LEVOCETIRIZINE KRKA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Levocetirizina Krka 5 mg film-coated tablets EFG

levocetirizine dihydrochloride

Read the package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Levocetirizina Krka and what is it used for
2. What you need to know before taking Levocetirizina Krka
3. How to take Levocetirizina Krka
4. Possible side effects
5. Storage of Levocetirizina Krka
6. Package contents and additional information

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

The active substance of Levocetirizina Krka is levocetirizine dihydrochloride.

Levocetirizina Krka is an antiallergic medication.

For the treatment of disease symptoms (symptoms) associated with:

• Allergic rhinitis (including persistent allergic rhinitis);
• Urticaria.

2. What you need to know before taking Levocetirizina Krka

Do not takeLevocetirizina Krka

• if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any other antihistamine or any of the other components of this medication (listed in section 6),

• if you have severe kidney disease that requires dialysis.

Warnings and precautions

Consult your doctor or pharmacist before taking Levocetirizina Krka.

If you have any condition that prevents you from emptying your urinary bladder (such as spinal cord damage or enlarged prostate), please inform your doctor.

If you are epileptic or at risk of seizures, please consult your doctor, as taking Levocetirizina Krka may worsen seizures.

If you are going to undergo an allergy test, ask your doctor if you need to stop taking Levocetirizina Krka a few days before. This medication may affect the results of the allergy test.

Children

Levocetirizina Krka is not recommended for children under 6 years of age, as the film-coated tablets do not allow for dose adjustment.

Other medications and Levocetirizina Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

TakingLevocetirizina Krka with food, drinks, and alcohol

Caution is advised if you take Levocetirizina Krka at the same time as alcohol or other agents that act on the brain.

In sensitive patients, taking Levocetirizina Krka and alcohol or other agents that act on the brain may cause additional reductions in attention and ability.

Levocetirizina can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

Some patients treated with Levocetirizina Krka may experience drowsiness, fatigue, and exhaustion. Be careful if you are going to drive or use machinery until you know how this medication affects you. However, in special tests performed on healthy individuals, no alterations in attention, reaction capacity, and driving ability were detected after taking levocetirizine at the recommended dose.

Levocetirizina Krka containslactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Levocetirizina Krka

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults and children over 6 years is one tablet per day.

Special dosing instructions for specific populations

Renal and hepatic impairment

Patients with renal impairment should receive a lower dose according to the severity of their kidney disease, and in children, the dose will be based on body weight; the dose to be taken will be determined by your doctor.

Patients with severe kidney disease that requires dialysis should not take levocetirizine.

Patients with only hepatic impairment should take the normal prescribed dose.

Patients with both renal and hepatic impairment should take a lower dose based on the severity of their kidney disease, and in children, the dose will be based on body weight; the dose to be taken will be determined by your doctor.

Patient over 65 years of age

In elderly patients, no dose adjustment is necessary if renal function is normal.

Children

Levocetirizina is not recommended for children under 6 years of age.

How and when to take Levocetirizina Krka?

For oral use only.

Tablets should be swallowed whole with water and can be taken with or without food.

How long should you take Levocetirizina Krka?

The duration of use depends on the type, duration, and course of your symptoms and will be determined by your doctor.

If you take moreLevocetirizina Krkathan you should

If you take more levocetirizine than you should, in adults, it may cause drowsiness. In children, it may initially cause agitation and restlessness, followed by drowsiness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to takeLevocetirizina Krka

If you have forgotten to take levocetirizine or if you take a lower dose than prescribed by your doctor, do not take a double dose to make up for the forgotten doses. Continue taking your normal dose when it is due.

If you stop takingLevocetirizina Krka

Stopping treatment should not have negative effects. However, rarely, intense itching (pruritus) may appear when stopping levocetirizine, even if these symptoms were not present at the start of treatment. The symptoms may disappear spontaneously. In some cases, the symptoms may be intense and require restarting treatment. The symptoms usually disappear when treatment is restarted.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Common side effects (affects 1 in 10 patients):

Dry mouth, headache, fatigue, and drowsiness.

Uncommon side effects (affects 1 in 100 patients):

Exhaustion and abdominal pain.

Frequency not known (cannot be estimated from available data):

Other side effects have also been reported, such as palpitations, increased heart rate (tachycardia), seizures, tingling, dizziness, syncope, tremors, dysgeusia (altered sense of taste), sensation of rotation or movement, convulsions, visual disturbances, blurred vision, oculogyric crisis (uncontrolled circular eye movements), pain or difficulty urinating, inability to urinate, edema, pruritus (itching), rash, urticaria (hives, redness, and itching of the skin), skin eruption, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurrent thoughts or concerns about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea. Intense itching (pruritus) when stopping treatment.

In case of the first signs of hypersensitivity reaction, stop taking Levocetirizina Krka and see your doctor immediately. The symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face, and/or neck, difficulty breathing or swallowing (chest tightness or wheezing), angioedema (hives), sudden drop in blood pressure that can lead to collapse or shock, which can be fatal.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system: Spanish Medicines Vigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Levocetirizina Krka

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofLevocetirizina Krka

• The active substance is levocetirizine dihydrochloride.

Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.

• The other components 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 coating. See section 2 "Levocetirizina Krka contains lactose".

Appearance of the productand package contents

The film-coated tablets are white, round, biconvex, and have beveled edges.

They are available in blister packs of 7, 10, 14, 20, 28, 30, 50, 60, 90, 98, and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

or

TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

You can request more information about this medication from the local representative of the marketing authorization holder:

Krka Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this package leaflet:March 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.