Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - betmiga

Document Subject

Generated Narrative: MedicinalProductDefinition mpf5fcc043447c207ce2e1eb4575399a55

identifier: http://ema.europa.eu/identifier/EU/1/12/809/001 - 006

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Betmiga 25 mg prolonged-release tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f5fcc043447c207ce2e1eb4575399a55

identifier: http://ema.europa.eu/identifier/EU/1/12/809/001 - 006

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - betmiga

Attesters

What is in this leaflet:

1. What Betmiga is and what it is used for
2. What you need to know before you take Betmiga
3. How to take Betmiga
4. Possible side effects
5. How to store Betmiga
6. Contents of the pack and other information

Betmiga contains the active substance mirabegron. It is a bladder muscle relaxant (a so called beta 3-adrenoceptor agonist), which reduces the activity of an overactive bladder and treats the related symptoms.

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

• suddenly needing to empty your bladder (called urgency)
• having to empty your bladder more than usual (called increased urinary frequency)
• not being able to control when to empty your bladder (called urgency incontinence)

Do not take 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 uncontrolled blood pressure.

Warnings and precautions Talk to your doctor or pharmacist before taking Betmiga:

• if you have trouble emptying your bladder or you have a weak urine stream or if you take other medicines for the treatment of overactive bladder such as anticholinergic medicines.
• if you have kidney or liver problems. Your doctor may need to reduce your dose or may 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 about the medicines that you take.
• if you have an ECG (heart tracing) abnormality known as QT prolongation or you are taking any medicine known to cause this such as: * medicines used for abnormal heart rhythm such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide, and amiodarone; * medicines used for allergic rhinitis; * antipsychotic medicines (medicines for mental illness) such as thioridazine, mesoridazine, haloperidol, and chlorpromazine; * anti-infectives such as pentamidine, moxifloxacin, erythromycin, and clarithromycin.

Mirabegron may cause your blood pressure to increase or make your blood pressure worse if you have a history of high blood pressure. It is recommended that your doctor check your blood pressure while you are taking Mirabegron.

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

Other medicines and Betmiga Tell your doctor or pharmacist if you are taking, have recently used or might use any other medicines.

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

• Tell your doctor if you use thioridazine (a medicine for mental illness), propafenone or flecainide (medicines for abnormal heart rhythm), imipramine or desipramine (medicines used for depression). These specific medicines may require dose adjustment by your doctor.
• Tell your doctor if you use digoxin (a medicine for heart failure or abnormal heart rhythm). Blood levels of this medicine are measured by your doctor. If the blood level is out of range, your doctor may adjust the dose of digoxin.
• Tell your doctor if you use dabigatran etexilate (a medicine which is used to reduce the risk of brain or body vessel obstruction by blood clot formation in adult patients with an abnormal heart beat (atrial fibrillation) and additional risk factors). This medicine may require dose adjustment by your doctor.

Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are planning to have a baby you should not take Betmiga.

If you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine. It is likely that this medicine passes into your breast milk. You and your doctor should decide if you should take Betmiga or breastfeed. 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.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one 50 mg tablet by mouth once daily. If you have kidney or liver problems, your doctor may need to reduce your dose to one 25 mg tablet by mouth once daily. You should take this medicine with liquids and swallow the tablet whole. Do not crush or chew the tablet. Betmiga can be taken with or without food.

If you take 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 for advice immediately.

Symptoms of overdose may include a forceful beating of the heart, an increased pulse rate or an increased 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 your next scheduled dose, skip the dose and continue to take your medicine at the usual time.

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

If you stop taking Betmiga Do not stop treatment with Betmiga early if you do not see an immediate effect. Your bladder might need some time to adapt. You should continue taking your tablets. Do not stop taking them when your bladder condition improves. Stopping treatment may result in recurrence of symptoms of overactive bladder.

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

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

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

The most serious side effects may include irregular heart beat (atrial fibrillation). This is an uncommon side effect (may affect up to 1 in 100 people), but if this side effect occurs, immediately stop taking the medicine and seek urgent medical advice.

If you get headaches, especially sudden, migraine-like (throbbing) headaches, tell your doctor. These may be signs of severely elevated blood pressure.

