SILOGREAT D TAB by MANKIND PHARMA LTD.

Name

Brand Name: SILOGREAT D TAB

Composition

Each tablet contains a combination of two active ingredients:

• Silodosin: 8 mg
• Dutasteride: 0.5 mg

Uses

SILOGREAT D TAB is prescribed for the management of Benign Prostatic Hyperplasia (BPH) in adult men, a condition characterized by an enlarged prostate gland. It helps alleviate various urinary symptoms associated with BPH, including frequent urination (especially at night), weak urine flow, difficulty initiating urination, incomplete bladder emptying, urgency to urinate, and straining during urination. The medicine works by relaxing the muscles around the bladder and prostate and reducing the size of the prostate gland over time, thereby improving urinary flow and reducing the risk of acute urinary retention.

Dosage and Administration

This medicine should be taken as directed by a healthcare professional. Typically, one tablet is taken orally once daily. The tablet should be swallowed whole with water, without crushing, chewing, or breaking it. It can be taken with or without food, though some sources suggest taking it with a light meal. For optimal benefits, it is recommended to take it at the same time each day. Significant symptom relief may take up to 4 weeks, with full benefits potentially observed after 6 months of consistent use.

Side Effects

Common side effects include:

• Dizziness, headache
• Nasal congestion, diarrhea
• Decreased libido, difficulty achieving erection (impotence), abnormal ejaculation (e.g., retrograde ejaculation)
• Breast tenderness and enlargement (gynecomastia)
• Fatigue, nausea, abdominal discomfort
• Orthostatic hypotension (a sudden drop in blood pressure upon standing)

Precautions

• Contraindications: Do not take if allergic to Silodosin, Dutasteride, or any other components. This medication is intended for male patients only and should not be used by women or children under 18. It is contraindicated during pregnancy and breastfeeding.
• Warnings: Avoid alcohol consumption as it may increase dizziness and drowsiness. Due to potential dizziness, avoid driving or operating heavy machinery until you know how the medicine affects you. Use with caution in patients with kidney or liver disease, and inform your doctor if you have a history of heart conditions, low blood pressure, or certain eye diseases. Concomitant use with antihypertensive medications can lead to a dangerous drop in blood pressure. Men taking SILOGREAT D TAB should not donate blood for at least 6 months after their last dose.

Storage

Store SILOGREAT D TAB in a cool and dry place, away from direct sunlight and moisture, at a temperature below 30°C (ideally between 10ºC and 25ºC). Keep out of sight and reach of children.

Here are the Frequently Asked Questions about SILOGREAT D TAB by MANKIND PHARMA LTD.:

What is SILOGREAT D TAB used for?

SILOGREAT D TAB is a prescription medication primarily used to manage the symptoms of benign prostatic hyperplasia (BPH), also known as an enlarged prostate, in adult men. It helps relieve urinary symptoms such as frequent urination (especially at night), difficulty starting urination, a weak or interrupted urine flow, and a feeling of incomplete bladder emptying. It also aims to reduce the size of the prostate and improve overall urinary function.

How does SILOGREAT D TAB work?

SILOGREAT D TAB contains two active ingredients: Silodosin and Dutasteride.

• Silodosin is an alpha-blocker that works by relaxing the muscles in the prostate gland and bladder neck. This relaxation helps improve urine flow and reduces urinary symptoms.
• Dutasteride is a 5-alpha reductase inhibitor. It works by blocking the enzyme that converts testosterone into dihydrotestosterone (DHT), a hormone responsible for prostate growth. By reducing DHT levels, Dutasteride helps to shrink the size of the prostate gland over time. Together, these actions effectively manage BPH symptoms and improve the ability to urinate.

What is the usual dosage for SILOGREAT D TAB?

The usual recommended dose is one tablet daily. It should be taken at the same time every day, preferably after a meal to reduce the risk of stomach upset. The tablet should be swallowed whole without breaking, chewing, or crushing it. Your doctor will determine the appropriate dosage and duration of treatment based on your medical condition.

What are the possible side effects of SILOGREAT D TAB?

Common side effects may include dizziness, headache, ejaculation problems (such as decreased or no semen), decreased libido (sexual desire), breast tenderness or enlargement, nausea, abdominal discomfort, diarrhea, trouble getting or keeping an erection (impotence), nasal congestion, and low blood pressure when standing up (orthostatic hypotension). Most side effects are temporary and resolve over time, but you should consult your doctor if they persist or worsen.

Is SILOGREAT D TAB safe during pregnancy or breastfeeding?

SILOGREAT D TAB is not recommended for women, especially those who are pregnant or breastfeeding, as it is intended only for male patients with BPH. Dutasteride, one of its components, can cause birth defects in male fetuses. Men taking this medication should not donate blood for at least 6 months after their last dose to prevent exposure to pregnant women via blood transfusion.

Can SILOGREAT D TAB be taken with other medications?

It's crucial to inform your doctor about all other medications, including over-the-counter drugs, supplements, and herbal products, to avoid potential drug interactions.

• Combining with other alpha-blockers can increase the risk of low blood pressure, dizziness, and fainting.
• CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, certain antifungals) can increase Silodosin levels, potentially leading to more side effects like dizziness and low blood pressure.
• Phosphodiesterase-5 (PDE5) inhibitors (e.g., Sildenafil, Tadalafil) can enhance the blood pressure-lowering effects.
• If taken with antihypertensive medicines, blood pressure could drop significantly.

What precautions should be taken while using SILOGREAT D TAB?

• Inform your doctor if you have low blood pressure, liver or kidney conditions, or are scheduled for cataract or other eye surgeries.
• Avoid consuming alcohol as it can increase side effects like dizziness and drowsiness.
• Do not drive or operate heavy machinery if you experience dizziness or lightheadedness, especially at the start of treatment.
• Regular monitoring of blood pressure is advised, particularly if you are also taking antihypertensive medications.
• Do not stop taking the medication without consulting your doctor, even if you feel better.

What happens if a dose of SILOGREAT D TAB is missed?

If you miss a dose, take it as soon as you remember. However, if it's 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 SILOGREAT D TAB be stored?

Store SILOGREAT D TAB at room temperature, ideally below 30°C, away from heat, moisture, and direct light. Keep it in a secure place out of reach of children. Always check the expiry date and do not use the medication if it has expired.