Silofast D 4 Mg Capsules ( 10 Cap )

SILOFAST D 4 MG CAPSULES

SILOFAST D 4 MG CAPSULES, manufactured by CIPLA LTD., is a combination medication designed for the comprehensive management of benign prostatic hyperplasia (BPH) in adult men.

Composition Each capsule contains:

• Silodosin: 4 mg
• Dutasteride: 0.5 mg

Silodosin acts as an alpha-blocker, relaxing the muscles in the prostate and bladder neck to improve urine flow. Dutasteride is a 5-alpha-reductase inhibitor that works by reducing the size of the enlarged prostate gland by inhibiting a hormone responsible for its growth.

Uses SILOFAST D is prescribed for the treatment of benign prostatic hyperplasia (BPH). It helps alleviate associated urinary symptoms such as:

• Difficulty initiating urination
• Weak or slow urine stream
• Frequent or urgent need to urinate, especially at night
• Feeling that the bladder is not fully empty
• Straining during urination
• Dribbling after urination

Dosage and Administration The typical dosage is one capsule taken orally once daily with a meal. Capsules should be swallowed whole and not crushed, chewed, or broken. Consistent daily timing is recommended for optimal results. Symptom improvement may be noticed within 4 weeks, but the full benefits may take up to 6 months.

Side Effects Common side effects may include:

• Decreased libido
• Ejaculation disorders (e.g., retrograde ejaculation, reduced semen during ejaculation)
• Impotence (inability to get an erection)
• Dizziness or lightheadedness
• Headache
• Nasal congestion (stuffy nose) or nasopharyngitis
• Diarrhea
• Breast enlargement or tenderness in males

Serious side effects, though less common, can include an increased risk of high-grade prostate cancer and painful erections lasting several hours.

Precautions

• Contraindications: SILOFAST D is contraindicated in women, particularly those who are pregnant or breastfeeding, and in children. It should not be used by patients with severe kidney or liver impairment. Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) or strong P-glycoprotein inhibitors (e.g., cyclosporine) is contraindicated.
• General Warnings: Patients should be screened for prostate cancer before starting treatment, as BPH and prostate cancer can co-exist. Caution is advised for individuals with existing kidney or liver conditions, low or high blood pressure, or heart disease.
• Driving and Machinery: This medicine may cause dizziness, drowsiness, or blurring of vision. Patients should avoid driving or operating heavy machinery until they understand how the medication affects them. It is recommended to rise slowly from a sitting or lying position to minimize dizziness.
• Alcohol Interaction: Alcohol consumption may increase the risk of dizziness and drowsiness.
• Eye Surgery: Patients planning cataract or glaucoma surgery should inform their eye doctor about SILOFAST D usage.

Storage Store SILOFAST D 4 MG CAPSULES below 30°C in a cool, dry place, protected from sunlight and moisture. Keep out of reach of children.

What is SILOFAST D 4 MG CAPSULES used for?

SILOFAST D 4 MG CAPSULES is primarily used to manage the signs and symptoms of Benign Prostatic Hyperplasia (BPH) in adult men with an enlarged prostate gland. It helps to relieve urinary symptoms such as difficulty urinating, a weak urine stream, frequent or urgent need to urinate (especially at night), and the feeling of an incompletely emptied bladder. It is not used to prevent prostate cancer.

How does SILOFAST D 4 MG CAPSULES work?

This medicine is a combination of two active ingredients: Silodosin and Dutasteride. Silodosin is an alpha-blocker that works by relaxing the muscles around the bladder exit and prostate gland, which helps improve urine flow. Dutasteride is a 5-alpha-reductase inhibitor that helps shrink the prostate gland by decreasing the levels of a hormone (dihydrotestosterone or DHT) that contributes to prostate growth.

What is the usual dosage for SILOFAST D 4 MG CAPSULES?

The usual adult dosage is one capsule taken orally once daily with a meal, preferably at the same time each day. It should be swallowed whole and not broken, chewed, or crushed. Your doctor will determine the most suitable dose for you.

What are the possible side effects of SILOFAST D 4 MG CAPSULES?

Common side effects can include decreased libido (sex drive), erectile dysfunction (impotence), ejaculation disorders (such as reduced or no semen, or retrograde ejaculation), dizziness, headache, nausea, diarrhea, breast tenderness, and breast enlargement in males. More serious side effects, though rare, can include significant breast changes, a potential increased risk of high-grade prostate cancer, and painful erections lasting several hours. If you experience persistent or severe side effects, consult your doctor.

Is SILOFAST D 4 MG CAPSULES safe during pregnancy or breastfeeding?

No, SILOFAST D 4 MG CAPSULES is contraindicated for use in women, especially those who are pregnant or may become pregnant, due to the risk of fetal harm from Dutasteride. It is also not indicated for use in children. Information regarding its use during breastfeeding is not available, and women should consult their doctor.

Can SILOFAST D 4 MG CAPSULES be taken with other medications?

Caution is advised when taking SILOFAST D 4 MG CAPSULES with certain other medications. It should not be taken with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) or strong P-gp inhibitors (e.g., cyclosporine), as these can significantly increase the concentration of Silodosin in the body. Concomitant use with other alpha-blockers is also not recommended. If taken with antihypertensive medications, it may cause an additive blood pressure-lowering effect, leading to dizziness or orthostatic hypotension. Always inform your doctor about all other medications, herbal preparations, and supplements you are currently taking.

What precautions should be taken with SILOFAST D 4 MG CAPSULES?

Patients should be evaluated for prostate cancer before starting treatment with this medicine, as BPH and prostate cancer can have similar symptoms. Caution is advised if you have kidney or liver disease; it is contraindicated in severe cases. Due to the potential for dizziness, drowsiness, or blurred vision, avoid driving or operating heavy machinery until you understand how the medication affects you. Alcohol consumption should be avoided or limited as it can increase drowsiness and lower blood pressure. Do not donate blood while taking this medicine or for 6 months after stopping it, to prevent pregnant women from receiving the drug through blood transfusions. Inform your eye doctor if you are scheduled for cataract or glaucoma surgery, as it may cause Intraoperative Floppy Iris Syndrome.

What happens if a dose of SILOFAST D 4 MG CAPSULES is missed?

If you miss a dose, 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 make up for a missed one.

How should SILOFAST D 4 MG CAPSULES be stored?

SILOFAST D 4 MG CAPSULES should be stored below 30°C in a cool, dry place, protected from direct sunlight and moisture. Keep it out of the reach of children and pets.