Fixtat 20 Tablet 1 Strip

Fixtat 20 mg Tablet contains Bilastine, a long-acting, non-sedating antihistamine used to relieve symptoms associated with allergic conditions. It is indicated for the symptomatic treatment of seasonal and perennial allergic rhinoconjunctivitis and urticaria. It can also help relieve common hay fever symptoms such as sneezing, itching, runny or blocked nose, and red or watery eyes.

Adults and adolescents aged 12 years and above:

• The recommended dose is 20 mg once daily for allergic rhinitis, allergic rhinoconjunctivitis, and urticaria.
• The maximum recommended dose is 20 mg once daily.
• The tablet should be swallowed with water on an empty stomach for optimal absorption.
• If a dose is missed, take the next dose at the usual scheduled time. Do not take an extra dose.

Children aged 6–11 years:

• The recommended dose is 10 mg once daily as an orally disintegrating tablet.
• The tablet may be placed directly in the mouth to dissolve in saliva. Alternatively, it may be dispersed in a teaspoon of water before administration.
• Do not exceed 10 mg once daily.

Children aged 2–11 years:

• The recommended dose is 4 mL once daily, according to the prescribed pediatric formulation and medical advice.

রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন।

Drug Interactions

Concomitant use of Bilastine with medicines such as ketoconazole, erythromycin, cyclosporine, or diltiazem may increase Bilastine concentrations in the blood. Available information indicates that these changes do not appear to significantly affect the safety profile.

Bilastine did not show an additional clinically relevant effect on psychomotor performance when taken with alcohol in the referenced study. Concomitant administration with lorazepam did not increase the central nervous system depressant effect of lorazepam.

Contraindications

Bilastine should not be used in patients with a known hypersensitivity to Bilastine or any of the other ingredients in the formulation.

Side Effects

Commonly reported adverse effects include:

• Headache
• Dizziness
• Drowsiness
• Fatigue

These effects were reported at frequencies comparable to those seen with placebo in clinical studies.

Pregnancy & Lactation

There is limited information regarding the use of Bilastine during pregnancy. Animal studies have not demonstrated direct or indirect harmful effects on reproductive function or postnatal development. As a precaution, Bilastine should preferably be avoided during pregnancy unless considered necessary by a doctor.

It is not established whether Bilastine passes into human breast milk. Breastfeeding and treatment should therefore be considered by the physician based on the potential benefit to the mother and the infant.

Precautions & Warnings

Bilastine generally has little effect on driving ability. However, a small number of patients may experience drowsiness or dizziness. Patients should therefore be cautious when driving or operating machinery until they know how the medicine affects them.

Clinical data indicate that elderly patients aged 65 years and above generally have similar safety and efficacy outcomes to younger adults.

No dosage adjustment is generally required in patients with renal impairment according to the provided information. Bilastine is not significantly metabolized in humans, and changes in liver function are not expected to have a clinically important effect on its elimination.

Use in Special Populations

Children:
The safety and efficacy of Bilastine have not been established in children below 2 years of age. Due to limited clinical experience, use in children aged 2–5 years is also not recommended unless specifically advised by a healthcare professional.

Overdose

In clinical studies, administration of Bilastine at doses substantially higher than the recommended therapeutic dose resulted mainly in dizziness, headache, and nausea. No serious adverse reactions or clinically significant QTc prolongation were reported in the referenced studies.

If an overdose is suspected, seek medical attention promptly and provide supportive treatment as required.

Therapeutic Class

Non-sedating antihistamines

Storage

Store below 30°C, protected from light and moisture. Keep out of reach of children.