PARACETAMOL RATIO 650 mg TABLETS

2. What you need to know before taking Paracetamol ratio

Do not take Paracetamol ratio

• 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 Paracetamol ratio.

• Do not take more than the recommended dose.
• Avoid taking this medicine simultaneously with 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.
• 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 anemia (reduced hemoglobin levels in the blood), consult your doctor before taking this medicine.
• In chronic alcoholics, be cautious not to take more than 2 g/day of paracetamol.

During treatment with paracetamol, inform your doctor immediately 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 have malnutrition, chronic alcoholism, or are also 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 using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

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 of these tests.

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

Other medicines and Paracetamol ratio:

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Paracetamol may interact with the following medicines:

• Oral anticoagulants (used to treat thromboembolic diseases)
• Antiepileptics (used to treat epileptic seizures)
• Diuretics (used to increase urine elimination)
• Flucloxacillin (antibiotics), due to a serious 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)
• Propranolol (used to treat hypertension, cardiac arrhythmias)
• Rifampicin (used to treat tuberculosis)
• Colestyramine (used to reduce cholesterol levels in the blood)

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor. As a general rule for any medicine, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medicine. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

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, beer, wine, liquor...) may cause liver damage.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

In case of need, 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 or midwife if the pain or fever does not decrease or if you need to take the medicine more frequently.

Pregnancy

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. The use of 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 undesirable effects due to the use of paracetamol in the recommended doses, but patients should follow their doctor's advice regarding its use.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Small amounts of paracetamol may appear in breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible.

3. How to take Paracetamol ratio

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

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

This medicine should be taken orally. According to your preferences, the tablets can be swallowed directly or broken in half with water, milk, or fruit juice.

The score line allows you to divide the tablet into two equal doses.

The recommended dose is:

Adults and adolescents over 15 years

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

Children and adolescents

It is necessary to respect the dosages defined according to weight. The age of the child according to weight is given only 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 in weight (from 6 to 10 years): half a tablet per dose, every 6 hours, up to a maximum of 2 tablets per day.

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

Patient with liver disease:

Before taking this medicine, they must consult their doctor. They should take the amount of medicine prescribed by their doctor with a minimum interval between each dose of 8 hours. They should not take more than 3 tablets of 650 mg of paracetamol in 24 hours.

Patient with kidney disease:

Before taking this medicine, they must consult their doctor.

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.

Elderly patients

Your doctor will indicate the most suitable treatment for you.

If you think that the action of this medicine is too strong or too weak, talk to your doctor or pharmacist.

When lower doses of paracetamol are required per dose (less than 650 mg), 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 915 620 420, indicating the medicine and the amount ingested.

If you have taken an overdose, you should go to a medical center immediately, even if you do not have symptoms, as they may not appear until three days after taking the overdose, even in cases of severe poisoning.

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

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

Treatment of overdose is most effective if started within 4 hours of taking the medicine.

Patient taking barbiturates or 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 forgotten doses. Simply take the forgotten dose when you remember, taking the next doses with the indicated interval between them (at least 4 hours).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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 frequency (cannot be estimated from the 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 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).

Unknown:Liver damage

Metabolic and nutrition disorders

Very rare:Hypoglycemia (low blood sugar levels).

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

Blood and lymphatic system disorders

Very rare:Leukopenia, neutropenia (reduced white blood cell count), hemolytic anemia (reduced red blood cell count).

Unknown:Thrombocytopenia (reduced platelet count), agranulocytosis.

Vascular disorders

Rare:Hypotension (low blood pressure).

Renal and urinary disorders

Very rare:Sterile pyuria (cloudy 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 acute generalized exanthematous pustulosis (AGEP)).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report side effects 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 ratio

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Paracetamol ratio

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 vegetable magnesium stearate.

Appearance of the product and pack contents

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

Not all 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 (Almodovar del Río) - 14720, Spain

Or

SAG MANUFACTURING S.L.U.

Carretera Nacional I, Km. 36, 28750 San Agustin de Guadalix, Spain

Date of last revision of this package leaflet:January 2025