LEVOCETIRIZINA 5 mg Tabletki Powlekane
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Levocetirizina Aurobindo 5 mg film-coated tablets
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 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 Aurobindo is and what it is used for
- 2. What you need to know before you take Levocetirizina Aurobindo
- 3. How to take Levocetirizina Aurobindo
- 4. Possible side effects
- 5. How to store Levocetirizina Aurobindo
- 6. Contents of the pack and other information
1. What Levocetirizina Aurobindo is and what it is used for
The name of your medicine is Levocetirizina Aurobindo film-coated tablets and it contains the active substance levocetirizine dihydrochloride.
Levocetirizina Aurobindo is an antihistamine medicine.
For the treatment of signs of the disease (symptoms) associated with:
- allergic rhinitis (including perennial allergic rhinitis);
- urticaria.
2. What you need to know before you take Levocetirizina Aurobindo
Do not take Levocetirizina Aurobindo
- If you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine or any of the other ingredients of Levocetirizina Aurobindo (listed in section 6).
- If you have a severe impairment of kidney function (severe renal insufficiency with creatinine clearance less than 10 ml/min).
- If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizina Aurobindo.
If you are unable to empty your bladder (due to medical conditions such as spinal cord injury
or an enlarged prostate), ask your doctor for advice.
If you suffer from epilepsy or are at risk of seizures, ask your doctor for advice as the use of
Levocetirizina Aurobindo may worsen the seizure.
If you are going to have an allergy test, ask your doctor if you should stop taking Levocetirizina
Aurobindo for a few days before the test. This medicine may alter the results of the allergy test.
Children
The use of Levocetirizina Aurobindo is not recommended in children under 6 years of age, as the film-coated
tablets do not allow for dose adjustment.
Other medicines and Levocetirizina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Levocetirizina Aurobindo with food, beverages and alcohol
Caution is advised if Levocetirizina Aurobindo is taken together with alcohol or other substances that act on the
brain. In sensitive patients, the simultaneous intake of Levocetirizina Aurobindo and alcohol or other
substances that act on the brain may cause further reduction in alertness and impairment of
performance.
Levocetirizine can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are 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, following treatment with levocetirizine, may experience drowsiness/torpor,
fatigue and weakness. Caution is advised when driving or operating machinery until you know
the effect of this medicine on you. Specific tests conducted on healthy volunteers have not
however detected any reduction in alertness, reaction ability or driving ability following the intake of levocetirizine at the recommended dosage.
Levocetirizina Aurobindo contains lactose
These tablets contain lactose; if your doctor has diagnosed you with an intolerance to certain
sugars, contact him/her before taking this medicine.
3. How to take Levocetirizina Aurobindo
Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
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 with impaired renal function may be given a lower dose according to
the severity of their kidney disease, and in children the dose will be chosen based on body weight; the dose
will be determined by the doctor.
Patients who have severe impairment of renal function should not take Levocetirizina
Aurobindo.
Patients who have only impaired hepatic function should take the usual prescribed dose.
Patients who have both hepatic and renal impairment may be given a lower dose
in relation to the severity of the kidney disease and, in children, the dose will also be chosen based on weight
body; the dose will be determined by the doctor.
Elderly patients aged 65 years and over
No dose adjustment is necessary in elderly patients, provided their renal function is
normal.
Use in children
Levocetirizina Aurobindo is not recommended for children under 6 years of age.
How and when to take Levocetirizina Aurobindo?
For oral use only.
The film-coated tablets of Levocetirizina Aurobindo must be swallowed whole with water and
can be taken with or without food.
How long should you take Levocetirizina Aurobindo?
The duration of treatment depends on the type, duration and course of your disorder and is established by the
doctor.
If you take more Levocetirizina Aurobindothan you should
If you take more levocetirizine 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 Aurobindo, inform your doctor, who will decide what actions should be
taken.
