Alphacept M 25 Tab Combikit

ALPHACEPT M 25 TAB COMBIKIT

ALPHACEPT M 25 is a fixed-dose combination medication manufactured by Lupin Ltd.

• Composition: Each tablet contains Silodosin 8.00 mg and Mirabegron 25.00 mg.

  • Mirabegron is a beta-3 adrenergic agonist that relaxes the bladder muscle, increasing bladder capacity and reducing the frequency and urgency of urination.
  • Silodosin is a selective alpha-1A adrenergic receptor antagonist that relaxes smooth muscle tissue in the prostate gland and bladder neck, improving urine flow.

• Uses: ALPHACEPT M 25 is prescribed for the treatment of Benign Prostatic Hyperplasia (BPH) with symptoms of an overactive bladder. It helps to relieve associated urinary symptoms such as:

  • Urgency, frequency, and incontinence related to overactive bladder.
  • Difficulty starting urination.
  • Weak or interrupted urine stream.
  • Frequent or urgent urination (especially at night).
  • Feeling of incomplete bladder emptying.
  • Straining during urination.

• Dosage and Administration: Take ALPHACEPT M 25 as prescribed by your healthcare provider. Swallow the tablet whole with water, without crushing or chewing, as it is an extended-release formulation. It can be taken with or without food, but consistency in timing is key for optimal results. If a dose is missed, take it as soon as remembered, but skip it if it's almost time for the next dose; do not double the dose.

• Side Effects: Common side effects may include:

  • Abnormal ejaculation (less or no noticeable semen released during sex).
  • Dizziness, especially lightheadedness or a sudden drop in blood pressure when standing up (orthostatic hypotension).
  • Headache.
  • Fatigue.
  • Constipation.
  • Nausea.
  • Increased heart rate (tachycardia).
  • Urinary tract infections.
  • Runny or blocked nose (nasal congestion, nasopharyngitis).

• Precautions:

  • Allergies: Do not take if allergic to Mirabegron, Silodosin, or any other ingredients.
  • Pregnancy and Breastfeeding: Not recommended for use during pregnancy or breastfeeding. It is primarily meant for use in men.
  • Children: Not recommended for individuals under 18 years of age.
  • Driving and Machinery: Exercise caution, as it may cause dizziness.
  • Medical Conditions: Use with caution in patients with heart conditions, severe uncontrolled high blood pressure, liver or kidney problems, and ECG abnormalities (QT prolongation).
  • Interactions: Inform your doctor about all medications (including over-the-counter, supplements, and herbal products) to avoid potential interactions. Specifically, concomitant use with other alpha-blockers or PDE-5 inhibitors (like sildenafil) may lead to excessive blood pressure lowering. Antifungal medicines (e.g., ketoconazole, itraconazole), immunosuppressants (e.g., cyclosporine), and antiviral medicines (e.g., ritonavir) should be avoided.
  • Surgery: Inform your eye specialist if you are taking this medication before cataract eye surgery, as it may cause complications.
  • Alcohol: Avoid or limit alcohol consumption, as it can worsen side effects like dizziness.

• Storage: Store ALPHACEPT M 25 at room temperature (20-25°C) or below 30°C, away from moisture and heat. Keep it out of reach of children and pets.

ALPHACEPT M 25 TAB COMBIKIT, manufactured by Lupin Ltd., is a combination medication containing Silodosin (8 mg) and Mirabegron (25 mg). It is primarily used to manage urinary symptoms in men.

Here are some frequently asked questions about ALPHACEPT M 25 TAB COMBIKIT:

What is ALPHACEPT M 25 TAB COMBIKIT used for?

ALPHACEPT M 25 TAB COMBIKIT is used to treat symptoms of Benign Prostatic Hyperplasia (BPH) that are complicated by an overactive bladder (OAB). These symptoms can include urinary urgency, frequent urination (including at night), difficulty starting urination, a weak or interrupted urine stream, and a feeling of incomplete bladder emptying.

