Daxas 500 micrograms film-coated tablets – roflumilast for severe chronic obstructive pulmonary disease (COPD)

Daxas contains roflumilast, an anti-inflammatory medicine from the group of phosphodiesterase type 4 (PDE4) inhibitors. By reducing the activity of this enzyme it eases inflammation in the lungs and so, in chronic obstructive pulmonary disease (COPD), helps to stop the restriction of airflow through the airways.

It is intended for adults with severe COPD and is taken in addition to bronchodilator therapy. In Serbia it is authorised as a 500 microgram film-coated tablet in a pack of 30 tablets and is supplied on prescription. The medicine is subject to additional safety monitoring.

What is Daxas used for and how should it be taken?

Key facts about the medicine

What is Daxas used for?

According to the Summary of Product Characteristics, Daxas is used for maintenance treatment of severe chronic obstructive pulmonary disease (post-bronchodilator FEV1 less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations.

It is used as an add-on to bronchodilator treatment. COPD causes narrowing of the airways and inflammation of the walls of the small airways, leading to cough, wheezing, chest tightness and difficulty breathing.

How is it taken and dosed?

• Maintenance dose: one 500 microgram tablet once a day.
• According to the leaflet, treatment may start with a lower starting dose (250 micrograms once a day for the first 28 days) for better tolerability; according to the Summary of Product Characteristics the 250 microgram strength is not authorised in Serbia – the doctor decides how treatment is started.
• Swallow the tablet with a little water, at the same time every day, with or without food.
• It sometimes takes several weeks of regular use to reach the full effect.
• Continue your other COPD medicines (inhaled or oral corticosteroids, bronchodilators) and do not reduce their dose unless your doctor advises it.

This is the general dosage from the leaflet – your treatment is decided by your doctor.

Special patient groups

• Children and adolescents under 18 years: the medicine must not be used.
• Elderly patients: no dose adjustment is needed.
• Impaired kidney function: no dose adjustment is needed.
• Impaired liver function: caution is needed in mild impairment (Child-Pugh A); in moderate or severe impairment (Child-Pugh B or C) the medicine must not be taken.

Contraindications – when the medicine must not be used

• allergy to roflumilast or any of the excipients
• moderate or severe liver disease (Child-Pugh B or C)

Warnings and precautions

• The medicine is not intended to relieve a sudden attack of breathlessness – you need a different medicine for that, which you should always keep with you.
• Check your body weight regularly and tell your doctor if you lose weight unexpectedly (not related to diet or exercise).
• It is not recommended in severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus, PML), severe acute infections (tuberculosis, acute hepatitis), cancer (except basal cell carcinoma) or severe heart failure. Experience is also limited in people who have had tuberculosis, viral hepatitis, herpes or shingles.
• It is not recommended for people who have had depression with suicidal thoughts or behaviour; insomnia, anxiety, nervousness or depressed mood may occur.
• In the first weeks diarrhoea, nausea, abdominal pain or headache may occur – tell your doctor if they do not go away.
• The medicine contains lactose.

Interactions with other medicines, food and drink

• Tell your doctor if you take theophylline, medicines for immune diseases (methotrexate, azathioprine, infliximab, etanercept) or long-term oral corticosteroids.
• Fluvoxamine, enoxacin and cimetidine may increase the effect of roflumilast.
• Rifampicin, phenobarbital, carbamazepine and phenytoin may reduce the effect of the medicine.
• Daxas can be taken with inhaled or oral corticosteroids and bronchodilators.
• Food: the medicine can be taken with or without food.

Pregnancy and breast-feeding

Do not take Daxas if you are pregnant, think you may be pregnant, are planning a pregnancy or are breast-feeding. You must not become pregnant during treatment and must use an effective method of contraception, because the medicine may harm the unborn child. According to the Summary of Product Characteristics, animal data show that roflumilast or its metabolites are excreted in milk, so a risk to the infant cannot be excluded and the medicine is not given to breast-feeding women.

Driving and using machines

Daxas has no influence on the ability to drive or use machines.

Possible side effects

• Common (up to 1 in 10 people): diarrhoea, nausea, abdominal pain, weight loss and decreased appetite, headache, insomnia.
• Uncommon (up to 1 in 100 people): trembling, vertigo, dizziness, palpitations, gastritis, vomiting, acid reflux, indigestion, rash, muscle pain, weakness or cramps, back pain, feeling weak or tired, anxiety, allergic reactions.
• Rare (up to 1 in 1,000 people): nervousness, panic attacks, depressed mood, suicidal thoughts and behaviour, breast enlargement in men, reduced sense of taste, respiratory infections (excluding pneumonia), blood in the stool, constipation, increased liver or muscle enzymes, hives, swelling of the face, lips and tongue.

Report any suspected side effects to your doctor, pharmacist or ALIMS (the Serbian Medicines and Medical Devices Agency).

Overdose, missed dose and stopping treatment

• Overdose: contact your doctor or pharmacist immediately and take the pack and leaflet with you. According to the SmPC, headache, digestive complaints, dizziness, palpitations, clammy cold skin and low blood pressure may occur.
• Missed dose: take the tablet as soon as you remember; if you missed it for a whole day, carry on as usual the next day. Do not take a double dose.
• Stopping treatment: take the medicine for as long as your doctor has prescribed, even when you have no symptoms, to keep your lung function under control.

Related information

For devices used in the treatment of respiratory diseases, see also the Inhalers category – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substance: roflumilast 500 micrograms per film-coated tablet.
• Excipients – core: lactose monohydrate; maize starch; povidone K 90; magnesium stearate. Film coat: hypromellose, macrogol 4000, titanium dioxide (E171), yellow iron oxide (E172).
• Pack: carton with 3 PVC/PVDC/Al blisters of 10 film-coated tablets (30 tablets).
• Marketing authorisation holder: PREDSTAVNIŠTVO ASTRAZENECA UK LIMITED BEOGRAD, Milutina Milankovića 1i, Belgrade. Manufacturers: Takeda GmbH, Oranienburg, Germany; Corden Pharma GmbH, Plankstadt, Germany.

Storage

• This medicine does not require any special storage conditions.
• Keep out of the sight and reach of children. Do not use after the expiry date.

Frequently asked questions

Does Daxas help during an attack of breathlessness?

No. Daxas is a medicine for long-term control of severe COPD and does not work in a sudden attack of breathlessness. For such situations your doctor prescribes a separate medicine that you should always keep with you.

Why should I monitor my weight while taking Daxas?

Weight loss and decreased appetite are common side effects. The leaflet advises regular weighing and telling your doctor about unexpected weight loss.

How long does it take for Daxas to work?

According to the leaflet, it sometimes takes several weeks of regular use to achieve the expected effect. The medicine should be taken every day, even when there are no symptoms.

Can I stop my inhalers when I start Daxas?

No. Daxas is taken in addition to bronchodilators; do not stop your inhaler treatment or reduce the dose without your doctor’s advice.

Sources

• ALIMS – Summary of Product Characteristics Daxas®, 500 micrograms, film-coated tablets (Serbian)
• ALIMS – Patient leaflet Daxas®, 500 micrograms, film-coated tablets (September 2022, Serbian)

Sources checked on: 25 October 2026.