Levocetirizine Viatris 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Levocetirizine Viatris 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 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, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

The active substance of Levocetirizine Viatris 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 starting to take 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 requiring dialysis.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Levocetirizine Viatris.

If you have any condition impairing 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 may worsen seizures.

If you are scheduled for any allergy testing, ask your doctor whether you need to stop taking levocetirizine several days beforehand. This medicine may affect the results of allergy tests.

Children

Levocetirizine is not recommended for use in children under 6 years of age, as the film-coated tablets do not allow for dose adjustment.

Other medicines and Levocetirizine Viatris

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

Taking Levocetirizine Viatris with food, drinks, and alcohol

Caution is advised when taking levocetirizine together with alcohol or other agents acting on the brain.

In sensitive patients, taking levocetirizine simultaneously with alcohol or other central nervous system-acting agents may cause additional reduction in attention capacity and decreased 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 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/sedation, fatigue, and exhaustion. Exercise caution when driving or operating machinery until you know how this medicine affects you. However, in special tests conducted in healthy individuals, no impairment of attention, reaction ability, or driving skills has been detected after taking levocetirizine at the recommended dose.

Levocetirizine Viatris 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 Viatris

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. 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 dosing 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 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 use in children under 6 years of age.

How and when to take Levocetirizine Viatris?

For oral use only.

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

How long should your treatment with Levocetirizine Viatris 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 Viatris than you should

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

In case of overdose or accidental ingestion of levocetirizine, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 915 620 420.

If you forget to take Levocetirizine Viatris

If you forget 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 missed dose. Continue taking your normal dose at the next scheduled time.

If you stop taking Levocetirizine Viatris

Stopping treatment is not expected to have negative effects. However, rarely, pruritus (intense itching) may 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 can cause adverse effects, although not everyone will experience 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 adverse effects that have also been reported include palpitations, increased heart rate (tachycardia), seizures, tingling sensations, dizziness, fainting, tremor, dysgeusia (altered sense of taste), sensation of spinning or movement, visual disturbances, blurred vision, oculogyric crisis (involuntary circular eye movements), pain or difficulty urinating, inability to urinate, edema, pruritus (itching), rash, urticaria (swelling, redness and itching of the skin), skin rash, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurrent thoughts or preoccupation with suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhea. Pruritus (intense itching) when treatment is discontinued.

If you experience any signs of hypersensitivity reaction, stop taking levocetirizine and inform your doctor immediately. Symptoms of hypersensitivity reaction may include: swelling of the mouth, tongue, face and/or throat, difficulty breathing or swallowing (chest tightness or whistling sounds), hives, sudden drop in blood pressure which may lead to collapse or shock, and which may be fatal.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Viatris

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

Do not use this medicine after the expiry date stated on the packaging and label following CAD/EXP. The first two digits indicate the month, and the last four digits indicate the year.

The expiry date refers to the last day of the stated month.

Store in the original packaging to protect from moisture.

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

6. Contents of the container and additional information

Composition of Levocetirizine Viatris

• The active substance 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 container

The film-coated tablets are white or almost white, oval, biconvex tablets, marked with “L9CZ” 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.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturers:

Synthon BV

Microweg 22

6545 CM Nijmegen

The Netherlands

Or

Synthon Hispania S.L.

Castelló 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

Date of the most recent review of this leaflet: December 2024.

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