Analgilasa 500 mg/30 mg/10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Analgilasa 500 mg/30 mg/10 mg film-coated tablets

paracetamol/caffeine/codeine phosphate hemihydrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Analgilasa is and what it is used for

Analgilasa is a combination of paracetamol, codeine, and caffeine. Paracetamol is an analgesic medicine whose effects are enhanced by the action of codeine and caffeine.

This medicine is indicated for the symptomatic treatment of mild to moderate pain.

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.

You should consult a doctor if your pain worsens or does not improve after 3 days.

2. What you need to know before taking Analgilasa

Do not take Analgilasa

• if you are allergic (hypersensitive) to paracetamol, codeine, caffeine (or its derivatives such as aminophylline, theophylline, etc.), or to any of the other ingredients of this medicine (listed in section 6).
• to relieve pain in children and adolescents (0–18 years) after tonsil or adenoid removal 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 taking Analgilasa

• if you have kidney, liver, heart disease, respiratory problems, or anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells). You should consult your doctor before taking this medicine.
• if you have suffered a head injury or have been diagnosed with increased intracranial pressure.
• in elderly or debilitated patients, and in certain patients such as those with gallbladder disorders, multiple sclerosis, thyroid disease (hypothyroidism), or conditions associated with reduced respiratory capacity (tendency to suffer acute asthma attacks, chronic bronchitis, emphysema).
• if you have obstructive or inflammatory intestinal disorders (Crohn’s disease, ulcerative colitis, chronic constipation).
• if you are taking any 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.
• if you have urinary problems due to prostate disorders (prostatic hypertrophy) or urethral narrowing.
• if you are an aspirin-sensitive asthmatic. Consult your doctor before taking this medicine.
• if you have cardiac arrhythmias (abnormal heart rhythms), increased thyroid function (hyperthyroidism), or anxiety syndromes, as the dose of caffeine may need to be reduced.
• if you have hypertension or insomnia. In such cases, take this medicine with caution, as caffeine may worsen these conditions.
• if you are diabetic. Be aware that caffeine may increase blood sugar levels.
• if you have a history of cholecystectomy. Consult your doctor before using this medicine, as it may cause acute pancreatitis in some patients.

During treatment with Analgilasa, inform your doctor or pharmacist immediately if you experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to increased doses, if you have serious 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 breathing difficulties with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

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

In chronic alcoholics, take care 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 individuals have a genetic variation in this enzyme, which may affect people differently. In some individuals, little or no morphine is produced, resulting in inadequate pain relief. In others, excessive morphine may be produced, increasing the risk of serious adverse reactions. If you experience any of the following adverse effects, stop taking this medicine immediately and seek medical help: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

Do not exceed the recommended dose. To avoid this, avoid using other medicines containing paracetamol or codeine simultaneously.

Prolonged or frequent use of analgesics to treat headaches may worsen symptoms, which should not be treated with higher doses of the medicine.

Sleep-related breathing disorders

Analgilasa 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, an opioid drug. It may cause dependence and/or addiction.

Repeated use of opioids may reduce the drug's effectiveness (the body becomes accustomed to it; this is called tolerance). Repeated use of Analgilasa 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 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 Analgilasa if:

• You or a family member have abused or been dependent on alcohol, prescription medicines, or drugs ("addiction").
• You smoke.
• You have had mood disorders (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 Analgilasa, it may 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 resume it ("withdrawal effects").

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

The benefit-risk balance during continued use should be periodically reassessed by your doctor.

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

Children and adolescents

Use in children and adolescents after surgery

Codeine should not be used for pain relief in children and adolescents after tonsil or adenoid removal 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 more severe in these children.

Other medicines and Analgilasa

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Paracetamol may interact with the following medicines:

• Antibiotics (chloramphenicol, flucloxacillin).
• Anticoagulants (used to treat thromboembolic disorders).
• Oral contraceptives.
• Antiepileptics (used to treat epileptic seizures).
• 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).
• Colestyramine (used to lower blood cholesterol levels).

Inform your doctor or pharmacist if you are taking flucloxacillin (antibiotic), due to the risk of a serious blood and fluid disorder (called metabolic acidosis) requiring urgent treatment (see section 2).

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

As a general rule for any medicine, always inform your doctor or pharmacist if you are taking another medicine. In the case of treatment with oral anticoagulants, this medicine may occasionally be used as the analgesic of choice.

Codeine 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).
• Hypnotic neuroleptics (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-like analgesics, barbiturates, benzodiazepines (used to treat pain).

Caffeine may interact with the following medicines:

• Sympathomimetics, medicines used as: anti-asthmatics, vasopressors (to raise blood pressure), in the treatment of hyperkinetic child syndrome (ADHD), in opioid withdrawal syndrome, in the treatment of spasticity (muscle function disorder). Caffeine may increase the tachycardic effects (increased heart rate) of these medicines.
• Mexiletine (used to control heart rhythm disorders).
• Medicines or beverages containing caffeine or other medicines that stimulate the nervous system.
• Cimetidine (used as an antacid and anti-ulcer agent).
• Anti-asthmatics (theophylline, ephedrine).

Interference with diagnostic tests: If you are scheduled for any diagnostic tests (including blood or urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Analgilasa with alcohol

Do not consume alcohol during treatment with Analgilasa due to the increased risk of adverse reactions caused by codeine. The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day: beer, wine, spirits...) 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 before using this medicine.

