25 mg and 50 mg prolonged-release tablets are 
mirabegron

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Betmiga is and what it is used for 
2. What you need to know before you use Betmiga 
3. How to use Betmiga 
4. Possible side effects 
5. How to store Betmiga 
6. Contents of the packaging and other information 

1. What Betmiga is and what it is used for

Betmiga contains the active substance mirabegron. It has a muscle-relaxing effect on the bladder (a so-called beta-3-adrenoceptor agonist), which reduces the overactivity of the bladder and treats the symptoms that occur.

Betmiga is used to treat the symptoms of an overactive bladder in adults such as:

  • suddenly have to empty the bladder (urge)
  • empty the bladder more often than normal (increased frequency of urination)
  • not being able to control when to empty the bladder (urge incontinence)

2. What you need to know before using Betmiga

Do not use Betmiga

  • if you are allergic to mirabegron or any of the other ingredients of this medicine (listed in section 6).
  • if you have very high blood pressure that is not under control.

Warnings and cautions

Talk to your doctor or pharmacist before taking Betmiga:

  • if you have problems emptying your bladder, if you have a weak urine stream or if you are taking other medicines to treat overactive bladder such as anticholinergic medicines.
  • if you have kidney or liver problems. Your doctor may need to reduce your dose perhaps tell you not to take Betmiga, especially if you are taking other medicines such as itraconazole, ketoconazole (fungal infections), ritonavir (HIV / AIDS), or clarithromycin (bacterial infections). Tell your doctor which medicines you are taking.
  • if you have an ECG abnormality called QT prolongation or if you are taking any medicine known to cause it such as:
    • drugs used to treat abnormal heart rhythms such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide, and amiodarone
    • drugs for allergic rhinitis
    • antipsychotic drugs (drugs for mental illness), such as thioridazine, mesoridazine, haloperidol, and chlorpromazine
    • drugs against infection s such as pentamidine, moxifloxacin, erythromycin, and clarithromycin.

Mirabegron may cause your blood pressure to rise or your blood pressure to drop if you have had high blood pressure in the past. Your doctor should check your blood pressure while you are taking mirabegron.

Children and young people

Do not give this medicine to children and adolescents under 18 years of age as the safety and efficacy of Betmiga in this age group have not been established.

Other medicines and Betmiga

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Betmiga may affect the way other medicines work and other medicines may affect the way this medicine works.

  • Tell your doctor if you are taking thioridazine (a medicine for mental illness), propafenone or flecainide (medicines for abnormal heart rhythms), imipramine or desipramine (medicines for depression). These specific medicines may require dose adjustment by your doctor.
  • Tell your doctor if you are taking digoxin (medicines for heart failure or abnormal heart rhythms). Blood levels of this medicine are measured by your doctor. If your blood pressure is too high, your doctor may need to adjust the dose of digoxin.
  • Tell your doctor if you are using dabigatran etexilate (a medicine used to reduce the risk of blood clots forming in the blood vessels of the brain or body in adult patients with abnormal heart rhythm ( atrial fibrillation ) and additional risk factors. This medicine may require dose adjustment by your doctor.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, do not take Betmiga.

If you are breast-feeding, talk to your doctor or pharmacist before taking this medicine. It is likely that this medicine passes into breast milk. You and your doctor should decide whether to take Betmiga or breast-feed. You should not do both.

Driving and using machines

There is no information to suggest that this medicine affects your ability to drive or use machines.

3. How to use Betmiga

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is a 50 mg Betmiga tablet taken orally once daily. If you have kidney or liver problems, your doctor may need to reduce the dose to one 25 mg Betmiga tablet, which is taken orally once a day. You should take this medicine with liquid and swallow the tablet whole. The tablet must not be crushed or chewed. Betmiga can be taken with or without food.

If you use more Betmiga than you should 

If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, contact your doctor, pharmacist or hospital immediately for advice.

Symptoms of overdose may include severe heartbeat, increased heart rate, or high blood pressure.

