Roflumilast Aurovitas 500 micrograms tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

RoflumilastAurovitas 500 micrograms tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents

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

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

This medicine contains the active substance roflumilast, which is a phosphodiesterase-4 inhibitor anti-inflammatory agent. Roflumilast reduces the activity of phosphodiesterase-4, a protein naturally present in the body's cells. By reducing the activity of this protein, inflammation in the lungs decreases. This helps prevent the narrowing of the airways that occurs in chronic obstructive pulmonary disease (COPD). Therefore, this medicine relieves breathing problems.

Roflumilast is used for the maintenance treatment of severe COPD in adults who have previously experienced frequent worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis. COPD is a chronic lung disease that results in 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 cough, wheezing, chest tightness, or difficulty breathing. Roflumilast should be used in combination with bronchodilators.

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

Do not take Roflumilast Aurovitas

• if you are allergic to roflumilast or to any of the other ingredients of this medicine (listed in section 6)
• if you have moderate or severe liver problems.

Warnings and precautions

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

Sudden episodes of dyspnea (difficulty breathing)

Roflumilast is not indicated for the treatment of acute episodes of dyspnea (acute bronchospasms). To relieve a sudden episode of dyspnea, it is very important that your doctor provides you with another medicine, which you must always have available to manage such 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 experience unintentional weight loss (not due to diet or an exercise program).

Other diseases

This medicine is not recommended if you have one or more of the following conditions:

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

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

Experience with this medicine is also limited in patients with a prior diagnosis of tuberculosis, viral hepatitis, viral herpes, or herpes zoster. Consult your doctor if you have any of these conditions.

Symptoms you should be aware of

During the first weeks of treatment with roflumilast, you may experience diarrhea, nausea, abdominal pain, or headache. If these adverse effects do not resolve 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, restlessness, or depression. Before starting treatment with roflumilast, inform your doctor if you have any of these symptoms or if you are taking any additional medicines that could increase the likelihood of these adverse effects. You or your caregivers should immediately report any changes in behavior or mood, or any suicidal thoughts, to your doctor.

Children and adolescents

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

Other medicines and Roflumilast Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially the following:

• a medicine containing theophylline (a medicine used to treat respiratory diseases), or
• a medicine used to treat immunological diseases, such as methotrexate, azathioprine, infliximab, etanercept, or long-term oral corticosteroids.
• a medicine containing fluvoxamine (a medicine to treat anxiety and depression disorders), enoxacin (a medicine to treat bacterial infections), or cimetidine (a medicine to treat stomach ulcer or acid reflux).

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

Roflumilast may be used together 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 instructed by your doctor.

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 taking this medicine.

You must not become pregnant during treatment with this medicine, and you should use an effective method of contraception during treatment, as roflumilast may be harmful to the fetus.

Driving and using machines

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

Roflumilast Aurovitas contains lactose

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

3. How to take Roflumilast Aurovitas

Follow exactly the instructions for using this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

• During the first 28 days – the recommended initial dose is one 250 microgram roflumilast tablet once daily.

• This initial dose is a low dose used to help your body get used to the medicine before starting the full dose. This low dose will not provide the full effect of the medicine; therefore, it is important to 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 as 500 microgram tablets, which cannot be divided into two equal halves. Other formulations are available on the market for administration of the initial 250 microgram dose.

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

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

It may take several weeks before Roflumilast Aurovitas produces its full 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, diarrhoea, dizziness, palpitations, confusion, mucus production, and low blood pressure. Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20. If possible, bring the medicine and this leaflet with you.

If you forget to take Roflumilast Aurovitas

If you forget to take a tablet at the usual 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 your normal dose the next day. Keep taking the medicine at your usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Roflumilast Aurovitas

It is important that you continue taking Roflumilast for the period indicated by your doctor in order to control your lung function, even if your symptoms improve.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

You may experience diarrhoea, nausea, stomach pain or headache during the first weeks of treatment with this medicine. Consult your doctor if these adverse effects do not resolve within the first weeks of treatment.

Some adverse effects may be serious. In clinical studies and post-marketing experience, rare cases of suicidal thoughts and behaviours (including suicide) have been reported. Inform your doctor immediately if you experience any suicidal thoughts. You may also experience insomnia (frequent), anxiety (uncommon), nervousness (rare), panic attacks (rare), or depressed mood (rare).

In uncommon cases, allergic reactions may occur. Allergic reactions may affect the skin and, in rare instances, cause swelling of the eyelids, face, lips and tongue, which may lead to breathing difficulties and/or a drop in blood pressure and rapid heart rate. If you experience an allergic reaction, stop taking roflumilast immediately and contact your doctor or go straight to the nearest hospital emergency department. Take all your medicines and this leaflet with you and provide full information about your current medication.

Other adverse effects include the following:

Frequent adverse effects: may affect up to 1 in 10 people

• diarrhoea, nausea, stomach pain
• weight loss, decreased appetite
• headache.

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

• tremor, sensation of spinning (vertigo), dizziness
• awareness of rapid or irregular heartbeat (palpitations)
• gastritis, vomiting
• acid reflux from stomach to throat (acid regurgitation), indigestion
• rash
• muscle pain, muscle weakness or cramps
• back pain
• feeling of weakness or fatigue; general malaise.

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

• gynaecomastia (enlargement of breast tissue in men)
• loss of sense of taste
• respiratory tract infections (excluding pneumonia)
• blood in stools, constipation
• increased liver and muscle enzymes (observed in blood tests)
• hives (urticaria).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the packaging and blister, following EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Roflumilast Aurovitas

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

Appearance of the product and contents of the pack

Tablet.

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

Roflumilast Aurovitas tablets are available in blister packs.

Pack sizes:

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

Only some pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

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 European Economic Area member states under the following names:

Czech Republic: Roflumilast Aurovitas
Germany: RoflumilaPUREN 500 Mikrogramm Tabletten
Portugal: Roflumilaste Generis
Spain: Roflumilast Aurovitas 500 microgramos comprimidos EFG

Date of the most recent revision of this leaflet: September 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).