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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)
Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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

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: 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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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:

  • Diagnosis and treatment of acute and chronic conditions (high blood pressure, diabetes, respiratory infections, cardiovascular symptoms)
  • Evaluation of symptoms and guidance on further diagnostic testing
  • Preventive check-ups and regular health monitoring
  • Medical support during travel or after relocation
  • 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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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Chikeluo Okeke

General medicine 4 years exp.

Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

Dr Okeke focuses on general internal medicine and adult primary care, combining clinical accuracy with careful attention to lifestyle, personal context, and everyday health concerns. His consultations are particularly well suited for people who seek medical advice online, live abroad, or need clear guidance without unnecessary complexity.

He provides online consultations covering symptom assessment, prevention, and long-term management of chronic conditions, helping patients understand what is happening and decide on appropriate next steps.

Common reasons for consultation:

  • General internal medicine concerns and initial health assessment.
  • Acute symptoms such as fever, cough, infections, pain, or weakness.
  • Chronic conditions and treatment adjustment.
  • Blood pressure issues, fatigue, metabolic concerns.
  • Preventive consultations and routine check-ups.
  • Interpretation of laboratory results and medical reports.
  • Medical advice for patients receiving care online.

Dr Okeke is known for his clear communication, calm approach, and cultural awareness. He listens carefully, explains medical decisions in a structured way, and supports patients in making informed choices about their health.

Online consultations with Dr Chikeluo Okeke offer reliable internal medicine care without geographic limitations, focused on medical relevance, clarity, and patient comfort.

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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
  • Family medicine: hypertension, diabetes, cholesterol, chronic disease management
  • Travel medicine: pre-travel advice, vaccinations, fit-to-fly certificates, travel-related illnesses
  • Sexual and reproductive health: PrEP, STD prevention, counselling, treatment
  • Weight management and wellness: personalised weight loss programmes, lifestyle guidance
  • Skin and ENT issues: acne, eczema, allergies, rashes, sore throat, sinusitis
  • Pain management: acute and chronic pain, post-surgical care
  • Public health: prevention, health screenings, long-term monitoring
  • Sick leave (Baixa médica) connected to Segurança Social in Portugal
  • IMT medical certificates for driving licence exchange
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
  • gastrointestinal complaints (nausea, diarrhoea, abdominal pain, gastroenteritis)
  • sudden changes in how a child or adult feels
  • questions about existing treatment and whether adjustments are needed
  • renewal of prescriptions when clinically appropriate

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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Doctor

Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
  • chest discomfort, palpitations, dizziness, fatigue, and blood pressure concerns;
  • digestive problems: abdominal pain, nausea, diarrhoea, constipation, reflux;
  • sexually transmitted infections, erectile dysfunction;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders, weight loss, hair loss;
  • review and interpretation of lab tests, imaging reports, and medical documents;
  • medication review and treatment adjustment;
  • medical advice while travelling or living abroad;
  • second opinions and guidance on whether in-person care is needed.

Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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€50

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.
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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