Instructions for Nixar tablets 10 mg No. 30
Composition
active ingredient: bilastine;
1 orodispersible tablet contains bilastine 10 mg;
excipients: mannitol, croscarmellose sodium, sodium stearyl fumarate, sucralose (E 955), red grape flavoring (main components: gum arabic, ethyl butyrate, triacetin, methyl anthranilate, ethanol, D-limonene, linalool).
Dosage form
Orodispersible tablets.
Main physicochemical properties: round, slightly biconvex white tablets with a diameter of 8 mm.
Pharmacotherapeutic group
Antihistamines for systemic use. Other antihistamines for systemic use. ATX code R06A X29.
Pharmacological properties
Pharmacodynamics.
Mechanism of action: Bilastine is a long-acting, non-sedating histamine antagonist, a highly selective blocker of peripheral H1 receptors that does not bind to muscarinic receptors.
After a single application, bilastine inhibits the development of skin reactions with blisters and redness caused by histamine for 24 hours.
Clinical efficacy. The efficacy of bilastine has been studied in adults and adolescents. According to the recommendations, the proven efficacy in adults and adolescents can be considered acceptable for children, taking into account that the systemic exposure of 10 mg bilastine in children aged 6 to 11 years with a body weight of at least 20 kg corresponds to the exposure in adults when taking 20 mg bilastine (see section "Pharmacokinetics"). Extrapolation of data obtained in adults and adolescents is considered justified for this medicinal product, since the pathophysiology of allergic rhinoconjunctivitis and urticaria is the same in all age groups.
In clinical studies conducted in adults and adolescents with allergic rhinoconjunctivitis (seasonal and perennial), bilastine 20 mg once daily for 14-28 days was effective in relieving symptoms such as sneezing, nasal discharge, nasal itching, nasal congestion, itchy eyes, tearing and redness. Symptoms were effectively controlled by bilastine for 24 hours.
In two clinical studies in patients with chronic idiopathic urticaria, bilastine 20 mg once daily for 28 days was effective in reducing the intensity of itching and the number and size of wheals, as well as the discomfort caused by urticaria. Patients also experienced improvements in sleep and quality of life.
In clinical studies with bilastine, no clinically significant prolongation of the QTc interval or any other cardiovascular effects were observed, even when administered at a dose of 200 mg per day (10 times the clinical dose) for 7 days in 9 subjects or when co-administered with P-gp inhibitors such as ketoconazole (24 subjects) and erythromycin (24 subjects). In addition, a thorough QT study was conducted in 30 volunteers.
In controlled clinical trials at the recommended dose of 20 mg once daily, the CNS safety profile of bilastine and placebo was similar, and the incidence of somnolence with bilastine was not statistically different from that with placebo. Bilastine at doses up to 40 mg daily had no effect on psychomotor performance in clinical trials and did not affect the ability to drive in a standard driving test.
In elderly patients (≥ 65 years) who participated in phase II and III studies, the efficacy and safety of the drug did not differ from those in younger patients.
Clinical safety: In a 12-week controlled clinical study in children aged 2 to 11 years (a total of 509 children, of whom 260 received 10 mg bilastine: 58 aged 2 to < 6 years, 105 aged 6 to < 9 years and 97 aged 9 to < 12 years, and 249 children received placebo: 58 aged 2 to < 6 years, 95 aged 6 to < 9 years and 96 aged 9 to < 12 years) at the recommended paediatric dose of 10 mg once daily, the safety profile of bilastine (n = 260) was similar to that of placebo (n = 249), with adverse reactions occurring in 5.8% and 8.0% of patients receiving 10 mg bilastine and placebo, respectively. Both 10 mg bilastine and placebo resulted in a small reduction in sleepiness and sedation as assessed by the Pediatric Sleep Quality Questionnaire, with no statistically significant difference between treatment groups. In children aged 2 to 11 years, no significant difference in QTc was observed after 10 mg bilastine per day compared to those receiving placebo. A special questionnaire on the quality of life of children with allergic rhinoconjunctivitis or chronic urticaria showed an overall improvement in scores over 12 weeks, with no statistically significant difference between the bilastine and placebo groups. A total of 509 children participated in the study, including 479 participants with allergic rhinoconjunctivitis and 30 participants with diagnosed chronic urticaria. 260 children received bilastine, 252 (96.9%) for the treatment of allergic rhinoconjunctivitis and 8 (3.1%) for the treatment of chronic urticaria. Similarly, 249 children received placebo: 227 (91.2%) for the treatment of allergic rhinoconjunctivitis and 22 (8.8%) for the treatment of chronic urticaria.
