Tadalafil 20 mg to 40 mg Given Every Second Day Is Effective in Secondary Pulmonary Hypertensio

Take OPSYNVI® exactly as instructed by your healthcare provider.

Administration Instructions for Tadalafil

The purpose of the trial is to assess the effect of tadalafil compared to placebo (inactive comparator) on the urethral - and anal pressure and on urine flow in healthy females. Further, the purpose of the trial is to evaluate the potential for going forward with studies of tadalafil in patients suffering from urine or fecal incontinence. Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2) Sexual abstinence or use of safe contraceptive methods i.e. intrauterine devices, hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long acting injections), or surgically sterilized partner throughout the course of the study and until six days after the study has ended for the subject. Women who are postmenopausal (defined as no menstrual periods for 12 months or more prior to enrolment) can be included without use of contraceptive methods.

CAUTION & SCHEDULE:

Presentation of a negative urine human chorionic gonadotropin (hCG) urine pregnancy test prior to dosing (on both study days) Current acute or chronic condition, unless considered clinically irrelevant and stable by the investigator. Average systolic blood pressure <100 mmHg or >140 mmHg and/or average diastolic blood pressure <60 mmHg or >90 mmHg (average of three measurements performed at screening). Average pulse < 40 or > 100 beats/minute (average of three measurements performed at screening). Pregnancy within 6 months before screening and throughout the study period. Breastfeeding throughout the study period and 6 days after study day 2. Do not stop taking OPSYNVI® unless your healthcare provider tells you to do so.

OPSYNVI® is an oral pill of macitentan 10-mg/tadalfil 40-mg taken once daily by mouth.

5.2 Worsening Pulmonary Vascular Occlusive Disease

The results of the research have been published in several scientific publications in the USA. In particular, The Journal of Sexual Medicine published an article "The efficacy and safety of tadalafil in men with erectile dysfunction: a double-blind placebo-controlled phase 3 study". It provides data on the safety and effectiveness of tadalafil in the treatment of erectile dysfunction. According to data from scientific publications in the United States, in 2022, global sales of tadalafil amounted to more than $ 2.5 billion. This drug occupies a leading position in the market for the treatment of erectile dysfunction.

Related support groups

If you are not currently on any PAH therapy or are transitioning from an ERA alone: One OPSYNVI® pill (macitentan 10mg/tadalafil 20mg), once daily for 1 week. If tolerated, the doctor will increase your dose to one OPSYNVI® pill (macitentan 10mg/tadalafil 40mg), once daily. If you are transitioning from a PDE5i alone or taking tadalafil daily the combination of an ERA and a PDE5i as individual pills: Start with one OPSYNVI® pill (macitentan 10mg/tadalafil 40mg), once daily. The pills illustrated above are not actual size. Once you and your healthcare provider decide that OPSYNVI® is right for you, OPSYNVI® will be mailed to you by a specialty pharmacy. OPSYNVI® can be taken with or without food. Take the pill whole and do not cut, crush, or chew OPSYNVI® pills. If you accidentally take too much OPSYNVI®, contact your healthcare provider or go to the nearest hospital emergency room right away. If you miss a dose of OPSYNVI®, take it as soon as you remember that day. Take the next dose at your regular time. Do not take 2 doses at the same time to make up for a missed dose. Download the OPSYNVI® brochure for quick access to the benefits and patient support options available to you. If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively.

4.1 Concomitant Organic Nitrates

Are samples available?Yes, for qualified importers. Do you export to Africa?Yes, to over 25 African nations. Is Tadalafil effective for BPH?Yes, it helps relieve urinary symptoms. Are Taj Pharma products WHO-GMP certified?Absolutely. What packaging options are available?Blister, bottle, and custom designs.

THERAPEUTIC INDICATIONS:

Is registration support provided?Full regulatory documentation available. Do you accept bulk tenders?Yes, Taj Pharma supplies government & private tenders. What payment terms are offered?LC, TT, and advance-based options. How fast is delivery?Typically 3–4 weeks after confirmation. Why choose Taj Pharma?Quality, affordability, compliance, and global reliability. See full prescribing information for TADALAFIL TABLETS.TADALAFIL tablets, for oral useInitial U.S.

