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DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE capsule


  1. What Are Dutasteride And Tamsulosin Hydrochloride Capsules?
  2. Who Should Not Take Dutasteride And Tamsulosin Hydrochloride Capsules? Do Not Take Dutasteride And Tamsulosin Hydrochloride Capsules If You Are:
  3. Before You Take Dutasteride And Tamsulosin Hydrochloride Capsules, Tell Your Healthcare Provider If You:
  4. How Should I Take Dutasteride And Tamsulosin Hydrochloride Capsules?
  5. What Should I Avoid While Taking Dutasteride And Tamsulosin Hydrochloride Capsules?
  6. Dutasteride And Tamsulosin Hydrochloride Capsules May Cause Serious Side Effects, Including:
  7. The Most Common Side Effects Of Dutasteride And Tamsulosin Hydrochloride Capsules Include:
  8. Active Ingredients:
  9. Inactive Ingredients:
  10. How Does Dutasteride And Tamsulosin Hydrochloride Capsules Work?
  11. Patient Information
  12. Do Not Take Dutasteride And Tamsulosin Hydrochloride Capsules If You Are:
  13. Before You Take Dutasteride And Tamsulosin Hydrochloride Capsules, Tell Your Healthcare Provider If You:
  14. How Should I Take Dutasteride And Tamsulosin Hydrochloride Capsules?
  15. What Should I Avoid While Taking Dutasteride And Tamsulosin Hydrochloride Capsules?
  16. Dutasteride And Tamsulosin Hydrochloride Capsules May Cause Serious Side Effects, Including:
  17. Rare And Serious Allergic Reactions, Including:
  18. The Most Common Side Effects Of Dutasteride And Tamsulosin Hydrochloride Capsules Include:
  19. Prostate-specific Antigen (psa) Test:
  20. How Do Dutasteride And Tamsulosin Hydrochloride Capsules Work?
  21. Revised: 2/2018document Id:

What Are Dutasteride And Tamsulosin Hydrochloride Capsules? 

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

Who Should Not Take Dutasteride And Tamsulosin Hydrochloride Capsules? Do Not Take Dutasteride And Tamsulosin Hydrochloride Capsules If You Are: 

  • pregnant or could become pregnant. Dutasteride and tamsulosin hydrochloride capsules may harm your unborn baby. Pregnant women should not touch dutasteride and tamsulosin hydrochloride capsules. If a woman who is pregnant with a male baby gets enough dutasteride and tamsulosin hydrochloride capsules in her body by swallowing or touching dutasteride and tamsulosin hydrochloride capsules, 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 dutasteride and tamsulosin hydrochloride 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 dutasteride and tamsulosin hydrochloride capsules.

Before You Take Dutasteride And Tamsulosin Hydrochloride Capsules, 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. Dutasteride and tamsulosin hydrochloride capsules and other medicines may affect each other, causing side effects. Dutasteride and tamsulosin hydrochloride capsules may affect the way other medicines work, and other medicines may affect how dutasteride and tamsulosin hydrochloride capsules 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 Dutasteride And Tamsulosin Hydrochloride Capsules? 

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

What Should I Avoid While Taking Dutasteride And Tamsulosin Hydrochloride Capsules? 

  • Avoid driving, operating machinery, or other dangerous activities when starting treatment with dutasteride and tamsulosin hydrochloride capsules until you know how dutasteride and tamsulosin hydrochloride capsules affects you. dutasteride and tamsulosin hydrochloride capsules 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 dutasteride and tamsulosin hydrochloride capsules or for 6 months after you have stopped dutasteride and tamsulosin hydrochloride capsules. This is important to prevent pregnant women from receiving dutasteride and tamsulosin hydrochloride capsules through blood transfusions.

