Analgiplus 500 mg/30 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

AnalgiPlus 500 mg/30 mg film-coated tablets

paracetamol/codeine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• 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.

Leaflet Contents

1. What AnalgiPlus is and what it is used for
2. What you need to know before taking AnalgiPlus
3. How to take AnalgiPlus
4. Possible side effects
5. How to store AnalgiPlus
6. Contents of the pack and other information

1. What AnalgiPlus is and what it is used for

AnalgiPlus 500 mg/30 mg film-coated tablets is a combination of paracetamol and codeine. Paracetamol is an analgesic and antipyretic medicine (relieves pain and reduces fever) with proven efficacy, whose effects are enhanced by the action of codeine, a centrally-acting analgesic.

This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics, which work by relieving pain. It may be used alone or in combination with other analgesics such as paracetamol.

2. What you need to know before taking AnalgiPlus

Do not take AnalgiPlus

• if you are allergic (hypersensitive) to paracetamol or propacetamol (a precursor of paracetamol), codeine, or any of the other ingredients of this medicine listed in section 6.

• if you have respiratory depression.

• to relieve pain in children and adolescents (0–18 years) after removal of tonsils or adenoids due to obstructive sleep apnea syndrome.

• if you know that you metabolize codeine rapidly into 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 if you have anemia (reduced hemoglobin levels in the blood, with or without a decrease in red blood cells). In such cases, you should consult your doctor before taking this medicine.
• if you have thyroid disease, prostate disorders (prostatic hypertrophy), intracranial lesions, or acute asthma attacks, consult your doctor before taking this medicine.
• if you have anemia, chronic cardiorespiratory insufficiency, or any pulmonary conditions, as this medicine should be used with caution in these cases, avoiding prolonged treatment.
• 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 medicine.
• elderly patients are advised to consult their doctor before taking this medicine.
• if you have a history of cholecystectomy. Consult a doctor before using this medicine, as it may cause acute pancreatitis in some patients.

During treatment with AnalgiPlus, inform your doctor immediately if you experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to an increased dose of the medicine, if you have severe illnesses 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 regularly 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, malaise (nausea), and vomiting.

Contact your doctor if you have severe abdominal pain possibly radiating to the back, nausea, vomiting, or fever, as these may be symptoms of inflammation of the pancreas (pancreatitis) or of the biliary system.

Do not take more than the recommended dose.

Consumption of alcoholic beverages (three or more alcoholic drinks per day) may cause paracetamol to cause liver damage.

In chronic alcoholics, caution should be taken not to exceed 2 g/day of paracetamol.

Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance responsible for pain relief. Some people have a variation of this enzyme that can affect individuals differently. In some people, morphine is not produced or is produced in very low amounts, resulting in insufficient pain relief. In others, a very high amount of morphine may be produced, increasing the risk of serious adverse reactions. If you experience any of the following adverse effects, you must stop taking this medicine and seek immediate medical help: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

If pain persists for more than 3 days, worsens, or new symptoms appear, you should stop treatment and consult your doctor.

In children under 15 years of age, consult your doctor or pharmacist, as use of this medicine is not recommended in this patient group.

Sleep-related breathing disorders

AnalgiPlus may cause sleep-related breathing disorders, such as sleep apnea (breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Tolerance, dependence, and addiction

This medicine contains codeine, which is an opioid. It may cause dependence and/or addiction.

Repeated use of opioids may reduce the effectiveness of the drug (the body becomes accustomed to it; this is called tolerance). Repeated use of AnalgiPlus may also lead to dependence, abuse, and addiction, which in turn may lead to potentially fatal overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you have lost control over how much medicine you need to take or how often you need to take it.

The risk of developing dependence or addiction varies from person to person. You may have a higher risk of dependence or addiction to AnalgiPlus if:

• You or a family member have abused or been dependent on alcohol, prescription medicines, or drugs ("addiction").
• You smoke.
• You have had mood-related problems (depression, anxiety, or personality disorders) or have been treated by a psychiatrist for other psychiatric disorders.

