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ROFLUMILAST 500 micrograms Tablets

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Doctor
5.0(38)

Andrei Popov

General medicinePain medicine7 years of experience

Dr. Andrei Popov is a General Practitioner with specialized training in chronic pain. He provides online consultations for adult patients in Spain and other European countries.

Dr. Popov understands that seeking help with weight-related concerns or pain that has persisted for months can be difficult. Many patients come to him after trying different approaches without feeling truly heard. During the consultation, the doctor creates a comfortable and supportive, non-judgmental environment where the patient’s medical history can be discussed in detail, questions can be answered, and the next steps can be decided together.

Weight Management and Metabolic Health

Dr. Popov can help assess overweight, obesity, and related conditions such as hypertension, diabetes, or metabolic disorders. During the consultation, the patient’s medical history, test results, current medications, and previous treatments will be reviewed.

If you would like to learn about possible medication options or have already started treatment, the doctor can assess your situation, review the effectiveness and tolerability of the therapy, and clearly explain its benefits, potential risks, and alternatives.

Not every patient requires the same treatment. A consultation does not guarantee a prescription — it provides an objective medical assessment and a plan tailored to your individual situation.

Pain and General Medicine

You can also consult Dr. Popov regarding:

* chronic pain, migraines, neuralgia, and fibromyalgia;

* back, neck, lower back, or joint pain;

* hypertension, diabetes, and follow-up of chronic conditions;

* review of test results, medical reports, and current treatment;

* preventive medicine and a second medical opinion.

How the Consultation Works

The video consultation lasts up to 30 minutes. The doctor will listen carefully, review the information you provide, and explain the next steps in clear and understandable language.

If additional tests, an in-person consultation, or urgent medical care are required, the doctor will inform you directly.

Dr. Popov’s goal is to make sure the patient feels heard and leaves the consultation with a clear understanding of their condition and the next steps they can take.

Book a video appointment
€86
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 ROFLUMILAST AUROVITAS 500 micrograms TABLETS

Contents of the leaflet

  1. Introduction
  2. What is Roflumilast Aurovitas and what is it used for
  3. What you need to know before you take Roflumilast Aurovitas
  4. How to take Roflumilast Aurovitas
  5. Possible side effects
  6. Storage of Roflumilast Aurovitas
  7. Contents of the pack and other information

Introduction

Patient Information: Summary of Product Characteristics

RoflumilastAurovitas 500 micrograms tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Roflumilast Aurovitas and what is it used for

This medicinal product contains the active substance roflumilast, which is a phosphodiesterase-4 inhibitor anti-inflammatory. Roflumilast reduces the activity of phosphodiesterase-4, a protein that occurs naturally in the body's cells. When the activity of this protein is reduced, inflammation in the lungs decreases. This helps to stop the narrowing of the airways that occurs in chronic obstructive pulmonary disease (COPD). Therefore, this medicinal product alleviates respiratory problems.

Roflumilast is used for the maintenance treatment of severe COPD in adults who have had frequent exacerbations of COPD symptoms in the past and who have chronic bronchitis. COPD is a chronic lung disease that results in the narrowing of the airways (obstruction) and swelling and irritation of the walls of the small airways in the lungs (inflammation).

This leads to symptoms such as coughing, wheezing, chest tightness, or difficulty breathing. Roflumilast should be used in conjunction with bronchodilators.

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 Roflumilast Aurovitas

Do not take Roflumilast Aurovitas

  • if you are allergic to roflumilast or any of the other ingredients of this medicinal product (listed in section 6)

if you have moderate or severe liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Roflumilast Aurovitas.

Sudden episodes of shortness of breath (dyspnea)

Roflumilast is not indicated for the treatment of acute bronchospasm (sudden episodes of shortness of breath). To alleviate a sudden episode of shortness of breath, it is essential that your doctor provides you with another medicinal product that you should always carry with you to manage such episodes. Roflumilast will not help in these situations.

Weight

You should check your weight periodically. Consult your doctor if, while taking this medicinal product, you notice an unintentional weight loss (not due to diet or exercise).

Other diseases

This medicinal product is not recommended if you have one or more of the following diseases:

  • severe immunological diseases such as HIV infection, multiple sclerosis (MS), systemic lupus erythematosus (SLE), or progressive multifocal leukoencephalopathy (PML)
  • severe acute infectious diseases such as acute hepatitis
  • cancer (except for patients with basal cell carcinoma, a type of slow-growing skin cancer)
  • or severe heart disease

There is limited experience with this medicinal product in these diseases. If you are diagnosed with any of these diseases, consult your doctor.

Experience with the use of this medicinal product in patients with a previous diagnosis of tuberculosis, viral hepatitis, viral herpes, or herpes zoster is also limited. Consult your doctor if you have any of these diseases.

Symptoms you should be aware of

During the first few weeks of treatment with roflumilast, you may experience diarrhea, nausea, abdominal pain, or headache. If these side effects do not disappear after the first few weeks of treatment, consult your doctor.

