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  • Active ingredient: Roflumilast
  • Medical form: Pill
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Daliresp, with Roflumilast as the active ingredient, is used to reduce flare-ups in patients with severe COPD linked to chronic bronchitis. It works by lowering inflammation in the airways, making breathing easier over time. The medication is taken once daily and may cause gastrointestinal or mood-related side effects. Monitoring during treatment is important for safety and effectiveness.

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Generic Daliresp Information

Introduction

Daliresp (generic name : roflumilast) is a prescription medicine approved in the United Kingdom for the long‑term management of chronic obstructive pulmonary disease (COPD) in patients with a history of frequent exacerbations. The drug is marketed by Takeda Pharmaceuticals and belongs to the therapeutic groups Skin Care and General health as classified in some regulatory databases, reflecting its anti‑inflammatory properties. Beyond its primary respiratory indication, roflumilast is investigated for other inflammatory conditions, but such uses remain off‑label in the UK.


What is Daliresp?

Daliresp is a tablet formulation that contains the active compound roflumilast, a selective phosphodiesterase‑4 (PDE‑4) inhibitor. It was developed by Takeda and received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) in 2011. The tablet is supplied in 250 µg and 500 µg strengths for oral administration once daily.


How Daliresp Works

Roflumilast blocks the enzyme phosphodiesterase‑4, which is responsible for breaking down cyclic adenosine monophosphate (cAMP) inside inflammatory cells such as neutrophils, macrophages and eosinophils. By inhibiting PDE‑4, intracellular cAMP levels rise, leading to reduced release of pro‑inflammatory cytokines (e.g., TNF‑α, IL‑6, IL‑8). The net effect is a dampened inflammatory response within the airways, decreasing the frequency and severity of COPD exacerbations.

Pharmacokinetic data show that roflumilast reaches peak plasma concentrations about 1 hour after a tablet is swallowed; its active metabolite (roflumilast N‑oxide) peaks at approximately 4 hours. The elimination half‑life of the metabolite is 30 hours, supporting once‑daily dosing. Steady‑state concentrations are achieved after 4–5 days of continuous therapy.


Conditions Treated with Daliresp

  • Chronic Obstructive Pulmonary Disease (COPD) with a history of exacerbations – The only indication approved by the MHRA. Clinical trials (e.g., the UPLIFT and Horizon studies) demonstrated a ≈ 15 % reduction in the rate of moderate‑to‑severe exacerbations compared with placebo. In the UK, COPD affects around 1.2 million adults, and exacerbations are a major cause of hospital admission.

Off‑label investigations – Roflumilast’s anti‑inflammatory mechanism has prompted research into psoriasis, atopic dermatitis and other skin disorders, which explains its listing under the “Skin Care” group in some databases. No such indication is authorised in the UK at present.


Who is Daliresp For?

  • Adults (≥ 18 years) diagnosed with COPD whose lung function is classified as GOLD stage II–IV and who have experienced at least two exacerbations in the previous year despite optimal inhaled therapy.
  • Patients already receiving long‑acting bronchodilators (LABA/LAMA) and inhaled corticosteroids, where an additional anti‑inflammatory oral agent is needed to further reduce exacerbation risk.
  • Individuals without significant liver disease (Child‑Pugh class A only) and with a body mass index ≥ 18 kg/m², as these factors affect drug metabolism and tolerability.

Contra‑indications – Daliresp is not suitable for patients with severe hepatic impairment (Child‑Pugh B or C), uncontrolled depression or active psychosis, and it should be avoided in pregnancy or lactation due to lack of safety data.


Risks, Side Effects, and Interactions

Common

  • Diarrhoea – Usually mild to moderate, occurring in up to 20 % of users.
  • Nausea and abdominal discomfort – Reported in 10–15 % of patients.
  • Weight loss – Average loss of 1–2 kg over the first 3 months.
  • Headache – A frequent, typically transient complaint.

Rare

  • Back pain – Observed in < 1 % of treated individuals.
  • Dry mouth – Slightly less common but may affect adherence.
  • Insomnia – Reported sporadically, often resolving with dose adjustment.

Serious

  • Psychiatric disturbances – Including depression, suicidal ideation, and anxiety. Patients with a prior psychiatric history should be monitored closely; any emergence of mood changes warrants immediate medical review.
  • Severe liver enzyme elevations – ALT or AST > 3 × upper limit of normal (ULN) accompanied by bilirubin rise may indicate hepatotoxicity.
  • Severe gastrointestinal events – Rare cases of ulcerative colitis flare‑ups have been documented.

Drug–Drug Interactions

  • Cytochrome P450 3A4 inhibitors (e.g., ketoconazole, clarithromycin) – May increase roflumilast plasma concentrations; dose adjustment or alternative therapy is recommended.
  • Strong inducers (e.g., rifampicin, carbamazepine) – Can reduce roflumilast exposure, potentially diminishing efficacy.
  • Warfarin – No direct interaction, but routine INR monitoring is advised if concomitant use is necessary.
  • CYP1A2 substrates (e.g., theophylline) – No clinically relevant effect, but clinicians may choose to monitor levels in high‑risk scenarios.

