Silotime D Capsule (10 Cap)

SILOTIME D CAPSULE

SILOTIME D CAPSULE is a medication manufactured by INTAS PHARMACEUTICALS LTD, primarily used for the management of benign prostatic hyperplasia (BPH).

• Name: Silotime D Capsule

• Composition: Each capsule contains Silodosin (8mg) and Dutasteride (0.5mg).

• Uses: SILOTIME D CAPSULE is prescribed for the treatment of urinary symptoms associated with benign prostatic hyperplasia (BPH) in adult men with an enlarged prostate gland. It helps to alleviate symptoms such as:

  • Frequent urination (including at night, known as nocturia).
  • Weak or interrupted urine flow.
  • Difficulty starting urination.
  • Incomplete bladder emptying.
  • Urgency to urinate.
  • Dribbling after urination.
  • Straining during urination.
  • Urinary retention. The combination of Silodosin, an alpha-blocker, and Dutasteride, a 5-alpha reductase inhibitor, works by relaxing the muscles in the prostate and bladder neck, and by shrinking the size of the prostate gland over time. This dual action improves urine flow and reduces BPH symptoms.

• Dosage and Administration:

  • Typically, one capsule is taken orally once daily.
  • It is generally recommended to take the capsule after a meal, preferably a light meal, and at the same time each day to ensure consistency and reduce the risk of stomach upset.
  • Swallow the capsule whole with a glass of water; do not crush, chew, or break it.
  • The appropriate dosage and duration of treatment will be determined by a physician. It may take up to 4 weeks for noticeable symptom relief, and up to 6 months to experience the full benefits.

• Side Effects:

  • Common side effects: Dizziness (especially upon standing quickly), headache, fatigue, ejaculation problems (including decreased semen volume or retrograde ejaculation), decreased libido, breast tenderness or enlargement (gynecomastia), nasal congestion, nausea, abdominal discomfort, diarrhea, and impotence (difficulty getting or keeping an erection).
  • Serious side effects (rare): Allergic reactions (rash, itching, swelling of face or throat), or priapism (prolonged erection lasting more than 4 hours), requiring immediate medical attention.

• Precautions:

  • Contraindications: SILOTIME D CAPSULE is not recommended for women or children under 18 years of age. It is specifically contraindicated during pregnancy and breastfeeding. It should also be avoided by individuals with a known allergy to any of its components.
  • Medical Conditions: Inform your doctor if you have low blood pressure, or liver or kidney conditions, heart conditions (like heart attack, stroke, or heart failure), certain eye diseases, or vision problems, as the medicine may not be appropriate or may require dosage adjustments.
  • Drug Interactions: This medicine can interact with other medications, particularly antihypertensive drugs, which could lead to a sudden and dangerous drop in blood pressure. Inform your doctor about all medications you are taking, including other alpha-blockers, 5-alpha-reductase inhibitors, and certain antifungal agents. Avoid grapefruit products.
  • Alcohol: Avoid consuming alcohol as it may increase side effects such as dizziness, drowsiness, and low blood pressure.
  • Activities: Exercise caution when driving or operating heavy machinery, as the medication can cause dizziness and drowsiness. Rise slowly from sitting or lying positions to prevent dizziness or fainting.
  • Blood Donation: Men taking SILOTIME D CAPSULE should not donate blood for at least 6 months after their last dose to prevent exposure of the medicine to pregnant women.
  • Eye Surgery: Inform your ophthalmologist if you are undergoing cataract or glaucoma surgery, as this medicine may cause Intraoperative Floppy Iris Syndrome (IFIS).
  • Monitoring: Regular check-ups for prostate size, symptom management, and overall health are recommended.

• Storage: Store in a cool and dry place, below 30°C, away from sunlight, moisture, and light. Keep out of sight and reach of children and pets.

Here are the most frequently asked questions about SILOTIME D CAPSULE, along with their concise answers:

What is SILOTIME D CAPSULE used for?

SILOTIME D CAPSULE is primarily used to manage the symptoms of benign prostatic hyperplasia (BPH) in adult men, a condition characterized by an enlarged prostate gland. It helps alleviate symptoms such as difficulty urinating, frequent or urgent urination, a weak urine stream, and the sensation of incomplete bladder emptying. It is important to note that this medication does not prevent prostate cancer.

How does SILOTIME D CAPSULE work?

This medicine combines two active ingredients: Silodosin and Dutasteride. Silodosin is an alpha-blocker that works by relaxing the smooth muscles in the prostate gland and bladder neck, which facilitates easier urine flow. Dutasteride is a 5-alpha reductase inhibitor that reduces the size of the prostate gland by blocking the production of dihydrotestosterone (DHT), a hormone that contributes to prostate growth.

What is the usual dosage of SILOTIME D CAPSULE?

The usual dosage is one capsule once daily, as prescribed by your doctor. It is recommended to take the capsule orally with a meal for better absorption and to reduce the risk of stomach upset. The capsule should be swallowed whole with a glass of water and not crushed, chewed, or broken.

What are the possible side effects of SILOTIME D CAPSULE?

Common side effects may include dizziness (especially when standing up quickly), headache, ejaculation disorders (such as decreased semen volume or retrograde ejaculation), impotence (difficulty achieving or maintaining an erection), decreased libido, and breast enlargement or tenderness in males. Other common side effects can include nasal congestion, nausea, abdominal pain, and diarrhea. In rare cases, serious side effects such as allergic reactions or a prolonged erection (priapism) may occur, requiring immediate medical attention.

Is SILOTIME D CAPSULE safe during pregnancy or breastfeeding?

No, SILOTIME D CAPSULE is not intended for use in women and is contraindicated during pregnancy and breastfeeding. The Dutasteride component can cause birth defects in a male fetus. Men taking this medication should avoid donating blood for at least 6 months after their last dose to prevent potential exposure to pregnant women through blood transfusion.

Can SILOTIME D CAPSULE be taken with other medications?

SILOTIME D CAPSULE can interact with other medications. It is crucial to inform your doctor about all medicines you are taking. Concomitant use with other alpha-blockers or antihypertensive drugs (blood pressure-lowering medications) can lead to a significant drop in blood pressure, causing dizziness or fainting. Medications that inhibit CYP3A4 enzymes (e.g., ketoconazole, itraconazole, ritonavir) can increase the levels of Silodosin in the body, potentially raising the risk of side effects. Also, PDE5 inhibitors (like sildenafil or tadalafil) can enhance the blood pressure-lowering effects of SILOTIME D CAPSULE.

What precautions should be taken while using SILOTIME D CAPSULE?

Several precautions should be observed:

• Alcohol: Avoid alcohol consumption as it can increase dizziness and drowsiness.
• Driving/Operating Machinery: Do not drive or operate heavy machinery if you experience dizziness or blurring of vision.
• Medical Conditions: Inform your doctor if you have or have had liver or kidney problems, low blood pressure, heart conditions (like heart attack, stroke, or heart failure), or certain eye diseases.
• Eye Surgery: If you are scheduled for cataract or glaucoma surgery, inform your ophthalmologist about taking this medicine, as it may cause Intraoperative Floppy Iris Syndrome (IFIS).
• Movement: Rise slowly from a sitting or lying position to prevent dizziness or fainting due to a sudden drop in blood pressure.
• Blood Donation: Do not donate blood for at least 6 months after your last dose.

What happens if a dose of SILOTIME D CAPSULE 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 the missed one.

How should SILOTIME D CAPSULE be stored?

SILOTIME D CAPSULE should be stored in its original container below 30°C in a cool and dry place, away from direct sunlight. Keep it out of the reach of children and pets.