Universal reference book for medicines
Product name: FEBRICET ® (FEBRICET)

Active substance: ascorbic acid, paracetamol, pheniramine

Type: The drug for symptomatic therapy of acute respiratory diseases

Manufacturer: HEMOFARM (Serbia)
Composition, form of production and packaging
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Powder for the preparation of a solution for ingestion from white to yellowish white, with the smell of honey and lemon; The prepared solution is slightly turbid, with the smell of honey and lemon.
1 pack.
(4 g)
paracetamol 500 mg

Pheniramine maleate 25 mg

ascorbic acid 200 mg

Excipients: citric acid anhydrous, isomalt, sodium saccharin, aroma lemon honey, silicon dioxide colloidal anhydrous.

4 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 analgetic-antipyretic, has an antipyretic and analgesic effect: it reduces the pain syndrome observed in colds - sore throat, headache, muscle and joint pain, reduces heat.

Pheniramine has an antiallergic effect: it eliminates the itching of the eyes, nose and throat, swelling and flushing of the mucous membranes of the nasal cavity, nasopharynx and paranasal sinuses, reduces rhinorrhea and lacrimation.

Ascorbic acid (vitamin C) replenishes the increased demand for vitamin C for colds and flu, especially in the initial stages of the disease.
Increases the body's resistance to infectious diseases.
PHARMACOKINETICS

Data on the pharmacokinetics of the drug Fabricet ® are not provided.

INDICATIONS

Symptomatic treatment of colds, flu, SARS:

febrile syndrome;

- pain syndrome;

- Rhinorrhea.

DOSING MODE

The drug is taken orally.
The contents of 1 sachet should be dissolved in a glass of warm water and drunk after the end of the foaming. Take the drug with a lot of liquid, 1-2 hours after eating.
Adults and children over 15 years of age are prescribed 1 packet of powder 2-3 times / day.
The maximum daily dose is 3 sachets.
The interval between doses is 4-6 hours.

In chronic renal failure (QC 10 ml / min), the interval between doses of the drug should be more than 8 hours.

The maximum duration of treatment for adolescents is 3 days.

The duration of treatment (without consulting a doctor) is no more than 5 days.

SIDE EFFECT

From the side of the central nervous system: headache, dizziness, sleep disturbances, increased excitability, decreased speed of psychomotor reaction.

On the part of the digestive system: nausea, vomiting, epigastric pain, dry mouth;
with prolonged use in high doses - hepatotoxic effect, erosive and ulcerative lesions of the gastrointestinal tract, bleeding from the gastrointestinal tract.
On the part of the hematopoiesis system: anemia, thrombocytopenia, agranulocytosis;
with prolonged use in high doses - hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia.
From the urinary system: urinary retention;
with prolonged use in high doses - nephrotoxicity (papillary necrosis).
Allergic reactions: incl.
skin rash, itching, urticaria, angioedema, anaphylactic shock, bronchial obstruction.
Other: paresis of accommodation.

CONTRAINDICATIONS

- portal hypertension;

- chronic alcoholism;

- Pregnancy;

- the period of lactation (breastfeeding);

- children's age till 15 years;

- taking other drugs containing the active ingredients of the Fabricet;

- Hypersensitivity to the components of the drug.

Caution should be used in patients with bronchial asthma, COPD, blood diseases, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), erosive-ulcerative gastrointestinal lesions, hyperoxaluria, hepatic and / or renal insufficiency, with closed-angle glaucoma, prostatic hyperplasia gland, deficiency of glucose-6-phosphate dehydrogenase.

PREGNANCY AND LACTATION

The drug is contraindicated for use in pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

Caution should be used in cases of kidney failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Caution should be used in patients with congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), erosive-ulcerative gastrointestinal lesions, hyperoxaluria, liver failure.

APPLICATION FOR CHILDREN

Contraindicated: children under 15 years .

SPECIAL INSTRUCTIONS

During the treatment period, do not use sleeping pills and anxiolytic (tranquilizers), the patient should refrain from drinking alcohol.

Do not prescribe Fabricet ® together with other medicines containing paracetamol.

If the symptoms do not go away within 3-5 days, the patient should consult a doctor.

Impact on the ability to drive vehicles and manage mechanisms

During the period of treatment, patients should be careful when performing work that requires concentration of attention and increased speed of psychomotor reactions.

OVERDOSE

Symptoms are caused, as a rule, by paracetamol and appear after taking it at a dose of more than 10-15 g. Pale skin, anorexia, nausea, vomiting are possible;hepatonecrosis;
an increase in the activity of hepatic transaminases, an increase in prothrombin time.
Treatment: gastric lavage followed by administration of activated charcoal;
symptomatic therapy, the introduction of methionine 8-9 hours after an overdose and N-acetylcysteine ​​- after 12 hours.
When symptoms of an overdose occur, the patient should immediately consult a doctor.

DRUG INTERACTION

Febrietet ® enhances the effects of sedatives, ethanol.

With simultaneous use with febrietetom antidepressants, antiparkinsonics, antipsychotics, phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation.

With simultaneous application with Febricet, GCS increases the risk of developing glaucoma.

Paracetamol reduces the effectiveness of uricosuric medicines.

Phenyramin simultaneously with MAO inhibitors, furazolidone can lead to hypertensive crisis, agitation, hyperpyrexia.

With simultaneous administration of the drug with barbiturates, diphenin, carbamazepine, rifampicin and other inducers of microsomal oxidation (phenytoin, ethanol, phenylbutazone, tricyclic antidepressants), production of hydroxylated active metabolites increases and the risk of hepatotoxic action of paracetamol increases with small overdoses.

Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic effects.

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 15 ° to 25 ° C.
Shelf life - 2 years.
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