Aspirin^® Complex (Powder) Instructions for Use

Marketing Authorization Holder

BAYER, JSC (Russia)

Manufactured By

Kern Pharma S.L. (Spain)

Contact Information

BAYER AG (Germany)

ATC Code

R05X (Other remedies for the treatment of colds)

Active Substances

Acetylsalicylic acid (Ph.Eur. European Pharmacopoeia)

Chlorphenamine (Rec.INN WHO registered)

Phenylephrine (Rec.INN WHO registered)

Dosage Form

Aspirin® Complex

Effervescent powder for oral solution 500 mg+15.58 mg+2 mg/1 sachet: sachet 3.5475 g 10 pcs.

Dosage Form, Packaging, and Composition

Effervescent powder for oral solution as a mixture of crystalline powders from almost white to white with a yellowish tint.

Excipients : anhydrous citric acid – 1220 mg, sodium bicarbonate – 1709.6 mg, lemon flavor – 100 mg, quinoline yellow dye (E104) – 0.32 mg.

3.5475 g – laminated paper sachets (2) – strips (5) – cardboard packs.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

ARI and “common cold” symptoms relieving agent (NSAID+alpha-adrenomimetic+H1-histamine receptor blocker)

Pharmacological Action

A combined drug, the action of which is due to its active components.

Acetylsalicylic acid has analgesic, antipyretic and anti-inflammatory effects. The mechanism of action involves irreversible inhibition of the cyclooxygenase enzyme, which regulates the synthesis of prostaglandins. Acetylsalicylic acid inhibits platelet aggregation by blocking the synthesis of thromboxane A₂.

Phenylephrine is a sympathomimetic and, having a vasoconstrictive effect, reduces swelling of the nasal mucosa and paranasal sinuses, thereby facilitating breathing.

Chlorphenamine is a histamine H₁-receptor blocker, has an anti-allergic effect, and relieves symptoms such as sneezing and lacrimation.

Pharmacokinetics

Data on the pharmacokinetics of Aspirin^® Complex are not provided.

Indications

• Symptomatic treatment of influenza, acute respiratory viral infections and other colds accompanied by high fever, chills, headache and muscle pain, rhinitis and/or nasal congestion, sore throat and sneezing.

ICD codes

Dosage Regimen

Adults and children over 15 years of age are prescribed 1 sachet every 6-8 hours. The maximum daily dose is 4 sachets, and the interval between doses should be at least 6 hours.

The duration of treatment (without consulting a doctor) should not exceed 5 days when used as an analgesic and more than 3 days as an antipyretic.

The drug should be taken orally after meals, after dissolving the contents of the sachet in a glass of water at room temperature.

Adverse Reactions

Acetylsalicylic acid

From the digestive system dyspepsia, nausea, vomiting, gastric and duodenal ulcers, gastrointestinal bleeding, incl. occult; rarely (<1%) – toxic liver damage, especially in patients with juvenile rheumatoid arthritis.

From the blood coagulation system hypoprothrombinemia.

From the hematopoietic system rarely (<1%) – anemia.

From the CNS dizziness, tinnitus, headache, hearing loss.

From the urinary system renal failure, acute interstitial glomerulonephritis.

Allergic reactions urticaria, exanthema, angioedema, rhinitis, bronchospasm, shortness of breath.

From the body as a whole hyperhidrosis; rarely (<1%) – Reye’s syndrome in children.

Phenylephrine

From the CNS headache, dry mouth, insomnia, nausea, excitability, anxiety; rarely – severe headache, inappropriate behavior.

From the cardiovascular system rarely – increased blood pressure, tachycardia.

From the genitourinary system rarely – painful or difficult urination.

Chlorphenamine

From the body as a whole dry mouth, dryness of the oral and nasal mucosa, accommodation disturbance (blurred vision).

From the cardiovascular system tachycardia.

From the digestive system constipation.

From the urinary system urinary retention, difficulty and pain during urination.

From the CNS attention impairment, drowsiness, dizziness. In children and elderly patients, lethargy, agitation, dizziness, anxiety, and irritability are possible.

The patient should be informed that if any adverse reactions occur, they should stop taking the drug and consult a doctor.

Contraindications

• Erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase);
• Chronic or recurrent course of gastric and duodenal ulcers;
• Asthma induced by salicylates or other NSAIDs;
• Blood clotting disorders (hemophilia, hypoprothrombinemia);
• Severe liver and/or kidney dysfunction;
• Nasal polyposis associated with bronchial asthma and intolerance to acetylsalicylic acid;
• Arterial hypertension;
• Angina pectoris;
• Enlarged thyroid gland;
• Concomitant use with oral anticoagulants;
• Concomitant use with MAO inhibitors, including the period of 15 days after their discontinuation;
• Concomitant use of methotrexate at a dose of 15 mg per week or more;
• Urinary retention;
• I and III trimesters of pregnancy;
• Lactation period (breastfeeding);
• Hypersensitivity to acetylsalicylic acid and other NSAIDs or other components of the drug.

The drug is not prescribed to children under 15 years of age with acute respiratory diseases caused by viral infections due to the risk of developing Reye’s syndrome (encephalopathy and acute fatty liver degeneration with acute development of liver failure).

The drug should be used with caution in case of lung and kidney diseases, glaucoma, pheochromocytoma, cardiovascular diseases, diabetes mellitus, prostate hyperplasia, anemia.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy (especially in the I and III trimesters) and during breastfeeding.

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency.

Use in Renal Impairment

Contraindicated in renal insufficiency.

