Composition, form of production and packaging
? Powder for preparation of a solution for ingestion of light yellow color with impregnations of yellow color, with characteristic odor.
1 pack.
paracetamol 280 mg
Pheniramine maleate 10 mg
ascorbic acid 100 mg
Excipients: sucrose, riboflavin sodium phosphate, trimagnesium dicitrate anhydrous, aspartame, banana-caramel flavor.
3 g - sachets of combined material (6) - cardboard boxes.
3 g - sachets of combined material (8) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
A combination drug that contains paracetamol and a phenyramine maleate. Has analgesic, antipyretic and antihistamine action. Ascorbic acid, which is part of the enzyme for children, takes part in the regulation of oxidation-reduction processes, reduces vascular permeability and increases the body's resistance.
PHARMACOKINETICS
Data on the pharmacokinetics of the FERVEX preparation for children are not available.
INDICATIONS
For children aged 6 to 15 years for short-term treatment of conditions accompanied by:
- Increased body temperature, moderate pain syndrome, rhinitis with colds;
- rhinitis and rhinopharyngitis infectious-inflammatory and allergic nature.
DOSING MODE
The drug is prescribed inside. The dose depends on the child's age:
children from 6 to 10 years - 1 packet 2 times / day;
children from 10 to 12 years - 1 packet 3 times / day;
children from 12 to 15 years - 1 packet 4 times / day.
The interval between doses of the drug is at least 4 hours. Duration of treatment is no more than 5 days.
Before taking the contents of the sachet should be dissolved in a glass (200 ml) of warm water.
SIDE EFFECT
On the part of the digestive system: dry mouth, nausea, vomiting, abdominal pain, constipation; with prolonged use in doses exceeding the recommended, possibly hepatotoxic effect.
On the part of the urinary system: it may delay urination; with prolonged use in doses exceeding the recommended, possibly nephrotoxic effect.
From the hemopoietic system: rarely - anemia, leukopenia, agranulocytosis, thrombocytopenia; with prolonged use in doses exceeding the recommended - hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia.
Allergic reactions: skin rash, itching, hives, Quincke's edema are possible.
Other: drowsiness.
The drug is well tolerated at recommended doses.
CONTRAINDICATIONS
severe hepatic impairment;
- severe renal dysfunction;
- Blood diseases;
- deficiency of the enzyme glucose-6-phosphate dehydrogenase;
- children's age till 6 years;
- Hypersensitivity to the components of the drug.
With caution should be applied to the drug in violation of liver or kidney function, with Gilbert's syndrome, with diabetes.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated use of the drug in severe violations of kidney function.
Caution should be applied to the drug in case of impaired renal function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated use of the drug in severe violations of liver function.
With caution should be used in cases of impaired liver function, with Gilbert syndrome.
APPLICATION FOR CHILDREN
The drug is prescribed for children older than 6 years .
SPECIAL INSTRUCTIONS
Fervex for children should not be used concomitantly with other medicines containing paracetamol.
When using the drug for more than a week, it is necessary to monitor the functional state of the liver and the picture of peripheral blood.
In case of taking the drug children suffering from diabetes or on a diet with a low sugar content, it should be borne in mind that each packet contains 2.4 g of sugar.
Paracetamol distorts the results of laboratory studies of glucose and uric acid in the blood plasma.
In the absence of a therapeutic effect (hyperthermia lasting more than 3 days and pain syndrome for more than 5 days), a doctor's consultation is required.
OVERDOSE
Symptoms: anorexia, nausea, vomiting, stomach pain, sweating, pale skin, drowsiness. After 1-2 days, signs of liver damage appear. In severe cases, hepatic failure, hepatonecrosis, encephalopathy and coma are developing.
Treatment: recommended gastric lavage, reception of enterosorbents (activated charcoal, polyphepan), iv administration of the antidote N-acetylcysteine, methionine intake. It is necessary to monitor the patient's condition.
DRUG INTERACTION
FERVEX for children, due to the maleate included in the phenylamine, enhances the effect of sedatives. When used together with antipsychotic drugs (phenothiazine derivatives), the risk of side effects of the drug increases (urinary retention, dry mouth, constipation).
When using Fervex for children containing paracetamol, simultaneously with barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), zixorin, phenylbutazone, rifampicin and ethanol, the risk of hepatotoxic effect is significantly increased.
Admission simultaneously with salicylates increases the risk of nephrotoxic action.
When used simultaneously with levomitsetinom (chloramphenicol), the toxicity of the latter increases.
Paracetamol, contained in the preparation, enhances the effect of anticoagulants of indirect action; reduces the effectiveness of uricosuric drugs.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, dry place at a temperature of no higher than 25 В° C. Shelf life - 3 years.
