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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.

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Tarek Agami

General medicine 11 years exp.

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

Main areas of consultation:

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  • Treatment adjustments and lifestyle recommendations based on your personal history
Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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Nuno Tavares Lopes

Family medicine 18 years exp.

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies
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Dr. Nuno Tavares Lopes provides medical support for patients using GLP-1 medications (Mounjaro, Wegovy, Ozempic, Rybelsus) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Europe.

Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.

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Anastasiia Shalko

Family medicine 13 years exp.

Dr. Anastasiia Shalko is a general practitioner with a background in both paediatrics and general medicine. She graduated from Bogomolets National Medical University in Kyiv and completed her paediatric internship at the P.L. Shupyk National Medical Academy of Postgraduate Education. After working as a paediatrician in Kyiv, she relocated to Spain, where she has been practising general medicine since 2015, providing care for both adults and children.

Her work focuses on urgent, short-term medical concerns – situations where patients need quick guidance, symptom assessment and clear next steps. She helps people understand whether their symptoms require in-person evaluation, home management or a change in treatment. Common reasons for booking an online consultation include:

  • acute respiratory symptoms (cough, sore throat, runny nose, fever)
  • viral illnesses such as colds and seasonal infections
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  • sudden changes in how a child or adult feels
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Dr. Shalko works specifically with urgent and short-term problems, providing practical recommendations and helping patients determine the safest next step. She explains symptoms clearly, guides patients through decision-making and offers straightforward medical advice for everyday acute issues.

She does not provide long-term management of chronic conditions, ongoing follow-up or comprehensive care plans for complex long-term illnesses. Her consultations are designed for acute symptoms, sudden concerns and situations where timely medical input is important.

With clinical experience in both paediatrics and general medicine, Dr. Shalko confidently supports adults and children. Her communication style is clear, simple and reassuring, helping patients feel informed and supported throughout the consultation.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

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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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