Aspirin Complex, 3.5g 10 pcs

Aspirin Complex is a combination drug.

Acetylsalicylic acid has antipyretic, analgesic and anti-inflammatory effects, and also reduces platelet aggregation.

Phenylephrine is a sympathomimetic and, having a vasoconstrictor effect, reduces swelling of the mucous membranes of the nose and paranasal sinuses, which facilitates breathing.

Chlorphenamine is a blocker of histamine H1-receptors and has antiallergic effect: it eliminates itching (including eyes, nose), swelling and hyperemia of mucous membranes of the nasal cavity, nasopharynx and sinuses, reduces exudation.

Indications

Symptomatic treatment of flu, SARS and other colds accompanied by fever, chills, headache, muscle pain, runny nose and/or stuffy nose, sore throat and sneezing.

Composition

1 sachet (3.5475 g) acting ingredients:

acetylsalicylic acid – 500 mg,

phenylephrine hydrotartrate – 15.58 mg,

How to take, the dosage

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

The duration of treatment (without physician’s consultation) should not exceed 5 days when used as an analgesic and more than 3 days when used as an antipyretic.

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

Interaction

Acetylsalicylic acid

Combination with Methotrexate at a dose of > 15 mg/week is contraindicated. Drug combinations used with caution: Methotrexate at a dose of less than 15 mg/week: When concomitant use of drugs increases hematological toxicity of methotrexate due to the fact that NSAIDs in general reduce renal clearance of methotrexate, and salicylagents in particular displaces it from binding to plasma proteins.

Anticoagulants (coumarin, heparin): concomitant administration of ASA and indirect aticoagulants increases the risk of bleeding due to suppression of platelet function, damage to the mucosa of the stomach and duodenum and displacement of oral anticoagulants from their binding to plasma proteins.

Other NSAIDs with salicylates in high dose (at a dose of 3 g/day or more): when the drugs are used concomitantly, due to the synergistic effect, the risk of gastrointestinal mucosal ulcers and bleeding increases.

Uricosuric drugs (probenecid, sulfinpyrazone): therapeutic effect of uricosuric drugs is reduced due to competitive tubular elimination of uric acid.

Digoxin: Concomitant use of the drugs increases the concentration of digoxin in plasma due to decreased excretion.

Antidiabetic drugs (insulin, sulfonylurea): The hypoglycemic effect is increased due to the fact that ASA in high dose has hypoglycemic properties and displaces sulfonylurea from plasma proteins binding.

Trombolytics/antiplatelet drugs of other classes (ticlopidine): increased risk of bleeding.

Diuretics in combination with ASA at a dose of 3 g/day or more: glomerular filtration decreases, due to reduced prostaglandin synthesis in the kidneys.

Systemic glucocorticosteroids (GCS) except hydrocortisone (used for treatment of Addison’s disease): Simultaneous use of the drugs decreases salicylate concentration in blood, because GCS increases elimination of salicylates.

Angiotensin-converting enzyme (ACE) inhibitors: When ACE inhibitors and ASA at a dose of 3 g/day or more are used concomitantly, the hypotensive effect of ACE inhibitors decreases due to reduced glomerular filtration.

Valproic acid: ASA disrupts binding of valproic acid to plasma proteins, resulting in increased toxicity.

Alcohol: in combination with ASA, the damaging effect on the mucous membrane of the gastrointestinal tract is increased and the bleeding time is prolonged.

Phenylephrine

Monoamine oxidase inhibitors (MAO inhibitors) – when phenylephrine and MAO inhibitors (antidepressants – tranylcypromine, moclobemide; anti-Parkinsonian drugs – selegiline) severe side effects in the form of intense headache, increased blood pressure and body temperature are possible.

Beta-adrenoblockers – with simultaneous use, an increase in blood pressure (arterial hypertension) and pronounced bradycardia are possible. Sympathomimetics concomitant use increases the effect of sympathomimetics on the CNS and cardiovascular system. Agitation, irritability and insomnia are possible.

Inhaled anesthetics – use of phenylephrine prior to inhalational anesthesia increases the risk of heart rhythm disturbances. Treatment with phenylephrine should be discontinued several days before planned surgical treatment.

Rauwolfia alkaloids – The therapeutic effect of phenylephrine may decrease with concomitant use.

