Bilagra Oro

Package Leaflet: Information for the Patient

Bilagra ORO, 10 mg, Oral Disintegrating Tablets

Bilastine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. 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, please tell your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents:

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

1. What is Bilagra ORO and what is it used for

Bilagra ORO contains the active substance bilastine, which has antihistamine properties.
Bilagra ORO is used to relieve symptoms of hay fever (sneezing, itching, runny or stuffy nose, and red or itchy eyes) and other forms of allergic rhinitis. The medication may also be used to treat itchy skin rashes (hives or urticaria).
Bilagra ORO, 10 mg, oral disintegrating tablets are indicated for use in children aged 6 years and older and weighing at least 20 kg, as well as in adolescents and adults.

2. Important information before taking Bilagra ORO

When Not to Take Bilagra ORO

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

Warnings and Precautions

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

Children

Do Not Give this Medication to Children Under 6 Years of Age or Weighing Less Than 20 kg Due to Limited Data.

Bilagra ORO and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those obtained without a prescription.
Some medicines should not be taken at the same time, and for others, the dose may need to be changed if taken together.
In particular, inform your doctor or pharmacist if you or your child are taking any of the following medicines:

• ketokonazole tablets (used to treat Cushing's syndrome when the body produces too much cortisol)
• erythromycin (an antibiotic)
• diltiazem (a medication used to treat chest pain or discomfort in coronary artery disease)
• cyclosporine (a medication used to reduce the activity of the immune system and thus prevent rejection of a transplant or reduce disease activity in autoimmune or allergic diseases such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (used in the treatment of AIDS)
• rifampicin (an antibiotic).

Bilagra ORO with Food, Drink, and Alcohol Do Not Take this Medication with Food, Grapefruit Juice, or Other Fruit Juices

asthey weaken the effect of bilastine. To avoid reducing the effect of the medication, you should:

• swallow the tablet and wait one hour before eating or drinking fruit juice, or
• wait two hours after eating or drinking fruit juice before taking the tablet.

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

Pregnancy, Breastfeeding, and Fertility

There are limited or no data on the use of bilastine in pregnant or breastfeeding women, as well as 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 medication, 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 this medication affects you.

Bilagra ORO Contains Sodium

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

3. How to Take Bilagra ORO

Always take this medication exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Use in Adults and Adolescents Aged 12 Years and Older

The recommended dose for adults, including the elderly, and adolescents aged 12 years and older is 20 mg once daily (two 10 mg tablets).

Use in Children

The recommended dose for children aged 6 to 11 years and weighing at least 20 kg is one 10 mg tablet once daily. Do not give this medication to children under 6 years of age or weighing less than 20 kg, as there is limited data on its use.

• The tablet is for oral use.
• Place the tablet in the mouth, where it will dissolve immediately in saliva and can be swallowed easily.
• The oral disintegrating tablet can also be dissolved in a spoonful of water before administration. Ensure that no medicine remains on the spoon.
• Only water should be used to dissolve the medication. Do not use grapefruit juice or any other fruit juice.
• Take the tablet one hour before or two hours after any meal or fruit juice (see section 2, "Bilagra ORO with food, drink, and alcohol").

Regarding the duration of treatment, your doctor will determine the underlying condition and decide how long you should take Bilagra ORO.

Overdose of Bilagra ORO

If you take more Bilagra ORO than you should, contact your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Take the package leaflet and any remaining tablets with you.

Missed Dose of Bilagra ORO

Do nottake a double dose to make up for a forgotten dose.
If you miss a dose or forget to give a dose to your child, take the missed dose as soon as possible on the same day. The next day, resume your regular dosing schedule at the usual time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

Stopping Bilagra ORO Treatment

Usually, stopping Bilagra ORO treatment does not cause any side effects.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

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

Side Effects in Children May Include:

Common: may affect up to 1 in 10 people

• nasal congestion (irritation of the nose)
• allergic conjunctivitis (eye irritation)
• headache
• stomach pain (abdominal pain, discomfort 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

Side Effects in Adults and Adolescents May Include:

Common: may affect up to 1 in 10 people

• headache
• drowsiness

Uncommon: may affect up to 1 in 100 people

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

Frequency not known: cannot be estimated from the available data

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

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration 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 medication.

5. How to Store Bilagra ORO

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the month.
This medication 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. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Bilagra ORO Contains

• The active substance is bilastine. Each tablet contains 10 mg of bilastine.
• The other ingredients are: mannitol, microcrystalline cellulose, sodium croscarmellose (see section 2, "Bilagra ORO contains sodium"), magnesium aluminometasilicate, sucralose, strawberry flavor, magnesium stearate, colloidal anhydrous silica.

What Bilagra ORO Looks Like and Contents of the Pack

Bilagra ORO, 10 mg, oral disintegrating tablets are round, white or almost white, smooth to slightly mottled, and biconvex with a diameter of approximately 7.5 mm, with "10" embossed on one side and smooth on the other.
The tablets are packaged in blisters of 10, 20, 30, or 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer/Importer

Marketing Authorization Holder

Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands
For further information on this medicine, please contact the local representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00

Manufacturer/Importer

Saneca Pharmaceuticals a.s., Nitrianska 100, 920 27 Hlohovec, Slovakia

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

Bulgaria: Биластин Тева 20 mg таблетки, диспергиращи се устата
Spain: Bilastina Teva 10 mg comprimidos bucodispersables EFG
Poland: Bilagra ORO
Portugal: Bilastina Teva
Sweden: Bilastine Teva

Date of Last Revision of the Package Leaflet: February 2025