Dutasteride And Tamsulosin Hydrochloride Capsules May Cause Serious Side Effects, Including: 

  • Decreased blood pressure.dutasteride and tamsulosin hydrochloride capsules 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

The Most Common Side Effects Of Dutasteride And Tamsulosin Hydrochloride Capsules 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

*Some of these events may continue after you stop taking dutasteride and tamsulosin hydrochloride capsules

Depressed mood has been reported in patients receiving dutasteride, an ingredient of dutasteride and tamsulosin hydrochloride capsules.

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

Active Ingredients: 

dutasteride and tamsulosin hydrochloride

Inactive Ingredients: 

. acetyltributyl citrate, butylated hydroxytoluene, carrageenan, corn starch, ethylcellulose, gelatin (from certified BSE-free bovine sources), glycerin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, iron oxide black, iron oxide yellow, medium-chain triglycerides, mono-di-glycerides of caprylic/capric acid, potassium chloride, propylene glycol, sodium lauryl sulfate, soy lecithin, sucrose, talc, and titanium dioxide

How Does Dutasteride And Tamsulosin Hydrochloride Capsules Work? 

Dutasteride and tamsulosin hydrochloride capsules contain 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.

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

Manufactured by:
Actavis Laboratories FL, Inc.
Fort Lauderdale, FL 33314 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: November 2015

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Orthostatic Hypotension

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 Dutasteride and Tamsulosin Hydrochloride capsules. Caution patients starting treatment with Dutasteride and Tamsulosin Hydrochloride capsules to avoid situations where injury could result should syncope occur (e.g., driving, operating machinery, performing hazardous tasks). Advise patients to sit or lie down at the first signs of orthostatic hypotension[

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

Do Not Take Dutasteride And Tamsulosin Hydrochloride Capsules If You Are: 

pregnant or could become pregnant. Dutasteride and Tamsulosin Hydrochloride capsules may harm your unborn baby. Pregnant women should not touch Dutasteride and Tamsulosin Hydrochloride capsules. If a woman who is pregnant with a male baby gets enough Dutasteride and Tamsulosin Hydrochloride in her body by swallowing or touching Dutasteride and Tamsulosin Hydrochloride capsules, 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 Dutasteride and Tamsulosin Hydrochloride 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 Dutasteride and Tamsulosin Hydrochloride capsules.

Before You Take Dutasteride And Tamsulosin Hydrochloride Capsules, Tell Your Healthcare Provider If You: 

have a history of low blood pressure
take medicines to treat high blood pressure
plan to have cataract or glaucoma 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 over-the-counter medicines, vitamins, and herbal supplements. Dutasteride and Tamsulosin Hydrochloride capsules and other medicines may affect each other, causing side effects. Dutasteride and Tamsulosin Hydrochloride capsules may affect the way other medicines work, and other medicines may affect how Dutasteride and Tamsulosin Hydrochloride capsules work.

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 Dutasteride And Tamsulosin Hydrochloride Capsules? 

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

What Should I Avoid While Taking Dutasteride And Tamsulosin Hydrochloride Capsules? 

Avoid driving, operating machinery, or other dangerous activities when starting treatment with Dutasteride and Tamsulosin Hydrochloride capsules until you know how Dutasteride and Tamsulosin Hydrochloride capsules affect you. Dutasteride and Tamsulosin Hydrochloride capsules 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 Dutasteride and Tamsulosin Hydrochloride capsules or for 6 months after you have stopped Dutasteride and Tamsulosin Hydrochloride capsules. This is important to prevent pregnant women from receiving Dutasteride and Tamsulosin Hydrochloride through blood transfusions.

Dutasteride And Tamsulosin Hydrochloride Capsules May Cause Serious Side Effects, Including: 

Decreased blood pressure.Dutasteride and Tamsulosin Hydrochloride capsules 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
difficulty breathing
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 or glaucoma surgery.During cataract or glaucoma surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) can happen if you take or have taken Dutasteride and Tamsulosin Hydrochloride capsules in the past. If you need to have cataract or glaucoma surgery, tell your surgeon if you take or have taken Dutasteride and Tamsulosin Hydrochloride capsules.
A painful erection that will not go away.Rarely, Dutasteride and Tamsulosin Hydrochloride capsules 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 Dutasteride And Tamsulosin Hydrochloride Capsules 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

*Some of these events may continue after you stop taking Dutasteride and Tamsulosin Hydrochloride capsules.

