Treatment: symptomatic of allergic rhinoconjunctivitis (seasonal and perannual) and urticaria

Orally.

Adults and adolescents (over 12 years old)

The recommended dosage is 20 mg (one tablet) once a day.
It is recommended that the daily dose be administered in a single dose.
Subjects, aged

No dosage adjustment is necessary in the elderly (see section 5.1 Pharmacodynamic properties and Pharmacokinetic properties) .The experiment is limited in persons over 65 years of age.

Children under 12 years

The efficacy and safety of bilastin in children less than 12 years of age have not been established.
Renal insufficiency

No dose adjustment is necessary in patients with renal insufficiency (see section Properties, Pharmacokinetics).
Hepatic Insufficiency

No data is available in patients with hepatic impairment

Due to the absence of metabolism of bilastin and its elimination mainly by urine, there is no expected significant increase in exposure, systemic in patients with hepatic impairment, beyond Margins of safety.

Therefore, no dose adjustment is necessary in patients with hepatic impairment (see section Pharmacokinetics).
Duration of the processing

The use of bilastin in the treatment of allergic rhinitis should be limited to the period of exposure to allergens

In case of seasonal allergic rhinitis, the treatment may be stopped after the symptoms disappear and will be resumed at the time of their reappearance

In case of perennial allergic rhinitis, continuous treatment could be offered to patients during periods of exposure to allergens

In case of urticaria the duration of the treatment will depend on the nature, duration and evolution of the symptomatology.

Tablet white, oval, biconvex.

The breaking bar is there only, in order to facilitate the taking of the tablet, it does not divide it into two equal half-doses

Class: Pharmacotherapeutic: OTHER ANTIHISTAMINICS FOR SYSTEMIC USE, ATC code: R06AX29

Bilastin is a non-sedative antihistamine of prolonged action with a selective antagonist effect on peripheral H1 receptors and has no affinity for muscarinic receptors.

Bilastin administered as a single dose inhibits histamine-induced erythematopoietic reactions for 24 hours.



Bilastin (all dosages)

N '= 2525

Placebo

N '= 1362

Frequency

Adverse reaction

Infections and infestations

Uncommon

Herpes labialis

2; (0.12%)

2 (0.08%)

0, (0,0%)

Metabolism and nutrition disorders

Uncommon

Increased appetite

10 (0.59%)

11 (0.44%)

7 (0.51%)

Psychiatric disorders

Uncommon

Anxiety

6 (0.35%)

8; (0.32%)

0, (0,0%)

Insomnia

2; (0.12%)

4; (0.16%)

0, (0,0%)

Trouble in the ear and the labyrinth

Uncommon

Tinnitus
2 (0.12%)

2 (0.08%)

0, (0,0%)

Dizziness

3 (0.18%)

3 (0.12%)

0, (0,0%)

Cardiac disorders

Uncommon

Block of right branch

4 (0.24%)

5 (0.20%)

3 (0.22%)

Arrhythmia, sinusal

5 (0.30%)

5 (0.20%)

1 (0.07%)

Extension of the QT interval

9 (0.53%)

10 (0.40%)

5 (0.37%)

Other ECG abnormalities

7 (0.41%)

11 (0.44%)

2 (0.15%)

Nervous system disorders

Common

Somnolence

52 (3.06%)

82 (3.25%)

39; (2.86%)

Headaches

68 (4.01%)

90 (3.56%)

46, (3.38%)

Uncommon

Sensations, dizzines

14 (0.83%)

23 (0.91%)

8, (0.59%)

Respiratory, thoracic and mediastinal disorders

Uncommon

Dyspnea

2 (0.12%)

2 (0.08%)

0 (0,0%)

Nasal discomfort

2 (0.12%)

2 (0.08%)

0 (0,0%)

Nasal dryness
3 (0.18%)

6 (0.24%)

4 (0.29%)

Gastrointestinal Disorders

Uncommon

Abdominal pain, high

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%)

Gastric discomfort

3 (0.18%)

4 (0.16%)

0, (0,0%)

Diarrhea

4 (0.24%)

6 (0.24%)

3 (0.22%)

Dryness, buccale

2 (0.12%)

6 (0.24%)

5 (0.37%)

Dyspepsia

2 (0.12%)

4 (0.16%)

4 (0.29%)

Gastrite

4 (0.24%)

4 (0.16%)

0 (0,0%)

Skin and tissue disorders, subcutaneous

Uncommon

Pruritus

2 (0.12%)

4 (0.16%)

2 (0.15%)

General disorders and administration site abnormalities

Uncommon

Fatigue

14 (0.83%)

19; (0.75%)

18; (1.32%)

Sensation of thirst

3 (0.18%)

4 (0.16%)

1 (0.07%)

Treatment: symptomatic of allergic rhinoconjunctivitis (seasonal and perannual) and urticaria

Pre-existing disease, improved

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%)

Investigations

Uncommon

Gamma increase; GT

7 (0.41%)

8; (0.32%)

2 (0.15%)

Increase of ALAT

5 (0.30%)

5 (0.20%)

3 (0.22%)

Increase in ASAT

3 (0.18%)

3; (0.12%)

3 (0.22%)

Increase in serum creatinine

2; (0.12%)

2 (0.08%)

0, (0,0%)

Increase in triglycerides

2; (0.12%)

2 (0.08%)

3 (0.22%)

Weight gain

8; (0.47%)

12 (0.48%)

2 (0.15%)