Betmiga - (mirabegron)

How do I take Betmiga?

• The usual dose is one 50mg Betmiga tablet taken regularly once a day, however always follow the instructions given by your doctor. Try to always take your tablet at the same time of day.
• Betmiga tablets should be swallowed whole with a drink. The tablets should not be chewed, broken or crushed. They can be taken either with or without food.
• If you forget to take a dose at your usual time, take it as soon as you remember. However, if it is less than six hours until your next dose is due just leave out the forgotten dose. Do not take a double dose to make up for a missed dose.

Important information about Betmiga

• You should not stop taking this medicine if you do not notice an improvement in your symptoms straightaway. It may take some time for your bladder to adapt and your symptoms to improve. You should continue with the tablets and only stop taking them if you have discussed it with your doctor, because if you stop treatment your overactive bladder symptoms may come back.
• Your blood pressure should be checked before you start treatment with Betmiga. As this medicine can sometimes cause blood pressure to increase, your blood pressure should be regularly monitored while you are taking this medicine.

Betmiga should be used with caution in

• People with decreased kidney function.
• People with mild to moderately decreased liver function.
• People with high blood pressure.
• People with a personal or family history of an abnormal heart rhythm, see on a heart monitoring trace (ECG) as a 'prolonged QT interval'.
• People taking medicines that can cause a 'prolonged QT interval' (see end of page for examples).

Betmiga should not be used in

• People with severe uncontrolled high blood pressure.
• People with severely decreased liver function.
• People with end stage kidney disease or who are having haemodialysis for kidney failure.
• People with moderately decreased liver function or severely decreased kidney function who are  also taking ketoconazole, itraconazole, ritonavir or clarithromycin.
• Pregnancy.
• Breastfeeding.

Children under 18 years old, as the safety and effectiveness of this medicine have not been studied in children. This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

• Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
• The safety of this medicine for use during pregnancy has not been established. It should not be used during pregnancy. Seek further medical advice from your doctor. The manufacturer recommends that women who could get pregnant should use contraception to avoid pregnancy while taking this medicine.
• If you do get pregnant or want to plan a pregnancy while taking this medicine it is important to consult your doctor straight away for advice.
• It is not known if this medicine passes into breast milk. The manufacturer recommends that it is avoided in breastfeeding mothers. Seek medical advice from your doctor.

Possible side effects of Betmiga

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Urinary tract infection.
• Faster than normal heartbeat (tachycardia).
• Feeling sick.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Cystitis.
• Vaginal infections such as vaginal thrush.
• Vaginal and vulval itching.
• Awareness of your heartbeat (palpitations).
• Irregular heartbeat (atrial fibrillation).
• Inflammation of the stomach (gastritis).
• Indigestion.
• Increased blood pressure.
• Swelling of the joints.
• Rash or itching.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Swelling of eyelids or lips.
• Red or purple areas of skin discolouration caused by bleeding under the skin (purpura).
• Difficulty passing urine (urinary retention).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it's necessary they'll report it for you.

How can Betmiga affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

There may be an increased risk of an abnormal heart rhythm (prolonged QT interval on a heart monitoring trace or ECG) if this medicine is taken in combination with any of the following medicines:

• antiarrhythmics (medicines to treat abnormal heart beats), eg amiodarone, procainamide, disopyramide, sotalol
• the antihistamines astemizole, mizolastine or terfenadine
• arsenic trioxide
• atomoxetine
• certain antidepressants, eg amitriptyline, imipramine, maprotiline
• certain antimalarials, eg halofantrine, chloroquine, quinine, mefloquine, Riamet
• certain antipsychotics, eg thioridazine, haloperidol, sertindole, pimozide
• cisapride
• dronedarone
• droperidol
• intravenous erythromycin or pentamidine
• methadone
• moxifloxacin.

The following medicines may reduce the breakdown of mirabegron by the liver and so may increase the amount of the medicine in the blood. If you are taking any of these and you have mild liver or kidney problems, your daily dose of this medicine may be reduced to 25mg daily:

• clarithromycin
• itraconazole
• ketoconazole
• ritonavir.

The medicines listed above should not be taken in combination with this medicine if you have severely decreased kidney function or moderately decreased liver function. (Your doctor will know.)

Mirabegron can increase the level of digoxin in the blood. If you are taking this medicine in combination with digoxin your doctor will monitor your digoxin levels and may decrease your digoxin dose if necessary.

Mirabegron may also increase the blood levels of the following medicines, which could increase the risk of their side effects:

• dabigatran
• flecainide
• imipramine
• metoprolol
• propafenone
• thioridazine.

References:

https://www.medicines.org.uk/emc/medicine/27429

http://patient.info/medicine/mirabegron-for-urinary-symptoms-betmiga

http://www.mims.co.uk/betmiga-first-in-class-treatment-overactive-bladder/genito-urinary-system/article/1171985

http://ec.europa.eu/health/documents/community-register/2012/20121220125028/anx_125028_en.pdf

http://www.netdoctor.co.uk/medicines/liver-kidney-and-urinary-system/a8827/betmiga-mirabegron/

http://www.medicines.ie/medicine/15718/PIL/Betmiga+25mg+%26+50mg/