Daxas 500 mcg. 30 tablets

What is Daxas and what is it used for?
Daxas contains the active substance roflumilast, an anti-inflammatory drug called the phosphodiesterase 4 inhibitor. Roflumilast decreases the activity of phosphodiesterase 4, a protein found naturally in the body's cells. When the activity of this protein is reduced, it reduces the inflammation in the lungs. This helps to stop the narrowing of the airway, occurring in chronic obstructive pulmonary disease (COPD). So Daxas relieves breathing problems.
Daxas is used for the maintenance of severe COPD in adults who have had a worsening of COPD symptoms (so-called exacerbations) in the past and who have chronic bronchitis. COPD is a chronic lung disease, which leads to contraction of the airways (obstruction) and swelling and irritation of the small airways (inflammation). This causes symptoms such as coughing, wheezing, tightness in the chest or difficulty in breathing. Daxas is used as an adjunct to bronchodilators.

2. What you need to know before taking Daxas
Do not take Daxas
- 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 disease.
Warning and precautions
Talk to your doctor or pharmacist before taking Daxas.
- Sudden shortness of breath
Daxas is not intended for the treatment of sudden onset of shortness of breath (acute bronchospasm). In order to relieve a sudden dyspnea, it is very important for your doctor to provide you with another medicine that is always at your disposal so that you can cope with such an attack. Daxas will not help you in this situation.

Body weight
You should check your weight regularly. Tell your doctor if you notice unwanted weight loss (not on diet or exercise) while taking this medicine.

Other diseases
Daxas is not recommended for patients with one or more of the following diseases:
Severe immunological diseases (such as HIV infection, multiple sclerosis (MS), lupus
Erythematosus (LE) or progressive multifocal leukoencephalopathy (PML)
Severe acute infectious diseases such as tuberculosis or acute hepatitis
Cancer (excluding basal cell carcinoma, slow-growing skin cancer)
Severe heart failure
There is no relevant experience with Daxas in these diseases. You should talk to your doctor if you have any of these conditions diagnosed.
Experience is also limited in patients with pre-existing diagnosis of tuberculosis, viral hepatitis, herpes virus or herpes zoster virus. Please talk to your doctor if you have one of these conditions.

Symptoms that you should be aware of
You may experience diarrhea, nausea, abdominal pain or headache during the first few weeks of treatment with Daxas. Tell your doctor if these side effects do not disappear during the first weeks of treatment.
Daxas is not recommended for patients with a history of depression associated with thoughts or suicidal behaviors. You may also experience drowsiness, anxiety, nervousness or depressed mood. Before you start treatment with Daxas, tell your doctor if you suffer from such symptoms or any additional medicines you should take, as some of them may increase the likelihood of these side effects. If you have a change in behavior or mood or any thoughts of suicide, you or your carer should also immediately inform your doctor.

Children and adolescents
Daxas should not be used by children and adolescents under 18 years of age.
Other medicines and Daxas
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular the following:
A medicine containing theophylline (medicine for the treatment of respiratory diseases) or
- a medicine used to treat immunological diseases such as methotrexate, azathioprine, infliximab, etanercept, or long-term oral corticoids
- medicines containing fluvoxamine (a medicine to treat anxiety disorders and depression), enoxacin (a medicine to treat bacterial infections), or cimetidine (a medicine used to treat stomach ulcers or heartburn).
The effect of Daxas may be reduced if you take it with rifampicin (antibiotic) or phenobarbital, carbamazepine or phenytoin (medicines commonly prescribed to treat epilepsy). Ask your doctor for advice. Daxas can be taken with other medicines used to treat COPD, such as inhaled or oral corticosteroids or bronchodilators. Do not stop taking these medicines and do not reduce their doses unless your doctor advises you.
Pregnancy and breastfeeding
Do not take Daxas, if you are pregnant or plan to become pregnant, think you may be pregnant or breast-feeding. You should not get pregnant during treatment with this medicine and you should use an effective method of contraception during treatment because Daxas can be harmful to your unborn baby.

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

3. How to take Daxas?
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one 500 microgram tablet per day. Do not take more tablets than your doctor has recommended.
Swab the tablet with some water. You may take this medicine with or without food. Take the tablet at the same time each day.
You may need to take Daxas for a few weeks until it has a beneficial effect.

If you take more Daxas than you should
If you take more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhea, dizziness, palpitations, fainting, cold sweat and low blood pressure. Tell your doctor or pharmacist immediately. 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 the same day. If you forget to take a Daxas tablet one day, take the next tablet the next day as usual. Do not take a double dose to make up for the forgotten dose.

If you stop taking Daxas
It is important that you continue to take Daxas as prescribed by your doctor even if you have no complaints in order to maintain control of your respiratory function.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
You may experience diarrhea, nausea, stomach pain or headache during the first weeks of treatment with Daxas. Tell your doctor if these side effects do not disappear during the first weeks of treatment.
Some side effects can be serious. In clinical trials and post-marketing experience, rare cases of suicidal thoughts and behavior (including suicide) have been reported. If you have a suicidal thought, please tell your doctor immediately. You may also get drowsiness (often), anxiety (uncommon), nervousness (rarely) or depressed mood (rarely).
Uncommon cases of allergic reactions may occur. Allergic reactions may affect the skin and, in rare cases, cause swelling of the eyelids, face, lips and tongue, which may lead to difficulty in breathing and / or falling blood pressure and palpitations. In the event of a severe allergic reaction, discontinue Daxas and contact your doctor immediately or go to the emergency room of the nearest hospital immediately. Take all your medicines and this leaflet with you to provide full information on your current treatment.

Other side effects include:
Common side effects (may affect up to 1 in 10 people)
- diarrhea, nausea, stomach pain
- weight loss, decreased appetite
- headache.

Uncommon side effects (may affect up to 1 in 100 people)
- shivering, dizziness (vertigo), dizziness
- feeling of rapid or irregular heartbeat (palpitations)
- gastritis, vomiting
- Return of acid stomach contents into the esophagus (heartburn), indigestion
- rash
- muscle pain, muscle weakness or cramps
- back pains

- Feeling weak or tired; Malaise.
Rare side effects (may affect up to 1 in 1,000 people)
- breast enlargement in men
- reduced taste
- respiratory tract infections (excluding pneumonia)
- Bloody stools, constipation
- elevation of liver or muscle enzymes (detected by blood test)
- rash (urticaria)
How to store Daxas?
Keep out of the reach and sight of children.
Do not use this medicine 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.
Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What does Daxas contain?
- The active substance is roflumilast. 1 film-coated tablet (tablet) contains 500 micrograms roflumilast.
- The other ingredients are:
- PPro: lactose monohydrate, corn starch, povidone (K90), magnesium stearate.

- Shell: Hypromellose 2910, Macrogol 4000, Titanium dioxide (E171), Yellow Iron Oxide (E172).

What Daxas looks like and contents of the pack
Daxas 500 micrograms film-coated tablets are yellow in the form of the letter "D" film-coated tablets with a convex embossment "D" on one side.
Each PVC / PVDC aluminum blister contains 10, 14, 28, 30, 84, 90 or 98 film-coated tablets.
Not all pack sizes may be marketed.

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