500 micrograms film-coated tablets
What Roflumilast Accord is and what it is used for
Roflumilast Accord contains the active substance roflumilast which is an anti-inflammatory agent called phosphodiesterase ‑4 ‑ inhibitor. Roflumilast reduces the activity of phosphodiesterase ‑4, a protein that occurs naturally in the body’s cells. When the activity of this protein is reduced, inflammation in the lungs decreases. This helps to stop the narrowing of the airways that occurs in chronic obstructive pulmonary disease (COPD). Roflumilast Accord thus relieves breathing problems.
Roflumilast Accord is used for maintenance treatment of severe COPD in adults whose COPD symptoms have often worsened in the past (so-called exacerbations ) and who have chronic bronchitis. COPD is a chronic disease of the lungs that leads to the airways becoming narrower ( obstruction ) and to the walls of the small airways becoming swollen and irritated ( inflammation ). This causes symptoms such as coughing, wheezing and voice, chest tightness, and difficulty breathing. Roflumilast Accord should be used as an adjunct to bronchodilators.
Roflumilast contained in Roflumilast Accord may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Roflumilast Accord
Do not take Roflumilast Accord
- if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in section 6)
- if you have moderate or severe liver problems.
Warnings and cautions
Talk to your doctor or pharmacist before taking Roflumilast Accord.
Sudden attacks of shortness of breath
Roflumilast Accord should not be used to relieve sudden attacks of shortness of breath (acute bronchospasm ). To relieve a sudden attack of shortness of breath, your doctor must prescribe another medicine that is designed for this and that you can always carry with you. Roflumilast Accord does not help in such situations.
You should weigh yourself regularly. Talk to your doctor if you inadvertently lose weight while taking this medicine (a weight loss that is not linked to any particular diet or exercise program).
Roflumilast Accord is not recommended if you have any of the following diseases:
- severe immunological diseases e.g. HIV infection, multiple sclerosis (MS), lupus erythematosus (LE), or progressive multifocal leukoencephalopathy (PML)
- severe acute infectious diseases e.g. acute hepatitis
- cancer (in addition to basal cell carcinoma, a slowly growing type of skin cancer)
- or severe disorders of heart function.
This is due to the lack of experience with the use of the Roflumilast Accord in these conditions. Tell your doctor if you have such a disease.
Experience is also limited in the treatment of patients who have previously had tuberculosis, hepatitis caused by a viral infection, herpes infection, or shingles. Talk to your doctor if you have any of these conditions.
Symptoms you should be aware of
During the first weeks of treatment with Roflumilast Accord, you may experience diarrhea, nausea, abdominal pain, or headache. Talk to your doctor if these side effects do not go away after the first few weeks of treatment.
Roflumilast Accord is not recommended for patients who have a history of depression associated with suicidal ideation or behavior. You may also experience insomnia, anxiety, nervousness, or depression. Before starting treatment with Roflumilast Accord, tell your doctor if you are suffering from or taking any of these conditions. Such drugs may increase the risk of getting any of these side effects. You or your healthcare provider should immediately tell your doctor if your behavior or mood has changed and if you have any suicidal thoughts.
Children and young people
This medicine should not be given to children and adolescents under 18 years of age.
Other medicines and Roflumilast Accord
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, especially the following:
- a medicine containing theophylline (a medicine for respiratory diseases) or
- a drug for any immunological disease, e.g. methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken for a long time
- medicines containing fluvoxamine (a medicine for anxiety and depression), enoxacin (a medicine for bacterial infections), or cimetidine (a medicine for stomach ulcers and acid reflux).
The effect of the Roflumilast Accord may be reduced if it is taken with rifampicin (an antibiotic ) or with phenobarbital, carbamazepine, or phenytoin (medicines commonly used for epilepsy ). Consult a doctor.
Roflumilast Accord can be taken with other medicines used to treat COPD, e.g. inhaled or oral corticosteroids or bronchodilators. Do not stop using these medicines or do not reduce the dose of one of them unless your doctor has given you the go-ahead.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You must not become pregnant during treatment with this medicine and you must use an effective method of contraception during treatment as Roflumilast Accord may be harmful to the unborn baby.