The European Medicines Agency has waived the obligation to submit the results of studies with bilastine in all paediatric subjects below 2 years of age (see section 4.2 for information on paediatric use).
Pharmacokinetics.
Absorption: After oral administration, bilastine is rapidly absorbed, with peak plasma concentrations occurring approximately 1.3 hours after administration. No accumulation was observed. The mean oral bioavailability of bilastine is 61%.
Distribution: In vitro and in vivo studies have shown that bilastine is a substrate of P-gp (see section "Interaction with other medicinal products and other forms of interaction": "Interaction with ketoconazole or erythromycin" and "Interaction with diltiazem") and OATP (see section "Interaction with other medicinal products and other forms of interaction": "Interaction with grapefruit juice"). When used in therapeutic doses, 84-90% of bilastine is bound to plasma proteins.
Biotransformation: In in vitro studies, bilastine did not show the ability to induce or inhibit the activity of CYP450 isoenzymes.
Elimination: In a mass balance study conducted in healthy adult volunteers, after a single administration of 20 mg 14C-bilastine, almost 95% of the administered dose was recovered in urine (28.3%) and feces (66.5%) as unchanged bilastine, suggesting that bilastine is only slightly metabolized in humans. The mean elimination half-life in healthy volunteers is 14.5 hours.
Linearity: In the dose range studied (5 to 220 mg), bilastine exhibits linear pharmacokinetics with low interindividual variability.
Renal impairment: The effects of bilastine in renal impairment have been studied in adults.
In a study in patients with renal impairment, the mean AUC0-¥ (SD) increased from 737.4 (± 260.8) ng•h/mL in subjects with normal renal function (GFR: > 80 mL/min/1.73 m2) to 967.4 (± 140.2) ng•h/mL in patients with mild impairment (GFR: 50–80 mL/min/1.73 m2), 1384.2 (± 263.23) ng•h/mL in patients with moderate impairment (GFR: 30–< 50 mL/min/1.73 m2) and 1708.5 (± 699.0) ng•h/mL in patients with severe impairment (GFR: < 30 mL/min/1.73 m2). In subjects with normal renal function, the mean half-life (T1/2) of bilastine was 9.3 h (± 2.8), in subjects with mild renal impairment it was 15.1 h (± 7.7), in subjects with moderate renal impairment it was 10.5 h (± 2.3), and in subjects with severe renal impairment it was 18.4 h (± 11.4). In all subjects, bilastine was almost undetectable in the urine 48–72 h after dosing. These changes in pharmacokinetics are not expected to have a clinically significant impact on the safety of bilastine, as plasma bilastine levels in subjects with renal impairment remain within safe limits.
Hepatic impairment. Pharmacokinetic data in patients with hepatic impairment are not available. Bilastine is not metabolised in humans. A study in patients with renal impairment showed that bilastine is mainly excreted by the kidneys; it is likely to be excreted only to a minor extent in the bile. Changes in hepatic function have no clinically significant effect on the pharmacokinetics of bilastine.
Paediatric population: Pharmacokinetic data in children were obtained in a phase II pharmacokinetic study involving 31 children aged 4 to 11 years with allergic rhinoconjunctivitis or chronic urticaria who received 1 bilastine orodispersible tablet 10 mg once daily. Analysis of the pharmacokinetic data on plasma bilastine concentrations showed that after administration of bilastine at a dose of 10 mg once daily, recommended for the treatment of paediatric patients, its systemic exposure is consistent with that observed in adults and adolescents after administration of the drug at a dose of 20 mg, and the mean AUC in children aged 6 to 11 years is 1014 ng h/ml. These results were mainly below the maximum safe level established on the basis of data on the use of the drug in adults at a dose of 80 mg once daily according to the safety profile of the medicinal product. These results confirmed that a bilastine dose of 10 mg orally once daily is a reasonable therapeutic dose for pediatric patients aged 6 to 11 years with a body weight of at least 20 kg.
Preclinical safety data.
Preclinical data obtained during standard studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential of bilastine revealed no special hazard for humans.
In reproductive toxicity studies, effects of bilastine on the fetus (pre- and post-implantation fetal death in rats and incomplete ossification of the skull, sternum and limbs in rabbits) were observed only at doses toxic to the mother. At the no-observed-adverse-effect level (NOAEL), systemic exposure was significantly (> 30-fold) higher than the systemic exposure in humans at the recommended therapeutic dose.
