EFFERALDOL WITH VITAMIN C 330mg/200mg EFFERVESCENT TABLETS

Introduction

Package Leaflet: Information for the User

Efferaldol with Vitamin C 330 mg/200 mg Effervescent Tablets

Paracetamol/ Ascorbic Acid

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or if the fever does not improve within 3 days or the pain within 5 days.

Contents of the Package Leaflet

1. What Efferaldol with Vitamin C is and what it is used for
2. What you need to know before taking Efferaldol with Vitamin C
3. How to take Efferaldol with Vitamin C
4. Possible side effects
5. Storage of Efferaldol with Vitamin C
6. Package Contents and Additional Information

1. What Efferaldol with Vitamin C is and what it is used for

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

You should consult a doctor if your condition worsens or if the fever persists after 3 days or the pain after 5 days.

2. What you need to know before taking Efferaldol with Vitamin C

Do not take Efferaldol with Vitamin C:

• if your weight is less than 27 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 amount in section 3. How to take Efferaldol with Vitamin C.
• Chronic alcoholics should be cautious not to take more than 2 g/day of paracetamol.
• Patient with kidney, liver, heart, or lung disease and patients with anemia should consult their doctor before taking the 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.
• Paracetamol may cause severe skin reactions, such as acute 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 should discontinue the use of the medication at the first symptom of skin rash or any other sign of hypersensitivity.
• Frequent use of analgesics for a long time may 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.

During treatment with Efferaldol with Vitamin C, 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 suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in 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.

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 medication, as it may alter the results.

Other Medications and Efferaldol with Vitamin C

Inform your doctor or pharmacist if you are using, have recently used, or may need to use 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:

• 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 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 (cardiac arrhythmias): propranolol
• Ethyl alcohol
• Basic or acidic medications: the administration of high doses of vitamin C may decrease 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 serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that should be treated urgently (see section 2).

Taking Efferaldol with Vitamin C with Food, Drinks, and Alcohol

Taking this medication with food does not affect its efficacy.

Pregnancy and Breastfeeding

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

If necessary, Efferaldol with Vitamin C 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 medication more frequently.

Paracetamol passes into breast milk, and there are limited data on the use of high doses of vitamin C during pregnancy and breastfeeding, so the use of Efferaldol with Vitamin C is not recommended, except under medical supervision.

Driving and Using Machines

The influence of paracetamol and vitamin C on the ability to drive and use machines is zero 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 (or your child) that you have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, 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/cooking salt) in each effervescent tablet. This is equivalent to 16.5% of the maximum daily intake of sodium recommended for an adult.

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

3. How to Take Efferaldol with Vitamin C

Follow the administration instructions for this medication contained in this package leaflet or as 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 least 27 kg.

The recommended dose is:

Adults and adolescents over 14 years:

Administer 1 to 2 tablets every 4-6 hours as needed.

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

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

Take a maximum of 1 tablet per dose.

Depending on their condition, their doctor will indicate whether they should take their medication with a minimum interval of 6 or 8 hours.

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

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

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

Use in Children and Adolescents

Children under 9 years old or weighing less than 27 kg cannot take this medication.

Children from 9-14 years old who weigh 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.

The effervescent tablets should be dissolved in a glass of water. Do not ingest until the bubbling has completely stopped.

Always take the lowest effective dose.

Taking 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 in adults and 3 days in children, the fever for more than 3 days, or the pain or fever worsen or other symptoms appear, treatment should be discontinued and a doctor consulted.

For sore throat, do not take the medication for more than 2 consecutive days without consulting a doctor.

If You Take More Efferaldol with Vitamin C Than You Should

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

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

Patient taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

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

4. Possible Side Effects

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

The possible side effects of Efferaldol with Vitamin C are:

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

Very rare side effects that may affect up to 1 in 10,000 people: 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).

Side effects with unknown frequency (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) and purpura.

Paracetamol may damage the liver when taken in high doses or for prolonged periods.

High doses of vitamin C (above 1g) may cause the formation of kidney stones in certain patients and may increase hemolysis in subjects with G6PD deficiency in chronic forms of hemolysis.

The following have been observed with unknown frequency: 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 Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Efferaldol with Vitamin C

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

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your 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

Composition of Efferaldol with Vitamin C

• The active ingredients are paracetamol and ascorbic acid (Vitamin C).
• The other ingredients (excipients) are sorbitol (E-420), sodium carbonate, potassium carbonate, sodium benzoate (E-211), anhydrous citric acid, dioctyl sodium sulfosuccinate, and polyvinylpyrrolidone.

Appearance of the Product and Package Contents

Efferaldol with Vitamin C is presented in a box with 2 tubes of 10 effervescent tablets each.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Manufacturer

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 Revision of this Package Leaflet:January 2025

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/