Efferaldol 1 g tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Efferaldol 1 g tablets
paracetamol
Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Always follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, consult your doctor or pharmacist.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
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You should consult a doctor if your condition worsens or does not improve, if fever persists for more than 3 days, or if pain lasts longer than 5 days.
Contents of this leaflet
- What Efferaldol is and what it is used for
- What you need to know before taking Efferaldol
- How to take Efferaldol
- Possible side effects
- How to store Efferaldol
- Contents of the pack and other information
1. What Efferaldol is and what it is used for
Paracetamol is effective in reducing pain and fever.
It is indicated for the relief of mild to moderate occasional pain, such as headache, dental pain, muscle pain (muscle spasms), or back pain (lumbago), as well as for feverish conditions.
Efferaldol is indicated for use in adults.
2. What you need to know before taking Efferaldol
Do not take Efferaldol
- If you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine.
- Do not take more than the recommended dose stated in section 3, How to take Efferaldol.
- Avoid using this medicine simultaneously with other medicines containing paracetamol, for example, cold and flu remedies, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
- Chronic alcoholics should take care not to exceed 2 g of paracetamol in 24 hours.
- Patients with kidney, liver, heart or lung disease, and patients with anemia, should consult their doctor before taking this medicine.
- If you are being treated with any antiepileptic medication, 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.
During treatment with Efferaldol, 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 known as metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.
Children and adolescents
Do not use in individuals under 18 years of age.
Other medicines and Efferaldol
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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.
Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.
Inform your doctor or pharmacist if you are taking:
Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance
(known as metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).
As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking other medicines. In the case of treatment with oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.
Interference with laboratory tests:
If you are scheduled to undergo any laboratory tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, 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 drinks per day: beer, wine, spirits) may cause liver damage.
Taking this medicine with food does not affect its efficacy.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
IMPORTANT FOR WOMEN
If necessary, Efferaldol may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever does not improve or if you need to take the medicine more frequently.
Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.
Driving and using machines
The effect of this medicine on the ability to drive and use machines is negligible or none.
3. How to take Efferaldol
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Recommended dose:
Adults: Take 1 tablet (1 g of paracetamol) every 6–8 hours, 3 times a day. Do not exceed 3 g (3 tablets) in 24 hours.
Always use the lowest dose that is effective.
Patients with liver disease: You must consult your doctor before taking this medicine.
You should take the amount of medicine prescribed by your doctor, with a minimum interval of 8 hours between doses. Do not exceed 2 grams of paracetamol in 24 hours, divided into 2 doses.
Patients with kidney disease: You must consult your doctor before taking this medicine.
Take a maximum of 500 milligrams per dose.
Due to the dose (1 gram of paracetamol), this medicine is not indicated for this patient group.
This medicine is for oral use.
The tablets may be taken whole or split in half, with a glass of liquid, preferably water.
The score line is intended only to facilitate splitting the tablet if you have difficulty swallowing it whole.
Avoid using high daily doses of paracetamol for prolonged periods, as this increases the risk of adverse effects such as liver damage.
Administration of this medicine should be based on the presence of pain or fever. As these symptoms subside, treatment should be discontinued.
If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, you should consult your doctor to reassess your clinical condition.
Use in children and adolescents:
Do not use this medicine in children or adolescents under 18 years of age.
When doses lower than 1 g of paracetamol per administration are required, other paracetamol formulations appropriate for the required dosage should be used.
If you take more Efferaldol than you should
Contact 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), stating the name of the medicine and the amount ingested.
Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
If you have taken an overdose, you must go immediately to a medical center even if you do not feel any 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 those 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 a missed dose. Simply take the missed dose as soon as you remember, and then take the following doses at the recommended intervals.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.
Rare adverse effects (occurring in up to 1 in 1,000 people) are: malaise, low blood pressure (hypotension), and increased blood transaminase levels.
Very rare adverse effects (occurring in up to 1 in 10,000 people) are: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Paracetamol may cause liver damage when taken in high doses or during prolonged treatment. Very rarely, serious skin reactions have been reported.
Frequency not known (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 who are using paracetamol (see section 2).
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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Efferaldol
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Efferaldol
- The active substance is paracetamol. Each tablet contains 1 g of paracetamol.
- The other components are: pregelatinized corn starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable-source magnesium stearate.
Appearance of the medicine and contents of the pack
The medicine is presented as white, oblong, film-coated tablets, scored on one side, packed in:
Aluminum-PVC-PVDC blisters.
HDPE bottles with polypropylene caps.
Only certain pack 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
Or
Farmalider, S.A.
C/ Aragoneses,
2 28108 Alcobendas - Madrid
Spain
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: June 2020
"Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/"