Levocetirizine Aurovitas Spain 5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Levocetirizine Aurovitas Spain 5 mg film-coated tablets EFG

For adults and children aged 6 years and older

levocetirizine dihydrochloride

Read all of this 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; do not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Levocetirizine Aurovitas Spain is and what it is used for

The active substance of Levocetirizine Aurovitas Spain is levocetirizine dihydrochloride.

Levocetirizine is an antiallergic medicine used to treat the signs of illness (symptoms) associated with:

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

2. What you need to know before taking Levocetirizine Aurovitas Spain

Do not take Levocetirizine Aurovitas Spain

• If you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or 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 Aurovitas Spain.

If you have any condition that impairs your ability to empty your urinary bladder (such as spinal cord injury 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 may worsen seizures.

If you are due to undergo any allergy testing, ask your doctor whether you need to stop treatment with levocetirizine several days beforehand. This medicine may affect the results of allergy tests.

Children

The use of Levocetirizine Aurovitas Spain is not recommended in children under 6 years of age, as the current formulation in coated tablets does not allow dose adjustment in children.

Other medicines and Levocetirizine Aurovitas Spain

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

Taking Levocetirizine Aurovitas Spain with food, drinks and alcohol

Caution is advised when taking levocetirizine together with alcohol or other agents acting on the central nervous system. In sensitive patients, concomitant use of levocetirizine with alcohol or other central nervous system agents may cause additional reduction in attention capacity and reduced performance.

Levocetirizine may be taken with or without food.

Pregnancy, breastfeeding and fertility

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 may experience drowsiness, fatigue, or tiredness. 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 was observed after taking levocetirizine at the recommended dose.

Levocetirizine Aurovitas Spain contains lactose

Levocetirizine Aurovitas Spain contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Levocetirizine Aurovitas Spain

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

The recommended dose in adults and children over 6 years of age is one tablet per day.

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, and in children, the dose will also be selected based on body weight; the dose will be determined by your doctor.

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

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

Patients aged 65 years and older

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

Use in children

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

How and when to take Levocetirizine Aurovitas Spain

For oral use only.

The tablets should be swallowed whole with water and may be taken with or without food.

How long should your treatment with Levocetirizine Aurovitas Spain last?

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

If you take more Levocetirizine Aurovitas Spain than you should

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

If you think you have taken an overdose of levocetirizine, please inform your doctor (or pharmacist); they will decide what actions should be taken, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Levocetirizine Aurovitas Spain

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

If you stop taking Levocetirizine Aurovitas Spain

Stopping treatment should not have negative effects. However, itching (intense pruritus) 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 restarted.

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.

Common: may affect up to 1 in 10 people.

Dry mouth, headache, fatigue, and drowsiness.

Uncommon: may affect up to 1 in 100 people.

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), seizures, tingling, dizziness, fainting, tremor, dysgeusia (disturbance of taste sensation), sensation of rotation or movement, visual disturbances, blurred vision, oculogyric crisis (involuntary circular eye movements), pain or difficulty urinating, inability to urinate, edema, pruritus (itching), rash, urticaria (skin swelling, redness, and itching), skin eruptions, 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. Pruritus (intense itching) upon discontinuation of treatment.

At the first signs of a hypersensitivity reaction, stop taking levocetirizine and inform 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, sudden drop in blood pressure that may lead to collapse or shock, which could 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 Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levocetirizine Aurovitas Spain

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly discard medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Levocetirizine Aurovitas Spain

• The active substance is levocetirizine. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride (equivalent to 4.2 mg of levocetirizine).
• The other components are: microcrystalline cellulose, lactose monohydrate, magnesium stearate (core), and hypromellose (E464), titanium dioxide (E171) and polyethylene glycol (coating).

Appearance of the product and contents of the pack

Levocetirizine film-coated tablets are oval, biconvex, white or almost white, marked with “L9CZ” on one side and “5” on the other.

Available in blisters of 1, 2, 4, 5, 7, 10, 14, 15, 20, 21, 28, 30, 40, 50, 56, 60, 70, 90, 100, 112 and 120 tablets, and unit-dose blisters containing 30x1 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

Spain: Levocetirizine Aurovitas Spain 5 mg film-coated tablets EFG

Portugal: Levocetirizine Generis

Date of the most recent review of this leaflet: April 2025

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