Daxas 500 micrograms film-coated tablets Roflumilast - United Kingdom[英国药品]

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Daxas 500 micrograms film-coated tablets Roflumilast

2015-01-08 16:37:26 来源: 作者: 【大中小】浏览:401次评论:0条

For doctors

What is it and how is it used?

Daxas 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 Daxas eases breathing problems.

Daxas is used to treat severe COPD in adults. 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) leading to symptoms such as coughing, wheezing, chest tightness or difficulty in breathing. Daxas is to be used in addition to bronchodilators.

What do you have to consider before using it?

Do not take Daxas

Take special care with Daxas
Daxas 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. Daxas will not help you in this situation.

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).

Daxas is not recommended for patients having severe immunological diseases (such as HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy, and others), severe acute infectious diseases (such as tuberculosis, or acute hepatitis), cancer (except basal-cell carcinoma, a slow-growing type of skin cancer), or severe impairment of the heart function, due to lack of relevant experience with Daxas 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.

You may experience diarrhoea, nausea, abdominal pain or headache during the first weeks of treatment with Daxas. Talk to your doctor if these side effects do not resolve within the first weeks of treatment.

You may also experience sleeplessness, anxiety, nervousness, or depressive mood. Before starting treatment with Daxas, inform your doctor if you are suffering from any symptoms of this kind and of any additional medicinal products you may take since some of those could increase the probability of these side effects. You should also immediately inform your doctor of any suicidal thoughts you may have.

Children
Daxas should not be used by children and adolescents under 18 years of age.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Daxas 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.

Please let your doctor know before you start to take Daxas, if you already take:

The effect of Daxas 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.

Taking Daxas with food and drink
You may take this medicine with or without food.

Pregnancy and breast-feeding
Do not take Daxas if you are or plan to become pregnant, think you may be pregnant, or are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Daxas has no influence on the ability to drive and use machines.

Important information about some of the ingredients of Daxas
Daxas tablets contain 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 is it used?

Always take Daxas exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is one 500 micrograms tablet once daily. Do not take more tablets than your doctor has recommended.

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 Daxas for several weeks to achieve its beneficial effect.

If you take more Daxas than you should
Tell your doctor or pharmacist straight away. If possible take your medicine and this leaflet with you.

If you forget to take Daxas
If you forget to take a tablet at the usual time, take the tablet as soon as you remember. If on one day you have forgotten to take a tablet of Daxas, 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.

If you stop taking Daxas
It is important to continue taking Daxas 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.

What are possible side effects?

Like all medicines, Daxas can cause side effects, although not everybody gets them.

Side effects may occur with certain frequencies, which are defined as follows very common affects more than 1 user in 10 common affects 1 to 10 users in 100 uncommon affects 1 to 10 users in 1,000 rare affects 1 to 10 users in 10,000 very rare affects less than 1 user in 10,000 not known frequency cannot be estimated from the available data.

Common side effects
Weight decrease, decreased appetite; sleeplessness; headache; diarrhoea, nausea, stomach ache.

Uncommon side effects
Hypersensitivity (a generalised allergic reaction that may affect the skin, mouth and tongue, possibly leading to difficulties in breathing and/or a drop in blood pressure and accelerated heartbeat); feeling anxious; trembling, sensation of spinning head (vertigo), dizziness; sensation of rapid or irregular heartbeat (palpitations); gastritis, vomiting, reflux of stomach acid to the gullet (acid regurgitations), indigestion; rash; muscle pain or cramps; back pain; feeling of weakness or tiredness; feeling unwell.

Rare side effects
Male breast enlargement; feeling nervous or depressed; decreased sense of taste; respiratory tract infections (excluding pneumonia); bloody stools, constipation; elevation of liver or muscle enzymes (seen in blood tests); wheals (urticaria).

In the rare case of a severe allergic reaction, stop taking Daxas and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital. Take your medicine and this leaflet with you to provide full information of your proper treatment. Typical symptoms of a severe allergic reaction are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, hives (nettle rash), severe dizziness with very fast heartbeat and heavy sweating.

In clinical studies, some instances of suicidal thinking and behavior (including suicide) were reported. Please notify your doctor immediately of any suicidal thoughts you may have.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Daxas after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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.

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For doctors

What is it?

Daxas is a medicine that contains the active substance roflumilast. It is available as yellow, D-shaped tablets (500 micrograms).

What is it used for?

Daxas is used to treat severe chronic obstructive pulmonary disease (COPD) in adults who have chronic bronchitis (long-term inflammation of their airways), and whose COPD flares up frequently. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing air in and out of the lungs.

Daxas is not used on its own but as an ‘add-on’ to treatment with bronchodilators (medicines that widen the airways in the lungs).

The medicine can only be obtained with a prescription.

How is it used?

The recommended dose of Daxas is one tablet once a day. The tablets should be swallowed with water at the same time each day. Patients may need to take Daxas for several weeks before it starts to have an effect.

How does it work?

The active substance in Daxas, roflumilast, belongs to a group of medicines called ‘phosphodiesterase type 4 (PDE4) inhibitors’. It blocks the action of the PDE4 enzyme, which is involved in the inflammation process that leads to COPD. By blocking the action of PDE4, roflumilast reduces the inflammation in the lungs, helping to reduce the patient’s symptoms or to prevent them from getting worse.

How has it been studied?

The effects of Daxas were first tested in experimental models before being studied in humans.

Daxas has been compared with placebo (a dummy treatment) in two main studies involving over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year. The patients could continue to receive treatment with a bronchodilator during the study. The main measure of effectiveness was the improvement in forced expiratory volumes (FEV ) and the reduction in the number of moderate or severe flare-ups of their COPD over a year of treatment. FEV is the most air a person can breathe out in one second.

What benefits has it shown during the studies?

Daxas was shown to be more effective than placebo at treating COPD. At the beginning of the study, both groups of patients had an FEV of around 1 litre (1,000 ml). After a year, the patients who took Daxas had an average increase of 40 ml while those given placebo had an average decrease of 9 ml. In addition, the patients who took Daxas had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.

What is the risk associated?

The most common side effects with Daxas (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache). Because patients taking Daxas may lose weight, they are advised to weigh themselves on a regular basis. The doctor may stop treatment with Daxas if the patient loses too much weight. For the full list of all side effects reported with Daxas, see the Package Leaflet.

Daxas should not be used in people who may be hypersensitive (allergic) to roflumilast or any of the other ingredients. It must not be used in patients who have moderate or severe problems with their liver. Daxas is not recommended in patients with diseases that severely weaken the immune system (the body's natural defences). Because there have been rare cases of patients taking Daxas feeling suicidal, the medicine is also not recommended in patients who have had depression with suicidal thoughts.

Why has it been approved?

The CHMP noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daxas in patients with severe COPD. This benefit was seen on top of the effects of the treatments that the patients were already receiving. After considering all of the available data on the effects of the medicine, the Committee decided that Daxas’s benefits are greater than its risks and recommended that it be given marketing authorisation.

How has it been studied?

The company that makes Daxas will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine’s side effects and how it should be used. The company will also provide cards for patients, telling them what information that they need to give their doctor about their symptoms and past illnesses to help the doctor know whether Daxas is appropriate for them. The card will include an area where patients can record their weight.

Further information

The European Commission granted a marketing authorisation valid throughout the EU for Daxas to Nycomed GmbH on 5 July 2010. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Daxas, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 05-2010.

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