In a fertility study in rats, oral administration of bilastine up to 1000 mg/kg/day did not show any effects on female or male reproductive organs. Mating, fertility and pregnancy indices were not altered.
According to a distribution study in rats, in which drug concentrations were determined by autoradiography, bilastine does not accumulate in the CNS.
Indication
Symptomatic treatment of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria. The drug Nixar® 10 mg is indicated for children aged 6 to 11 years with a body weight of at least 20 kg.
Contraindication
Hypersensitivity to the active substance or to any of the excipients listed in the "Composition" section.
Interaction with other medicinal products and other types of interactions
Interaction studies have been conducted only in adults.
Food Interaction: Food significantly reduces the oral bioavailability of bilastine, in particular when taken in the form of 20 mg tablets - by 30%, and in the form of 10 mg orodispersible tablets - by 20%.
Interaction with grapefruit juice. When bilastine 20 mg was co-administered with grapefruit juice, the bioavailability of bilastine was reduced by 30%. A similar effect may also be observed with other fruit juices. The extent of the reduction in bioavailability may vary depending on the manufacturer of the juice and the fruit. The mechanism of this interaction is inhibition of the transporter protein OATP1A2, for which bilastine is a substrate (see section 5.2). Medicinal products that are substrates or inhibitors of OATP1A2, such as ritonavir or rifampicin, may also reduce the plasma concentration of bilastine.
Interaction with ketoconazole or erythromycin. When 20 mg bilastine once daily was co-administered with 400 mg ketoconazole once daily or 500 mg erythromycin three times daily, the AUC of bilastine was doubled and the Cmax was increased 2-3-fold. Such changes can be explained by interactions at the level of transport proteins responsible for drug efflux from intestinal cells, since bilastine is a substrate for P-gp and is not metabolized (see section 5.2). The safety profile of bilastine on the one hand and ketoconazole or erythromycin on the other hand is unlikely to be affected by these changes. Other drugs that are substrates or inhibitors of P-gp, such as cyclosporine, may also increase bilastine plasma concentrations.
Interaction with diltiazem. When 20 mg bilastine once daily was co-administered with 60 mg diltiazem once daily, the Cmax of bilastine was increased by 50%. This effect may be explained by an interaction at the level of transport proteins responsible for the excretion of drugs from intestinal cells (see section "Pharmacokinetics"), but it is unlikely to affect the safety profile of bilastine.
Interaction with alcohol. After concomitant administration of alcohol and 20 mg bilastine once daily, psychomotor functions were similar to those observed after alcohol and placebo.
Interaction with lorazepam. When 20 mg bilastine was administered once daily with 3 mg lorazepam once daily for 8 days, no increase in the CNS depressant effect of lorazepam was observed.
Paediatric population: Interaction studies with bilastine orodispersible tablets have not been conducted in children. As there is no clinical experience of interactions of bilastine with other medicinal products, food or fruit juices in children, the results of interaction studies in adults should be taken into account when prescribing bilastine to children. There are no clinical data on the basis of which it would be possible to conclude whether changes in AUC or Cmax due to interactions affect the safety profile of bilastine in children.
Application features
Paediatric population: Since the efficacy and safety of bilastine in children under 2 years of age have not been established and there is limited clinical experience in children aged 2 to 5 years, bilastine should not be administered to these age groups.
In patients with moderate or severe renal impairment, concomitant use of bilastine with P-glycoprotein inhibitors, such as ketoconazole, erythromycin, cyclosporine, ritonavir or diltiazem, may lead to increased plasma levels of bilastine and therefore an increased risk of adverse reactions. Therefore, concomitant use of bilastine and P-glycoprotein inhibitors should be avoided in patients with moderate or severe renal impairment.
This medicine contains a small amount of ethanol (alcohol), less than 100 mg/dose. The small amount of alcohol in this medicine will not have any noticeable effects.
Use during pregnancy or breastfeeding
Pregnancy: There are no or limited amount of data from the use of bilastine in pregnant women.
Breastfeeding. Studies on the excretion of bilastine in human milk have not been conducted. Available pharmacokinetic data have shown that bilastine passes into milk in animals (see section "Preclinical safety data"). A decision on whether to continue/discontinue breast-feeding or to discontinue/abstain from therapy with Nixar® 10 mg should be made taking into account the benefit of breast-feeding for the child and the benefit of bilastine therapy for the mother.
