Pulmopres Tablet (15 Tab)

PULMOPRES TABLET (15 TAB) by CIPLA LTD.

PULMOPRES Tablet is a medication manufactured by Cipla Ltd., primarily used to manage various conditions, including pulmonary arterial hypertension, erectile dysfunction, and benign prostatic hyperplasia.

Name

• Brand Name: PULMOPRES TABLET
• Common Name: Tadalafil

Composition

Each film-coated tablet contains Tadalafil IP 20 mg.

Uses

PULMOPRES Tablet is indicated for the treatment of:

• Pulmonary Arterial Hypertension (PAH): It is used to improve exercise capacity in patients with PAH (WHO Group I), a condition characterized by high blood pressure in the arteries of the lungs.
• Erectile Dysfunction (ED): It helps men achieve and maintain an erection firm enough for sexual activity by increasing blood flow to the penis when sexually stimulated.
• Benign Prostatic Hyperplasia (BPH): It helps relieve urinary symptoms associated with an enlarged prostate gland, such as difficulty in urination and urinary urgency.

Dosage and Administration

• For Pulmonary Arterial Hypertension (PAH): The recommended dose is 40 mg (two 20 mg tablets) taken once daily, with or without food. Dividing the 40 mg dose over the day is not recommended.
  • Renal Impairment: For mild to moderate impairment (creatinine clearance 31 to 80 mL/min), start with 20 mg once daily and increase to 40 mg once daily based on tolerability. For severe renal impairment or patients on hemodialysis, the use of tadalafil should be avoided.
  • Hepatic Impairment: For mild to moderate (Child-Pugh Class A or B), consider a starting dose of 20 mg once daily. Avoid use in severe hepatic cirrhosis (Child-Pugh Class C).
• For Erectile Dysfunction (ED): Typically, it is recommended to be taken approximately one hour before anticipated sexual activity. It can be effective from 30 minutes to 4 hours prior.
• General: It can be taken with or without food. Treatment should be initiated and monitored by a physician experienced in treating the respective conditions. Do not exceed one dose within a 24-hour period.

Side Effects

Common Side Effects:

• Headache
• Muscle pain, back pain, pain in arms and legs
• Flushing (sense of warmth in the face, ears, neck, and trunk)
• Nausea, upset stomach, indigestion
• Stuffy or congested nose
• Blurred vision
• Rash

Serious Side Effects (Seek immediate medical attention if experienced):

• Severe allergic reactions (hives, difficulty breathing, swelling of the face, lips, tongue, or throat)
• Chest pain or discomfort, irregular heartbeat
• Sudden decrease or loss of vision in one or both eyes (NAION)
• Sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness
• Priapism (an erection lasting more than 4 hours, with or without pain)

Precautions

• Nitrates: Do not take PULMOPRES if you are taking any medicines called nitrates (often prescribed for chest pain or heart conditions) as this can lead to a dangerous drop in blood pressure. At least 48 hours should elapse after the last dose of tadalafil before taking nitrates.
• Alcohol: Avoid excessive alcohol consumption as it can temporarily decrease the ability to get an erection and may cause increased dizziness and a sudden drop in blood pressure.
• Grapefruit Juice: Avoid grapefruit juice as it may interact with the medicine.
• Medical Conditions: Inform your doctor about any pre-existing medical conditions, especially cardiovascular issues (recent heart attack or stroke, unstable angina, severe heart failure, uncontrolled high blood pressure, low blood pressure), liver or kidney impairment, bleeding disorders, stomach ulcers, retinitis pigmentosa, or anatomical deformities of the penis (e.g., angulation, Peyronie's disease) or conditions predisposing to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).
• Drug Interactions: Inform your healthcare provider about all medicines, supplements, or herbal products you are taking. PULMOPRES may interact with alpha-blockers, anti-hypertensives, potent inhibitors of CYP3A (e.g., ketoconazole, itraconazole), and potent inducers of CYP3A (e.g., rifampin).
• Other PDE-5 Inhibitors: Do not take other PDE-5 inhibitors or medicines for erectile dysfunction while taking PULMOPRES.
• Driving: PULMOPRES may cause dizziness or blurred vision, so caution is advised when driving or operating machinery.
• Pregnancy and Breastfeeding: PULMOPRES is not recommended for use during pregnancy or breastfeeding.
• Children: It is not known if PULMOPRES is safe or effective in children.

