EBASTINA 10 mg Tabletka Orodispersyjna
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Treść ulotki
Ebastina Mylan Pharma 10 mg orodispersible tablets, 20 mg orodispersible 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 their symptoms are the same as yours, as it could 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 is Ebastina Mylan Pharma and what it is used for
2. What you need to know before you take Ebastina Mylan Pharma
3. How to take Ebastina Mylan Pharma
4. Possible side effects
5. How to store Ebastina Mylan Pharma
6. Contents of the pack and other information
1. What is Ebastina Mylan Pharma and what it is used for
Ebastine is an antihistamine that helps relieve allergy symptoms such as sneezing, runny nose, watery eyes and itchy skin rashes.
In adults and children aged 12 years and over, Ebastina Mylan Pharma is used to relieve the symptoms of seasonal and perennial allergic rhinitis (hay fever), including cases with allergic conjunctivitis.
In adults over 18 years of age, Ebastina Mylan Pharma 10 mg is used to relieve itching and the development of wheals in urticaria.
2. What you need to know before taking Ebastina Mylan Pharma
Do not take Ebastina Mylan Pharma
- if you are allergic to ebastine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Ebastina Mylan Pharma:
- if you have low levels of potassium in your blood;
- if you are already taking certain antibiotics or medicines used to treat fungal infections: see below “ Other medicines andEbastina Mylan Pharma”;
- if you have severely impaired liver function (hepatic insufficiency).
Children and adolescents
This medicine should only be used in children aged 12 years and over. Do not
give this medicine to children under 12 years of age as safety and efficacy in this age group have not been established.
Other medicines and Ebastina Mylan Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
The concurrent use of Ebastina Mylan Pharma and erythromycin (antibiotic) or
ketoconazole, itraconazole (active ingredients for the treatment of fungal infections) may
lead to elevated blood levels of ebastine. The concomitant administration of ebastine
with rifampicin (antituberculosis agent) may cause low blood levels of ebastine and therefore
reduced effects. The concomitant use of Ebastina Mylan Pharma with clarithromycin or
josamycin (antibiotics) is not recommended.
Ebastina Mylan Pharma with food and drink
You can take Ebastina Mylan Pharma independently of meals.
Pregnancy, breastfeeding and fertility
Currently there are limited data in humans on safety for the fetus. Therefore, you should take
Ebastina Mylan Pharma during pregnancy only if the doctor considers that the expected benefit outweighs the
possible risks.
Do not take Ebastina Mylan Pharma if you are breastfeeding a newborn baby, as it is
not known whether the active ingredient passes into breast milk.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Driving and using machines
Most patients treated with Ebastina Mylan Pharma can drive or perform
other activities that require good reaction ability. However, as with all
medicines, you should check your individual reaction after taking Ebastina
Mylan Pharma before driving or performing complicated activities, as some patients
may experience drowsiness or dizziness.
Ebastina Mylan Pharma contains
- lactose: if you have been diagnosed with intolerance to certain sugars, contact your doctor
before taking Ebastina Mylan Pharma;
- aspartame (E951), a source of phenylalanine, which may be harmful to you if you have phenylketonuria.
3. How to take Ebastina Mylan Pharma
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is:
Indication Age Dose
Allergic rhinitis
In case of
severe symptoms
One tablet of Ebastina Mylan Pharma 10
mg (10 mg of ebastine) per day
Two tablets of Ebastina Mylan Pharma 10
mg or one tablet of Ebastina Mylan
Pharma 20 mg (20 mg of ebastine) once a
day
Urticaria Adults over 18
years
Children aged 12
years and over and adults
One tablet of Ebastina Mylan Pharma 10
mg (10 mg of ebastine) once a day
In patients with impaired renal function, no dose adjustment is necessary.
In patients with mild to moderate hepatic impairment, no dose adjustment is necessary.
In patients with severe hepatic insufficiency, there is no experience with doses higher than
10 mg; therefore, in these patients, the dose should not exceed 10 mg.
Do not push the tablet out of its compartment to avoid breakage.
Each blister contains tablets separated into compartments by perforations. Detach one
compartment along the dotted lines (figure 1).
Carefully remove the protective film, starting from the corner indicated by the arrow
(figures 2 and 3).
With dry hands, remove the tablet from the strip.
