ASPIRIN COMPLEX Effervescent Granules

Introduction

Package Leaflet: Information for the User

ASPIRINA COMPLEX Effervescent Granules

Acetylsalicylic Acid, Phenylephrine, Chlorphenamine

Contents of the Package Leaflet

1. What ASPIRINA COMPLEX Effervescent Granules are and what they are used for
2. What you need to know before you take ASPIRINA COMPLEX Effervescent Granules
3. How to take ASPIRINA COMPLEX Effervescent Granules
4. Possible side effects
5. Storage of ASPIRINA COMPLEX Effervescent Granules
6. Package Contents and Additional Information

1. What ASPIRINA COMPLEX is and what it is used for

ASPIRINA COMPLEX Effervescent Granules are 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 medicine is indicated for the symptomatic relief of catarrhal and flu-like processes that occur with mild or moderate pain, fever, congestion, and nasal secretion in adults and adolescents over 16 years of age.

2. What you need to know before you take ASPIRINA COMPLEX Effervescent Granules

Do not take ASPIRINA COMPLEX Effervescent Granules if:

• you are allergic (hypersensitive) or have had an allergic reaction to acetylsalicylic acid, chlorphenamine, phenylephrine, or any other component of this medicine.
• you have kidney and/or liver disease (renal and/or hepatic insufficiency).
• you have had allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases cough or wheezing when breathing) when taking non-steroidal anti-inflammatory drugs, acetylsalicylic acid, other analgesics, as well as the dye tartrazine.
• you have asthma.
• you have nasal polyps associated with asthma that are produced or increased by acetylsalicylic acid.
• you have hemophilia or other blood coagulation problems.
• you are being treated with oral anticoagulant medications.
• you have heart problems (ischemic cardiopathy, severe cardiovascular disease).
• you have tachycardia (rapid heartbeats).
• you have severe arterial disease.
• you have high blood pressure (arterial hypertension).
• you have thyroid disease (hyperthyroidism).
• you have glaucoma (elevated eye pressure).
• you have stomach ulcers, duodenal ulcers, or recurring stomach discomfort.
• you have obstruction of the bladder neck or urinary retention.
• you are taking medication for depression or Parkinson's disease that inhibits monoamine oxidase (MAOI) (see "Use of other medications" below).
• you are under 16 years of age, as the use of acetylsalicylic acid has been linked to 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 medicine, you should consult your doctor if:

• you have high blood pressure, or have reduced kidney, heart, or liver function, or have blood coagulation disorders.
• you have had stomach ulcers or intestinal ulcers.
• you are being treated with anticoagulants, you should consult your doctor before taking this medicine.
• you are taking anti-inflammatory or other medications, as certain medications can interact with ASPIRINA COMPLEX Effervescent Granules and produce side effects (see "Use of other medications").
• you are allergic to other anti-inflammatory or antirheumatic medications.
• you have a deficiency of glucose-6-phosphate dehydrogenase.
• you have or have had rhinitis or urticaria.

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

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

• you are being treated with medications for depression with tricyclic antidepressants, such as maprotiline, or are being treated with medications with anticholinergic action, such as some medications used in Parkinson's disease, you should inform your doctor if you experience stomach problems as soon as possible, as you may develop paralytic ileus (decreased or stopped movement of the intestine).

• you have intolerance to any antihistamine medication (used to treat allergies) or analgesic (medications used to relieve pain), cross-sensitivity may occur, which means that patients sensitive to one antihistamine may be sensitive to others.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, homeopathic, herbal, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

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

• other analgesics or non-steroidal anti-inflammatory drugs (medications used to treat pain and/or muscle inflammation),
• certain antidepressants, such as selective serotonin reuptake inhibitors, as it increases the risk of bleeding,
• anticoagulants (medications used to "thin" the blood and prevent clot formation) such as warfarin,
• oral antidiabetics (medications to lower blood sugar levels),
• barbiturates (medications used to treat convulsions),
• beta-blockers (medications to control high blood pressure),
• cimetidine and ranitidine (used for stomach acidity),
• medications used to prevent transplant rejection (cyclosporine and tacrolimus),
• corticosteroids (used for inflammation), as it may increase the risk of gastrointestinal bleeding,
• digoxin (medication for the heart),
• high blood pressure (diuretics and ACE inhibitors),
• phenytoin and valproic acid (antiepileptics),
• interferon alpha (used to treat certain viral and tumor infections),
• lithium (used in certain psychiatric diseases),
• cancer or rheumatoid arthritis (methotrexate),
• medications used to treat gout (probenecid),
• vancomycin (antibiotic used for infections),
• zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, the cause of AIDS).

