LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for thepatient

Levocetirizine Sandoz 5 mg film-coated tablets EFG

levocetirizine (dihydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. (See section 4).

Contents of the package leaflet:

1. What is Levocetirizine Sandoz and what is it used for
2. What you need to know before taking Levocetirizine Sandoz
3. How to take Levocetirizine Sandoz
4. Possible side effects

5 Conservation of Levocetirizine Sandoz

6. Contents of the pack and additional information

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

Levocetirizine Sandoz contains the active substance levocetirizine, which is an antiallergic medication. It is used to treat symptoms associated with allergic conditions in adults and children from 6 years of age, such as:

• allergic rhinitis (including persistent allergic rhinitis),

• chronic urticaria (chronic idiopathic urticaria).

2. What you need to know before taking Levocetirizine Sandoz

Do not take Levocetirizine Sandoz:

• if you are allergic to levocetirizine hydrochloride, cetirizine, or hydroxyzine, or to any of the other components of this medication (listed in section 6),
• if you have severe renal impairment that requires dialysis.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levocetirizine Sandoz.

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

If you have epilepsy or are at risk of seizures, consult your doctor, as the use of Levocetirizine may worsen seizures.

If you have an appointment for an allergy test, consult your doctor if you should stop taking Levocetirizine for several days before the test. This medication may affect the test results.

Children

The use of levocetirizine tablets is not recommended in children under 6 years of age, as the tablets do not allow for dose adjustment.

Taking Levocetirizine Sandoz withother medications

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

Taking Levocetirizine Sandoz with food, beverages, and alcohol

Caution is recommended if levocetirizine is taken with alcohol or with other agents that act on the brain.

In sensitive patients, the concurrent administration of levocetirizine and alcohol or other agents that act on the brain may produce additional reduction in alertness and decreased 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

In some patients, levocetirizine may cause drowsiness, fatigue, and exhaustion.

If you plan to drive, engage in any potentially hazardous activity, or operate machinery, it is recommended that you first wait and observe your response to this medication.

However, certain special tests performed in healthy individuals after taking levocetirizine at the recommended dose have shown that there is no impairment of mental alertness or ability to react while driving.

Levocetirizine Sandoz contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Levocetirizine Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, 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

Patient with renal impairment and patients with both renal and hepatic impairment should be given a lower dose according to the severity of their renal disease, and in children, the dose should also be chosen based on body weight; the dose will be determined by your doctor.

Patient with severe renal impairment that requires dialysis should not take levocetirizine.

Those patients who only have hepatic impairment should take the normal recommended dose prescribed by their doctor.

Elderly patients from 65 years of age

No dose adjustment is necessary in elderly patients, provided that their renal function is normal.

Use in children

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

How and when to take Levocetirizine Sandoz

For oral use only.

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

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

If you take more Levocetirizine Sandoz than you should

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

If you have taken more Levocetirizine Sandoz than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Levocetirizine Sandoz

Do not take a double dose to make up for forgotten doses, or if you take a dose lower than prescribed by your doctor. Skip the forgotten dose and take the next tablet at the usual time.

If you stop taking Levocetirizine Sandoz

Stopping treatment should not have negative effects. However, it may rarely cause pruritus (intense itching) if you stop taking levocetirizine, even if this symptom was not present.

This symptom may resolve spontaneously. In some cases, the symptoms may be intense and may require restarting treatment. The symptoms should resolve when treatment is restarted.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

With the first signs of an allergic reaction, stop taking levocetirizine and consult your doctor immediately. The symptoms of allergic reactions may include: swelling of the mouth, tongue, face, and/or throat, difficulty swallowing or breathing (chest tightness or urticaria (angioedema), sudden drop in blood pressure leading to collapse or shock, which can be fatal.

Common side effects,may affect up to 1 in 10 people:

• dry mouth,
• headache,
• fatigue,
• drowsiness/dizziness.

Uncommon side effects,may affect up to 1 in 100 people

• exhaustion,
• abdominal pain.

Side effects of unknown frequency(cannot be estimated from the available data)

• palpitations,
• increased heart rate.
• seizures,
• pinch and tingling,
• dizziness,
• syncope,
• tremor,
• distortion of taste (dysgeusia),
• sensation of rotation or movement,
• visual disturbances,
• blurred vision,
• ocular crisis (uncontrolled circular movements of the eyes),
• pain or difficulty urinating,
• inability to empty the bladder completely,
• edema,
• pruritus (itching), also after discontinuation,
• rash,
• urticaria (swelling, redness, and itching of the skin),
• skin rash,
• shortness of breath,
• weight gain,
• muscle pain,
• joint pain,
• agitated or aggressive behavior,
• hallucinations,
• depression,
• insomnia,
• recurrent thoughts or concerns about suicide,
• nightmares,
• hepatitis,
• abnormal liver function,
• vomiting,
• increased appetite,
• nausea,
• diarrhea.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package 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 medication.

5. Conservation of Levocetirizine Sandoz

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

Do not use this medication after the expiration date stated on the packaging after CAD/EXP. 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 disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Levocetirizine Sandoz

• The active substance is levocetirizine. Each tablet contains 5 mg of levocetirizine dihydrochloride, equivalent to 4.2 mg of levocetirizine.
• The other components are: microcrystalline cellulose, lactose monohydrate, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), and macrogol (400).

Appearance of the product and contents of the pack

The film-coated tablets are white or almost white, oval, biconvex, and have the markings 'L9CZ' on one side and '5' on the other.

The tablets are packaged in PVC/PE/PVDC/Al blisters inserted into a cardboard box.

Pack sizes: 7, 10, 14, 15, 20, 21, 28, 30, 40, 50, 56, 60, 70, 90, 100, 112, or 120 tablets, and single-dose blisters containing 30x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

c/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmBH

Otto von Guericke-Alle 1,

39179 Barleben

Germany

Date of the last revision of thispackage leaflet:January 2025.

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