Tadalafila EMS Side effects

• Side effects of Tadalafila EMS in details
• Tadalafila EMS contraindications
• Tadalafila EMS reviews

What are the possible side effects of Tadalafila EMS?

Get emergency medical help if you have any signs of an allergic reaction to Tadalafila EMS: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Tadalafila EMS and get emergency medical help if you have:

• erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis);

• vision changes or sudden vision loss; or

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Also call your doctor right away if you have:

• ringing in your ears, or sudden hearing loss;

• irregular heartbeat;

• swelling in your hands, ankles, or feet;

• shortness of breath;

• seizure (convulsions); or

• a light-headed feeling, like you might pass out.

Common Tadalafila EMS side effects may include:

• headache;

• diarrhea;

• sinus pain, sore throat; or

• muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Tadalafila EMS in details

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Tadalafila EMS was administered to over 9000 men during clinical trials worldwide. In trials of Tadalafila EMS for once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For Tadalafila EMS for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.

Tadalafila EMS For Use As Needed For ED

In eight primary placebo-controlled clinical studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and the discontinuation rate due to adverse events in patients treated with Tadalafila EMS 10 or 20 mg was 3.1%, compared to 1.4% in placebo treated patients.

When taken as recommended in the placebo-controlled clinical trials, the following adverse reactions were reported for Tadalafila EMS for use as needed:

Table 1: Treatment-Emergent Adverse Reactions Reported by ≥ 2% of Patients Treated with Tadalafila EMS (10 or 20 mg) and More Frequent on Drug than Placebo in the Eight Primary Placebo- Controlled Clinical Studies (Including a Study in Patients with Diabetes ) for Tadalafila EMS for Us e as Needed for ED

Tadalafila EMS For Once Daily Use For ED

In three placebo-controlled clinical trials of 12 or 24 weeks duration, mean age was 58 years (range 21 to 82) and the discontinuation rate due to adverse events in patients treated with Tadalafila EMS was 4.1%, compared to 2.8% in placebo-treated patients.

The following adverse reactions were reported in clinical trials of 12 weeks duration:

Table 2: Treatment-Emergent Adverse Reactions Reported by ≥ 2% of Patients Treated with Tadalafila EMS for Once Daily Us e (2.5 or 5 mg) and More Frequent on Drug than Placebo in the Three Primary Placebo-Controlled Phase 3 Studies of 12 weeks Treatment Duration (Including a Study in Patients with Diabetes ) for Tadalafila EMS for Once Daily Us e for ED

The following adverse reactions were reported over 24 weeks treatment duration in one placebo-controlled clinical study:

Table 3: Treatment-Emergent Adverse Reactions Reported by ≥ 2% of Patients Treated with Tadalafila EMS for Once Daily Us e (2.5 or 5 mg) and More Frequent on Drug than Placebo in One Placebo-Controlled Clinical Study of 24 Weeks Treatment Duration for Tadalafila EMS for Once Daily Use for ED

Tadalafila EMS For Once Daily Use For BPH And For ED And BPH

In three placebo-controlled clinical trials of 12 weeks duration, two in patients with BPH and one in patients with ED and BPH, the mean age was 63 years (range 44 to 93) and the discontinuation rate due to adverse events in patients treated with Tadalafila EMS was 3.6% compared to 1.6% in placebo-treated patients. Adverse reactions leading to discontinuation reported by at least 2 patients treated with Tadalafila EMS included headache, upper abdominal pain, and myalgia. The following adverse reactions were reported.

Table 4: Treatment-Emergent Adverse Reactions Reported by ≥ 1% of Patients Treated with Tadalafila EMS for Once Daily Use (5 mg) and More Frequent on Drug than Placebo in Three Placebo- Controlled Clinical Studies of 12 Weeks Treatment Duration, including Two Studies for Tadalafila EMS for Once Daily Us e for BPH and One Study for ED and BPH

Additional, less frequent adverse reactions ( < 1%) reported in the controlled clinical trials of Tadalafila EMS for BPH or ED and BPH included: gastroesophageal reflux disease, upper abdominal pain, nausea, vomiting, arthralgia, and muscle spasm.

Back pain or myalgia was reported at incidence rates described in Tables 1 through 4. In Tadalafila EMS clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. The back pain/myalgia associated with Tadalafila EMS treatment was characterized by diffuse bilateral lower lumbar, gluteal, thigh, or thoracolumbar muscular discomfort and was exacerbated by recumbency. In general, pain was reported as mild or moderate in severity and resolved without medical treatment, but severe back pain was reported with a low frequency ( < 5% of all reports). When medical treatment was necessary, acetaminophen or non-steroidal anti-inflammatory drugs were generally effective; however, in a small percentage of subjects who required treatment, a mild narcotic (e.g., codeine) was used. Overall, approximately 0.5% of all subjects treated with Tadalafila EMS for on demand use discontinued treatment as a consequence of back pain/myalgia. In the 1-year open label extension study, back pain and myalgia were reported in 5.5% and 1.3% of patients, respectively. Diagnostic testing, including measures for inflammation, muscle injury, or renal damage revealed no evidence of medically significant underlying pathology. Incidence rates for Tadalafila EMS for once daily use for ED, BPH and BPH/ED are described in Tables 2, 3 and 4. In studies of Tadalafila EMS for once daily use, adverse reactions of back pain and myalgia were generally mild or moderate with a discontinuation rate of < 1% across all indications.

