Label: information for the user

ASPIRINACOMPLEX effervescent granule

Acid acetylsalicylic, phenylephrine, chlorphenamine

ASPIRINA COMPLEX effervescent granuleis an association of acetylsalicylic acid, an analgesic that acts on pain and fever, chlorphenamine, an antihistamine that reduces sneezing and tearing, and phenylephrine, a vasoconstrictor that acts on nasal congestion.

This medication is indicated for symptomatic relief of catarrhal and influenza-like processes that are accompanied by mild or moderate pain, fever, congestion, and nasal secretion, in adults and adolescents over 16 years old.

Do not take ASPIRINA COMPLEX effervescent granules if:

• You are allergic (hypersensitive) or have had an allergic reaction to acetylsalicylic acid, chlorphenamine, pheniramine or any other component of this medication.
• You have kidney and/or liver diseases (renal and/or hepatic insufficiency).
• You have had asthmatic reactions (difficulty breathing, choking, bronchospasm and in some cases coughing or wheezing) when taking anti-inflammatory, acetylsalicylic acid, other analgesics, as well as tartrazine dye.
• You have asthma.
• You have nasal polyps associated with asthma that are produced or increased by acetylsalicylic acid.
• You have hemophilia or other blood clotting disorders.
• You are taking oral anticoagulant medications.
• You have heart disease (ischemic cardiopathy, severe cardiovascular disease).
• You have tachycardia (rapid heartbeats).
• You have severe arterial disease.
• You have high blood pressure (hypertension).
• You have thyroid disease (hyperthyroidism).
• You have glaucoma (elevated intraocular pressure).
• You have gastric, duodenal ulcers or repeated stomach discomfort.
• You have urinary retention or bladder neck obstruction.
• You are taking medications for depression or Parkinson's disease that inhibit monoamine oxidase (MAO) (see below Use of other medications).
• You are under 16 years old, as the use of acetylsalicylic acid has been associated with Reye's syndrome, a rare but serious disease.
• You are in the third trimester of pregnancy.

Be especially careful with ASPIRINA COMPLEX effervescent granules:

Before taking this medication, consult your doctor if:

• You have high blood pressure, or have reduced kidney, heart or liver function, or have bleeding disorders.
• You have had stomach ulcers or intestinal ulcers.
• You are taking anticoagulant medications and should consult your doctor before taking this medication.
• You are taking anti-inflammatory or other medications, as certain medications may interact with ASPIRINA COMPLEX effervescent granules and cause adverse effects (see below Use of other medications).
• You are allergic to other anti-inflammatory or antirheumatic medications.
• You have glucose-6-phosphate dehydrogenase deficiency.
• You have had rhinitis or urticaria.

• You have recently undergone or will undergo surgery, including dental surgery, within the next 7 days.
• You are in the first or second trimester of pregnancy.

• Do not use this medication to prevent discomfort caused by vaccinations.
• You have diabetes mellitus, prostate disease (prostatic hypertrophy), pancreatitis (inflammation of the pancreas), pyloric obstruction (obstruction between the stomach and intestine).
• You have thyroid disease, cardiovascular, pulmonary and renal diseases or anemia and should consult your doctor before taking this medication, as it may worsen the underlying condition or interact with medications used to treat these conditions.

• You are taking medications for depression with tricyclic antidepressants, such as maprotiline, or medications with anticholinergic action, such as some medications used to treat Parkinson's disease, and you experience stomach problems, inform your doctor as soon as possible, as you may develop paralytic ileus (decreased or cessation of intestinal movement).

• You have cross-sensitivity to antihistamines or analgesics, which may cause sensitivity to other medications.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including over-the-counter medications, homeopathic medications, herbal remedies and other health-related products, as it may be necessary to discontinue treatment or adjust the dosage of one or more medications.

Due to its content of acetylsalicylic acid, this medication may interact with the following medications:

• Other analgesics or nonsteroidal anti-inflammatory drugs (medications used to treat pain and/or inflammation).
• Some antidepressants, such as selective serotonin reuptake inhibitors, as it increases the risk of bleeding.
• Anticoagulants, such as warfarin.
• Oral antidiabetic medications.
• Barbiturates (medications used to treat seizures).
• Beta-blockers (medications used to control hypertension).
• Cimetidine and ranitidine (used to treat stomach acid).
• Medications used to prevent transplant rejection (cyclosporine and tacrolimus).
• Corticosteroids (used to treat inflammation), as it may increase the risk of gastrointestinal bleeding.
• Digoxin (medication used to treat heart disease).
• Diuretics and inhibitors of the enzyme angiotensin-converting enzyme (ACE), used to treat hypertension.
• Phenobarbital and valproic acid (antiepileptic medications).
• Interferon-alpha (used to treat certain viral and tumor infections).
• Lithium (used to treat certain psychiatric conditions).
• Metotrexate (used to treat cancer or rheumatoid arthritis).
• Probenecid (used to treat gout).
• Vancomycin (antibiotic used to treat infections).
• Zidovudine (used to treat patients infected with the human immunodeficiency virus, which causes AIDS).

