Package Insert: Information for the Patient

RoflumilastAurovitas 500 microgram tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2.What you need to know before starting to take Roflumilast Aurovitas

3.How to take Roflumilast Aurovitas

4.Possible adverse effects

5.Storage of Roflumilast Aurovitas

6.Contents of the package and additional information

This medication contains the active ingredient roflumilast, which is a phosphodiesterase-4 inhibitor. Roflumilast reduces the activity of phosphodiesterase-4, a naturally occurring protein 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 inchronic obstructive pulmonary disease (COPD). Therefore, this medication alleviates respiratory problems.

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

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

Do not take Roflumilast Aurovitas

- if you are allergic to roflumilast or any of the other ingredients of this medication (listed in section 6)

- if you have severe or moderate liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Roflumilast Aurovitas.

Sudden episodes of dyspnea (difficulty breathing)

Roflumilast is not indicated for the treatment of episodes of dyspnea (acute bronchospasms). To alleviate a sudden episode of dyspnea, it is very important that your doctor provide you with another medication, which you will have available at all times to overcome these episodes. Roflumilast will not help in these situations.

Weight

You should check your weight periodically. Consult your doctor if, while taking this medication, you observe an involuntary weight loss (not attributable to a diet or exercise program).

Other diseases

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

- severe immunological diseases such as HIV infection, multiple sclerosis (MS), lupus erythematosus (LE), or progressive multifocal leukoencephalopathy (PML)

- acute and severe infectious diseases such as acute hepatitis

- cancer (except for patients with basal cell carcinoma, a type of slow-evolving skin cancer)

- or severe heart disease

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

The experience of use in patients with a previous diagnosis of tuberculosis, viral hepatitis, viral herpes, or herpes zoster is also limited. Consult your doctor if you suffer from any of these diseases.

Symptoms you should be aware of

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

Roflumilast is not recommended for 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 additional medication that may increase the likelihood of these adverse effects. You or your caregivers should immediately inform your doctor of any change in behavior or mood and any suicidal thoughts you may have.

Children and adolescents

Do not administer this medication to children or adolescents under 18 years old.

Other medications and Roflumilast Aurovitas

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication, especially the following:

- a medication containing theophylline (a medication used to treat respiratory diseases), or

- a medication used to treat immunological diseases, such as methotrexate, azathioprine, infliximab, etanercept, or prolonged oral corticosteroids.

- a medication containing fluvoxamine (a medication for anxiety and depression disorders), enoxacine (a medication for bacterial infections), or cimetidine (a medication for stomach ulcers or acid reflux).

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

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

Pregnancy and breastfeeding

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

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

Driving and operating machinery

Roflumilast does not affect your ability to drive or operate machinery.

Roflumilast Aurovitas contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

• During the first 28 days - The recommended initial dose is one 250 microgram roflumilast tablet once a day.

- The initial dose is a low dose used to help your body get used to the medication before starting the full dose. With this low dose, you will not get the full effect of the medication, so it is essential to switch to the full dose (called the "maintenance dose") after 28 days.

This dosage is not possible with Roflumilast Aurovitas. Roflumilast Aurovitas is only available in a 500 microgram tablet presentation, 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 a day.

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

You may need to take Roflumilast Aurovitas for several weeks 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, mucus, and low blood pressure. Go immediately to your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20. If possible, bring the medication and this leaflet with you.

If you forget to take Roflumilast Aurovitas

If you forget to take a tablet at your usual time, take it as soon as you remember on the same day. If you have forgotten to take it all day, continue taking the normal dose the next day. Continue taking the medication at your usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Roflumilast Aurovitas

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You may experience diarrhea, nausea, stomach pain or headache during the first weeks of treatment with this medicine. Consult your doctor if these side effects do not resolve in the first 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. Inform your doctor immediately of any suicidal thoughts you may have. You may also experience insomnia (frequent), anxiety (infrequent), nervousness (rare), anxiety 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 may lead to breathing difficulties and/or decreased blood pressure and rapid heart rate. In case of an allergic reaction, stop taking roflumilast and immediately contact your doctor or go to the nearest hospital emergency department. Bring all your medications and this leaflet with you and provide all information about your current medication.

Other side effects, including the following:

Frequent side effects: can affect up to 1 in 10 people

- diarrhea, nausea, stomach pain

- weight loss, loss of appetite

- headache.

Infrequent side effects:can affect up to 1 in 100 people

- tremors, sensation of spinning (vertigo), dizziness

- sensation of rapid or irregular heartbeats (palpitations)

- gastritis, vomiting

- acid reflux from the stomach to the throat (acid regurgitations), indigestion

- rash

- muscle pain, muscle weakness or cramps

- back pain

- feeling of weakness or fatigue; general discomfort.

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

- gynecomastia (enlargement of breast tissue in men);

- loss of taste

- respiratory tract infections (except pneumonia)

- stools with blood, constipation

- elevation of liver and muscle enzymes (observed in blood tests)

- hives (urticaria).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and blister, CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofRoflumilastAurovitas

-The active ingredient is roflumilast. Each tablet contains 500 micrograms ofroflumilast.

-The other components are: Lactose monohydrate, cornstarch, hypromellose (type 2910), poloxamer (Type 188), magnesium stearate

Appearance of the product and contents of the package

Tablet.

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

Roflumilast Aurovitas tabletsare available in blister packs.

Package size:

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

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Manufacturer responsible

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Republic of Czechia:Roflumilast Aurovitas

Germany:RoflumilaPUREN 500 Mikrogramm Tabletten

Portugal:Roflumilaste Generis

Spain:Roflumilast Aurovitas 500 microgramos comprimidos EFG

Last review date of this leaflet: September 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).