LEVOCETIRIZINA 5 mg Tabletki Powlekane

Andrei Popov

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Dr Andrei Popov jest lekarzem rodzinnym ze specjalistycznym przygotowaniem w zakresie leczenia bólu przewlekłego. Prowadzi konsultacje wideo dla dorosłych w Hiszpanii i w całej Europie: zarówno jeśli od miesięcy zmagasz się z bólem, którego nikt nie potrafił dobrze wyjaśnić, jak i wtedy, gdy potrzebujesz rozwiązać problem zdrowotny bez czekania tygodniami na wizytę.

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Jak stosować LEVOKETIRITSINA SANDOTS

Treść ulotki

LEVOCETIRIZINA SANDOZ 5 mg film-coated tablets

LEVOCETIRIZINA SANDOZ 5 mg film-coated tablets

Levocetirizine (as dihydrochloride)

Read this leaflet carefully before you start to use 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, because 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 Sandoz is and what it is used for
2. What you need to know before you take Levocetirizina Sandoz
3. How to take Levocetirizina Sandoz
4. Possible side effects
5. How to store Levocetirizina Sandoz
6. Contents of the pack and other information.

1. WHAT IS LEVOCETIRIZINE SANDOZ AND WHAT IT IS USED FOR

Levocetirizine is an antihistamine medicine that is used to treat symptoms associated with allergic conditions, such as for example:

hay fever
perennial allergies, such as those to dust or animal dander
chronic urticaria

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOCETIRIZINE SANDOZ

Do not take Levocetirizine Sandoz

if you are allergic (hypersensitive) to levocetirizine or to any of the other ingredients of thismedicine(listed in section 6 ‘Contents of the pack and other information’).
if you suffer from severe renal impairment(creatinine clearance less than 10 ml/min)

Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizine Sandoz.
Inform and ask your doctor for advice if:

you suffer from epilepsy or if you are at risk of seizures for any other reason
you suffer from renal impairment. You may require a lower dose and must discuss your condition with your doctor
you are likely to be unable to empty your bladder (in conditions such as spinal cord injury or enlarged prostate)
you are planning to have allergy tests. Ask your doctor if you need to stop taking Levocetirizine Sandoz several days before the test. This medicine may affect the results of the allergy test.

Children
Levocetirizine Sandoz is not recommended in children under 6 years of age because the coated tablets
currently available do not allow for dose adjustment.

Other medicines and Levocetirizine Sandoz
The effects of other medicines can be affected by levocetirizine or can in turn affect the effects of levocetirizine.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter medicines.

Levocetirizine Sandoz with food, beverages and alcohol
Levocetirizine can be taken independently of food.
Taking levocetirizine at the same time as alcoholrequires caution. In sensitive patients, the effect of alcohol may be greater or different than expected.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
In some patients levocetirizine can cause drowsiness, fatigue and weakness. If you experience any of these symptoms, refrain from driving and operating any machinery.

Levocetirizine Sandoz contains lactose.
These tablets contain lactose; if your doctor has diagnosed you with intolerance tosome sugars, contact them before taking this medicine.

3. HOW TO TAKE LEVOCETIRIZINA SANDOZ

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
The tablet must be swallowed whole, with water or other liquid.
The normal dose for adults and children from 6 years of age is one tablet a day. Children under 6
years of age should not take Levocetirizina Sandoz 5 mg.
If you suffer from mild to moderate renal insufficiency, your doctor may prescribe you a lower dose,
depending on the severity of the kidney disease.
The duration of treatment depends on the type, duration and course of the disorders. Your doctor or
pharmacist will determine the duration of treatment.

If you take more Levocetirizina Sandoz than you should
If you have taken more levocetirizine than you should, drowsiness may occur in adults. Children may
initially show agitation and restlessness, followed by drowsiness.
Contact your doctor or pharmacist immediately, who may perform gastric lavage or adopt
other measures to relieve the symptoms.

If you forget to take Levocetirizina Sandoz
Do not take a double dose to make up for a missed dose. Skip the missed
dose and take the next one, at the usual time.

If you stop taking Levocetirizina Sandoz
Premature discontinuation of treatment with Levocetirizina Sandoz 5 mg should not cause any adverse
effects. The symptoms for which you took levocetirizine may however reappear.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, levocetirizine may cause side effects, although not everybody gets them.

