Tamsulosin 0.4 mg (Modified Release) Dutasteride 0.5 mg Tablet For PCD Franchise

Treating symptoms of benign prostatic hyperplasia (BPH) in men who have an enlarged prostate gland.

Dutasteride/tamsulosin is a 5 alpha-reductase inhibitor and alpha-blocker combination. The 5 alpha-reductase inhibitor (dutasteride) works by lowering levels of a hormone called dihydrotestosterone (DHT), which is a major cause of prostate growth. The alpha-blocker (tamsulosin) works by relaxing muscles in the prostate and bladder. Dutasteride/tamsulosin helps to decrease the size of the prostate and reduce symptoms of BPH.

MK Medicine is a leading pcd franchise provider, contract manufacturer and hospital supplier of WHO-GMP certified Tamsulosin 0.4 mg (Modified Release) Dutasteride 0.5 mg Tablet

10x10 (Alu-Alu)

You are allergic to any ingredient in dutasteride/tamsulosin or to other 5 alpha-reductase inhibitors (eg, finasteride).
The patient is a woman who is pregnant or may become pregnant.
The patient is a child.
You are taking another alpha-blocker (eg, prazosin).
You are taking certain azole antifungals (eg, itraconazole, ketoconazole, posaconazole), HIV protease inhibitors (eg, ritonavir), certain macrolide antibiotics (eg, clarithromycin), nefazodone, or telithromycin.

Contact your doctor or health care provider right away if any of these apply to you.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; cough; decreased amount of semen released during ejaculation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; headache; light-headedness; mild sore throat; runny or stuffy nose; sinus inflammation; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blurred vision; breast enlargement, lumps, pain, or tenderness; chest pain; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; nipple discharge; prolonged, painful erection; red, swollen, blistered, or peeling skin; severe or persistent dizziness or light-headedness; shortness of breath.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

Adverse Reactions Reported over a 48-Month Period in ≥1% of Subjects and More Frequently in the Coadministration Therapy Group than the Dutasteride or Tamsulosin Monotherapy Group (CombAT) by Time of Onset
Adverse Reaction	Adverse Reaction Time of Onset
Adverse Reaction	Year 1		Year 2	Year 3	Year 4
Months 0‑6	Months 7‑12		Year 2	Year 3	Year 4
Coadministrationa	(n = 1,610)	(n = 1,527)	(n = 1,428)	(n = 1,283)	(n = 1,200)
Dutasteride	(n = 1,623)	(n = 1,548)	(n = 1,464)	(n = 1,325)	(n = 1,200)
Tamsulosin	(n = 1,611)	(n = 1,545)	(n = 1,468)	(n = 1,281)	(n = 1,112)
Ejaculation disordersb,c
Coadministration	7.8%	1.6%	1.0%	0.5%	<0.1%
Dutasteride	1.0%	0.5%	0.5%	0.2%	0.3%
Tamsulosin	2.2%	0.5%	0.5%	0.2%	0.3%
Impotencec,d
Coadministration	5.4%	1.1%	1.8%	0.9%	0.4%
Dutasteride	4.0%	1.1%	1.6%	0.6%	0.3%
Tamsulosin	2.6%	0.8%	1.0%	0.6%	1.1%
Decreased libidoc,e
Coadministration	4.5%	0.9%	0.8%	0.2%	0.0%
Dutasteride	3.1%	0.7%	1.0%	0.2%	0.0%
Tamsulosin	2.0%	0.6%	0.7%	0.2%	<0.1%
Breast disordersf
Coadministration	1.1%	1.1%	0.8%	0.9%	0.6%
Dutasteride	0.9%	0.9%	1.2%	0.5%	0.7%
Tamsulosin	0.4%	0.4%	0.4%	0.2%	0.0%
Dizziness
Coadministration	1.1%	0.4%	0.1%	<0.1%	0.2%
Dutasteride	0.5%	0.3%	0.1%	<0.1%	<0.1%
Tamsulosin	0.9%	0.5%	0.4%	<0.1%	0.0%

Some medical conditions may interact with dutasteride/tamsulosin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines or other substances
if you have heart failure, kidney problems, urinary tract problems, or problems urinating
if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any sulfonamide (sulfa) medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), probenecid, sulfamethoxazole, sulfonylureas (eg, glyburide), valdecoxib, or zonisamide
if you will be having a certain type of eye surgery (cataract surgery)
if you have a history of high or low blood pressure, prostate cancer, increased serum prostate-specific antigen (PSA) levels, abnormal liver function tests, or liver problems
if you take medicine for high blood pressure

Some MEDICINES MAY INTERACT with dutasteride/tamsulosin. Tell your health care provider if you are taking any other medicines, especially any of the following:

Azole antifungals (eg, fluconazole, itraconazole, ketoconazole, posaconazole), cimetidine, fluoxetine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, paroxetine, telithromycin, or terbinafine because they may increase the risk of dutasteride/tamsulosin‚s side effects
Phosphodiesterase type 5 (PDE5) inhibitors (eg, sildenafil) or other medicines that contain alpha-blockers (eg, prazosin) because symptoms of low blood pressure (eg, severe dizziness, light-headedness, fainting) may occur
Warfarin because the risk of side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if dutasteride/tamsulosin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Dutasteride

Dutasteride is a synthetic 4-azasteroid compound chemically designated as (5α,17β)-N-{2,5 bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C₂₇H₃₀F₆N₂O₂, representing a molecular weight of 528.5 .Dutasteride is a white to pale yellow powder with a melting point of 242° to 250°C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water.

Tamsulosin

Tamsulosin hydrochloride is a synthetic compound chemically designated as (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride.The empirical formula of tamsulosin hydrochloride is C₂₀H₂₈N₂O₅S•HCl. The molecular weight of tamsulosin hydrochloride is 444.97. Tamsulosin hydrochloride is a white or almost white crystalline powder that melts with decomposition at approximately 234°C. It is sparingly soluble in water and slightly soluble in methanol, ethanol, acetone, and ethyl acetate.

Important Notice:- The Database is still under development and may contain inaccuracies. It is not intended as a substitute for the expertise and judgement of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that the use of any medication in any country is safe, appropriate or effective for you. Consult with your healthcare professional before taking any medication.