JALYN (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

JALYN Capsules, containing 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, are oblong hard-shell capsules with a brown body and an orange cap imprinted with “GS 7CZ” in black ink. They are available in bottles with child-resistant closures as follows:

Bottle of 30 (NDC 54868-6328-0).

Store at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature]. Capsules may become deformed and/or discolored if kept at high temperatures.

Dutasteride is absorbed through the skin. JALYN Capsules should not be handled by women who are pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see Warnings and Precautions (5.6)].

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)

17.1 Orthostatic Hypotension

Physicians should inform patients about the possible occurrence of symptoms related to orthostatic hypotension, such as dizziness and vertigo, and the potential risk of syncope when taking JALYN. Patients starting treatment with JALYN should be cautioned to avoid situations where injury could result should syncope occur (e.g., driving, operating machinery, performing hazardous tasks). Patients should sit or lie down at the first signs of orthostatic hypotension [see Warnings and Precautions (5.1)].

17.2 PSA Monitoring

Physicians should inform patients that JALYN reduces serum PSA levels by approximately 50% within 3 to 6 months of therapy, although it may vary for each individual. For patients undergoing PSA screening, increases in PSA levels while on treatment with JALYN may signal the presence of prostate cancer and should be evaluated by a healthcare provider [see Warnings and Precautions (5.3)].

17.3 Risk of High-grade Prostate Cancer

Physicians should inform patients that there was an increase in high-grade prostate cancer in men treated with 5 alpha-reductase inhibitors (which are indicated for BPH treatment), including dutasteride, which is a component of JALYN, compared with those treated with placebo in studies looking at the use of these drugs to reduce the risk of prostate cancer [see Indications and Usage (1.2), Warnings and Precautions (5.4), Adverse Reactions (6.1)].

17.4 Exposure of Women—Risk to Male Fetus

Physicians should inform patients that JALYN Capsules should not be handled by a woman who is pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus. Dutasteride is absorbed through the skin and could result in unintended fetal exposure. If a pregnant woman or woman of childbearing potential comes in contact with leaking JALYN Capsules, the contact area should be washed immediately with soap and water [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)].

17.5 Instructions for Use

JALYN Capsules should be swallowed whole and not chewed, crushed, or opened. JALYN Capsules may become deformed and/or discolored if kept at high temperatures. If this occurs, capsules should not be used.

17.6 Priapism

Physicians should inform patients about the possibility of priapism as a result of treatment with JALYN or other alpha adrenergic antagonist-containing medications. Patients should be informed that this reaction is extremely rare, but can lead to permanent erectile dysfunction if not brought to immediate medical attention [see Warnings and Precautions (5.7)].

17.7 Blood Donation

Physicians should inform men treated with JALYN that they should not donate blood until at least 6 months following their last dose to prevent pregnant women from receiving dutasteride through blood transfusion [see Warnings and Precautions (5.8)]. Serum levels of dutasteride are detectable for 4 to 6 months after treatment ends [see Clinical Pharmacology (12.3)].

17.8 Intraoperative Floppy Iris Syndrome (IFIS)

Physicians should advise patients considering cataract surgery to tell their ophthalmologist that they take or have taken JALYN, an alpha adrenergic antagonist-containing product [see Warnings and Precautions (5.9)].

JALYN and AVODART are trademarks of GlaxoSmithKline.

The other brands listed are trademarks of their respective owners and are not trademarks of GlaxoSmithKline. The makers of these brands are not affiliated with and do not endorse GlaxoSmithKline or its products.

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

©2012, GlaxoSmithKline. All rights reserved.

March 2012
JLN:3PI

Additional barcode label by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

PHARMACISTDETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

PATIENT INFORMATION

JALYN™ [JAY-lin]

( dutasteride and tamsulosin hydrochloride)

Capsules

JALYN is for use by men only.

Read this patient information before you start taking JALYN and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is JALYN?

JALYN is a prescription medicine that contains 2 medicines: dutasteride and tamsulosin. JALYN is used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

Who should not take JALYN?

Do Not Take JALYN if you are:

  • pregnant or could become pregnant. JALYN may harm your unborn baby. Pregnant women should not touch JALYN Capsules. If a woman who is pregnant with a male baby gets enough JALYN in her body by swallowing or touching JALYN, the male baby may be born with sex organs that are not normal. If a pregnant woman or woman of childbearing potential comes in contact with leaking JALYN Capsules, the contact area should be washed immediately with soap and water.
  • a child or teenager.
  • allergic to dutasteride, tamsulosin, or any of the ingredients in JALYN. See the end of this leaflet for a complete list of ingredients in JALYN.
  • taking another medicine that contains an alpha-blocker.
  • allergic to other 5 alpha-reductase inhibitors, for example, PROSCAR (finasteride) Tablets.

