LEVOCETIRIZINA 5 mg Tabletki Powlekane
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Treść ulotki
LEVOCETIRIZINA TEVA 5 mg film-coated tablets
For adults and children starting from 6 years of age
Levocetirizine dihydrochloride
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 Levocetirizina Teva is and what it is used for
- 2. What you need to know before you take Levocetirizina Teva
- 3. How to take Levocetirizina Teva
- 4. Possible side effects
- 5. How to store Levocetirizina Teva
- 6. Contents of the pack and other information
1. What is Levocetirizina Teva and what it is used for
The active ingredient of Levocetirizina Teva is levocetirizine dihydrochloride.
Levocetirizina Teva is an antiallergic medicine.
Levocetirizina Teva is used for the treatment of signs of the disease (symptoms) associated with:
- allergic rhinitis (including persistent allergic rhinitis);
- urticaria. Antihistamines such as Levocetirizina Teva relieve the unpleasant symptoms and discomfort associated with the conditions listed below, such as sneezing, irritated, runny or congested nose, itching, redness and watering of the eyes and skin rashes.
2. What you need to know before taking Levocetirizina Teva
Do not take Levocetirizina Teva
- if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine or any of the other ingredients of this medicine (listed in section 6).
- if you have severe impairment of kidney function (severe renal insufficiency with creatinine clearance less than 10 ml/min).
Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizina Teva.
Ask your doctor for advice if you are likely to be unable to empty your bladder (in conditions such as spinal cord injury or enlarged prostate).
If you suffer from epilepsy or are otherwise at risk of seizures, ask your doctor.
If you are to have an allergy test, ask your doctor if you should stop taking Levocetirizina Teva for a few days before the test. This medicine may alter the results of the allergy test.
Children
The use of Levocetirizina Teva is not recommended in children under 6 years of age as the film-coated tablets do not allow for dose adjustment.
Other medicines andLevocetirizina Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Levocetirizina Teva with food, beverages and alcohol
Caution is advised if Levocetirizina Teva is taken together with alcohol or other substances that affect the brain.
In sensitive patients, the simultaneous use of Levocetirizina Teva and alcohol or other substances that affect the brain may cause further reduction in alertness and impaired performance.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine .
Driving and using machines
Some patients, following treatment with Levocetirizina Teva, may experience drowsiness/somnolence, fatigue and weakness. Caution is advised when driving or operating machinery until you know how this medicine affects you. Specific tests, conducted on healthy volunteers, have not however detected any reduction in the degree of alertness, reaction capacity or driving ability following the administration of levocetirizine at the recommended dosage.
Levocetirizina Teva contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.
3. How to take Levocetirizina Teva
Always take this medicine exactly as your doctor or pharmacist has told you. If you have doubts
consult your doctor or pharmacist.
Adults and children starting from 6 years of age
The recommended dose for adults and children 6 years of age and over is one tablet a day.
Special dosage instructions for specific populations
Renal and hepatic impairment
Patients who have severe impairment of renal function (severe renal insufficiency with
creatinine clearance less than 10 ml/min) should not take Levocetirizina Teva.
Patients with impaired renal function and patients who have both renal and hepatic
impairment may be given a lower dose according to the severity of their renal disease and,
in children, the dose will be chosen based on body weight; the dose will be determined by the doctor.
Patients who have only impaired hepatic function should take the usual prescribed dose.
Elderly patients aged ≥ 65 years
No dose adjustment is necessary in elderly patients, provided their renal function is
normal.
Use in children
Levocetirizina Teva is not recommended for children under 6 years of age.
How and when should you take Levocetirizina Teva?
For oral use only.
The tablets should be swallowed whole with water and can be taken with or without food.
How long should you take Levocetirizina Teva?
The duration of treatment depends on the type, duration and course of your condition and is determined by the doctor.
If you take more Levocetirizina Teva than you should
If you take more Levocetirizina Teva than you should, drowsiness may occur in adults. Children may initially show excitement and restlessness, followed by drowsiness.
If you think you have taken an excessive dose of Levocetirizina Teva, inform your doctor, who will decide what actions
need to be taken.
If you forget to take Levocetirizina Teva
If you forget to take Levocetirizina Teva, do not take a double dose to make up for the missed
dose; take the next dose at the scheduled time.
If you stop taking Levocetirizina Teva
Stopping treatment with Levocetirizina Teva does not cause any harmful effects. However, if
you stop treatment with Levocetirizina Teva, itching (intense tingling) may rarely occur, even
if this symptom was not present before starting treatment.
These symptoms may resolve spontaneously. In some cases, the symptoms may be severe and it may be
necessary to restart treatment. These symptoms should resolve when you restart treatment.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Levocetirizina Teva can cause side effects, although not everybody gets them.