Fertility: There are no or limited clinical data. A study in rats did not reveal any adverse effects on fertility (see section 5.3).
Ability to influence reaction speed when driving vehicles or other mechanisms
A study conducted in adults to assess the effects of bilastine on driving ability demonstrated that treatment with bilastine 20 mg did not affect driving ability. However, as individual response to the drug may vary, patients should be advised to refrain from driving or operating machinery until their own response to bilastine is known.
Method of administration and doses
Method of application.
Oral use.
The orodispersible tablet should be placed in the mouth, where it quickly disperses in saliva, making it easy to swallow.
Alternatively, the orodispersible tablet may be dispersed in water before administration. Grapefruit juice or any other fruit juice should not be used for dispersion (see section 4.5).
Dosage.
Pediatric population.
- Children aged 6 to 11 years with a body weight of at least 20 kg.
10 mg bilastine (1 orodispersible tablet) once daily for the relief of symptoms of allergic rhinoconjunctivitis (seasonal allergic rhinitis and perennial allergic rhinitis) and urticaria.
The orodispersible tablet should be taken 1 hour before or 2 hours after food or fruit juice (see section “Interaction with other medicinal products and other types of interactions”).
- Children under 6 years of age with a body weight of up to 20 kg.
Currently available data are described in sections 4.4, 4.8, 4.8, 4.9, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.6, 5.7, 5.8, 5.9, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.6, 5.7, 5.8, 5.9, 5.1, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.6, 5.7, 5.8, 5.9, 5.1, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.6, 5.7, 5.8, 5.9, 5.1, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 5.1, 5.1, 5.2, 5.3
Adults and adolescents (aged 12 years and over) can use bilastine 20 mg tablets.
Duration of treatment.
In allergic rhinoconjunctivitis, treatment should be limited to the period of exposure to allergens. In seasonal allergic rhinitis, treatment can be stopped after symptoms disappear and resumed when they reappear. In perennial allergic rhinitis, patients can be offered continuous treatment during periods of allergen exposure. In urticaria, the course of treatment depends on the type, duration and dynamics of complaints.
Special patient groups.
Renal impairment. The safety and efficacy of bilastine in children with renal impairment have not been established. Studies in adults at high risk (patients with renal impairment) have shown that there is no need to adjust the dose of bilastine for adults (see section 5.2).
Hepatic impairment. The safety and efficacy of bilastine in children with hepatic impairment have not been established. There is no clinical experience in patients with hepatic impairment in either adults or paediatric patients. However, since bilastine is not metabolised and is excreted unchanged in the urine and faeces, hepatic impairment is not expected to increase its systemic exposure to a hazardous level in adult patients. Therefore, no dose adjustment is required in adult patients with hepatic impairment (see section 5.2).
Children
Since the efficacy and safety of bilastine in children under 2 years of age have not been established, and clinical experience in children aged 2 to 5 years is limited, bilastine should not be administered to these age groups.
Overdose
There are no data on overdose in children.
In a thorough crossover study of QT/QTc intervals in 30 healthy adult volunteers, a critical assessment of the effects of multiple doses of bilastine (100 mg × 4 days) on ventricular repolarization revealed no significant prolongation of the QTc interval.
In case of overdose, symptomatic and supportive treatment is recommended.
The specific antidote to bilastine is unknown.
Adverse reactions
General safety profile in pediatric patients. During clinical development, the frequency, type and severity of adverse reactions in adolescents (aged 12 to 17 years) were similar to those in adults. Information collected in this group (adolescents) during post-marketing surveillance confirmed the results of clinical trials.
The percentage of children (2–11 years) who experienced adverse reactions after treatment of allergic rhinoconjunctivitis or chronic idiopathic urticaria with bilastine 10 mg during a 12-week controlled clinical trial was comparable to the percentage of patients receiving placebo (68.5% vs. 67.5%).
The most frequently reported adverse reactions in 291 children (2–11 years) treated with bilastine (orodispersible tablets) in clinical trials (#260 children in the safety study, 31 children in the pharmacokinetic study) included headache, allergic conjunctivitis, rhinitis, and abdominal pain. These adverse reactions were reported with comparable frequency in 249 patients treated with placebo.
Table of adverse reactions in pediatric patients. The table below lists adverse reactions that were possibly related to bilastine and were reported in more than 0.1% of children (2–11 years) who received bilastine during clinical development.
