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.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

• if you are allergic (hypersensitive) to paracetamol or propacetamol (paracetamol precursor), codeine, or any of the other components of this medication listed in section 6.
• if you have respiratory depression.

• to relieve pain in children and adolescents (0-18 years) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.
• if you know that you metabolize codeine very quickly to morphine.
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take AnalgiPlus

• if you have liver, kidney, heart, or lung disease, or have anemia (decreased hemoglobin levels in the blood due to or not due to decreased red blood cells). In this case, you should consult your doctor before taking this medication.
• if you have thyroid disease, prostate enlargement (prostatic hypertrophy), head injuries, or acute asthma attacks, consult your doctor before taking this medication.
• if you have anemia, chronic heart and respiratory failure, or any lung disease, as this medication should be administered with caution, avoiding prolonged treatments.
• if you are asthmatic or have a history of asthma, and are also sensitive to acetylsalicylic acid, you should consult your doctor before taking this medication.
• in elderly patients, it is recommended that they consult their doctor before taking this medication.
• if you have a history of cholecystectomy. Consult a doctor before using this medication, as it may cause acute pancreatitis in some patients.

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:

• Antibiotics (chloramphenicol, flucloxacillin).
• Anticoagulants (used to treat thromboembolic diseases).
• Oral contraceptives and hormone replacement therapy.
• Antiepileptics (used to treat seizures).
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Activated charcoal, used to treat diarrhea or gas.
• Diuretics (used to increase urine elimination).
• Isoniazid (used to treat tuberculosis).
• Lamotrigine (used to treat epilepsy).
• Probenecid (used to treat gout).
• Propranolol (used to treat hypertension and arrhythmias).
• Rifampicin (used to treat tuberculosis).
• Anticholinergics (used to relieve spasms or contractions of the stomach, intestines, and bladder).
• Zidovudine (used to treat HIV infections).
• Colestiramine (used to reduce cholesterol levels in the blood).

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:

• Nalbuphine, buprenorphine, pentazocine (used to treat pain).
• Antidepressants (used to treat depression).
• Sedatives (used to treat depression, anxiety).
• Antihistamines H1 sedatives (used to treat allergies).
• Anxiolytics (used to treat anxiety).
• Hypnotic neuroleptics (used to treat insomnia).
• Clonidine and related medications (used to treat hypertension and migraine).
• Other morphine analgesics, barbiturates, benzodiazepines (used to treat pain).

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

• The active principles are: paracetamol and codeine phosphate hemihydrate. Each tablet contains 500 mg of paracetamol and 30 mg of codeine (phosphate hemihydrate).
• The other components (excipients) are: glyceryl palmitostearate, magnesium stearate, croscarmellose sodium, cornstarch without gluten, stearic acid, povidone, hypromellose, microcrystalline cellulose, poloxyl 40 stearate, and titanium dioxide (E-171).

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.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

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