Attributes
- Form
- Dosage mg
- Pack
- Description en
- ZEFEXAL™ film-coated tablets Zefeksal™ International Nonproprietary Name: Fexofenadine hydrochloride Composition: One film-coated tablet contains: Active substance: 180 mg Fexofenadine hydrochloride Excipients: Microcrystalline cellulose, Avicel PH 101 (PH 102), Starch 1500, Croscarmellose sodium, Magnesium stearate, Opadry II 85F200041 Violet (Polyvinyl alcohol), Titanium dioxide, Polyethylene glycol/Macrogol, Talc, FD&C Blue #2/Indigo Carmine Aluminum Lake, Carmine 4R Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake Description: Light violet, oblong, film-coated tablets, with "180" engraved on one side Pharmacotherapeutic group: H1 histamine receptor blocker ATC code: RO6AX26 See blog: Zefeksal - an anti-allergy preparation for adults and children Pharmacological properties Pharmacodynamics: Zefeksal is a non-sedating antihistamine. It acts by selectively blocking peripheral H1 histamine receptors. It does not cross the blood-brain barrier and therefore has no significant sedative activity and does not cause side effects on the central nervous system. Tolerance to the preparation has not been observed after one month of treatment. Pharmacokinetics: After administration, the preparation is rapidly absorbed from the gastrointestinal tract, with Tmax being approximately 1-3 hours. After a single daily dose of 60, 120, or 180 mg, Cmax is 142 ng/mL, 289 ng/mL, and 494 ng/mL, respectively. Distribution: Plasma protein binding is 60-70%. Biotransformation: Fexofenadine is metabolized to a minor extent in the liver. Excretion: After a single dose of 60 mg, 80% is excreted with bile, and 10% with urine. The terminal elimination half-life of fexofenadine is T½ 11-16 hours. The preparation is likely mainly excreted with bile, while 10% is excreted unchanged in the urine. Indications for use Symptomatic treatment of chronic idiopathic urticaria in adults and children aged 12 years and above. Contraindications Hypersensitivity to the components of the preparation. Special instructions Elderly patients and patients with renal and hepatic insufficiency do not require any special instructions regarding the use of the preparation. Patients with cardiovascular diseases (including in their history) should be informed that taking antihistamines may cause palpitations and tachycardia. Each 180 mg Zefeksal tablet contains less than 0.0005 mmol (less than 0.0115 mg) of sodium; at this amount, no sodium-related reactions are expected. Interactions with other drugs: Fexofenadine is not biotransformed in the liver, therefore it does not interact with drugs that are metabolized in the liver. Co-administration of fexofenadine hydrochloride with erythromycin or ketoconazole increases fexofenadine concentration in blood plasma by 2-3 times. These changes do not cause changes in the QT interval. No difference in the occurrence of adverse reactions has been observed when taking these drugs as monotherapy and with fexofenadine. The above-mentioned increase in fexofenadine plasma concentrations may be related to the absorption of fexofenadine and the reduction of its biliary excretion and gastrointestinal secretion. No interaction between fexofenadine and omeprazole has been observed. Taking antacids containing aluminum or magnesium 15 minutes before taking fexofenadine reduces its bioavailability. The interval between taking fexofenadine and antacids should be at least 2 hours. Use during pregnancy and lactation: There is no information on the use of fexofenadine hydrochloride in pregnant women. As with other medicinal products, its administration during pregnancy is possible when the benefit to the mother outweighs the potential risk to the fetus. There are no reports of the preparation being excreted in breast milk. However, it has been established that when terfenadine was taken, fexofenadine was found in breast milk. Therefore, taking the preparation during breastfeeding is not recommended. Effect on the ability to drive and operate other potentially dangerous machinery: Based on the pharmacodynamic profile and data on side effects, it can be assumed that the preparation's tablets are unlikely to affect the ability to drive and operate other potentially dangerous machinery. Since fexofenadine does not significantly affect CNS function, it is possible to drive and perform tasks requiring high concentration while taking the preparation. Patients with unusual reactions to medications are recommended to test their individual reaction to the preparation before driving and performing tasks that require high concentration. Dosage and administration: The recommended dose of the preparation for adults and children aged 12 years and above is 180 mg once daily. Additional data related to special