Prostudox oral solution powder blackcurrant 5g sachets, 5pcs

Composition

Active ingredients: paracetamol 750 mg, phenylephrine hydrochloride 10 mg, ascorbic acid 60 mg; Excipients: sodium citrate pentahemihydrate (sodium citric acid 5,5-water), citric acid, sodium saccharinate (sodium saccharin), currant flavor (food powder flavor “black currant”), sugar-up to 5 g

Pharmacological action

A remedy for eliminating the symptoms of colds and acute respiratory infections.

Analgesic non-narcotic drug + alpha-adrenomimetic + vitamin.

The combined agent, the action of which is due to the components included in its composition, has the following properties: :

• Antipyretic.
• Analgesic.
• Vasoconstrictor effect.
• Eliminates the symptoms of the “common cold”.

Narrows the vessels of the nose, eliminates swelling of the mucous membrane of the nasal cavity and nasopharynx, makes up for vitamin C deficiency in “cold” diseases.

Onset of action 20-30 minutes after use, duration 4-4.5 hours.

Indications

Effective relief of cold and flu symptoms :

• Elevated temperature.
• Headache.
• Chills.
• Nasal congestion.
• Sore throat when swallowing.

Use during pregnancy and lactation

Contraindicated during pregnancy and lactation.

Contraindications

• Simultaneous use of other paracetamol-containing drugs.
• Hypersensitivity to the ingredients that make up the drug.
• Thyrotoxicosis.
• Diseases of the cardiovascular system: severe aortic stenosis, acute myocardial infarction, tachyarrhythmia.
• Arterial hypertension.
• Diabetes mellitus.
• Pheochromocytoma.
• Prostatic hyperplasia.
• Angle-closure glaucoma.
• Concomitant use of tricyclic antidepressants, beta-blockers, monoamine oxidase inhibitors (including for 14 days after their withdrawal).
• Children under 14 years of age.
• Pregnancy.
• Lactation period.

With caution:

• Kidney failure.
• Liver failure.
• Congenital hyperbilirubinemia: Gilbert’s, Dabin-Johnson’s, and Rotor’s syndromes.
• Chronic obstructive pulmonary disease.
• Advanced age.
• Glucose-6-phosphate dehydrogenase deficiency.
• Blood diseases.

Side effects

Allergic reactions:  sometimes – skin rash, pruritus, urticaria, angioedema.

From the hematopoietic system:  rarely-thrombocytopenia, leukopenia, agranulocytosis.

From the digestive system:  rarely – nausea, vomiting, epigastric pain.

Other services:  rarely-increased intraocular pressure, urinary retention.

With prolonged use in excess of the recommended dose, hepatotoxic and nephrotoxic effects may occur.

Phenylephrine hydrochloride may cause nausea, headache, increased blood pressure; rarely-palpitation. These symptoms disappear after discontinuation of the drug.

Interaction

Stimulators of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites of paracetamol, which causes the possibility of severe intoxication with small overdoses.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxic effects of the drug.

Paracetamol enhances the effects of MAO inhibitors, sedatives, and ethanol.

Ethanol contributes to the development of acute pancreatitis.

Antidepressants, antiparkinsonian medications, antipsychotic medications, and phenothiazine derivatives increase the risk of urinary retention, dry mouth, and constipation.

Corticosteroids increase the risk of glaucoma.

Phenylephrine reduces the hypotensive effect of guanethidine.

Guanethidine enhances the alpha-adrenostimulating effect, while tricyclic antidepressants enhance the sympathomimetic effects of phenylephrine.

The drug reduces the effectiveness of uricosuric drugs.

When gastric emptying slows down (propanthelin), the drug may have a delayed onset of action.

When gastric emptying is accelerated (metoclopramide), the drug begins to act faster.

The drug may enhance the effect of indirect anticoagulants.

How to take, course of use and dosage

Adults and children over 14 years of age: take one packet every 4-6 hours, but no more than 4 packets within 24 hours.

It is not recommended to take the drug for more than five days without consulting a doctor.

If symptoms persist, you should consult a doctor.

Overdose

An overdose of paracetamol occurs after taking 10-15 g (15-20 sachets of Coldox).

Symptoms:  epigastric discomfort, nausea, vomiting, pallor of the skin, decreased appetite, nausea, vomiting, hepatonecrosis (the severity of necrosis directly depends on the degree of overdose), increased activity of hepatic transaminases, increased prothrombin time (12-48 hours after use), a detailed clinical picture of liver damage is manifested in 1-6 days. Rarely, liver dysfunction develops rapidly and can be complicated by renal failure (renal tubular necrosis).

Treatment:  symptomatic gastric lavage, use of SH-group donors and glutathione – methionine synthesis precursors 8-9 hours after overdose and N-acetylcysteine 12 hours later. The need for additional therapeutic measures (further use of methionine, intravenous use of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after taking it.

Special instructions

You should not simultaneously use other medications containing paracetamol, as well as other non-narcotic analgesics, non-steroidal anti-inflammatory drugs (metamizole, acetylsalicylic acid, ibuprofen), barbiturates, antiepileptic drugs, rifampicin, chloramphenicol.

Concomitant use of other medications should be agreed with your doctor.

Distorts the results of laboratory tests that assess the concentration of glucose and uric acid in plasma.

Form of production

Powder for the preparation of a solution for oral use.

Storage conditions

The drug should be stored out of the reach of children, dry, protected from light at a temperature not exceeding 25°C.

Shelf life

3 years

Active ingredient

Paracetamol, Phenylephrine, Ascorbic acid

Dosage form

oral solution