Leaflet: information for the user
AnalgiPlus 500 mg/ 30 mg film-coated tablets
paracetamol/ codeine
Read this leaflet carefully before you start taking this medicine, because it contains important information for you.
1.What is AnalgiPlus and what it is used for
2.What you need to know before starting to take AnalgiPlus
3.How to take AnalgiPlus
4.Possible side effects
5.Storage of AnalgiPlus
6.Contents of the pack and additional information
AnalgiPlus 500 mg/ 30 mg film-coated tablets is an association of paracetamol and codeine. Paracetamol is an analgesic and antipyretic (pain relief and fever reduction) medication of proven efficacy, whose effects are potentiated by the action of codeine, a central analgesic.
This product contains codeine. Codeine belongs to a group of medications called opioid analgesics that act to relieve pain. It may be used alone or in combination with other analgesics such as paracetamol.
Do not take AnalgiPlus
Warnings and precautions
Consult your doctor or pharmacist before starting to take AnalgiPlus
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 have malnutrition, chronic alcoholism, or 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.
Do not take more than the recommended dose.
Consuming alcoholic beverages (three or more alcoholic beverages per day) may cause paracetamol to damage the liver.
In chronic alcoholics, be careful not to take more than 2 g/day of paracetamol.
Codeine is transformed into morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme that can affect people differently. In some people, no morphine is produced or very little is produced, and it will not provide sufficient pain relief. In other people, it is more likely that they will experience severe adverse reactions because a very high amount of morphine is produced. If you experience any of the following adverse effects, stop taking this medication and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, loss of appetite.
If the pain persists for more than 3 days, worsens, or new symptoms appear, you should interrupt treatment and consult your doctor.
Do not use this medication in children under 15 years old. Consult your doctor or pharmacist.
Prolonged and excessive administration of codeine may cause dependence and/or tolerance, especially in people with a tendency to abuse and addiction. After prolonged treatments, you should interrupt administration gradually as advised by your doctor.
Children and adolescents
Use in children and adolescentsafter surgery
Do not use codeine to relieve pain in children and adolescents after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.
Use in children with respiratory problems
Do not recommend the use of codeine in children with respiratory problems, as the symptoms of morphine toxicity may be worse in these children.
Other medications and AnalgiPlus
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.
In particular, if you are using medications that contain the following active ingredients, as it may be necessary to modify the dose or interrupt treatment for any of them:
Paracetamol may interact with the following medications:
Do not use with other analgesics (pain-relieving medications) without consulting your doctor.
Inform your doctor or pharmacist if you are taking flucloxacillin (antibiotic), as there is a serious risk of blood and fluid alteration (metabolic acidosis) that requires urgent treatment (see section 2).
As a general rule for any medication, it is recommended to inform your doctor or pharmacist systematically if you are taking another medication.
On the other hand, codeine may interact with the following medications:
Interference with analytical tests:if you are to undergo any analytical test (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.
Taking AnalgiPlus with food and drinks
Using paracetamol in patients who regularly consume alcohol (three or more alcoholic beverages per day: beer, wine, liquor) may cause liver damage.
Pregnancy and lactation
If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.
Pregnancy
Do not administer AnalgiPlus during pregnancy.
If necessary, AnalgiPlus 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 under the supervision of your doctor, who will evaluate the possible risks and benefits of treatment.
Never exceed the recommended dose.
Contact your doctor if the pain or fever does not decrease or if you need to take the medication more frequently.
Lactation
Small amounts of paracetamol may appear in breast milk.
Do not take codeine if you are breastfeeding. Codeine and morphine pass into breast milk.
Driving and operating machinery
This medication may alter your ability to drive vehicles or operate machinery that requires special attention.
Do not drive or operate machinery until you check how you tolerate this medication.
Alcohol may enhance this effect, so do not consume alcoholic beverages during treatment.
Use in athletes
Be especially careful with AnalgiPlus if you are an athlete, as this medication contains a component, codeine, that may result in a positive analytical test for doping control.
Follow exactly the administration instructions for AnalgiPlus as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.
Your doctor will inform you of the amount of medication to take and the duration of treatment based on the intensity and characteristics of the pain.
The recommended dose is:
Adults and children over 15 years old
1 tablet every 6 hours. The maximum dose per intake will be 2 tablets and the maximum daily dose will be 8 tablets.
Never exceed the recommended dose.
AnalgiPlus should be taken orally. The ingestion of the tablets can be helped with a sip of water or another non-alcoholic liquid.
The administration of the preparation is subject to the appearance of painful or febrile symptoms. As these symptoms disappear, this medication should be discontinued.
