Bilagra Oro

Package Leaflet: Information for the Patient

Bilagra ORO, 20 mg, Orodispersible 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 or pharmacist.
• 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

• 1. What is Bilagra ORO and what is it used for
• 2. Before you take 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 acts as an antihistamine.
Bilagra ORO is used to relieve the symptoms of hay fever (hives, itching, runny nose, blocked nose, and red or itchy eyes) and other forms of allergic rhinitis. The medicine may also be used to treat itchy skin rashes (hives or urticaria).
Bilagra ORO, 20 mg, orodispersible tablets are indicated for use in adults and adolescents 12 years of age and older.

2. Before you take Bilagra ORO

When not to take Bilagra ORO

• 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 ORO, you should discuss it 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, if you have or have had an abnormal heart rhythm (known as QTc interval prolongation on an electrocardiogram), which may occur in some heart conditions, and also if you are taking other medicines (see "Bilagra ORO and other medicines").

Children

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

Bilagra ORO and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take or that are available without a prescription.
In particular, inform your doctor about 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 medicine used to treat chest pain or discomfort in coronary heart disease)
• cyclosporin (a medicine used to reduce the activity of the immune system, thereby preventing transplant rejection or reducing the activity of the disease in autoimmune or allergic diseases such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (used to treat AIDS)
• rifampicin (an antibiotic).

Bilagra ORO with food, drink, and alcohol

Do not take the medicine with food, grapefruit juice, or other fruit juices, as this 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 or
• after eating or drinking fruit juice, wait 2 hours before taking the tablet.

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

Pregnancy, breastfeeding, and fertility

There are no or limited 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 plan 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 patient to patient.
Therefore, before driving or operating machinery, check how the medicine affects you.

Bilagra ORO contains sodium

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

3. How to take Bilagra ORO

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 of age and older is 1 tablet of 20 mg once a day.

Use in children

Other forms of this medicine - bilastine, 10 mg, orodispersible tablets or bilastine, 2.5 mg/mL, oral solution - are intended for children aged 6 to 11 years 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 are insufficient data on the use of the medicine.

• The tablet is for oral use.
• Place the tablet in the mouth, where it dissolves immediately in saliva and can be swallowed easily.
• The orodispersible tablet can also be dissolved in a spoonful of water before administration. Then make sure there are no remaining medicine particles on the spoon.
• Only water should be used to dissolve the medicine. 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 type of disease and decide how long you should take Bilagra ORO.

Overdose of Bilagra ORO

If you have taken more than the recommended dose of Bilagra ORO, contact your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Take the medicine package or leaflet with you.

Missed dose of Bilagra ORO

Do not take a double dose to make up for a forgotten dose.
If you miss a dose, take the missed dose as soon as possible, and then return to your regular dosing schedule.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Stopping treatment with Bilagra ORO

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any allergic reactions, including difficulty breathing, dizziness, fainting, or loss of consciousness, facial, lip, tongue, or throat swelling, and (or) skin redness and swelling, 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 results
• blood test changes 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 feeling of spinning)
• feeling of weakness
• increased thirst
• shortness of breath (difficulty breathing)
• dry mouth
• indigestion
• itching
• oral thrush (oral thrush)
• fever
• tinnitus (ringing in the ears)
• sleep disorders
• blood test changes indicating kidney function disorders
• 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 (nasal irritation)
• 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 possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 ORO

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. 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 20 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, anhydrous colloidal silica.

What Bilagra ORO looks like and contents of the pack

Bilagra ORO 20 mg orodispersible tablets are oval, white or almost white, smooth to slightly mottled, biconvex tablets with dimensions of approximately 10.3 mm x 5.5 mm with the engraving "20" 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

Marketing authorization holder

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

Manufacturer/Importer

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: БиластинТева20 mg таблетки, диспергиращисевустата
Spain: Bilastina Teva 10 mg comprimidos bucodispersables EFG
Poland: Bilagra ORO
Portugal: Bilastina Teva
Sweden: Bilastine Teva

Date of last revision of the leaflet: February 2025