Additionally, this medicine may interact with other medications such as: medications to lower blood pressure (antihypertensives), nasal decongestants, antidepressants, stimulants, sedatives, tranquilizers, and depressants of the nervous system, so you should consult your doctor or pharmacist if you are taking these medications.

Due to its content of Phenylephrine, if you are being treated with some of the following medications or with ASPIRINA COMPLEX, it may be necessary to interrupt treatment or separate administration by at least 15 days:

• Monoamine oxidase inhibitors (MAOIs) (medications used for depression, Parkinson's disease, or other diseases). You should separate the administration of ASPIRINA COMPLEX Effervescent Granules by at least 15 days after finishing treatment.
• Alpha-adrenergic blockers (medications for migraine or other conditions for childbirth, blood pressure, or other diseases).
• Beta-adrenergic blockers (for tension and other ailments).
• Tricyclic and tetracyclic antidepressants.
• General anesthetics.
• Antihypertensives (medications for blood pressure) with a mechanism of action related to the sympathetic nervous system.
• Medications that cause potassium loss (such as diuretics for treating high blood pressure or other conditions).
• Medications that affect heart conduction (used for the heart) such as cardiac glycosides and antiarrhythmics.
• Thyroid hormones.

- Alpha and beta-adrenergic blockers such as labetalol and carvedilol (used for the heart or arterial diseases).

• Atropine sulfate (for the heart or digestive diseases).

Due to its content of Chlorphenamine, simultaneous use with the following medications may potentiate the production of side effects:

• Medications that produce depression of the central nervous system (such as those used for insomnia or anxiety or antihistamines).

- Monoamine oxidase inhibitors (MAOIs) used to treat depression (tranilcipromine, moclobemide) or Parkinson's disease (selegiline), severe side effects may occur, which manifest as severe headache, elevated blood pressure, and sudden elevation of temperature. If you have taken one of these medications, wait at least 15 days before taking ASPIRINA COMPLEX. If you are not sure if your medication contains an MAOI, consult your doctor or pharmacist before taking ASPIRINA COMPLEX Effervescent Granules.

- Tricyclic and tetracyclic antidepressants.

Interference with analytical tests:

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

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

Taking ASPIRINA COMPLEX Effervescent Granules with food and drinks

Take this medication after meals or with some food.

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, this medication should be suspended.

If the fever continues after 3 days of treatment, or the symptoms worsen or do not improve after 5 days, or other symptoms appear, you should 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 notice the following symptoms: nausea, vomiting, ringing in the ears, deafness, sweating, vasodilation, and hyperventilation, headache, blurred vision, mental confusion, and occasionally diarrhea, excessive nervous stimulation, anxiety, fear, agitation, headache (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 bleeding, dehydration, etc.), severe bradycardia (slow heartbeats), increased heart rate, irregular or rapid heartbeats, decreased urine output, metabolic acidosis (decrease in blood alkaline reserve), paresthesias (sensitivity alterations in body areas). In prolonged use, it may cause plasma volume depletion (decrease in blood volume), 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 (feeling of fainting).

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

Overdose is treated with gastric lavage, forced alkaline diuresis, and supportive therapy. It may be necessary to restore acid-base balance along with hemodialysis in acute cases. The treatment of overdose of chlorphenamine and phenylephrine is symptomatic and supportive.

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

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

If you forget to take ASPIRINA COMPLEX Effervescent Granules

Do not take a double dose to make up for forgotten doses. Take it again as indicated in section 3. How to take ASPIRINA COMPLEX.

3. How to take ASPIRINA COMPLEX Effervescent Granules

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

Consult your doctor or pharmacist if you have doubts.