Pregnancy

Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor.

If necessary, Analgilasa may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible duration.

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

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Small amounts of paracetamol may appear in breast milk.

Do not take codeine while breastfeeding. Codeine and morphine pass into breast milk.

Driving and use of machines

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

Therefore, do not drive or operate machinery until you know how you react to this medicine.

Alcohol may enhance this effect, so alcoholic beverages should not be consumed during treatment.

3. How to take Analgilasa

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain to you what to expect from using Analgilasa, when and for how long you should use it, when you should contact your doctor, and when you should stop treatment.

The duration of treatment will be determined by your doctor. Do not take this medicine for longer than indicated by your doctor.

If pain and/or fever persist for more than 3 days, or if pain or fever worsen or new symptoms appear, you must stop treatment and consult your doctor. This medicine must not be taken for longer than 3 days.

Analgesic should be used for the shortest period necessary to relieve symptoms. If adequate pain relief is not achieved during treatment with this medicine, you should consult a doctor.

The recommended dose is:

• Adults and adolescents over 15 years of age: 1 or 2 tablets every 4–6 hours. The maximum dose per administration is 2 tablets, and the maximum daily dose is 8 tablets. Treatment is recommended to begin with 2 tablets.

Use in children and adolescents

Dosages based on body weight must be strictly observed. The age range for adolescents based on weight is provided for informational purposes only.

• Adolescents weighing between 33 and 41 kg (aged 12 to 15 years): 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.
• Adolescents weighing between 41 and 50 kg (aged 12 to 15 years): 1 tablet per dose, every 6 or 4 hours depending on weight, as needed, up to a maximum of 6 tablets per day.

This medicine must not be administered to adolescents weighing less than 33 kg.

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

Patients with kidney or liver disease

The dose should be reduced and the interval between doses increased. These patients should consult their doctor.

Elderly patients

Should consult their doctor.

This medicine is taken orally. Tablets may be swallowed with a glass of water or another non-alcoholic liquid.

If you feel that the effect of Analgilasa is too strong or too weak, inform your doctor or pharmacist.

If you take more Analgilasa than you should

If you have taken more Analgilasa than recommended or accidentally ingested the entire contents of the package, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915 620 420, stating the name of the medicine and the amount ingested.

If an overdose has occurred, you must go immediately to a medical center even if there are no symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

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

Symptoms of overdose due to codeine 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.

Symptoms of overdose due to caffeine may include: difficulty urinating, insomnia, restlessness (nervous overstimulation).

Treatment of overdose is most effective if started within 4 hours after taking the medicine.

Patients receiving treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Analgilasa

Do not take a double dose to make up for a missed dose. 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, Analgisasa may cause adverse effects, although not everyone experiences them.

The adverse effects observed are described below according to their frequency of occurrence: very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), and frequency not known (cannot be estimated from available data).

The following adverse effects have been observed with paracetamol:

General

Rare: malaise.

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).

Gastrointestinal

Rare: increased levels of hepatic transaminases (liver enzymes).

Very rare: hepatotoxicity (liver toxicity) and jaundice (yellowing of the skin and mucous membranes).

Metabolism

Very rare: hypoglycemia (reduced blood glucose levels).

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

Blood

Very rare: thrombocytopenia (reduced platelet count), agranulocytosis, leucopenia, neutropenia (decreased white blood cells), hemolytic anemia (decreased red blood cells).

Vascular disorders

Rare: hypotension (low blood pressure).

Kidney and urine

Very rare: sterile pyuria (cloudy urine), adverse renal effects.

Skin and subcutaneous tissue

Very rare cases of serious skin reactions have been reported.

The following adverse effects have also been described with codeine, with frequency not known:

General

Malaise, drowsiness (somnolence), skin rashes.

Gastrointestinal

Constipation, nausea, and yellowish discoloration of the skin and eyes (jaundice).

Symptoms associated with inflammation of the pancreas (pancreatitis) and a condition affecting a valve in the intestine (dysfunction of the sphincter of Oddi).

Metabolism

Low blood glucose (hypoglycemia).

Blood

Blood disorders.

The following adverse effects have been observed with caffeine, with frequency not known:

Nervous system

Nervousness, restlessness.

Gastrointestinal

Irritation of the stomach or intestine.

Cardiac

Tachycardias.

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 Analgiasa

Keep this medicine out of sight and reach of children. Store this medicine in a safe place where others cannot access it. It may cause serious harm and could be fatal to individuals for whom it has not been prescribed.

Do not use Analgiasa 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. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Analgysa 500 mg/30 mg/10 mg tablets

• The active substances are: paracetamol, codeine phosphate hemihydrate and caffeine. Each tablet contains 500 mg of paracetamol, 30 mg of caffeine and 10 mg of codeine (hemihydrate phosphate).
• The other components (excipients) are: corn starch, stearic acid, povidone, glycerol diesters of stearic acid, sodium croscarmellose, and magnesium stearate, which form part of the core; and Macrogol 6000, microcrystalline cellulose, hypromellose, titanium dioxide (E-171) and erythrosine (E-127), which form part of the tablet coating.

Appearance of the product and contents of the pack

Each pack contains 20 tablets. The medicine is packaged using a blister system (Aluminum/PVC) that individually separates and protects each dosage 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 of Medicines and Health Products (AEMPS): http://www.aemps.gob.es