Aspirin Complex - instructions for use, dose, side effects, contraindications

Active substanceAcetylsalicylic acid + Phenylephrine + ChlorphenamineAcetylsalicylic acid + Phenylephrine + Chlorphenamine

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Aspirin® Complex

powder inwards

BAYER, AO Russia

Dosage form: & nbsppowder effervescent for solution for oral administration

Composition:

Each sachet contains:

active ingredients:

Acetylsalicylic acid - 500 mg,

phenylephrine hydrotartrate - 15.58 mg,

chlorphenamine maleate - 2.00 mg;

Excipients: citric acid anhydrous 1220 mg, sodium hydrogen carbonate 1709.6 mg, lemon flavor 100 m g, quinoline yellow color (E 104) 0.32 mg.

Description:A mixture of crystalline powders from almost white to white with a yellowish hue of color.

Pharmacotherapeutic group:Remedy for the elimination of symptoms of acute respiratory disease and "colds" (NSAIDs + alpha-adrenomimetic + H1-histamine receptor blocker)

ATX: & nbsp

N.02.B.A.51 Acetylsalicylic acid in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

Combined drug, the effect of which is due to its active components:

Acetylsalicylic acid (ASA) has analgesic, antipyretic, anti-inflammatory effect, which is due to inhibition of cyclooxygenase enzymes involved in the synthesis of prostaglandins. Acetylsalicylic acid inhibits platelet aggregation by blocking the synthesis of thromboxane A2.

Phenylephrine is sympathomimetic and, having a vasoconstrictive effect, reduces edema of the mucous membranes of the sinuses of the nose, thereby facilitating breath.

Chlorphenamine belongs to the group of antihistamines, relieves symptoms such as sneezing and lacrimation.

Indications:

Apply to alleviate the symptoms of "colds", acute respiratory infections, flu such as: fever and chills, headache and muscle pain, runny nose and / or congestion of the nose, sore throat and sneezing.

Contraindications:

- Hypersensitivity to acetylsalicylic acid and other NSAIDs or other components of the drug;

- erosive-ulcerative lesion of the gastrointestinal tract (in the phase of exacerbation), chronic or recurrent ulcer disease;

- asthma caused by the intake of salicylates or other NSAIDs;

- clotting disorders, such as hemophilia; hypoprothrombinemia;

- Severe violations of the liver and / or kidney function;

- polyposis of the nose, associated with bronchial asthma and intolerance to acetylsalicylic acid;

- arterial hypertension;

- angina pectoris;

- an increase in the thyroid gland;

- combined use with oral anticoagulants;

- combined use with monoamine oxidase inhibitors, including 15 days after discontinuation;

- combined use of methotrexate in a dose of 15 mg per week or more;

- retention of urine;

- pregnancy (I and III trimester), the period of breastfeeding.

The drug is not prescribed for 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 hepatic insufficiency).

Carefully:

In patients with lung and kidney disease, with glaucoma,pheochromocytoma, cardiovascular diseases, sugar diabetes, hypertrophy of the prostate, with anemia.

Dosing and Administration:

Dissolve the contents of the sachet in a glass of water room temperature. Take inside after eating.

Adults and children over 15 years of age: one packet 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 consulting a doctor) should not exceed 5 days with an appointment as an anesthetic and more than 3 days inas an antipyretic agent.

Side effects:

Acetylsalicylic acid

Organism as a whole: hyperhidrosis.

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

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

Hemopoietic system: hypoprothrombinemia.

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

Urinary system: renal failure, acute interstitial glomerulonephritis.

In rare cases (<1%) toxic liver damage, especially in patients with juvenile rheumatoid arthritis; anemia, Reye's syndrome in children.

Phenylephrine

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

In rare cases:

Central nervous system: severe headache, inadequate behavior.

The cardiovascular system: increased blood pressure, tachycardia.

Urinary system: painful or difficult urination. .

Chlorphenamine

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

The cardiovascular system: tachycardia.

Gastrointestinal tract: constipation.

Urinary system: delayed urination, difficulty and pain in urination.

Central nervous system and sensory organs: attention disturbance, drowsiness, dizziness. Children and elderly patients are possible: retardation,excitement, dizziness, anxiety, irritability.

If any adverse reactions occur, stop taking the medication and consult a doctor.

Overdose:

Symptoms: nausea, vomiting, ringing in the ears, deterioration, hearing and vision, breath, pronounced, headache, imbalance, pronounced drowsiness, disturbance of the heart rhythm.

Treatment: gastric lavage, the appointment of activated charcoal, symptomatic therapy.

Interaction:

Acetylsalicylic acid

Combination with methotrexate in a dose 15 mg per week is contraindicated.

Combinations of drugs that are used with caution:

Methotrexate in a dose of less than 15 mg / week: With simultaneous use of drugs, the hematological toxicity of methotrexate is increased because NSAIDs generally decrease the renal clearance of methotrexate, and salicylates in particular are displacing it from the bond with plasma proteins.

