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ALFUZOSIN HYDROCHLORIDE tablet


  1. Your Risk Of Having This Problem May Be Increased If You Take Alfuzosin Hcl Extended-release Tablets With Certain Other Medicine That Lowers Blood Pressure:
  2. Do Not Take Alfuzosin Hcl Extended-release Tablets If You:
  3. Alfuzosin Hcl Extended-release Tablets Can Cause Serious Side Effects, Including:
  4. Active Ingredient:
  5. Distributed By:
  6. Revised: 7/2012document Id:
  7. Patient Information
  8. Your Risk Of Having This Problem May Be Increased If You Take Alfuzosin Hydrochloride Extended-release Tablets With Certain Other Medicine That Lowers Blood Pressure:
  9. Do Not Take Alfuzosin Hydrochloride Extended-release Tablets If You:
  10. Alfuzosin Hydrochloride Extended-release Tablets Can Cause Serious Side Effects, Including:
  11. Inactive Ingredients:
  12. Manufactured By:

Your Risk Of Having This Problem May Be Increased If You Take Alfuzosin Hcl Extended-release Tablets With Certain Other Medicine That Lowers Blood Pressure: 

  • medicines for high blood pressure
  • a nitrate medicine for angina

Ask your doctor if you are not sure if you are taking one of these medicines.

  • Do not drive, operate machinery, or do any dangerous activities until you know how alfuzosin HCl extended-release tablets affects you.This is especially important if you already have a problem with low blood pressure or take medicines to treat high blood pressure.
  • If you begin to feel dizzy or lightheaded, lie down with your legs and feet up. If your symptoms do not improve call your doctor.

Alfuzosin HCl extended-release tablets are a prescription medicine that is called an "alpha-blocker". Alfuzosin HCl extended-release tablets are used in adult men to treat the symptoms of benign prostatic hyperplasia (BPH). Alfuzosin HCl extended-release tablets may help to relax the muscles in the prostate and the bladder which may lessen the symptoms of BPH and improve urine flow.

Before prescribing alfuzosin HCl extended-release tablets, your doctor may examine your prostate gland and do a blood test called a prostate specific antigen (PSA) test to check for prostate cancer. Prostate cancer and BPH can cause the same symptoms. Prostate cancer needs a different treatment.

Alfuzosin HCl extended-release tablets are not for use in women or children.

Some medicines called "alpha-blockers" are used to treat high blood pressure. Alfuzosin HCl extended-release tablets are not for the treatment of high blood pressure.

Do Not Take Alfuzosin Hcl Extended-release Tablets If You: 

  • have certain liver problems
  • take antifungal medicines like ketoconazole (Nizarol) or itraconazole (Sporanox)
  • take anti-HIV medicines like ritonavir (Norvir, Kaletra)
  • are allergic to alfuzosin hydrochloride or any of the ingredients in alfuzosin HCl extended-release tablets.

    • Take alfuzosin HCl extended-release tablets exactly as your doctor prescribes it.
    • Take alfuzosin HCl extended-release tablets after the same meal each day. Do not take it on an empty stomach.
    • Swallow the alfuzosin HCl extended-release tablet whole. Do not crush, split, or chew alfuzosin HCl extended-release tablets.
    • If you take too much alfuzosin HCl extended-release tablets call your local poison control center or emergency room right away.

Alfuzosin Hcl Extended-release Tablets Can Cause Serious Side Effects, Including: 

    • Store alfuzosin HCl extended-release tablets at 20 -25 C (68 -77 F), [

Active Ingredient: 

alfuzosin hydrochloride, USP

Distributed By: 