Practical Use: Dosing, Missed Dose, Overdose

  • Standard dose – The usual maintenance dose is 500 µg (one tablet) taken orally once daily with food to improve tolerability. In patients who experience intolerable gastrointestinal effects, the dose may be reduced to 250 µg after a minimum of 2 weeks at the higher strength.
  • Missed dose – If a dose is forgotten, take it as soon as remembered unless the scheduled time for the next dose is within 12 hours. In that case, skip the missed tablet and resume the regular dosing schedule. Do not double‑dose.
  • Overdose – Acute overdose is rare; symptoms may include severe nausea, vomiting, diarrhoea and dizziness. Management is supportive, focusing on hydration and symptomatic treatment. Contact NHS 111 or the local poison information centre immediately.
  • Food & Alcohol – Taking Daliresp with a meal reduces gastrointestinal upset. Moderate alcohol intake does not significantly affect roflumilast metabolism, but excessive consumption may exacerbate weight loss and liver enzyme alterations.
  • Renal & Hepatic considerations – No dose reduction is required for mild renal impairment. In moderate to severe hepatic dysfunction (Child‑Pugh B/C), Daliresp is contraindicated.

Buying Daliresp from Our Online Pharmacy

Patients who encounter limited availability or high cost through conventional UK pharmacies can obtain Daliresp from our online pharmacy in the United Kingdom. Our service offers several advantages:

  • Affordable pricing – We source the medication at near‑manufacturer cost, passing the savings directly to the customer.
  • Verified quality – All tablets are supplied by licensed overseas manufacturers that meet EU‑GMP standards; each batch undergoes third‑party quality testing before dispatch.
  • Guaranteed delivery – Discreet, reliable shipping is provided with options for 7‑day express delivery or standard airmail (approximately 3 weeks). Tracking information is supplied for every order.
  • International access – As a pharmacy‑broker service, we collaborate with overseas licensed pharmacies, enabling patients to obtain medicines that are not routinely stocked locally while maintaining strict privacy safeguards.

Our online platform complies with UK regulations for the personal import of prescription medicines for personal use. All transactions are conducted securely, and patient data are handled in accordance with GDPR.


FAQ

  • Is Daliresp available in both brand‑name and generic forms in the UK?
    Yes. Daliresp is the brand‑name tablet produced by Takeda, while generic roflumilast tablets containing the identical active ingredient are also authorised and can be sourced from accredited suppliers.

  • What does the Daliresp tablet look like?
    The 250 µg tablet is white, round, and debossed with “250 RFL.” The 500 µg tablet is pink, round, and marked “500 RFL.” Inactive ingredients include lactose, magnesium stearate, and microcrystalline cellulose.

  • Can Daliresp be stored in a refrigerator?
    No. The medication should be kept at controlled room temperature (15‑30 °C). Refrigeration is unnecessary and may cause condensation, potentially affecting tablet integrity.

  • How long does a Daliresp tablet remain stable after opening the blister pack?
    Once a blister is opened, tablets remain stable for up to 12 months provided they are stored in the original container, away from moisture and direct sunlight.

  • Is it safe to travel internationally with Daliresp?
    Yes, provided the medication is kept in its original packaging with a copy of the prescription or a doctor’s letter if required by customs. Carrying a reasonable supply for personal use (up to a 3‑month supply) is generally acceptable.

  • Does Daliresp interact with commonly used over‑the‑counter supplements?
    Roflumilast does not have major interactions with most vitamins or mineral supplements. However, St John’s wort (a CYP3A4 inducer) could lower roflumilast concentrations, potentially reducing efficacy.

  • Are there any differences between the EU and US formulations of roflumilast?
    The active ingredient and dosage strengths are identical. Minor variations may exist in excipients due to regional manufacturing practices, but these do not alter clinical effectiveness.

  • What monitoring is recommended while taking Daliresp?
    Baseline liver function tests (ALT, AST, bilirubin) should be performed before initiation, with follow‑up testing at 4‑6 weeks and periodically thereafter. Weight and mood assessments are also advised.

  • Can Daliresp cause a false‑positive result on drug‑testing screens?
    Roflumilast is not listed among substances that trigger standard urine drug screens for opioids, cannabinoids, or amphetamines. Specialized testing would be required to detect it.

  • Is there a specific population that should avoid Daliresp due to genetic factors?
    Patients with known poor CYP3A4 metaboliser status may have higher systemic exposure, but routine genetic testing is not required. Clinicians may consider dose adjustment if adverse effects are pronounced.

  • What is the environmental impact of disposing unused Daliresp tablets?
    Unused tablets should be returned to a pharmacy waste program or disposed of according to local hazardous‑waste guidelines. Flushing medications is discouraged because traces can enter water supplies.


Glossary

Phosphodiesterase‑4 (PDE‑4) inhibitor
A drug class that blocks the PDE‑4 enzyme, leading to increased intracellular cAMP and reduced inflammatory signalling.
GOLD classification
The Global Initiative for Chronic Obstructive Lung Disease staging system (I–IV) used to assess COPD severity based on spirometric measurements.
CYP3A4
A major liver enzyme that metabolises many pharmaceuticals; inhibition or induction of CYP3A4 can markedly alter drug concentrations.
Steady‑state concentration
The point during repeated dosing when the rate of drug administration equals the rate of elimination, resulting in a stable blood level.

⚠️ Disclaimer

The information provided about Daliresp is for general knowledge only. It does not replace professional medical consultation. All treatment decisions should be made under the supervision of a qualified healthcare provider. We assume all readers are responsible adults capable of making informed decisions about their health. Our online pharmacy offers access to Daliresp for individuals who may have limited availability through traditional pharmacies, prescription‑based insurance schemes, or who are seeking affordable generic alternatives. Always consult your doctor before starting, changing, or discontinuing any medication.

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