This medication may also interact with other medications, such as medications used to lower blood pressure (anti-hypertensives), nasal decongestants, antidepressants, stimulants, sedatives, tranquilizers and central nervous system depressants, so consult your doctor or pharmacist if you are taking these medications.

Due to its content of pheniramine, if you are taking some of the following medications or ASPIRINA COMPLEX, you may need to discontinue treatment or separate the administration by at least 15 days:

- Monoamine oxidase inhibitors (MAOIs) (medications used to treat depression, Parkinson's disease or other conditions). You should separate the administration of ASPIRINA COMPLEX effervescent granules by at least 15 days after completing treatment.

- Alpha-adrenergic blockers (medications used to treat migraines or other conditions).

- Beta-adrenergic blockers (medications used to treat hypertension or other conditions).

- Tricyclic and tetracyclic antidepressants.

- General anesthetics.

- Anti-hypertensive medications with a mechanism of action related to the sympathetic nervous system.

- Medications that cause potassium loss (such as diuretics used to treat hypertension or other conditions).

- Medications that affect heart conduction (used to treat heart disease), such as cardiac glycosides and anti-arrhythmics.

- Thyroid hormones.

- Alpha and beta-adrenergic blockers, such as labetalol and carvedilol (used to treat heart disease or arterial disease).

- Atropine sulfate (used to treat heart disease or gastrointestinal disorders).

Due to its content of chlorphenamine, the simultaneous use of this medication with the following medications may increase the risk of adverse effects:

- Medications that depress the central nervous system, such as those used to treat insomnia or anxiety or antihistamines.

- Monoamine oxidase inhibitors (MAOIs) used to treat depression (tranilcipromina, moclobemida) or Parkinson's disease (selegilina), which may cause severe adverse effects, such as severe headache, elevated blood pressure and sudden fever. If you have taken one of these medications, wait at least 15 days before taking ASPIRINA COMPLEX. If you are unsure whether your medication contains an MAOI, consult your doctor or pharmacist before taking ASPIRINA COMPLEX effervescent granules.

- Tricyclic and tetracyclic antidepressants.

Interference with diagnostic tests:

This medication may interfere with skin tests that use allergens. It is recommended to discontinue treatment with this medication at least 3 days before starting the tests and inform your doctor.

If you are undergoing any diagnostic tests (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the test results.

Taking ASPIRINA COMPLEX effervescent granules with food and beverages:

Take this medication after meals or with food.

Do not consume alcohol during treatment with ASPIRINA COMPLEX, as it may cause symptoms of overdose with increased sedative effects.

If you regularly consume alcohol (three or more alcoholic beverages per day), taking ASPIRINA COMPLEX effervescent granules may cause stomach bleeding.

Pregnancy:

Consult your doctor or pharmacist before using any medication.

This medication should not be used during pregnancy.

Last trimester of pregnancy:

Do not take Aspirina Complex if you are in the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. This medication may cause kidney and heart problems in the fetus. It may affect your bleeding tendency and that of your baby, causing a possible delay in delivery or prolonging it beyond the expected time.

First and second trimester of pregnancy:

Do not take Aspirina Complex during the first 6 months of pregnancy, unless it is absolutely necessary and your doctor advises you to do so. If you need treatment during this period or while trying to become pregnant, the dosage will be limited to the lowest possible dose for the shortest possible time.

If you take this medication for several days from week 20 of pregnancy, it may cause kidney problems in the fetus that may lead to low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for several days, your doctor may recommend additional follow-up.

Lactation:

Consult your doctor or pharmacist before using any medication.

ASPIRINA COMPLEX effervescent granules are excreted in breast milk, so women who are breastfeeding should not use this medication.

Use in children:

Do not administer to children under 16 years old.

Use in elderly patients:

Older adults should not take this medication without consulting their doctor, as they are more prone to experiencing adverse effects.

