EFFERALDOL 1 G TABLETS

2. What you need to know before taking Efferaldol

Do not take Efferaldol

• 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 this medication.

• Do not take more than the recommended dose in section 3. How to take Efferaldol.
• Avoid taking this medication simultaneously with other medications that contain paracetamol, such as flu and cold medications, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be cautious not to take more than 2 g of paracetamol in 24 hours.
• Patient with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medication.
• When being treated with medication for epilepsy, consult your doctor before taking this medication, as the efficacy of paracetamol may be decreased and hepatotoxicity increased, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.

During treatment with Efferaldol, inform your doctor immediately if:

• You have severe illnesses, 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 of discomfort (nausea), and vomiting.

Children and Adolescents

Do not use in children under 18 years of age.

Other Medications and Efferaldol

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications for treating tuberculosis: (isoniazid, rifampicin)
• Medications for treating depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood: (cholestyramine)
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• Medications used to treat gout (probenecid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.

Do not use with other pain relievers (medications that reduce pain) without consulting your doctor.

Inform your doctor or pharmacist if you are taking:

Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion imbalance) that must be treated urgently (see section 2).

As a general rule for any medication, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medication. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Interference with Analytical Tests:

If you are going to have any analytical tests (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.

Taking Efferaldol with Food, Drinks, and Alcohol:

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages per day: beer, wine, liquor) may cause liver damage.

Taking this medication with food does not affect its efficacy.

Pregnancy, Breastfeeding, and Fertility

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

IMPORTANT FOR WOMEN

If necessary, Efferaldol 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 medication more frequently.

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

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is nil or insignificant.

3. How to Take Efferaldol

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults: take 1 tablet (1 g of paracetamol) every 6-8 hours, 3 times a day. Do not take more than 3 g (3 tablets) in 24 hours.

Always use the lowest effective dose.

Patient with liver disease: before taking this medication, they must consult their doctor.

They should take the prescribed amount of medication by their doctor with a minimum interval of 8 hours between each dose. They should not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

Patient with kidney disease: before taking this medication, they must consult their doctor.

Take a maximum of 500 milligrams per dose.

Due to the dose, 1 gram of paracetamol, the medication is not indicated for this group of patients.

This medication should be taken orally.

The tablets can be swallowed directly or broken in half, with the help of a glass of liquid, preferably water.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of side effects such as liver damage increases.

The administration of this medication is subject to the appearance of pain or fever. As they 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 consult your doctor and reevaluate the clinical situation.

Use in children and adolescents:

Do not use this medication in children or adolescents under 18 years of age.

When lower doses of paracetamol are required, other presentations of paracetamol should be used that adapt to the required dosage.

If You Take More Efferaldol Than You Should

Consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

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

If you have ingested an overdose, you should go immediately to a medical center, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

Treatment of overdose is most effective if started within 4 hours of ingestion of the medication.

Patient being treated with barbiturates or suffering from chronic alcoholism may be more susceptible to the toxicity of a paracetamol overdose.

If You Forget to Take Efferaldol

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 in each case.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Rare side effects that may occur (up to 1 in 1,000 people) are: discomfort, low blood pressure (hypotension), and increased transaminase levels in the blood.

Very rare side effects that may occur (up to 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Paracetamol may damage the liver when taken in high doses or for prolonged periods. Very rare cases of severe skin reactions have been reported.

Frequency not known (cannot be estimated from available data): A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Efferaldol

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Efferaldol Composition

• The active ingredient is paracetamol. Each tablet contains 1 g of paracetamol.
• The other ingredients are: pregelatinized cornstarch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable magnesium stearate.

Appearance of the Product and Package Contents

It is presented in the form of oblong tablets, white in color, and scored on one of its faces, in packages of 10 tablets packaged in:

Aluminum-PVC-PVDC blister packs.

HDPE bottles with polypropylene closures.

Only some package sizes may be marketed.

Marketing Authorization Holder:

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Manufacturer:

Toll Manufacturing Services, S.L.

C/ Aragoneses,

2 28108 Alcobendas - Madrid

Spain

O

Farmalider, S.A.

C/ Aragoneses,

2 28108 Alcobendas - Madrid

Spain

Local Representative:

NEWLINE PHARMA, S.L.U.

Calle Tarragona 151-157, Planta 11, Puerta 1, Bloque A

08014 Barcelona (Spain)

Tel.: 931851380

Date of the Last Revision of this Package Leaflet:June 2020

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