patient groups Patients with renal/hepatic insufficiency: Studies in special risk groups have shown that patients with renal and hepatic insufficiency do not require dose adjustment. Use in children: The safety and efficacy of using 180 mg of the preparation in children under 12 years of age have not been studied. Use in elderly patients: Studies in special risk groups have shown that elderly patients do not require dose adjustment. Side effects: Placebo-controlled clinical trials have shown that side effects are similar during placebo and fexofenadine administration. Frequency of adverse reactions: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10000 to <1/1000); Very rare (<1/10000); Unknown frequency (cannot be estimated based on available data). Immune system disorders: Rare: Hypersensitivity reactions, such as erythema, urticaria, itching, angioneurotic edema, difficulty breathing, skin hyperemia, systemic anaphylactic reactions. Nervous system disorders: Very common: Headache (3%), Somnolence (1-3%), Dizziness (1-3%). Common: Insomnia, nervousness, sleep disturbances or nightmares. Cardiovascular system disorders: Rare: Tachycardia, palpitations. Gastrointestinal system disorders: Very common: Nausea (1-3%). Rare: Diarrhea. Reporting of suspected adverse reactions: Reporting of suspected adverse effects after the medicinal product is registered is of great importance. This allows for continuous monitoring of the benefit/risk ratio of the medicinal product's use. In case of adverse effects, consult a doctor. Overdose: Information on overdose of the preparation is limited. There are reports of somnolence, malaise, and dry mouth. The maximum tolerable dose of fexofenadine hydrochloride has not been established. Standard measures to remove unabsorbed preparation from the body should be carried out. Symptomatic and supportive therapy is recommended. Hemodialysis is not effective in removing fexofenadine hydrochloride from the blood. Dosage form: Zefeksal 180 mg film-coated tablets, 10 film-coated tablets in a blister. 2 blisters (20 film-coated tablets) in a cardboard box, packed with instructions for use. Storage conditions: Store at room temperature, not exceeding 25°C, in the original packaging and out of reach of children. Shelf life: 2 years. Do not use after the expiry date. Dispensing regime: Pharmaceutical product group III, available without a prescription.
- Active
- fexofenadine
What is it?
ZEFEXAL™ film-coated tablets Zefeksal™ International Nonproprietary Name: Fexofenadine hydrochloride Composition: One film-coated tablet contains: Active substance: 180 mg Fexofenadine hydrochloride Excipients: Microcrystalline cellulose, Avicel PH 101 (PH 102), Starch 1500, Croscarmellose sodium, Magnesium stearate, Opadry II 85F200041 Violet (Polyvinyl alcohol), Titanium dioxide, Polyethylene glycol/Macrogol, Talc, FD&C Blue #2/Indigo Carmine Aluminum Lake, Carmine 4R Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake Description: Light violet, oblong, film-coated tablets, with "180" engraved on one side Pharmacotherapeutic group: H1 histamine receptor blocker ATC code: RO6AX26 See blog: Zefeksal - an anti-allergy preparation for adults and children Pharmacological properties Pharmacodynamics: Zefeksal is a non-sedating antihistamine. It acts by selectively blocking peripheral H1 histamine receptors. It does not cross the blood-brain barrier and therefore has no significant sedative activity and does not cause side effects on the central nervous system. Tolerance to the preparation has not been observed after one month of treatment. Pharmacokinetics: After administration, the preparation is rapidly absorbed from the gastrointestinal tract, with Tmax being approximately 1-3 hours. After a single daily dose of 60, 120, or 180 mg, Cmax is 142 ng/mL, 289 ng/mL, and 494 ng/mL, respectively. Distribution: Plasma protein binding is 60-70%. Biotransformation: Fexofenadine is metabolized to a minor extent in the liver. Excretion: After a single dose of 60 mg, 80% is excreted with bile, and 10% with urine. The terminal elimination half-life of fexofenadine is T½ 11-16 hours. The preparation is likely mainly excreted with bile, while 10% is excreted unchanged in the urine. Indications for use Symptomatic treatment of chronic idiopathic urticaria in adults and children aged 12 years and above. Contraindications Hypersensitivity to the components of the preparation. Special instructions Elderly patients and patients with renal and hepatic insufficiency do not require any special instructions regarding the use of the preparation. Patients with cardiovascular diseases (including in their history) should be informed that taking antihistamines may cause palpitations and tachycardia. Each 180 mg Zefeksal tablet contains less