Common side effects(may affect up to 1 in 10 people):
Drowsiness, headache, dry mouth, fatigue

Uncommon side effects(may affect up to 1 in 100 people):
Asthenia, abdominal pain.

Not known(frequency cannot be estimated from the available data)
Palpitations, increased heart rate, convulsions, paraesthesia, dizziness, syncope, tremor,
dysgeusia (distorted sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, oculogyric crisis (eyes with uncontrolled circular movements), painful or difficult urination,
inability to completely empty the bladder, oedema, pruritus, rash, urticaria (swelling, redness and
itching of the skin), skin eruption, shortness of breath, weight increase, muscle pain, joint pain,
aggressive or agitated behaviour, hallucinations, depression, insomnia, suicidal thoughts or recurrent suicidal ideation, hepatitis, hepatic dysfunction, vomiting, increased appetite, nausea, diarrhoea.
Pruritus (intense itching) after discontinuation.
At the first signs of hypersensitivity reactions, stop taking Levocetirizine Sandoz and inform your doctor.
Hypersensitivity reactions can include: swelling of the mouth, tongue, face and/or throat, difficulty
breathing or swallowing (feeling of tightness in the chest or wheezing), urticaria,
sudden drop in blood pressure which can cause 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
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE LEVOCETIRIZINA SANDOZ

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 and blister after
EXP.
The expiry date refers to the last day of the month.
Store the medicine in the original package to protect it 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 Levocetirizina Sandoz contains
The active ingredient is levocetirizine.
Each tablet contains 5 mg of levocetirizine dihydrochloride.
The other excipients are: microcrystalline cellulose, lactose (as monohydrate), magnesium stearate,
hypromellose (E 464), titanium dioxide (E 171) and macrogol 400.

Description of the appearance of Levocetirizina film Sandoz and package contents
Film-coated tablets, oval, biconvex, white to off-white in color, with “L9CZ” imprinted on
one side and “5” imprinted on the other.
The tablets are packaged in ALU/PVC/PVDC or OPA/ALU/PVC/ALU blisters inserted
in cardboard boxes.
Available packs:
6, 7, 10, 14, 15, 18, 20, 21, 28, 30, 30x1, 40, 50, 56, 60, 70, 90, 100, 112 or 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
SANDOZ S.p.A. Largo U. Boccioni, 1 21040 Origgio (VA)

Manufacturer responsible for batch release
Synthon BV, Microweg 22, 6545 CM Nijmegen, Netherlands
Synthon Hispania S.L., Castelló 1 Polígono Las Salinas, 08830 Sant Boi de Llobregat, Spain
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1 39179 Barleben - Germany

This medicinal product has been authorised in the Member States of the European Economic Area
under the following designations:
Belgium Levocetirizine Sandoz 5 mg film-coated tablets
France Levocetirizine Sandoz 5 mg, film-coated tablet
Germany Levocetirizin HEXAL® for Allergies
Italy Levocetirizina Sandoz
Netherlands Levocetirizine diHCl Sandoz 5 mg, film-coated tablets
United Kingdom Levocetirizine dihydrochloride 5 mg Tablets

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Kraj rejestracji
Włochy
Postać farmaceutyczna
Film-coated tablet, 5 MG
Kod ATC
R06AE09
Substancja czynna
levocetirizine
Wymaga recepty
Tak
Producent
SANDOZ S.P.A.
Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
Zamienniki LEVOKETIRITSINA SANDOTS
LEVOKETIRITSINA AUROBINDO
Postać farmaceutyczna: Film-coated tablet, 5 MG
Substancja czynna: levocetirizine
Producent: AUROBINDO PHARMA (ITALIA) S.R.L.
Wymaga recepty
LEVOKETIRITSINA DOK JENERIKI
Postać farmaceutyczna: Film-coated tablet, 5 MG
Substancja czynna: levocetirizine
Producent: DOC GENERICI SRL
Wymaga recepty
LEVOKETIRITSINA KRKA
Postać farmaceutyczna: Film-coated tablet, 5 MG
Substancja czynna: levocetirizine
Producent: KRKA D.D. NOVO MESTO
Wymaga recepty

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Odpowiednik LEVOKETIRITSINA SANDOTS w Hiszpania

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