ANALGILASA 500 mg / 30 mg / 10 mg FILM-COATED TABLETS

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.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Analgilasa and what is it used for

Analgilasa is an association of paracetamol, codeine, and caffeine. Paracetamol is a pain-relieving medication whose effects are enhanced by the action of codeine and caffeine.

This medication is indicated for the symptomatic treatment of mild or moderate pain.

Codeine belongs to a group of medications called opioid analgesics that act by relieving pain. It can 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 you take Analgilasa

Do not take Analgilasa

• if you are allergic (hypersensitive) to paracetamol, codeine, caffeine (or its derivatives such as aminophylline, theophylline, etc.) or any of the other components of this medication (listed in section 6).
• to relieve pain in children and adolescents (0-18 years) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.
• if you know you metabolize codeine very quickly into morphine.
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Analgilasa

• if you have any kidney, liver, heart, or respiratory problems or have anemia (decrease in hemoglobin levels in the blood due to or not due to a decrease in red blood cells). You should consult your doctor before taking this medication.
• if you have had a head injury or have been diagnosed with increased pressure inside the skull.
• in elderly or debilitated patients and in certain patients, such as those with biliary colic, multiple sclerosis, or if you have any thyroid gland disease (hypothyroidism) and diseases that cause decreased respiratory capacity (tendency to suffer from acute asthma attacks, chronic bronchitis, emphysema).
• if you have intestinal obstruction or inflammatory problems (Crohn's disease, ulcerative colitis, chronic constipation).
• if you are being treated with any medication for epilepsy. Consult your doctor before taking this medication because when used at the same time, the efficacy is decreased and the hepatotoxicity of paracetamol is potentiated, especially in treatments with high doses of paracetamol.
• if you have urination problems due to prostate problems (prostatic hypertrophy) or urethral stricture.
• if you are an asthmatic patient sensitive to acetylsalicylic acid. Consult your doctor before taking this medication.
• if you have cardiac arrhythmias (heart rhythm disorders), increased thyroid function (hyperthyroidism), or anxiety disorders, as you should reduce the dose of caffeine.
• if you have hypertension or insomnia. In that case, you will take this medication with caution since caffeine can potentiate these situations.
• if you are diabetic. You should be aware that caffeine can increase blood sugar levels.
• if you have a history of cholecystectomy. Consult your doctor before using this medication as it may cause acute pancreatitis in some patients.

During treatment with Analgilasa, immediately inform your doctor if you have serious diseases, such as severe renal insufficiency 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 serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

In chronic alcoholics, caution should be taken 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 in different ways. In some people, morphine is not produced or is produced in very low quantities, and it will not provide sufficient pain relief. Other people are more likely to suffer from serious adverse reactions because they produce a very high amount of morphine. If you experience any of the following side effects, you should stop taking this medication and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, loss of appetite.

Do not take more than the recommended dose. To do this, avoid taking other medications that contain paracetamol or codeine at the same time.

The prolonged or frequent use of analgesics to treat headaches can worsen the symptoms, which should not be treated with higher doses of the medication.

With repeated administration of this medication, physical dependence and tolerance (the body gets used to it and more medication is needed to achieve the same effect) may appear. The administration should be gradually suspended after prolonged treatments.

The benefit/risk balance during continued use should be periodically reevaluated by the doctor.

If the pain or fever persists for more than 3 days, or the pain or fever worsens or other symptoms appear, the treatment should be discontinued and the doctor consulted.

Children and adolescents

Use in children and adolescents after surgery

Codeine should not be used to relieve pain in children and adolescents after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.

Use in children with respiratory problems

Codeine is not recommended for use in children with respiratory problems since the symptoms of morphine toxicity can be worse in these children.

Other medications and Analgilasa

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medications, including those bought without a prescription.

Paracetamolmay interact with the following medications:

• Antibiotics (chloramphenicol, flucloxacillin).
• Anticoagulants (used to treat thromboembolic diseases).
• 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 stomach, intestine, and bladder spasms or contractions).
• Zidovudine (used to treat HIV infections).
• Colestyramine (used to decrease blood cholesterol levels).

Tell your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis) that requires urgent treatment (see section 2).

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

As a general rule for any medication, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medication. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

On the other hand, codeinemay 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 morphinic analgesics, barbiturates, benzodiazepines (used to treat pain).

Similarly, caffeinemay interact with the following medications:

• Sympathomimetics, medications used as: anti-asthmatics, hypertensives (used to raise blood pressure), in the treatment of hyperactive child syndrome (hyperkinetic syndrome), in the syndrome of withdrawal from opium derivatives, in the treatment of spasticity (alteration of muscle function). Caffeine can increase the tachycardic effects (increased heart rate) of these medications.
• Mexiletine (used to control heart rhythm disorders).
• Medications or beverages with caffeine or other medications that stimulate the nervous system.
• Cimetidine (used as an antiacid and antiulcer medication).
• Anti-asthmatics (theophylline, ephedrine).

