Leaflet: information for the user

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

paracetamol/ caffeine / codeine phosphate hemihydrate

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 doubts, consult 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.
• Ifyou experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Analgilasa is and what it is used for

2. What you need to know before you start taking Analgilasa

3. How to take Analgilasa

4. Possible side effects

5. Storage of Analgilasa

6. Contents of the pack and additional information

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

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

Lacodeinebelongstoagroupof medications called opioid analgesics that act by relieving pain.Itmaybe used alone or in combination with other pain-relieving medications such as paracetamol.

You should consult a doctor if your pain worsens or does not improve after3days.

Do not take Analgilasa

• if you are allergic (hypersensitive) to paracetamol, codeine, caffeine (or derivatives such as aminophylline, theophylline, etc.) or to 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 that you metabolize codeine very quickly to 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 disease 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 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 disease, multiple sclerosis, or those with thyroid gland disease (hypothyroidism) and diseases that cause respiratory capacity reduction (tendency to suffer acute asthma attacks, chronic bronchitis, emphysema).
• if you have obstructive or inflammatory intestinal 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 together, the efficacy is reduced and the hepatotoxicity of paracetamol is potentiated, especially in high-dose paracetamol treatments.
• if you have urinary problems due to prostate enlargement (prostatic hypertrophy) or urethral narrowing.
• if you are an asthmatic sensitive to acetylsalicylic acid. Consult your doctor before taking this medication.
• if you have cardiac arrhythmias (alterations in heart rhythm), increased thyroid function (hyperthyroidism) or anxiety syndromes, as you should reduce the dose of caffeine.
• if you have hypertension or insomnia. In this case, you will take this medication with caution as caffeine can exacerbate 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 can cause acute pancreatitis in some patients.

Inform your doctor immediately if you have severe 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 if you 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 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 respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

In chronic alcoholics, you should 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, morphine is not produced or is produced in very small quantities, and it will not provide sufficient pain relief. Other people are more likely to suffer from severe adverse reactions because they produce a very high amount of morphine. 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.

Do not take more than the recommended dose. To do this, avoid the simultaneous use of other medications that contain paracetamol or codeine.

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

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

The benefit-risk balance during continuous use should be reevaluated periodically by the doctor.

If the pain or fever persists for more than 3 days, or if the pain or fever worsen or other symptoms appear, the treatment should be interrupted 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 should not be used in children with respiratory problems because the symptoms of morphine toxicity can be worse in these children.

Other medications and Analgilasa

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.

Theparacetamolmay interact with the following medications:

• Antibiotics (chloramphenicol, flucloxacillin).
• Anticoagulants (used to treat thromboembolic diseases).
• Contraceptives.
• Antiepileptics (used to treat 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, intestines and bladder).
• Zidovudine (used to treat HIV infections).
• Colestiramine (used to reduce cholesterol levels in the blood).

Inform your doctor or pharmacist if you are taking flucloxacillin (antibiotic) because there is a serious risk of blood and fluid alteration (metabolic acidosis) that must receive 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 inform your doctor or pharmacist systematically if you are being treated with another medication. In the case of oral anticoagulants, this medication can be administered occasionally as the preferred analgesic.

On the other hand, thecodeinemay interact with the following medications:

• Nalbufine, 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 (used to treat hypertension and migraine).
• Other morphine analgesics, barbiturates, benzodiazepines (used to treat pain).

Furthermore, thecaffeinemay interact with the following medications:

• Sympathomimetics, medications used as: antihistamines, hypertensives (used to increase blood pressure), in the treatment of attention deficit hyperactivity disorder (ADHD), in opioid withdrawal syndrome, in the treatment of spasticity (muscle function alteration). Caffeine can increase the effects of these medications.
• Mexiletine (used to control heart rhythm alterations).
• Medications or beverages with caffeine or other medications that stimulate the nervous system.
• Cimetidine (used as an antiacid and antiulcer).
• Antihistamines (theophylline, ephedrine).

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

Use of Analgilasa with alcohol

You should 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 beverages per day: beer, wine, liquor ...) may cause liver damage.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor before using this medication.

Pregnancy

The consumption of medications during pregnancy can be dangerous for the embryo or fetus, and should be monitored by your doctor.

In case of need, Analgilasa 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.

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

Lactation

Consult your doctor or pharmacist before using 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 operating machinery

This medication may alter your ability to drive vehicles or operate machinery that requires special attention.

Therefore, do not drive or operate machinery until you check how you tolerate this medication.

Alcohol may exacerbate this effect, so you should not consume alcoholic beverages during treatment.

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

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

If the pain and/or fever persists for more than 3 days or worsens, or if other symptoms appear, you must interrupt 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 old: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

The dosages defined according to weight must be respected. The age of the adolescent according to weight is given for information only.

• Adolescents between 33 and 41 kg of weight (12 to 15 years old):1 tablet per intake, every 6 hours, up to a maximum of 4 tablets per day.
• Adolescents between 41 and 50 kg of weight (12 to 15 years old):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 old should not take Analgilasa due to the risk of severe respiratory problems.

Patients with kidney or liver disease

The dose must be reduced and the interval between intakes increased. They must consult their doctor.

Older patients

They must 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 estimate that the action 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 you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If a overdose has been taken, you must go to a medical center immediately, even if there are no symptoms, since they often do not appear until 3 days after the overdose, even in cases of severe intoxication.

The symptoms of overdose due toparacetamolcan be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice), abdominal pain.

The symptoms of overdose due tocodeinecan 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.

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

The treatment of overdose is more effective if it is initiated within 4 hours of taking the medication.

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forgot to take Analgilasa

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, omit the missed dose and continue taking the medication as planned. 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.

Like all medicines,Analgilasacan 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) andunknown frequency(cannot be estimated from available data).

The following side effects have been observed produced byparacetamol:

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 levels of liver transaminases (liver enzymes).

Very rare:hepatotoxicity (liver toxicity) and jaundice (yellow discoloration of skin and mucous membranes).

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

Metabolism

Very rare:hypoglycemia (low blood glucose levels).

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

Blood

Very rare:thrombocytopenia (reduction of platelets in blood), agranulocytosis, leucopenia, neutropenia (decrease in white blood cells), hemolytic anemia (decrease in red blood cells).

Vascular disorders

Rare:hypotension (decrease in blood pressure).

Renal and urinary disorders

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

Skin and subcutaneous tissue

Very rarely, severe skin reactions have been reported.

Also, the following side effects have been produced bycodeinewhose frequency has not been established with precision:

General

Discomfort, drowsiness, skin rashes.

Gastrointestinal

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

Metabolism

Low blood glucose levels (hypoglycemia).

Blood

Blood alterations.

The following side effects have been observed produced bycaffeinewhose frequency has not been established with precision:

Nervous system

Nervousness, restlessness.

Gastrointestinal

Stomach or intestinal irritation.

Cardiac

Tachycardia.

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 tothrough the Spanish System for Pharmacovigilance of Medicines for Human Use: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 useAnalgilasaafter 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 conservation conditions.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

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

• The active principles 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, diestearoyl glycerol, sodium croscarmellose, and magnesium stearate that form part of the core, and Macrogol 6000, microcrystalline cellulose, hypromellose, titanium dioxide (E-171), and erythrosine (E-127) that form part of the tablet coating.

Appearance of the product and content of the packaging

Each package contains 20 tablets. The medication is presented conditioned and packaged in a blister system (Aluminum/PVC) that 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