Valga selveri apteek. Apotheka.ee (Estonia) Phone: +3727661766 
Gintarinė vaistinė nvaistine.lt (Lithuania) Phone: 880010008
Meness aptieka T. 8555, Open hours: Working days: 9.00-18.00. *Real final price may be varied.
Unreasonable use of drugs is harmful to your health! |
|
|
|||||||||||||||||||||||||||||
BETMIGA 50MG PROLONG REL TBL N30
Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.
# On 2024-May-03
aproximate price on "BETMIGA 50MG PROLONG REL TBL N30" in Riga city, Latvia is:57.90€ 61.94$ 49.53£ 6687Rub 676.4SEK 251PLN 231.87₪
| Maximum allowed state defined price ( from ZVA webpage) Euro: | Recheck |
ATC code: G04BD12
Active substances: Mirabegronum
Vendor, principal: Astellas Pharma Europe.
Prescription drug (℞)
* This table was compiled fully automatically, independently from any advertisers, transparently and without any modification relaying the open offers available on the mentioned dates.Only the distribution of over-the-counter remedies through the website is permitted in Latvia in accordance with national laws and regulations.
EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
EMA/591015/2015
EMEA/H/C/002388
EPAR summary for the public
Betmiga
mirabegron
This is a summary of the European public assessment report (EPAR) for Betmiga. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Betmiga.
What is Betmiga?
Betmiga is a medicine containing the active substance mirabegron. It is available as prolonged-release tablets (25 mg, 50 mg). NProlonged-release' means that mirabegron is released slowly from the tablet over a few hours.
What is Betmiga used for?
Betmiga is used in adults with overactive bladder syndrome. It is used to treat certain symptoms of the condition: urgency (sudden urge to urinate), increased urinary frequency (the need to urinate frequently) and urge incontinence (involuntary leakage of urine from the bladder when a sudden strong need to urinate is felt).
The medicine can only be obtained with a prescription.
How is Betmiga used?
The recommended dose of Betmiga is 50 mg once a day. In patients who have reduced kidney or liver function the doctor may need to prescribe a lower dose or avoid the use of Betmiga, especially in patients taking certain other medicines.
For full details, see the package leaflet (also part of the EPAR).
An agency of the European Union
30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.
How does Betmiga work?
The active substance in Betmiga, mirabegron, is a beta-3-adrenergic-receptor agonist. It works by attaching to and activating beta-3 receptors that are found in the muscle cells of the bladder. Experimental studies have shown that, when activated, beta-3 receptors cause the bladder muscles to relax. This is thought to lead to an increase in the capacity of the bladder and changes in the way the bladder contracts, resulting in fewer bladder contractions and thus fewer unwanted urinations.
How has Betmiga been studied?
Betmiga has been studied in three main studies involving 4,611 patients with overactive bladder syndrome. Patients received Betmiga (25 mg, 50 mg or 100 mg) or placebo (a dummy treatment) every day for 3 months. The main measure of effectiveness was the change in the number of urinations and incontinence episodes per day after 3 months of treatment.
What benefit has Betmiga shown during the studies?
Treatment with 50 mg a day of Betmiga was shown to be effective in reducing the number of urination and incontinence episodes. After 3 months of treatment, on average Betmiga 50 mg reduced the number of urinations by 1.8 per day compared with a reduction of 1.2 per day for placebo. Betmiga 50 mg resulted in a reduction of 1.5 incontinence episodes per day compared with a reduction of 1.1 incontinence episodes per day for placebo.
What is the risk associated with Betmiga?
The most common side effects with Betmiga are tachycardia (rapid heartbeat) seen in just over 1 person in 100, and urinary tract infection (infection of the structures that carry urine) seen in just under 3 people in 100. Serious but uncommon side effects include atrial fibrillation (cardiac rhythm disorder). For the full list of all side effects reported with Betmiga, see the package leaflet.
Betmiga must not be used in people who have hypertension (high blood pressure) that is severe and uncontrolled. For the full list of restrictions, see the package leaflet.
Why has Betmiga been approved?
The CHMP noted that the beneficial effects seen with Betmiga were modest but comparable to the benefits of other medicines authorised for this condition. Regarding its safety, most side effects are comparable to those of other medicines used for treating overactive bladder syndrome. The potential risk of hypersensitivity (allergic reactions) and effects on the heart has been adequately addressed in the product information. The CHMP therefore decided that Betmiga's benefits are greater than its risks and recommended that it be given marketing authorisation.
What measures are being taken to ensure the safe and effective use of Betmiga?
A risk management plan has been developed to ensure that Betmiga is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Betmiga, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information about Betmiga
The European Commission granted a marketing authorisation valid throughout the European Union for Betmiga on 20 December 2012.
The full EPAR for Betmiga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Betmiga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in 09-2015.
Betmiga
EMA/591015/2015
Page 3/3
Instruction , annotation source: The European Medicines Agency
| ||
| For pharmacies & healthstores For advertisers About |
|
|