PARACETAMOL RATIO 1 g TABLETS

2. What you need to know before taking Paracetamol ratio

Do not take Paracetamol ratio:

• If you are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (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.
• 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, due to or not due to a reduction in red blood cells), consult your doctor before taking this medicine.
• In chronic alcoholics, take no 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 paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Using Paracetamol ratio with other medicines:

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

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 (antibiotic), 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.

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.

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, etc.) may cause liver damage.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

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 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 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 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 paracetamol on the ability to drive and use machines is negligible.

3. How to take Paracetamol ratio

Follow the administration instructions of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The tablet can be divided into equal doses.

Adults and adolescents over 15 years:

The recommended dose is half or 1 tablet (500 mg-1 g of paracetamol) as needed.

Doses should be spaced at least 4 hours apart.

No more than 4 tablets (4 g) should be taken in 24 hours.

Pediatric population:

Adolescents over 12 years (>42 kg): The recommended dose is half a tablet (500 mg of paracetamol) 3 times a day. Doses should be spaced at least 4 hours apart. The daily dose should not exceed 2 and a half tablets (2.5 g of paracetamol).

Children (under 12 years): Due to the paracetamol dose, this medicine is not suitable for use in children.

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 2 grams of paracetamol in 24 hours, divided into 2 doses.

Patient with kidney disease:

Before taking this medicine, they must consult their doctor.

In case of severe or moderate impairment, take no more than half a tablet (500 mg) per dose.

Elderly patients:

Your doctor will indicate the most suitable treatment for you.

This medicine is not suitable for use in children or adolescents under 15 years.

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 Toxicology 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. The symptoms of overdose may be: 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 a 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 following doses with the indicated spacing between doses (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:Malaise

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 liver transaminases (liver enzymes).

Very rare:Hepatotoxicity (liver toxicity) and jaundice (yellowing of the skin and mucous membranes).

Unknown:Liver damage

Metabolism and nutrition disorders

Very rare:Hypoglycemia (reduced glucose levels in the blood).

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 (reduced 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 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 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. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and further information

Composition of Paracetamol ratio

The active ingredient is paracetamol. Each tablet contains 1 g of paracetamol.

The other ingredients are: pregelatinized maize starch, stearic acid, povidone K-30, crospovidone, microcrystalline cellulose, and magnesium stearate of vegetable origin.

Appearance of the product and package contents

Paracetamol ratio are oblong tablets, white in color, and scored on one side.

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:

Holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B,

1st floor, Alcobendas,

28108 Madrid (Spain)

Manufacturer:

Toll Manufacturing Services S.L

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.

National Highway I, Km. 36

28750 San Agustín de Guadalix,

Spain

This package leaflet was approved in January 2025

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”