The frequency of adverse reactions is distributed as follows: very common (≥ 1/10); common (≥ 1/100 - < 1/10); uncommon (≥ 1/1000 - < 1/100); rare (≥ 1/10000 - < 1/1000); very rare (< 1/10000); unknown (cannot be estimated from the available data).
Reactions that occur rarely and very rarely, as well as those whose frequency is unknown, have not been included in the table.
| Organs and organ systems | Bilastine, 10 mg (n = 291) # | Placebo (n = 249) | |
| Frequency | Adverse reaction | | |
| Infectious and parasitic diseases | | | |
| Often | Rhinitis | 3 (1.0%) | 3 (1.2%) |
| Nervous system disorders | | | |
| Often | Headache | 6 (2.1%) | 3 (1.2%) |
| Infrequently | Dizziness | 1 (0.3%) | 0 (0.0 %) |
| Loss of consciousness | 1 (0.3%) | 0 (0.0 %) | |
| Vision disorders | | | |
| Often | Allergic conjunctivitis | 4 (1.4%) | 5 (2.0%) |
| Infrequently | Eye irritation | 1 (0.3%) | 0 (0.0 %) |
| Gastrointestinal disorders | | | |
| Often | Abdominal pain/upper abdominal pain | 3 (1.0%) | 3 (1.2%) |
| Infrequently | Diarrhea | 2 (0.7%) | 0 (0.0 %) |
| Nausea | 1 (0.3%) | 0 (0.0 %) | |
| Lip swelling | 1 (0.3%) | 0 (0.0 %) | |
| Skin and subcutaneous tissue disorders | | | |
| Infrequently | Eczema | 1 (0.3%) | 0 (0.0 %) |
| Urticaria | 2 (0.7%) | 2 (0.8%) | |
| General disorders and administration site conditions | | | |
| Infrequently | Fatigue | 2 (0.7%) | 0 (0.0 %) |
#260 children received the drug during clinical safety studies, 31 children received the drug during pharmacokinetic studies
Description of selected adverse reactions in the paediatric population. Headache, abdominal pain, allergic conjunctivitis and rhinitis were observed in both children treated with bilastine 10 mg and children treated with placebo. The reported frequencies were: 2.1% vs. 1.2% for headache; 1.0% vs. 1.2% for abdominal pain; 1.4% vs. 2.0% for allergic conjunctivitis and 1.0% vs. 1.2% for rhinitis.
General safety profile in adult and adolescent patients: In clinical trials in adult and adolescent patients with allergic rhinoconjunctivitis or chronic idiopathic urticaria, the incidence of adverse reactions with bilastine 20 mg was comparable to that in patients receiving placebo (12.7% vs. 12.8%).
Table of adverse reactions in adult and adolescent patients. The table below lists adverse reactions that were possibly related to bilastine and occurred in more than 0.1% of patients treated with bilastine 20 mg during clinical development (N = 1697).
The frequency of adverse reactions is distributed as follows: very common (≥ 1/10); common (≥ 1/100 - < 1/10); uncommon (≥ 1/1000 - < 1/100); rare (≥ 1/10000 - < 1/1000); very rare (< 1/10000); unknown (cannot be estimated from the available data).
Reactions that occur rarely and very rarely, as well as those whose frequency is unknown, have not been included in the table.