If you notice any of the following signs while taking AnalgiPlus, it could indicate that you have developed dependence or addiction:

• You need to take the medicine for longer than recommended by your doctor.
• You need to take a higher dose than recommended.
• You feel you need to keep taking the medicine, even if it does not help relieve your pain.
• You take the medicine for reasons other than the one it was prescribed for, for example, to "feel calm" or "help you sleep."
• You have tried several times to stop or control your use of the medicine without success.
• You feel unwell when you stop taking the medicine and feel better when you take it again ("withdrawal effects").

If you notice any of these signs, talk to your doctor to determine the best treatment approach for you, when to stop treatment, and how to do so.

Children and adolescents

Use in children and adolescents after surgery

Codeine should not be used for pain relief in children and adolescents after removal of tonsils or adenoids due to obstructive sleep apnea syndrome.

Use in children with respiratory problems

The use of codeine is not recommended in children with respiratory problems, as symptoms of morphine toxicity may be worse in these children.

Other medicines and AnalgiPlus

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine, including those obtained without a prescription.

In particular, if you are using medicines containing any of the following active ingredients, a dose adjustment or discontinuation of treatment may be necessary:

Paracetamol may interact with the following medicines:

• Antibiotics (chloramphenicol, flucloxacillin).
• Anticoagulants (used to treat thromboembolic disorders).
• Oral contraceptives and estrogen treatments.
• Antiepileptics (used to treat epileptic seizures).
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Activated charcoal, used for diarrhea or gas treatment.
• 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, cardiac arrhythmias).
• Rifampicin (used to treat tuberculosis).
• Anticholinergics (used to relieve spasms or contractions of the stomach, intestine, and bladder).
• Zidovudine (used to treat HIV infections).
• Colestipol (used to lower blood cholesterol levels).

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.

Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis) requiring 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 another medicine.

Codeine, on the other hand, may interact with the following medicines:

• Nalbuphine, buprenorphine, pentazocine (used to treat pain).
• Antidepressants (used to treat depression).
• Sedatives (used to treat depression, anxiety).
• Sedating H1 antihistamines (used to treat allergies).
• Anxiolytics (used to treat anxiety).
• Neuroleptic hypnotics (used to treat insomnia).
• Clonidine and related drugs (used to treat hypertension and migraine).
• Gabapentin or pregabalin (used to treat epilepsy or nerve injury-related pain [neuropathic pain]).
• Other morphine-type analgesics, barbiturates, benzodiazepines (used to treat pain).

Interference with laboratory tests: if you are 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 such tests.

Taking AnalgiPlus with food and drinks

Using paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day: beer, wine, liquor) may cause liver damage.

Pregnancy and breastfeeding

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

Pregnancy

The administration of AnalgiPlus is not recommended during pregnancy.

If necessary, AnalgiPlus may be used during pregnancy. The lowest possible dose that relieves pain or fever should be used for the shortest possible time, always under the supervision of your doctor, who will assess the potential risks and benefits of treatment.

Never exceed the recommended dose.

Contact your doctor if pain or fever does not decrease or if you need to take the medicine more frequently.

Breastfeeding

Small amounts of paracetamol may pass into breast milk.

Do not take codeine if you are breastfeeding. Codeine and morphine pass into breast milk.

Driving and using machines

This medicine may affect your ability to drive vehicles or operate machinery requiring special attention.

Therefore, do not drive or operate machinery until you know how you tolerate this medicine. Alcohol may enhance this effect, so alcoholic beverages should not be consumed during treatment.

Use in athletes

Take special care with AnalgiPlus if you are an athlete, as this medicine contains a component, codeine, which may result in a positive doping test.

3. How to take AnalgiPlus

Follow exactly the instructions for the administration of AnalgiPlus provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Before starting treatment and regularly during treatment, your doctor will explain to you what to expect from the use of AnalgiPlus, when and for how long you should use it, when you should contact your doctor, and when you should discontinue treatment.

Your doctor will determine the amount of medication you should take and the duration of treatment based on the intensity and characteristics of your pain.

The recommended dose is:

Adults and children over 15 years of age

1 tablet every 6 hours. The maximum dose per administration is 2 tablets, and the maximum daily dose is 8 tablets.

Never exceed the recommended dose.

AnalgiPlus is taken orally. Tablets should be swallowed with a glass of water or another non-alcoholic liquid.

This medication should be taken only when pain or fever symptoms occur. As symptoms subside, this medication should be discontinued.