Driving and operating machinery:

Avoid driving vehicles or operating hazardous machinery, as it may impair your reaction time. This medication may cause drowsiness and sedation.

Important information about some components of ASPIRINA COMPLEX effervescent granules:

This medication contains 468 mg of sodium (main component of table salt/for cooking) in each tablet, which is equivalent to 24% of the recommended daily maximum sodium intake for an adult.

Consult your doctor or pharmacist if you need one or more daily packets for an extended period, especially if you have been advised to follow a low-sodium diet.

Athletes:

It is reported to athletes that this medication contains a component that may result in a positive analytical result for doping control.

Follow these instructions unless your doctor has given you different instructions.

Consult your doctor or pharmacist if you have any doubts.

The normal dose is:

Adults and adolescents over 16 years old:

The dose is 1 tablet every 8 hours and if necessary every 6 hours.

The maximum daily dose is 4 tablets with a minimum interval of 6 hours between each dose.

Children:

Do not use this medication in children under 16 years old.

Patients with reduced liver or kidney function: consult your doctor as you must reduce the dose.

This medication is administered orally.

Dissolve the entire content of one packet preferably in a glass with water and drink the entire content of the glass when the bubbling has completely stopped.

Take the medication after meals or with some food, especially if you notice digestive discomfort.

Do not take this medication on an empty stomach.

Always use the smallest effective dose.

The administration of this medication is subject to the appearance of symptoms, pain, fever, congestion, and nasal secretion. As these symptoms disappear, you must discontinue this medication.

If the fever continues after 3 days of treatment, or the symptoms worsen or do not improve after 5 days, or new symptoms appear, you must interrupt treatment and consult your doctor.

If you take more ASPIRINA COMPLEX effervescent granules than you should

If you take more Aspirina Complex than you should, you may experience the following symptoms: nausea, vomiting, ringing, deafness, sweating, vasodilation, and hyperventilation, headache, blurred vision, mental confusion, and occasionally diarrhea, excessive nervous stimulation, anxiety, fear, agitation, headache (which may be a symptom of hypertension), convulsions, insomnia, confusion, irritability, tremors, anorexia (loss of appetite), psychosis with hallucinations (more frequent in children) and effects on the cardiovascular system such as hypertension, cerebral hemorrhage, and pulmonary edema, peripheral vasoconstriction with possible reduction of blood flow to vital organs (severe effects may appear more likely in hypovolemic patients, i.e., with decreased blood volume, due to hemorrhage, dehydration, etc.), severe bradycardia (slow heart rate), increased heart workload, irregular or rapid heartbeats, decreased urine output, metabolic acidosis (decreased blood alkalinity reserve), paresthesias (sensory alterations in body areas). In prolonged use, plasma volume depletion (decreased blood volume) may occur, instability, intense numbness, severe dryness of the mouth, nose, or throat, facial flushing, dyspnea (difficulty breathing), cardiac arrhythmias (rapid or irregular heartbeats), nervous stimulation (hallucinations, convulsions), these latter symptoms may appear late, hypotension (dizziness).

There is no antidote for salicylate poisoning. In the event of a suspected overdose, the patient should be kept under observation for at least 24 hours, as symptoms and blood salicylate levels may not become apparent for several hours.

The overdose is treated with gastric lavage, forced alkaline diuresis, and supportive therapy. Hemodialysis may be required to restore acid-base balance in acute cases. The treatment of clorfenamina and fenilefrina overdose is symptomatic and supportive.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

In case of overdose or accidental ingestion, go to a medical center immediately,consultyour doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take ASPIRINA COMPLEX effervescent granules

Do not take a double dose to compensate for the missed doses. Take it again as indicated in section 3. How to take Aspirina Complex.

Like all medicines, ASPIRINA COMPLEX effervescent granulesmay cause side effects, although not everyone will experience them.

Frequent side effects(observed in 1 to 10 out of every 100 people):

• Gastrointestinal disorders, such as stomach ulcers, intestinal ulcers, gastrointestinal bleeding, abdominal pain, heavy digestion, burning, heartburn, stomach discomfort, nausea, vomiting, constipation.

• Respiratory disorders, such as difficulty breathing (asthma, bronchial spasm), nasal congestion and rhinitis.
• Urticaria, skin rashes, angioedema (inflammation and swelling that affects theface, lips, mouth, tongue or throat, which can cause difficulty swallowing or breathing)and itching.
• Neurological disorders: drowsiness, dizziness, vertigo.
• Hypoprothrombinemia (coagulation alteration) when administered in high doses.

