Daliresp (Roflumilast) – Patient Information (Australia)

Daliresp is a medicine used to help reduce flare-ups (exacerbations) of certain chronic lung conditions. The active ingredient is roflumilast, which works in a targeted way to reduce inflammation and airway overactivity.

This page is designed to be patient-friendly and practical. Always follow the advice of your healthcare professional and read the consumer medicines information provided with your medicine.

Key Product Information

• Medicine name: Daliresp
• Active ingredient: Roflumilast
• Medicine class: PDE4 inhibitor (phosphodiesterase-4 inhibitor)
• Common reasons for use: to reduce exacerbations in severe COPD with chronic bronchitis
• Typical form: oral tablets (strength varies by product presentation)

In Australia, availability and brand presentation may vary. Your local pharmacy can confirm what is currently supplied.

How Daliresp Works (Mechanism of Action)

Daliresp (roflumilast) is a PDE4 inhibitor. PDE4 (phosphodiesterase-4) is an enzyme that helps break down intracellular signalling molecules involved in inflammation.

By inhibiting PDE4, roflumilast can increase levels of cAMP (cyclic adenosine monophosphate) within cells. Higher cAMP can reduce the release of inflammatory mediators such as cytokines and can help limit inflammation-related effects in the airways.

• Helps reduce inflammatory activity linked to COPD flare-ups
• Supports fewer exacerbations when used as part of overall COPD management
• Does not replace rescue medicines (e.g., short-acting bronchodilators)

What It’s Used For (Indications) – COPD

Daliresp is used in adults to reduce the risk of COPD exacerbations in people with severe to very severe COPD associated with chronic bronchitis (often defined as long-term productive cough).

It is generally considered when exacerbations continue despite standard COPD inhaled treatments.

Not for sudden attacks: Daliresp is not a “quick relief” medicine for an immediate breathing emergency.

Typical Dosing & Timing

Dosing is individualised, but roflumilast is usually started at a lower dose to improve tolerance and is then increased. Your healthcare professional will advise your exact schedule.

Timing with the day: Many people find taking it in the morning or with their main meal helps with gastrointestinal side effects. Choose a routine that you can maintain daily.

Pharmacokinetics (How the Body Handles Roflumilast)

Pharmacokinetics explains what the body does with a medicine—how it is absorbed, metabolised, and cleared. While individual responses vary, the main practical points are:

• Absorption: Roflumilast is absorbed after oral dosing.
• Metabolism: It is metabolised mainly in the liver to an active metabolite (roflumilast N-oxide).
• Onset of effect: Improvements (especially reduction in exacerbations) are not immediate; benefit is expected over time as part of ongoing COPD treatment.
• Excretion: Metabolites are cleared primarily via the kidneys and through bile/faeces.
• Steady state: Concentrations build with repeated daily dosing over days.

Because roflumilast works by reducing inflammatory processes, it’s important to keep taking it consistently unless your healthcare professional advises otherwise.

Food Interactions

Roflumilast can generally be taken with or without food. However, food may influence tolerability for some people—especially if you experience nausea or stomach upset.

• If you are sensitive to gastrointestinal side effects, consider taking it with meals.
• A consistent routine can help you notice whether a side effect is related to timing.

Practical tip: If you notice worsening nausea when taken fasting, try taking it after breakfast (or your usual main meal) rather than on an empty stomach.

Alcohol and Medicine Interactions

Alcohol

There is no single “safe maximum” for alcohol with roflumilast, but drinking alcohol may worsen common side effects such as dizziness, nausea, or reduced appetite. If you choose to drink alcohol, keep it modest and monitor how you feel.

Medicine interactions (general safety overview)

Interactions depend on the specific medicines you take. Several drug interactions are possible because roflumilast is metabolised in the liver and can be affected by other drugs that change liver enzyme activity.

• Tell your healthcare professional about all medicines you use, including inhalers, tablets, creams, supplements, and over-the-counter products.
• Include medicines such as antibiotics, antifungals, seizure medicines, smoking-cessation therapies, and herbal products (e.g., St John’s wort).
• Be cautious with medicines that can strongly alter liver enzymes, as they may change roflumilast levels.

Important: Do not start or stop medicines (including herbal products) without checking first.

Safety Profile & Side Effects

Like all medicines, Daliresp can cause side effects. Many people experience mild to moderate effects early in treatment, which may improve as the body adjusts. If side effects are severe or persistent, contact your healthcare professional.

Common side effects

• Diarrhoea
• Nausea
• Loss of appetite
• Weight loss (sometimes clinically significant)
• Headache
• Insomnia or sleep disturbance
• Dizziness

Serious or important side effects (seek medical advice promptly)

• Severe diarrhoea or dehydration
• Significant weight loss or inability to maintain nutrition
• Mental health changes such as new/worsening depression, agitation, or suicidal thoughts
• Allergic reactions (rare): swelling, rash, breathing difficulties

Who should be extra cautious?

• People with a history of depression or mood disorders
• People at risk of low body weight or who have experienced unintentional weight loss
• People with liver problems or other chronic illnesses
• People who develop persistent gastrointestinal symptoms

Practical Use Tips (Patient-Friendly)

• Take it at the same time each day to maintain consistent levels.
• Manage nausea: consider taking with food; small, frequent meals can help.
• Protect your weight: if you notice reduced appetite, focus on nutrient-dense foods and discuss appetite support if needed.
• Stay hydrated especially if you experience diarrhoea.
• Don’t use it for flare rescue: keep your prescribed fast-acting reliever medicines for sudden shortness of breath.
• Track symptoms: note any change in appetite, weight, mood, or bowel habits during the first weeks.
• Review regularly: COPD treatment often includes inhalers, vaccinations, smoking cessation, and pulmonary rehab. Roflumilast is one part of a broader plan.