Caffeine – concomitant use may increase the therapeutic and toxic effects of caffeine.

Indomethacin, bromocriptine – in single cases, when phenylephrine and indomethacin or bromocriptine are used concomitantly, severe arterial hypertension may occur.

Selective serotonin reuptake inhibitors – Simultaneous use with antidepressants in this group (fluvoxamine, paroxetine, sertraline) may increase both the sensitivity of the body to sympathomimetics and the risk of serotonergic effects.

Hypotensive drugs from the group of sympatholytic drugs, such as reserpine, guanethidine – phenylephrine reduces the hypotensive effect of these drugs.

Chlorphenamine

Alcohol, sleeping pills, tranquilizers, antipsychotics (neuroleptics), neutral analgesics-chlorphenamine may increase the CNS suppressive effect of these drugs.

The anticholinergic drugs (atropine, antispasmodics, tricyclic antidepressants, MAO inhibitors, antiparkinsonian drugs)-Chlorphenamine increases the anticholinergic effect of these drugs.

Special Instructions

Acetylsalicylic acid may cause bronchospasm, an attack of bronchial asthma or other hypersensitivity reactions. Risk factors include the presence of bronchial asthma, nasal polyps, fever, chronic bronchopulmonary disease, history of allergies (allergic rhinitis, skin rashes).

Acetylsalicylic acid may increase the tendency to bleeding, which is associated with its inhibitory effect on platelet aggregation. This should be considered when surgical interventions are necessary, including minor interventions such as tooth extraction. Before surgical intervention, in order to reduce bleeding during the operation and in the postoperative period, the drug administration should be cancelled 5-7 days in advance and the physician should be informed. Children should not be prescribed drugs containing acetylsalicylic acid, because in case of viral infection, the risk of Reye’s syndrome increases. Symptoms of Reye syndrome include prolonged vomiting, acute encephalopathy, and enlarged liver.

Alcohol consumption is not recommended during treatment because of the increased risk of gastrointestinal side effects associated with taking acetylsalicylic acid, and increased sedative effect of chlorphenamine.

With regard to the possibility of changes in skin allergy testing when using chlorphenamine, it is advisable to inform the physician about the use of the drug and to cancel it three days before performing skin tests.

The use of pain medications, sympathomimetics, guanethidine, and beta-adrenoblockers is not recommended during treatment.

It is not recommended that the drug be taken systemically or prophylactically before vaccinations.

Patients who restrict salt intake should be aware that each sachet contains sodium bicarbonate.

The active ingredient phenylephrine in the drug can cause a positive result in doping tests in athletes.

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

Contraindications

Side effects

Acetylsalipilic acid

Body in general: hyperhidrosis.

Gastrointestinal tract: nausea, dyspepsia, vomiting, gastric and 12 duodenal ulcers; gastrointestinal bleeding, including hidden (black stools).

Allergic reactions: urticaria; eczematous skin rash; angioedema (Quincke’s edema), runny nose, bronchospasm and shortness of breath.

Hematopoietic system: hypoprothrombinemia.

Central nervous system and sensory organs: dizziness, tinnitus, headache, decreased hearing.

Relinary system: renal failure, acute interstitial glomerulonephritis. In rare cases (

Phenylephrine

Central nervous system and the senses: headache; dry mouth, insomnia, nausea, agitation, anxiety.

In rare cases:

Central nervous system: pronounced headache, inadequate behavior.

Cardiovascular system: increased blood pressure, tachycardia.

The urinary system: painful or difficult urination.

Chlorphenamine

The body in general: dry mouth; dry mucous membranes of the mouth and nose, impaired accommodation (blurred vision).

Cardiovascular system: tachycardia.

Gastrointestinal tract: constipation.

The urinary system: urinary retention, difficulty and pain when urinating.

Central nervous system and sensory organs: impaired attention, drowsiness, dizziness.

In children and elderly patients, lethargy, agitation, dizziness, restlessness, irritability may occur.

In case of any adverse reactions the drug should be stopped and a doctor should be consulted

Overdose

Symptoms: nausea, vomiting, tinnitus, impaired hearing and vision, rapid breathing, marked headache, impaired balance, marked drowsiness, cardiac arrhythmia.

Treatment: gastric lavage, prescription of activated charcoal, symptomatic therapy.

Pregnancy use

It is contraindicated during breastfeeding and pregnancy.