Eazialis 5

Eazialis 5

Pharmacodynamic properties:
  Eazialis® is a potent, selective, reversible inhibitor of cyclic guanosine 
  monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual 
  stimulation causes the local release of nitric oxide, inhibition of PDE5 by   
  Eazialis® produces increased levels of cGMP in the corpus cavernosum. This 
  results in smooth muscle relaxation and inflow of blood into the penile tissues, 
  thereby producing an erection. Tadalafil has no effect in the absence of sexual 
  stimulation. Eazialis® administered to healthy subjects produced no significant  
  difference compared to placebo in supine systolic and diastolic blood pressure, or 
  in standing systolic and diastolic blood pressure, and no significant change in 
  heart rate. There were no clinically relevant effects on sperm concentration, sperm  
  count, motility or morphology after daily doses of 10 mg and 20 mg for 6 
 Pharmacokinetic properties:
- Tadalafil is readily absorbed after oral administration and the mean maximum 
  observed plasma concentration (Cmax) is achieved at a median time of 2 hours 
  after dosing. 
- The rate and extent of absorption of tadalafil are not influenced by food, thus 
  Eazialis® may be taken with or without food. The time of dosing (morning versus 
  evening) had no clinically relevant effects on the rate and extent of absorption. 
- The mean volume of distribution is approximately 63 liters, indicating  that 
  tadalafil is distributed into tissues. At therapeutic concentrations, 94% of Tadalafil 
  in plasma is bound to proteins. Protein binding is not affected by impaired renal 
- Less than 0.0005% of the administered dose appeared in the semen of healthy 
- Tadalafil is predominantly metabolized by the cytochrome P450 (CYP3A4) 
- The mean oral clearance for tadalafil is 2.5 L/hr and the mean half-life is 17.5 
   hours in healthy subjects. 
- Tadalafil is excreted predominantly as inactive metabolites, mainly in the faeces  
  (approximately 61% of the dose) and to a lesser extent in the urine (approximately 
  36% of the dose).

-  Each film-coated tablet of  Eazialis® 5mg contains:
   Tadalafil     5mg

- If you are allergic to Tadalafil or any of the other ingredients of this 
- If you are taking any form of organic nitrate or nitric oxide donors such as 
   amyl nitrite.
- If you have a serious heart disease or recently had a heart attack within the 
  last 90 days.
- The co-administration of PDE5 inhibitors, including Tadalafil, with 
  guanylate cyclase stimulators, such as riociguat, is contraindicated as it 
  may potentially lead to symptomatic hypotension.
- If you have low blood pressure or uncontrolled high blood pressure.
- Patients with uncontrolled arrhythmias, hypotension (< 90/50mmHg), or 
  uncontrolled hypertension.
- Patients with a stroke within the last 6 months.
- Tadalafil is contraindicated in patients who have loss of vision in one eye

- Tadalafil is principally metabolised by CYP3A4.  
- Anti-hypertensives (including calcium channel blockers):
  Co-administration of doxazosin (4 mg and 8 mg daily) and Tadalafil (5 
  mg daily dose and 20 mg as a single dose) increases the blood 
  pressure-lowering effect of this alpha-blocker in a significant manner. This 
  effect lasts at least 12 hours and may be symptomatic, including syncope.  
  Therefore, this combination is not recommended. 
- Cytochrome P450 inhibitors such as ketoconazole, saquinavir, 
  erythromycin, clarithromycin, itraconazole, and grapefruit juice increased 
  Tadalafil exposure.
- A CYP3A4 inducer such as rifampicin,phenobarbital, phenytoin, and 
  carbamazepine decrease the efficacy of Tadalafil.
- where nitrate administration is deemed medically necessary in a 
  life-threatening situation, at least 48 hours should have elapsed after the 
  last dose of Tadalafil (2.5 mg to 20 mg) before nitrate administration is 

fertility pregnancy and lactation:
- Tadalafil 5mg is not indicated for use by women.

- If you experience any of the following side effects stop using the 
  medicine and seek medical help immediately:
- allergic reactions including rashes (frequency uncommon).
­- chest pain - do not use nitrates but seek immediate medical assistance 
  (frequency uncommon).
­- priapism, a prolonged and possibly painful erection after taking Tadalafil  
  (frequency rare). If you have such an erection, which lasts continuously for  
   more than 4 hours you  should contact a doctor immediately.
- sudden loss of vision (frequency rare).
  Other side effects have been reported:
- Common (may affect up to 1 in 10 people):headache, back pain, muscle 
  aches, pain in arms and legs, facial flushing, nasal congestion, and 
- Uncommon (may affect up to 1 in 100 people):dizziness, stomach ache, 
  feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty 
  in breathing, presence of blood in urine, prolonged erection, pounding 
  heartbeat sensation, a fast heart rate, high blood pressure, low blood 
  pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or 
  ankles and feeling tired.
- Rare (may affect up to 1 in 1,000 people) fainting, seizures and passing 
  memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of 
  hearing, hives (itchy red welts on the surface of the skin), penile bleeding, 
  presence of blood in semen and increased sweating
- Heart attack and stroke have also been reported rarely in men taking   
  Tadalafil. Most of these men had known heart problems before taking this 
- Some additional rare side effects have been reported in men taking 
  Tadalafil that were not seen in clinical trials. These include:
­  migraine, swelling of the face, serious allergic reaction which causes 
  swelling of the face or throat, serious skin rashes, some disorders affecting 
  blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
  If you get any side effect, talk to your doctor or pharmacist.

Over dose:
- Single doses of Tadalafil up to 500 mg have been given to healthy subjects, 
  and multiple daily doses up to 100 mg have been given to patients which 
  adverse events were similar to those seen at lower doses.
- In cases of overdose, supportive measures should be adopted, as required.

- Talk to your doctor or pharmacist before taking Eazialis®.
- Be aware that sexual activity carries a possible risk to patients with heart 
  disease because it puts an extra strain on your heart. 
- If you have a heart problem you should tell your doctor.
- If you have sickle cell anaemia (an abnormality of red blood cells ) 
  multiple myeloma, leukaemia, any deformation of your penis,a serious 
  liver problem and a severe kidney problem you should tell your doctor.
- Since benign prostatic hyperplasia and prostate cancer may have the same          
  symptoms, your doctor will check you for prostate cancer before starting 
  treatment with Eazialis® for benign prostatic hyperplasia,Eazialis® does 
  not treat prostate cancer.
- Decreased or sudden hearing loss noted in some patients taking Eazialis®.

- Blister of 10 tablets, pack of 3 blisters

- Store in a dry place at temperature not exceeding 25 °C