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LEVOCETIRIZINE BLUEFISH 5 mg FILM-COATED TABLETS

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About the medicine

How to use LEVOCETIRIZINE BLUEFISH 5 mg FILM-COATED TABLETS

Translated with AI

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 THE USER

Levocetirizine Bluefish 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, pharmacist or nurse.
  • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

The active substance of Levocetirizine Bluefish is levocetirizine dihydrochloride. Levocetirizine is an antiallergic medicine.

It is used for the treatment of symptoms associated with:

  • Allergic rhinitis (including persistent allergic rhinitis)
  • Urticaria (hives)
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2. What you need to know before you take Levocetirizine Bluefish

Do not take Levocetirizine Bluefish:

  • 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 (severe kidney failure with a creatinine clearance below 10 ml/min).

Warnings and precautions

Consult your doctor, pharmacist or nurse before taking levocetirizine.

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

If you are epileptic or have a history of seizures, please consult your doctor, as the use of levocetirizine may worsen seizures.

If you are going to have an allergy test, ask your doctor if you need to stop taking levocetirizine a few days before. This medicine may affect the results of the allergy test.

Children

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

Other medicines and Levocetirizine Bluefish

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

Taking Levocetirizine Bluefish with food, drinks and alcohol

Caution is recommended if you take levocetirizine and alcohol or other substances that act on the brain at the same time.

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

Levocetirizine can be taken with or without food.

Pregnancy and breastfeeding

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 may experience somnolence/drowsiness, fatigue and exhaustion. Be careful if you are driving or using machinery, until you know how this medicine affects you. However, in special tests conducted in healthy individuals, no alterations in attention, reaction capacity and ability to drive were detected after taking levocetirizine at the recommended dose.

Levocetirizine Bluefish 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 Bluefish

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

The recommended dose in 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 should receive a lower dose according to the severity of their kidney disease and in children the dose will also be chosen based on body weight; the dose will be decided by your doctor.

Patient with severe renal impairment should not take levocetirizine.

Patient with only hepatic impairment should take the normal prescribed dose.

Patient with hepatic and renal impairment 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.

Patient from 65 years of age

In elderly patients, no dose adjustment is necessary if renal function is normal.

Use in children

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

How and when to take Levocetirizine Bluefish

For oral use only

The tablets should be swallowed whole with water, with or without food.

How long should your treatment with Levocetirizine Bluefish 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 Bluefish than you should

If you take more levocetirizine than you should, in adults it may cause drowsiness. In children it may initially cause agitation and restlessness followed by drowsiness. Consult your doctor immediately who will advise you on the treatment you need.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Phone: 91 562 04 20

If you forget to take Levocetirizine Bluefish

If you have forgotten to take levocetirizine, or if you take a lower dose than prescribed by your doctor, do not take a double dose to make up for forgotten doses. Continue taking your normal dose when it is due.

If you stop taking Levocetirizine Bluefish

If you stop treatment, it should not have negative effects. However, rarely, intense itching (pruritus) may appear when stopping levocetirizine, 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 that treatment with levocetirizine be restarted. 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.

Medicine questions

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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 and drowsiness.

Uncommon: may affect up to 1 in 100 people

Exhaustion and abdominal pain.

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

Other side effects have also been reported, such as palpitations, increased heart rate, seizures, tingling, dizziness, syncope, tremor, dysgeusia (altered sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, oculogyric crisis (uncontrolled circular movements of the eyes), 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, hallucination, depression, insomnia, recurrent thoughts or concern with suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhea. Intense itching (pruritus) when treatment is stopped.

At the first signs of a hypersensitivity reaction, stop taking levocetirizine and inform your doctor immediately. The symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face and/or throat, difficulty breathing or swallowing (chest tightness or wheezing), hives, sudden drop in blood pressure that may lead to collapse or shock, which can be fatal.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levocetirizine Bluefish

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 packaging and label after “EXP”. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Levocetirizine Bluefish

  • The active substance is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
  • The other ingredients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate (E572) (core), and titanium dioxide (E171), hypromellose (E464) macrogol 400 and polysorbate 80 (coating).

Appearance and packaging

White, film-coated, scored, round, biconvex tablets engraved with “161” on one side and “H” on the other.