Interference with analytical tests: if you are going to undergo any diagnostic test (including blood or urine tests), inform your doctor that you are taking this medication, as it may alter the results.

Taking Analgilasa with alcohol

You should not consume alcohol during treatment with Analgilasa due to the increased risk of adverse reactions due to codeine. The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic beverages a day: beer, wine, liquor...) can cause liver damage.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

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

Analgilasa can be used during pregnancy if necessary. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time.

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

Breastfeeding

Ask your doctor or pharmacist for advice before taking any medication.

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 using machines

This medication may alter your ability to drive vehicles or operate machines that require special attention.

Therefore, do not drive or operate machines until you have checked how you tolerate this medication.

Alcohol can potentiate this effect, so you should not drink alcoholic beverages during treatment.

3. How to take Analgilasa

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

If the pain and/or fever persist for more than 3 days or the pain or fever worsen or other symptoms appear, you should discontinue treatment and consult your doctor. This medication should not be taken for more than 3 days.

The recommended dose is:

• Adults and adolescents over 15 years:1 or 2 tablets every 4-6 hours. The maximum dose per intake will be 2 tablets and the maximum daily dose will be 8 tablets. It is recommended to start treatment with 2 tablets.

Use in children and adolescents

It is necessary to respect the defined posologies according to weight. The age of the adolescent is given for informational purposes.

• Adolescents between 33 and 41 kg in weight (12 to 15 years):1 tablet per intake, every 6 hours, up to a maximum of 4 tablets per day.
• Adolescents between 41 and 50 kg in weight (12 to 15 years):1 tablet per intake, every 6 or 4 hours according to weight, when necessary, up to a maximum of 6 tablets per day.

This medication should not be administered to adolescents with less than 33 kg of body weight.

Children under 12 years should 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 intakes increased. They should consult their doctor.

Elderly patients

They should consult their doctor.

This medication is taken orally. The ingestion of the tablets can be helped with a sip of water or another non-alcoholic liquid.

If you think the action of Analgilasa is too strong or too weak, tell your doctor or pharmacist.

If you take more Analgilasa than you should

If you have taken more Analgilasa than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you have taken an overdose, you should go to a medical center immediately, even if you do not have symptoms, since they often do not appear until 3 days after taking the overdose, even in cases of severe poisoning.

The symptoms of overdose due to paracetamolcan be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain.

The symptoms of overdose due to codeinecan be: initial excitement, anxiety, insomnia, and later in certain cases drowsiness, headache, changes in blood pressure, arrhythmias, dry mouth, skin rashes, tachycardia, convulsions, gastrointestinal disorders, nausea, vomiting, and respiratory depression.

The symptoms of overdose due to caffeinecan be: difficulty urinating, insomnia, restlessness (nervous overexcitement).

Treatment of the overdose is more effective if started within 4 hours after taking the medication.

Patients treated 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 forgotten doses. Take the missed dose as soon as you remember and if your next dose is near in time, skip the missed dose and continue taking the medication as scheduled. In case of doubt, consult your doctor or pharmacist.

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

4. Possible Adverse Effects

Like all medicines, Analgilasa can cause adverse effects, although not all people suffer from them.

The observed adverse effects are described below according to their frequency of presentation: very frequent(may affect more than 1 in 10 patients), frequent(may affect up to 1 in 10 patients), infrequent(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 of unknown frequency(cannot be estimated from the available data).

The following adverse effects have been observed with paracetamol:

General

Rare:discomfort.

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).

Gastrointestinal

Rare:increased liver transaminases (liver enzymes).

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

Unknown frequency:acute pancreatitis in patients with a history of cholecystectomy.

Metabolism

Very rare:hypoglycemia (reduced glucose levels in the blood).

Unknown frequency:a severe condition that can make the blood more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

Blood

Very rare:thrombocytopenia (reduced platelets in the blood), agranulocytosis, leukopenia, neutropenia (decreased white blood cells in the blood), hemolytic anemia (decreased red blood cells in the blood).

Vascular Disorders

Rare:hypotension (decreased blood pressure).

Kidney and Urinary

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

Skin and Subcutaneous Tissue

Very rare cases of severe skin reactions have been reported.

The following adverse effects have been described with codeine, whose frequency has not been established with precision:

General

Discomfort, drowsiness (somnolence), skin rashes.

Gastrointestinal

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

Metabolism

Decreased blood glucose (hypoglycemia).

Blood

Blood disorders.

The following adverse effects have been observed with caffeine, whose frequency has not been established with precision:

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Analgilasa

Keep this medicine out of sight and reach of children.

Do not use Analgilasa after the expiration date that appears on the packaging after CAD.

The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Content of the Packaging and Additional Information

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

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

Appearance of the Product and Content of the Packaging

Each package contains 20 tablets. The medicine is presented in a blister pack (aluminum/PVC) that individualizes 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 Last Revision of this Prospectus:January 2025

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