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Fervex is an over-the-counter sachets medicine used to relieve symptoms of colds and flu. The preparation is in the form of granules which, when dissolved in water, form an oral solution intended for drinking. Fervex is a drug that uses several active substances – paracetamol, ascorbic acid and phenyramine maleate. When using Fervex, adhere to the recommendations contained in the leaflet and be careful when combining the preparation with other drugs.
Manufacturer
Compound
Each 4.95 g sachet contains:
- Active ingredients:
- Paracetamol 0.500 g
- Pheniramine maleate 0.025 g
- Ascorbic acid 0.200 g
- Excipients: mannitol 3.515 g; citric acid 0.050 g; povidone K30 0.010 g; magnesium citrate 0.400 g; aspartame 0.050 g, lemon-rum flavor* 0.200 g
*Composition of lemon-rum flavor: maltodextrin, acacia gum, α-pinene, β-pinene, limonene, γ-terpinene, linalool, neral, α-terpineol, geranial, dextrose, silicon dioxide E551, butylhydroxyanisole.
pharmachologic effect
ATC CODE: N02BE51 PHARMACOLOGICAL PROPERTIES
Fervex® is a combined preparation containing paracetamol, pheniramine and ascorbic acid. Paracetamol is a non-narcotic analgesic that blocks cyclooxygenase, mainly in the central nervous system, affecting the centers of pain and thermoregulation; has analgesic and antipyretic effect.
Pheniramine is a blocker of H1-histamine receptors, reduces rhinorrhea and lacrimation, eliminates spastic phenomena, swelling and hyperemia of the mucous membrane of the nasal cavity, nasopharynx and paranasal sinuses. Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, in the synthesis of steroid hormones; reduces vascular permeability, reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid. Improves the tolerability of paracetamol and prolongs its action (associated with prolongation of T1 / 2).
Pharmacokinetics
Paracetamol
After oral administration, it is rapidly absorbed from the gastrointestinal tract. The maximum concentration of the drug in the blood plasma is reached within 10-60 minutes after administration. It is rapidly distributed throughout the tissues of the body, penetrates the blood-brain barrier. Communication with plasma proteins is negligible and has no therapeutic value, but increases with increasing dose.
Metabolism occurs in the liver, 80% of the dose taken enters into conjugation reactions with glucuronic acid and sulfates with the formation of inactive metabolites; 17% undergoes hydroxylation with the formation of 8 active metabolites, which are conjugated with glutathione to form already inactive metabolites. One of the hydroxylated metabolic intermediates is hepatotoxic. This metabolite is neutralized by conjugation with glutathione, however, it can accumulate and in case of an overdose of paracetamol (150 mg paracetamol / kg or 10 g paracetamol orally) cause necrosis of hepatocytes. It is excreted by the kidneys in the form of metabolites, mainly in the form of conjugates. Less than 5% of the dose taken is excreted unchanged. The half-life is from 1 to 3 hours.
Pheniramine:
Well absorbed in the digestive tract. The elimination half-life from blood plasma is from one to one and a half hours. It is excreted from the body mainly through the kidneys.
Ascorbic acid:
Well absorbed in the digestive tract. The time to create the maximum therapeutic concentration (TCmax) after oral administration is 4 hours. It is metabolized mainly in the liver. It is excreted by the kidneys, through the intestines, with sweat, unchanged and in the form of metabolites.
Fervex – indications for use
Fervex is a combined preparation that, thanks to several active substances has an analgesic and antipyretic effect, provides vitamin C, and reduces swelling and congestion of the mucous membranesby relieving symptoms such as sneezing, stuffy nose and watery eyes. Due to the described effects of Fervex, the main indications for its use are the relief of symptoms of colds and flu, including fever, headache and inflammation in the throat and nose. Before using the drug, it is worth consulting with your family doctor. You can also order an appointment home.
Fervex – composition
The Fervex formulation is granules for oral solution. Each sachet contains the following active substances: paracetamol (500 mg), ascorbic acid (200 mg), pheniramine maleate (25 mg). Additionally, the composition of Fervex contains the following auxiliary substances:
- sodium saccharin;
- sucrose;
- acacia gum (in the lemon flavored variant) or acacia gum (in the raspberry flavored variant);
- citric acid anhydrous;
- lemon-rum flavor (Lemon Fervex) or raspberry flavor (Raspberry Fervex).
In the case of the drug Fervex with raspberry flavor the composition includes a raspberry flavor which contains: acetic acid, ethyl acetate, isoamyl acetate, triacetin, vanillin, benzyl alcohol, maltodextrin, p-hydroxybenzylacetone, modified corn starch E 1450, brilliant blue E 133, Allura Red E 129 dye, yellow orange, Permastabil 505528 RI, raspberry 054428 A, sodium chloride, sodium sulfate.
