Influblock (Powder) Instructions for Use

Marketing Authorization Holder

Polpharma Pharmaceutical Works, Sa (Poland)

Manufactured By

Laboratorios Alcala Farma, S.L. (Spain)

ATC Code

N02BE71 (Paracetamol in combination with psycholeptics)

Dosage Form

Influblock

Effervescent powder for the preparation of oral solution: pouch 2.8 g 10 pcs.

Dosage Form, Packaging, and Composition

2.8 g – pouches made of combined material (10) – cardboard packs.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Acute respiratory diseases and “common cold” symptoms elimination agent (non-narcotic analgesic agent + opioid antitussive agent + alpha-adrenergic agonist + H1-histamine receptor blocker)

Pharmacological Action

A combination drug used for “common cold” diseases, the action of which is due to its constituent components.

Paracetamol is an analgesic-antipyretic, it blocks cyclooxygenase predominantly in the central nervous system, affecting the centers of pain and thermoregulation. It reduces pain syndrome observed in colds – sore throat, headache, muscle and joint pain, and reduces high body temperature.

Ascorbic acid replenishes vitamin C deficiency in “common cold” diseases. Caffeine stimulates the psychomotor centers of the brain, enhances the effect of analgesics, and eliminates drowsiness and fatigue.

Dextromethorphan is an antitussive agent, similar in potency to codeine. It increases the sensitivity threshold of the cough center in the medulla oblongata without causing depression of the respiratory center, suppresses cough of any origin, and eliminates the irritating effect of dry non-productive cough. It has some sedative effect, does not have analgesic, narcotic, or hypnotic action.

Chlorphenamine is an H₁-histamine receptor blocker, it has an antiallergic effect, reduces vascular permeability of the mucous membrane of the upper respiratory tract, and eliminates lacrimation, itching in the eyes and nose.

Pharmacokinetics

A study of the pharmacokinetics of the drug Influblock has not been conducted.

Indications

• Symptomatic treatment of infectious and inflammatory diseases (ARVI, influenza), accompanied by high fever, severe chills, body aches, headache and muscle pain, runny nose (including allergic), nasal congestion, sneezing.

ICD codes

Dosage Regimen

Orally. Dissolve the contents of the pouch in 1/2 glass of hot water and drink. The recommended dose for adults is 1 pouch 3 times a day every 8 hours (no more than 3 doses within 24 hours).

The drug should be taken when the first symptoms of the disease appear. Discontinue the drug as the symptoms disappear. The course of treatment should not exceed 5 days.

If no relief of symptoms is observed within 5 days after starting the drug, it is necessary to consult a doctor.

Adverse Reactions

From the central nervous system drowsiness, headache, dizziness, sleep onset insomnia, increased excitability, attention deficit, tremor, mydriasis, increased intraocular pressure, accommodation paresis.

From the cardiovascular system increased blood pressure, tachycardia, ventricular extrasystole, cardialgia.

From the digestive system nausea, epigastric pain, decreased appetite, dyspepsia, dry mouth, constipation. With long-term use in high doses – hepatotoxic effect, bleeding in the gastrointestinal tract.

From the hematopoietic system anemia, with long-term use in high doses – hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia, thrombocytopenia, leukopenia, agranulocytosis.

From the urinary system urinary retention, with long-term use in high doses – nephrotoxicity (renal colic, glucosuria, interstitial nephritis, papillary necrosis).

Allergic reactions skin rash, itching, urticaria, angioneurotic edema.

Other bronchospastic syndrome.

Contraindications

• Portal hypertension;
• Alcoholism;
• Glucose-6-phosphate dehydrogenase deficiency;
• Bronchial asthma;
• Concomitant use of MAO inhibitors (MAO);
• Pregnancy;
• Lactation period;
• Age under 18 years;
• Hypersensitivity to paracetamol and other components of the drug.

With caution arterial hypertension; diabetes mellitus; chronic obstructive pulmonary disease; closed-angle glaucoma; severe diseases of the liver or kidneys, lungs; difficulty urinating with benign prostatic hyperplasia; blood diseases; congenital hyperbilirubinemias (Gilbert’s, Dubin-Johnson and Rotor syndromes); erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase).

