BLXT3378
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BILAXTEN20 mg tablet
It is taken orally.
Active ingredient
Each tablet contains 20 mg of bilastine.
Excipients
Microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide anhydride, magnesium stearate.
What is BILAXTEN and what is it used for?
BILAXTEN contains bilastine, an antihistamine active substance, and is in the form of a white, oval, biconvex and notched tablet. It is supplied in blister packs of 10, 20, 30, 40, 50 tablets. BILAXTEN is used in the treatment of hay fever (sneezing, itching, runny nose and congestion, as well as red and watery eyes) and other forms of allergic rhinitis. It can also be used to treat itchy skin rashes (hives or urticaria).
3. How to use BILAXTEN?
Your doctor will determine the duration of your treatment, the type of your disease and the time you should use BILAXTEN.
Application route and method
Adults, including adolescents over the age of 12 and the elderly
• One tablet should be taken a day.
• The tablet should be taken on an empty stomach, eg before breakfast in the morning. Food should not be eaten until 1 hour after taking BILAXTEN.
• The tablet should be swallowed with a glass of water.
• The notched line on the tablet is not intended to divide the tablet into two equal parts. It can be used to break the tablet in order to facilitate swallowing.
Different age groups
Use in children
The safety and efficacy of bilastine in children younger than 12 years has not yet been established.
Use in the elderly
No dosage adjustment is required in elderly patients. There is not enough experience with patients over 65 years of age.
Special use cases
Kidney / Liver failure
No dosage adjustment is required in patients with kidney failure.
There is no clinical experience in patients with liver failure.
If you have an impression that the effect of BILAXTEN is too strong or too weak, talk to your doctor or pharmacist.
If you use more BILAXTEN than you should
If you have used more than you should use from BILAXTEN, talk to a doctor or pharmacist.
4. What are the possible side effects?
As with all medicines, BILAXTEN may cause side effects in individuals who are hypersensitive to any substance in its content.
Possible side effects are as follows: Common: affects 1 to 10 out of 100 people.
• Headache
• dizziness
Uncommon: affects 1 to 10 out of 1,000 people.
Abnormal ECG results
Blood tests that show changes in how the liver works
Dizziness
Abdominal pain
• Tiredness
Increased appetite
Irregular heartbeat
Weight gain
Nausea (feeling sick)
• Anxiety
Dryness or discomfort in the nose
Pain in the belly
• Diarrhea
Gastritis (inflammation of the stomach wall)
Vertigo (dizziness or lightheadedness)
Feeling weak
• Thirst
Dyspnoea (difficulty breathing)
Dry mouth
Indigestion
Itching
Cold sores (oral herpes)
• Fire
Tinnitus (tinnitus)
Difficulty sleeping
Blood tests that show changes in how the kidney works.
Increase in blood fats
2.Things to watch out for before using BILAXTEN
DO NOT USE BILAXTEN in the following situations
If;
• If you are allergic (hypersensitive) to BILAXTEN or any of its ingredients.
USE BILAXTEN CAREFULLY in the following situations
If;
• If you have moderate or severe renal impairment and are taking other medicines (see section below).
It is not suitable for use in children younger than 12 years.
If these warnings are valid for you, even at any time in the past, please consult your doctor.
Using BILAXTEN with food and drink
It should not be taken with food or grapefruit juice or other fruit juices, as it will reduce the effect of BILAXTEN. To prevent this:
• wait an hour to consume food or fruit juice after using the tablet, or
• If you have consumed food or fruit juice, use the tablet after waiting two hours.
BILAXTEN, used in the recommended dose (1 tablet), does not increase the dizziness caused by alcohol.
Pregnancy
Consult your doctor or pharmacist before using the medicine.
There are no clinical data or limited clinical data on the use of BILAXTEN in pregnant women.
If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.
Breast-feeding
Before using the medicine, consult your doctor or pharmacist.
It is not known whether bilastine passes into human breast milk. Studies on the passage of bilastine into breast milk in animals have not been conducted.
Vehicle and machine use
In a study conducted to demonstrate the effect of BILAXTEN on driving, it was revealed that 20 mg of BILAXTEN treatment did not affect the driving performance.