Bilagra oro
Poland
Table of Contents
Package leaflet: Information for the patient
Bilagra ORO, 10 mg, orodispersible tablets
Bilastinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of the leaflet:
- What Bilagra ORO is and what it is used for
- Important information before taking Bilagra ORO
- How to take Bilagra ORO
- Possible side effects
- How to store Bilagra ORO
- Contents of the pack and other information
1. What Bilagra ORO is and what it is used for
Bilagra ORO contains the active substance bilastinum, which has antihistaminic properties.
Bilagra ORO is used to relieve symptoms of hay fever (sneezing, itching, nasal discharge, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. The medicine may also be used to treat itchy skin rashes (blisters or hives).
Bilagra ORO, 10 mg, orodispersible tablets are indicated for use in children aged 6 years and older with a body weight of at least 20 kg, as well as in adolescents and adults.
2. Important information before using Bilagra ORO
When not to use Bilagra ORO
- if the patient or their child is allergic to bilastine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Bilagra ORO, consult a doctor or pharmacist if
the patient or their child has moderate or severe kidney or liver function disorders,
low blood levels of potassium, magnesium, or calcium, if the patient has or has had heart rhythm disorders or very slow heart rate, if they are taking medicines that may affect heart rhythm,
if they have or have had an abnormal heart rhythm pattern (known as QTc prolongation on electrocardiogram), which may occur in certain types of heart disease, and additionally
if the patient or their child is taking other medicines (see "Bilagra ORO and other medicines").
Children
This medicine must not be given to children under 6 years of age weighing less than 20 kg due to insufficient data.
Bilagra ORO and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently used, including those to be taken in the future and those available without prescription.
Some medicines must not be taken at the same time, while for others a dose adjustment may be necessary when taken concomitantly.
In particular, inform the doctor or pharmacist if the patient or their child is taking any of the following medicines:
- ketoconazole tablets (used in the treatment of Cushing's syndrome, when the body produces excess cortisol)
- erythromycin (an antibiotic)
- diltiazem (a medicine used to treat chest pain or angina in coronary artery disease)
- cyclosporine (a medicine used to reduce immune system activity, thereby preventing transplant rejection or reducing disease activity in autoimmune and allergic conditions 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 the medicine with food or grapefruit juice or other fruit juices, as this may reduce the effectiveness of bilastine. To avoid reduced effectiveness, either:
- swallow the tablet and wait one hour before eating a meal or drinking fruit juice, or
- wait two hours after eating a meal or drinking fruit juice before taking the tablet.
Bilastine at the recommended adult dose (20 mg) does not increase drowsiness caused by alcohol consumption.
Pregnancy, breastfeeding, and fertility
There are no data or limited data available on the use of bilastine during pregnancy, breastfeeding, or its effect on fertility.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
It has been shown that taking bilastine at a dose of 20 mg does not affect the ability to drive in adults. However, individual response to treatment may vary.
Therefore, before driving or operating machinery, the patient should assess how this medicine affects them.
Bilagra ORO contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".
3. How to use Bilagra ORO
This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Use in adults and adolescents aged 12 years and older
The recommended dose for adults, including elderly individuals, 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 with body weight of at least 20 kg is one
10 mg tablet once daily. This medicine should not be given to children under 6 years of age or
weighing less than 20 kg, due to insufficient data on use.
- Tablet for oral administration.
- Place the tablet in the mouth, where it dissolves rapidly in saliva and can be easily swallowed.
- The orally disintegrating tablet may also be dissolved in a teaspoon of water before administration. In this case, ensure that no residue of the medicine remains on the spoon.
- Only water should be used to dissolve the medicine. Do not use grapefruit juice or any other fruit juice.
- The tablet should be taken one hour before or two hours after any meal or fruit juice consumption (see section 2. "Bilagra ORO with food, drink and alcohol").
Regarding duration of treatment, the treating doctor will determine the nature of the underlying condition and decide how long Bilagra ORO should be taken.
Taking more than the recommended dose of Bilagra ORO
If more than the recommended dose of Bilagra ORO has been taken, contact a doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Bring the medicine packaging or leaflet with you.
Missing a dose of Bilagra ORO
Do not take a double dose to make up for a missed dose.
If a dose is missed or not given to a child at the correct time, the missed dose should be taken or given as soon as possible on the same day. On the following day, return to taking or giving the dose at the usual time.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.
Stopping Bilagra ORO
Usually, stopping treatment with Bilagra ORO does not cause any adverse effects.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences hypersensitivity reactions, including: difficulty breathing, dizziness,
collapse or loss of consciousness, swelling of the face, lips, tongue or throat and (or) skin rash and redness,
the medicine should be discontinued immediately and medical advice should be sought without delay.
Adverse reactions that may occur in children:
Common: may occur in less than 1 in 10 people
- Nasal mucositis (nasal irritation)
- Allergic conjunctivitis (eye irritation)
- Headache
- Stomach pain (abdominal pain, epigastric pain)
Uncommon: may occur in less than 1 in 100 people
- Eye irritation
- Dizziness
- Loss of consciousness
- Diarrhoea
- Nausea
- Swelling of the lips
- Rash
- Urticaria
- Fatigue
Adverse reactions that may occur in adults and adolescents:
Common: may occur in less than 1 in 10 people
- Headache
- Somnolence
Uncommon: may occur in less than 1 in 100 people
- Abnormal ECG findings
- Blood test abnormalities indicating liver function disorders
- Dizziness
- Stomach pain
- Fatigue
- Increased appetite
- Heart rhythm disturbances
- Weight gain
- Nausea
- Anxiety
- Dryness or discomfort in the nose
- Abdominal pain
- Diarrhoea
- Gastritis (inflammation of the stomach wall)
- Dizziness (dizziness or sensation of spinning)
- Feeling of weakness
- Increased thirst
- Dyspnoea (difficulty breathing)
- Dry mouth
- Dyspepsia
- Itching
- Herpes (oral herpes)
- Fever
- Tinnitus (ringing in the ears)
- Sleep disturbances
- Blood test abnormalities indicating kidney function disorders
- Increased blood lipid levels
Frequency not known: cannot be estimated from the available data
- Palpitations (awareness of heart beating)
- Tachycardia (rapid heartbeat)
- Vomiting
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.
5. How to store Bilagra ORO
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP".
The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must 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 packaging 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 aluminosilicate, sucralose, strawberry flavour, magnesium stearate, colloidal anhydrous silica.
What Bilagra ORO looks like and contents of the pack
Bilagra ORO 10 mg orodispersible tablets are round, white or almost white, smooth to marbled, biconvex, approximately 7.5 mm in diameter, with the imprint "10" on one side and plain on the other.
The tablets are packed in blisters of 10, 20, 30 or 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder
Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, Poland
Tel.: (22) 345 93 00
Manufacturer/Importer
Saneca Pharmaceuticals a.s., Nitrianska 100, 920 27 Hlohovec, Slovakia
This medicinal product is authorised in the European Economic Area countries 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