The normal dose is:

Adults and adolescents over 16 years of age:

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

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

Children:

Do not use this medication in children under 16 years of age.

Patient with reduced liver or kidney function: consult your doctor as the dose should be reduced.

This medication is administered orally.

Dissolve the entire contents of a sachet preferably in a glass of water and drink the entire contents of the glass when the bubbling has completely stopped.

Take the medication after meals or with some food, especially if you notice stomach 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, this medication should be suspended.

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

4. Possible Adverse Effects

Like all medicines, ASPIRINA COMPLEX effervescent granule can cause adverse effects, although not all people suffer from them.

Frequent adverse effects(observed between 1 and 10 out of every 100 people):

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

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

Uncommon adverse effects (observed between 1 and 100 out of every 1000 people):

• Reye's syndrome in children under 16 years of age with febrile processes, flu, or chickenpox (see section "Before taking ASPIRINA COMPLEX effervescent granule").
• Liver disorders, especially in patients with juvenile arthritis.
• Anemia.
• Nervous system disorders: confusion (especially in elderly patients), euphoria, nervousness, restlessness (especially in children and elderly patients), insomnia, headache, abnormal behavior.

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

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

With prolonged doses of acetylsalicylic acid, the following adverse effects have been observed, whose frequency has not been established with precision: dizziness, ringing in the ears, deafness, sweating, headache, confusion, renal insufficiency, and acute interstitial nephritis (inflammation at the kidney level).

If you observe the appearance of any of the following symptoms, stop taking the medicine and consult your doctor immediately, as they may indicate the onset of side effects that require urgent medical attention:

• Discomfort or stomach pain, gastric or intestinal bleeding, or black stools.
• Skin disorders, such as rashes or redness.
• Difficulty breathing.
• Unforeseen change in the amount or appearance of urine.
• Swelling of the face, feet, or legs.
• Deafness, ringing in the ears, or dizziness.

Adverse effects due to phenylephrine:

-With unknown frequency: anxiety, nervousness, irritability, weakness, dizziness, tremors, insomnia, hypertension (increase in 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 (very slow heartbeats), peripheral vasoconstriction (reduction of blood vessel caliber), reduction of heart performance that especially affects the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease, urinary retention, breathing difficulties, paleness, goosebumps, increased sweating, hyperglycemia (increase in blood sugar), decrease in potassium in the blood, metabolic acidosis, coldness in the extremities (legs or arms), flushing, hypotension (feeling of fainting); with high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur.

• Rarely, the following may appear: myocardial infarction, ventricular arrhythmia, pulmonary edema, and cerebral hemorrhage (at high doses or in sensitive patients)

Adverse effects due to chlorphenamine:

• Those that may appear more frequently: mild drowsiness, dizziness, muscle weakness; these adverse effects may disappear after 2-3 days of treatment, difficulty in facial movements, clumsiness, tremors, alterations in sensations and tingling, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal disorders that may decrease if the medicine is administered with food (nausea, vomiting, diarrhea, constipation, stomach pain), urinary retention, dryness of the nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.
• 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 adverse effects: chest tension, lung noises, rapid or irregular heartbeats (usually with overdose), liver disorders (which can be presented with stomach pain or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeats, itching, swelling of the eyelids around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to chlorphenamine-related medications, rarely blood disorders (changes in the formula of blood cells, such as agranulocytosis, leucopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; decrease or increase in blood pressure, edema (swelling), alterations in the ears, impotence, menstrual disorders.

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of ASPIRINA COMPLEX effervescent granule

It does not require special storage conditions.

Keep this medicine out of sight and reach of children.

Expiration date:

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in 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. Packaging content and additional information

Composition of ASPIRINA COMPLEX effervescent granule

Each sachet 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 flavor, yellow quinoline colorant (E-104).

Appearance of the product and packaging content

This medicine is an effervescent granule. It is presented in packaging that contains 10 and 20 sachets.

Marketing authorization holder and manufacturer

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

Av. Baix Llobregat, 3-5 Polígono Ind. Colón II

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

Spain 08228 Terrassa (Barcelona)

Spain

Date of the last revision of this prospectus: October 2023

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