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 MYLAN

Treść ulotki

Levocetirizina Mylan 5 mg film-coated tablets

Levocetirizina Mylan 5 mg film-coated tablets

levocetirizine dihydrochloride

generic medicine

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

1. What Levocetirizina Mylan is and what it is used for

Levocetirizina is an anti-allergic agent that is used to treat symptoms associated with allergic conditions, such as for example:
allergic rhinitis (including persistent allergic rhinitis)
urticaria.

2. What you need to know before you take Levocetirizina Mylan

Do not take Levocetirizina Mylan

if you are allergic to levocetirizine, cetirizine, hydroxyzine or other drugs known as piperazines or to any of the other ingredients of this medicine (listed in section 6)
if you have severe kidney failure (severe renal insufficiency with creatinine clearance less than 10 ml/min)

Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizina Mylan.
If you are unable to empty your bladder (due to conditions such as a spinal cord injury or
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 Mylan may worsen the seizure.
If you need to have an allergy test, ask your doctor if you should stop taking Levocetirizina Mylan
for a few days before the test. This medicine may alter the results of the allergy test.

Children
The use of Levocetirizina Mylan is not recommended in children under 6 years of age because the
tablets cannot be broken to allow dosage adjustment.

Other medicines and Levocetirizina Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The effects of other medicines can be influenced by levocetirizine or, in turn, influence the effects of levocetirizine.

Levocetirizina Mylan with alcohol
Taking Levocetirizina Mylan at the same time as alcohol or other substances that affect the
brain requires caution. In sensitive patients, it may cause a 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 with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
In some patients levocetirizine may cause drowsiness/somnolence, fatigue and exhaustion. Special
tests have not revealed any impairment of mental alertness, reaction capacity or ability to
drive in healthy people after taking levocetirizine at the recommended dose. However, if you experience any
of these symptoms, refrain from driving and operating any machinery.

Levocetirizina Mylan contains lactose
These tablets contain lactose; if your doctor has diagnosed you with an intolerance to some
sugars,contact your doctor before taking this medicine.

3. How to take Levocetirizina Mylan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The tablet should be swallowed whole with water and can be taken with or without food.
The recommended 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 Mylan.

Instructions for dosage in specific patient populations:
If you suffer from renal insufficiencyfrom mild to moderate, your doctor may prescribe a lower dose to
you depending on the severity of the kidney disease.
Patients with only impaired liver function should take the usual prescribed dose.
Patients who present with simultaneous impairment of liver and kidney function may
take a lower dose depending on the severity of the kidney disease.
No dose adjustment is necessary in elderly patients, provided their kidney function is
normal.

Use in children and adolescents
Levocetirizina Mylan is not recommended in children under 6 years of age as
the tablets cannot be broken to take the correct dose. For children between the ages of 2 and 6
years, it is recommended to use a formulation intended for children.
In children suffering from reduced kidney function, the dose will be calculated based on kidney
function and body weight; the dose will be determined by the doctor.

If you take more Levocetirizina Mylan than you should
If you have taken more Levocetirizina Mylan than you should, drowsiness/torpor may occur in adults. Children may initially show excitement and restlessness followed by drowsiness/torpor.
If you think you have taken an excessive dose of Levocetirizina Mylan, inform your doctor who will decide what
measures need to be taken.

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

If you stop taking Levocetirizina Mylan
Stopping treatment should have no negative effects. However, itching (tingling) may
occur even if it was not present before starting treatment. This symptom may resolve
spontaneously or become more intense and it may be necessary to restart treatment.
If you have any further questions 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.
manifest.

Immediately inform your doctor or contact the nearest emergency room if you experience the following
serious side effects:
Not known (frequency cannot be estimated based on available data)

Allergic reactions, such as swelling of the mouth, face and/or throat or difficulty swallowing with hives (angioedema), difficulty breathing or a sudden drop in blood pressure leading to collapse or shock, which can be fatal.
Convulsions or epileptic seizures.
Recurrent thoughts of worry and suicide.

Other side effects are:
Common (may affect up to 1 in 10 people):

Dry mouth
Headache
Fatigue
Drowsiness/sedation

Uncommon (may affect up to 1 in 100 people):

Weakness
Abdominal pain.

Not known (frequency cannot be estimated based on available data):

Aggression
Agitation
Vision disorders
Oculogyric crisis (eyes with uncontrolled circular movements)
Palpitations
Nausea
Diarrhoea
Liver inflammation
Itching
Rash
Urticaria
Muscle pain
Joint pain
Weight gain
Abnormal liver function tests
Increased heart rate
Tingling
Dizziness
Fainting
Tremor
Dysgeusia (altered sense of taste)
Sensation of spinning or shifting
Blurred vision
Painful or difficult urination
Inability to completely empty the bladder
Skin eruption
Shortness of breath
Hallucinations (seeing, feeling or hearing things that do not exist)
Depression
Insomnia (difficulty sleeping)
Nightmares
Vomiting
Edema (swelling due to fluid accumulation)
Increased appetite.

Itching (tingling) may occur when stopping treatment.

Additional side effects in children:
Common (may affect up to 1 in 10 children):

Diarrhoea
Constipation
Difficulty sleeping

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the Italian
Medicines Agency to 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 Mylan

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 first two
digits indicate the month, the last four the year.
The expiry date refers to the last day of that month.
Keep 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. Contents of the pack and other information

What Levocetirizina Mylan contains
The active ingredient is levocetirizine. Levocetirizine is present as levocetirizine dihydrochloride (5 mg),
corresponding to 4.2 mg of levocetirizine.
The excipients are microcrystalline cellulose, lactose monohydrate, magnesium stearate (core) and
hypromellose (E464), titanium dioxide (E171) and macrogol (coating).

Description of the appearance of Levocetirizina Mylan and contents of the pack
Film-coated tablets, oval, biconvex, white to off-white in colour, with “L9CZ” imprinted on one
side and “5” imprinted on the other.
Blister packs containing 20 tablets per box are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder:
Mylan SpA
Via Vittor Pisani 20
20124 Milan

Responsible Manufacturer for batch release
Synthon BV
Microweg 22, 6545CM Nijmegen
Netherlands
Synthon Hispania SL
Castelló 1, Polígono Las Salinas, 08830 Sant Boi de Llobregat
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy – Levocetirizina Mylan

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Kraj rejestracji
Włochy
Postać farmaceutyczna
Film-coated tablet, 5 MG
Kod ATC
R06AE09
Substancja czynna
levocetirizine
Wymaga recepty
Tak
Producent
MYLAN S.P.A.
Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
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