Package Insert: Information for the User

Efferaldol with Vitamin C 330 mg/200 mg Effervescent Tablets

Paracetamol/ Ascorbic Acid

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your fever worsens or does not improve within 3 days or if your pain persists for more than 5 days.

This medication is indicated for the symptomatic treatment of occasional mild or moderate pain in adults and children 9 years of age and older.

Consult a doctor if the fever worsens or persists after 3 days or the pain lasts for 5 days.

Do not take Efferaldol with vitamin C:

• if your weight is less than27 kg
• if you are allergic to the active ingredients or any of the other components of this medication (listed in section 6)
• if you have fructose intolerance

Warnings and precautions

Consult your doctor or pharmacist before starting to take Efferaldol with vitamin C.

• Do not take more than the recommended amountin the section 3. How to take Efferaldol with vitamin C.
• Chronic alcoholics should be careful not to take more than 2 g/day of paracetamol.
• Patients with kidney, liver, heart, or lung diseases and patients with anemia, should consult their doctor before taking the medication.
• When taking medication for epilepsy, consult your doctor before taking this medication, as when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially with high doses of paracetamol.
• Patients with asthma sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
• Paracetamol can cause severe skin reactions, such asacute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), which can be fatal. Patients should be informed about the signs of severe skin reactions, and the use of the medication should be interrupted at the first sign of skin eruption or any other sign of hypersensitivity.
• The frequent use of analgesics over a long period can cause or worsen headaches. If you suffer from chronic headaches and have been taking analgesics for more than 3 months, at least on alternate days, do not increase the dose of analgesics, but consult your doctor.

Inform your doctor immediately if you experience any of the following during treatment with Efferaldol with vitamin C:

• 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 chronic malnutrition, alcoholism, or if you 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 to undergo any analytical tests (including blood and urine tests, etc.) as this medication may alter the results.

Other medications and Efferaldol with vitamin C

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

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

• Medications to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)
• Medications to treat epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications to treat tuberculosis: isoniazid, rifampicin
• Medications to treat depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower blood cholesterol levels: cholestyramine
• Medications used to increase urine elimination: 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 (hypertension) and heart rhythm disorders (arrhythmias): propranolol
• Alcohol
• Basic or acidic medications: high doses of vitamin C may reduce the excretion of acidic medications and increase the urinary excretion of basic medications
• Iron: vitamin C facilitates the absorption of iron in the digestive tract
• Flucloxacillin (antibiotic): due to a severe risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Taking Efferaldol with vitamin C with food, drinks, and alcohol

The taking of this medication with food does not affect its efficacy.

Pregnancy and lactation

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

Efferaldol with vitamin C can 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.

Paracetamol passes into breast milkand there are limited data on the use of high doses of vitamin C during pregnancy and lactation, so it is not recommended to use Efferaldol with vitamin C, except under the supervision of a doctor.

Driving and operating machinery

The influence of paracetamol and vitamin C on the ability to drive and operate machinery is negligible or insignificant.

Efferaldol with vitamin C contains sorbitol, sodium, and sodium benzoate

This medication contains 300 mg of sorbitol in each effervescent tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have a condition that makes you intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

This medication contains 330 mg of sodium (main component of table salt/for cooking) in each effervescent tablet. This is equivalent to 16.5% of the maximum daily sodium intake recommended for an adult.

This medication contains 50 mg of sodium benzoate in each effervescent tablet.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Efferaldol with vitamin C is restricted to adults and children who weigh at least27kg.

The recommended dose is:

Adults and adolescents over 14 years:

Administer1 to2 tablets every 4-6 hours, as needed.

Do not exceed 8 tablets in 24 hours divided into several doses.

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

Take a maximum of 1 tablet per dose.

According to their disease, their doctor will indicate whether they should take their medication with a minimum interval of 6 or 8 hours.

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

They must take the amount of medication prescribed by their doctor with a minimum interval of 8 hours between each dose.

Do not take more than 6 tablets in 24 hours, divided into several doses.

Use in children and adolescents

Children under 9 years or weighing less than27 kgcannot take this medication.

Children aged 9-14 years weighing more than 27 kg:

1 tablet every 4-6 hours as needed. Do not exceed 5 tablets in 24 hours divided into 5 doses.

This medication is taken orally.

Fizzy tablets must be dissolved in a glass of water. Do not ingest until the bubbling has completely stopped.

Always take the lowest effective dose.

The taking of this medication is subject to the appearance of pain or fever. As these disappear, treatment should be suspended.

If pain persists for more than 5 days in adults and 3 days in children, fever for more than 3 days, or pain or fever worsen or other symptoms appear, treatment should be interrupted and the doctor consulted.

For sore throat, the medication should not be taken for more than 2 consecutive days without consulting a doctor.

If you take more Efferaldol with vitamin C than you should

You must consult your doctor or pharmacist immediately.

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 must go to a medical center immediately, even if you do not notice the symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

When an overdose has been taken, the treatment of the overdose is more effective if it is initiated within 4 hours of taking the medication..

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

Incase of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The possible adverse effects of Efferaldol with vitamin C are:

Rare adverse effects that may affect up to 1 in 1,000 people: discomfort, increased levels of transaminases in the blood, anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity, and angioedema.

Very rare adverse effects that may affect up to 1 in 10,000 people: kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

Adverse effects of unknown frequency (cannot be estimated from available data): 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) and purpura.

Paracetamolcan damage the liverwhen taken inhigh doses or prolonged treatments.

High doses of vitamin C (above 1g) may cause in certain patients the

formation of kidney stones and may increase hemolysis in subjects with G6PD deficiency in chronic forms of hemolysis.

Frequency unknown: gastrointestinal disorders (abdominal pain, diarrhea), nervous system disorders (dizziness), urinary tract and kidney disorders (chromaturia and hyperoxaluria), skin and subcutaneous tissue disorders (rash and urticaria).

Reporting Adverse Effects

If you experienceany type of adverse effect,consult your doctor orpharmacist, even if it is apossibleadverse effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from humidity.

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.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. 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 ofEfferaldol with vitamin C

- The active principles are paracetamol and ascorbic acid (Vitamin C).

- The other components (excipients) are sorbitol (E-420), sodium carbonate, monopotassium carbonate, sodium benzoate (E-211), anhydrous citric acid, dioctyl sulfosuccinate sodium, and polyvinylpyrrolidone.

Appearance of the product and content of the packaging

Efferaldol with vitamin Cis presented in a box with 2 tubes of 10 effervescent tablets each.

The tablets are effervescent, white in color, and scored. The score should not be used to divide the tablet.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Responsible for manufacturing

UPSA

979, Avenue des Pyrénées

47520 Le Passage - France

or

UPSA

304, Av. Dr. Jean Bru – Agen - France

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 review of this prospectus:January 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/