Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - elmiron

Document Subject

Generated Narrative: MedicinalProductDefinition mp5245a6b0f8b8592e9406a25ffe7ba2b2

identifier: http://ema.europa.eu/identifier/EU/1/17/1189/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: elmiron 100 mg capsules, hard

type: Full name

part

part: nan

type: Invented name part

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part: nan

type: Scientific name part

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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-5245a6b0f8b8592e9406a25ffe7ba2b2

identifier: http://ema.europa.eu/identifier/EU/1/17/1189/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - elmiron

Attesters

What is in this leaflet

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

elmiron is a medicine that contains the active substance pentosan polysulfate 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.

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 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, particularly 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 .

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.

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
• 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 effects, you can help provide more information on the safety of this medicine.

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.

What elmiron contains

• The active substance is pentosan polysulfate sodium. One capsule contains 100 mg pentosan polysulfate sodium.
• The other ingredients are:

Capsule content: microcrystalline cellulose, magnesium 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 749fax: +49 (0)89 74987e-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, / N mecko / Saksamaa / / Germany / skaland / Germania / V cija / Il- ermanja / Alemanha / Nemecko, Tel / Te . / / S mi / Tel.: +49 (0)89 749870, contact@bene-arzneimittel.de

AT SIGMAPHARM Arzneimittel GmbH, Leystra e 129, A-1200 Wien, sterreich, Tel.: +43 (0) 1 330 06 71-0, mail@sigmapharm.at

BE, LU, NL Pharmanovia Benelux B.V., Burgemeester Gulj laan 2, NL-4837 CZ Breda, Pays-Bas, Nederland, Niederlande, T l/Tel: +31 (0)76 5600030, info.benelux@pharmanovia.com

DE
Dr. Pfleger Arzneimittel GmbH, D-96045 Bamberg,
Deutschland,
Tel.: +49 (0)951 6043-0, info@dr-pfleger.de

DK, NO Navamedic AB, G teborgsv gen 74, S-433 63 S vedalen, Sverige, Tlf: +46 (0)31 3351190, infose@navamedic.com

ES Lacer S.A., Sardenya 350, 08025 Barcelona, Espa a, Tel: +34 (0)934465300, infog@lacer.es

FI, SE Navamedic AB, G teborgsv gen 74, S-433 63 S vedalen, Ruotsi/Sverige, Puh/Tel: +46 (0)31 3351190, infose@navamedic.com

FR Inresa SAS, 1 rue Jean Monnet, F-68870 Bartenheim, France, T l: +33 (0)389 707660, info@inresa.fr

HR
MEDICOPHARMACIA d.o.o., Pere Budmanija 5, 10000 Zagreb, Hrvatska, Tel: + 385 1 55 84 HU K ri Pharma Hungary Kft., 4032 Debrecen, Bartha B. u. 7,
Magyarorsz g, Tel.: +36 52 431 IE Consilient Health, Block 2A Richview Office Park, Clonskeagh, Dublin 14, D14 Y0A5 Ireland, Tel: +353 (0) 1 2057760, irishoffice@consilienthealth.com

LT UAB Norameda, Meistr g. 8A, LT-02189 Vilnius, Lietuva, Tel. +370 5 2306PL Norameda Polska Sp. z o.o., Kili skiego 20, PL-05-500 Piaseczno, Polska, Tel.: +48 (0) 504 278 778, kontakt.pl@norameda.com

SI Lenis d.o.o., Litostrojska cesta 52, 1000 Ljubljana, Slovenija, Tel: +386(0) 1 235 07 00, info@lenis.si

XI Consilient Health Limited Tel: +353 (0)1 205 7This leaflet was last revised in

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