What should I tell my healthcare provider before taking JALYN?

Before you take JALYN, tell your healthcare provider if you:

  • have a history of low blood pressure
  • take medicines to treat high blood pressure
  • plan to have cataract surgery
  • have liver problems
  • are allergic to sulfa medications
  • have any other medical conditions

Tell your healthcare provider about all the medicines you take , including prescription and non-prescription medicines, vitamins, and herbal supplements. JALYN and other medicines may affect each other, causing side effects. JALYN may affect the way other medicines work, and other medicines may affect how JALYN works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take JALYN?

  • Take JALYN exactly as your healthcare provider tells you to take it.
  • Swallow JALYN Capsules whole. Do not crush, chew, or open JALYN Capsules because the contents of the capsule may irritate your lips, mouth, or throat.
  • Take your JALYN 1 time each day, about 30 minutes after the same meal every day. For example, you may take JALYN 30 minutes after dinner every day.
  • If you miss a dose, you can take it later that same day, 30 minutes after a meal. Do not take 2 JALYN capsules in the same day. If you stop or forget to take JALYN for several days, talk with your healthcare provider before starting again.
  • If you take too much JALYN, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking JALYN?

  • Avoid driving, operating machinery, or other dangerous activities when starting treatment with JALYN until you know how JALYN affects you. JALYN can cause a sudden drop in your blood pressure, especially at the start of treatment. A sudden drop in blood pressure may cause you to faint, feel dizzy or lightheaded.
  • You should not donate blood while taking JALYN or for 6 months after you have stopped JALYN. This is important to prevent pregnant women from receiving JALYN through blood transfusions.

What are the possible side effects of JALYN?

JALYN may cause serious side effects, including:

  • Decreased blood pressure. JALYN may cause a sudden drop in your blood pressure upon standing from a sitting or lying position, especially at the start of treatment. Symptoms of low blood pressure may include:
  • fainting
  • dizziness
  • feeling lightheaded
  • Rare and serious allergic reactions, including:
  • swelling of your face, tongue, or throat
  • serious skin reactions, such as skin peeling

Get medical help right away if you have these serious allergic reactions.

  • Higher chance of a more serious form of prostate cancer.
  • Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken JALYN in the past. If you need to have cataract surgery, tell your surgeon if you take or have taken JALYN.
  • A painful erection that will not go away. Rarely, JALYN can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, there could be lasting damage to your penis, including not being able to have an erection.

The most common side effects of JALYN include:

  • ejaculation problems
  • trouble getting or keeping an erection (impotence)
  • a decrease in sex drive (libido)
  • dizziness
  • enlarged or painful breasts. If you notice breast lumps or nipple discharge, you should talk to your healthcare provider.
  • runny nose

Dutasteride, an ingredient of JALYN, has been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of JALYN on male fertility is not known.

Prostate-Specific Antigen (PSA) Test: Your healthcare provider may check you for other prostate problems, including prostate cancer before you start and while you take JALYN. A blood test called PSA (prostate-specific antigen) is sometimes used to see if you might have prostate cancer. JALYN will reduce the amount of PSA measured in your blood. Your healthcare provider is aware of this effect and can still use PSA to see if you might have prostate cancer. Increases in your PSA levels while on treatment with JALYN (even if the PSA levels are in the normal range) should be evaluated by your healthcare provider.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects with JALYN. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may 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 2 medications, dutasteride and tamsulosin. These 2 medications 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 2 medications, 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

©2012, GlaxoSmithKline. All rights reserved.

March 2012

JLN:3PIL

Principal Display Panel

NDC 54868-6328-0

bottle label
(click image for full-size original)

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 25o C (77o F); excursions permitted 15o to 30o C (59o to 86o F) [see USP Controlled Room Temperature].

Do not use if printed safety seal under cap is broken or missing.

JALYN
dutasteride and tamsulosin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6328(NDC:0173-0809)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DUTASTERIDE (DUTASTERIDE) DUTASTERIDE 0.5 mg
TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN) TAMSULOSIN HYDROCHLORIDE 0.4 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES
FERRIC OXIDE YELLOW
GELATIN
GLYCERIN
TITANIUM DIOXIDE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
CELLULOSE, MICROCRYSTALLINE
TALC
TRIETHYL CITRATE
CARRAGEENAN
FD&C YELLOW NO. 6
HYPROMELLOSES
FERRIC OXIDE RED
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (brown body and a orange cap) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code GZ;7CZ
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6328-0 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022460 05/02/2012
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 05/2012 Physicians Total Care, Inc.

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