Across placebo-controlled studies with Tadalafila EMS for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with Tadalafila EMS (2.5% of patients).

Across all studies with any Tadalafila EMS dose, reports of changes in color vision were rare ( < 0.1% of patients).

The following section identifies additional, less frequent events ( < 2%) reported in controlled clinical trials of Tadalafila EMS for once daily use or use as needed. A causal relationship of these events to Tadalafila EMS is uncertain. Excluded from this list are those events that were minor, those with no plausible relation to drug use, and reports too imprecise to be meaningful:

Body as a Whole - asthenia, face edema, fatigue, pain, peripheral edema

Cardiovascular - angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia

Digestive - abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhage

Musculoskeletal - arthralgia, neck pain

Nervous - dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo Renal and Urinary

What is the most important information I should know about Tadalafila EMS?

• Tadalafila EMS may cause dizziness, drowsiness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Tadalafila EMS with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Tadalafila EMS may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do not drink large amounts of alcohol (eg, 5 drinks or more) while you take Tadalafila EMS. Doing so may increase your risk of dizziness, headache, fast heartbeat, and low blood pressure. Check with your doctor before you drink alcohol while you use Tadalafila EMS.
• Do not take more than the recommended dose, change your dose, or take Tadalafila EMS more often than prescribed without checking with your doctor.
• Patients with heart problems who take Tadalafila EMS may be at increased risk of heart-related side effects, including a heart attack or stroke. Symptoms of a heart attack may include chest, shoulder, neck, or jaw pain; numbness of an arm or leg; severe dizziness, headache, nausea, stomach pain, or vomiting; fainting; or vision changes. Symptoms of a stroke may include confusion; vision or speech changes; one-sided weakness; or fainting. Contact your doctor or seek medical attention right away if you experience these symptoms.
• Tadalafila EMS may rarely cause a prolonged (eg, more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
• Tadalafila EMS does not stop the spread of HIV or other sexually transmitted diseases (STDs) to others through sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD.
• Tadalafila EMS will not prevent pregnancy. If your partner may become pregnant and you wish to avoid pregnancy, be sure to use an effective form of birth control.
• Tadalafila EMS may uncommonly cause mild, temporary vision changes (eg, blurred vision, sensitivity to light, blue/green color tint to vision). Contact your doctor if vision changes persist or are severe.
• Rarely, an eye problem called nonarteritic anterior ischemic optic neuropathy (NAION) has been reported in patients who took Tadalafila EMS. This may lead to decreased vision or permanent loss of vision in some cases. If you notice a sudden decrease in vision or loss of vision in one or both eyes, contact your doctor right away.
• Sudden decreases in hearing and loss of hearing have been reported in some patients who have taken Tadalafila EMS. Sometimes they also noticed ringing in the ears or dizziness. If you notice a sudden decrease or loss of hearing, contact your doctor right away.
• Do not use other medicines or treatments for ED while you are taking Tadalafila EMS without first checking with your doctor.
• Be sure to keep all doctor and lab appointments while you are taking Tadalafila EMS.
• Use Tadalafila EMS with caution in the ELDERLY; they may be more sensitive to its effects.
• Tadalafila EMS is not recommended for use in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Tadalafila EMS is not approved for use in women. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tadalafila EMS while you are pregnant. It is not known if Tadalafila EMS is found in breast milk. If you are or will be breast-feeding while you use Tadalafila EMS, check with your doctor. Discuss any possible risks to your baby.

Tadalafila EMS contraindications

5 mg Film-coated Tablet: Hypersensitivity to the active substance or to any of the excipients.

In clinical studies, Tadalafila EMS was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and Tadalafila EMS on the nitric oxide/cGMP pathway. Therefore, administration of Tadalafila EMS to patients who are using any form of organic nitrate is contraindicated..

Tadalafila EMS, must not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.

20 mg Film-coated Tablet: Nitrates and Tadalafila EMS must not be used concomitantly. Co-administration of Tadalafila EMS with nitric oxide donors, organic nitrates or organic nitrites in any form either regularly or intermittently is contraindicated. Drugs which must not be used concomitantly include, but are not limited to, glyceryl trinitrate (injection, tablets, sprays or patches), isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil or organic nitrates in any form. In clinical studies, Tadalafila EMS was shown to potentiate the hypotensive effects of both acute and chronic nitrate administration. This is thought to result from the combined effects of nitrates and Tadalafila EMS on the nitric oxide/cGMP pathway.

Based on the results of a clinical study in which 150 subjects receiving daily doses of Tadalafila EMS 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last Tadalafila EMS dose. Thus, in a patient prescribed Tadalafila EMS, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of Tadalafila EMS before nitrate administration is considered. In such circumstances, nitrates should only be administered under close medical supervision with appropriate haemodynamic monitoring.

5 mg and 20 mg Film-coated Tablet: The following groups of patients with cardiovascular disease were not included in clinical trials and the use of Tadalafila EMS is therefore contraindicated: Patients with myocardial infarction within the last 90 days; patients with unstable angina or angina occurring during sexual intercourse; patients with New York Heart Association Class 2 or greater heart failure in the last 6 months; patients with uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension; patients with a stroke within the last 6 months.

Tadalafila EMS is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.

Tadalafila EMS should not be used in patients with a known hypersensitivity to Tadalafila EMS or to any ingredient of the tablet.

References

1. DailyMed. "TADALAFIL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DTP/NCI. "Tadalafil: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "(6R,12aR)-6-(1,3-Benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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