BILASTINA 20 mg Tabletki Powlekane
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Treść ulotki
Bilastina TecniGen 20 mg tablets
Bilastina
Generic medicine
Read this leaflet carefully before taking this medicine because 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Bilastina TecniGen is and what it is used for
- 2. What you need to know before you take Bilastina TecniGen
- 3. How to take Bilastina TecniGen
- 4. Possible side effects
- 5. How to store Bilastina TecniGen
- 6. Contents of the pack and other information
1. What is Bilastina TecniGen and what is it used for?
Bilastina TecniGen contains the active ingredient bilastine which is an antihistamine. Bilastina
TecniGen is used to relieve the symptoms of hay fever (sneezing, itching, runny nose, blocked nose and red 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 TecniGen
Do not take Bilastina TecniGen
if you are allergic to bilastine 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 TecniGen if you have moderate or severe
kidney impairment and are taking other medicines (see “Other medicines and Bilastina
TecniGen”).
Children
Do not give this medicine to children under 12 years of age.
Donot exceed the recommended dose. If symptoms persist, consult your doctor.
Other medicines and Bilastina TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines 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 TecniGen with food, drinks and alcohol
The tablets should not be taken with food or with grapefruit juice or other fruit juices, as this decreases the effect of bilastine. To avoid this happening, you can:
- take the tablet and wait one hour before consuming food or fruit juices;
- if you have consumed food or fruit juices, wait for two hours before taking the tablet.
Bilastine, at the recommended dose (20 mg), does not increase drowsiness caused by alcohol.
Pregnancy, breastfeeding and fertility
Data on the use of bilastine in pregnant women and during breastfeeding and data on
effects on fertility are limited or not available.
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine. Ask your
doctor or pharmacist before taking any medicine.
Driving and using machines
Doses of 20 mg of bilastine have been shown not to impair 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
machines.
Bilastina TecniGen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially
‘sodium-free’.
3. How to take Bilastina TecniGen
Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The recommended dose in adults, including the elderly and adolescents starting from 12 years of age,
is 1 tablet (20 mg) per day.
- The tablet is for oral use.
- The tablet must be taken one hour before or two hours after taking food or fruit juice (see paragraph 2, “Bilastina TecniGen with food, drinks and alcohol”).
- Swallow the tablet with a glass of water.
- The score line is to facilitate breaking the tablet in case you have difficulty swallowing it whole.
Regarding the duration of treatment, the doctor will identify the type of illness you suffer from and
decide how long you must take Bilastina TecniGen.
Use in children
Other forms of this medicine – orally disintegrating tablets of bilastine 10 mg or oral solution
of bilastine 2.5 mg/mL – may be more suitable for children aged between 6 and 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 TecniGen than you should
If you, or someone else, has taken an excessive amount of Bilastina TecniGen, contact
your doctor or pharmacist immediately or go to the emergency room of the nearest hospital. You
If you forget to take Bilastina TecniGen
Donot take a double dose to make up for a missed dose.
If you forget to take a dose on time, take it as soon as possible and then return to the regular
dosing schedule.
If you have any doubts about 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 notice symptoms of allergic reactions, the signs of which may include difficulty breathing,
dizziness, collapse 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 contact 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 from 1 to 10 users out of 1,000 to 1 in 100 people:
- abnormal electrocardiogram (ECG);
- blood tests showing changes in liver function;
- dizziness;
- stomach pain;
- fatigue;
- increased appetite;
- irregular heartbeat;
- weight gain;
- nausea;
- anxiety;
- feeling of dryness or discomfort in the nose;
- abdominal pain;
- diarrhea;
- gastritis (inflammation of the stomach lining);
- vertigo (a sensation of dizziness or spinning);
- feeling of weakness;
- thirst;
- dyspnea (difficulty breathing);
- dry mouth;
- indigestion;
- itching;
- cold sores (oral herpes);
- fever;
- tinnitus (ringing in the ears);
- difficulty sleeping;
- 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);
- 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 (pain in the abdomen/upper abdomen).
Uncommon: may affect up to 1 in 100 people:
- eye irritation;
- dizziness;
- loss of consciousness;
- diarrhea;
- nausea;
- swelling of the lips;
- eczema;
- urticaria;
- fatigue.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system
at
https:// 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 TecniGen
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 conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Bilastina TecniGen contains
- The active ingredient is bilastine. Each tablet contains 20 mg of bilastine.
- The other ingredients are microcrystalline cellulose (grade 102), sodium starch glycolate
(type A), anhydrous colloidal silica and magnesium stearate.
Description of the appearance of Bilastina TecniGen and contents of the pack
Bilastina TecniGen tablets are white to off-white in colour, oval in shape
with a break line and imprinted with "2" on one side of the break line and "0" on the other
side of the break line on one side, smooth on the other side.
Bilastina TecniGen tablets are available in blisters of 10, 20, 30, 40, 50 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tecnigen srl
Via Galileo Galilei 40
20092 Cinisello Balsamo (Italy).
Manufacturer
Tecnimede – Sociedade Técnico-Medicinal SA
Quinta da Cerca, Caixaria
2565-187 Dois Portos, Portugal.
Atlantic Pharma - Produções Farmacêuticas s.a., Rua
Tapada Grande 2, 2710-089 Abrunheira, Sintra, Portugal.
This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:
Italy - Bilastina TecniGen
Portugal – Bilastina Verum Pharma
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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 TEKNIJENPostać farmaceutyczna: Coated tablet, 20 MGSubstancja czynna: bilastineProducent: AUROBINDO PHARMA (ITALIA) S.R.L.Wymaga receptyPostać farmaceutyczna: Coated tablet, 20 MGSubstancja czynna: bilastineWymaga receptyPostać farmaceutyczna: Coated tablet, 20 mgSubstancja czynna: bilastineProducent: AUROBINDO PHARMA (ITALIA) S.R.L.Wymaga recepty
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BILASTINA TEKNIJEN 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 TEKNIJEN jest bilastine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
BILASTINA TEKNIJEN jest produkowany przez TECNIGEN 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 TEKNIJEN 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 TEKNIJEN 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 AUROBINDO. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