Approval: 2003INDICATIONS AND USAGETadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.

Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). (1.1)DOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHSTablets (not scored): 20 mg (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSHypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of tadalafil.

16.1 How Supplied

Any systemic drug use within 2 weeks before first study drug administration (prescription drugs, over-the-counter drugs, herbal drugs and illicit drugs), except for occasional use of paracetamol (up to 4 g/day), hormonal contraceptives and hormone replacement therapy. Smoking or other regular use of any form of nicotine product during the study period and the previous 3 months. Alcohol consume 24 hours prior to dosing. Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator). 24 participants in 2 patient groups, including a placebo group Subjects are randomized to either 40 mg tadalafil on study day 1 and placebo on study day 2, or placebo on study day 1 and 40 mg tadalafil on study day 2.

STORAGE & DOSAGE:

Subjects are randomized to either 40 mg tadalafil on study day 1 and placebo on study day 2, or placebo on study day 1 and 40 mg tadalafil on tadalafil 2 5 mg study day 2. Tadalafil (Generic Tadafil) is a drug that is used to treat erectile dysfunction. It was developed in 1992 by ICI Pharmaceuticals. Tadalafil relaxes the smooth muscles in the cavernous body of the penis, which helps to increase blood flow and, as a result, the appearance of an erection. More than 3,000 men participated in clinical trials of tadalafil. Not recommended in patients with pulmonary veno-occlusive disease.

• Tadalafil 40mg is effective for both erectile dysfunction and BPH symptoms.
• It is important to hydrate well when using this medication.
• Avoid grapefruit or grapefruit juice when taking Tadalafil 40mg.
• Do not use Tadalafil 40mg if you are allergic to similar medications.
• Monitor blood pressure regularly during Tadalafil therapy.
• Side effects tend to be mild but consult a doctor if severe.

(5.1, 5.2)Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent. (5.3)Hearing impairment: Cases of sudden decrease or loss of hearing have been reported with CIALIS.

(5.4)Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors. (5.5)Prolonged erection: Advise patients to seek emergency treatment if an erection lasts greater than 4 hours. (5.6)ADVERSE REACTIONSThe most common adverse reaction is headache. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc. at 1-855-664-7744 or FDA at 1-800-FDA-1088 or IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 10/2025 Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) tadalafil pills (WHO Group 1) to improve exercise ability.

• Tadalafil 40mg is sometimes prescribed for pulmonary hypertension.
• Regular use of Tadalafil 40mg may help in certain benign prostatic hyperplasia cases.
• Use caution if you have kidney or liver problems before taking this dose.
• It's essential to follow your healthcare provider’s dosage instructions.
• Combining Tadalafil 40mg with other ED medications can increase risk.
• Alcohol can enhance side effects of Tadalafil, such as dizziness and low blood pressure.

Hypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of tadalafil. Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent. Hearing impairment: Cases of sudden decrease or loss of hearing have been reported with CIALIS. Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors. Prolonged erection: Advise patients to seek emergency treatment if an erection lasts greater than 4 hours. The most common adverse reaction is headache. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Pulmonary Arterial Hypertension2 DOSAGE AND ADMINISTRATION2.1 Pulmonary Arterial Hypertension2.2 Dose Adjustment in Renal Impairment2.3 Dose Adjustment in Hepatic Impairment2.4 Dose Adjustment for Use with Ritonavir3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Concomitant Organic Nitrates4.2 Concomitant Guanylate Cyclase (GC) Stimulators4.3 Hypersensitivity Reactions5 WARNINGS AND PRECAUTIONS5.1 Hypotension5.2 Worsening Pulmonary Vascular Occlusive Disease5.3 Visual Loss5.4 Hearing Impairment5.5 Combination with Other PDE5 Inhibitors5.6 Prolonged Erection6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Nitrates7.2 Alpha-Blockers7.3 Antihypertensives7.4 Alcohol7.5 CYP3A Inhibitors/Inducers8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.3 Females and Males of Reproductive Potential8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 Tadalafil tablets for Pulmonary Arterial Hypertension14.2 Long-Term Treatment of Pulmonary Arterial Hypertension16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS AND USAGE 1.1 Pulmonary Arterial HypertensionTadalafil Tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.