If you forget to take Levocetirizina Aurobindo
If you forget to take Levocetirizina Aurobindo, 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 scheduled time.
If you stop taking Levocetirizina Aurobindo
Stopping treatment should have no negative effects. However, if you stop the
treatment with Levocetirizina Aurobindo, itching (intense tingling) may rarely occur, even if
this symptom was not present before the start of treatment. This symptom may resolve
spontaneously. In some cases, the symptom may be severe and it may be necessary to restart the
treatment. This symptom should resolve when you restart treatment.
If you have any further 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: may affect up to 1 in 10 people
Dry mouth, headache, fatigue and drowsiness/somnolence.
Uncommon: may affect up to 1 in 100 people
Weakness and abdominal pain
Not known: frequency cannot be estimated from available data
Other side effects have been reported such as palpitations, increased heart rate, convulsions,
tingling, dizziness, syncope, tremor, dysgeusia (altered sense of taste), sensation of rotation or
movement, visual disturbances, blurred vision, oculogyric crisis (eyes with uncontrolled circular movements),
pain or difficulty in urination, inability to completely empty the bladder, edema, itching, rash,
urticaria (swelling, redness and itching of the skin), skin eruption, shortness of breath, increase in
weight, muscle pain, joint pain, aggressive or agitated behaviour, hallucination, depression,
insomnia, recurring worries or suicidal thoughts, hepatitis, abnormal liver function, vomiting,
increased appetite, nausea and diarrhoea. Itching (intense prickling) following discontinuation of treatment.
Stop taking Levocetirizina Aurobindo at the first signs of a hypersensitivity reaction and contact your
doctor immediately. Symptoms of a hypersensitivity reaction may include: swelling of the mouth,
tongue, face and/or throat, difficulty breathing or swallowing (tightness in the chest or wheezing),
urticaria, sudden drop in blood pressure which can lead 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 provide more
information on the safety of this
medicine.
5. How to store Levocetirizina 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 packaging after “EXP”.
The expiry date refers to the last day of the month.
Store in the original packaging to protect the medicine from moisture.
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 LevocetirizinaAurobindocontains
- The active ingredient is levocetirizine. Each tablet contains 5 mg of levocetirizine dihydrochloride, equivalent to 4.2 mg of levocetirizine.
- The excipients are microcrystalline cellulose, lactose monohydrate, magnesium stearate (core) and hypromellose (E464), titanium dioxide (E171) and macrogol 400 (coating).
Description of the appearance of Levocetirizina Aurobindo and package contents
Film-coated tablets, white to off-white in color, oval, biconvex with “L9CZ” imprinted on one side and “5” imprinted on the other.
Packs of blisters containing 7, 10, 14, 15, 20, 21, 28, 30, 40, 50, 56, 60, 70, 90, 100, 112 or 120
tablets per pack are available.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
- 21047 - Saronno (VA)
Manufacturer
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Belgium Levocetirizin AB 5 mg film-coated tablets
France Levocetirizine Arrow 5 mg coated tablet
Germany Levocetirizin-Actavis 5 mg film tablets
Italy Levocetirizina Aurobindo
Netherlands Levocetirizine 2HCl Aurobindo 5 mg, film-coated tablets
United Kingdom Levocetirizine dihydrochloride 5 mg 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 AUROBINDOPostać 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 receptyPostać farmaceutyczna: Film-coated tablet, 5 MGSubstancja czynna: levocetirizineProducent: MYLAN S.P.A.Wymaga recepty
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LEVOKETIRITSINA 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 LEVOKETIRITSINA AUROBINDO jest levocetirizine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
LEVOKETIRITSINA 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 LEVOKETIRITSINA 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.
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Możesz kupić LEVOKETIRITSINA AUROBINDO w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
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Inne leki zawierające tę samą substancję czynną (levocetirizine) to m.in. LEVOKETIRITSINA DOK JENERIKI, LEVOKETIRITSINA KRKA, 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.
