Caffetin COLDmax^® (Powder) Instructions for Use

Marketing Authorization Holder

Alkaloid AD (Macedonia)

Manufactured By

Hermes Pharma, Ges.m.b.H. (Austria)

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Active Substances

Paracetamol (Rec.INN registered by WHO)

Phenylephrine (Rec.INN registered by WHO)

Dosage Form

Caffetin COLDmax®

Powder for oral solution 1000 mg+12.2 mg: sachet 5.15 g 10 pcs.

Dosage Form, Packaging, and Composition

Powder for oral solution white with a yellowish tint, with a characteristic odor.

Excipients : sucrose – 3821.6 mg, ascorbic acid – 50 mg, citric acid – 38.4 mg, sodium citrate – 29.4 mg, aspartame – 35 mg, sodium saccharin – 14.4 mg, colloidal silicon dioxide – 5 mg, lemon flavor “MN”, code 143 – 48 mg [natural lemon oil (code 5243), natural lemon oil (code 5051) – 13.2%; maltodextrin – 20.9%; mannitol – 38.3%; gluconolactone – 16.7%; acacia gum (gum arabic) – 9.3%; sorbitol – 1.2%; colloidal silicon dioxide – 0.4%]; lemon flavor “OS”, code 134 – 96 mg [lemon flavor (code 5090R), lime flavor (code 5151), natural lemon oil (code 5050) – 15%; maltodextrin – 49.85 %; mannitol – 19.8%; gluconolactone – 8.7%; acacia gum (gum arabic) – 6%; sorbitol – 0.6%; α-tocopherol (E307) – 0.05%].

5.15 g – paper sachets (10) – cardboard packs.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

ARI and “common cold” symptoms relieving agent

Pharmacological Action

Combined drug.

Paracetamol – analgesic-antipyretic. It has analgesic, antipyretic and weak anti-inflammatory effects. The mechanism of action is associated with inhibition of prostaglandin synthesis, with a predominant effect on the thermoregulation center in the hypothalamus.

Phenylephrine – alpha₁-adrenomimetic, causes vasoconstriction, eliminates swelling and hyperemia of the nasal mucosa.

The effect occurs 15-20 minutes after taking the drug and lasts 4-6 hours.

Pharmacokinetics

Paracetamol is rapidly and completely absorbed from the small intestine. C_max in the blood is observed 15-20 minutes after oral administration. Systemic bioavailability is determined by presystemic metabolism and, depending on the dose, ranges from 70% to 90%. Paracetamol is rapidly distributed throughout all body tissues and has

T_1/2 of paracetamol is approximately 2 hours. Paracetamol is metabolized in the liver and excreted in the urine as glucuronides and sulfate compounds (>80%).

Phenylephrine is rapidly absorbed from the gastrointestinal tract. C_max is reached in 1-2 hours. The level of phenylephrine metabolism during the “first pass” through the liver is quite high (about 60%), so oral use of phenylephrine reduces its bioavailability (about 40%). T_1/2 varies from 2 to 3 hours. It is excreted in the urine as sulfate compounds.

Indications

Symptomatic treatment of colds and influenza: pain of various locations, incl. headache; sore throat and paranasal sinuses; nasal congestion; elevated body temperature.

ICD codes

Dosage Regimen

Administer orally. Dissolve the entire contents of one sachet in a glass of warm water. Stir thoroughly until the powder is completely dissolved. Consume the prepared solution immediately.

Adhere to a minimum 4-hour interval between doses. Do not exceed four sachets (4000 mg paracetamol) in any 24-hour period.

The maximum recommended duration of treatment is five consecutive days for pain and three consecutive days for fever. Discontinue use and consult a physician if symptoms persist beyond these durations.

This product is contraindicated in children and adolescents under 18 years of age.

Avoid concurrent use with other medications containing paracetamol to prevent overdose and severe liver damage.

Refrain from driving or operating machinery until your individual response is known, as dizziness may occur.

Consult a physician before use if you have liver disease, kidney disease, or are taking other medications, especially blood thinners like warfarin.

Adverse Reactions

Allergic reactions skin rash, urticaria, angioedema.

From the hematopoietic system anemia, thrombocytopenia, agranulocytosis, hemolytic and aplastic anemia, methemoglobinemia, pancytopenia.

From the CNS dizziness, sleep onset disturbance, increased excitability.

From the cardiovascular system increased blood pressure, tachycardia.

From the sensory organs accommodation paresis, mydriasis, increased intraocular pressure.

Other hepatotoxic effect, nephrotoxicity (papillary necrosis), bronchospasm, nausea, vomiting, dry mouth, urinary retention.

Contraindications

Arterial hypertension; coronary artery atherosclerosis; aortic stenosis; acute myocardial infarction; tachyarrhythmia; thyrotoxicosis; pheochromocytoma; angle-closure glaucoma; prostatic hyperplasia; renal/hepatic failure; simultaneous use of beta-blockers, tricyclic antidepressants, MAO inhibitors (including within 14 days after their discontinuation); pregnancy; lactation period (breastfeeding); children under 18 years of age; hypersensitivity to paracetamol and/or phenylephrine.

With caution

Diabetes mellitus, bronchial asthma, COPD, blood diseases, congenital hyperbilirubinemias (Gilbert’s, Dubin-Johnson, Rotor syndromes), hyperoxaluria.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindication — hepatic failure.

Use in Renal Impairment

Contraindication — renal failure.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age

Special Precautions

The drug should not be combined with ethanol intake.

During treatment, it is necessary to refrain from taking hypnotics, anxiolytic drugs, other drugs containing Paracetamol, as well as from drinking alcohol.

The use of this combination distorts the results of laboratory tests assessing the concentration of glucose and uric acid in plasma.

If symptoms persist for more than 5 days, the patient should consult a doctor.

Drug Interactions

Stimulators of microsomal oxidation in the liver (including phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites of paracetamol, which may lead to the development of severe intoxications.

Paracetamol reduces the effectiveness of uricosuric drugs.

The absorption rate of paracetamol increases under the influence of metoclopramide or domperidone and decreases under the influence of cholestyramine.

The anticoagulant effect of warfarin and other coumarin derivatives is enhanced with long-term use of paracetamol.

This combination enhances the effects of MAO inhibitors, sedatives, ethanol.

With simultaneous use of phenylephrine with antidepressants, antiparkinsonian, antipsychotic drugs, phenothiazine derivatives, urinary retention, dry mouth, and constipation are possible.

When used with corticosteroids, the risk of developing glaucoma increases.

Tricyclic antidepressants enhance the adrenomimetic effect of phenylephrine, simultaneous administration of halothane increases the risk of developing ventricular arrhythmia.

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.