Other side effects include:

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

• Increased heart rate (tachycardia)
• Infection of the structures that carry urine (urinary tract infections)
• Nausea
• Constipation
• Headache
• Diarrhoea
• Dizziness

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

• Bladder infection (cystitis)
• Feeling your heartbeat (palpitations)
• Vaginal infection
• Indigestion (dyspepsia)
• Infection of the stomach (gastritis)
• Swelling of the joints
• Itching of the vulva or vagina (vulvovaginal pruritus)
• Increased blood pressure
• Increase in liver enzymes (GGT, AST and ALT)
• Itching, rash or hives (urticaria, rash, rash macular, rash papular, pruritus)

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

• Swelling of the eyelid (eyelid oedema)
• Swelling of the lip (lip oedema)
• Swelling of the deeper layers of the skin caused by a build-up of fluid, which can affect any part of the body including the face, tongue or throat and may cause difficulty in breathing (angioedema)
• Small purple spots on the skin (purpura)
• Inflammation of small blood vessels mainly affecting the skin (leukocytoclastic vasculitis)
• Inability to completely empty the bladder (urinary retention)

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

• Hypertensive crisis

Not known side effects (frequency cannot be estimated from the available data)

• Insomnia
• Confusion

Betmiga may increase your chances of not being able to empty your bladder if you have bladder outlet obstruction or if you are taking other medicines to treat overactive bladder. Tell your doctor right away if you are unable to empty your bladder.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 or blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Betmiga contains

• 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.
• The other ingredients are: Tablet core: Macrogols, hydroxypropylcellulose, butylhydroxytoluene, magnesium stearate Film-coating: Hypromellose, macrogol, iron oxide yellow (E172), iron oxide red (E172) (25 mg tablet only).

What Betmiga looks like and contents of the pack Betmiga 25 mg prolonged release film-coated tablets are oval, brown film-coated tablets, debossed with the company logo and 325 on the same side. Betmiga 50 mg prolonged release film-coated tablets are oval, yellow film-coated tablets, debossed with the company logo and 355 on the same side.

Betmiga is available in aluminium-aluminium blister in packs containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets.

Not all pack sizes may be available in your country.

Marketing Authorisation Holder and Manufacturer

Astellas Pharma Europe B.V. Sylviusweg 2333 BE Leiden The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Astellas Pharma B.V. Branch T l/Tel: +32 (0)2 5580Lietuva Biocodex UAB Tel.: +370 37 408

Te .: +359 2 862 53 Luxembourg/Luxemburg Astellas Pharma B.V. Branch Belgique/Belgien T l/Tel: +32 (0)2 5580 esk republika Astellas Pharma s.r.o. Tel: +420 221 401 Magyarorsz g Astellas Pharma Kft. Tel.: +36 1 577 8Danmark Astellas Pharma a/s Tlf: +45 43 430Malta Astellas Pharmaceuticals AEBE Tel: +30 210 8189Deutschland Astellas Pharma GmbH Tel.: +49 (0)89 454Nederland Astellas Pharma B.V. Tel: +31 (0)71 5455Eesti Biocodex O
Tel: +372 6 056 Norge Astellas Pharma Tlf: +47 66 76 46
Astellas Pharmaceuticals AEBE : +30 210 8189 sterreich Astellas Pharma Ges.m.b.H. Tel.: +43 (0)1 8772Espa a Astellas Pharma S.A. Tel: +34 91 4952Polska Astellas Pharma Sp.z.o.o. Tel.: +48 225451 France Astellas Pharma S.A.S. T l: +33 (0)1 55917Portugal Astellas Farma, Lda. Tel: +351 21 4401Hrvatska Astellas d.o.o Tel: +385 1670 0Rom nia S.C.Astellas Pharma SRL Tel: +40 (0)21 361 04 95/96/Ireland Astellas Pharma Co. Ltd. Tel: +353 (0)1 4671Slovenija Astellas Pharma d.o.o Tel: +386 14011 sland Vistor hf S mi: +354 535 7Slovensk republika Astellas Pharma s.r.o. Tel: +421 2 4444 2Italia Astellas Pharma S.p.A. Tel: +39 (0)2 921Suomi/Finland Astellas Pharma Puh/Tel: +358 (0)9 85606

Astellas Pharmaceuticals AEBE : +30 210 8189Sverige Astellas Pharma AB Tel: +46 (0)40-650 15 Latvija Biocodex SIA Tel: +371 67 619United Kingdom (Northern Ireland) Astellas Pharma Co., Limited Free call from Northern Ireland: 0800 783 5International number: +353 (0)1 4671This leaflet was last revised in {MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.