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA

Iss.190112

LabelLabel
ALFUZOSIN HYDROCHLORIDE
alfuzosin hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55648-738
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALFUZOSIN HYDROCHLORIDE(UNII: 75046A1XTN) (ALFUZOSIN - UNII:90347YTW5F)ALFUZOSIN HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
ColorWHITE (White) , YELLOW (Yellow)Scoreno score
ShapeROUND (bi-layered circular shaped standard convex tablets)Size20mm
FlavorImprint CodeW738
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55648-738-0130 in 1 BOTTLE
2NDC:55648-738-02100 in 1 BOTTLE
3NDC:55648-738-03500 in 1 BOTTLE
4NDC:55648-738-0510 in 1 CARTON
410 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09022108/15/2012
Labeler -Wockhardt Limited (650069115)
Registrant -Wockhardt Limited (650069115)
Establishment
NameAddressID/FEIBusiness Operations
Wockhardt Limited676257570ANALYSIS(55648-738) , MANUFACTURE(55648-738) , PACK(55648-738) , LABEL(55648-738)

Revised: 7/2012document Id: 

684641a9-69ac-47dc-9fc5-3dc6c9b4028cSet id: 30f97b8e-4486-4b5f-896a-d7dfa1e2e33aVersion: 1Effective Time: 20120720Wockhardt Limited

Patient Information 

Alfuzosin hydrochlorideextended-release tablets can cause serious side effects, including a sudden drop in blood pressure, especially when you start treatment.This may cause you to faint, or to feel dizzy or lightheaded.

Your Risk Of Having This Problem May Be Increased If You Take Alfuzosin Hydrochloride Extended-release Tablets With Certain Other Medicine That Lowers Blood Pressure: 

  • medicines for high blood pressure
  • a nitrate medicine for angina

Ask your doctor if you are not sure if you are taking one of these medicines.

  • Do not drive, operate machinery, or do any dangerous activities until you know how alfuzosinhydrochlorideextended-release tablets affects you.This is especially important if you already have a problem with low blood pressure or take medicines to treat high blood pressure.
  • If you begin to feel dizzy or lightheaded, lie down with your legs and feet up. If your symptoms do not improve call your doctor.

Alfuzosin hydrochloride extended-release tablets are a prescription medicine that is called an "alpha-blocker". Alfuzosin hydrochloride extended-release tablets are used in adult men to treat the symptoms of benign prostatic hyperplasia (BPH). Alfuzosin hydrochloride extended-release tablets may help to relax the muscles in the prostate and the bladder which may lessen the symptoms of BPH and improve urine flow.

Before prescribing alfuzosin hydrochloride extended-release tablets, your doctor may examine your prostate gland and do a blood test called a prostate specific antigen (PSA) test to check for prostate cancer. Prostate cancer and BPH can cause the same symptoms. Prostate cancer needs a different treatment.

Alfuzosin hydrochloride extended-release tablets are not for use in women or children.

Some medicines called "alpha-blockers" are used to treat high blood pressure. Alfuzosin hydrochloride extended-release tablets are not for the treatment of high blood pressure.

Who should not take alfuzosin hydrochloride

Do Not Take Alfuzosin Hydrochloride Extended-release Tablets If You: 

  • have certain liver problems
  • take antifungal medicines like ketoconazole (Nizarol) or itraconazole (Sporanox)
  • take anti-HIV medicines like ritonavir (Norvir, Kaletra)
  • are allergic to alfuzosin hydrochloride or any of the ingredients in alfuzosin hydrochloride extended-release tablets.

    • Take alfuzosin hydrochloride extended-release tablets exactly as your doctor prescribes it.
    • Take alfuzosin hydrochloride extended-release tablets after the same meal each day. Do not take it on an empty stomach.
    • Swallow the alfuzosin hydrochloride extended-release tablet whole. Do not crush, split, or chew alfuzosin hydrochloride extended-release tablets.
    • If you take too much alfuzosin hydrochloride extended-release tablets call your local poison control center or emergency room right away.

    What are the possible side effects of alfuzosin hydrochloride

Alfuzosin Hydrochloride Extended-release Tablets Can Cause Serious Side Effects, Including: 

    • Store alfuzosin hydrochloride extended-release tablets at 20 -25 C (68 -77 F), [

Inactive Ingredients: 

colloidal silicon dioxide, hydroxy propyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc, and yellow ferric oxide.

Manufactured By: 

Wockhardt Limited

H-14/2, M.I.D.C. Area, Waluj,

Aurangabad, Maharashtra, India.



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