Tadalafil Stella 5mg Treatment of erectile dysfunction (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Tadalafil

Ingredient

Composition information	Content
Tadalafil	5mg

Uses

indications

Tadalafil 5mg Stella is indicated in the following cases:

indicated the treatment of erectile dysfunction in adult men. The drug only works when there is sexual stimulation.

Indications for treatment of signs and symptoms of benign prostate hyperplasia in adult men. When sexual stimulation leads to on -site nitric release, the PDE5 inhibitor of Tadalafil increases the CGMP level in the cave. This leads to smooth muscle relaxation and increased blood flow into the penis tissue, thereby causing penis. When there is no sexual stimulation, Tadalafil does not work.

The effectiveness of PDE5 inhibitors on CGMP concentrations in the cave is also observed in the smooth muscle of the prostate, bladder and their blood vessels. As a result, vasodilation increases perfusion that may be a mechanism to reduce the symptoms of prostate hygiene. These effects on blood vessels can be supplemented by inhibiting the nerve activity towards the bladder and the smooth muscle relaxation of the prostate and the bladder.

pharmacokinetics

Tadalafil absorb well after drinking. The peak concentration of plasma is achieved within 2 hours, the speed and level of absorption are not affected by food. Tadalafil is widely distributed to tissues and about 94% associated with plasma proteins.

The drug is metabolized mainly in the liver through cytochrome P450 isoenzym CYP3A4. The main metabolites form methylcatechol Glucuronid is not active.

Tadalafil's average disposal time is about 17.5 hours. Tadalafil is eliminated mainly in the form of metabolic in stool (61% of the dose) and less in urine (36% of the dose of use). The clearance of the elderly and patients with kidney failure.

Before taking Tadalafil Stella 5mg Treatment of erectile dysfunction (3 blisters x 10 tablets)

How to use

Tadalafil 5mg Stella is used by oral and does not depend on meals.

Dosage

erectile dysfunction in adult men

The recommended dose is 10 mg, used before planning to have sex. In patients with Tadalafil 10 mg dose do not bring satisfactory effect, can try the dose of 20 mg. Should take the drug at least 30 minutes before sex.

Maximum frequency of use is 1 time/day.

10 mg and 20 mg tadalafil dose is used before planning to have sex and recommend not to be used continuously every day.

In patients intending to use Tadalafil regularly (at least 2 times/ week), the mode 1 time/ day with the lowest tadalafil dose may be considered appropriate, depending on the patient's choice and the doctor's evaluation. In these patients, the recommended dose is 5 mg x 1 time/day oral at the same time of the day. The dose can be reduced to 2.5 mg x 1 time/day (using other preparations with a content of 2.5 mg) depending on the ability to tolerate each person. Should re -evaluate periodically the appropriateness of continuing daily use.

Prostate hygiene in adult men

recommended dose is 5 mg, oral at the same time every day. For adult men being treated for both prostate hyperplasia and erectile dysfunction, the recommended dose is also 5 mg oral at the same time every day. Patients can not tolerate the dose of Tadalafil 5 mg in the treatment of benign hyper -tank hypertension should consider another alternative therapy because the effectiveness of the tadalafil 2.5 mg dose in the treatment of benign hypertension has not been proven.

Renal failure

No need to adjust the dose in mild to moderate renal failure. For people with severe renal failure, 10 mg is the maximum recommended dose for treatment according to demand. Tadalafil dose mode 2.5 mg or 5 mg x 1 time/day to treat erectile dysfunction or benign hyperplasia is not recommended in people with severe renal failure.

People with liver failure

Treatment of erectile dysfunction using Tadalafil according to the needs, the recommended dose of Tadalafil is 10 mg before intending to have sex. There is a limited clinical data on the safety of Tadalafil in people with severe liver failure (Child-Pugh c); If prescribed, the doctor should carefully evaluate the benefits/risks of each person.

There is no data on the use of 10 mg higher doses for people with liver failure. Tadalafil doses 1 time/day for both erectile dysfunction and benign hyperplasia has not been assessed in people with hepatic impairment; Therefore, if prescribed, the doctor should carefully evaluate the benefits/risks of each person.

People with diabetes

No dose adjustment.

Children

The use of Tadalafil is not suitable for children in the treatment of erectile dysfunction.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do

do when using overdose? Side reactions are similar to low doses. In case of overdose, supportive measures should be used as required. Blood division is negligible to the elimination of Tadalafil.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using Tadalafil 5mg Stella you may experience unwanted effects (ADR).

Common, ADR> 1/100

Nervous system: headache.

Cardiovascular: flushing.

Respiratory: Nasal congestion.

Digestive: indigestion, gastroesophageal reflux.

musculoskeletal: back pain, muscle pain, limb pain.

Uncommon, 1/1000

The immune system: Hypersensitivity reactions.

