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SOFTACORT 3.35 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use SOFTACORT 3.35 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS

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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

Package Leaflet:information for the user

Softacort 3.35 mg/ml eye drops, solution in single-dose containers

Sodium hydrocortisone phosphate

Read the entire package leaflet carefully before starting to use this medication,as it contains important information for you.

  • Keep this package leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor, pharmacist, or nurse.
  • This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

  1. What is Softacort and what is it used for
  2. What you need to know before taking Softacort
  3. How to use Softacort
  4. Possible side effects
    1. Storage of Softacort
  1. Container contents and additional information

1. What is Softacort and what is it used for

This medication is an eye drop solution in single-dose containers containing a substance called hydrocortisone. This substance is a corticosteroid that inhibits inflammation symptoms.

It is used to treat mild allergic or inflammatory conditions of the superficial part of your eye or eyes (conjunctiva).

The eye should not be infected (see Do not use Softacort).

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 taking Softacort

Do not use Softacort

  • If you are allergic to the active ingredient (hydrocortisone) or to any of the other components of this medication (listed in section 6).
  • If you have high eye pressure (ocular hypertension), which is known to be associated with the use of glucocorticoids (corticosteroid family) or other causes.
  • If you have acute viral infections caused by the herpes virus and in most other viral diseases in the ulceration phase (unless the infection is being treated with anti-infectious treatment for the herpes virus).
  • If you have conjunctivitis with ulcerative inflammation of the cornea (keratitis), even in the initial phase.
  • If you have a bacterial infection in the eye (acute purulent infection, conjunctivitis, blepharitis, and hordeolum).
  • If you have a fungal infection in the eye (ocular mycosis).
  • If you have a bacterial infection called tuberculosis that affects your eye (ocular tuberculosis).

Warnings and precautions

  • Consult your doctor, pharmacist, or nurse before starting to use this medication.
  • If you have a red eye that has not been diagnosed, do not use this medication.
  • If you have a viral eye infection (herpes), use this medication only if the infection is being treated with anti-infectious treatment and close monitoring of your eyes is required.
  • If you have a disease that causes thinning of the outer part of your eye (cornea and sclera), there may be a higher risk of perforation due to the use of topical corticosteroids applied to the eye.
  • If you have been using a corticosteroid medication for a long time and have an eye wound (corneal ulcer), a fungal infection may be suspected.
  • During your treatment, close and regular monitoring of your eyes is required. Prolonged use of corticosteroids has been shown to cause increased pressure inside the eye and the onset of glaucoma, especially in patients who already suffer from high intraocular pressure or are at risk of developing such a condition with local steroid treatment (see Possible side effects) and cause lens opacity in your eye (cataract), particularly in children and the elderly population.
  • The use of corticosteroids can cause opportunistic eye infections. Additionally, topical ocular corticosteroids can promote, exacerbate, or mask signs and symptoms of opportunistic eye infections.
  • You should avoid wearing contact lenses during treatment with this medication.
  • Contact your doctor if you experience blurred vision or other visual disturbances.

Children

There are no safety and efficacy data in children.

Long-term treatment with corticosteroids can produce adrenal suppression.

Increased eye pressure in children occurs more frequently, with greater severity, and with greater rapidity than in adults.

Using Softacort with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including medications that can be obtained without a prescription.

Some medications may increase the effects of Softacort, and your doctor may want to monitor you closely if you are using these medications (including some medications for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

  • The use of this medication is not recommended during pregnancy except when your doctor considers it necessary and under strict supervision.

It is unknown whether this medication passes into breast milk. Your doctor will decide whether you can use this medication during breastfeeding.

Driving and using machines

You may experience blurred vision immediately after applying Softacort. Do not drive or use machines until this effect has disappeared.

Softacort contains phosphate

This medication contains 0.227 mg of phosphates in each drop.

3. How to use Softacort

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 2 drops in the affected eye(s), 2 to 4 times a day, as prescribed by your doctor. A gradual reduction in dose is recommended to avoid relapse. The duration of treatment may vary from a few days to a maximum of 14 days.

The same dose is used for both adults and elderly patients.