Rare side effects (observed in 1 to 1000 out of every 1000 people):

• Reye's syndrome in children under 16 years with feverish processes, flu or chickenpox (see section “Before takingASPIRINA COMPLEXeffervescent granules”).
• Liver disorders, especially in patients with juvenile arthritis.
• Anemia.
• Neurological disorders: confusion (especially in elderly patients), euphoria, nervousness, restlessness (especially in children and elderly patients), insomnia, headache, strange behavior.

• Cardiovascular effects: alterations in pulse (palpitations, tachycardia), elevated blood pressure (hypertension), which can sometimes be severe (hypertensive crisis).

• Difficulty urinating.
• Dryness in the mouth, nose or throat.

With prolonged doses of acetylsalicylic acid, the following side effects have been observed, whose frequency has not been established with precision: dizziness, ear noises, hearing loss, sweating, headache, confusion, renal insufficiency and acute interstitial nephritis (inflammation at the level of the kidney).

If you notice the appearance of any of the following symptomsdiscontinue taking the medication and consult your doctor immediately, as they may indicate the onset of side effects that require urgent medical attention:

• Abdominal discomfort or pain, gastrointestinal bleeding or black stools.
• Skin disorders, such as rashes or redness.
• Difficulty breathing.
• Unusual change in the amount or appearance of urine.
• Swelling of the face, feet or legs.
• Hearing loss, ear ringing or dizziness.

Side effects due to phenylephrine:

-Unknown frequency: anxiety, nervousness, irritability, weakness, dizziness, tremors, insomnia, hypertension (elevated blood pressure) (usually with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), chest pain or discomfort, severe bradycardia (slow heart rate), peripheral vasoconstriction (reduction of blood vessel diameter), reduced heart function that affects especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease, urinary retention, breathing difficulty, pallor, goosebumps, increased sweating, hyperglycemia (elevated blood sugar), decreased potassium in the blood, metabolic acidosis, cold extremities (legs or arms), flush, hypotension (dizziness); with high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur.

-In rare cases, the following may occur: myocardial infarction, ventricular arrhythmia, pulmonary edema and cerebral hemorrhage (with high doses or in sensitive patients)

Side effects due to chlorphenamine:

-Those that may occur more frequently: mild drowsiness, dizziness, muscle weakness; these side effects may disappear after 2-3 days of treatment, facial movement difficulties, clumsiness, tremors, sensory alterations and paresthesias, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal disorders that may decrease if the medication is taken with food (nausea, vomiting, diarrhea, constipation, abdominal pain), urinary retention, dryness of the nose and throat, thickening of mucous secretions, sweating, blurred vision or other visual disturbances.

-Less frequently or rarely: occasional nervous excitement (usually with high doses and more frequent in the elderly and children) with symptoms such as restlessness, insomnia, nervousness and even convulsions; other side effects: chest tightness, lung noises, rapid or irregular heartbeats (usually with overdose), liver disorders (which may present with abdominal pain or dark urine and other symptoms), allergic reactions, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeats, itching, swelling around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) with related medications, rarely blood disorders (changes in blood formula, such as agranulocytosis, leukopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat or fatigue; decreased or increased blood pressure, edema (swelling), ear disorders, impotence, menstrual disorders.

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist or nurse, 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 for the 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 medication.

No requires special conditions for conservation.

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

Expiration date:

Do not use ASPIRINA COMPLEX effervescent granuleafter the expiration date that appears on the packaging, following the CAD abbreviation. The expiration date is the last day of the month indicated.

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

Composition of ASPIRINA COMPLEX effervescent granule

Each blister pack contains:

- The active ingredients are: acetylsalicylic acid 500 mg, phenylephrine 8.21 mg (equivalent to 15.58 mg of phenylephrine bitartrate) and chlorphenamine 1.41 mg (equivalent to 2 mg of chlorphenamine maleate).

- The other components (excipients) are: anhydrous citric acid, sodium hydrogen carbonate, lemon aroma, quinoline yellow (E-104) dye.

Appearance of the product and contents of the packaging

This medication is an effervescent granule. It is presented in packaging containing 10 and 20 blister packs.

Holder of the marketing authorization Responsible for manufacturing

Bayer Hispania, S.L.KERN PHARMA, S.L.

Av. Baix Llobregat, 3-5Colón II Industrial Estate

08970 Sant Joan Despí (Barcelona)C/Venus, 72

Spain08228 Terrassa (Barcelona)

Spain

Last review date of this leaflet: October 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es