elmiron – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine elmiron, 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 elmiron is and what it is used for
elmiron is a medicine that contains the active substance pentosan polysulf ate sodium. After taking the medicine, it passes into the urine and attaches to the lining of the bladder, helping to form a protective layer. elmiron is used in adults to treat bladder pain syndrome characterised by many tiny bleeds or distinctive lesions on the bladder wall and moderate to severe pain and a frequent urge to urinate.
⚠️ 2. What you need to know before you take elmiron
Do not take elmiron if you are
- allergic to pentosan polysulfate sodium or any of the other ingredients of this medicine (listed in section 6)
- bleeding (other than menstrual bleeding )
Warnings and precautions
Talk to your doctor or pharmacist before taking elmiron if you have:
- to undergo surgery
- a blood clotting disorder or increased risks of bleeding, such as using a medicine that inhibits blood clotting
- ever had a reduced number of blood platelets caused by the medicine called heparin
- reduced liver or kidney function Rare cases of retinal disorders (pigmentary maculopathy) have been reported with use of elmiron (especially after long term use). Tell your doctor immediately if you experience visual changes such as difficulty when reading, visual distortions, altered colour vision and/or slower adjustment to low or reduced light. Your doctor will discuss with you whether the treatment should be continued. For early detection of retinal disorders, eye examination will be performed regularly.
Children and adolescents
24 elmiron is not recommended in children under 18 years as safety and efficacy have not been established in this group.
Other medicines and elmiron
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Inform your doctor or pharmacist , particular ly if you use medicines that prevent blood clotting, or painkillers that reduce blood clotting.
Pregnancy and breast -feeding elmiron is not recommended during pregnancy or breast-feeding.
Driving and using machines
elmiron has no or negligible influence on the ability to drive and use machines. elmiron contains sodium.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
💊 3. H ow to take elmiron
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
1 capsule, 3 times daily Your doctor will assess your response to elmiron every 6 months.
Method of use Take the capsules whole with one glass of water, at least 1 hour before or 2 hours after meals.
If you take more elmiron than you should
Inform your doctor in case of overdose . Stop taking elmiron if side effects occur until they disappear.
If you forget to take elmiron
Do not take a double dose to make up for a forgotten capsule.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects have been observed with the following frequencies :
Common : may affect up to 1 in 10 people
- infections, flu
- headache, back pain
- dizziness
- nausea, indigestion, diarrhoea, abdominal pain, abdomen enlarged
- rectal bleeding
- accumulation of fluid in arms or legs
- hair loss
- weakness, pelvic (lower abdomen) pain 25 • need to urinate more frequently than usual
- abnormal liver function
Uncommon : may affect up to 1 in 100 people
- lack of blood platelets, red or white blood cells
- bleeding, including small bleeding beneath the skin
- allergic reactions, increased sensitivity to light
- loss of appetite , weight gain or loss
- severe mood swings or depression
- increased sweating , sleeplessness
- restlessness
- abnormal sensation such as prickling, tingling and itchiness
- flow of tears, lazy eye
- ringing or buzzing in the ears
- breathing difficulties
- indigestion, vomiting, wind, difficulty passing stools
- mouth ulcer
- skin rash, increased mole size
- joint or muscle pain
Not known: frequency cannot be estimated from the available data
- blood clotting disorders
- allergic reactions
- abnormal liver function
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 ef fects, you can help provide more information on the safety of this medicine.
🌡️ 5. How to store elmiron
Keep this medicine out of the sight and reach of children.
- bottle Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Keep the bottle tightly closed in order to protect from moisture.
After first opening: use within 45 days. Dispose any remaining capsules after this period .
- blister Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Do not store above 30 ° C.
Do not throw away any medicines via wastewater. 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 elmiron contains
26 • The active substance is pentosan polysulfate sodium.
One capsule contains 100 mg pentosan polysulfate sodium.
- The other ingredients are:
Capsule content : microcrystalline cellulose, m agnesium stearate Capsule shell : gelatin, titanium dioxide (E171)
What elmiron looks like and contents of the pack
The capsules are white and non -transparent, provided in a plastic bottle with child resistant closure or plastic/aluminium blisters, packed in a carton.
- bottle Each carton contains 90 capsules or 300 (3 bottles x 100) capsules.
- blister Each carton contains 90 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
bene-Arzneimittel GmbH Herterichstrasse 1 -3 D-81479 Munich tel: +49 (0)89 749870 fax: +49 (0)89 74987142 e-mail: contact@bene -arzneimittel.de For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: BG, CZ, EE, EL, IS, IT, CY, LV, MT, PT, RO, SK bene-Arzneimittel GmbH, D -81479 Munich, Германия / Německo / Saksamaa / Γερμανία / Germany / Þýskaland / Germania / Vācija / Il- Ġermanja / Alemanha / Nemecko, Tel / Teл. / Τηλ / Sími / Tel.: +49 (0)89 749870, contact@bene- arzneimittel.de AT SIGMAPHARM Arzneimittel GmbH, Leystraße 129, A -1200 Wien, Österreich, Tel.: +43 (0) 1 330 06 71-0, [email protected] BE, LU, NL Lamepro B.V., Burgemeester Guljélaan 2, NL-4837 CZ Breda, Pays-Bas, Nederland, Niederlande, Tél/Tel: +31 (0)76 5600030, [email protected] DE Dr. Pfleger Arzneimittel GmbH , D-96045 Bamberg, Deutschland, Tel.: +49 (0)951 6043-0, [email protected] DK, NO Navamedic AB, Göteborgsvägen 74, S-433 63 Sävedalen, Sverige, Tlf: +46 (0)31 3351190, [email protected] 27 ES Lacer S.A., Sardenya 350, 08025 Barcelona, España, Tel: +34 (0)934465300, [email protected] FI, SE Navamedic AB, Göteborgsvägen 74, S-433 63 Sävedalen, Ruotsi/Sverige, Puh/Tel: +46 (0)31 3351190, [email protected] FR Inresa SAS, 1 rue Jean Monnet, F-68870 Bartenheim, France, Tél: +33 (0)389 707660, [email protected] HR MEDICOPHARMACIA d.o.o., Pere Budmanija 5, 10000 Zagreb, Hrvatska, Tel: + 385 1 55 84 604 HU Kéri Pharma Hungary Kft., 4032 Debrecen, Bartha B. u. 7, Magyarország, Tel.: +36 52 431 313 IE Consilient Health, Block 2A Richview Office Park, Clonskeagh, Dublin 14, D14 Y0A5 Ireland, Tel: +353 (0) 1 2057760, [email protected] LT UAB Norameda, Meistrų g. 8A, LT-02189 Vilnius, Lietuva, Tel. +370 5 2306499 PL Norameda Polska Sp. z o.o., Kilińskiego 20, PL-05-500 Piaseczno, Polska, Tel.: +48 (0) 504 278 778, [email protected] SI Lenis d.o.o., Litostrojska cesta 52, 1000 Ljubljana, Slovenija, Tel: +386( 0) 1 235 07 00, [email protected] XI Consilient Health Limited Tel: +353 (0)1 205 7760
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
📄 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 elmiron (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/17/1189).
⚠️ 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.