Duman 0.5mg Tablet

DUMAN 0.5MG TABLET by INTAS PHARMACEUTICALS LTD.

Name

Brand Name: DUMAN 0.5MG TABLET Common Name: Dutasteride Tablet

Composition

Each tablet contains Dutasteride 0.5 mg as the active ingredient. Dutasteride belongs to a class of medicines known as 5-alpha reductase inhibitors.

Uses

DUMAN 0.5MG TABLET is primarily prescribed for the management of signs and symptoms associated with Benign Prostatic Hyperplasia (BPH), also known as an enlarged prostate, in adult men. It works by shrinking the enlarged prostate gland, thereby alleviating urinary symptoms such as difficulty in passing urine, weak urine flow, frequent urination (especially at night), and urinary incontinence. It also helps to reduce the risk of acute urinary retention and the need for prostate surgery.

Dosage and Administration

DUMAN 0.5MG TABLET should be taken regularly at the same time each day, with or without meals, as advised by your doctor. The tablet should be swallowed whole and not chewed, crushed, or broken. It may take approximately 4 weeks to several months (3 to 6 months) for the medicine to show its full beneficial effects.

Side Effects

Common side effects include:

• Decreased sex drive (libido)
• Impotence (difficulty in maintaining an erection)
• Difficulty in reaching orgasm
• Low sperm count and ejaculation problems (decreased ejaculate volume)
• Breast enlargement (gynecomastia) and tenderness in men
• Dizziness

Serious side effects (seek immediate medical attention if experienced):

• Severe allergic reactions such as skin rash with redness and lumps, swelling of the face, eyelids, lips, mouth, or tongue, causing difficulty in breathing or swallowing.
• Signs of prostate cancer (e.g., difficulty urinating, decreased force in urine flow, blood in urine or semen, bone pain, sudden weight loss, erectile dysfunction).
• Signs of male breast cancer (e.g., breast enlargement with pain, lump formation in breasts, discharge from nipples).

Precautions

• Pregnancy and Women: DUMAN 0.5MG TABLET is not intended for use in women and can cause serious harm to a developing male fetus. Pregnant women or women who may become pregnant should not handle the tablets (especially if broken or crushed) as the active ingredient can be absorbed through the skin.
• Blood Donation: Do not donate blood while on therapy with DUMAN 0.5MG TABLET and for at least 6 months after stopping the treatment, to prevent exposure of dutasteride to a pregnant female transfusion recipient.
• Liver and Kidney: Use with caution in patients with liver or kidney problems; dose adjustment may be required for liver issues. Patients with severe liver disease should avoid this medication.
• Alcohol: Avoid consumption of alcohol as it may increase dizziness.
• Children: Not recommended for use in children and adolescents below 18 years of age.
• PSA Testing: DUMAN 0.5MG TABLET may alter Prostate-Specific Antigen (PSA) levels, which are used to screen for prostate cancer. Inform your doctor if you are undergoing PSA testing.

Storage

Store DUMAN 0.5MG TABLET at room temperature, typically between 10°C to 25°C or below 30°C. Protect the medicine from light and moisture, and keep it out of the sight and reach of children and pets. Do not use the medicine after its expiry date.

DUMAN 0.5MG TABLET, containing the active ingredient Dutasteride, is a medication primarily used to treat benign prostatic hyperplasia (BPH) in adult men. It belongs to a class of drugs called 5-alpha reductase inhibitors.

Here are some frequently asked questions about DUMAN 0.5MG TABLET:

What is DUMAN 0.5MG TABLET used for?

DUMAN 0.5MG TABLET is used to manage the signs and symptoms of benign prostatic hyperplasia (BPH), also known as an enlarged prostate, in adult men. It helps shrink the enlarged prostate gland, improving urinary flow and reducing symptoms such as difficulty urinating, frequent urination, and weak urine flow. It may also reduce the risk of acute urinary retention and the need for surgery.

How does DUMAN 0.5MG TABLET work?

This medicine contains Dutasteride, a 5-alpha reductase inhibitor. It works by blocking the activity of an enzyme called 5-alpha reductase, which is responsible for converting testosterone into dihydrotestosterone (DHT). DHT is a hormone that contributes to the growth and enlargement of the prostate gland. By reducing DHT levels, DUMAN 0.5MG TABLET helps to shrink the prostate and alleviate BPH symptoms.

What is the usual dosage for DUMAN 0.5MG TABLET?

The usual dosage is one 0.5 mg tablet taken once daily. It can be taken with or without food, but it is recommended to take it at the same time each day for consistent effectiveness. It may take several months (around 3 to 6 months) to observe the full beneficial effects of the medication.

What are the possible side effects of DUMAN 0.5MG TABLET?

Common side effects may include decreased sex drive (libido), impotence (difficulty in maintaining an erection), difficulty with ejaculation, low sperm count, and breast enlargement or tenderness in men. Less common side effects can include dizziness, headache, and rare but serious allergic reactions (e.g., skin rash, swelling of the face, lips, tongue).

Is DUMAN 0.5MG TABLET safe during pregnancy or breastfeeding?

No, DUMAN 0.5MG TABLET is not intended for use in women and is contraindicated during pregnancy and breastfeeding. It can cause serious harm to a developing male fetus if a pregnant woman is exposed to it, as Dutasteride can be absorbed through the skin. Pregnant women should avoid contact with broken or leaking capsules, and if contact occurs, the area should be washed immediately with soap and water. Men taking this medication should also avoid donating blood for at least six months after stopping the therapy to prevent exposure to a pregnant female transfusion recipient.

Can DUMAN 0.5MG TABLET be taken with other medications?

DUMAN 0.5MG TABLET may interact with certain medications. Inform your doctor about all medicines, supplements, or herbal products you are taking. Interactions may occur with medicines used to manage heart problems (e.g., verapamil, diltiazem), HIV infection (e.g., ritonavir, indinavir), fungal infections (e.g., itraconazole, ketoconazole), or depression (e.g., nefazodone). It may also interact with other alpha-blockers used for BPH.

What precautions should be taken while taking DUMAN 0.5MG TABLET?

It's important to inform your doctor if you have any liver problems, as DUMAN 0.5MG TABLET is metabolized in the liver and may require caution or dose adjustment in patients with liver disease. Regular monitoring of prostate-specific antigen (PSA) levels will be conducted by your doctor, as this medicine can affect PSA readings. Avoid consuming alcohol as it may worsen dizziness. Do not stop taking DUMAN 0.5MG TABLET without consulting your doctor, even if your symptoms improve.

What happens if a dose of DUMAN 0.5MG TABLET is missed?

If you miss a dose of DUMAN 0.5MG TABLET, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to compensate for the missed one.

How should DUMAN 0.5MG TABLET be stored?

DUMAN 0.5MG TABLET should be stored at 25°C in an airtight container. Keep the medicine out of the reach and sight of children and pets.