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LEVOCETIRIZINE PHARMA COMBIX 5 mg FILM-COATED TABLETS

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About the medicine

How to use LEVOCETIRIZINE PHARMA COMBIX 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 Patient

LevocetirizinePharma Combix5mgcomprimidos recubiertos con película 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, as 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 and other information

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

1. What Levocetirizine Pharma Combix is and what it is used for

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

For the treatment of symptoms associated with:

  • Allergic rhinitis (including persistent allergic rhinitis);
  • Urticaria.
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2. What you need to know before you take Levocetirizine Pharma Combix

Do not take Levocetirizine Pharma Combix

  • if you are allergicto levocetirizine dihydrochloride, to an antihistamine or to any of the other ingredients of this medicine (listed in section 6)
  • if you have severe kidney disease(severe renal impairment with a creatinine clearance below 10 ml/min).

Warnings and precautions

Consult your doctor or pharmacist before taking Levocetirizine Pharma Combix.

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

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

Use of Levocetirizine Pharma Combix with other medicines

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

Taking Levocetirizine Pharma Combix with food, drinks and alcohol

Cautions should be taken if you take this medicine and alcohol at the same time.

In sensitive patients, the simultaneous intake of cetirizine or levocetirizine and alcohol or other centrally acting agents may have effects on the central nervous system, although the racemate cetirizine has shown that it does not potentiate the effect of alcohol.

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, fatigue and tiredness. If you are going to drive, perform potentially hazardous activities or use machinery, it is advisable to wait and observe your response to this medication. However, in special tests performed in healthy individuals, no alterations in attention, reaction capacity and ability to drive were detected after taking levocetirizine at the recommended dose.

Levocetirizine Pharma Combix 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 Pharma Combix

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

Dosage

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

Special dosage instructions for specific populations

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

Patients with severe renal impairment should not take this medicine.

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

Patients 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.

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

In elderly patients, no dose adjustment is necessary, provided that their renal function is normal.

How and when to take Levocetirizine Pharma Combix?

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

If you take more Levocetirizine Pharma Combix than you should

If you take more Levocetirizine Pharma Combix than you should, it may cause somnolence in adults. In children, it may initially cause agitation and restlessness followed by somnolence.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Levocetirizine Pharma Combix

If you have forgotten to take Levocetirizine Pharma Combix, or if you have taken 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 dose and take the normal dose prescribed by your doctor.

If you stop taking Levocetirizine Pharma Combix

Stopping treatment should not have negative effects. The symptoms may reappear, but they should not be worse than the symptoms before treatment.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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

Common side effects (may affect up to 1 in 10 people):

Dry mouth, headache, fatigue and somnolence.

Uncommon side effects (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 (tachycardia), convulsions, tingling, dizziness, syncope, tremor, dysgeusia (alteration of taste), sensation of rotation or movement, visual disturbances, oculogyric crisis (uncontrolled circular movements of the eyes), blurred vision, difficulty or pain when 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, aggressive or agitated behavior, hallucination, depression, insomnia, recurrent thoughts or concern with suicide, hepatitis, abnormal liver function, vomiting, increased appetite and nausea.

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 can lead to collapse or shock, which can be fatal.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 medicine.

5. Storage of Levocetirizine Pharma Combix

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Place the empty cartons and any remaining medicines in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the cartons and any remaining medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Levocetirizine Pharma Combix

  • The active substance is levocetirizine in the form of levocetirizine dihydrochloride.

Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride, which is equivalent to 4.2 mg of levocetirizine.

  • The other ingredients (excipients) are:

Core of the tablet: Lactose monohydrate, microcrystalline cellulose (E460i), crospovidone, magnesium stearate (E470b) and anhydrous colloidal silica (E551).

Coating of the tablet: Opadry white 03B180001 (hypromellose (E464), titanium dioxide (E171) and macrogol 400 (E1521)).

Appearance of the product and contents of the pack

White or almost white, oval, biconvex, film-coated tablet with beveled edges and smooth surfaces on both sides.

OPA/Al/PVC-Aluminum and PVC/PVDC-Aluminum blisters (standard or perforated).

Packs of 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C / Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

Date of last revision of this leaflet: June 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 PHARMA COMBIX 5 mg FILM-COATED TABLETS

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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.
  • 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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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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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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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;
  • 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 PHARMA COMBIX 5 mg FILM-COATED TABLETS?
LEVOCETIRIZINE PHARMA COMBIX 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 PHARMA COMBIX 5 mg FILM-COATED TABLETS?
The active ingredient in LEVOCETIRIZINE PHARMA COMBIX 5 mg FILM-COATED TABLETS is levocetirizine. This information helps identify medicines with the same composition but different brand names.
How much does LEVOCETIRIZINE PHARMA COMBIX 5 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for LEVOCETIRIZINE PHARMA COMBIX 5 mg FILM-COATED TABLETS is around 5.9 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures LEVOCETIRIZINE PHARMA COMBIX 5 mg FILM-COATED TABLETS?
LEVOCETIRIZINE PHARMA COMBIX 5 mg FILM-COATED TABLETS is manufactured by Laboratorios Combix S.L.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of LEVOCETIRIZINE PHARMA COMBIX 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 PHARMA COMBIX 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 PHARMA COMBIX 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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