Daliresp - Roflumilast

1. WHAT IS DALIRESP AND WHAT IT IS USED FOR

Daliresp contains the active substance roflumilast, which is an anti-inflammatory drug called phosphodiesterase 4 inhibitor. Roflumilast reduces the activity of phosphodiesterase 4, a protein found naturally in the body's cells. When the activity of this protein is reduced, there is less inflammation in the lungs. This helps to interrupt the narrowing of the airways that occurs in chronic obstructive pulmonary disease (COPD). Thus Daliresp improves respiratory problems.

Daliresp is indicated for the treatment of severe COPD in adults. COPD is a chronic lung disease that produces narrowing of the airways (obstruction) and swelling and irritation of the walls of the small airways (inflammation) causing symptoms such as coughing, wheezing, chest tightness or difficulty breathing. Daliresp is to be used in addition to bronchodilators.

2. BEFORE YOU TAKE FROM THE IRESP

Don't take Daliresp

- if you are allergic (hypersensitive) to roflumilast or to any of the excipients of Daliresp (listed in section 6 'What Daliresp contains')

- if you have moderate or severe liver problems.

Take special care with Daliresp

Daliresp is not indicated for the treatment of a sudden attack of breathlessness (acute bronchospasm). To resolve a sudden attack of breathlessness it is very important that your doctor provide you with another medicine to take with you whenever you face this type of attack. Daliresp will not be useful in this situation.

He must regularly check his body weight. Talk to your doctor if you notice unintentional weight loss (unrelated to a diet or exercise program) while taking this medicine.

Daliresp is not recommended for patients who have severe immunological problems (such as HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy, and others), problems with severe acute infections (such as tuberculosis, or acute hepatitis), cancer ( except basal cell carcinoma, a type of slow-developing skin cancer), or severe reduction in cardiac function, due to lack of relevant data with Daliresp in these conditions. Talk to your doctor if you have been diagnosed with any of these problems.

Experience is also limited in patients with a previous diagnosis of tuberculosis, viral hepatitis, herpes-type viral infections or shingles.

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

It could also manifest insomnia, anxiety, nervousness, or depressed mood. Before starting treatment with Daliresp, tell your doctor if you are experiencing any symptoms of this type and any other medicines you have taken as some of them may increase the likelihood of these side effects. He must also immediately inform the doctor of any suicidal thoughts he may have.

children

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

Taking Daliresp with other medicines

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

Daliresp can be taken with other medicines used to treat COPD such as inhaled or oral corticosteroids or bronchodilators. Do not stop taking these medicines or reduce their doses without consulting your doctor.

Tell your doctor before you start taking Daliresp, if you are already using:

- a medicine containing theophylline (a drug used to treat respiratory problems), or

- a medicine used to treat immunological problems, such as methotrexate, azathioprine,

infliximab, etanercept, or oral corticosteroids for long-term treatment

- a medicine containing fluvoxamine, enoxacin or cimetidine.

The effect of Daliresp may decrease if taken simultaneously with rifampicin (an antibiotic) or phenobarbital, carbamazepine or phenytoin (medicines normally prescribed for the treatment of epilepsy). Ask your doctor for advice.

Taking Daliresp with food and drink

You can take this medicine with and without food.

Pregnancy and breastfeeding

Do not take Daliresp if you are pregnant or planning to have one, think you are pregnant, or are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Daliresp has no effect on the ability to drive or use machines.

Important information about some of the ingredients of Daliresp

Daliresp tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugar, contact your doctor before taking this medicine.

3. HOW TO TAKE FROM THE IRESP

Always take Daliresp exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

The usual dose is one 500 microgram tablet once a day. Do not take more tablets than your doctor has recommended.

Take the tablet with some water. You can take this medicine with or without food.

Take your tablet every day at the same time.

You may need to take Daliresp for several weeks to achieve the beneficial effect.

If you take more Daliresp than you should

Tell your doctor or pharmacist immediately. If possible, take the medicine and this leaflet with you.

If you forget to take Daliresp

If you forget to take the tablet at the usual time, take it as soon as you remember. If one day you forgot to take the Daliresp tablet, simply continue the next day by taking the next tablet as usual. Keep taking the tablet at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Daliresp

It is important to continue taking Daliresp for as long as your doctor tells you, even when you have no symptoms, to maintain control of your lung function.

If you have any questions on the use of Daliresp, talk to your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Undesirable effects that can occur quite frequently are defined as follows:

very common: affects more than 1 in 10 patients

common: affects 1 to 10 patients in 100

uncommon: affects 1 to 10 patients in 1, 000

rare: affects 1 to 10 patients in 10, 000

very rare: affects less than 1 in 10, 000 patients

not known: frequency cannot be defined based on available data.

Common side effects

Weight loss, decreased appetite; insomnia; headache; diarrhea, nausea, stomach pain.

Uncommon side effects

Hypersensitivity (a generalized allergic reaction that can affect skin, mouth and tongue, generally leading to difficulty in breathing and / or a decrease in blood pressure and rapid heart rate); feeling of anxiety; tremors, feeling of dizziness (vertigo), dizziness; feeling of accelerated or irregular heart beat (palpitations); gastritis, vomiting, reflux of gastric acid in the esophagus (acid regurgitation), indigestion; rash; muscle pain or cramps; back pain, feeling tired or tired; malaise.

Rare side effects

Breast enlargement in the male; feeling of nervousness or depression; decreased sense of taste; respiratory tract infections (excluding pneumonia); blood in the stool, constipation; increased liver or muscle enzymes (visible in blood tests); ponfi (urticaria).

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

In clinical studies, some cases of suicidal thinking and behavior (including suicide) have been reported. Tell your doctor immediately about 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.

5. HOW TO STORE DALIRESP

Keep Daliresp out of the reach and sight of children.

Do not use Daliresp after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of the 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 you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What does Daliresp contain?

- The active ingredient is roflumilast. Each film-coated tablet (tablet) contains 500 micrograms of roflumilast.

- The excipients are:

- Core: lactose monohydrate, corn starch, povidone (K90), magnesium stearate,

- Coating: hypromellose 2910, Macrogol 4000, titanium dioxide (E171), and yellow iron oxide (E172).

Description of the appearance of Daliresp and contents of the package

Daliresp 500 micrograms film-coated tablets are yellow, D-shaped, marked with "D" on one side.

Each package in PVC / PVDC aluminum blister contains 10, 30 or 90 film-coated tablets.

Not all pack sizes may be marketed.

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