Bilagra

Package Leaflet: Information for the Patient

Bilagra, 20 mg, Tablets

Bilastine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Bilagra and what is it used for
• 2. Important information before taking Bilagra
• 3. How to take Bilagra
• 4. Possible side effects
• 5. How to store Bilagra
• 6. Contents of the pack and other information

1. What is Bilagra and what is it used for

Bilagra contains the active substance bilastine, which has antihistamine properties.
Bilagra is used to relieve the symptoms of hay fever (sneezing, itching, runny nose, blocked nose, and red and itchy eyes) and other forms of allergic rhinitis. The medicine may also be used to treat itchy skin rashes (hives or urticaria).

2. Important information before taking Bilagra

When not to take Bilagra

• if you are allergic to bilastine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Bilagra, discuss with your doctor or pharmacist if you have moderate or severe kidney problems, low potassium, magnesium, or calcium levels in your blood, if you have or have had heart rhythm problems or very slow heart rate, if you are taking medicines that may affect your heart rhythm, or if you have or have had an abnormal heart rhythm (known as QTc interval prolongation on an electrocardiogram), which may occur in certain types of heart disease, and you are taking other medicines (see "Bilagra and other medicines").

Children

Do not give this medicine to children under 12 years of age.

Do notexceed the recommended dose. If symptoms persist, consult your doctor.

Bilagra and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any you plan to take, including those obtained without a prescription.
In particular, inform your doctor about taking any of the following medicines:

• ketokonazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for coronary heart disease)
• cyclosporine (a medicine used to reduce the activity of the immune system, and thus prevent rejection of a transplant or reduce the activity of the disease in autoimmune and allergic diseases, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (used to treat AIDS)
• rifampicin (an antibiotic).

Bilagra with food, drink, and alcohol Do not take the medicine with food or grapefruit juice, or other fruit juices

asthis reduces the effect of bilastine. To avoid reducing the effect of the medicine, you should:

• swallow the tablet and wait one hour before eating or drinking fruit juice (see section 2, "Bilagra with food, drink, and alcohol").
• after eating or drinking fruit juice, wait 2 hours before taking the tablet.

Bilastine at the recommended dose (20 mg) does not increase drowsiness caused by alcohol consumption.

Pregnancy, breastfeeding, and fertility

There are no or limited data on the use of bilastine in pregnant or breastfeeding women, or on its effects on fertility.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

It has been shown that taking bilastine at a dose of 20 mg does not affect the ability to drive in adults. However, the response to treatment may vary from person to person.
Therefore, before driving or operating machinery, check how the medicine affects you.

Bilagra contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Bilagra

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults, including the elderly, and adolescents 12 years and older is 1 tablet (20 mg) once daily.

• The tablet is for oral use.
• Take the tablet one hour before or two hours after any meal or fruit juice (see section 2, "Bilagra with food, drink, and alcohol").
• Swallow the tablet with a glass of water. As for the duration of treatment, your doctor will determine the type of disease and decide how long you should take Bilagra.

Use in children

Other forms of this medicine - bilastine 10 mg orodispersible tablet or bilastine 2.5 mg/mL oral solution - are intended for children from 6 to 11 years of age with a body weight of at least 20 kg - ask your doctor or pharmacist.

Do not give bilastine to children under 6 years of age with a body weight below 20 kg, as there is limited data on the use of the medicine in this population.

Overdose of Bilagra

If you take more Bilagra than you should, immediatelycontact your doctor or pharmacist or go to the emergency department of your nearest hospital. Bring the medicine package or leaflet with you.

Missed dose of Bilagra

Do nottake a double dose to make up for a forgotten dose.
If you forget to take a dose, take the missed dose as soon as possible, and then continue with your regular dose at the usual time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bilagra can cause side effects, although not everybody gets them.
If you experience an allergic reaction, including: difficulty breathing, dizziness, fainting, or loss of consciousness, swelling of the face, lips, tongue, or throat, and (or) swelling and redness of the skin, stop taking the medicine and consult your doctor immediately.

Side effects that may occur in adults and adolescents are:

Common: may affect up to 1 in 10 people

• headache
• drowsiness

Uncommon: may affect up to 1 in 100 people

• abnormal ECG
• changes in blood tests indicating liver problems
• dizziness
• stomach pain
• fatigue
• increased appetite
• heart rhythm disorders
• weight gain
• nausea
• anxiety
• feeling of dryness or discomfort in the nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• dizziness (feeling of spinning or vertigo)
• feeling of weakness
• increased thirst
• shortness of breath (difficulty breathing)
• dry mouth
• indigestion
• itching
• oral thrush (mouth infection)
• fever
• ringing in the ears (tinnitus)
• sleep disorders
• changes in blood tests indicating kidney problems
• increased lipid levels in the blood

Frequency not known: cannot be estimated from the available data

• palpitations (feeling of heartbeat)
• tachycardia (fast heartbeat)
• vomiting.

Side effects that may occur in children are:

Common: may affect up to 1 in 10 people

• rhinitis (irritation of the nose)
• allergic conjunctivitis (eye irritation)
• headache
• stomach pain (abdominal pain, pain in the upper abdomen) Uncommon: may affect up to 1 in 100 people
• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea
• lip swelling
• rash
• hives
• fatigue

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bilagra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bilagra contains

• The active substance is bilastine. Each tablet contains 20 mg of bilastine.
• The other ingredients are: mannitol, microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium aluminometasilicate, magnesium stearate, anhydrous colloidal silica.

What Bilagra looks like and contents of the pack

Bilagra tablets are round, white or almost white, biconvex tablets with a diameter of about 7 mm.
The tablets are packaged in blisters of 10, 20, 30, 50, or 100 tablets, and in single-dose blisters of 10x1, 20x1, 30x1 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands
Manufacturer/Importer
Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec
Slovakia

Date of last revision of the leaflet: February 2025