Flucoldex-N instructions for use of the drug

Release form, packaging and composition of the drug Clinical-pharmacological group Pharmaco-therapeutic group Pharmacological action Indications for use Method of administration and doses Side effects Contraindications for use Use in children Special instructions Drug interactions

Registration Certificate Holder:

NABROS PHARMA, Pvt. Ltd. (India)

ATX Code:

N02BE51

Active substance:

caffeine

Dosage form:

Flucoldex-N

The drug is approved for use as an over-the-counter productFlucoldex-NTablets
reg.
No.: P N013278/01 dated 12/29/11 - Valid

Pharmacodynamics and pharmacokinetics

The therapeutic effect is achieved through the interaction of Flukold's components.

Paracetamol inhibits cyclooxygenase, which leads to decreased production of prostaglanins , arachidonic acid, thromboxane and prostacyclins . It is a non-narcotic analgesic . It has a slight anti-inflammatory effect, but a pronounced antipyretic and analgesic effect. Reduces the level of prostaglandins in the central nervous system, in the thermoregulation center of the hypothalamus.

Phenylpropanolamine and chlorpheniramine eliminate swelling of the nasal mucosa, fight rhinorrhea and facilitate breathing through the nose.

Chlorpheniramine blocks H1-histamine receptors and has an anticholinergic and sedative effect.

Caffeine is an antipsychotic ; it enhances the therapeutic effect of NSAIDs, improves memory, attention, improves performance, and stimulates the activity of the central nervous system.

Flukold is absorbed into the gastrointestinal tract, metabolites are excreted in the urine. The components of the drug pass through the hematoplacental and blood-brain barriers and enter breast milk.

Drug interactions

NSAIDs and CNS depressants

- possible increased side effects of the drug. The risk of hepatotoxicity increases with the simultaneous administration of
barbiturates, phenytoin, carbamazepine, rifampicin, zidovudine and other inducers of microsomal liver enzymes, ethanol
. Reduces excretion and increases the toxicity
of chloramphenicol. Metoclopramide and domperidone
increase the rate of absorption of paracetamol, cholestyramine slows it down. Simultaneous administration
with indirect anticoagulants
should be carried out under constant medical supervision.

Side effects

Flukold is well tolerated. Side effects are rare.

Gastrointestinal tract: dyspeptic disorders, epigastric pain, dry mouth , stool disorders.

Cardiovascular system: Increased blood pressure, thrombocytopenia, leukopenia, cardiac arrhythmia, neutropenia, methemoglobinemia .

Central nervous system: limb tremor , migraine , increased excitability, sleep disturbance, emotional lability, dizziness.

Allergy.

Pharmacological properties of the drug Flucoldex

Flucoldex is a combination drug. The analgesic effect of paracetamol includes effects on the central and peripheral nervous system. The antipyretic effect is mediated by the effect on the regulatory centers of the hypothalamus. Caffeine has a stimulating effect on the central nervous system, mainly on the cerebral cortex, respiratory and vasomotor centers, increases mental and physical performance, reduces drowsiness, a feeling of fatigue and weakens the effect of central nervous system depressants. Caffeine has a pronounced effect on the cardiovascular system: it increases strength and increases heart rate, blood pressure during hypotension, and has a moderate diuretic effect. Increases the secretion of gastric glands. Phenylpropanolamine hydrochloride, an α-adrenergic active compound without irritating effects on the central nervous system, has a predominantly direct effect on adrenergic receptors. Often included in combination medications to reduce the severity of cold symptoms. Chlorpheniramine maleate is an antiallergic agent, a blocker of histamine H1 receptors. Shows a moderate sedative effect and has antimuscarinic activity. Flucoldex is a multicomponent drug. The effect of the drug is the cumulative effect of its components, so pharmacokinetic observations are impossible; the dynamics of all components cannot be studied using markers or biological methods.

Instructions for use of Flukold (Method and dosage)

Flukold N tablets, instructions for use

Do not chew the Flucold tablet, swallow it whole, and wash it down with water.

The drug is taken three times a day, 1 tablet.

At least 4 hours should pass between doses.

No more than 4 tablets per day, no longer than a week.

Flukold sachets, instructions for use

The contents of the sachet are dissolved in water.

Take three times a day, but not more than once every four hours.

No more than 4 sachets per day.

The course of treatment should be no more than 3 days.

Flucoldex 100ml syrup for children nabros pharma

pharmachologic effect

Combined drug.
Paracetamol blocks COX only in the central nervous system, affecting the centers of pain and thermoregulation. The lack of influence of paracetamol on the synthesis of prostaglandins in peripheral tissues determines the absence of a negative effect on water-salt metabolism (retention of sodium and water ions) and the gastrointestinal mucosa.