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

With caution: severe liver diseases.

Use in Renal Impairment

With caution: severe kidney diseases.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

During the use of the drug, one should refrain from consuming alcohol, hypnotic or anxiolytic drugs.

Concomitant use of other drugs containing Paracetamol should be avoided due to the content of the latter in the drug Influblock.

Effect on ability to drive vehicles and machinery

During the use of the drug, caution should be exercised when engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Overdose

Symptoms

Paracetamol pallor of the skin, decreased appetite, nausea, vomiting; hepatonecrosis (the severity of necrosis due to intoxication is directly dependent on the degree of overdose). Toxic effects in adults are possible after taking more than 10-15 g of paracetamol: increased activity of “liver” transaminases, increased prothrombin time (12-48 hours after ingestion); the full clinical picture of liver damage appears after 1-6 days. Rarely, liver failure develops rapidly and may be complicated by renal failure (tubular necrosis).

Dextromethorphan nausea, vomiting, dizziness, drowsiness, visual impairment, lethargy, impaired coordination of movement, difficulty breathing.

Caffeine gastralgia, agitation, anxiety, excitation, motor restlessness, confusion, delirium, dehydration, tachycardia, arrhythmia, hyperthermia, frequent urination, headache, increased tactile or pain sensitivity, tremor or muscle twitching; nausea and vomiting, sometimes with blood; tinnitus, epileptic seizures (with acute overdose – tonic-clonic). Caffeine in doses of more than 300 mg/day (including against the background of coffee abuse – more than 4 cups of natural coffee of 150 ml) can cause anxiety, tremor, headache, confusion, extrasystole.

Ascorbic acid: diarrhea, nausea, irritation of the gastrointestinal mucosa, flatulence, abdominal pain of a spasmodic nature, frequent urination, nephrolithiasis, insomnia, irritability, hypoglycemia. Chlorphenamine: nausea, vomiting, anorexia, dry mouth, dryness of the nasal mucosa, abdominal pain or pain in the liver area, heart rhythm disturbances (arrhythmias, bradycardia or tachycardia), in severe cases – liver failure.

Treatment: gastric lavage within the first 6 hours, followed by the administration of activated charcoal, laxative drugs. Symptomatic therapy. Maintaining fluid and salt balance, lung ventilation and oxygenation; for epileptic seizures – intravenous diazepam, phenobarbital or phenytoin. Administration of SH-group donors and precursors of glutathione synthesis – methionine within 8-9 hours and acetylcysteine within 12 hours after overdose. The need for additional therapeutic measures (further administration of methionine, intravenous administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its intake. Naloxone is a specific antidote for dextromethorphan. In case of respiratory depression and difficulty in coordination of movements, it is necessary to prescribe naloxone and artificial lung ventilation.

Drug Interactions

Dextromethorphan enhances the effects of MAO inhibitors, sedative drugs, ethanol. Amiodarone, fluoxetine, quinidine, by inhibiting the cytochrome P450 system, may increase the concentration of dextromethorphan in the blood. Ethanol enhances the sedative effect of chlorphenamine. With simultaneous use of chlorphenamine with antidepressants, antiparkinsonian, antipsychotic drugs and phenothiazine derivatives, the risk of urinary retention, dry mouth, and constipation increases.

When used together, Paracetamol reduces the effectiveness of uricosuric drugs and increases the effectiveness of indirect anticoagulants. With simultaneous use with paracetamol, an increase in the toxicity of chloramphenicol is possible.

The risk of hepatotoxic action of paracetamol increases with simultaneous administration of barbiturates, diphenylhydantoin, carbamazepine, rifampicin, zidovudine and other inducers of liver microsomal enzymes.

With simultaneous use with oral contraceptives, the excretion of paracetamol from the body is accelerated and a decrease in its analgesic effect is possible. With simultaneous use with metoclopramide, an increase in the absorption of paracetamol and an increase in its plasma concentration are possible.

Storage Conditions

In a place protected from light at a temperature not exceeding 30°C (86°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

Over-the-counter.

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.