This medication should not be taken for more than 3 days. If the pain does not improve after 3 days, consult your doctor.
Use in children and adolescents
Children under 15 years old
Consult your doctor as this medication is not recommended for this age group.
Children under 12 years old
Children under 12 years old should not take AnalgiPlus due to the risk of severe respiratory problems.
Patients with liver disease
Consult your doctor before taking this medication.
Take the amount of medication prescribed by your doctor with a minimum interval of 8 hours between each intake. Do not take more than 2 grams of paracetamol in 24 hours, divided into several doses.
Patients with kidney disease
Consult your doctor before taking this medication.
Your doctor will indicate whether you should take your medication with a minimum interval of 6 or 8 hours. Do not take more than 2 grams of paracetamol in 24 hours, divided into several doses, and never exceed 500 milligrams per dose.
Older adults
Consult your doctor before taking this medication.
If you estimate that the action of AnalgiPlus is too strong or too weak, inform your doctor or pharmacist.
If you take more AnalgiPlus than you should
If you have taken more AnalgiPlus than you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.
If you have taken an overdose, go to a medical center immediately, even if you do not have symptoms, as they often do not appear until 3 days after the overdose, even in cases of severe poisoning.
The treatment of an overdose is more effective if it is initiated within 4 hours of taking the medication.
A paracetamol overdose is considered to be the ingestion of a single dose of more than 6 grams in adults (12 AnalgiPlus tablets) and more than 100 milligrams per kilogram of body weight in children (for a 20 kilogram child, 4 tablets in a single dose).
The symptoms of a paracetamol overdose can be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain.
The symptoms of a codeine overdose can be: initial excitement, anxiety, inability to fall asleep (insomnia) and later in some cases a feeling of sleepiness (somnolence), headache (cephalalgia), blood pressure alterations, arrhythmias, dry mouth, skin eruptions, tachycardia, convulsions, gastrointestinal disturbances, nausea, vomiting, and respiratory depression.
If you forget to take AnalgiPlus
Do not take a double dose to compensate for the missed doses. Take the missed dose as soon as you remember and if your next dose is due soon, skip the missed dose and continue taking the medication at the usual time. If in doubt, consult your doctor or pharmacist.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Like all medicines, AnalgiPlus can cause side effects, although not everyone will experience them.
The observed side effects are described below according to their frequency of presentation: very common (may affect more than 1 in 10 patients), common (may affect up to 1 in 10 patients), uncommon (may affect up to 1 in 100 patients), rare (may affect up to 1 in 1,000 patients), very rare (may affect up to 1 in 10,000 patients), and unknown frequency (cannot be estimated from available data).
The following side effects have been observed caused byparacetamol:
Rare:unpleasantness, increased levels of liver enzymes (liver enzymes), hypotension (decreased blood pressure).
Very rare:allergic reactions (hypersensitivity) ranging from a simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a type of severe allergic reaction), severe skin reactions, hepatotoxicity (liver toxicity), jaundice (yellow discoloration of the skin and mucous membranes), hypoglycemia (low blood glucose levels), thrombocytopenia (reduced platelet count in the blood), agranulocytosis, leukopenia, neutropenia (reduced white blood cell count), hemolytic anemia (reduced red blood cell count), sterile pyuria (cloudy urine), adverse renal effects.
Unknown frequency:a severe disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease using paracetamol (see section 2).
The following side effects have also been described caused bycodeine:
Rare: unpleasantness, drowsiness, constipation, and nausea.
Very rare:allergic reactions (hypersensitivity) ranging from a simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a type of severe allergic reaction), fever, yellow discoloration of the skin and eyes (jaundice), low blood glucose levels (hypoglycemia), blood alterations.
Unknown frequency:acute pancreatitis in patients with a history of cholecystectomy.
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Do not use AnalgiPlus 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.
Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.
Composition of AnalgiPlus 500 mg/ 30 mg coated tablets
Appearance of the product and content of the packaging
Each package contains 20 coated tablets. The medication is presented conditioned and packaged in the "blister" system (Aluminum / PVC), which individualizes and protects each pharmaceutical form.
Faes Farma, S.A.
Autonomia Etorbidea, 10
48940 Leioa (Bizkaia)
Spain
Faes Farma, S.A.
Maximo Agirre Kalea, 14
48940 Leioa (Bizkaia)
Spain
O
Faes Farma, S.A.
Parque Científico y Tecnológico de Bizkaia
Ibaizabal Bidea,Edificio 901
48160 Derio (Bizkaia)
Spain
Last review date of this leaflet:January 2025
The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.