BILASTINA 20 mg Tabletki Powlekane
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Treść ulotki
Bilastina Aurobindo 20 mg tablets
Generic medicine
Read this leaflet carefully before taking this medicine as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Bilastina Aurobindo is and what it is used for
- 2. What you need to know before you take Bilastina Aurobindo
- 3. How to take Bilastina Aurobindo
- 4. Possible side effects
- 5. How to store Bilastina Aurobindo
- 6. Contents of the pack and other information
1. What is Bilastina Aurobindo and what is it used for?
Bilastina Aurobindo contains the active ingredient bilastina, which is an antihistamine. Bilastina Aurobindo
is used to relieve the symptoms of hay fever (sneezing, itching, runny nose, stuffy nose
and redness and watery eyes) and other forms of allergic rhinitis. It can also be used
for the treatment of itchy skin rashes (such as hives).
2. What you need to know before you take Bilastina Aurobindo
Do not take Bilastina Aurobindo:
if you are allergic to bilastina or any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Bilastina Aurobindo if you have moderate or severe
kidney impairment and are taking other medicines (see “Other medicines and Bilastina
Aurobindo”).
Children
This medicine should not be taken by children under 12 years of age.
Do notexceed the recommended dose. If symptoms persist, consult your doctor.
Other medicines and Bilastina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
In particular, talk to your doctor if you are taking any of the following medicines:
- ketoconazole (an antifungal medicine);
- erythromycin (an antibiotic);
- diltiazem (for the treatment of angina);
- cyclosporine (to reduce the activity of the immune system to prevent rejection after transplantation or to reduce the activity of autoimmune and allergic diseases such as psoriasis, atopic dermatitis or rheumatoid arthritis);
- ritonavir (for the treatment of AIDS);
- rifampicin (an antibiotic).
Bilastina Aurobindo with food, drinks and alcohol
The tablets must notbe taken with food or with grapefruit juice or other fruit juices, as this decreases the effect of bilastina. To avoid this, you can:
- take the tablet and wait one hour before consuming food or fruit juice;
- if you have consumed food or fruit juice, wait for two hours before taking the tablet.
Bilastina, at the recommended dose (20 mg), does not increase the drowsiness caused by alcohol.
Pregnancy, breastfeeding and fertility
Data relating to the use of bilastina in pregnant and breastfeeding women and data relating to
the effects of bilastina on fertility are limited or unavailable.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine. Ask your doctor or
pharmacist for advice before taking any medicine.
Driving and using machines
Doses of 20 mg of bilastina have been shown not to affect driving ability in adults.
However, the response to the medicine by each patient may be different. Therefore it is
important to check the effect of the medicine on yourself before driving or using
machinery.
Bilastina Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
“sodium-free”.
3. How to take Bilastina Aurobindo
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose in adults, including the elderly and adolescents aged 12 years and over, is 1
tablet (20 mg) daily.
- The tablet is for oral use.
- The tablet should be taken one hour before or two hours after you have taken food or fruit juice (see paragraph 2, “Bilastina Aurobindo with food, beverages and alcohol”).
- Swallow the tablet with a glass of water.
- The score line is present only to help you break the tablet if you have difficulty swallowing it whole. Regarding the duration of treatment, the doctor will establish the type of illness you suffer from and decide how long you should take Bilastina Aurobindo.
Use in children
Other pharmaceutical forms of this medicine - bilastine 10 mg orodispersible tablets or bilastine
2.5 mg/ml oral solution - may be more suitable for children aged 6 to 11 years with a
body weight of at least 20 kg, ask your doctor or pharmacist.
Do not administer this medicine to children under 6 years of age with a body weight
less than 20 kg, as sufficient data are not available.
If you take more Bilastina Aurobindo than you should
If you, or someone else, has taken an excessive amount of Bilastina Aurobindo, contact
immediatelyyour doctor or pharmacist or go to the emergency room of the nearest hospital. If
you forget to take Bilastina Aurobindo
Do nottake a double dose to make up for a missed dose.