If you forget to take Betmiga

If you forget to take your medicine, take the missed dose as soon as you remember. If it is less than 6 hours before the next scheduled dose, skip dose one, and continue taking your medicine at the usual time.

Do not take a double dose to make up for a forgotten dose. If you miss several doses, contact your doctor and follow the advice given to you.

If you stop using Betmiga

Do not stop treatment with Betmiga too soon if you do not see an immediate effect. The bladder may need some time to adjust. You should continue to take the tablets. Do not stop taking them when your bladder problems improve. Discontinuation of treatment may result in recurrence of symptoms of overactive bladder.

Do not stop taking Betmiga without talking to your doctor first, as your symptoms of overactive bladder may return.

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

4. Possible side effects

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

The most serious side effects may be an irregular heartbeat ( atrial fibrillation ). This is a less common side effect (affects up to 1 in 100 people), if this side effect occurs, stop taking the medicine immediately and contact a doctor immediately.

If you get a headache, especially a sudden migraine-like (throbbing) headache, consult your doctor. This may be a sign of severe high blood pressure. 

Other side effects are:

Common side effects (may affect up to 1 in 10 people)

  • Rapid heartbeat ( tachycardia )
  • Urinary tract infection
  • Nausea
  • Constipation
  • Headache
  • Diarrhea
  • Dizziness

Uncommon side effects (may affect up to 1 in 100 people)

  • Cystitis ( cystitis )
  • Palpitations ( palpitation )
  • Vaginal infection
  • Indigestion ( dyspepsia )
  • Stomach infection ( gastritis )
  • Joint swelling
  • Itching of the vulva or vagina ( vulvovaginal pruritis)
  • High blood pressure
  • Increase in liver enzymes (GGT, AST, and ALT )
  • Itching, rash, or hives ( urticaria, rash, macular rash, papular rash, pruritus )

Rare side effects (may affect up to 1 in 1,000 people)

  • Swelling of the eyelid (eyelid edema)
  • Swelling of the lip (lipedema)
  • Swelling of the deeper layers of the skin caused by an accumulation of fluid that can affect any part of the body including the face, tongue, or throat, and can cause difficulty breathing ( angioedema )
  • Small purple spots on the skin (purpura)
  • Inflammation of small blood vessels, especially in the skin (leukocytoclastic vasculitis ).
  • Inability to empty the bladder completely ( urinary retention )

Very rare side effects (may affect up to 1 in 10,000 people)

  • Very high blood pressure

Has been reported (frequency can not be calculated from available data)

– Sleeping problems

– Confusion

Betmiga may increase the likelihood that you will not be able to empty your bladder if you have an obstruction in the lower urinary tract or if you are taking other medicines to treat an overactive bladder. Talk to your doctor immediately if you are unable to empty your bladder.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Betmiga

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister or can after EXP. The expiration date is the last day of the specified month.

After first opening the jar, the tablets can be stored for 6 months.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is mirabegron.Betmiga 25 mg prolonged-release tablets Each tablet contains 25 mg of mirabegron.Betmiga 50 mg prolonged-release tablets Each tablet contains 50 mg of mirabegron.
  • Other ingredients are Tablet core: Macrogol, hydroxypropyl cellulose, butylhydroxytoluene, magnesium stearate. Film coating: Hypromellose, macrogol, iron oxide, yellow (E172), iron oxide red (E172) (25 mg only).

What the medicine looks like and the contents of the pack

Betmiga 25 mg film-coated prolonged-release tablets: Oval, brown film-coated tablets, marked with the company logo and “325” on the same page.

Betmiga 50 mg film-coated prolonged-release tablets: Oval, yellow film-coated tablets, marked with the company logo and “355” on the same page.

Betmiga is supplied in aluminum blister packs containing 10, 20, 30, 50, 60, 90, 100, or 200 tablets and in HDPE jars with silica gel desiccant and childproof lid, containing 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Astellas Pharma Europe BV

Sylviusweg 62

2333 BE Leiden

Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

Astellas Pharma AB

Tel: +46 (0) 40-650 15 00

Muhammad Nadeem

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