Composition, form of production and packaging
? Powder for the preparation of solution for ingestion of lemon light beige color, with a characteristic odor; interspersed with brown.
1 pack.
paracetamol 500 mg
Pheniramine maleate 25 mg
ascorbic acid 200 mg
Excipients: mannitol, citric acid anhydrous, povidone, trimagnesium dicitrate anhydrous, aspartame, aromatizer lemon-rum (Antilles).
4.95 g - sachets of combined material (6) - packs of cardboard.
4.95 g - sachets of combined material (8) - packs of cardboard.
4.95 g - sachets of combined material (12) - packs of cardboard.
4.95 g - sachets from the combined material (16) - packs cardboard.
? Powder for the preparation of solution for ingestion (lemon and sugar) light beige, with a characteristic odor; interspersed with brown.
1 pack.
paracetamol 500 mg
Pheniramine maleate 25 mg
ascorbic acid 200 mg
Auxiliary substances: sucrose, citric acid anhydrous, gum arabic, soluble saccharin, aromatizer lemon-rum (Antilles).
13.1 g - sachets from the combined material (6) - packs cardboard.
13.1 g - sachets from the combined material (8) - packs cardboard.
? Powder for the preparation of solution for ingestion (raspberry with sugar) from light pink to light beige; admissions of a dark pink color.
1 pack.
paracetamol 500 mg
Pheniramine maleate 25 mg
ascorbic acid 200 mg
Excipients: sucrose, citric acid anhydrous, gum arabic, sodium saccharinate, raspberry flavor.
12.75 g - sachets from the combined material (4) - packs cardboard.
12.75 g - sachets of combined material (5) - packs of cardboard.
12.75 g - sachets from the combined material (6) - packs cardboard.
12.75 g - sachets from the combined material (8) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Combination drug for symptomatic therapy of acute respiratory disease.
Paracetamol - an analgesic-antipyretic, has an analgesic and antipyretic effect, which is associated with its influence on the center of thermoregulation in the hypothalamus; eliminates headache and other types of pain, reduces fever.
Ascorbic acid (vitamin C) is involved in the regulation of oxidation-reduction processes, carbohydrate metabolism, blood coagulation, tissue regeneration, synthesis of GCS, collagen and procollagen; normalizes the permeability of capillaries. Increases the resistance of the body, which is associated with the stimulation of the immune system.
Phenyramin - a blocker of histamine H 1 -receptors, reduces rhinorrhea, a feeling of nasal congestion, sneezing, lacrimation, itching and redness of the eyes.
PHARMACOKINETICS
Data on the pharmacokinetics of the Fervex preparation are not available.
INDICATIONS
- ARVI (symptomatic therapy);
- Rhinopharyngitis.
DOSING MODE
Ferveks designate the inside of 1 packet 2-3 times / day. preferably between meals. The interval between doses of the drug is at least 4 hours.
In patients with impaired liver or kidney function and elderly patients, the interval between doses should be at least 8 hours.
Duration of treatment (without consulting a doctor) is no more than 5 days when used as an analgesic and not more than 3 days - as an antipyretic.
The drug should be completely dissolved in a glass of warm water and the resulting solution immediately drink.
SIDE EFFECT
From the digestive system: nausea, pain in the epigastric region; rarely dry mouth; with prolonged use in doses significantly exceeding the recommended, increases the likelihood of impaired liver function.
From the hemopoietic system: rarely - anemia, thrombocytopenia, methemoglobinemia.
From the urinary system: rarely - urinary retention; with prolonged use in doses significantly exceeding the recommended, the probability of impaired renal function increases.
Allergic reactions: skin rash, itching, urticaria, angioedema.
Other: rarely - paresis of accommodation, drowsiness.
The drug is well tolerated at recommended doses.
CONTRAINDICATIONS
- erosive-ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation);
- kidney failure;
- portal hypertension;
- chronic alcoholism;
- deficiency of glucose-6-phosphate dehydrogenase;
- children's age till 15 years;
- I and III trimesters of pregnancy;
- the period of lactation (breastfeeding);
- Hypersensitivity to the components of the drug.
With caution should be used in patients with liver failure, zakratougolnoy glaucoma, prostatic hyperplasia, congenital hyperbilirubinemia (syndromes Gilbert, Dubin-Johnson and Rotor), with viral hepatitis, alcoholic hepatitis, in elderly patients.
PREGNANCY AND LACTATION
Contraindicated use of the drug in the I and III trimesters of pregnancy and lactation (breastfeeding).
APPLICATION FOR FUNCTIONS OF THE LIVER
In patients with impaired renal function, the interval between doses should be at least 8 hours.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
In patients with impaired liver function, the interval between doses should be at least 8 hours.
With caution should be used in patients with hepatic insufficiency, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), viral hepatitis, alcoholic hepatitis.
APPLICATION FOR CHILDREN
Contraindication: children under 15 years.
APPLICATION IN ELDERLY PATIENTS
With caution should be used in elderly patients.
SPECIAL INSTRUCTIONS
If you need to take metoclopramide, domperidone, or colestyramine during the use of Fervex, the patient should consult a doctor.
During the application of Fervex, the parameters of laboratory tests may be distorted in the quantitative determination of the concentration of uric acid and glucose in the plasma.
To avoid toxic damage to the liver, paracetamol should not be combined with alcohol intake, and should also be taken to persons prone to chronic alcohol use.
When using the drug, the risk of liver damage increases in patients with alcoholic hepatosis.
With prolonged use in doses that are significantly higher than recommended, monitoring of the peripheral blood pattern is necessary.
Use in patients with diabetes mellitus
The drug in the form of powder for the preparation of a solution for ingestion of lemon is sugar-free and can be used in patients with diabetes mellitus.
In 1 packet of the drug in the form of a powder for the preparation of a solution for ingesting lemon with sugar or raspberry with sugar contains 11.5 g of sugar, which corresponds to 0.9 XE. This should be considered when it is necessary to use this dosage form in patients with diabetes mellitus or in patients on a diet with a low sugar content.
OVERDOSE
Symptoms are caused by paracetamol: pallor of the skin, decreased appetite, nausea, vomiting; hepatonecrosis (the severity of necrosis due to intoxication directly depends on the degree of overdose). Toxic effect in adults is possible after taking paracetamol in a dose of more than 10-15 g: increased activity of hepatic transaminases, an increase in prothrombin time (12-48 hours after administration); a detailed clinical picture of liver damage manifests itself after 1-6 days. Rarely is the rapid development of liver failure, which can be complicated by renal failure (tubular necrosis).
Treatment: in the first 6 hours after an overdose - gastric lavage, administration of SH-group donors and glutathione-methionine synthesis precursors 8-9 hours after an overdose and N-acetylcysteine ​​after 12 hours. The need for additional therapeutic measures (further introduction of methionine, in / in the introduction of N-acetylcysteine) is determined by the concentration of paracetamol in the blood, as well as the time passed after its administration.
DRUG INTERACTION
Antidepressants, antiparkinsonics, antipsychotics (phenothiazine derivatives) - increase the risk of side effects (retention of urine, dry mouth, constipation) Fervex.
When used simultaneously with Ferveks, GCS increases the risk of developing glaucoma.
Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites of paracetamol, which allows the development of severe intoxication with a slight drug overdose.
Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxic effects of paracetamol.
Paracetamol reduces the effectiveness of uricosuric drugs.
Ethanol promotes the development of acute pancreatitis.
Ethanol enhances the sedative effect of antihistamines.
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.