Obgemsa – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Obgemsa, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start taking 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 or pharmacist.
- 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 or pharmacist. This includes any possible side effects not listed in this leaflet . See section 4.
ℹ️ 1. What Obgemsa is and what it is used for
Obgemsa contains the active substance vibegron . It is a bladder muscle relaxant (a beta- 3 adrenergic receptor agonist ) which reduces the activity of an overactive bladder and treats the related symptoms.
Obgemsa is used to treat the symptoms of an overactive bladder in adults, such as:
- a sudden need 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 and wetting yourself ( called urge urinary incontinence)
⚠️ 2. What you need to know before you take Obgemsa
Do not take Obgemsa
- if you are allergic to vibegron or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Obgemsa:
- if you have trouble emptying your bladder or you have a weak urine stream, or if you are taking any other medicines for the treatment of overactive bladder syndrome, such as anticholinergic medicines for exampl e oxybutynin, diphenhydramine, solifenacin.
If you have severe liver problems or if you have an end- stage kidney disease as Obgemsa should not be used in these cases.
23 Children and adolescents Do not give this medicine to children and adolescents under the age of 18 years because the safety and efficacy of Obgemsa in this age group has not yet been established.
Other medicines and Obgemsa
Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines .
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 (an anticoagulant agent) , apixaban (an anticoagulant agent) or rivaroxaban (an antithrombotic agent). These medicines may require dose adjustments by your doctor.
Pregnancy and breast -feeding Women of childbearing potential If you think that you may be pregnant or planning to have a baby, you should not take Obgemsa . This is because it is not known how this medicine will affect the foetus .
Pregnancy
If you are pregnant, you should not take Obgemsa . This is because it is not known how this medicine will affect the baby.
Breast -feeding It is likely that this medicine passes into breast milk , but the risks for the baby are unknown.
Therefore, you should not breast -feed while taking Obgemsa .
Driving and using machines
Obgemsa has no or negligible influence on the ability to drive or use machines.
Obgemsa contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine .
Obgemsa contains sodium
This medicine contains less than 1 mmol sodium (23 mg) p er tablet , that is to say essentially ‘sodium -free’.
💊 3. How to take Obgemsa
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The r ecommended dose for this medicine is 1 tablet per day.
Swallow the tablet with a glass of water. If needed, the tablet can be crushed and mix ed with 1 tablespoon (about 15 mL) of soft food (e.g . applesauce) . Eat the mixture and drink a glass of water afterwards.
Once mixed in food, the mixture should be eaten immediately . You may take your tablet with or without food.
If you take more Obgemsa than you should
If you have taken too many tablets, contact your doctor, pharmacist or hospital for advice immediately. If someone else accidentally takes your tablets, contact your doctor, pharmacist or hospital for advice immediately. Symptoms of overdose may include troubles in digestive system, headache and difficulty breathing.
If you forget to take Obgemsa
If you miss a dose, take the next dose as normal on the next day. Do not take a double dose to make up for a forgotten tablet. If you miss several doses, tell your doctor and follow the advice given to you.
If you stop taking Obgemsa
Do not stop treatment with Obgemsa early if you do not see an immediate effect. Your bladder might need some time to adapt and y ou should continue taking your tablets.
Do not stop taking Obgemsa when your symptoms improve , as s topping treatment may cause symptoms of overactive bladder syndrome to return. Talk to your doctor before you stop taking Obgemsa.
If you have any further questions on the use of this medici ne, ask your doctor or pharmacist .
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
An uncommon side effect (may affect up to 1 in 100 people) is the inability to empty your bladder (urinary retention). Obgemsa may increase the probability of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor straight away if you are unable to empty your bladder.
Other side effects include
Common side effects (may affect up to 1 in 10 people)
- headache
- diarrhoea
- nausea (feeling sick)
- constipation
- urinary tract infection (infection of structures that carry urine)
- residual urine volume increased (an increase in the amount of urine left in the bladder after a voluntary urination)
Uncommon side effects (may affect up to 1 in 100 people)
- hot flush
- urinary retention , including urinary strainin g (inability to empty your bladder)
- rash (including itchy rash, and red rash)
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.
🌡️ 5. How to store Obgemsa
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 and bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
25 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 protect the environment.
📦 6. Contents of the pack and other information
What Obgemsa contains
- The active substance is vibegron. Each film-coated tablet contains 75 mg of vibegron.
- The other ingredients are:
- Tablet core: mannitol, microcrystalline cellulose, croscarmellose sodium, hydroxypropylcellulose, and magnesium stearate. See section 2 “Obgemsa contains sodium ”.
- F ilm -coating : indigo carmine alumin ium lake (E132) , hypromellose, iron oxide yellow (E172) , lactose, titanium dioxide (E171) , and triacetin. See section 2 “Obgemsa contains lactose”.
What Obgemsa looks like and contents of the pack
Obgemsa are light green oval film -coated tablets (tablets) , debossed with V75 on one side and plain on the other side. Tablet dimension is approximately 9 mm (length) x 4 mm (width) x 3 mm (height).
Obgemsa is available in white plastic , square or round bottles with a child -resistance plastic closure.
Pack sizes: 7, 30 or 90 film- coated tablets.
Not all pack sizes may be marketed .
Marketing A uthorisation Holder PIERRE FABRE MEDICAMENT Les Cauquillous 81500 Lavaur France
Manufacturer
PATHEON FRANCE 40 boulevard de Champaret 38300 Bourgoin Jallieu France
This leaflet was last revised i n
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .
This leaflet is available in all EU /EEA languages on the European Medicines Agency website.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Obgemsa (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/24/1822).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.