than 0.0005 mmol (less than 0.0115 mg) of sodium; at this amount, no sodium-related reactions are expected. Interactions with other drugs: Fexofenadine is not biotransformed in the liver, therefore it does not interact with drugs that are metabolized in the liver. Co-administration of fexofenadine hydrochloride with erythromycin or ketoconazole increases fexofenadine concentration in blood plasma by 2-3 times. These changes do not cause changes in the QT interval. No difference in the occurrence of adverse reactions has been observed when taking these drugs as monotherapy and with fexofenadine. The above-mentioned increase in fexofenadine plasma concentrations may be related to the absorption of fexofenadine and the reduction of its biliary excretion and gastrointestinal secretion. No interaction between fexofenadine and omeprazole has been observed. Taking antacids containing aluminum or magnesium 15 minutes before taking fexofenadine reduces its bioavailability. The interval between taking fexofenadine and antacids should be at least 2 hours. Use during pregnancy and lactation: There is no information on the use of fexofenadine hydrochloride in pregnant women. As with other medicinal products, its administration during pregnancy is possible when the benefit to the mother outweighs the potential risk to the fetus. There are no reports of the preparation being excreted in breast milk. However, it has been established that when terfenadine was taken, fexofenadine was found in breast milk. Therefore, taking the preparation during breastfeeding is not recommended. Effect on the ability to drive and operate other potentially dangerous machinery: Based on the pharmacodynamic profile and data on side effects, it can be assumed that the preparation's tablets are unlikely to affect the ability to drive and operate other potentially dangerous machinery. Since fexofenadine does not significantly affect CNS function, it is possible to drive and perform tasks requiring high concentration while taking the preparation. Patients with unusual reactions to medications are recommended to test their individual reaction to the preparation before driving and performing tasks that require high concentration. Dosage and administration: The recommended dose of the preparation for adults and children aged 12 years and above is 180 mg once daily. Additional data related to special patient groups Patients with renal/hepatic insufficiency: Studies in special risk groups have shown that patients with renal and hepatic insufficiency do not require dose adjustment. Use in children: The safety and efficacy of using 180 mg of the preparation in children under 12 years of age have not been studied. Use in elderly patients: Studies in special risk groups have shown that elderly patients do not require dose adjustment. Side effects: Placebo-controlled clinical trials have shown that side effects are similar during placebo and fexofenadine administration. Frequency of adverse reactions: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10000 to <1/1000); Very rare (<1/10000); Unknown frequency (cannot be estimated based on available data). Immune system disorders: Rare: Hypersensitivity reactions, such as erythema, urticaria, itching, angioneurotic edema, difficulty breathing, skin hyperemia, systemic anaphylactic reactions. Nervous system disorders: Very common: Headache (3%), Somnolence (1-3%), Dizziness (1-3%). Common: Insomnia, nervousness, sleep disturbances or nightmares. Cardiovascular system disorders: Rare: Tachycardia, palpitations. Gastrointestinal system disorders: Very common: Nausea (1-3%). Rare: Diarrhea. Reporting of suspected adverse reactions: Reporting of suspected adverse effects after the medicinal product is registered is of great importance. This allows for continuous monitoring of the benefit/risk ratio of the medicinal product's use. In case of adverse effects, consult a doctor. Overdose: Information on overdose of the preparation is limited. There are reports of somnolence, malaise, and dry mouth. The maximum tolerable dose of fexofenadine hydrochloride has not been established. Standard measures to remove unabsorbed preparation from the body should be carried out. Symptomatic and supportive therapy is recommended. Hemodialysis is not effective in removing fexofenadine hydrochloride from the blood. Dosage form: Zefeksal 180 mg film-coated tablets, 10 film-coated tablets in a blister. 2 blisters (20 film-coated tablets) in a cardboard box, packed with instructions for use. Storage conditions: Store at room temperature, not exceeding 25°C, in the original packaging and out of reach of children. Shelf life: 2 years. Do not use after the expiry date. Dispensing regime: Pharmaceutical product group III, available without a prescription.