Do not take this medicine for more than 3 days. If pain does not improve after 3 days, consult your doctor. AnalgiPlus should be used for the shortest duration necessary to relieve symptoms. If adequate pain relief is not achieved during treatment, consult your doctor.

Use in children and adolescents

Children under 15 years of age

Consult your doctor, as administration of this medicine is not recommended in this population group.

Children under 12 years of age

Children under 12 years of age must not take AnalgiPlus due to the risk of serious breathing problems.

Patients with liver disease

Consult your doctor before taking this medicine.

They should take the amount of medication prescribed by their doctor, with a minimum interval of 8 hours between doses. They must 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 medicine.

Depending on the severity of the condition, your doctor will advise whether you should take the medication every 6 or 8 hours. They must not take more than 2 grams of paracetamol in 24 hours, divided into several doses, and must not exceed 500 milligrams per dose.

Elderly patients

Consult your doctor before taking this medicine.

If you feel that the effect 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 Toxicology Information Service at telephone number 915 620 420, indicating the name of the medicine and the amount ingested.

If you have taken an overdose, you must go immediately to a medical center, even if you have no 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 after taking the medicine.

An overdose of paracetamol is considered when a single dose exceeding 6 g is ingested in adults (12 tablets of AnalgiPlus) and more than 100 mg per kg of body weight in children (for a 20 kg child, 4 tablets in a single dose).

Symptoms of paracetamol overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Symptoms of codeine overdose may include: initial excitement, anxiety, inability to fall asleep (insomnia), followed in some cases by drowsiness (somnolence), headache (cephalalgia), changes in blood pressure, arrhythmias, dry mouth, skin rashes, tachycardia, seizures, gastrointestinal disturbances, nausea, vomiting, and respiratory depression.

If you forget to take AnalgiPlus

Do not take a double dose to make up for missed doses. Take the missed dose as soon as you remember. If your next dose is due soon, skip the missed dose and continue with your regular dosing schedule. If in doubt, consult your doctor or pharmacist.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, AnalgiPlus can cause adverse effects, although not everyone will experience them.

The adverse effects observed are described below according to their frequency of occurrence: 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 not known frequency (cannot be estimated from available data).

The following adverse effects have been observed with paracetamol:

Rare: malaise, increased levels of hepatic transaminases (liver enzymes), hypotension (reduction in blood pressure).

Very rare: allergic reactions (hypersensitivity) ranging from simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a type of severe allergic reaction), serious skin reactions, hepatotoxicity (liver toxicity) and jaundice (yellowing of the skin and mucous membranes), hypoglycemia (reduced glucose levels in blood), thrombocytopenia (reduction in platelets in blood), agranulocytosis, leucopenia, neutropenia (decrease in white blood cells in blood), hemolytic anemia (decrease in red blood cells in blood), sterile pyuria (cloudy urine), adverse renal effects.

Frequency not known: a serious condition that may cause blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

The following adverse effects have also been reported with codeine:

Rare: malaise, drowsiness (somnolence), constipation, and nausea.

Very rare: allergic reactions (hypersensitivity) ranging from simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a type of severe allergic reaction), fever, yellowing of the skin and eyes (jaundice), low blood glucose (hypoglycemia), blood disorders.

Frequency not known: symptoms associated with inflammation of the pancreas (pancreatitis) and a problem affecting a valve in the intestine (Oddi sphincter dysfunction).

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 AnalgiPlus

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

Store this medicine in a safe place inaccessible to other people. It may cause serious harm and could be fatal to individuals for whom it has not been prescribed.

Do not use AnalgiPlus after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of AnalgiPlus 500 mg/30 mg film-coated tablets

• The active substances are: paracetamol and codeine phosphate hemihydrate. Each tablet contains 500 mg of paracetamol and 30 mg of codeine (hemihydrate phosphate).
• The other components (excipients) are: glyceryl palmitostearate, magnesium stearate, sodium croscarmellose, gluten-free corn starch, stearic acid, povidone, hypromellose, microcrystalline cellulose, polyoxyl 40 stearate, titanium dioxide (E-171).

Appearance of the product and contents of the pack

Each pack contains 20 film-coated tablets. The medicine is packaged using the "blister" system (Aluminum / PVC), which individually separates and protects each pharmaceutical form.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the most recent review of this leaflet: February 2026

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es