Levocetirizine Bluefish is available in blister packs of 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Bluefish Pharmaceuticals AB

P.O.Box 49013, 100 28 Stockholm, Sweden

Manufacturer

Bluefish Pharmaceuticals AB

Gävlegatan 22, 113 30 Stockholm, Sweden

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Local representative:

Bluefish Pharma S.L.U.,

AP 36007, 2832094 Madrid, Sucursal 36 - Spain

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

Member State

Medicine name

Portugal

Levocetirizina Bluefish

Spain

Levocetirizina Bluefish 5 mg film-coated tablets EFG

Germany

Levocetirizin Bluefish 5 mg film-coated tablets

Date of last revision of this leaflet: March 2023

Detailed 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 BLUEFISH 5 mg FILM-COATED TABLETS

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

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Doctor

Antonio Cayatte

General medicine 44 years exp.

Dr Antonio Cayatte is a physician in General and Acute Medicine with over 30 years of experience across clinical care, medical research, and education. He offers online consultations for adults with a wide range of symptoms, both acute and chronic. His clinical background includes: 

  • assessment of sudden or unclear symptoms
  • ongoing care for chronic conditions
  • follow-up after hospital discharge
  • interpretation of test results
  • medical support while abroad

Dr Cayatte earned his degree from the University of Lisbon and taught internal medicine at Boston University School of Medicine. He holds active medical registrations in both Portugal and the UK and is a Fellow of the American Heart Association. Consultations are available in English and Portuguese. Patients value his clarity, professionalism, and balanced approach to evidence-based care.

Dr. Antonio Cayatte provides comprehensive care for a broad spectrum of common health concerns, including:

  • Respiratory & ENT: acute bronchitis, concerns related to pneumonia, sinusitis, tonsillitis, ear infections, sore throat conditions, and allergic rhinitis
  • Eye Health: allergic and infectious conjunctivitis, as well as red or irritated eyes
  • Digestive & Urinary: gastroesophageal reflux disease (GERD), gastritis, urinary tract infections, and cystitis
  • Chronic Conditions: hypertension, elevated cholesterol, and structured weight management planning
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Maria Martelli

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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Taisiia Proida

Family medicine 7 years exp.

Taisiia Proida is a general practitioner with a specialization in mental health and a cognitive behavioral therapist (CBT), a member of the European Psychiatric Association. She offers online consultations for adults aged 18 and over, combining evidence-based medicine with an individualised approach to mental health care. She specialises in consultations and ongoing support for a wide range of mental health concerns, including: 

  • Mood disorders: depression, bipolar disorder, postpartum depression.
  • Anxiety disorders: generalised anxiety, OCD, panic attacks, phobias.
  • Post-traumatic stress disorder (PTSD) and complex PTSD.
  • Attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD). Assessment is provided only after an initial psychiatric evaluation and during a follow-up appointment.
  • Personality disorders and emotional instability.
  • Cyclothymia and mood fluctuations.
  • Schizophrenia spectrum and related conditions.

Dr. Proida combines clinical expertise with an empathetic approach, offering structured support based on evidence-based practices. Her work integrates CBT techniques with medical management, with a focus on anxiety and depressive disorders. She works with clients from different countries and cultural backgrounds, adapting her communication style and recommendations to individual needs. With experience in international clinical trials (Pfizer, Merck), she values clarity, trust, and collaborative partnership in patient care.

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Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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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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Doctor

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. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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Frequently Asked Questions

Is a prescription required for LEVOCETIRIZINE BLUEFISH 5 mg FILM-COATED TABLETS?

LEVOCETIRIZINE BLUEFISH 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 BLUEFISH 5 mg FILM-COATED TABLETS?

The active ingredient in LEVOCETIRIZINE BLUEFISH 5 mg FILM-COATED TABLETS is levocetirizine. This information helps identify medicines with the same composition but different brand names.

Who manufactures LEVOCETIRIZINE BLUEFISH 5 mg FILM-COATED TABLETS?

LEVOCETIRIZINE BLUEFISH 5 mg FILM-COATED TABLETS is manufactured by Bluefish Pharmaceuticals Ab (Publ). Pharmacy brands and packaging may differ depending on the distributor.

Which doctors can assess the use of LEVOCETIRIZINE BLUEFISH 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 BLUEFISH 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.

How to buy LEVOCETIRIZINE BLUEFISH 5 mg FILM-COATED TABLETS in Spain?

Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.

You can buy LEVOCETIRIZINE BLUEFISH 5 mg FILM-COATED TABLETS in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.

To obtain a prescription, you can use Oladoctor:

What are the alternatives to LEVOCETIRIZINE BLUEFISH 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 CINFA 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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