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LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS

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About the medicine

How to use LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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).
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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.

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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/

Online doctors for LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS

Discuss questions about LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (29)
Doctor

Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
  • Obesity medicine: structured weight management plans, nutritional counselling, obesity-related health risks.
  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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5.0 (2)
Doctor

Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

  • High blood pressure, headaches, dizziness, swelling, palpitations.
  • Diagnosis and management of hypertension, arrhythmias, and tachycardia.
  • Metabolic syndrome, excess weight, high cholesterol.
  • Chronic fatigue, insomnia, poor concentration, anxiety.
  • Respiratory symptoms: colds, flu, sore throat, cough, fever.
  • Digestive issues: heartburn, bloating, constipation, IBS symptoms.
  • Chronic conditions: diabetes, thyroid disorders.
  • Interpretation of lab tests and medical reports, therapy adjustment.
  • Second opinion and decision-making support.
  • Cardiovascular disease prevention and metabolic risk reduction.
  • Long-term follow-up and dynamic health monitoring.

Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Doctor

Марія Мартеллі

Anaesthesiology 12 years exp.

Dr Maria Martelli is a medical doctor specialising in anaesthesiology and pain medicine. She provides online consultations for adults, focusing on the assessment and management of acute, chronic, and complex pain conditions, as well as supportive care in serious illness.

She graduated from the Medical University of Silesia in Katowice and completed her specialisation in Anaesthesiology and Intensive Care. Alongside hospital work, she has extensive experience in home and inpatient hospice care, supporting patients with severe pain and advanced disease. Since 2021, she has been a certified specialist and continues to work in anaesthesiology, intensive care, and pain treatment.

Patients consult her for:

  • Chronic pain lasting more than 3 months (musculoskeletal, neuropathic, mixed pain).
  • Acute pain requiring medical assessment and treatment planning.
  • Post-operative pain and recovery support.
  • Cancer-related pain and symptom relief.
  • Palliative care support and quality-of-life improvement.
  • Adjustment and optimisation of pain medication.
  • Second opinions for complex or treatment-resistant pain.
Dr Martelli takes a structured, evidence-based approach, carefully analysing symptoms, previous treatments, and overall health status. Her consultations focus on realistic pain control goals, safety of therapy, and improving daily functioning.

She is especially attentive to patients living with long-term pain or serious illness, providing clear explanations, compassionate guidance, and medically sound recommendations adapted to each individual situation.

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5.0 (2)
Doctor

Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

  • Test interpretation and guidance on diagnostic plans.
  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
  • Food and drug allergies, skin rashes, angioedema.
  • Atopic dermatitis, urticaria, contact allergies.
  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
  • Other issues related to allergology and internal medicine.

During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

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0.0 (0)
Doctor

Марта Регеро Капілья

Allergology 8 years exp.

Dr Marta Reguero Capilla is an allergist and immunologist who works with both adults and children. She specialises in the diagnosis, treatment, and ongoing management of allergic and immune-related conditions through online consultations.

In her practice, Dr Reguero Capilla helps patients understand the causes of their symptoms, review test results, and choose appropriate treatment or monitoring strategies. Her consultations are suitable both for first-time assessments and for follow-up care over time.

Patients commonly consult Dr Marta Reguero Capilla for:

  • allergic rhinitis, seasonal allergies, and perennial allergy symptoms;
  • allergic conditions in adults and children;
  • bronchial asthma and allergy-related respiratory symptoms;
  • urticaria (acute and chronic) and angioedema;
  • food allergies and reactions to foods, additives, or medications;
  • atopic dermatitis, allergic rashes, and persistent itching;
  • unexplained or recurrent allergic reactions;
  • interpretation of laboratory tests, allergy testing, and immunology results;
  • immune system concerns, frequent infections, and reduced immune response;
  • ongoing medical follow-up and treatment adjustment.
Dr Reguero Capilla works in a structured and attentive manner, explaining medical decisions clearly and helping patients make informed choices about their own health or their child’s care.

When clinically appropriate, she may provide recommendations for further tests or referrals that patients can use within Spanish medical networks, including Sanitas and DKV, in accordance with the terms and conditions of those services.

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Frequently Asked Questions

Is a prescription required for LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS?
LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS?
The active ingredient in LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS is levocetirizine. This information helps identify medicines with the same composition but different brand names.
How much does LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS is around 5.9 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS?
LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS is manufactured by Sandoz Farmaceutica S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to LEVOCETIRIZINE SANDOZ 5 mg FILM-COATED TABLETS?
Other medicines with the same active substance (levocetirizine) include ARALEVO 5 mg FILM-COATED TABLETS, LEVOCETIRIZINE AUROVITAS SPAIN 5 mg FILM-COATED TABLETS, LEVOCETIRIZINE BLUEFISH 5 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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