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LEVOCETIRIZINE STADA 5 mg FILM-COATED TABLETS

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About the medicine

How to use LEVOCETIRIZINE STADA 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

Hypodermic needle inserted into the skin at a 90-degree angle showing the entrance and the plunger retractedPackage Leaflet: Information for the User

Levocetirizine STADA 5 mg film-coated tablets EFG

Levocetirizine dihydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What is Levocetirizine Stada and what is it used for
  1. What you need to know before you take Levocetirizine Stada
  2. How to take Levocetirizine Stada
  3. Possible side effects
  1. Storage of Levocetirizine Stada
  1. Contents of the pack and further information

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

The active substance of Levocetirizine Stada is levocetirizine dihydrochloride.

Levocetirizine dihydrochloride is an antiallergic medicine.

For the treatment of disease symptoms (symptoms) associated with:

  • Allergic rhinitis (including persistent allergic rhinitis);
  • Urticaria.
Doctor consultation

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2. What you need to know before you take Levocetirizine Stada

Do not take Levocetirizine Stada:

  • if you are allergicto levocetirizine dihydrochloride, to cetirizine, to hydroxyzine or to any of the other components of this medicine (listed in section 6).
  • if you have severe kidney impairment(severe renal insufficiency with a creatinine clearance of less than 10 ml/min).

Warnings and precautions

Consult your doctor or pharmacist before taking Levocetirizine Stada.

If you have any condition that makes it difficult for you to empty your urinary bladder (such as damaged spinal cord or enlarged prostate), please inform your doctor.

If you are epileptic or have a risk of convulsions, please consult your doctor as the use of levocetirizine dihydrochloride may worsen the crises.

If you are going to undergo any allergy testing, ask your doctor if you should stop taking levocetirizine dihydrochloride a few days before. This medicine may affect the results of the allergy test.

Children

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

Hypodermic needle inserted into the skin at a 90-degree angle showing the entrance of the bevel and the plunger retractedOther medicines and Levocetirizine Stada

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

Taking Levocetirizine Stada with food, drinks and alcohol

Caution is recommended if you take this medicine at the same time as alcohol or other agents that act on the brain.

In sensitive patients, taking levocetirizine with alcohol or other agents that act on the brain may cause additional decreased attention and decreased performance

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Some patients treated with levocetirizine dihydrochloride may experience somnolence or drowsiness, fatigue and exhaustion. If you are going to drive, perform potentially hazardous activities or use machinery, you are advised to wait and observe your response to the medication. However, in special tests performed in healthy people, no alterations in attention, reaction capacity and ability to drive were detected after taking levocetirizine at the recommended dose.

Levocetirizine Stada contains lactose

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

3. How to take Levocetirizine Stada

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

Posology:

The normal dose for adults and children from 6 years of age is one tablet per day.

Special dosing instructions for specific populations:

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

Patients with severe kidney impairment should not take this medicine.

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

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

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

Use in children

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

Hypodermic needle inserted into the skin at a 90-degree angle showing the entrance and the plunger retractedHow and when should you take Levocetirizine Stada?

The tablets should be swallowed whole with water and can be taken both on an empty stomach and with food.

How long should your treatment with Levocetirizine Stada last?

The duration of treatment depends on the type, duration and course of the symptoms and it is your doctor who must determine it.

If you take more Levocetirizine Stada than you should

If you take more levocetirizine dihydrochloride 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Levocetirizine Stada

If you have forgotten to take levocetirizine dihydrochloride, or if you take a lower dose than prescribed by your doctor, do not take a double dose to make up for the forgotten doses; simply wait until the next scheduled intake and take the normal dose prescribed by your doctor.

