Roliflo Od-4 (10 Capsule)

ROLIFLO OD-4 (10 CAPSULE)

Manufacturer: SUN PHARMA LABORATORIES LTD.

Name

• Common Name: ROLIFLO OD-4 Capsule, Roliflo OD-4 Capsule ER
• Brand Name: ROLIFLO OD-4

Composition

ROLIFLO OD-4 contains a combination of two active ingredients:

• Tamsulosin (0.4 mg): An alpha-blocker.
• Tolterodine (4 mg): An antimuscarinic.

Uses

ROLIFLO OD-4 is primarily prescribed for the treatment of:

• Benign Prostatic Hyperplasia (BPH): It alleviates lower urinary tract symptoms associated with an enlarged prostate, such as difficulty in urination, weak stream, hesitancy, urinary dribbling, and incomplete bladder emptying.
• Overactive Bladder (OAB) Symptoms: It helps manage symptoms like urinary urgency, frequent urination, and incontinence. It works by relaxing the muscles around the bladder exit and prostate gland, making urination easier and controlling the urge to urinate.

Dosage and Administration

• Take ROLIFLO OD-4 exactly as prescribed by your doctor.
• Swallow the capsule whole with water; do not chew, crush, or break it.
• It is generally recommended to take this medicine with food.
• The typical dosage is one capsule daily. Continue taking it for the duration advised by your doctor.

Side Effects

Common Side Effects:

• Dry mouth, constipation, blurred vision, dry eyes
• Ejaculation disorder (e.g., little or no semen, cloudy urine after climax)
• Dizziness, headache, fatigue/tiredness
• Stomach pain, nausea, flushing
• Nasal congestion, pharyngitis
• Orthostatic hypotension (sudden drop in blood pressure upon standing)

Serious Side Effects (Rare):

• Signs of Stevens-Johnson syndrome or angioedema
• Hypersensitivity reactions
• Signs of heart failure

Precautions

• Inform your doctor about any allergies to the components, all current medications, and pre-existing medical conditions (e.g., liver/kidney disease, low blood pressure, heart problems, prostate cancer, glaucoma, myasthenia gravis, stomach/bowel issues).
• ROLIFLO OD-4 may cause drowsiness or dizziness; avoid driving or operating heavy machinery if affected.
• Avoid alcohol consumption as it can intensify dizziness and drowsiness.
• This medicine is for men only and not recommended for pregnant or breastfeeding women. Use a condom during sexual intercourse if your partner is pregnant, as it can pass into semen.
• Do not donate blood while on this medication or for six months after the last dose.
• Disclose use to your doctor before any surgical procedures, especially cataract or glaucoma surgery, due to the risk of Floppy Iris Syndrome.

Storage

• Store in a cool and dry place, away from direct sunlight.
• Keep the medicine below 30°C and protect it from moisture.
• Ensure it is out of sight and reach of children.

Here are the most frequently asked questions about ROLIFLO OD-4 (10 CAPSULE) by SUN PHARMA LABORATORIES LTD.

What is ROLIFLO OD-4 used for?

ROLIFLO OD-4 Capsule is primarily used to treat the symptoms of benign prostatic hyperplasia (BPH) in men. BPH is an overgrowth of the prostate gland that can cause urinary problems. It also helps manage symptoms of overactive bladder (OAB) such as urinary urgency, frequency, and incontinence.

How does ROLIFLO OD-4 work?

ROLIFLO OD-4 contains two active ingredients: Tamsulosin (an alpha-blocker) and Tolterodine (an antimuscarinic). Tamsulosin relaxes the smooth muscles in the prostate, prostatic capsule, prostatic urethra, and bladder neck, which improves urine flow and reduces BPH symptoms. Tolterodine works by relaxing the urinary bladder muscles and inhibiting involuntary bladder contractions, preventing urgent, frequent, or uncontrolled urination. Together, these components make urination easier and control the urge to urinate.

What is the usual dosage for ROLIFLO OD-4?

The typical dosage is one capsule daily. It should be swallowed whole with a glass of water, without chewing, crushing, or breaking it. It is often recommended to take it with food. Always follow your doctor's instructions regarding the dose and duration of treatment.

What are the possible side effects of ROLIFLO OD-4?

Common side effects include dryness in the mouth, constipation, blurred vision, ejaculation disorder (such as little or no semen ejaculated), dizziness, headache, nausea, fatigue, and flushing (a sense of warmness in the face, ears, neck, and trunk). Most of these side effects are usually mild and temporary, resolving as your body adjusts to the medication. If side effects persist or worsen, consult your doctor.

Is ROLIFLO OD-4 safe during pregnancy or breastfeeding?

ROLIFLO OD-4 is indicated for use in men only and is not recommended for pregnant or breastfeeding women. If a man's partner is pregnant, a condom should be used during sexual intercourse as the medication can pass into semen.

Can ROLIFLO OD-4 be taken with other medications?

ROLIFLO OD-4 can interact with other medications. It is important to inform your doctor about all other medicines you are currently taking. Interactions can occur with other alpha-blockers (e.g., prazosin, alfuzosin), which may increase blood pressure-lowering effects leading to dizziness. Anticholinergic medications (e.g., oxybutynin) may enhance muscle-relaxing effects and increase side effects. Certain antifungals (e.g., ketoconazole, itraconazole), antibiotics (e.g., erythromycin, clarithromycin), and medicines used for HIV (e.g., indinavir, ritonavir) may increase the levels of ROLIFLO OD-4's components in the body, potentially leading to increased side effects. Avoid consuming grapefruit or its juice as it can also increase drug levels.

What precautions should be taken while using ROLIFLO OD-4?

Exercise caution if you have liver or kidney issues, low blood pressure, a history of prostate cancer, or if you are allergic to any components of the medication. Inform your doctor if you have controlled narrow-angle glaucoma, stomach or bowel problems (including constipation), a history of heart rhythm problems (including QT prolongation), gastrointestinal disorders, or myasthenia gravis. ROLIFLO OD-4 may cause dizziness or blurred vision, so it's advised to be cautious when driving or operating machinery. Do not donate blood while taking this medication.

What happens if a dose of ROLIFLO OD-4 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 one and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should ROLIFLO OD-4 be stored?

ROLIFLO OD-4 should be stored in a cool and dry place, away from direct sunlight, at a temperature below 30°C. Keep it out of the sight and reach of children.