Dutas T + 0.4 Mg/0.5 Mg Capsule (15 Cap)

DUTAS T + 0.4 MG/0.5 MG CAPSULE (15 CAP) by DR REDDY S LABORATORIES LTD

Name

Brand Names: Dutas T Plus Capsule, Dutas T, Dutas T+ Capsule, Dutas T 0.4mg/0.5mg Capsule PR Common Name: Dutasteride and Tamsulosin Hydrochloride Capsules

Composition

Each capsule contains a combination of two active ingredients:

• Dutasteride: 0.5 mg
• Tamsulosin: 0.4 mg

Uses

Dutas T Plus Capsule is primarily prescribed for the treatment of benign prostatic hyperplasia (BPH), commonly known as an enlarged prostate gland, in men. It helps alleviate symptoms associated with BPH, such as:

• Difficulty passing urine
• Frequent urination or urgent need to urinate
• Weak urine flow
• Feeling of incomplete bladder emptying

This medication works by relaxing the muscles in the prostate and urethra (tamsulosin) and by reducing the size of the prostate gland by inhibiting the hormone dihydrotestosterone (dutasteride). It also helps to decrease the risk of acute urinary retention and the potential need for surgery related to BPH.

Dosage and Administration

• The typical dosage for adults is one capsule once a day.
• It should be taken orally, preferably at least 30 minutes after the same meal each day.
• Swallow the capsule whole; do not chew, crush, or open it.
• It may take a few weeks to months to notice an improvement in symptoms, and up to 6 months for the full therapeutic effects. Do not miss doses, even if feeling well.

Side Effects

Common Side Effects:

• Dizziness or lightheadedness
• Decreased sexual drive (libido)
• Impotence (erectile dysfunction)
• Ejaculation problems (e.g., reduced semen amount)
• Breast enlargement or tenderness (gynecomastia)
• Drowsiness
• Runny or stuffy nose

Serious Side Effects (requires medical attention):

• Priapism (persistent painful penile erection)
• Floppy iris syndrome during cataract surgery

Precautions

• Allergies: Do not take if allergic to tamsulosin, dutasteride, or any other ingredients of the capsule.
• Liver and Kidney Issues: Inform your doctor if you have a liver disorder or liver function problem, or kidney disease. Severe liver disease may contraindicate its use.
• Blood Pressure: Avoid if you have low blood pressure that causes dizziness, lightheadedness, or fainting. Rise slowly from sitting or lying positions to prevent dizziness.
• Women and Children: This medicine is not for use in women or children under 18 years of age. Pregnant women or those who may be pregnant should not handle this medicine due to the risk of absorption through the skin, which can cause birth defects in male fetuses.
• Sexual Activity: Use a condom during sexual intercourse if your partner is or may be pregnant, as dutasteride can be present in semen. It may also reduce sperm count, semen volume, and sperm movement, potentially affecting male fertility.
• Driving and Machinery: May cause dizziness, lightheadedness, or drowsiness. Avoid driving or operating machinery if you experience these effects.
• Surgical Procedures: Inform your eye doctor if you are taking this medicine or have used it in the last 9 months if you are scheduled for cataract or glaucoma surgery.
• Interactions: Inform your doctor about all other medicines, supplements, or herbal products you are currently taking to avoid possible interactions. Blood pressure-lowering medicines, sildenafil, or prazosin may increase the risk of low blood pressure when taken with Dutas T Plus Capsule.
• Prostate Cancer: This medicine is not meant to be used for the prevention of prostate cancer.
• Alcohol: Avoiding alcohol consumption is advisable to reduce the risk of excessive dizziness.
• Blood Donation: Avoid donating blood while taking this medication and for six months after stopping it.

Storage

• Store in a cool and dry place away from direct sunlight.
• Keep out of sight and reach of children.
• Maintain storage temperatures between 10ºC and 25ºC or below 30ºC.
• Store the medicine in a closed container.

What is DUTAS T + 0.4 MG/0.5 MG CAPSULE used for?

DUTAS T + 0.4 MG/0.5 MG CAPSULE is primarily used to treat the symptoms of benign prostatic hyperplasia (BPH), commonly known as an enlarged prostate gland, in men. This medication helps relieve urinary symptoms such as difficulty passing urine, frequent urination, weak urine flow, urinary urgency, and the feeling of incomplete bladder emptying. It also works to reduce the risk of acute urinary retention (a complete blockage of urine flow) and the potential need for prostate surgery.

How does DUTAS T + 0.4 MG/0.5 MG CAPSULE work?