Recent Guidance & Clinical Considerations in COPD

COPD management guidelines emphasise a stepped approach: inhaled bronchodilators, inhaled corticosteroids for appropriate patients, vaccination, smoking cessation, and pulmonary rehabilitation. For patients with frequent exacerbations despite standard therapy, add-on options may be considered.

Roflumilast is typically considered for patients with severe COPD and chronic bronchitis, especially those who have had exacerbations. The goal is to reduce future flare-ups rather than provide immediate relief.

Because individual risk factors (including low body weight and mental health history) influence tolerability and safety, clinicians often reassess after initiation to determine whether the benefit outweighs side effects.

Note: Local prescribing decisions in Australia are guided by current clinical practice, product information, and eligibility criteria used by healthcare providers and health services.

Alternative Options (Discuss with Your Healthcare Professional)

If roflumilast is not suitable or is poorly tolerated, several other strategies and medicines may be considered depending on your COPD severity, inhaler regimen, and exacerbation history.

• Optimised inhaled therapy: ensure you are on appropriate long-acting bronchodilators (and inhaled corticosteroids if indicated).
• Macrolide therapy: some patients may be considered for long-term antibiotics under specialist guidance (risk-benefit must be assessed).
• Vaccinations: influenza and pneumococcal vaccination reduce infection-related exacerbations.
• Smoking cessation support: the most effective way to slow progression.
• Pulmonary rehabilitation: improves breathlessness and quality of life.
• Breathing techniques & exercise plans: support day-to-day function.
• Other add-on therapies: based on availability and patient phenotype (your clinician can advise).

Your best option depends on your symptoms, inhaler use, lung function, exacerbation frequency, and past tolerability of treatments.

Market & Legal Context for Australia

In Australia, medicines are supplied in accordance with the Therapeutic Goods Administration (TGA) regulatory framework and state/territory health requirements. Product availability can depend on current supply and the manufacturer’s distribution.

Daliresp (roflumilast) is a prescription medicine in Australia. Supply may be arranged through community pharmacies or other regulated channels. Online pharmacies typically require proper patient assessment and verification processes as required by Australian law and policy.

Always check current product availability with your chosen pharmacy, as stock can vary by location and time.

Delivery, Availability & What to Expect Online

Many Australian online pharmacies offer home delivery within metropolitan and regional areas. Delivery times depend on the pharmacy’s dispatch schedule, couriers, and your postcode.

• Availability: if the item is not in stock, your pharmacy may offer alternatives or order-in services.
• Packaging: medicines are typically dispatched in secure, protective packaging.
• Cold chain: roflumilast does not generally require refrigeration (unless product packaging advises otherwise).
• Tracking: some services provide tracking updates after dispatch.

During checkout, you may be asked for details such as your delivery address, identity verification, and confirmation of relevant information needed for safe dispensing.

FAQ – Daliresp (Roflumilast)

1. What does Daliresp do for COPD?

Daliresp (roflumilast) helps reduce the risk of COPD exacerbations in adults with severe COPD associated with chronic bronchitis. It works by reducing inflammation via PDE4 inhibition.

2. How quickly will I feel better?

Daliresp is not a rescue medicine and is not designed for immediate symptom relief. Benefits—especially fewer flare-ups—are typically assessed over weeks to months. Your clinician may review early tolerability and ongoing benefit.

3. Can I take Daliresp with food?

Yes. Roflumilast can generally be taken with or without food. If you experience nausea or stomach upset, taking it with a meal may help.

4. What should I do if I miss a dose?

If you miss a dose, take it when you remember unless it is close to your next dose. Do not take a double dose. If you’re unsure, check with your pharmacist or healthcare professional.

5. What side effects are common?

Common side effects include diarrhoea, nausea, loss of appetite, headache, dizziness, sleep disturbance, and weight loss. Many people find these effects improve over time, but persistent or severe symptoms should be discussed promptly.

6. Is weight loss a concern?

Yes. Because decreased appetite and weight loss can occur, clinicians often monitor weight and nutrition, particularly in people who start with a low body weight or are at risk of poor nutrition.

7. Does Daliresp affect mood?

Mental health changes (including new or worsening depression) have been reported. If you notice mood changes, agitation, or suicidal thoughts, seek urgent medical help and contact your healthcare professional immediately.

8. Can I drink alcohol while taking Daliresp?

Moderate alcohol may be acceptable for some people, but alcohol can worsen nausea, dizziness, and appetite. If you drink, keep it light and monitor your response. Seek advice if you notice worsening symptoms.

9. What medicines should not be taken with roflumilast?

Drug interactions can occur. Tell your healthcare professional about all medicines, including over-the-counter products and herbal supplements, so interactions can be assessed. In particular, medicines that affect liver enzymes may influence roflumilast levels.

10. Is Daliresp safe for everyone?

Not necessarily. People with certain medical histories (such as depression) or those at risk of weight loss may need extra caution. Your clinician will assess whether roflumilast is appropriate for you.

Need more help? For personalised guidance on suitability, side effects, and how to use your COPD treatment plan, contact your pharmacist or healthcare professional.