Place the tablet on your tongue where it will dissolve in a few seconds: no water or other liquids are necessary.
Ebastina Mylan Pharma can be taken regardless of meal times.
The doctor will determine the duration of use.
If you take more Ebastina Mylan Pharma than you should
There is no specific antidote for the active ingredient ebastine.
If you suspect an overdose with Ebastina Mylan Pharma, inform your doctor. Depending on the
severity of the intoxication, the doctor will take appropriate measures (monitoring of
vital functions, including monitoring via ECG for at least 24 hours, symptomatic
treatment and gastric lavage), if necessary.
If you forget to take Ebastina Mylan Pharma
Do not take a double dose to make up for a missed dose.
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 everyone gets them.
Stop taking Ebastina Mylan Pharma and contact your doctor immediately or go to the nearest hospital if the following occurs:
- Severe allergic reaction that causes swelling of the face, tongue or throat and that can cause difficulty swallowing or breathing.
Other side effects include:
Very common side effectscan affect more than 1 in 10 people :
Headache
Common side effectscan affect up to 1 in 10 people :
Drowsiness
Dry mouth
Uncommon side effectscan affect up to 1 in 100 people
Sore throat (pharyngitis), runny nose (rhinitis), nosebleeds
Rare side effectscan affect up to 1 in 1,000 people
Nervousness, insomnia
Altered sense of touch, decreased sense of touch
Taste disorders
Palpitations, fast heartbeat
Abdominal pain, nausea, indigestion
Vomiting
Abnormal liver function tests
Liver inflammation
Problems with the elimination of bile causing itching, yellowing of the skin and
eyes
Skin rash, hives, skin inflammation
Menstrual disorders
Edema (fluid retention in the tissues), weakness (asthenia)
Dizziness
Very rare side effectscan affect up to 1 in 10,000 people
Widespread skin rash, eczema.
Painful menstruation.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili”. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ebastina Mylan Pharma
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 blister and on the
pack after ‘EXP’. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
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 to
protect the environment.
6. Contents of the pack and other information
What Ebastina Mylan Pharma contains
The active ingredient is ebastine. Each orodispersible tablet contains 10 mg of
ebastine. Each orodispersible tablet contains 20 mg of ebastine.
The other ingredients are microcrystalline cellulose, lactose monohydrate, corn starch, croscarmellose sodium, aspartame (E951), peppermint flavour, anhydrous colloidal silica and
magnesium stearate.
Description of the appearance of Ebastina Mylan Pharma and contents of the pack
Orodispersible tablet
Ebastina 10 mg: white, biconvex, round tablets, with the inscription ‘E10’ on
one side, smooth on the other side.
Ebastina 20 mg: white, biconvex, round tablets, with the inscription ‘E20’ on
one side, smooth on the other side.
Available in packs of:
10 mg: 10, 20, 30, 40, 50, 90, 98 and 100 orodispersible tablets.
20 mg: 10, 15, 20, 30, 40, 50, 98 and 100 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan, Italy
Manufacturers:
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary
Teva Pharma, S.L.U.
C/C, n° 4, Poligono Industrial Malpica,
50016 Zaragoza
Spain
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- Kraj rejestracji
- Postać farmaceutycznaOrodispersible tablet, 10 MG
- Kod ATCR06AX22
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki EBASTINA MYLAN PARMAPostać farmaceutyczna: Film-coated tablet, 10 MGSubstancja czynna: ebastineProducent: ALMIRALL S.A.Wymaga receptyPostać farmaceutyczna: Orodispersible tablet, 10 MGSubstancja czynna: ebastineProducent: LABORATORIO CHIMICO DECA DR.CAPUANI S.R.L.Wymaga receptyPostać farmaceutyczna: Orodispersible tablet, 10 MGSubstancja czynna: ebastineProducent: ARISTO PHARMA GMBHWymaga recepty
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EBASTINA MYLAN PARMA wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w EBASTINA MYLAN PARMA jest ebastine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
EBASTINA MYLAN PARMA jest produkowany przez MYLAN S.P.A.. 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 EBASTINA MYLAN PARMA 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 EBASTINA MYLAN PARMA 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 (ebastine) to m.in. KLEVER, DEKASTIN, EBARIK. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