Fervex – contraindications
Before using Fervex, please read the contraindications to its use, such as:
- persons under the age of 15;
- people who are allergic to any of the ingredients of Fervex (active or excipient substances);
- patients with narrow-angle glaucoma;
- people suffering from conditions such as acute renal or hepatic failure;
- the occurrence of an enlarged prostate gland accompanied by difficulty urinating;
- patients with glucose-galactose malabsorption, fructose intolerance or sucrase-isomaltase deficiency.
Use during pregnancy and lactation
Adequate and well-controlled studies of Fervex® in pregnant women have not been conducted, so the use of the drug in this group of patients is not recommended.
It is not known whether the active substances of the drug pass into breast milk. The drug should not be used during lactation.
Fervex – precautions
Before taking Fervex, you should read the information about its safety precautions.
- Fervex can be used without consulting a doctor for no longer than 5 days.
- When taking Fervex, there is a risk of paracetamol overdose – the substance may also be present in other drugs used at the same time. The maximum daily dose of paracetamolacceptable for an adult weighing more than 50 kg is 4 g.
- Long-term use of Fervex or taking doses higher than recommended may lead to addiction – mainly psychological.
- Warning for people with diabetes – patients in this group should be especially careful as the Fervex sachet provides 11,5 g of sucrose.
- Caution should also be exercised by people with glucose-6-phosphate dehydrogenase deficiency – the risk is associated with the paracetamol contained in Fervex.
- The risk of liver damage increases for those who drink alcohol regularly or are starved.
- You should not take antihistamines at the same time, and do not consume alcoholic beverages or take sedatives.
- The use of the drug by pregnant and lactating women is not recommended, so you should consult a doctor first. Contracts gynecological visit via the portal halodoctor.pl.
Fervex – dosage and method of administration
Fervex can be used by adults and adolescents over 15 years of age. Dissolve the contents of one sachet of the preparation in a glass of water (hot or cold) and drink the prepared solution. If you get flu-like symptoms, it is best to take Fervex in the evening, mixing the powder with hot water. It is advisable to reach for the preparation as soon as possible after the symptoms appear – the recommended dosage should be adhered to.
The recommended dosage of Fervex is taking 2-3 sachets a day – 1 sachet usually every 4 hours. In case of kidney problems (when creatinine clearance is less than 10 ml / min), the intervals between taking consecutive Fervex sachets should be at least 8 hours. Due to the risk of overdose, if you miss a dose, do not supplement it by taking a double dose of the preparation.
Attention
Fervex should not be taken for more than 5 days without consulting a doctor first.
Interaction
Ethanol enhances the sedative effect of antihistamines (pheniramine), so it should be avoided during treatment with Fervex®. In addition, ethanol, when used simultaneously with pheniramine, contributes to the development of acute pancreatitis,
Pheniramine in the composition of Fervex® enhances the effect of sedatives: morphine derivatives, barbiturates, benzodiazepine and other tranquilizers, neuroleptics (meprobamate, phenothiazine derivatives), antidepressants (amitriptyline, mirtazapine, mianserin), centrally acting antihypertensive drugs, sedatives belonging to group H1 blockers, baclofen; this not only increases the sedative effect, but also increases the risk of side effects of the drug (urinary retention, dry mouth, constipation).
Consideration should be given to the possibility of enhancing central atropine-like effects when used in combination with other substances with anticholinergic properties (other antihistamines, antidepressants of the imipramine group, neuroleptics of the phenothiazine series, m-anticholinergic antiparkinsonian drugs, atropine-like antispasmodics, disopyramide).
When using the drug, together with inducers of microsomal oxidation: barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), flumecinol, phenylbutazone, rifampicin and ethanol, the risk of hepatotoxic action is significantly increased (due to paracetamol, which is part of it).
Glucocorticosteroids with simultaneous use increase the risk of developing glaucoma. Reception simultaneously with salicylates increases the risk of nephrotoxicity. With simultaneous use with levomycetin (chloramphenicol), the toxicity of the latter increases.
Paracetamol contained in the preparation enhances the effect of indirect anticoagulants and reduces the effectiveness of uricosuric drugs.
