ROFLUMILAST AUROVITAS 250 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 medicine (listed in section 6)

if you have moderate or severe liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take roflumilast.

Sudden episodes of shortness of breath (dyspnea)

Roflumilast is not indicated for the treatment of sudden episodes of shortness of breath (acute bronchospasm). To relieve a sudden episode of shortness of breath, it is very important that your doctor provides you with another medicine that you will have available at all times to overcome these episodes. Roflumilast will not help you in these situations.

Weight

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

Other diseases

This medicine 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)
• 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 medicine in these diseases. If you are diagnosed with any of these diseases, consult your doctor.

Experience with the use of roflumilast 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 additional medication that may increase the likelihood of these side 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 give this medicine to children or adolescents under 18 years of age.

Other medicines and Roflumilast Aurovitas

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

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

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

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

Pregnancy, breastfeeding, and fertility

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

You should not become pregnant during treatment with this medicine 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 medicine.

3. How to take Roflumilast Aurovitas

Follow exactly the instructions for administration of this medicine given 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 tablet of roflumilast once daily.

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

• 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 to produce its beneficial 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, mucosity, and low blood pressure. Immediately consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20. If possible, take the medicine 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 a whole day, continue taking the normal dose the next day. Continue taking the medicine at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Roflumilast Aurovitas

It is important that to control lung function you continue taking roflumilast during the period indicated by your doctor, even when you no longer have symptoms.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 medicine. 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 contact your doctor immediately or go to the emergency department of the nearest hospital. Take all your medicines and this leaflet with you and provide all the 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 reflux), 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)
• blood in stool, constipation
• elevation of 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 through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Roflumilast Aurovitas

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

This medicine does not require any special storage conditions.

Do not use this medicine 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 ofRoflumilastAurovitas

• The active substance is roflumilast.

Each tablet contains 250 micrograms of roflumilast.

• The other ingredients are: lactose monohydrate, corn starch, hypromellose (type 2910), poloxamer (type 188), magnesium stearate

Appearance and packaging

Tablet.

Roflumilast Aurovitas 250 micrograms tablets EFG:[Size: approximately 5 mm]

Uncoated white to off-white tablets, round, flat, with beveled edges, engraved with "T" and "250" on one side and smooth on the other side.

Roflumilast Aurovitas tablets are available in blister packs.

Pack 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.

Avenida de Burgos, 16-D

28036 Madrid

Spain

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 medicine is authorised in the Member States of the European Economic Area under the following names:

Czech Republic: Roflumilast Aurovitas

Germany: RoflumilaPUREN 250 Mikrogramm Tabletten

Portugal: Roflumilaste Generis

Spain: Roflumilast Aurovitas 250 micrograms tablets EFG

Date of last revision of this leaflet:July 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).