At the first signs of a hypersensitivity reaction, stop taking Levocetirizina Teva and tell your
doctor. Symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face and/or throat, difficulty
breathing or swallowing (chest tightness or wheezing), hives, sudden drop in blood pressure leading to collapse or
shock, which could be fatal.
Common side effects(may affect up to 1 in 10 people):
- dry mouth;
- headache;
- fatigue;
- drowsiness/sedation. Uncommon side effects(may affect up to 1 in 100 people):
- asthenia;
- abdominal pain.
Frequency not known(the frequency cannot be estimated from the available data):
- increased appetite;
- aggressive or agitated behaviour, hallucinations, depression, insomnia, recurrent worries or suicidal thoughts;
- convulsions, paraesthesia, dizziness, syncope, tremor, dysgeusia (altered taste);
- sensation of spinning or movement;
- visual disturbances, blurred vision, oculogyric crisis (eyes with uncontrolled circular movements);
- palpitations, increased heart rate;
- shortness of breath;
- nausea, vomiting and diarrhoea;
- hepatitis, abnormal liver function tests;
- painful urination or difficulty urinating, inability to completely empty the bladder;
- fixed drug eruption, itching, rash, urticaria (swelling, redness and itching of the skin);
- itching (intense prickling) following discontinuation of treatment;
- muscle pain, joint pain;
- oedema;
- weight gain.
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 reported at the
address www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects you
can help to provide more information on the safety of
this medicine.
5. How to store Levocetirizina Teva
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton or blister. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What Levocetirizina Teva Contains
- The active ingredient is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
- The other ingredients are microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide (E171) and macrogol 400.
Description of the Appearance of Levocetirizina Teva and Package Contents
The film-coated tablets of Levocetirizina Teva are white to almost white and oval; “LC5” is imprinted on one
side of the tablet. The other side of the tablet is smooth.
Levocetirizina Teva is available in blisters of 7, 10, 14, 15, 20, 21, 28, 30, 40, 50, 60, 90 and 100 film-coated
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. Piazzale Luigi Cadorna, 4 - 20123 Milano
Manufacturer
Teva Pharmaceutical Works Private Limited Company- Pallagi st. 13 - H-4042 Debrecen (Hungary)
Teva Pharmaceutical Works Private Limited Company - Tàncsics Mihàly st. 82 - 2100 Gödöllő (Hungary)
Teva UK Ltd. - Brampton Road - Hampden Park – BN 22 9AG Eastbourne – East Sussex (United Kingdom)
Pharmachemie B.V. - Swensweg 5 – P.O. Box 552 - 2003 RN Haarlem (Netherlands)
GALIEN LPS 98 Rue Bellocier, 89100 Sens, France
This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Belgium Levocetiriteva 5 mg film-coated tablets/comprimés pelliculés/Filmtabletten
Denmark Levocetirizindihydrochlorid Teva
France Levocetirizine teva 5 mg, comprimé pelliculé
Germany Levocetirizin Teva 5 mg Filmtabletten
Hungary Novocetrin 5 mg filmtabletta
Ireland Levocetirizine Teva 5 mg film coated tablets
Italy Levocetirizina Teva 5 mg film-coated tablets
Malta Levocetirizine Teva 5 mg film coated tablets
Slovakia Levocetirizin Teva 5 mg filmom obalené tablety
Spain Levocetirizina Teva 5 mg comprimidos recubiertos con película EFG
Netherlands Levocetirizine diHCl 5 PCH, filmomhulde tabletten 5mg
United Kingdom Levocetirizine 5mg Film coated tablets
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- Kraj rejestracji
- Postać farmaceutycznaFilm-coated tablet, 5 MG
- Kod ATCR06AE09
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki LEVOKETIRITSINA TEVAPostać farmaceutyczna: Film-coated tablet, 5 MGSubstancja czynna: levocetirizineProducent: AUROBINDO PHARMA (ITALIA) S.R.L.Wymaga receptyPostać farmaceutyczna: Film-coated tablet, 5 MGSubstancja czynna: levocetirizineProducent: DOC GENERICI SRLWymaga receptyPostać farmaceutyczna: Film-coated tablet, 5 MGSubstancja czynna: levocetirizineProducent: KRKA D.D. NOVO MESTOWymaga recepty
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LEVOKETIRITSINA TEVA wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w LEVOKETIRITSINA TEVA jest levocetirizine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
LEVOKETIRITSINA TEVA jest produkowany przez TEVA 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 LEVOKETIRITSINA TEVA 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 LEVOKETIRITSINA TEVA 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 (levocetirizine) to m.in. LEVOKETIRITSINA AUROBINDO, LEVOKETIRITSINA DOK JENERIKI, LEVOKETIRITSINA KRKA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