Roflumilast is not recommended in patients with a history of depression associated with suicidal ideation or behavior. You may also experience difficulty sleeping, anxiety, nervousness, or depression. Before starting treatment with roflumilast, inform your doctor if you suffer from any of these symptoms or if you are taking any other medicinal product that may increase the likelihood of these side effects. You or your caregivers should immediately inform your doctor about any change in behavior or mood and any suicidal thoughts you may have.

Children and adolescents

Do not give this medicinal product to children or adolescents under 18 years of age.

Other medicinal products and Roflumilast Aurovitas

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicinal products, especially the following:

  • a medicinal product containing theophylline (used to treat respiratory diseases), or
  • a medicinal product used to treat immunological diseases, such as methotrexate, azathioprine, infliximab, etanercept, or prolonged use of oral corticosteroids.
  • a medicinal product containing fluvoxamine (a medicinal product used to treat anxiety disorders and depression), enoxacin (a medicinal product used to treat bacterial infections), or cimetidine (a medicinal product used to treat stomach ulcers or acidity).

The effect of roflumilast may be reduced if combined with rifampicin (a type of antibiotic) or with phenobarbital, carbamazepine, or phenytoin (medicinal products used to treat epilepsy). Consult your doctor.

Roflumilast can be combined with other medicinal products for the treatment of COPD, such as bronchodilators and inhaled or oral corticosteroids. Do not stop taking these medicinal products or reduce their doses unless your doctor tells you to.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicinal product.

You should not become pregnant during treatment with this medicinal product and should use an effective contraceptive method during treatment, as roflumilast may be harmful to the fetus.

Driving and using machines

Roflumilast does not affect the ability to drive or use machines.

Roflumilast Aurovitas contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicinal product.

3. How to take Roflumilast Aurovitas

Take this medicinal product exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

  • During the first 28 days- the recommended initial dose is one 250 microgram tablet of roflumilast once daily.
  • The initial dose is a low dose that is used to help your body get used to the medicinal product before starting the full dose. With this low dose, you will not get the full effect of the medicinal product, so it is essential that you switch to the full dose (called the "maintenance dose") after 28 days.

This dosing regimen is not possible with Roflumilast Aurovitas. Roflumilast Aurovitas is only available in a 500 microgram tablet, which cannot be divided into two equal halves. For the administration of the initial 250 microgram dose, other presentations are available on the market.

  • After 28 days- the recommended maintenance dose is one 500 microgram tablet once daily.

Take the tablet with water. You can take it with or without food. Take it every day at the same time.

It may take several weeks for Roflumilast Aurovitas to produce its effect.

If you take more Roflumilast Aurovitas than you should

If you have taken more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhea, dizziness, palpitations, confusion, mucous, and low blood pressure. Immediately consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20. If possible, take the medicinal product and this leaflet with you.

If you forget to take Roflumilast Aurovitas

If you forget to take a tablet at the scheduled time, take it as soon as you remember on the same day. If you have forgotten to take it for the entire day, continue taking the normal dose the next day. Continue taking the medicinal product at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Roflumilast Aurovitas

It is essential that you continue taking Roflumilast Aurovitas for the period indicated by your doctor, even when you no longer have symptoms, to control lung function.

If you have any further questions on the use of this medicinal product, 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 medicinal products, this medicinal product can cause side effects, although not everybody gets them.

You may experience diarrhea, nausea, stomach pain, or headache during the first few weeks of treatment with this medicinal product. Consult your doctor if these side effects do not resolve within the first few weeks of treatment.

Some side effects can be serious. In clinical studies and post-marketing experience, rare cases of suicidal thoughts and behaviors (including suicide) have been reported. Immediately inform your doctor of any suicidal thoughts you may have. You may also experience insomnia (frequent), anxiety (uncommon), nervousness (rare), panic attacks (rare), or depressive mood (rare).

In rare cases, allergic reactions may occur. Allergic reactions can affect the skin and, in rare cases, cause swelling of the eyelids, face, lips, and tongue, which can lead to difficulty breathing and/or a decrease in blood pressure and rapid heart rate. In case of an allergic reaction, stop taking roflumilast and immediately contact your doctor or go to the emergency department of the nearest hospital. Take all your medicinal products and this leaflet with you and provide all information about your current medication.

Other side effects include the following:

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

  • diarrhea, nausea, stomach pain
  • weight loss, decreased appetite
  • headache

Uncommon side effects: may affect up to 1 in 100 people

  • tremors, feeling of dizziness (vertigo), dizziness
  • feeling of rapid or irregular heartbeats (palpitations)
  • gastritis, vomiting
  • acid reflux from the stomach to the throat (acid regurgitation), indigestion
  • rash
  • muscle pain, muscle weakness, or cramps
  • back pain
  • feeling of weakness or fatigue; general malaise

Rare side effects: may affect up to 1 in 1,000 people

  • gynecomastia (enlargement of breast tissue in men);
  • loss of taste
  • respiratory tract infections (except pneumonia)
  • bloody stools, constipation
  • elevated liver and muscle enzymes (observed in blood tests)
  • hives (urticaria)

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 to the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Roflumilast Aurovitas

Keep this medicinal product out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

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

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 other information

Composition of Roflumilast Aurovitas

  • The active substance is roflumilast. Each tablet contains 500 micrograms of roflumilast.
  • The other ingredients are: lactose monohydrate, corn starch, hypromellose (type 2910), poloxamer (type 188), magnesium stearate

Appearance and packaging

Tablet.

