Tamlocept D Capsule (15 Cap)

TAMLOCEPT D CAPSULE (15 CAP) by LUPIN LTD.

Tamlocept D Capsule is a combination medication primarily prescribed for men to manage the symptoms of Benign Prostatic Hyperplasia (BPH), also known as an enlarged prostate gland. It helps alleviate urinary difficulties associated with BPH, such as frequent urination, difficulty in passing urine, weak urine flow, and urgent urination, while also working to reduce the prostate gland's size.

Composition

• Active Ingredients:
  • Tamsulosin (0.4 mg)
  • Dutasteride (0.5 mg)

Tamsulosin is an alpha-blocker that works by relaxing the muscles in the prostate and bladder neck, making it easier to urinate and improving urine flow. Dutasteride is a 5-alpha-reductase inhibitor that reduces the size of the enlarged prostate gland by blocking the production of dihydrotestosterone (DHT), a hormone responsible for prostate growth.

Uses

• Benign Prostatic Hyperplasia (BPH): Used to treat an enlarged prostate gland in men, reducing symptoms like difficulty passing urine, frequent urination, and incomplete bladder emptying. It minimizes the need for prostate surgery and the risk of complete blockage of urine flow.

Dosage and Administration

• Tamlocept D Capsule should be taken orally once a day.
• It is typically taken about 30 minutes after the same meal each day.
• Swallow the capsule whole with a glass of water; do not chew, crush, or break it.
• Consistency in dosage and timing is crucial for optimal results. It may take up to 4 weeks to notice an improvement in symptoms, and up to 6 months for the full therapeutic effects.

Side Effects

• Common Side Effects: Dizziness, lightheadedness, drowsiness, sexual problems (decreased sex drive or libido, erectile dysfunction, ejaculation disorders like retrograde ejaculation), runny/stuffy nose, reduced amount of semen/sperm, testicle pain/swelling, increased breast size or breast tenderness, headache, fatigue, nasal congestion, and allergic reactions (skin rash, itching, hives). These often improve as the body adjusts to the medicine.
• Serious Side Effects: Though less common, these can include a sudden drop in blood pressure upon standing (orthostatic hypotension), which can lead to dizziness or fainting. Heart failure (shortness of breath, extreme tiredness, swelling in ankles and legs) is also an uncommon side effect.

Precautions

• Contraindications:
  • Not recommended for women or children under 18 years of age.
  • Individuals with known allergy to tamsulosin, dutasteride, soy, peanuts, or any other ingredients of the capsule.
  • Patients with severe liver disease or liver function problems.
  • Patients with low blood pressure that causes dizziness, lightheadedness, or fainting, or those with glaucoma.
• Warnings:
  • Inform your doctor if you have a history of heart problems, kidney disease, or low blood pressure.
  • If you experience dizziness, avoid driving or operating machinery.
  • Avoid alcohol consumption as it can worsen dizziness and drowsiness.
  • Use a condom during sexual intercourse if your partner is pregnant or may become pregnant, as the medication can be passed through semen and affect fetal development. Pregnant women should not even handle leaking capsules as the medicine can be absorbed through the skin.
  • Before undergoing any surgery (especially cataract or glaucoma surgery), inform your doctor about Tamlocept D Capsule usage.
  • Regular monitoring of prostate-specific antigen (PSA) levels is recommended to screen for prostate cancer.

Storage

• Store in a cool and dry place away from sunlight.
• Keep out of sight and reach of children.
• Store at room temperature, ideally between 20°C to 25°C (68°F to 77°F), in its original container.

What is TAMLOCEPT D CAPSULE used for?

TAMLOCEPT D CAPSULE is primarily used in men to treat Benign Prostatic Hyperplasia (BPH), commonly known as an enlarged prostate gland. It helps alleviate bothersome symptoms such as difficulty passing urine, frequent urination (including at night), a weak urine stream, and urinary urgency. This medication helps reduce the need for prostate surgery and the risk of complete blockage of urine flow. It is important to note that it does not prevent prostate cancer.

How does TAMLOCEPT D CAPSULE work?

