ROFLUMILAST AUROVITAS 500 micrograms TABLETS

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.

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/).