Driving and using machines
Roflumilast does not affect the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Roflumilast Accord contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Roflumilast Accord
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- For the first 28 days – the recommended starting dose is one 250 microgram tablet once a day.
- The starting dose is a low dose to help your body get used to the medicine before you start taking the full dose. At this low dose, you will not get the full effect of the medicine – therefore you must switch to the full dose (maintenance dose) after 28 days.
This dosage is not possible with Roflumilast Accord. Other preparations are available.
- After 28 days – the recommended maintenance dose is one 500 microgram tablet once a day.
Swallow the tablet with a little water. You can take this medicine with or without food. Take the tablet at the same time each day.
You may need to take Roflumilast Accord for several weeks before the intended effect is achieved.
If you take more Roflumilast Accord than you should
If you take more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhea, dizziness, palpitations, fainting, cold sweats, and low blood pressure. Contact a doctor or pharmacist as soon as possible. If possible, take the remaining tablets and this leaflet with you.
If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine immediately contact a doctor or hospital for risk assessment and advice.
If you forget to take Roflumilast Accord
If you forget to take a tablet at the usual time, take it as soon as you remember on the same day. If you forget to take your Roflumilast tablet one day, take the next tablet, as usual, the next day. Continue to take the medicine at the usual times. Do not take a double dose to make up for a forgotten dose.
If you stop taking Roflumilast Accord
For the best possible lung function, you must continue to take Roflumilast Accord for as long as your doctor prescribes it, even if you have no symptoms.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may experience diarrhea, nausea, abdominal pain, or headache during the first weeks of treatment with Roflumilast Accord. Talk to your doctor if these side effects do not subside during the first weeks of treatment.
Some side effects can be serious. In clinical trials and after market introduction, rare cases of suicidal ideation and suicidal behavior (including suicide) have been reported. Tell your doctor immediately if you have any suicidal thoughts. You may also experience side effects such as insomnia (common), anxiety (uncommon), nervousness (rare), panic attack (rare), or depression (rare).
In less common cases, allergic reactions occur. Allergic reactions can affect the skin and in rare cases cause swelling of the eyelids, face, lips, and tongue, which can cause difficulty breathing and/or a drop in blood pressure and increased heart rate. If you experience an allergic reaction, stop taking Roflumilast Accord immediately and contact a doctor or go to the emergency department of the nearest hospital. Bring the remaining tablets and this leaflet and provide full details of your current treatments.
Other side effects:
Common side effects (may affect up to 1 in 10 people)
- diarrhea, nausea, abdominal pain
- weight loss decreased appetite
Uncommon side effects (may affect up to 1 in 100 people)
- tremors, feeling of tingling in the head (dizziness), dizziness
- the feeling of irregular heartbeat or increased number of heartbeats (palpitations)
- gastritis, vomiting
- leakage of stomach acid to the esophagus (acid reflux), indigestion
- muscle pain, muscle weakness, or cramps
- back pain
- feeling weak or tired, feeling sick.
Rare side effects (may affect up to 1 in 1,000 people)
- enlarged breasts in men
- impaired sense of taste
- respiratory tract infections (other than pneumonia)
- blood in the stool, constipation
- elevated liver or muscle enzymes (examined using blood tests)
- raised, itchy rash on the skin ( hives ).
How to store Roflumilast Accord
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 and blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
The active substance is roflumilast.
One film-coated tablet contains 500 micrograms of roflumilast.
- Other ingredients are:
- Core: lactose monohydrate (see section 2 under “Roflumilast Accord contains lactose”), pregelatinized maize starch, magnesium stearate.
- Coating: hypromellose, titanium dioxide (E171), Macrogol 400, yellow iron oxide (E172), indigo carmine aluminum lacquer (E132), and red iron oxide (E172).
What the medicine looks like and the contents of the pack
Roflumilast Accord 500 micrograms film-coated tablets are yellowish, round film-coated tablets with a diameter of 9 mm.
One pack contains 30 or 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
3526 VK Utrecht
J. Uriach y Compañia SA
Poligon Industrial Riera De Caldes,
Avinguda Cami Reial 51-57,
08184 Palau-Solita I Plegamans, Barcelona,