Grippex^® (Tablets) Instructions for Use

Marketing Authorization Holder

Unipharm, Inc. (USA)

Manufactured By

Moscow Endocrine Plant FSUE (Russia)

Contact Information

Unipharm, Inc. (USA)

ATC Code

R05X (Other remedies for the treatment of colds)

Active Substances

Paracetamol (Rec.INN WHO registered)

Dextromethorphan (Rec.INN WHO registered)

Pseudoephedrine (Rec.INN WHO registered)

Dosage Form

Grippex®

Tablets 325 mg+30 mg+10 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets from white or almost white to light yellow or light brown in color, round, flat-cylindrical, with a bevel on both sides and a score on one side; marbling is allowed.

Excipients: microcrystalline cellulose, type 102 – 90.86 mg, corn starch pregelatinized – 63 mg, croscarmellose sodium – 15 mg, stearic acid – 12 mg, magnesium stearate – 6 mg, colloidal silicon dioxide – 2 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – 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 + sympathomimetic agent + opioid antitussive agent)

Pharmacological Action

Grippex^® tablets contain Paracetamol (analgesic-antipyretic), pseudoephedrine (sympathomimetic), and Dextromethorphan (antitussive agent). The drug alleviates the severity of symptoms usually accompanying “common cold” illnesses.

Paracetamol reduces elevated body temperature and relieves pain. Paracetamol blocks COX only in the CNS, acting on pain and thermoregulation centers (in inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on COX), which explains the almost complete absence of an anti-inflammatory effect. The lack of effect on the synthesis of prostaglandins in peripheral tissues determines the absence of a negative effect on water-salt metabolism (sodium and water retention) and the gastrointestinal mucosa.

Pseudoephedrine promotes vasoconstriction of the nasal and pharyngeal mucosa, reduces swelling of the mucous membranes and sinuses, thereby facilitating breathing.

Dextromethorphan suppresses the excitability of the cough center, suppresses cough of any origin, and does not cause a habituation effect.

Grippex^® provides effective relief of symptoms of acute respiratory diseases and the “common cold”: fever, chills, feeling of nasal congestion, sore throat, cough, headache, muscle and joint pain.

Pharmacokinetics

Pharmacokinetic data for the drug Grippex^® are not provided.

Indications

• Symptomatic treatment of “common cold” diseases.

ICD codes

Dosage Regimen

Administer the drug orally.

For adults and children over 12 years, take 1 to 2 tablets per dose.

Do not exceed 4 doses in 24 hours.

Maintain an interval of at least 4 hours between each dose.

The maximum daily dose is 8 tablets.

Limit the total duration of treatment to 3-5 days.

Do not use for more than 5 days without consulting a physician.

For patients with mild to moderate hepatic or renal impairment, use only under direct medical supervision.

Do not exceed the recommended dosage due to the risk of severe liver damage from paracetamol.

Consult a physician immediately if symptoms persist or worsen.

Adverse Reactions

When used in recommended doses, side effects of the drug occur rarely.

From the central nervous system sometimes (more than 0.1%, but less than 1%) – drowsiness, irritability and agitation; rarely (more than 0.01%, but less than 0.1%) – dizziness.

From the digestive system sometimes (more than 0.1%, but less than 1%) – nausea, dry mouth; rarely (more than 0.01%, but less than 0.1%) – epigastric pain; with long-term use in high doses – hepatotoxic effect.

From the cardiovascular system rarely (more than 0.01%, but less than 0.1%) – increased blood pressure, tachycardia.

Allergic reactions rarely (more than 0.01%, but less than 0.1%) – skin rash, itching, urticaria, angioedema.

From the hematopoietic system rarely (more than 0.01%, but less than 0.1%) – anemia, thrombocytopenia, agranulocytosis; with long-term use in high doses – hemolytic anemia, aplastic anemia, pancytopenia.

From the urinary system with long-term use in high doses – renal colic, interstitial nephritis, capillary necrosis.

Contraindications

• Severe liver dysfunction;
• Severe renal dysfunction;
• Severe arterial hypertension;
• Severe coronary artery disease (including angina pectoris);
• Concomitant use of MAO inhibitors, as well as use of the drug within the next 2 weeks after the end of treatment with MAO inhibitors;
• Concomitant use with antidepressants, drugs for the treatment of Parkinson’s disease;
• Children under 12 years of age;
• Hypersensitivity to paracetamol, pseudoephedrine, dextromethorphan or any other component of the drug.

With caution the drug should be prescribed to patients with Gilbert’s syndrome, glucose-6-phosphate dehydrogenase deficiency, blood diseases (severe forms of anemia), as well as elderly patients. Patients with mild and moderate impairment of renal and liver function can take the drug Grippex^® only on the recommendation of a doctor.

It is not recommended to take the drug for patients with heart disease (angina pectoris), arterial hypertension, thyroid diseases, increased intraocular pressure, diabetes mellitus and urination disorders associated with prostatic hyperplasia, except in cases where the drug is recommended by a doctor.

Caution should be exercised when using the drug in debilitated and emaciated patients and in patients with alcoholism.

Use in Pregnancy and Lactation

It is not recommended to prescribe the drug during pregnancy and lactation (breastfeeding), as the safety of its use has not been definitively established.

Use in Hepatic Impairment

The drug is contraindicated in severe liver dysfunction. Patients with mild and moderate impairment of liver function may be prescribed the drug only under medical supervision.

Use in Renal Impairment

The drug is contraindicated in severe renal dysfunction. Patients with mild and moderate impairment of renal function may be prescribed the drug only under medical supervision.

Pediatric Use

The drug is contraindicated in children under 12 years of age.

Geriatric Use

The drug should be prescribed with caution to elderly patients.

Special Precautions

The recommended dose should not be exceeded.

Without a doctor’s recommendation, the drug should not be taken for more than 5 days. If the condition does not improve or even worsens, it is necessary to consult a doctor.

Refrain from consuming alcohol while taking the drug.

Effect on ability to drive vehicles and operate machinery

Against the background of the drug use, a decrease in psychomotor reactions is possible, so patients should be careful when driving a car and working with machinery.

Overdose

Symptoms in patients, especially those with impaired renal and liver function, paracetamol overdose can cause pale skin, anorexia, nausea, vomiting and severe liver damage. The full clinical picture of liver damage appears after 1-6 days. Rarely, liver dysfunction develops rapidly and may be complicated by renal failure (tubular necrosis). Pseudoephedrine overdose can cause agitation, increased blood pressure and heart rhythm disturbances. Dextromethorphan overdose can cause nausea, vomiting, dizziness, drowsiness, visual disturbances, lethargy, impaired coordination of movements and difficulty breathing.

The patient should be warned that in case of accidental overdose, it is necessary to consult a doctor immediately.

Treatment gastric lavage followed by the administration of activated charcoal; if necessary, symptomatic therapy is carried out, methionine is administered within 8-9 hours after overdose, acetylcysteine – within 12 hours.

Drug Interactions

The patient should inform the attending physician that he is taking any other medications.

In case of using metoclopramide, domperidone, cholestyramine and warfarin, you should consult your doctor before starting to take Grippex^®.

The drug Grippex^® should not be taken simultaneously with barbiturates, antiepileptic drugs, rifampicin, chloramphenicol, dihydroergotamine, methyldopa, fluoxetine or haloperidol.

With simultaneous use of pseudoephedrine with MAO inhibitors, the development of a hypertensive crisis is possible.

The drug Grippex^® should not be taken simultaneously with other drugs containing Paracetamol.

Storage Conditions

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

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

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.