Use in children

The efficacy and safety have not been established in children.

Instructions for use

This medication is intended for administration in the eye.

To use the eye drops, follow these instructions:

  1. Wash your hands and sit or stand comfortably.
  2. Open the pouch containing 10 single-dose containers. Note the date of first opening on the pouch.
  3. Separate a single-dose container from the strip.

Hand holding four vials of medication with an arrow indicating the point of grip for handling

  1. Turn the tip of the single-dose container as shown. Do not touch the tip after opening the container.

Vial of medication with cap turning clockwise as indicated by a circular arrow

  1. Use your finger to gently separate the lower eyelid of the affected eye.
  2. Place the tip of the single-dose container near the eye, without touching it.
  3. Gently press the single-dose container so that two drops fall into the eye, then remove your finger from the lower eyelid.

Hand injecting medication into the skin with a needle, showing a drop coming out of the injection point and an arrow indicating the direction

  1. Press the tip of the affected eye, near the nose, with your finger. Apply pressure for 1 minute, keeping your eye closed.

Finger gently pulling the lower eyelid downward to expose the ocular conjunctiva

  1. Repeat the operation in the other eye, if your doctor has indicated it. Each single-dose container contains enough for both eyes.
  1. Discard the single-dose container after use. Do not save it for later use.
  1. Place the unopened single-dose containers inside the pouch. Place the opened pouch inside the box. Unopened containers can be used within one month after opening the pouch.

If you use any other eye drops, wait at least 5 minutes between each application.

If you use more Softacort than you should

Rinse your eye with sterile water if too much product has been administered in the eye and there is prolonged irritation.

Contact your doctor or pharmacist immediately.

If you forget to use Softacort

Do not apply an additional drop in the eye to make up for the missed dose.

If you stop treatment with Softacort

Do not stop treatment suddenly. Always consult your doctor if you are considering stopping treatment.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Frequency not known:cannot be estimated from available data

  • transient eye discomfort (burning, stinging) after application.

The following side effects have been reported with medications of the same group (corticosteroids) when used to treat eye conditions.

Frequency unknown:cannot be estimated from available data

  • allergic reactions
  • delayed wound healing
  • lens opacity (posterior subcapsular cataract)
  • opportunistic infections (herpes-like viral, fungal)
  • increased pressure in your eye (glaucoma)
  • pupil dilation (mydriasis)
  • drooping eyelids (ptosis)
  • inflammation inside your eye (uveitis)
  • changes in the thickness of the front part of your eye (cornea)
  • corneal inflammation (crystalline keratopathy)
  • blurred vision

If you suffer from severe damage to the transparent layer of the front part of your eye (cornea), treatment with phosphates, in very rare cases, can cause cloudy patches on the cornea due to calcium.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https//: notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Softacort

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box, pouch, and single-dose container after CAD or EXP. The expiration date is the last day of the month indicated.

Store below 25°C.

After first opening the pouch:use the single-dose container within one month.

Keep the single-dose containers inside the pouch to protect them from light.

Write the date of first opening of the pouch.

After first opening the single-dose container:use immediately and discard the single-dose container after use.

Sterility cannot be maintained after opening a single-dose container, so you must open a new container before each use.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

6. Container contents and additional information

Composition ofSoftacort

  • The active ingredient is sodium hydrocortisone phosphate.

1 ml of eye drop solution contains 3.35 mg of sodium hydrocortisone phosphate.

  • The other components are disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, disodium edetate, hydrochloric acid (for pH adjustment), and water for injectable preparations.

Appearance of the product and container contents

This medication is presented as an eye drop solution in single-dose containers.

The solution is practically transparent, colorless to slightly yellow, practically free of particles, presented inside a pouch with 10 units, each single-dose container contains 0.4 ml of eye drop solution.

The boxes contain 10 (1 x 10), 20 (2 x 10), 30 (3 x 10), or 60 (6 x 10) single-dose containers.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

LABORATOIRES THEA

12 RUE LOUIS BLERIOT

63017 CLERMONT-FERRAND CEDEX 2

FRANCE

Manufacturer

LABORATOIRES UNITHER

1 rue de l’Arquerie

50200 Coutances

FRANCE

or

LABORATOIRES THEA

12, rue Louis Blériot

63017 CLERMONT-FERRAND Cedex 2

FRANCE

Local representative

LABORATORIOS THEA, S.A.