If you stop taking Levocetirizine Stada

Stopping treatment should not have harmful effects. However, rarely, intense itching (pruritus) may appear when stopping levocetirizine dihydrochloride, even when these symptoms were not present at the start of treatment. The symptoms may disappear spontaneously. In some cases, the symptoms may be intense and require restarting treatment. The symptoms usually disappear when treatment is restarted.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common: may affect up to 1 in 10 people

Dry mouth, headache, fatigue, drowsiness/drowsiness

Uncommon: may affect up to 1 in 100 people

Exhaustion and abdominal pain

Frequency not known: frequency cannot be estimated from the available data

Other side effects have also been reported, such as palpitations, increased heart rate, convulsions, tingling, dizziness, syncope, tremor, dysgeusia (alteration of taste), sensation of movement, including sensation of spinning, visual disturbances, blurred vision, pain or difficulty urinating, inability to urinate, edema, pruritus (itching), rash, urticaria (swelling, redness and itching of the skin), skin eruption, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurrent thoughts of concern with suicidal ideation, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, diarrhea, and oculogyric crisis (uncontrolled circular movements of the eyes). Intense itching (pruritus) when stopping treatment.

In case of the first signs of hypersensitivity reaction, stop taking levocetirizine dihydrochloride and see your doctor immediately. The symptoms of the hypersensitivity reaction may include: swelling of the mouth, tongue, face and/or throat, difficulty breathing or swallowing (chest tightness or wheezing), urticaria (rash on the skin), sudden decrease in blood pressure that may lead to collapse or shock, which can be fatal.

Hypodermic needle inserted into the skin at a 90-degree angle showing the entrance and part of the shaftReporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levocetirizine Stada

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The first two digits indicate the month and the last four digits indicate the year. The expiry date is the last day of the month indicated.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Levocetirizine Stada

  • The active substance is levocetirizine. Levocetirizine is present in the form of levocetirizine dihydrochloride (5 mg), corresponding to 4.2 mg of levocetirizine.
  • 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 pack

The film-coated tablets are white or almost white, oval, biconvex, and have the marking “L9CZ” engraved on one side and “5” on the other side.

They are packaged in blisters of 7, 10, 14, 20, 21, 28, 30, 90 and 100 tablets per pack and unit-dose blisters containing 30 x 1 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Hypodermic needle inserted into the skin at a 90-degree angle showing the entrance and part of the shaftManufacturer:

Synthon BV

Microweg 22,

6545 Nijmegen

Netherlands

or

Synthon Hispania SL

Castelló 1, Polígono Las Salinas,

08830 Sant Boi de Llobregat

Spain

or

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

or

LAMP SAN PROSPERO S.p.A.

Via della Pace, 25/A

41030 San Prospero (Modena)

Italy

or

STADA Arzneimittel GmbH

Muthgasse 36

A-1190 - Wien

Austria

This medicine is authorised in the Member States of the European Economic Area under the following names:

Austria

Levocetirizin STADA 5 mg film-coated tablets

Denmark

Levocetirizin STADA 5mg, film-coated tablets

Finland

Levocetirizin STADA 5 mg, film-coated tablets

Portugal

Levocetirizina Ciclum 5 mg, tablets

Spain

Levocetirizina STADA 5 mg film-coated tablets EFG

Date of last revision of this leaflet: September 2018

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

Online doctors for LEVOCETIRIZINE STADA 5 mg FILM-COATED TABLETS

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

5.0 (29)
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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.
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  • 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.
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  • 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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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.
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  • Chronic conditions: diabetes, thyroid disorders.
  • Interpretation of lab tests and medical reports, therapy adjustment.
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  • 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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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).
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  • Post-operative pain and recovery support.
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  • 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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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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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;
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  • immune system concerns, frequent infections, and reduced immune response;
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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 STADA 5 mg FILM-COATED TABLETS?
LEVOCETIRIZINE STADA 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 STADA 5 mg FILM-COATED TABLETS?
The active ingredient in LEVOCETIRIZINE STADA 5 mg FILM-COATED TABLETS is levocetirizine. This information helps identify medicines with the same composition but different brand names.
How much does LEVOCETIRIZINE STADA 5 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for LEVOCETIRIZINE STADA 5 mg FILM-COATED TABLETS is around 5.9 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures LEVOCETIRIZINE STADA 5 mg FILM-COATED TABLETS?
LEVOCETIRIZINE STADA 5 mg FILM-COATED TABLETS is manufactured by Laboratorio Stada S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of LEVOCETIRIZINE STADA 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 STADA 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 STADA 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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