How does ALPHACEPT M 25 TAB COMBIKIT work?

This medicine combines two active ingredients:

• Silodosin is an alpha-blocker that works by relaxing the muscles around the bladder neck and prostate gland. This helps to improve urine flow and relieve urinary symptoms associated with BPH.
• Mirabegron is a beta-3 adrenergic agonist that relaxes the bladder muscle. This increases the bladder's capacity to hold urine, thereby reducing the symptoms of an overactive bladder such as urgency, frequency, and incontinence.

What is the usual dosage for ALPHACEPT M 25 TAB COMBIKIT?

ALPHACEPT M 25 TAB COMBIKIT should be taken exactly as prescribed by your healthcare provider. The tablet should be swallowed whole with water, without crushing or chewing. It can be taken with or without food, but consistency is important, so it's best to take it at the same time each day for optimal results.

What are the possible side effects of ALPHACEPT M 25 TAB COMBIKIT?

Common side effects may include abnormal ejaculation (retrograde ejaculation), dizziness, headache, constipation, nausea, increased heart rate, urinary tract infections, and a runny or blocked nose (nasal congestion). Some individuals may experience orthostatic hypotension, which is a sudden drop in blood pressure upon standing, leading to lightheadedness or dizziness.

Is ALPHACEPT M 25 TAB COMBIKIT safe during pregnancy or breastfeeding?

No, ALPHACEPT M 25 TAB COMBIKIT is not recommended for use in women, including those who are pregnant or breastfeeding, as it is indicated for male patients with prostate conditions. Information regarding its use during pregnancy or breastfeeding is not available, and it may pass into breast milk. Pregnant women should also avoid handling crushed or broken tablets.

Can ALPHACEPT M 25 TAB COMBIKIT be taken with other medications?

It is crucial to inform your doctor about all medications you are currently taking, including over-the-counter drugs, supplements, and herbal products, to avoid potential interactions.

• Increased risk of low blood pressure: Use with caution with other alpha-blockers, phosphodiesterase-5 (PDE-5) inhibitors (like sildenafil or tadalafil), and other blood pressure-lowering medicines, as this can lead to an excessive drop in blood pressure.
• Avoid concurrent use with: Antifungal medicines (such as ketoconazole, itraconazole), immunosuppressants (like cyclosporine), and certain antivirals (like ritonavir).
• Anticholinergic medicines may counteract the effects of Mirabegron on the bladder.

What precautions should be taken while using ALPHACEPT M 25 TAB COMBIKIT?

• Blood Pressure: Silodosin can lower blood pressure, which may cause dizziness or lightheadedness. Avoid sudden changes in posture, such as standing up quickly from a sitting or lying position.
• Pre-existing Conditions: Use with caution if you have heart conditions, or mild to moderate liver or kidney problems. It is not recommended for individuals with severe kidney disease, severe liver disease, or severe, uncontrolled high blood pressure.
• Surgery: Inform your eye surgeon about using this medicine if you are planning to undergo cataract or glaucoma surgery.
• Alcohol: Avoid or limit alcohol consumption as it can worsen certain side effects like dizziness and drowsiness.
• Driving: This medicine may cause dizziness; therefore, exercise caution when driving or operating machinery until you know how it affects you.
• Children: This medication is not recommended for use in children.
• Discontinuation: Do not stop taking the medicine abruptly without consulting your doctor, as symptoms may worsen or recur.

What happens if a dose of ALPHACEPT M 25 TAB COMBIKIT 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 (for instance, if more than 12 hours have passed since the missed 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 ALPHACEPT M 25 TAB COMBIKIT be stored?

Store ALPHACEPT M 25 TAB COMBIKIT at room temperature, typically below 30°C (or between 10°C and 25°C), in a cool, dry place away from moisture, heat, and direct sunlight. Keep the medicine out of reach and sight of children and pets.