Depressed mood has been reported in patients receiving dutasteride, an ingredient of Dutasteride and Tamsulosin Hydrochloride capsules.

Dutasteride, an ingredient of Dutasteride and Tamsulosin Hydrochloride capsules, has been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of Dutasteride and Tamsulosin Hydrochloride capsules 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 Dutasteride and Tamsulosin Hydrochloride capsules. A blood test called PSA (prostate-specific antigen) is sometimes used to

Store Dutasteride and Tamsulosin Hydrochloride capsules at room temperature (59 to 86 F or 15 to 30 C).
Dutasteride and Tamsulosin Hydrochloride capsules may become deformed and/or discolored if kept at high temperatures.
Do not use or touch Dutasteride and Tamsulosin Hydrochloride capsules if your capsules are deformed, discolored, or leaking.
Safely throw away medicine that is no longer needed.

Keep Dutasteride and Tamsulosin Hydrochloride capsules 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 Dutasteride and Tamsulosin Hydrochloride capsules for a condition for which it was not prescribed. Do not give Dutasteride and Tamsulosin Hydrochloride capsules 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 Dutasteride and Tamsulosin Hydrochloride capsules. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Dutasteride and Tamsulosin Hydrochloride capsules that is written for health professionals.

How Do Dutasteride And Tamsulosin Hydrochloride Capsules Work? 

Dutasteride and Tamsulosin Hydrochloride capsules contain 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.

The other brand listed is a trademark owned by or licensed to its respective owner and is not a trademark owned by or licensed to Prasco Laboratories. The maker of this brand is not affiliated with and does not endorse Prasco Laboratories or its products.

Manufactured for:
Prasco Laboratories
Mason, OH 45040 USA

January 2018

JLN-PS:3PIL

PRINCIPAL DISPLAY PANEL

NDC 66993-580-30

Dutasteride and Tamsulosin HCl

Capsules

PRASCO

0.5 mg/ 0.4 mg

Capsules should be swallowed whole and not chewed or opened.

30 Capsules

Rxonly

WARNING: DUTASTERIDE and TAMSULOSIN HYDROCHLORIDE should not be used by women or children. Women who are or may potentially be pregnant should not use or handle DUTASTERIDE and TAMSULOSIN HYDROCHLORIDE Capsules (see prescribing information). If contact is made with leaking capsule, wash immediately with soap and water.

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

Made in Germany

Rev. 1/17

A458601
Dutasteride and Tamsulosin HCl for Prasco 30 count carton
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
dutasteride and tamsulosin hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66993-580
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DUTASTERIDE(UNII: O0J6XJN02I) (DUTASTERIDE - UNII:O0J6XJN02I)DUTASTERIDE0.5 mg
TAMSULOSIN HYDROCHLORIDE(UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I)TAMSULOSIN HYDROCHLORIDE0.4 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES(UNII: U72Q2I8C85)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
CARRAGEENAN(UNII: 5C69YCD2YJ)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE RED(UNII: 1K09F3G675)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
Product Characteristics
ColorBROWN (brown body and a orange cap)Scoreno score
ShapeCAPSULESize23mm
FlavorImprint CodeGZ;7CZ
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66993-580-301 in 1 CARTON07/01/2016
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:66993-580-851 in 1 CARTON07/01/2016
290 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02246007/01/2016
Labeler -Prasco Laboratories (065969375)
Registrant -GlaxoSmithKline LLC (167380711)

Revised: 2/2018document Id: 

6a6ef980-a2d9-4d9c-9a72-68f156de600cSet id: 27bbcda6-72ba-40b4-82d6-8d1efb3a85a2Version: 7Effective Time: 20180212Prasco Laboratories



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