Ascorbic acid increases the concentration of benzylpenicillin and tetracyclines in the blood; at a dose of 1 g / day, it increases the bioavailability of ethinylestradiol (including that which is part of oral contraceptives). Improves absorption in the intestines of iron preparations (converts ferric iron to ferrous); May increase iron excretion when used concomitantly with deferoxamine. Reduces the effectiveness of heparin and indirect anticoagulants. With simultaneous use with acetylsalicylic acid (ASA), the excretion of ascorbic acid in the urine increases and the excretion of ASA decreases. ASA reduces the absorption of ascorbic acid by about 30%. Increases the risk of developing crystalluria in the treatment of short-acting salicylates and sulfonamides, slows down the excretion of acids by the kidneys, increases the excretion of drugs that have an alkaline reaction (incl. alkaloids), reduces the concentration in the blood of oral contraceptives. Increases the overall clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body. Medicines of the quinoline series, calcium chloride, salicylates, glucocorticosteroid drugs with prolonged use deplete the reserves of ascorbic acid. With the simultaneous use of ascorbic acid reduces the chronotropic effect of isoprenaline. With prolonged use or use in high doses, it may interfere with the interaction of disulfiram and ethanol. In high doses, it increases the excretion of mexiletin by the kidneys. Barbiturates and primidone increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of neuroleptics – phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants. reduces the concentration in the blood of oral contraceptives. Increases the overall clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body. Medicines of the quinoline series, calcium chloride, salicylates, glucocorticosteroid drugs with prolonged use deplete the reserves of ascorbic acid. With the simultaneous use of ascorbic acid reduces the chronotropic effect of isoprenaline. With prolonged use or use in high doses, it may interfere with the interaction of disulfiram and ethanol. In high doses, it increases the excretion of mexiletin by the kidneys. Barbiturates and primidone increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of neuroleptics – phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants. reduces the concentration in the blood of oral contraceptives. Increases the overall clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body. Medicines of the quinoline series, calcium chloride, salicylates, glucocorticosteroid drugs with prolonged use deplete the reserves of ascorbic acid. With the simultaneous use of ascorbic acid reduces the chronotropic effect of isoprenaline. With prolonged use or use in high doses, it may interfere with the interaction of disulfiram and ethanol. In high doses, it increases the excretion of mexiletin by the kidneys. Barbiturates and primidone increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of neuroleptics – phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants. which in turn reduces the concentration of ascorbic acid in the body. Medicines of the quinoline series, calcium chloride, salicylates, glucocorticosteroid drugs with prolonged use deplete the reserves of ascorbic acid. With the simultaneous use of ascorbic acid reduces the chronotropic effect of isoprenaline. With prolonged use or use in high doses, it may interfere with the interaction of disulfiram and ethanol. In high doses, it increases the excretion of mexiletin by the kidneys. Barbiturates and primidone increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of neuroleptics – phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants. which in turn reduces the concentration of ascorbic acid in the body. Medicines of the quinoline series, calcium chloride, salicylates, glucocorticosteroid drugs with prolonged use deplete the reserves of ascorbic acid. With the simultaneous use of ascorbic acid reduces the chronotropic effect of isoprenaline. With prolonged use or use in high doses, it may interfere with the interaction of disulfiram and ethanol. In high doses, it increases the excretion of mexiletin by the kidneys. Barbiturates and primidone increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of neuroleptics – phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants. calcium chloride, salicylates, glucocorticosteroids with prolonged use deplete the reserves of ascorbic acid. With the simultaneous use of ascorbic acid reduces the chronotropic effect of isoprenaline. With prolonged use or use in high doses, it may interfere with the interaction of disulfiram and ethanol. In high doses, it increases the excretion of mexiletin by the kidneys. Barbiturates and primidone increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of neuroleptics – phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants. calcium chloride, salicylates, glucocorticosteroids with prolonged use deplete the reserves of ascorbic acid. With the simultaneous use of ascorbic acid reduces the chronotropic effect of isoprenaline. With prolonged use or use in high doses, it may interfere with the interaction of disulfiram and ethanol. In high doses, it increases the excretion of mexiletin by the kidneys. Barbiturates and primidone increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of neuroleptics – phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants. With prolonged use or use in high doses, it may interfere with the interaction of disulfiram and ethanol. In high doses, it increases the excretion of mexiletin by the kidneys. Barbiturates and primidone increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of neuroleptics – phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants. With prolonged use or use in high doses, it may interfere with the interaction of disulfiram and ethanol. In high doses, it increases the excretion of mexiletin by the kidneys. Barbiturates and primidone increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of neuroleptics – phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants.
How to take, course of administration and dosage
Fervex is taken orally, completely dissolved in a glass (200 ml) of warm water (50-60 ° C), the resulting solution should be drunk immediately. It is better to take the drug between meals.
1 sachet 2-3 times a day. The interval between doses of the drug should be at least 4 hours. In patients with impaired liver or kidney function and in elderly patients, the interval between doses of the drug should be at least 8 hours.
The duration of admission without consulting a doctor is not more than 5 days when prescribed as an anesthetic and not more than 3 days as an antipyretic.
