Levocetirizine Sandoz 5 mg film-coated tablets EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Levocetirizine Sandoz 5 mg film-coated tablets EFG

levocetirizine (dihydrochloride)

Read the entire 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. (See section 4).

Contents of the leaflet:

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

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

Levocetirizine Sandoz contains the active substance levocetirizine, which is an antiallergic medicine. It is used to treat symptoms associated with allergic conditions in adults and children aged 6 years and older, 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 dihydrochloride, cetirizine, hydroxyzine, or any of the other ingredients of this medicine (listed in section 6),
• if you have severe renal impairment requiring dialysis.

Warnings and precautions

Consult your doctor or pharmacist before taking Levocetirizine Sandoz.

If you have any condition that impairs your ability to empty the urinary bladder (such as spinal cord damage or enlarged prostate), please inform your doctor.

If you suffer from epilepsy or are at risk of seizures, seek medical advice, as the use of Levocetirizine may worsen seizures.

If you have an appointment for an allergy test, consult your doctor about whether you should stop taking Levocetirizine several days before the test. This medicine 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 with other medicines

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

Taking Levocetirizine Sandoz with food, drinks and alcohol

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

In sensitive patients, concomitant administration of levocetirizine and alcohol or other central nervous system-acting agents may lead to further reduction in alertness and decreased performance.

Levocetirizine may 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

If you intend to drive, engage in potentially hazardous activities, or operate machinery, it is advisable to first wait and observe your response to this medication.

However, certain specific studies conducted in healthy individuals after taking levocetirizine at the recommended dose have shown no impairment of mental alertness or reaction ability related to driving.

Levocetirizine Sandoz contains lactose

This medicine 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 Sandoz

Follow exactly the instructions for use of 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 per day.

Special dosage instructions for specific populations:

Renal and hepatic impairment

Patients with renal impairment and those with both renal and hepatic impairment should receive a reduced dose according to the severity of their renal disease. In children, the dose should also be selected based on body weight; the dose will be determined by your doctor.

Patients with severe renal impairment requiring dialysis must not take levocetirizine.

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

Elderly patients aged 65 years and older

Dose adjustment is not necessary in elderly patients, provided their renal function is normal.

Use in children

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

How and when to take Levocetirizine Sandoz

For oral use only.

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

The duration of treatment will depend on the type, duration, and course of 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, drowsiness may occur in adults. In children, it may initially cause excitement and fatigue, followed by drowsiness.

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

If you forget to take Levocetirizine Sandoz

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

If you stop taking Levocetirizine Sandoz

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

This symptom may resolve spontaneously. In some cases, symptoms may be severe and may require restarting treatment. Symptoms should resolve once 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 may cause adverse effects, although not everyone experiences them.

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

Frequent adverse effects, may affect up to 1 in every 10 people:

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

Uncommon adverse effects, may affect up to 1 in every 100 people:

• exhaustion,
• abdominal pain.

Adverse effects of unknown frequency (cannot be estimated from available data):

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

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 may 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 Sandoz

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

Do not use this medicine after the expiry date stated on the packaging after CAD/EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other 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, marked with ‘L9CZ’ on one side and ‘5’ on the other.

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

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

Only some 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-Allee 1,

39179 Barleben

Germany

Date of the most recent review of this leaflet: January 2025.

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