if you are undergoing any analytical tests (including blood and urine tests) as this medication may alter the results of these tests.

Paracetamol may alter the values of uric acid and glucose analytical determinations.

Other medications and Paracetamol ratio:

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Paracetamol may interact with the following medications:

• Oral anticoagulants (used to treat thromboembolic diseases)
• Antiepileptics (used to treat epilepsy)
• Diuretics (used to increase urine elimination)
• Flucloxacillin (antibiotics), due to a severe risk of blood and fluid anomaly (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)
• Propanolol (used to treat hypertension and cardiac arrhythmias)
• Rifampicin (used to treat tuberculosis)
• Colestiramida (used to reduce blood cholesterol levels)

Do not use with other analgesics (pain-relieving medications) without consulting your doctor. As a general rule, it is recommended to inform your doctor or pharmacist systematically if you are taking another medication. In the case of oral anticoagulants, this medication may be administered occasionally as a pain-relieving medication of choice.

Paracetamol ratio and food, drinks, and alcohol:

The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic beverages per day, beer, wine, liquor...) may cause liver damage.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Paracetamol may be used during pregnancy if necessary. Use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor or midwife if the pain or fever does not decrease or if you need to take the medication more frequently.

Pregnancy

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The use of medications during pregnancy may be hazardous to the embryo or fetus, and should be monitored by your doctor.

Epidemiological studies in pregnant women have not shown undesirable effects due to the use of paracetamol at recommended doses, but patients should follow their doctor's advice regarding its use.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Small amounts of paracetamol may appear in breast milk, so it is recommended to consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist again.

This medication should be taken orally. According to your preference, the tablets can be taken directly or divided in half with water, milk, or fruit juice.

The groove allows the tablet to be divided into two equal doses.

The recommended dose is:

Adults and adolescents over 15 years old

1 tablet every 4-6 hours, as needed,up to a maximum of 6 tablets in 24 hours.

Children and adolescents

It is necessaryto respect the dosages defined according to weight. The child's age according to weight is only given for information purposes.

The recommended daily dose of paracetamol is approximately 60 mg/Kg/day, which is

divided into 4 or 6 daily doses, i.e. 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• Between 21 and 25 kg of weight (6 to 10 years old): half a tablet per dose, every 6 hours,

up to a maximum of 2 tablets a day.

• Between 26 and 40 kg of weight (8 to 13 years old): half a tablet per dose, every 4 hours,up to a maximum of 3 tablets a day.
• Between 41 and 50 kg of weight (12 to 15 years old): 1 tablet per dose, every 6 hoursup to a maximum of 4 tablets a 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 3 tablets of 650 mg of paracetamol in 24 hours.

Patients with kidney disease:

Before taking this medication, they must consult their doctor.

They should take a maximum of 500 milligrams of paracetamol per dose.

Due to the dose, 650 mg of paracetamol, it is not recommended for this group of patients.

Older patients

Your doctor will indicate the most suitable treatment for you.

If it is estimated that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

When requiring the administration of doses lower than 650 mg of paracetamol per dose

other presentations of paracetamol should be used that adapt to the required dosage.

If you take more Paracetamol ratio than you should:

If you have taken more paracetamol than you should,or have accidentally ingested the contents of the package,consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420indicating the medication and the amount ingested.

If an overdose has been taken, you should go immediately to a medical center

although there may be no symptoms, as they often do not appear until three days after the

overdose, even in cases of severe poisoning.

The symptoms of an overdose may be: nausea, dizziness, vomiting, loss of appetite, loss of appetite, yellowing of the skin and eyes (jaundice) and abdominal pain.

Later, liver and kidney damage may develop. Severe overdoses can cause death.

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the medication.

Patients undergoing barbiturate treatment or suffering from chronic alcoholism may

be more susceptible to a paracetamol overdose.

If you forgot to take Paracetamol ratio

Do not take a double dose to compensate for the missed doses, simply take the missed dose when you remember, taking the next doses with the indicated interval (at least 4 hours).

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The observed side effects are described below according to their frequency of presentation:

Rare side effects (may affect up to 1 in 1,000 people), very rare side effects (may affect up to 1 in 10,000 people), unknown (cannot be estimated from available data)

The following side effects have been observed.

General disorders and administration site conditions

Rare:Discomfort

Immune system disorders

Unknown:Allergic reactions (hypersensitivity) ranging from a simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a severe type of allergic reaction).

Hepatobiliary disorders

Rare:Increased levels of liver transaminases (liver enzymes).

Very rare:Liver toxicity (liver toxicity) and jaundice (yellow discoloration of skin and mucous membranes).

Unknown:Liver damage

Metabolism and nutrition disorders

Very rare:Hypoglycemia (low blood glucose levels).

Unknown:A severe disease that can make the blood more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Blood and lymphatic system disorders

Very rare:Leucopenia, neutropenia (decrease in white blood cells in the blood), hemolytic anemia (decrease in red blood cells in the blood).

Unknown:Thrombocytopenia (decrease in platelets in the blood), agranulocytosis

Vascular disorders

Rare:Hypotension (decrease in blood pressure).

Renal and urinary disorders

Very rare:Purulent urine, adverse renal effects.

Skin and subcutaneous tissue disorders

Unknown: Exanthema

Severe skin reactions have been reported in very rare cases (medicines that induce Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and exanthematous pustular exanthema (AGEP)).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not dispose of medications through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Paracetamol ratio

The active ingredient is paracetamol.Each tablet contains 650mg of paracetamol.

The other components are: maize pregelatinized starch, stearic acid,

povidone, crospovidone, microcrystalline cellulose and plant-derived magnesium stearate.

Appearance of the product and contents of the packaging

The tablets are oblong, scored, and white in color, they are packaged in blisters and are presented in packs of 20 and 40 tablets.

Only some pack sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Holder

Teva Pharma, S.L.U.

c/ Anabel Segura 11, Edificio Albatros B,

1st floor, Alcobendas,

28108 Madrid (Spain)

Responsible for manufacturing:

Toll Manufacturing Services S.L

C/ Aragoneses, 2. 28108 Alcobendas (Madrid)

Spain

Or

Pharmex Advanced Laboratories, S.LPol. Ind. Los Mochos. Polígono 8 - Parcela 20. Crta. A-431, Km 19 (Almodovar del Río) -

14720 – Spain

Or

SAG MANUFACTURING S.L.U.

National Highway I, Km. 36

28750 San Agustin de Guadalix,

Spain

Last review date of this leaflet:January 2025