Storage

Store PULMOPRES TABLET below 25°C. Protect from moisture and keep it in a cool, dark, and dry place, out of the sight and reach of children.

PULMOPRES TABLET (15 TAB) by CIPLA LTD. - Frequently Asked Questions

PULMOPRES Tablet is a medication containing tadalafil, primarily used to treat certain conditions by relaxing blood vessels and improving blood flow.

What is PULMOPRES Tablet used for?

PULMOPRES Tablet is used to treat Pulmonary Arterial Hypertension (PAH), which is high blood pressure in the lungs, to improve exercise capacity. It is also prescribed for Erectile Dysfunction (ED) and symptoms of Benign Prostatic Hyperplasia (BPH), an enlarged prostate gland.

How does PULMOPRES Tablet work?

PULMOPRES Tablet contains Tadalafil, which is a phosphodiesterase type 5 (PDE5) inhibitor. It works by increasing the levels of a substance called cyclic guanosine monophosphate (cGMP), which relaxes the smooth muscles in blood vessel walls. In PAH, this relaxation reduces blood pressure in the lungs. For ED, it increases blood flow to the penis during sexual stimulation, aiding erection. In BPH, it relaxes the muscles in the prostate and bladder, improving urinary symptoms.

What is the usual dosage of PULMOPRES Tablet?

For Pulmonary Arterial Hypertension (PAH), the recommended dose is typically 40 mg (two 20 mg tablets) taken once daily, with or without food. For conditions like Erectile Dysfunction, the dosage can vary, often starting at 10 mg or 20 mg, taken at least 30 minutes before sexual activity, as needed. Your doctor will determine the appropriate dose based on your specific condition and tolerability.

What are the possible side effects of PULMOPRES Tablet?

Common side effects can include headache, flushing (redness or warmth in the face), muscle pain, back pain, pain in the arms and legs, indigestion, upset stomach, and nasal congestion. More serious, but rare, side effects may include sudden decrease or loss of vision, sudden decrease or loss of hearing, and a prolonged erection lasting more than 4 hours (priapism). Seek immediate medical attention if you experience any severe side effects.

Is PULMOPRES Tablet safe during pregnancy or breastfeeding?

PULMOPRES Tablet is generally not recommended for use during pregnancy or while breastfeeding. It is not known if the medicine passes into breast milk. Your doctor will assess the potential benefits against any risks if its use is considered absolutely necessary.

Can PULMOPRES Tablet be taken with other medications?

It is crucial to inform your doctor about all medications you are taking. PULMOPRES Tablet should not be taken with any form of organic nitrates (often used for chest pain or heart problems) or with riociguat, as this can lead to a severe and sudden drop in blood pressure. Caution is advised when taken with alpha-blockers, other blood pressure medications, certain antifungal medications (like ketoconazole, itraconazole), antibiotics (like erythromycin), and medicines for HIV (like ritonavir). Avoid using it with other treatments for erectile dysfunction.

What precautions should be taken while taking PULMOPRES Tablet?

Avoid consuming alcohol or grapefruit juice while on this medication, as they can increase the risk of side effects. Inform your doctor if you have any pre-existing medical conditions, especially heart problems, uncontrolled high or low blood pressure, a history of stroke or heart attack, liver or kidney issues, stomach ulcers, certain eye conditions (like retinitis pigmentosa or sudden vision loss), a deformed penis, or a history of prolonged erections (priapism).

What happens if a dose of PULMOPRES Tablet is missed?

If you miss a dose of PULMOPRES Tablet (especially if on a scheduled regimen for PAH), 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 a missed one.

How should PULMOPRES Tablet be stored?

PULMOPRES Tablet should be stored below 25°C or between 20°C to 25°C. It should be kept in a cool, dry place, protected from moisture, heat, and direct sunlight. Keep the medicine out of sight and reach of children and pets. Do not freeze the tablets.