Patient Leaflet Updated 26-Jun-2026 | Aurobindo Pharma - Milpharm Ltd.
Roflumilast 500 micrograms Tablets
Roflumilast 500 micrograms Tablets
1. What Roflumilast tablets are and what they are used for
2. What you need to know before you take Roflumilast tablets
3. How to take Roflumilast tablets
4. Possible side effects
5. How to store Roflumilast tablets
6. Contents of the pack and other information
Roflumilast tablet contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase-4 inhibitor. Roflumilast reduces the activity of phosphodiesterase-4, a protein occurring naturally in body cells. When the activity of this protein is reduced, there is less inflammation in the lungs.
This helps to stop narrowing of airways occurring in chronic obstructive pulmonary disease (COPD). Thus roflumilast eases breathing problems.
Roflumilast is used for maintenance treatment of severe COPD in adults who in the past had frequent worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis. COPD is a chronic disease of the lungs that results in tightening of the airways (obstruction) and swelling and irritation of the walls of the small air passages (inflammation). This leads to symptoms such as coughing, wheezing, chest tightness or difficulty in breathing. Roflumilast is to be used in addition to bronchodilators.
Talk to your doctor or pharmacist before taking Roflumilast tablets.
Sudden attack of breathlessness
Roflumilast is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms). In order to relieve a sudden attack of breathlessness it is very important that your doctor provides you with another medicine to be available to you at all times that can cope with such an attack. Roflumilast will not help you in this situation.
Body weight
You should check your body weight on a regular basis. Talk to your doctor if, while taking this medicine, you observe an unintentional loss of body weight (not related to a diet or exercise programme).
Other diseases
Roflumilast is not recommended if you have one or more of the following diseases:
There is a lack of relevant experience with Roflumilast under these conditions. You should talk to your doctor, if you are diagnosed with any of these diseases.
Experience is also limited in patients with a previous diagnosis of tuberculosis, viral hepatitis, herpes viral infection or herpes zoster.
Please talk to your doctor if you have one of these diseases.
Symptoms you should be aware of
You may experience diarrhoea, nausea, abdominal pain or headache during the first weeks of treatment with Roflumilast. Talk to your doctor if these side effects do not resolve within the first weeks of treatment.
Roflumilast is not recommended in patients with a history of depression associated with suicidal thinking or behaviour. You may also experience sleeplessness, anxiety, nervousness, or depressive mood. Before starting treatment with Roflumilast, inform your doctor if you are suffering from any symptoms of this kind and of any additional medicines you may take since some of those could increase the probability of these side effects. You or your caregiver should also immediately inform your doctor of any changes in behaviour or mood and of any suicidal thoughts you may have.
Do not give this medicine to children and adolescents under 18 years of age.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially the following:
The effect of Roflumilast may be reduced if taken together with rifampicin (an antibiotic medicine) or with phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of epilepsy). Ask your doctor for advice.
Roflumilast tablets may be taken with other medicines used in the treatment of COPD such as inhaled or oral corticosteroids or bronchodilators. Do not stop taking these medicines or reduce their dose unless advised by your doctor.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not become pregnant during treatment with this medicine and should use an effective method of contraception during therapy, because roflumilast may be harmful for the unborn baby.
Roflumilast has no influence on the ability to drive and use machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Swallow the tablet with some water. You may take this medicine with or without food. Take the tablet at the same time every day.
You may need to take roflumilast for several weeks to achieve its beneficial effect.
If you have taken more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhoea, dizziness, throbbing of your heart, light-headedness, clamminess and low blood pressure. Tell your doctor or pharmacist straight away. If possible take your medicine and this leaflet with you.
If you forget to take a tablet at the usual time, take the tablet as soon as you remember on the same day. If on one day you have forgotten to take a tablet of roflumilast, just carry on the next day with the next tablet as usual. Continue taking your medicine at the usual times. Do not take a double dose to make up for a forgotten dose.
It is important to continue taking Roflumilast tablets for as long as prescribed by your doctor, even when you have no symptoms, in order to maintain control of your lung function.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may experience diarrhoea, nausea, stomach ache or headache during the first weeks of treatment with roflumilast. Talk to your doctor if these side effects do not resolve within the first weeks of treatment.
Some side effects could be serious. In clinical studies and post-marketing experience, rare instances of suicidal thinking and behaviour (including suicide) were reported. Please notify your doctor immediately of any suicidal thoughts you may have.
You may also experience sleeplessness (common), anxiety (uncommon), nervousness (rare), panic attack (rare) or depressive mood (rare).
In uncommon cases allergic reactions may occur. Allergic reactions may affect the skin and in rare cases cause swelling of the eyelids, face, lips and tongue, possibly leading to difficulties in breathing and/or a drop in blood pressure and accelerated heartbeat. In case of an allergic reaction, stop taking Roflumilast tablets and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital. Take all your medicines and this leaflet with you and provide full information of your current medications.
Other side effects include the following:
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
If you get 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton (EXP). The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active substance is roflumilast.
Each Roflumilast 500 micrograms tablet contains 500 micrograms roflumilast. The other ingredients are lactose monohydrate, maize starch, hyperomellose, poloxamer (type 188) and magnesium stearate.
Roflumilast 500 micrograms tablets are white to off-white, flat faced bevelled edged uncoated tablets, debossed with “T” and “500” on one side and plain on the other side.
Roflumilast 500 micrograms tablets are available in blister pack (i.e clear PVC/PVdC - Aluminium foil blister pack)
Blister pack sizes: 30 tablets
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This leaflet was last revised in 10/2025.
P1540257
Milpharm Limited, 1 Roundwood Avenue, Stockley Park, Uxbridge, UB11 1AF, UK
+ 44 (0)208 845 8811
+44 (0)208 845 8811
http://www.aurobindo.com
+44 (0)208 845 8795
