Aspirin Complex, sachets 3.5 g, 10 pcs.

Composition

1 sachet (3.5475 g) Active ingredients:

acetylsalicylic acid-500 mg,

phenylephrine hydrotartrate-15.58 mg,

chlorphenamine maleate-2.00 mg;

excipients:

citric acid anhydrous 1220 mg,

sodium bicarbonate 1709.6 mg,

lemon flavor 100 mg,

quinoline yellow dye (E 104) 0.32 mg

. Pharmacological action

Aspirin Complex is a combined drug.

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

Phenylephrine is a sympathomimetic and, having a vasoconstrictive effect, reduces swelling of the nasal and paranasal sinuses, as a result of which breathing is facilitated.

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

Indications

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

Use during pregnancy and lactation

Contraindicated in breast-feeding and pregnancy.

Contraindications

• acute and recurrent erosive and ulcerative gastrointestinal disease;
• hemorrhagic diathesis;
• bronchial asthma induced by ingestion of salicylates and NSAIDs;
• the combined use of methotrexate in a dose of 15 mg per week;
• kidney failure;
• liver failure;
• severe heart failure in the stage of decompensation;
• arterial hypertension;
• angina;
• enlarged thyroid gland;
• I and III trimester of pregnancy;
• lactation (breastfeeding);
• hypersensitivity to acetylsalicylic acid, other salicylates or to any components of the drug.

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

With caution, the drug should be prescribed for gout, hyperuricemia; patients with a history of ulcerative lesions of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum) or gastrointestinal bleeding, impaired renal and liver function, bronchial asthma, chronic respiratory diseases, hay fever, polyposis of the nasal mucosa; with allergic reactions to drugs (including NSAIDs), in the second trimester of pregnancy.

Side effects

of Acetylsalipylic acid

The body as a whole: hyperhidrosis.

Gastrointestinal tract: nausea, dyspepsia, vomiting, ulcers of the stomach and duodenum 12; gastrointestinal bleeding, including hidden (black stool).

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

Hematopoietic system: hypoprothrombinemia.

Central nervous system and sensory organs: dizziness, ringing in the ears, headache, hearing loss.

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

Phenylephrine

) Central nervous system and sensory organs: headache; dry mouth, insomnia, nausea, excitability, anxiety.

In rare cases:

Central nervous system: severe headache, inappropriate behavior.

Cardiovascular system: increased blood pressure, tachycardia.

Urinary system: painful or difficult urination.

Chlorphenamine

The body as a whole: dry mouth; dryness of the oral and nasal mucosa, impaired accommodation (blurred vision).

Cardiovascular system: tachycardia.

Gastrointestinal tract: constipation.

Urinary system: delayed urination, difficulty and pain when urinating.

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

Children and elderly patients may experience lethargy, agitation, dizziness, restlessness, and irritability.

If any adverse reactions occur, you should stop taking the drug and consult a doctor

Interaction

of Acetylsalicylic acid

Combination with Methotrexate at a dose of > 15 mg per week is contraindicated. Combinations of drugs that are used with caution: Methotrexate at a dose of less than 15 mg / week: With simultaneous use of drugs, the hematological toxicity of methotrexate increases due to the fact that NSAIDs generally reduce the renal clearance of methotrexate, and salicylates, in particular, displace it from plasma protein binding.

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

Other NSAIDs with high-dose salicylates (at a dose of 3 g / day or more): with the simultaneous use of drugs, due to the synergistic effect, the risk of ulceration of the gastrointestinal mucosa and bleeding increases.

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

Digoxin: with simultaneous use of drugs, the concentration of digoxin In plasma increases due to a decrease in its excretion.

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

Thrombolytics/antiplatelet drugs of other classes (ticlopidine): the risk of bleeding increases.

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

Systemic glucocorticosteroids (corticosteroids) other than hydrocortisone (used to treat Addison’s disease): with simultaneous use of drugs, the concentration of salicylates in the blood decreases, since corticosteroids increase the elimination of salicylates.

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

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

Alcohol: when combined with ASA, the damaging effect on the gastrointestinal mucosa increases and the bleeding time is prolonged.

Phenylephrine

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

Beta-blockers – when used simultaneously, it is possible to increase blood pressure (arterial hypertension) and severe bradycardia. Sympathomimetics simultaneous use increases the effect of sympathomimetics on the central nervous system and the cardiovascular system. Possible agitation, irritability, insomnia.

Inhaled anaesthetics-the use of phenylephrine prior to inhalation anaesthesia increases the risk of cardiac arrhythmias. Treatment with phenylephrine should be discontinued several days before elective surgery.

Rauvolfia alkaloids – when used simultaneously, the therapeutic effect of phenylephrine may decrease.

Caffeine-when used concomitantly, the therapeutic and toxic effects of caffeine may increase.

Indometacin, bromocriptine-in rare cases, when phenylephrine is used simultaneously with Indometacin or bromocriptine, severe arterial hypertension is possible.

Selective serotonin reuptake inhibitors-when used concomitantly with antidepressants of this group (fluvoxamine, paroxetine, sertraline), both the body’s sensitivity to sympathomimetics may increase, and the risk of developing a serotonergic effect may increase.

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

Chlorphenamine

Alcohol, sleeping pills, tranquilizers, antipsychotics (neuroleptics), neutral-acting analgesics-chlorphenamine can increase the depressing effect of these drugs on the central nervous system.

Anticholinergic drugs (atropine, antispasmodics, tricyclic antidepressants, MAO inhibitors, antiparkinsonian drugs)- chlorphenamine enhances the anticholinergic effect of these drugs.

How to take it, course of administration and 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 of the drug 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 a meal, after dissolving the contents of the sachet in a glass of water at room temperature.

Overdose

Symptoms: nausea, vomiting, ringing in the ears, impaired hearing and vision, rapid breathing, severe headache, balance disorders, severe drowsiness, heart rhythm disorders.

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

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 diseases, and a history of allergies (allergic rhinitis, skin rashes).

Acetylsalicylic acid may increase the tendency to bleed due to its inhibitory effect on platelet aggregation. This should be taken into account when surgical procedures are needed, including minor interventions such as tooth extraction. Before surgery, to reduce bleeding during the operation and in the postoperative period, you should stop taking the drug for 5-7 days and inform the doctor. Children should not be prescribed medications containing acetylsalicylic acid, because in the case of a viral infection, the risk of Reye’s syndrome increases. Symptoms of Reye’s syndrome include prolonged vomiting, acute encephalopathy, and enlarged liver.

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

Due to the fact that the use of chlorphenamine may change the indicators of skin allergic tests, it is recommended to inform the doctor about the use of the drug and cancel it three days before the 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 preventive purposes before vaccinations.

Patients who limit their salt intake should take into account that each sachet contains sodium bicarbonate.

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

With renal insufficiency and a low level of albumin in plasma, the risk of toxic effects of the drug increases.

Form of production

Effervescent powder for the preparation of an oral solution

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

4 years

Active Ingredient

Acetylsalicylic Acid, Phenylephrine, Chlorphenamine

Weight

Weight: 58 gr.