Pediatric Use

The drug is contraindicated in children under 15 years of age.

Special Precautions

It should be taken into account that Acetylsalicylic acid can cause bronchospasm, an attack of bronchial asthma or other hypersensitivity reactions. Risk factors are the presence of bronchial asthma, nasal polyps, fever, chronic bronchopulmonary diseases, history of allergies (allergic rhinitis, skin rash).

Acetylsalicylic acid may increase the tendency to bleed due to its inhibitory effect on platelet aggregation. This should be taken into account when surgical interventions are necessary (including minor surgical interventions, for example, tooth extraction). Before surgery, to reduce bleeding during and after surgery, the drug should be discontinued 5-7 days in advance and the doctor should be informed.

When using drugs containing acetylsalicylic acid in children with acute viral infections, the risk of Reye’s syndrome (vomiting, acute encephalopathy, liver enlargement) increases. Therefore, the prescription of Aspirin^® Complex in this category of patients is contraindicated.

During treatment, it is not recommended to consume alcohol due to the increased risk of gastrointestinal side effects associated with taking acetylsalicylic acid and the enhanced sedative effect of chlorphenamine.

Since the use of chlorphenamine may change the indicators of skin allergy tests, it is recommended to inform the doctor about the use of the drug and discontinue it 3 days before performing skin tests.

During treatment, it is not recommended to use painkillers, sympathomimetics, guanethidine and beta-blockers.

It is not recommended to take the drug systematically and for prophylactic purposes before vaccinations.

Patients limiting salt intake should take into account that each sachet contains sodium bicarbonate.

The active component phenylephrine, which is part of the drug, can cause a positive result in a doping test in athletes.

In case of renal failure and low plasma albumin levels, the risk of toxic effects of the drug increases.

Effect on the ability to drive vehicles and machinery

Aspirin^® Complex may cause drowsiness and thereby impair the ability to drive a car and moving machinery.

Overdose

Symptoms nausea, vomiting, tinnitus, hearing and vision impairment, rapid breathing, severe headache, loss of balance, severe drowsiness, heart rhythm disturbance.

Treatment gastric lavage, administration of activated charcoal, symptomatic therapy.

Drug Interactions

Acetylsalicylic acid

With simultaneous use of ethanol, cimetidine and ranitidine with acetylsalicylic acid, the toxic effect of the latter is enhanced.

With simultaneous use of heparin and indirect anticoagulants with acetylsalicylic acid, the risk of bleeding increases due to suppression of platelet function and displacement of indirect anticoagulants from binding to plasma proteins.

Acetylsalicylic acid reduces the absorption of indomethacin, fenoprofen, naproxen, flurbiprofen, ibuprofen, diclofenac, piroxicam.

With simultaneous use of glucocorticosteroids with acetylsalicylic acid, the risk of secondary damage to the gastrointestinal mucosa increases.

Acetylsalicylic acid, when used simultaneously, may increase the concentration of phenytoin due to its displacement from protein binding.

With simultaneous use of antidiabetic drugs (including insulin) with acetylsalicylic acid, the hypoglycemic effect is enhanced due to the fact that Acetylsalicylic acid in high doses has hypoglycemic properties and displaces sulfonylurea derivatives from binding to plasma proteins.

Acetylsalicylic acid, when used simultaneously, may enhance the toxic effect of vancomycin.

With simultaneous use of methotrexate with acetylsalicylic acid, the effect of methotrexate is enhanced due to a decrease in renal clearance and its displacement from protein binding.

Salicylates, when used simultaneously, reduce the uricosuric effect of probenecid and sulfinpyrazone due to competitive tubular elimination of uric acid.

With simultaneous use of zidovudine with acetylsalicylic acid, a mutual enhancement of toxic effects is noted.

Phenylephrine

With simultaneous use of phenylephrine and MAO inhibitors (antidepressants – tranylcypromine, moclobemide; antiparkinsonian drugs – selegiline), severe side effects are possible in the form of intense headache, increased blood pressure and body temperature.

With simultaneous use of phenylephrine with beta-blockers, increased blood pressure and severe bradycardia are possible.

With simultaneous use of phenylephrine with sympathomimetics, the effect of the latter on the central nervous system and cardiovascular system is enhanced. Excitation, irritability, and insomnia are possible.

The use of phenylephrine before inhalation anesthesia increases the risk of heart rhythm disturbances. Treatment with phenylephrine should be discontinued several days before planned surgical treatment.

With simultaneous use, rauwolfia alkaloids may reduce the therapeutic effect of phenylephrine.

With simultaneous use of phenylephrine and caffeine, the therapeutic and toxic effects of the latter may be enhanced.

In isolated cases, with simultaneous use of phenylephrine with indomethacin or bromocriptine, the development of severe arterial hypertension is possible.

With simultaneous use of phenylephrine with antidepressants of the selective serotonin reuptake inhibitor group (fluvoxamine, paroxetine, sertraline), both the body’s sensitivity to sympathomimetics may increase and the risk of developing serotonin syndrome may increase.

With simultaneous use, phenylephrine reduces the hypotensive effect of antihypertensive drugs from the sympatholytic group (reserpine, guanethidine).

Chlorphenamine

With simultaneous use, chlorphenamine may enhance the depressant effect on the central nervous system of ethanol, hypnotics, tranquilizers, antipsychotics (neuroleptics), and centrally acting analgesics.

With simultaneous use, chlorphenamine enhances the anticholinergic effect of anticholinergic drugs (atropine, antispasmodics, tricyclic antidepressants, MAO inhibitors).

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.