Anticoagulants (coumarin, heparin): with simultaneous admission, ASA and indirectanticoagulants increases the risk of bleeding due to the suppression of platelet function, damage to the mucous membrane of the stomach and duodenum and the displacement of oral anticoagulants from their association with plasma proteins.

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

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

Digoxin: with the simultaneous use of drugs increases the concentration of digoxin in the plasma by reducing its excretion.

Antidiabetic drugs (insulin.sulfonylurea): intensified hypoglycemic effect due to the fact that ASA in high dose has hypoglycemic properties and displaces sulfonylurea from the connection with plasma proteins.

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

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

Systemic glucocorticosteroids (GCS) excluding hydrocortisone (used to treat Addison's disease): when the simultaneous use of drugs, the concentration of salicylates in the blood decreases, as GCS enhances the elimination of salicylates.

Angiotensin-converting enzyme (ACE) inhibitors: while simultaneous use of ACE inhibitors and ASA at a dose of 3 g / day or more, a decrease in the hypotensive effect ACE inhibitors, due to a decrease in glomerular filtration.

Valproic Acid: ASA disrupts the association of valproic acid with plasma proteins, resulting in increased toxicity.

Alcohol: when combined with ASA, the damaging effect on the mucosagastrointestinal tract and lengthening the time of bleeding.

Phenylephrine

Monoamine oxidase inhibitors (MAO inhibitors) - with the 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.

Beta-blockers - with simultaneous application possible rise blood pressure (arterial hypertension) and pronounced bradycardia.

Sympathomimetics with simultaneous application increases the influence sympathomimetics on the central nervous system and cardiovascular system. Perhaps stimulation, irritability, insomnia.

Inhalation anesthetics - use of phenylephrine before Inhalation anesthesia increases the risk of heart rate abnormalities. It is necessary to stop phenylephrine treatment several days before the planned surgical treatment.

Rawwolfia alkaloids - with simultaneous use, the therapeutic effect of phenylephrine may decrease.

Caffeine- with simultaneous use, the therapeutic and toxic effects of caffeine can be enhanced.

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

Selective serotonin reuptake inhibitors - with simultaneous use with antidepressants of this group (fluvoxamine, paroxetine, sertraline) can be strengthened as the sensitivity of the body to sympathomimetics, and the risk of developing a serotonergic effect increases.

Hypotensive drugs from the sympatholytic group: such as reserpine. guanethidine - Phenylephrine reduces the hypotensive effect of these drugs.

Chlorphenamine

Alcohol, hypnotics, tranquilizers, antipsychotic drugs (antipsychotics); analgesics of neutral action- chlorphenamine can enhance, the inhibitory 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.

Special instructions:

Acetylsalicylic acid can cause bronchospasm, an attack of bronchial asthma or other hypersensitivity reactions. Risk factors are the presence of bronchial asthma, polyps of the nose, fever, chronic bronchopulmonary diseases, cases of an allergy in the anamnesis (allergic rhinitis, skin rashes).

Acetylsalicylic acid can increase the tendency to bleeding, which is associated with its inhibitory effect on platelet aggregation. This should be considered when surgical interventions are required, including minor interventions such as tooth extraction. Before surgery, to reduce bleeding during surgery and in the post-operation period, you should cancel taking the drug for 5-7 days and inform the doctor. Children should not be prescribed drugs containing acetylsalicylic acid, because in the case of a viral infection, the risk of developing Reye syndrome increases. Symptoms of Reye's syndrome include prolonged vomiting, acute encephalopathy, and enlargement of the liver.

During treatment, it is not recommended to drink alcohol because of the increased risk of side effects from the gastrointestinal tract associated withadmission acetylsalicylic acid, and enhance the sedative effect of chlorphenamine.

In connection with the fact that when chlorphenamine is used, it is possible to change the parameters of the 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, not it is recommended to use painkillers, sympathomimetics, guanethidine and beta-blockers.

It is not recommended to take the drug systematically and with a preventive goal before the vaccination.

Patients who limit the use of salt should take into account that each packet contains sodium hydrogen carbonate.

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

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

Effect on the ability to drive transp. cf. and fur:Aspirin® Complex can cause drowsiness and therefore worsen the ability to drive and move vehicles.

Form release / dosage:Powder effervescent to prepare a solution for oral administration of 500 mg + 15.58 mg + 2 mg.

Packaging:

For 3547.5 mg of the drug in a paper bag, laminated with aluminum foil and polyethylene film, 2 package are connected in 1 strip (divided perforated band). For 5 strips together with instructions for use in cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:4 years. Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LS-000478

Date of registration:21.06.2010 / 26.07.2016

Expiration Date:Unlimited

The owner of the registration certificate:BAYER, AO BAYER, AO Russia

Manufacturer: & nbsp

KERN PHARMA, S.L. Spain

Representation: & nbspBAYER, AOBAYER, AO

Information update date: & nbsp27.09.2017

Illustrated instructions

Instructions

Aspirin® Complex (Aspirin® Complex)