report side effects to FDA at 1-800-FDA-1088.
How should I store JALYN?
Store JALYN Capsules at room temperature (59° to 86°F or 15° to 30°C).
JALYN Capsules may become deformed and/or discolored if kept at high temperatures.
Do not use or touch JALYN if your capsules are deformed, discolored, or leaking.
Safely throw away medicine that is no longer needed.
Keep JALYN and all medicines out of the reach of children.
Medicines are sometimes prescribed for purposes other than those listed in a patient leaflet. Do not use JALYN for a condition for which it was not prescribed. Do not give JALYN to other people, even if they have the same symptoms that you have. It may harm them.
This patient information leaflet summarizes the most important information about JALYN. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about JALYN that is written for health professionals.
For more information, go to www.JALYN.com or call 1-888-825-5249.
What are the ingredients in JALYN?
Active ingredients: dutasteride and tamsulosin hydrochloride
Inactive ingredients: black ink, butylated hydroxytoluene, carrageenan, FD&C yellow 6, ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, hypromellose, iron oxide red, methacrylic acid copolymer dispersion, microcrystalline cellulose, mono-di-glycerides of caprylic/capric acid, potassium chloride, talc, titanium dioxide, and triethyl citrate.
How does JALYN work?
JALYN contains 2medications, dutasteride and tamsulosin. These 2medications work in different ways to improve symptoms of BPH. Dutasteride shrinks the enlarged prostate and tamsulosin relaxes muscles in the prostate and neck of the bladder. These 2medications, when used together, can improve symptoms of BPH better than either medication when used alone.
Jointly Manufactured by
Catalent Pharma Solutions
F-67930 Beinheim, France
D-73614 Schorndorf, Germany
and
Rottendorf Pharma GmbH
D-59320 Ennigerloh, Germany
Distributed by
GlaxoSmithKline
Research Triangle Park, NC 27709
©2011, GlaxoSmithKline. All rights reserved.
June 2011
JLN:2PIL
Principal Display Panel
NDC 0173-0809-13
JalynTM
(dutasteride and tamsulosin HCl)
Capsules
0.5 mg/ 0.4 mg
Rx only
30 Capsules
WARNING: JALYN should not be used by women or children. Women who are or may potentially be pregnant should not use or handle JALYN Capsules (see prescribing information). If contact is made with leaking capsule, wash immediately with soap and water.
Capsules should be swallowed whole and not chewed or opened.
Each capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride.
Usual Dosage: 1 capsule once daily. See prescribing information for dosage information.
Store at 25oC (77oF); excursions permitted 15o to 30oC (59o to 86oF) [see USP Controlled Room Temperature].
Do not use if printed safety seal under cap is broken or missing.
Jointly Manufactured by
Catalent Pharma Solutions
F-67930 Beinheim, France
D-73614 Schorndorf, Germany
and Rottendorf Pharma GmbH
D-59320 Ennigerloh, Germany
Distributed by GlaxoSmithKline
Research Triangle Park, NC 27709
Made in Germany
JALYN is a trademark of GlaxoSmithKline.
A285187 Rev. 6/10
JALYN
dutasteride and tamsulosin hydrochloride c |