| Organs and organ systems | Bilastine, 20 mg N = 1697 | All doses of bilastine N = 2525 | Placebo N = 1362 | |
| Frequency | Adverse reaction | | | |
| Infectious and parasitic diseases | | | | |
| Infrequently | Oral herpes | 2 (0.12%) | 2 (0.08%) | 0 (0.0 %) |
| Metabolic and nutritional disorders | | | | |
| Infrequently | Increased appetite | 10 (0.59%) | 11 (0.44%) | 7 (0.51%) |
| Mental disorders | | | | |
| Infrequently | Anxiety | 6 (0.35%) | 8 (0.32%) | 0 (0.0 %) |
| Insomnia | 2 (0.12%) | 4 (0.16%) | 0 (0.0 %) | |
| Nervous system disorders | | | | |
| Often | Drowsiness | 52 (3.06%) | 82 (3.25%) | 39 (2.86%) |
| Headache | 68 (4.01%) | 90 (3.56%) | 46 (3.38%) | |
| Infrequently | Dizziness | 14 (0.83%) | 23 (0.91%) | 8 (0.59%) |
| Hearing and labyrinth disorders | | | | |
| Infrequently | Tinnitus | 2 (0.12%) | 2 (0.08%) | 0 (0.0 %) |
| Vertigo | 3 (0.18%) | 3 (0.12%) | 0 (0.0 %) | |
| Heart disorders | | | | |
| Infrequently | Right bundle branch block | 4 (0.24%) | 5 (0.20%) | 3 (0.22%) |
| Sinus arrhythmia | 5 (0.30%) | 5 (0.20%) | 1 (0.07%) | |
| QT prolongation on electrocardiogram | 9 (0.53%) | 10 (0.40%) | 5 (0.37%) | |
| Other deviations of ECG indicators from normal levels | 7 (0.41%) | 11 (0.44%) | 2 (0.15%) | |
| Respiratory, thoracic and mediastinal disorders | | | | |
| Infrequently | Dyspnea | 2 (0.12%) | 2 (0.08%) | 0 (0.0 %) |
| Unpleasant sensations in the nose | 2 (0.12%) | 2 (0.08%) | 0 (0.0 %) | |
| Dry nose | 3 (0.18%) | 6 (0.24%) | 4 (0.29%) | |
| Gastrointestinal disorders | | | | |
| Infrequently | Upper abdominal pain | 11 (0.65%) | 14 (0.55%) | 6 (0.44%) |
| Abdominal pain | 5 (0.30 %) | 5 (0.20%) | 4 (0.29%) | |
| Nausea | 7 (0.41%) | 10 (0.40%) | 14 (1.03%) | |
| Abdominal discomfort | 3 (0.18%) | 4 (0.16%) | 0 (0.0 %) | |
| Diarrhea | 4 (0.24%) | 6 (0.24%) | 3 (0.22%) | |
| Dry mouth | 2 (0.12%) | 6 (0.24%) | 5 (0.37%) | |
| Dyspepsia | 2 (0.12%) | 4 (0.16%) | 4 (0.29%) | |
| Gastritis | 4 (0.24%) | 4 (0.16%) | 0 (0.0 %) | |
| Skin and subcutaneous tissue disorders | | | | |
| Infrequently | Itch | 2 (0.12%) | 4 (0.16%) | 2 (0.15%) |
| General disorders and administration site conditions | | | | |
| Infrequently | Fatigue | 14 (0.83%) | 19 (0.75%) | 18 (1.32%) |
| Thirst | 3 (0.18%) | 4 (0.16%) | 1 (0.07%) | |
| Exacerbation of pre-existing diseases | 2 (0.12%) | 2 (0.08%) | 1 (0.07%) | |
| Fever | 2 (0.12%) | 3 (0.12%) | 1 (0.07%) | |
| Asthenia | 3 (0.18%) | 4 (0.16%) | 5 (0.37%) | |
| Additional research methods | | | | |
| Infrequently | Increased gamma-glutamyltransferase levels | 7 (0.41%) | 8 (0.32%) | 2 (0.15%) |
| Increased alanine aminotransferase levels | 5 (0.30%) | 5 (0.20%) | 3 (0.22%) | |
| Increased aspartate aminotransferase levels | 3 (0.18%) | 3 (0.12%) | 3 (0.22%) | |
| Increased blood creatinine levels | 2 (0.12%) | 2 (0.08%) | 0 (0.0 %) | |
| Increased blood triglyceride levels | 2 (0.12%) | 2 (0.08%) | 3 (0.22%) | |
| Weight gain | 8 (0.47%) | 12 (0.48%) | 2 (0.15%) | |
Description of selected adverse reactions in adult and adolescent patients. Somnolence, headache, dizziness and fatigue were observed in both patients treated with bilastine 20 mg and placebo. Their incidence was 3.06% vs. 2.86% for somnolence; 4.01% vs. 3.38% for headache; 0.83% vs. 0.59% for dizziness and 0.83% vs. 1.32% for fatigue, respectively.
Information collected during post-marketing surveillance confirmed the safety profile observed during clinical development.
Reporting of suspected adverse reactions. Reporting of suspected adverse reactions after the authorisation of a medicinal product plays an important role. This allows for continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
Expiration date
5 years.
Storage conditions
No special storage conditions are required.
Packaging
10 tablets in a blister; 1 or 3 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
A. Menarini Manufacturing Logistics and Services S.r.L.
Location of the manufacturer and address of its place of business
Via Campo di Pile, 67100 L'Aquila (AC), Italy.
Applicant
Menarini International Operations Luxembourg S.A.
Applicant's location
1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg.