This medicine is a combination of two active ingredients: Tamsulosin (an alpha-blocker) and Dutasteride (a 5-alpha reductase inhibitor). Tamsulosin works by relaxing the muscles in the prostate gland and the bladder neck, which helps improve urine flow and makes urination easier. Dutasteride reduces the size of the enlarged prostate by blocking an enzyme called 5-alpha reductase, which is responsible for converting testosterone into dihydrotestosterone (DHT), a hormone that contributes to prostate growth. By lowering DHT levels, dutasteride helps to shrink the prostate over time.

What is the usual dosage for DUTAS T + 0.4 MG/0.5 MG CAPSULE?

The typical dosage is one capsule (containing Dutasteride 0.5 mg and Tamsulosin 0.4 mg) taken once daily. It is recommended to take the capsule approximately 30 minutes after the same meal each day. The capsule should be swallowed whole with water and should not be chewed, crushed, or opened, as the contents can irritate the mouth or throat.

What are the possible side effects of DUTAS T + 0.4 MG/0.5 MG CAPSULE?

Common side effects may include dizziness, lightheadedness, drowsiness, and various sexual problems such as decreased sex drive (libido), impotence (trouble getting or keeping an erection), ejaculation disorder, and a reduction in semen or sperm count. Other common side effects can include breast tenderness or enlargement (gynecomastia), testicle pain or swelling, and a runny or stuffy nose. Dizziness and lightheadedness are particularly common when changing position from lying or sitting to standing, a condition known as orthostatic hypotension. Serious, but rare, side effects that require immediate medical attention include allergic reactions (such as severe rash, swelling of the face, tongue, or throat) or breast tissue changes (like new lumps or nipple discharge).

Is DUTAS T + 0.4 MG/0.5 MG CAPSULE safe during pregnancy or breastfeeding?

No, this medicine is strictly for men and is not safe for women, especially those who are pregnant or may become pregnant. Pregnant women or women of childbearing potential should not handle or touch the capsules, particularly if they are leaking, as Dutasteride can be absorbed through the skin and may cause birth defects in a male fetus. If accidental skin contact occurs, the area should be washed immediately with soap and water. Men taking this medication should use a condom during sexual intercourse if their partner is pregnant or may become pregnant, as Dutasteride can be present in semen and could affect the normal development of a male baby. Additionally, men should not donate blood while taking this medicine and for at least 6 months after stopping treatment to prevent potential exposure to pregnant women through blood transfusions. There is limited information on its safety during breastfeeding, but it is not recommended for use in women who are breastfeeding.

Can DUTAS T + 0.4 MG/0.5 MG CAPSULE be taken with other medications?

It is crucial to inform your doctor about all prescription and over-the-counter medications, vitamins, herbal products, and supplements you are currently taking or plan to take. Taking DUTAS T + 0.4 MG/0.5 MG CAPSULE with certain other medicines can lead to interactions, potentially increasing side effects or altering how the medication works. It should not be taken with other alpha-blockers. Caution is advised when taken with blood pressure-lowering medicines (such as sildenafil or prazosin), as this combination can cause a significant drop in blood pressure. Increased risk of side effects may occur if taken with certain antifungal medications (like ketoconazole or itraconazole), HIV medications (protease inhibitors such as ritonavir or indinavir), and some blood pressure drugs (e.g., verapamil, diltiazem). Always inform your eye doctor if you are taking this medication before undergoing cataract surgery, as it can cause a complication called Intraoperative Floppy Iris Syndrome (IFIS).

What precautions should be taken while using DUTAS T + 0.4 MG/0.5 MG CAPSULE?

Due to the possibility of dizziness or drowsiness, avoid driving or operating heavy machinery until you know how this medicine affects you. To minimize dizziness, especially when standing up, rise slowly from a sitting or lying position. Inform your doctor about any history of liver disease, kidney disease, heart problems, or low blood pressure. Alcohol consumption should be avoided as it can increase the risk of dizziness. Regular monitoring of prostate-specific antigen (PSA) levels may be recommended by your doctor, as dutasteride can affect these results.

What happens if a dose of DUTAS T + 0.4 MG/0.5 MG CAPSULE is missed?

If you miss a dose, take it as soon as you remember on the same day. However, if you do not remember until the next day, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the forgotten one. If you stop taking the medication for several days or more, consult your doctor for advice on how to restart treatment.

How should DUTAS T + 0.4 MG/0.5 MG CAPSULE be stored?

Store the medicine in its original container in a cool and dry place, away from direct sunlight and moisture, preferably at room temperature (e.g., between 15°C and 30°C). Do not store it in the bathroom. Keep the capsules out of sight and reach of children. If the capsules become deformed, discolored, or start leaking, they should not be used and should be disposed of safely.