Chlorphenamine; - blocker of histamine H1 receptors. Prevents the development and facilitates the course of allergic reactions. It has antiallergic, antipruritic, antiexudative effects. Reduces capillary permeability, prevents the development of tissue edema, relieves spasm of smooth muscles. Has a suppressive effect on the central nervous system.

Composition and release form Flucoldex 100ml syrup for children nabros pharma

Syrup - 5 ml: paracetamol 125 mg, chlorphenamine maleate 2 mg.

100 ml - polymer bottles (1) complete with a measuring cup - cardboard packs.

Directions for use and doses

Inside.

Indications for use Flucoldex 100ml syrup for children nabros pharma

Feverish syndrome (colds and infectious diseases); pain syndrome (mild and moderate severity): arthralgia, myalgia, neuralgia, migraine, toothache and headache, algodismenorrhea; pain from injuries, burns; sinusitis; rhinorrhea (acute rhinitis, allergic rhinitis).

Contraindications

Hypersensitivity; deficiency of glucose-6-phosphate dehydrogenase; liver and/or kidney failure. With caution Congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), alcoholism, angle-closure glaucoma, prostatic hyperplasia, pregnancy, lactation; old age, children's age (up to 12 years).

Use of Flucoldex 100ml syrup for children nabros pharma during pregnancy and breastfeeding

With caution: during pregnancy and lactation (breastfeeding).

Use in children

With caution: children (up to 12 years).

special instructions

For hyperthermia lasting more than 3 days and pain lasting more than 5 days, consult a doctor.

Paracetamol distorts laboratory results when quantifying the content of sugar and uric acid in plasma.

During the treatment period, it is necessary to refrain from drinking ethanol (hepatotoxic effects may develop).

Impact on the ability to drive vehicles and machinery

During the treatment period, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Side effects of Flucoldex 100ml syrup for children nabros pharma

Systemic reactions: ;allergic reactions (skin rash, itching, urticaria, angioedema),

From the digestive system: nausea, epigastric pain, dry mucous membranes of the mouth, nose, throat.

From the organ of vision: mydriasis, accommodation paresis, increased intraocular pressure.

From laboratory parameters: hemolytic anemia, aplastic anemia, methemoglobinemia, thrombocytopenia, agranulocytosis, pancytopenia.

From the urinary system: nephrotoxicity (renal colic, glycosuria, interstitial nephritis, papillary necrosis), urinary retention.

Drug interactions

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxications even with a slight overdose.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Ethanol contributes to the development of acute pancreatitis.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity.

Paracetamol reduces the effectiveness of uricosuric drugs and increases the effect of indirect anticoagulants.

Long-term combined use of paracetamol and other NSAIDs increases the risk of developing “analgesic” nephropathy and renal papillary necrosis, and the onset of end-stage renal failure.

Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer.

Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Interaction

Ascorbic acid, codeine , propyphenazone , scopolamine enhance the therapeutic effect of the drug Flukold.

Ethanol, sedatives, tricyclic antidepressants, barbiturates increase the half-life of the drug.

It is not recommended to combine with drugs that contain paracetamol.

special instructions

Excessive consumption of tea, coffee and other products containing methylxanthines should be avoided. To avoid the hepatotoxic effect of paracetamol, ethanol should not be consumed during treatment .

With long-term (more than 1 week) use of the drug, monitoring of the peripheral blood picture and the functional state of the liver is necessary.
Effect on the ability to drive vehicles and machinery
During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Flukold's analogs

Level 4 ATC code matches: Phenacetin
Combiflu

Chlorphenamine

Coldflu

Calpol

Fervex

Panadol Extra

Panadol for children

Panadol

Solpadeine

Efferalgan

Milistan

Coldrex Maxgripp

Coldrex Hotrem

Coldrex

AntiGrippin

Unispaz

Pentalgin Plus

Rapidol

Maxicold

Analogs include: Coldrex , Adjicold , Lorcold , Neogrip , Radicold .

Flukold price, where to buy

200 tablets of Flukold N cost about 450 hryvnia in Ukraine.

  • Online pharmacies in RussiaRussia
  • Online pharmacies in UkraineUkraine

ZdravCity

  • Flucoldex forte tab.
    12 pcs Nabros Pharma Pvt Ltd RUR 139 order

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Pharmacy24

  • Flukold-N No. 200 tablets Nabros Pharma Pvt. Ltd., India
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