Levocetirizine Krka

Package leaflet: Information for the patient

Levocetirizine Krka 5 mg film-coated tablets

Levocetirizine dihydrochloride
Generic medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Levocetirizine Krka is and what it is used for
2. What you need to know before taking Levocetirizine Krka
3. How to take Levocetirizine Krka
4. Possible side effects
5. How to store Levocetirizine Krka
6. Contents of the pack and other information

1. What Levocetirizine Krka is and what it is used for

Levocetirizine dihydrochloride is the active substance in Levocetirizine Krka.
Levocetirizine Krka is an antiallergic medicinal product.
For the treatment of disease symptoms associated with:
allergic rhinitis (including persistent allergic rhinitis);
itching (urticaria).

2. What you need to know before taking Levocetirizine Krka

Do not take Levocetirizine Krka

• if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or to any of the excipients of this medicine (listed in section 6)
• if you have severely impaired kidney function (severe renal impairment with creatinine clearance less than 10 ml/min).

Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizine Krka.
If you may have difficulty emptying your bladder (in conditions such as spinal cord injury or enlarged prostate), consult your doctor.
If you suffer from epilepsy or are at risk of seizures, consult your doctor, as the use of Levocetirizine Krka may worsen seizures.
If you are scheduled for allergy testing, ask your doctor whether you should stop taking Levocetirizine Krka a few days before the test. This medicine may affect the results of allergy tests.
Children
The use of Levocetirizine Krka is not recommended in children under 6 years of age, as the film-coated tablets do not allow dose adjustment.
Other medicines and Levocetirizine Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Levocetirizine Krka with food, drinks and alcohol
Caution is advised if Levocetirizine Krka is taken together with alcohol or other agents acting on the brain.
In sensitive individuals, concomitant administration of Levocetirizine Krka and alcohol or other centrally acting agents may cause additional reductions in alertness and impaired performance.
Levocetirizine Krka can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Some patients taking Levocetirizine Krka may experience drowsiness, fatigue, or weakness. Exercise caution when driving or operating machinery until you know how this medicine affects you. However, specific studies have not shown any impairment of mental alertness, reaction ability, or driving capacity in healthy subjects tested after taking levocetirizine at recommended doses.
Levocetirizine Krka contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Levocetirizine Krka

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose for adults and children aged 6 years and older is one tablet daily.

Special dosage instructions for specific populations
Renal and hepatic impairment
Patients with renal impairment may be prescribed a reduced dose depending on the severity of their condition. In children, the dose will also be based on body weight; the dose will be determined by your doctor.
Patients with severe renal impairment must not take Levocetirizine Krka.
Patients with impaired liver function alone should take the usual prescribed dose.
Patients with both renal and hepatic impairment may be prescribed a reduced dose depending on the severity of renal impairment, and in children the dose will also be selected based on body weight; the dose will be determined by your doctor.

Patients aged over 65 years
Dose adjustment is not required in elderly patients, provided their renal function is normal.

Use in children
Levocetirizine Krka is not recommended for children under 6 years of age.

How and when to take Levocetirizine Krka?
For oral use only.
The tablets should be swallowed whole with water and may be taken with or without food.

How long to take Levocetirizine Krka?
The duration of treatment depends on the type, duration, and course of the symptoms and will be determined by your doctor.

If you take more Levocetirizine Krka than you should
If you take more Levocetirizine Krka than you should, drowsiness may occur in adults.
Children may initially show signs of excitability and restlessness, followed by drowsiness.
If you think you have taken an overdose of Levocetirizine Krka, inform your doctor, who will decide on the necessary measures.

If you forget to take Levocetirizine Krka
If you forget to take Levocetirizine Krka, or if you take a lower dose than prescribed by your doctor, do not take a double dose to make up for the missed dose. Take the next dose at your usual time.

If you stop taking Levocetirizine Krka
Stopping treatment should not have harmful effects. However, itching (intense sensation of itching) may rarely occur when stopping Levocetirizine Krka, even if these symptoms were not present before starting treatment. Symptoms should resolve spontaneously. In some cases, symptoms may be severe and may require resumption of treatment. Symptoms should resolve when treatment is restarted.
If you have any questions about how to use 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, tiredness and drowsiness/numbness.
Uncommon side effects (may affect up to 1 in 100 people):
Extreme tiredness 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,
fainting, tremor, dysgeusia (distortion of taste sensation), sensation of spinning or movement,
vision disorders, blurred vision, oculo-rotation (eyes with uncontrolled circular movements),
painful or difficult urination, inability to completely empty the bladder, oedema, itching, 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,
recurring thoughts or concerns about suicide, nightmares, hepatitis, abnormal liver function,
vomiting, increased appetite, nausea and diarrhoea. Itching (intense itching sensation) after
stopping treatment.
At the first signs of a hypersensitivity reaction, stop taking Levocetirizine Krka and seek immediate
medical advice. 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 may be fatal.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 Levocetirizine 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 packaging after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via 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 substance is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other excipients are monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica and magnesium stearate in the tablet core, and monohydrate lactose, hypromellose 6cP, titanium dioxide (E171), macrogol 3000 and triacetin in the coating film (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 Authorization Holder
KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative in 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 authorized in the Member States of the European Economic Area under the following names: