Gripend (Tablets) Instructions for Use

Marketing Authorization Holder

US PHARMACIA, Sp. z o.o (Poland)

ATC Code

R01BA52 (Pseudoephedrine in combination with other drugs)

Active Substances

Paracetamol (Rec.INN registered by WHO)

Dextromethorphan (Rec.INN registered by WHO)

Pseudoephedrine (Rec.INN registered by WHO)

Dosage Form

Gripend

Coated tablets, 325 mg+30 mg+10 mg: 6, 12, 24, or 60 pcs.

Dosage Form, Packaging, and Composition

* Composition of COMPAP L granulate 361.1 mg Paracetamol – 325 mg, pregelatinized starch – 28.9 mg, povidone – 2.7 mg, stearic acid – 2.7 mg, crospovidone – 1.8 mg.

12 pcs. – blisters (1) – cardboard packs.
12 pcs. – blisters (2) – cardboard packs.
2 pcs. – sachets (3) – cardboard packs.
2 pcs. – sachets (30) – 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

A combined drug that alleviates the severity of symptoms usually accompanying colds.

Paracetamol has antipyretic and analgesic effects. It blocks COX-1 and COX-2 predominantly 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 a blocking 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, which leads to a decrease in nasal secretion and easier nasal breathing.

Dextromethorphan acts on the cough center (increases the cough threshold), which leads to a reduction in dry cough associated with irritation of the nasopharyngeal mucosa in most colds.

Indications

Symptomatic therapy of colds.

ICD codes

Dosage Regimen

Administer orally.

For adults and children over 12 years: take 1 to 2 tablets as a single dose.

Repeat dosing every 6 hours as needed for symptom relief.

Do not exceed 8 tablets in a 24-hour period.

Adhere strictly to the maximum daily dose to avoid the risk of hepatotoxicity from paracetamol.

The dosing interval must be a minimum of 4 hours between administrations.

Limit treatment duration to a few days; do not use for prolonged therapy without medical consultation.

Discontinue use and seek medical advice if symptoms persist or worsen.

Adverse Reactions

From the digestive system nausea, dry mouth, rarely – epigastric pain; with long-term use in high doses – hepatotoxicity.

From the CNS drowsiness, irritability, agitation, rarely – dizziness.

Allergic reactions skin rash, skin itching, urticaria, angioedema.

From the cardiovascular system rarely – increased blood pressure, tachycardia.

From the hematopoietic system rarely – 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 – nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis).

Contraindications

Hypersensitivity; severe hepatic and/or renal failure; arterial hypertension; coronary artery disease; angina pectoris; childhood (under 12 years); pregnancy; lactation period; simultaneous use of MAO inhibitors, antidepressants, antiparkinsonian drugs.

With caution

Renal and/or hepatic impairment, closed-angle glaucoma, increased intraocular pressure, glucose-6-phosphate dehydrogenase deficiency, anemia, Gilbert’s syndrome (benign hyperbilirubinemia), diabetes mellitus, thyrotoxicosis, prostatic hyperplasia with urinary retention, alcoholism, elderly age, debilitated and emaciated patients.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Contraindication — severe hepatic failure.

With caution : hepatic impairment

Use in Renal Impairment

Contraindication — severe renal failure.

With caution : renal impairment

Pediatric Use

Use is contraindicated in children under 12 years of age.

Geriatric Use

With caution : elderly age

Special Precautions

During treatment, peripheral blood counts and liver functional state should be monitored.

During treatment, it is necessary to refrain from consuming ethanol (development of a hepatotoxic effect is possible).

Effect on ability to drive vehicles and mechanisms

During treatment, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Concomitant use of paracetamol in high doses enhances the effect of anticoagulant drugs .

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which determines the possibility of developing severe intoxications even with a slight overdose.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Long-term combined use of paracetamol and other NSAIDs increases the risk of developing analgesic nephropathy and renal papillary necrosis, and the onset of end-stage renal failure.

Simultaneous long-term use of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer.

Diflunisal increases the plasma concentration of paracetamol by 50%, thereby increasing the risk of hepatotoxicity.

With simultaneous use of pseudoephedrine with other sympathomimetics, an additive effect and development of toxic effects are possible; with MAO inhibitors – development of a hypertensive crisis is possible.

Propranolol may enhance the pressor effect of pseudoephedrine; Pseudoephedrine may reduce the hypotensive effect of reserpine, methyldopa, mecamylamine hydrochloride and Veratrum alkaloids.

Amiodarone, fluoxetine, quinidine , by inhibiting the cytochrome P450 system, may increase the concentration of dextromethorphan in the blood.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.