Země: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
TIOTROPIUM BROMIDE
Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands
R03BB04
TIOTROPIUM BROMIDE 0.016 mg
INHALATION POWDER, HARD CAPSULE
TIOTROPIUM BROMIDE 0.016 mg
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Withdrawn
2016-07-18
Page 1 of 11 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BRALTUS 10 MICROGRAM PER DELIVERED DOSE INHALATION POWDER, HARD CAPSULE tiotropium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Braltus is and what it is used for 2. What you need to know before you use Braltus 3. How to use Braltus 4. Possible side effects 5. How to store Braltus 6. Contents of the pack and other information 1. WHAT BRALTUS IS AND WHAT IT IS USED FOR Braltus contains the active substance tiotropium. Tiotropium helps people who have chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a chronic lung disease that causes shortness of breath and coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema. As COPD is a chronic disease you should use this medicine every day and not only when you have breathing problems or other symptoms of COPD. Braltus is a long-acting bronchodilator that helps to open your airways and makes it easier to get air in and out of the lungs. Regular use of this medicine can also help you when you have on-going shortness of breath related to your disease and will help you to minimise the effects of the disease on your everyday life. It also helps you to be active longer. Daily use of this medicine will also help to prevent sudden, short-term worsening of your COPD symptoms which may last for several days. The effect of this medicine lasts for 24 hours, so you only need to use it once a day. This medicine should Přečtěte si celý dokument
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 15 1. NAME OF THE MEDICINAL PRODUCT Braltus 10 microgram per delivered dose inhalation powder, hard capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 16 micrograms of tiotropium bromide, equivalent to 13 micrograms of tiotropium. The delivered dose (the dose that leaves the mouthpiece of the Zonda inhaler) is 10 micrograms of tiotropium per capsule. Excipient with known effect Each capsule contains 18 milligrams lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule. Colourless and transparent, size 3 capsules, containing white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Braltus is indicated as a maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD). Braltus is indicated for use in adults. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Route of administration: Inhalation use. _Recommended Dose _ Adults 18 years of age and older: Inhalation of the contents of ONE capsule once daily with the Zonda inhaler. Inhalation should be at the same time of day each day. The recommended dose should not be exceeded. The delivered dose of a single capsule (10 micrograms) is sufficient and is the standard dose for treatment with Braltus. Braltus capsules are for inhalation only; they must not be swallowed. Braltus capsules must only be inhaled with the Zonda inhaler. _ _ _Special populations_ Elderly patients can use tiotropium bromide at the recommended dose. Patients with mild renal impairment (creatinine clearance >50 ml/min) can use tiotropium bromide at the recommended dose. For patients with moderate to severe impairment (creatinine clearance ≤50 ml/min) see section 4.4 and section 5.2. Hepatically impaired patients can use tiotropium bromide at the recommended dose (see section 5.2). Page 3 of 15 _Paediatric population _ Braltus should not be used in children or adolescents under 18 Přečtěte si celý dokument