Prospecto: Information for the Patient

Levocetirizina Viatris 5 mg Film-Coated Tablets EFG

For adults and children 6 years and older

Levocetirizine dihydrochloride

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

2.What you need to know before starting to take Levocetirizina Viatris

3.How to take Levocetirizina Viatris

4.Possible adverse effects

5.Storage of Levocetirizina Viatris

6.Contents of the package and additional information

The active ingredient of Levocetiricina Viatrisislevocetirizine dihydrochloride. Levocetirizine is an antihistamine medication for the treatment of signs of illness (symptoms) associated with:

• Allergic rhinitis (including persistent allergic rhinitis);

Urticaria.

Do not take LevocetirizinaViatris

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take LevocetirizinaViatris.

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

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

If you are to undergo an allergy test, ask your doctor if you need to stop taking levocetirizine several days before. This medication may affect the results of the allergy test.

Children

Levocetirizine is not recommended for children under 6 years old as the film-coated tablets do not allow for dose adjustment.

Other medications and Levocetirizina ViatrisViatris

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Taking Levocetirizina Viatris with food, drinks, and alcohol

Caution is advised if levocetirizine is taken with alcohol or other central nervous system agents.

In sensitive patients, taking levocetirizine with alcohol or other central nervous system agents may cause additional decreased attention and performance. Levocetirizine can be taken either on an empty stomach or with food.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

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

Levocetirizina Viatris contains lactose

If your doctor has indicated that you have anintolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults and children aged 6 years and above is one tablet daily.

Special instructions for dosing in specific populations:

Renal and hepatic insufficiency

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

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

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

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

Patients aged 65 years and above

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

Use in children

Levocetirizine is not recommended for use in children under 6 years.

How and when should I take Levocetirizine Viatris?

Only for oral use

Levocetirizine tablets should be swallowed whole with water and can be taken either on an empty stomach or with food.

How long should my treatment with Levocetirizine Viatris last?The duration of treatment depends on the type, duration, and course of symptoms and will be determined by your doctor.

If I take more Levocetirizine Viatris than I 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 I forget to take Levocetirizine Viatris

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

If I interrupt treatment with Levocetirizine Viatris

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent: may affect up to 1 in 10 people

Dry mouth, headache, fatigue, and drowsiness.

Less frequent: may affect up to 1 in 100 patients

Exhaustion and abdominal pain.

Unknown frequency: cannot be estimated from available data

Other adverse effects that have been described include palpitations, increased heart rate (tachycardia), seizures, paresthesia, dizziness, syncope, tremor, dysgeusia (alteration of the sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, ocular crisis (uncontrolled circular movements of the eyes), pain or difficulty urinating, inability to urinate, edema, pruritus (itching), urticaria (skin swelling, redness, and itching), skin rash, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucination, depression, insomnia, recurrent thoughts or concern about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea. Intense pruritus (itching) when treatment is interrupted.

Stop taking levocetirizine and immediately inform your doctor if you experience the first signs of hypersensitivity reaction. Symptoms of hypersensitivity reaction may include: swelling of the mouth, tongue, face, and/or neck, difficulty breathing or swallowing (chest tightness or wheezing), sudden drop in blood pressure that can lead to collapse or shock, which can be fatal.

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.Reporting adverse effects can help provide more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and label after CAD/EXP. The first two digits indicate the month, and the last four digits indicate the year.

The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medications should not be thrown down the drain or in the trash.Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Levocetirizina Viatris

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

Appearance of the product and contents of the packaging

The film-coated tablets are white or almost white, oval, biconvex tablets with the indication “L9CZ” engraved on one face and “5” on the other.

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

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

Last review date of this leaflet:December 2024.

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