Fervex – overdose
Take Fervex as prescribed, as failure to follow the instructions in this leaflet may result in an overdose of the medicine. If you take too much of the drug (more than recommended), consult your doctor or pharmacist as soon as possible. The possible effects of an overdose may be related to too high a dose of pheniramine (disturbances of consciousness, coma, convulsions – the latter especially in children) or intoxication with paracetamol.
Symptoms of paracetamol poisoning are dangerous, and the particular risk associated with them concerns young children and the elderly. As a result of paracetamol overdose, nausea and vomiting, weakness, drowsiness, increased sweating may occur, and on the following day jaundice and a feeling of distension in the epigastrium. Poisoning with this active substance is even associated with the risk of death.
Fervex – interactions
People using Fervex should pay attention to possible drug interactions with other substances. The preparation should not be combined with alcohol (alcoholic beverages and drugs containing alcohol) due to the pheniramine present in Fervex. Caution should also be exercised with the use of sedative drugs (e.g. barbiturates, morphine, hypnotics, antidepressants, antihistamines and others) or atropine drugs.
In addition, interactions of Fervex with other substances are possible due to the paracetamol content. Applies to:
- caffeine – it increases the antipyretic and analgesic effect of the drug;
- salicylamide – this causes paracetamol to be removed from the body for longer;
- rifampicin, barbiturates, antiepileptic drugs and other drugs that induce microsomal enzymes – there is a higher risk of liver damage;
- coumarin derivative anticoagulants – their effect is enhanced by paracetamol;
- MAO inhibitors – there is a risk of high fever and agitation with the simultaneous use of paracetamol;
- the use of high doses of paracetamol and non-steroidal anti-inflammatory drugs – a negative effect on kidney function.
Important
Fervex may affect the results of laboratory tests, including blood uric acid levels and glucose levels measured by the oxidase-peroxidase method.
Due to the content of ascorbic acid in Fervex, it is possible to reduce the urine pH and plasma fluphenazine concentration while taking it, as well as reduce the effectiveness of warfarin.
Fervex – side effects
Like other medicines, Fervex can cause side effects in some people, including:
neurovegetative effects such as drowsiness, confusion, constipation, dry mucous membranes, difficulty concentrating, dizziness, palpitations, dilated pupils;
- hypersensitivity reactions including hives, itching and erythema;
- anaphylactic shock;
- Quincke’s edema;
- extremely rarely thrombocytopenia, neutropenia, leukocytopenia.
The occurrence of symptoms suggesting hypersensitivity (allergy) to the drug requires discontinuation of the drug.
For a complete list of possible side effects, see the package leaflet. It is worth remembering that there may also be other side effects that are not mentioned in the leaflet – you should report them to your doctor.
Fervex – variants of the drug
Fervex is available in several variants. Classic Fervex in sachets is a lemon-flavored preparation, but there is also another flavor option, i.e. Fervex with raspberry flavor. Also available in sachets:
- Fevex D – has the same concentration of active substances as the basic variant (500 mg of paracetamol, 200 mg of ascorbic acid, 25 mg of pheniramine maleate), but does not contain sugar and can be used by people with diabetes; suitable for adolescents over 15 years of age;
- Fervex Junior – the preparation is suitable for children from 6 years of age, does not contain sugar, one sachet is 280 mg of paracetamol, 100 mg of ascorbic acid and 10 mg of pheniramine.
In addition to Fervex, granules are also available for oral solution Fervex ExtraTabs – coated tablets for cold symptoms in children over 15 years of age and adults. The drug in one tablet provides 500 mg of paracetamol and 4 mg of chlorpheniramine maleate.
Special Instructions
The drug does not contain sugar and can be used by patients with diabetes
diabetes.
Fervex® should not be used simultaneously with other medicines containing paracetamol. To avoid toxic liver damage, paracetamol should not be combined with the intake of alcoholic beverages, and should not be taken by persons prone to chronic alcohol consumption.
The risk of developing liver damage increases in patients with alcoholic hepatosis. It should not be used simultaneously with drugs that have hypnotic and anxiolytic effects, and in case of impaired renal function without consulting a doctor. With prolonged use, it is necessary to control the picture of peripheral blood, glucose levels in the blood and urine, bilirubin, plasma uric acid, activity of “liver” transaminases and lactate dehydrogenase).
If the recommended doses are exceeded and with prolonged use, mental dependence on the drug may appear.
To avoid an overdose of paracetamol, make sure that the total daily dose of paracetamol contained in all drugs taken by the patient does not exceed 4 g.
The composition of the drug includes mannitol and aspartame (a source of phenylalanine); The fragrance contains dextrose.
EFFECT ON THE ABILITY TO DRIVE AND MECHANISMS
Given the possibility of developing such undesirable effects as drowsiness and dizziness, it is recommended to refrain from driving and operating mechanisms during the period of drug treatment.
Release form
Storage conditions
Keep out of the reach of children.