LEVOCETIRIZINE AUROVITAS SPAIN 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levocetirizine Aurovitas Spain 5 mg film-coated tablets EFG

For adults and children from 6 years of age

levocetirizine dihydrochloride

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Levocetirizine Aurovitas Spain and what is it used for
2. What you need to know before you take Levocetirizine Aurovitas Spain
3. How to take Levocetirizine Aurovitas Spain
4. Possible side effects
5. Storage of Levocetirizine Aurovitas Spain

1. Contents of the pack and further information

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

The active substance of Levocetirizine Aurovitas Spain is levocetirizine dihydrochloride.

Levocetirizine is an antiallergic medication for the treatment of symptoms associated with:

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

2. What you need to know before you take 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 that requires dialysis.

Warnings and precautions

Consult your doctor or pharmacist before taking Levocetirizine Aurovitas Spain.

If you have any condition that makes it difficult for you to empty your bladder (such as spinal cord injury or enlarged prostate), please inform your doctor.

If you are epileptic or have a risk of seizures, please consult your doctor as the use of levocetirizine may worsen the seizures.

If you are going to undergo any allergy testing, ask your doctor if you should stop taking levocetirizine a few days before. This medication may affect the results of the allergy test.

Children

Levocetirizine Aurovitas Spain is not recommended for children under 6 years of age since the current formulation in film-coated tablets does not allow for dose adaptation in children.

Other medicines and Levocetirizine Aurovitas Spain

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

Taking Levocetirizine Aurovitas Spain with food, drinks and alcohol

Caution is recommended if you take levocetirizine and alcohol or other substances that act on the brain at the same time. In sensitive patients, taking levocetirizine with alcohol or other substances that act on the brain may cause an additional decrease in attention and decrease performance.

Levocetirizine can 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Some patients treated with levocetirizine 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 or driving ability were detected after taking levocetirizine at the recommended dose.

Levocetirizine Aurovitas Spain contains lactose

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

3. How to take Levocetirizine Aurovitas Spain

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of 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 dosing instructions for specific populations:

Renal and hepatic insufficiency

Patient with renal insufficiency should receive a lower dose according to the severity of their kidney disease and, in children, the dose will also be chosen based on body weight; the dose will be decided by your doctor.

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

Patient with only hepatic insufficiency should take the normal prescribed dose. Patients with hepatic and renal insufficiency 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, it is not necessary to adjust the dose if their renal function is normal.

Use in children

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

How and when should you take Levocetirizine Aurovitas Spain?

For oral use only.

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

How long should your treatment with Levocetirizine Aurovitas Spain last?

The duration of the treatment depends on the type, duration and course of the symptoms and it is your doctor who must determine it.

If you take more Levocetirizine Aurovitas Spain than you should

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

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

If you forget to take Levocetirizine Aurovitas Spain

If you forget to take levocetirizine or if you take a lower dose than your doctor prescribed, do not take a double dose to make up for the forgotten doses. Take your next dose when it is due.

If you stop taking Levocetirizine Aurovitas Spain

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 the available data.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side 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 which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Levocetirizine Aurovitas Spain

• The active substance is levocetirizine. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride (which corresponds to 4.2 mg of levocetirizine).
• The other ingredients 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 and biconvex, white or almost white, with the marking “L9CZ” on one face and “5” on the other.

It is 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 monodose blisters containing 30x1 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 medicine is authorised in the Member States of the European Economic Area under the following names:

Spain Levocetirizine Aurovitas Spain 5 mg film-coated tablets EFG

Portugal Levocetirizina Generis

Date of last revision of this leaflet:April 2025

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