Levocetirizine Krka 5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Levocetirizine Krka 5 mg film-coated tablets EFG

levocetirizine dihydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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

The active substance of Levocetirizine Krka is levocetirizine dihydrochloride.

Levocetirizine Krka is an antiallergic medicinal product.

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

• Allergic rhinitis (including persistent allergic rhinitis);
• 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 any other antihistamine, or to any of the other ingredients of this medicine (listed in section 6),

• if you have severe kidney disease requiring dialysis.

Warnings and precautions

Talk to your doctor or pharmacist before starting Levocetirizine Krka.

If you have any condition that impairs your ability to empty the urinary bladder (such as spinal cord damage or enlarged prostate), please inform your doctor.

If you have epilepsy or are at risk of seizures, please consult your doctor, as the use of Levocetirizine Krka may worsen seizures.

If you are scheduled to undergo allergy testing, ask your doctor whether you need to stop treatment with Levocetirizine Krka several days beforehand. 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 for dose adjustment.

Other medicines and Levocetirizine Krka

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking Levocetirizine Krka with food, drinks and alcohol

Caution is advised when taking Levocetirizine Krka together with alcohol or other agents acting on the central nervous system.

In sensitive patients, concomitant use of Levocetirizine Krka and alcohol or other central nervous system-acting agents may cause additional reductions in alertness and impairment of performance.

Levocetirizine may be taken with or without food.

Pregnancy and breastfeeding

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

Driving and using machines

Some patients treated with Levocetirizine Krka may experience drowsiness, fatigue, or exhaustion. Exercise caution when driving or operating machinery until you know how this medicine affects you. However, in specific studies conducted in healthy individuals, no impairment of attention, reaction ability, or driving skills has been detected after taking levocetirizine at the recommended dose.

Levocetirizine Krka contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Levocetirizine Krka

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

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 should receive a reduced dose according to the severity of their kidney disease; in children, the dose will depend on body weight. Your doctor will determine the appropriate dose.

Patients with severe kidney disease requiring dialysis must not take levocetirizine.

Patients with hepatic impairment alone may take the standard prescribed dose.

Patients with both renal and hepatic impairment should take a reduced dose based on the severity of their kidney disease; in children, the dose will depend on body weight. Your doctor will determine the appropriate dose.

Patients aged 65 years and older

In elderly patients, dose adjustment is not necessary if renal function is normal.

Children

The use of levocetirizine is not recommended in 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 either on an empty stomach or with food.

How long should you take Levocetirizine Krka?

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

If you take more Levocetirizine Krka than you should

If you take more levocetirizine than recommended, somnolence may occur in adults. In children, initial agitation and restlessness may occur, followed by somnolence.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Levocetirizine Krka

If you forget to take levocetirizine or take a lower dose than prescribed, do not take a double dose to make up for the missed dose. Continue taking your next dose at the usual time.

If you stop taking Levocetirizine Krka

Discontinuation of treatment should not have negative effects. However, pruritus (intense itching) may rarely occur when stopping levocetirizine, even if these symptoms were not present at the start of treatment. Symptoms may resolve spontaneously. In some cases, symptoms may be severe and require restarting treatment. Symptoms usually resolve when treatment is resumed.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Frequent adverse effects (affects 1 in 10 patients):

Dry mouth, headache, fatigue and drowsiness.

Uncommon adverse effects (affects 1 in 100 patients):

Exhaustion and abdominal pain.

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

Other adverse effects that have also been reported include palpitations, increased heart rate (tachycardia), convulsions, tingling, dizziness, fainting (syncope), tremor, dysgeusia (disturbance of taste sensation), sensation of rotation or movement, seizures, visual disturbances, blurred vision, oculogyric crisis (uncontrollable circular eye movements), pain or difficulty urinating, inability to urinate, edema, pruritus (itching), rash, urticaria (skin swelling, redness and itching), skin rash, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurring thoughts or concerns about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhea. Pruritus (intense itching) when treatment is discontinued.

At the first signs of hypersensitivity reaction, stop taking Levocetirizine Krka and see your doctor immediately. Symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face and/or throat, difficulty breathing or swallowing (chest tightness or wheezing), hives (angioedema), sudden drop in blood pressure which may lead to collapse or shock, any of which may be fatal.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the national reporting system: Spanish System for Pharmacovigilance of Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levocetirizine 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 6 cP, titanium dioxide (E171), macrogol 3000 and triacetin in the coating. See section 2 “Levocetirizine Krka contains lactose”.

Nature and contents of the container

Film-coated tablets are white, round, biconvex, with bevelled edges.

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

Only some 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-Lohman-Strasse 5, 27472 Cuxhaven, Germany

For more information about this medicinal product, you may contact 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: March 2024

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/.