LEVOCETIRIZINA 5 mg Tabletki Powlekane
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Treść ulotki
Levocetirizina Krka 5 mg film-coated tablets
Levocetirizine dihydrochloride
Generic medicine
Read this leaflet carefully before you start 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 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 Levocetirizina Krka is and what it is used for
- 2. What you need to know before you take Levocetirizina Krka
- 3. How to take Levocetirizina Krka
- 4. Possible side effects
- 5. How to store Levocetirizina Krka
- 6. Contents of the pack and other information
1. What Levocetirizina Krka is and what it is used for
Levocetirizine dihydrochloride is the active ingredient of Levocetirizina Krka.
Levocetirizina Krka is an antiallergic medicine.
For the treatment of signs of illness (symptoms) associated with:
allergic rhinitis (including persistent allergic rhinitis);
itching (urticaria).
2. What you need to know before you take Levocetirizina Krka
Do not take Levocetirizina Krka
- if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine or any of the other ingredients of this medicine (listed in section 6)
- if your kidney function is severely impaired (severe renal insufficiency with creatinine clearance less than 10 ml/min).
Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizina Krka.
If you are likely to be unable to empty your bladder (in conditions such as spinal cord injury
or enlarged prostate), ask your doctor for advice.
If you suffer from epilepsy or there is a risk of seizures, ask your doctor for advice as the use of
Levocetirizina Krka may worsen seizures.
If an allergy test is planned, ask your doctor if you should stop taking Levocetirizina Krka for a few days before the test. This medicine may affect the results of the
allergy test.
Children
The use of Levocetirizina Krka is not recommended in children under 6 years of age because the
film-coated tablets do not allow for dose adjustment.
Other medicines and Levocetirizina Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Levocetirizina Krka with food, beverages and alcohol
Caution is advised if Levocetirizina Krka is taken at the same time as alcohol or other agents
that act on the brain.
In sensitive patients, the concomitant administration of Levocetirizina Krka and alcohol or other agents
that act at the central level may cause additional reductions in alertness and
impaired performance.
Levocetirizina Krka can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Some patients taking Levocetirizina Krka may experience drowsiness/torpor,
fatigue and weakness. Pay attention when driving or using machines until you
know how this medicine affects you. However, specific tests have not revealed
any impairment of mental alertness, reaction capacity or ability to drive
in healthy subjects tested after taking levocetirizine at the recommended doses.
Levocetirizina Krka contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact him
before taking the medicine.
3. How to take Levocetirizina Krka
Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
The recommended dose for adults and children aged 6 years and over is one tablet
per day.
Special instructions for dosage in specific populations
Renal and hepatic impairment
Patients with renal impairment may be prescribed a lower dose, depending on the
severity of their condition, and in children the dose will also be chosen based on body
weight; the dose will be established by your doctor.
Patients who have severe renal impairment should not take Levocetirizina Krka.
Patients who have only impaired liver function should take the usual
prescribed dose.
Patients with impaired function of both the kidneys and liver may be prescribed a lower dose
depending on the severity of the renal disease and in children the dose will also be chosen based on
body weight; the dose will be determined by the doctor.
Elderly patients over 65 years of age
No dose adjustment is necessary for elderly patients, provided their renal function
is normal.
Use in children
Levocetirizina Krka is not recommended for children under 6 years of age.
How and when to take Levocetirizina Krka?
For oral use only.
The tablets should be swallowed whole with water and can be taken with or without food.
For how long to take Levocetirizina Krka?
The duration of treatment depends on the type, duration and course of the disorders and is determined by
the doctor.
If you take more Levocetirizina Krka than you should
If you take more Levocetirizina Krka than you should, adults may experience drowsiness.
Children may initially show excitement and restlessness followed by drowsiness.
If you think you have taken an overdose of Levocetirizina Krka, inform your doctor who will decide the
measures to take.
If you forget to take Levocetirizina Krka
If you forget to take Levocetirizina Krka, or if you take a dose lower than that prescribed by
the doctor, do not take a double dose to make up for the missed dose. Take the next dose
at the usual time.
If you stop taking Levocetirizina Krka
Stopping treatment should have no harmful effects. However, rarely, itching (intense itching sensation) may occur if you stop treatment with Levocetirizina Krka, even if
these symptoms were not present before starting treatment. The symptoms should resolve
spontaneously. In some cases, the symptoms may be severe and may require resumption of
treatment. The symptoms should resolve when treatment is resumed.
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.
Common side effects (may affect up to 1 in 10 people):
Dry mouth, headache, fatigue and drowsiness/numbness.
Uncommon side effects (may affect up to 1 in 100 people):
Extreme fatigue and abdominal pain.
Not known (frequency cannot be estimated from the available data):
Other side effects such as palpitations, increased heart rate, seizures, tingling, dizziness,
syncope, tremor, dysgeusia (distortion of the sense of taste), sensation of spinning or of
movement, visual disturbances, blurred vision, oculo-rotation (eyes with uncontrolled circular movements)), painful or difficult urination, inability to completely empty the bladder, edema,
pruritus, rash, urticaria (swelling, redness and itching of the skin), skin eruption, shortness of breath,
weight gain, muscle pain, joint pain, aggressive or agitated behaviour,
hallucination, depression, insomnia, recurrent thoughts or suicidal worry, nightmares, hepatitis,
abnormal liver function, vomiting, increased appetite, nausea and diarrhoea. Pruritus (intense
itching sensation) after discontinuation of treatment.
At the first signs of a hypersensitivity reactionstop taking Levocetirizina Krka and see
your doctor immediately. Symptoms of a hypersensitivity reaction may include swelling of the
mouth, tongue, face and/or throat, difficulty breathing or swallowing (chest tightness or
breathlessness), urticaria, sudden drop in blood pressure leading to collapse or shock, which
can be fatal.
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.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help to provide more information on the
safety of this medicine.
5. How to store Levocetirizina Krka
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 pack after EXP. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
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 Levocetirizina Krka contains
- The active ingredient is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
- The other excipients are lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica and magnesium stearate in the tablet core and lactose monohydrate, hypromellose 6cP, titanium dioxide (E171), macrogol 3000 and triacetin in the film coating (see section 2).
Description of the appearance of Levocetirizina Krka and package contents
The tablets are white, round, biconvex, film-coated with bevelled edges.
The tablets are available in packs of 7, 10, 14, 20, 28, 30, 50, 60, 90, 98 and 100 film-coated tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. Viale Achille Papa 30, 20149 Milano, Italy
Manufacturer
KRKA, d.d., Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Str.5, 27472 Cuxhaven, Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following denominations:
| Member State Name | Medicinal Product Name |
| Czech Republic, Estonia, Lithuania, Hungary, Poland, Romania, Slovakia, Slovenia | l e Cezera |
| Bulgaria | ЦЕЗЕРА |
| Austria, Denmark | d Levocetirizin Krka |
| Italy, Spain | Levocetirizina Krka |
| France, Ireland, Netherlands | Levocetirizine Krka |
| Greece | a Levocet |
| Germany | Levocetirizin TAD |
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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 KRKAPostać 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: MYLAN S.P.A.Wymaga recepty
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LEVOKETIRITSINA KRKA 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 KRKA jest levocetirizine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
LEVOKETIRITSINA KRKA jest produkowany przez KRKA D.D. NOVO MESTO. 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 KRKA 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 KRKA 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 MYLAN. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