Uncoated white to off-white tablets, round, flat, with beveled edges, engraved with "T" and "500" on one side and smooth on the other side. [Size: approximately 5 mm].

Roflumilast Aurovitas tablets are available in blister packs.

Package sizes

Blister pack: 10, 14, 28, 30, 60, 84, 90, 98, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

Czech Republic: Roflumilast Aurovitas

Germany: RoflumilaPUREN 500 Mikrogramm Tabletten

Portugal: Roflumilaste Generis

Spain: Roflumilast Aurovitas 500 micrograms tablets EFG

Date of last revision of this leaflet: September 2020

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

Online doctors for ROFLUMILAST AUROVITAS 500 micrograms TABLETS

Discuss questions about ROFLUMILAST AUROVITAS 500 micrograms TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

Doctor
5.0(38)

Andrei Popov

General medicinePain medicine7 years of experience

Dr. Andrei Popov is a General Practitioner with specialized training in chronic pain. He provides online consultations for adult patients in Spain and other European countries.

Dr. Popov understands that seeking help with weight-related concerns or pain that has persisted for months can be difficult. Many patients come to him after trying different approaches without feeling truly heard. During the consultation, the doctor creates a comfortable and supportive, non-judgmental environment where the patient’s medical history can be discussed in detail, questions can be answered, and the next steps can be decided together.

Weight Management and Metabolic Health

Dr. Popov can help assess overweight, obesity, and related conditions such as hypertension, diabetes, or metabolic disorders. During the consultation, the patient’s medical history, test results, current medications, and previous treatments will be reviewed.

If you would like to learn about possible medication options or have already started treatment, the doctor can assess your situation, review the effectiveness and tolerability of the therapy, and clearly explain its benefits, potential risks, and alternatives.

Not every patient requires the same treatment. A consultation does not guarantee a prescription — it provides an objective medical assessment and a plan tailored to your individual situation.

Pain and General Medicine

You can also consult Dr. Popov regarding:

* chronic pain, migraines, neuralgia, and fibromyalgia;

* back, neck, lower back, or joint pain;

* hypertension, diabetes, and follow-up of chronic conditions;

* review of test results, medical reports, and current treatment;

* preventive medicine and a second medical opinion.

How the Consultation Works

The video consultation lasts up to 30 minutes. The doctor will listen carefully, review the information you provide, and explain the next steps in clear and understandable language.

If additional tests, an in-person consultation, or urgent medical care are required, the doctor will inform you directly.

Dr. Popov’s goal is to make sure the patient feels heard and leaves the consultation with a clear understanding of their condition and the next steps they can take.

Book a video appointment
€86
Doctor
5.0(12)

Yevgen Yakovenko

General medicine12 years of experience

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.

Book a video appointment
€72
Doctor
5.0(3)

Lina Travkina

General medicine13 years of experience

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.

  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.

  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.

  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.

  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.

  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.

  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.

  • Medical advice and follow-up consultations.

  • Test interpretation and diagnostic guidance.

  • Structured support for undiagnosed complaints.

  • Second opinion on diagnoses and treatment plans.

  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.

  • Post-operative recovery support and pain management.

  • Preconception counselling and postpartum support.

  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

Book a video appointment
€75
Doctor
5.0(21)

Nuno Tavares Lopes

General medicine18 years of experience

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.

Book a video appointment
€70

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Frequently Asked Questions

ROFLUMILAST AUROVITAS 500 micrograms TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.

The active ingredient in ROFLUMILAST AUROVITAS 500 micrograms TABLETS is roflumilast. This information helps identify medicines with the same composition but different brand names.

The average pharmacy price for ROFLUMILAST AUROVITAS 500 micrograms TABLETS is around 34.69 EUR. Prices may vary depending on the manufacturer and dosage form.

ROFLUMILAST AUROVITAS 500 micrograms TABLETS is manufactured by Aurovitas Spain, S.A.U.. Pharmacy brands and packaging may differ depending on the distributor.

Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ROFLUMILAST AUROVITAS 500 micrograms TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

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 ROFLUMILAST AUROVITAS 500 micrograms TABLETS in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.

To obtain a prescription, you can use Oladoctor:

Other medicines with the same active substance (roflumilast) include DAXAS 250 micrograms tablets, DAXAS 500 micrograms FILM-COATED TABLETS, ROFLUMILAST AUROVITAS 250 micrograms 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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