If you forget to take a dose, take it 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects that may occur in adults and adolescents are as follows:
Common: may affect up to 1 in 10 people
- headache;
- drowsiness.
Uncommon: may affect up to 1 in 100 people
- abnormal electrocardiogram (ECG);
- blood tests showing changes in liver function;
- dizziness;
- stomach pain;
- fatigue;
- increased appetite;
- irregular heartbeat;
- increased body weight;
- nausea (feeling of wanting to vomit);
- anxiety;
- feeling of dryness or discomfort in the nose;
- abdominal pain;
- diarrhoea;
- gastritis (inflammation of the stomach lining);
- vertigo (a sensation of spinning or whirling);
- feeling of weakness;
- thirst;
- dyspnoea (difficulty breathing);
- dry mouth;
- indigestion;
- itching;
- herpes labialis (oral herpes);
- fever;
- tinnitus (ringing in the ears);
- difficulty falling asleep;
- blood tests showing changes in kidney function;
- increased fats in the blood.
Frequency not known: cannot be estimated from the available data
- palpitations (feeling the heartbeat);
- tachycardia (fast heartbeat);
- allergic reactions whose signs may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and/or skin swelling and redness. If you notice any of these serious side effects, stop taking the medicine and contact your doctor immediately;
- vomiting.
Side effects that may occur in children are as follows:
Common: may affect up to 1 in 10 people
- rhinitis (nasal irritation);
- allergic conjunctivitis (eye irritation);
- headache;
- stomach pain (abdominal/upper abdominal pain).
Uncommon: may affect up to 1 in 100 people
- eye irritation;
- dizziness;
- loss of consciousness;
- diarrhoea;
- nausea (feeling unwell);
- swelling of the lips;
- eczema;
- urticaria;
- fatigue.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Bilastina Aurobindo
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 package and on the blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage precautions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Bilastina Aurobindo contains
- The active ingredient is bilastine. Each tablet contains 20 mg of bilastine.
- The other ingredients are: microcrystalline cellulose, sodium starch glycolate (type A), anhydrous colloidal silica, magnesium stearate.
Description of the appearance of Bilastina Aurobindo and package contents
Tablets.
Uncoated tablets of white to almost white color, oval, biconvex, imprinted with ‘BN’ and ‘2’
separated by a score line on one side, and smooth on the other side.
The score line on the tablet is only to facilitate breaking and swallowing,
not to divide the tablet into equal doses.
Bilastina Aurobindo 20 mg tablets are available in blister packs.
Packs:
Blister packs: 10, 14, 20, 28, 30, 40, 50, 56, 60, 90, 100 and 120 tablets.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
Marketing authorization holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
- 21047 - Saronno (VA) Italy
Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica SA
Rua João de Deus, 19,
- 2700- 487 Amadora Portugal
Arrow Generiques
26 Avenue Tony Garnier,
69007 Lyon,
France
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Belgium: Bilastine AB 20mg tabletten /comprimés /Tabletten
Denmark: Bilastin Aurobindo
France: Bilastine Arrow 20 mg, comprimé
Italy: Bilastina Aurobindo
Poland: Bellix
Portugal: Bilastina Generis
Romania: Bilastină Aurobindo 20 mg comprimate
Spain: Bilastina Aurovitas 20 mg comprimidos EFG
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- Kraj rejestracji
- Postać farmaceutycznaCoated tablet, 20 mg
- Kod ATCR06AX29
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki BILASTINA AUROBINDOPostać farmaceutyczna: Coated tablet, 20 MGSubstancja czynna: bilastineProducent: AUROBINDO PHARMA (ITALIA) S.R.L.Wymaga receptyPostać farmaceutyczna: Coated tablet, 20 MGSubstancja czynna: bilastineWymaga recepty
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BILASTINA AUROBINDO wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w BILASTINA AUROBINDO jest bilastine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
BILASTINA AUROBINDO jest produkowany przez AUROBINDO PHARMA (ITALIA) S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie BILASTINA AUROBINDO jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić BILASTINA AUROBINDO w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (bilastine) to m.in. ALYNE, AYRINAL, BILASTINA EG. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