C/ Enric Granados nº 86-88, 2ª planta

08008 – BARCELONA

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany, Austria, Bulgaria, Cyprus, Croatia, Denmark, Slovenia, Spain, Finland, France, Greece, Iceland, Norway, Poland, Portugal, Czech Republic, Slovak Republic, United Kingdom, Romania, Sweden Softacort

Belgium, Netherlands, Luxembourg Softacor

Ireland Zoftazot

Italy Sofacor

Date of last revision of this package leaflet: October 2023

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

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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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Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

Subsequently, between January 2021 and December 2021, he completed the General Internship at the Entre Douro e Vouga Hospital Center in Santa Maria da Feira, where he had the opportunity to work in different hospital settings and deepen his competencies in several areas of medicine.

From January 2022 until March 2026, he works as a Resident Physician in General and Family Medicine at USF Salvador Machado in Oliveira de Azeméis, developing clinical activities in primary healthcare, follow-up of chronic patients, and health promotion in the community.

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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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  • 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.

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
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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
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Sviatoslav Chekhun

Oncology 13 years exp.

Dr. Sviatoslav Chekhun is a medical oncologist with international clinical and research experience, specializing in modern medical oncology and a personalized approach to cancer treatment.

Currently (since 2025), he works as a Medical Oncologist at Institut Català d’Oncologia (Girona, Spain). Previously, he completed his residency in Medical Oncology and was involved in clinical research at Hospital Universitari Germans Trias i Pujol.

Dr. Chekhun has a strong academic and scientific background. He served as a lecturer in Internal Medicine at O.O. Bohomolets National Medical University and conducted research in experimental oncology at the R.E. Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology.

Earlier in his career, he worked as a medical oncologist at the Kyiv City Clinical Oncological Center and contributed to regulatory evaluation of medicinal products at the State Expert Center of the Ministry of Health of Ukraine.

When to consult Dr. Chekhun:

  •  for diagnosis or clarification of a cancer diagnosis
  •  to obtain a second opinion on an existing treatment plan 
  •  when you need a personalized treatment strategy 
  •  for interpretation of test results, CT, MRI, PET-CT, and biopsies 
  •  when choosing between treatment options (chemotherapy, targeted therapy, immunotherapy) 
  •  in case of doubts about treatment strategy or disease progression 

Consultation format

Dr. Chekhun provides online consultations, where you can receive:

  •  expert second opinion 
  •  detailed case review 
  •  recommendations based on current international treatment guidelines 
  •  personalized treatment and follow-up plan 

Important:
Prescription and monitoring of medications must be carried out by your treating physician in an in-person (offline) setting. An online consultation does not replace a face-to-face visit but helps you make more informed decisions about your treatment.

Dr. Sviatoslav Chekhun combines clinical practice, research, and international experience, enabling him to provide patients with modern, evidence-based approaches in oncology.

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Frequently Asked Questions

Is a prescription required for SOFTACORT 3.35 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS?

SOFTACORT 3.35 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS 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 SOFTACORT 3.35 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS?

The active ingredient in SOFTACORT 3.35 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS is hydrocortisone. This information helps identify medicines with the same composition but different brand names.

Who manufactures SOFTACORT 3.35 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS?

SOFTACORT 3.35 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS is manufactured by Laboratoires Thea. Pharmacy brands and packaging may differ depending on the distributor.

Which doctors can assess the use of SOFTACORT 3.35 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS 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 SOFTACORT 3.35 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS 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 SOFTACORT 3.35 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS 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 SOFTACORT 3.35 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS 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 SOFTACORT 3.35 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS?

Other medicines with the same active substance (hydrocortisone) include OFTALMOLOSA CUSI HYDROCORTISONE 15 mg/g OPHTHALMIC OINTMENT, AMEXXINE 1 mg/ml EYE DROPS SOLUTION, COLIRCUSI DEXAMETHASONE 1 mg/ml eye drops solution. 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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