Nervous system: Stunned.

Eyes: blurred vision, eye pain.

ears: tinnitus.

Cardiovascular: tachycardia, brushing chest drum, hypotension, hypertension.

Respiratory: Difficulty breathing, nosebleeds.

Digestive: abdominal pain.

Skin and subcutaneous tissue: rash, increased sweating.

Kidney and urinary tract: urine bleeding.

Reproductive system: Penis bleeding, semen with blood.

general: chest pain.

Rare, ADR

Immune system: Evana.

Nervous system: stroke (including hemorrhage cases), fainting, transient ischemic attacks, migraine, epilepsy, temporary memory loss.

Eyes: Vision defect, eyelid swelling, conjunctival congestion, optic neuropathy due to anemia in the front is not due to artery inflammation, retinal veins.

ears: Sudden hearing loss.

Cardiovascular: myocardial infarction, unstable angina, ventricular arrhythmia.

Skin and subcutaneous tissue: urticaria, Stevens-Johnson syndrome, flaking dermatitis.

Reproductive system: penis erection.

General: Facial edema, sudden heart due to heart.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Tadalafil 5mg Stella is contraindicated in the following cases:

Hypersensitivity to Tadalafil or any ingredients of the drug.

Patients taking nitrate derivatives.

Patients with cardiovascular disease without sexual activity.

Patients with a history of optic neuropathy due to anemia in the front area are not due to artery causes.

Arrhythmic, uncontrolled hypertension.

stroke within 6 months ago. Heart myocardial infarction within 90 days.

Caution when using

should check to eliminate the possibility of prostate cancer and carefully assess cardiovascular condition before starting treatment with Tadalafil for prostate hyperplasia patients.

Cardiovascular effects

Sexual activity is related to cardiovascular risk. Therefore, it is advisable to assess the patient's cardiovascular condition before starting treatment with Tadalafil. The serious effects related to Tadalafil have been reported including myocardial infarction, sudden cardiac arrest, stroke, chest pain, suspense and fast circuit.

Do not treat erectile dysfunction with Tadalafil in patients who are recommended not to be sexually active because of cardiovascular condition. Particularly interested in the risk of hypotension or vasodilation in patients with left ventricular congestion (aortic stenosis, narrowing under the aorta due to spontaneous hypertrophy) or seriously reducing the ability to automatically control blood pressure.

Salm influence

Do not use Tadalafil in patients with genetic degenerative retinal disorders, including pigmentitis.

Effects on the urinary tract

Be cautious when taking the drug in patients with anatomical deformation of the penis (penis folded, caves, peyronie disease) and diseases that can cause penile pain (sickle cell anemia, multi -marrow tumor, leukemia).

Do not coordinate Tadalafil at the same time with other drugs to treat erectile dysfunction because of the safety and effectiveness of these drugs that have not been studied.

The use of Tadalafil for people under 18 has not been evaluated. Therefore, do not use tadalafil for children or babies.

Tadalafil 5mg Stella contains lactose. Patients with rare genetic problems are galactose intolerance, Lapp Lactase deficiency, or malposive glucose-galactose should not take this drug.

The ability to drive and operate machinery

There has been no research on affecting the ability to drive and operate machinery. Although the dizziness impact rate of placebo and Tadalafil in clinical trials is the same, the patient should be warned about the use of tadalafil before driving and operating machinery.

Pregnancy

Tadalafil is not indicated for women.

Breastfeeding period

Tadalafil is not indicated for women.

Interactive drug

organic nitrates and nitric derivative oxide

Increased hypotension, including inhaled nitrite. Contraindicated when coordinating Tadalafil with these drugs.

Medicines affect the liver microsom enzyme

Combined with strong CYP3A4 inhibitors (ketoconazole, HIV protease inhibitors, non-nucleoside transcriptase inhibitors): Tadalafil's AUC increases. Ritonavir, Nelfinavir, Ritonavir, Saquinavir, Tipranavir combined with low-dose Ritonavir) or Non-Nucleoside reverse copy inhibitors: Increasing plasma peak concentrations, tadalafil's absorption and sale time.

High blood pressure medication

The risk of hypotension when combined simultaneously with high blood pressure medications (Doxazosin, Angiotensin II receptor blockers).

Be cautious when used simultaneously with PDE type 5 inhibitors and alpha receptor blockers because both are vasodilators.

Combining Tadalafil with Metoprolol, Enalapril, Amlodipin or Bendrofluazid reduces blood pressure.

Theophylline

Potential pharmaceutical interaction (the slight increase of theophylin increases the heart rate).

antacids

Potential pharmacokinetic interaction (reducing the speed but the absorption level of tadalafil does not decrease) when used simultaneously with antacids containing magnesium magox/aluminum hydroxyd.

Storage

Store in a dry place, the temperature does not exceed 30 ° C, avoiding light.

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