Efferaldol with Vitamin C 330 mg/200 mg effervescent tablets
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What Efferaldol with vitamin C is and what it is used for
- 2. What you need to know before starting to take Efferaldol with vitamin C
- **Pregnancy and Breastfeeding**
- **Driving and Use of Machines**
- 3. How to take Efferaldol with vitamin C
- 4. Possible adverse effects
- 5. Storage of Efferaldol with vitamin C
- 6. Contents of the pack and other information
Patient Information Leaflet
Introduction
Patient Information Leaflet
Efferaldol with vitamin C 330 mg/200 mg effervescent tablets
Paracetamol / Ascorbic acid
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if fever persists for more than 3 days or pain for more than 5 days.
Leaflet Contents
- What Efferaldol with vitamin C is and what it is used for
- What you need to know before taking Efferaldol with vitamin C
- How to take Efferaldol with vitamin C
- Possible side effects
- How to store Efferaldol with vitamin C
- Contents of the pack and other information
1. What Efferaldol with vitamin C is and what it is used for
This medicinal product is indicated for the symptomatic treatment of mild to moderate occasional pain in adults and children from 9 years of age.
You should consult a doctor if symptoms worsen or if fever persists for more than 3 days or pain for more than 5 days.
2. What you need to know before starting to take 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 substances or to any of the other components of this medicine (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 dose indicated in section 3, How to take Efferaldol with vitamin C.
- Chronic alcoholics should take care not to exceed 2 g/day of paracetamol.
- Patients with kidney, liver, heart, or lung disease, or with anemia, should consult their doctor before taking this medicine.
- If you are being treated with medication for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
- Asthmatic patients who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
- Paracetamol may cause serious 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 serious skin reactions, and treatment should be discontinued at the first sign of skin rash or any other sign of hypersensitivity.
- Frequent long-term use of analgesics may cause or worsen headaches. If you suffer from chronic headaches and have been taking analgesics for more than 3 months on alternate days or more frequently, do not increase the dose of analgesics but consult your doctor instead.
During treatment with Efferaldol with vitamin C, inform your doctor immediately if:
- You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.
Interference with laboratory tests
If you are scheduled to undergo any laboratory tests (including blood or urine tests), inform your doctor that you are taking this medicine, as it may alter test results.
Other medicines and Efferaldol with vitamin C
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.
In particular, if you are taking any of the following medicines, dosage adjustments or discontinuation of treatment may be necessary:
- Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)
- Medicines for epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
- Medicines for tuberculosis: isoniazid, rifampicin
- Medicines for depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants)
- Medicines to lower blood cholesterol levels: cholestyramine
- Medicines used to increase urine output: loop diuretics such as furosemide
- Medicines used to treat gout: probenecid and sulfinpyrazone
- Medicines used to prevent nausea and vomiting: metoclopramide and domperidone
- Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol
- Ethyl alcohol
- Acidic or basic medicines: high-dose vitamin C administration may decrease the excretion of acidic drugs and increase the urinary excretion of basic drugs
- Iron: vitamin C enhances iron absorption in the gastrointestinal tract
- Flucloxacillin (antibiotic): due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap) that requires urgent treatment (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 BreastfeedingIf you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Efferaldol with vitamin C may be used during pregnancy if necessary. The lowest possible dose that controls pain or fever should be used, and for the shortest possible duration. Contact your doctor or midwife if pain or fever do not improve, or if you need to take the medicine more frequently. Paracetamol passes into breast milk, and there is limited information on the use of high doses of vitamin C during pregnancy and breastfeeding. Therefore, the use of Efferaldol with vitamin C is not recommended except under the supervision of a doctor. Driving and Use of MachinesThe influence of paracetamol and vitamin C on the ability to drive and operate machinery is negligible or none. Efferaldol with vitamin C contains sorbitol, sodium, and sodium benzoate This medicine contains 300 mg of sorbitol in each effervescent tablet. Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) 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 medicine. This medicine contains 330 mg of sodium (main component of table/cooking salt) in each effervescent tablet. This corresponds to 16.5% of the maximum daily recommended sodium intake for an adult. This medicine contains 50 mg of sodium benzoate in each effervescent tablet. 3. How to take Efferaldol with vitamin CFollow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Efferaldol with vitamin C is restricted to adults and children weighing at least 27 kg. Recommended dosage: Adults and adolescents over 14 years of age: Take 1 to 2 tablets every 4-6 hours as needed. Do not exceed 8 tablets in 24 hours, divided into several doses. Patients with renal or hepatic impairment: Dosage must be adjusted according to the degree of renal and/or hepatic impairment. Consult your doctor before taking this medicine. Other special populations: The maximum daily dose should be reduced to 2 g in patients weighing less than 50 kg, or with chronic alcoholism, chronic malnutrition, or dehydration. Dose adjustment is not required in elderly patients. If you think the effect of this medicine is too strong or too weak, do not change the dose; consult your doctor or pharmacist. Use in children and adolescents Children under 9 years of age or weighing less than 27 kg must not take this medicine. 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 medicine is for oral use. Effervescent tablets must be dissolved in a glass of water. Do not swallow until the fizzing has completely stopped. Always take the lowest effective dose. This medicine should only be taken when pain or fever occurs. As symptoms improve, treatment should be discontinued. If pain persists for more than 5 days in adults or 3 days in children, fever lasts more than 3 days, or if pain or fever worsen or new symptoms appear, stop treatment and consult your doctor. For sore throat, do not take the medicine for more than 2 consecutive days without consulting your doctor. If you take more Efferaldol with vitamin C than you should Contact your doctor or pharmacist immediately. Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. The following effects have been observed after paracetamol overdose:
If you have taken an overdose, go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning. Treatment for overdose is most effective if started within 4 hours of taking the medicine. Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose. 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 medicine and the amount ingested. 4. Possible adverse effectsLike all medicines, this medicine can cause adverse effects, although not everyone will experience them. The possible adverse effects of Efferaldol with vitamin C are: Rare adverse effects (may affect up to 1 in 1,000 people): malaise, increased blood transaminase levels, anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity, and angioedema. Very rare adverse effects (may affect up to 1 in 10,000 people): kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Adverse effects with unknown frequency (cannot be estimated from available data): a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2), purpura, bronchospasm (excessive and prolonged contraction of the muscles in the airways causing difficulty breathing), and fixed drug eruption (red or purple skin lesions that reappear in the same location). Paracetamol can cause liver damage when taken at high doses or during prolonged treatment. High doses of vitamin C (above 1 g) may cause kidney stone formation in certain patients and may increase hemolysis in individuals with G6PD deficiency in chronic forms of hemolysis. Adverse effects 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 of adverse effects If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine. 5. Storage of Efferaldol with vitamin CKeep this medicine out of the sight and reach of children. Do not store above 25°C. Store in the original packaging to protect it from moisture. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated. Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment. 6. Contents of the pack and other informationComposition of Efferaldol with vitamin C
Appearance of the product and contents of the pack Efferaldol with vitamin C comes in a box containing 2 tubes, each with 10 effervescent tablets. The tablets are effervescent, white in colour, and scored. The score line is not intended for dividing 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, 11th Floor, Door 1, Block A 08014 Barcelona (Spain) Tel.: 931851380 Date of the most recent revision of this leaflet: February 2026 Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/ |