LEVOCETIRIZINE VIATRIS 5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Levocetirizine Viatris 5 mg film-coated tablets EFG

For adults and children from 6 years of age

Levocetirizine dihydrochloride

Read this leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this leaflet, as 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, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

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

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

The active substance of Levocetirizine Viatris is levocetirizine dihydrochloride. Levocetirizine is an antiallergic medicine for the treatment of symptoms associated with:

• Allergic rhinitis (including persistent allergic rhinitis);

Urticaria.

2. What you need to know before taking Levocetirizine Viatris

Do not take Levocetirizine Viatris

• If you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any of the other ingredients of Levocetirizine Viatris (listed in section 6).
• If you have severe kidney disease that requires dialysis.

Warnings and precautions

Talk to your doctor or pharmacist before taking Levocetirizine Viatris.

If you have any condition that prevents you from emptying 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 have an allergy test, ask your doctor if you need to stop taking levocetirizine a few days before. This medicine may affect the results of the allergy test.

Children

The use of levocetirizine 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 Viatris

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

Taking Levocetirizine Viatris 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 additional decreased attention and performance. You can take levocetirizine with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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 driving or using machinery until you know how this medicine affects you. However, in special tests conducted in healthy individuals, no alterations in attention, reaction capacity, or driving ability were detected after taking levocetirizine at the recommended dose.

Levocetirizine Viatris contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Levocetirizine Viatris

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

The recommended dose for adults and children from 6 years of age 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 also be chosen based on body weight; the dose will be decided 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 hepatic and renal impairment should take a lower dose based on the severity of their kidney disease, and in children, the dose will also be chosen 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 their renal function is normal.

Use in children

The use of levocetirizine is not recommended in children under 6 years of age.

How and when should you take Levocetirizine Viatris?

For oral use only

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

How long should your treatment with Levocetirizine Viatris last?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 Viatris than 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 of levocetirizine, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 915 620 420.

If you forget to take Levocetirizine Viatris

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 taking Levocetirizine Viatris

Stopping treatment should not have negative effects. However, rarely, intense itching (pruritus) may appear when stopping levocetirizine, even when 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 further questions about the use of 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: 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 (altered sense 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 concerns about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea. Intense itching (pruritus) when stopping treatment.

If you experience the first signs of a hypersensitivity reaction, stop taking levocetirizine and inform your doctor immediately. The 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 can be fatal.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through 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 Viatris

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 and blister after EXP. The first two digits indicate the month, and the last four digits indicate the year.

The expiry date is the last day of the month stated.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Levocetirizine Viatris

• The active substance is levocetirizine dihydrochloride.
• Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, magnesium stearate (core) and hypromellose (E464), titanium dioxide (E171), and macrogol 400 (coating).

Appearance of the product and pack contents

The film-coated tablets are white or almost white, oval, biconvex, with the marking "L9CZ" engraved on one side and "5" on the other.

They are available in blisters of 7, 10, 14, 15, 20, 21, 28, 30, 40, 50, 56, 60, 70, 90, 100, 112, or 120 tablets per box.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturers:

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

Or

Synthon Hispania S.L.

Castelló 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

Date of last revision of this leaflet:December 2024.

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