TAMLOCEPT D CAPSULE contains two active ingredients: Tamsulosin and Dutasteride. Tamsulosin is an alpha-blocker that works by relaxing the muscles around the bladder exit and prostate gland, which makes it easier for urine to flow. Dutasteride is a 5-alpha-reductase inhibitor that reduces the size of the enlarged prostate by blocking the production of a hormone called dihydrotestosterone (DHT), which contributes to prostate growth. Together, these two components provide both quick relief of urinary symptoms and long-term reduction in prostate size.

What is the usual dosage for TAMLOCEPT D CAPSULE?

The usual dosage is one capsule taken once daily, approximately 30 minutes after the same meal each day, or as advised by your doctor. The capsule should be swallowed whole with a glass of water and not chewed, crushed, or broken. For optimal results, it is important to take the medication consistently at the same time each day. While some improvement in symptoms may be noticed within 4 weeks, the full benefits might take up to 6 months to become apparent.

What are the possible side effects of TAMLOCEPT D CAPSULE?

Common side effects can include dizziness, lightheadedness, drowsiness, decreased sex drive (libido), difficulty achieving or maintaining an erection (impotence), ejaculation disorders (such as decreased semen or sperm amount), breast enlargement or tenderness in males, and a runny or stuffy nose. These side effects are often more noticeable at the beginning of treatment and may improve over time. If any side effects persist or worsen, or if you experience severe allergic reactions (e.g., skin rash, swelling) or signs of prostate/breast cancer, consult your doctor immediately.

Is TAMLOCEPT D CAPSULE safe during pregnancy or breastfeeding?

No, TAMLOCEPT D CAPSULE is not safe for women and should not be used by them. It is highly unsafe during pregnancy, and pregnant women should not even handle the capsules, as the active ingredient Dutasteride can be absorbed through the skin and may cause harm to a male fetus. For breastfeeding, there is limited information, but the medication is not indicated for use in females, and breastfeeding women should avoid contact with it. Men taking this medication should use a condom during sexual intercourse if their partner is pregnant or may become pregnant, as the medication can be passed through semen.

Can TAMLOCEPT D CAPSULE be taken with other medications?

It is crucial to inform your doctor about all medications, supplements, and herbal products you are currently taking to avoid potential drug interactions. Taking TAMLOCEPT D CAPSULE with alcohol should be avoided as it can increase dizziness and lower blood pressure. The medication may interact with other alpha-blockers, certain antifungals (e.g., ketoconazole), some erectile dysfunction treatments (e.g., sildenafil, tadalafil), certain antivirals for HIV, specific antibiotics (e.g., erythromycin), and blood thinners (e.g., warfarin). Cold and cough medications should also be avoided as they may increase the urge to urinate.

What precautions should be taken while using TAMLOCEPT D CAPSULE?

TAMLOCEPT D CAPSULE should not be given to women or children under 18 years of age. Pregnant women should not handle this medicine due to the risk of absorption through the skin and potential harm to a male fetus. Inform your doctor if you have low blood pressure, liver or kidney disease, or a history of heart problems. Since this medication can cause dizziness, avoid driving or operating heavy machinery until you understand how it affects you. To reduce the chance of feeling dizzy, rise slowly when standing up from a sitting or lying position. If you are scheduled for cataract or glaucoma eye surgery, inform your eye doctor about your use of this medicine, as it can cause a condition called Intraoperative Floppy Iris Syndrome (IFIS). Regular monitoring of Prostate-Specific Antigen (PSA) levels is recommended to screen for prostate cancer, although the medication itself does not prevent prostate cancer and may affect PSA test results. Men should not donate blood for 6 months after their last dose due to the presence of Dutasteride in the blood.

What happens if a dose of TAMLOCEPT D CAPSULE is missed?

If you miss a dose of TAMLOCEPT D CAPSULE, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed one and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one, as this can increase the risk of side effects.

How should TAMLOCEPT D CAPSULE be stored?

TAMLOCEPT D CAPSULE should be stored in a cool, dry place, away from direct sunlight, and kept below 30°C. Keep it in its original container, tightly closed, and away from excess heat and moisture to prevent deformation or discoloration. Ensure the medication is kept out of sight and reach of children.