Cialis Tablets, Packaging Type : Titanium Dioxide, Iron Oxide Yellow

20 mg Tablet contains : 20 mg of Tadalafil I.P. as active ingredient 210.195 mg Lactose Monohydrate, 35 mg Lactose Monohydrate (Spray Dried), 5.6 mg Hydroxypropyl Cellulose (EF  Extra  Fine),  12.6  mg  Croscarmellose  Sodium,  2.45  mg  Hydroxypropyl  Cellulose  (EF),  0.980  mg  Sodium  Laurylsulphate, 52.5 mg Microcrystalline Cellulose (Granular 102), 9.8 mg Croscarmellose Sodium, 0.875 mg Magnesium Stearate (Vegetable).

Men with hepatic impairment :

• The  recommended  dose  of  Cialis is  10  mg  taken  prior  to  anticipated  sexual  activity  and  with  or  without food.  There  is  limited  clinical  data  on  the  safety  of  Cialis in  patients  with  severe  hepatic  impairment  (Child-Pugh  Class  C);  if  prescribed,  a  careful  individual  benefit/risk  evaluation  should  be  undertaken  by  the  prescribing  physician.  There  are  no  available  data  about  the  administration  of  doses  higher  than  10  mg  of  tadalafil to patients with hepatic impairment. Once-a-day dosing has not been evaluated in patients with hepatic impairment;  therefore  if  prescribed,  a  careful  individual  benefit/risk  evaluation  should  be  undertaken  by  the
• prescribing physician. (see sections Special warnings and precautions for use and Pharmacokinetic properties).

Men with diabetes :

• Dose adjustments are not required in diabetic patients.
• Paediatric population
• There is no relevant use of Cialis in the paediatric population with regard to the treatment of erectile dysfunction.

Method of administration :

• Cialis is available as 10 mg and 20 mg film-coated tablets for oral use.
• Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section List of Excipients.
• In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration
• of Cialis to patients who are using any form of organic nitrate is contraindicated. (see section
• Interaction with other medicinal products and other forms of interaction).
• Cialis, 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.

The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil 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.
• Cialis is  contraindicated  in  patients  who  have  loss  of  vision  in  one  eye  because  of  non-arteritic  anterior is chaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section Special warnings and precautions for use).
• 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 (see section Interaction with other medicinal products and other forms of interaction).

Special warnings and precautions for use Before treatment with Cialis :

• A  medical  history  and  physical  examination  should  be  undertaken  to  diagnose  erectile  dysfunction  and  determine potential underlying causes, before pharmacological treatment is considered. Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their  patients,  since  there  is  a  degree  of  cardiac  risk  associated  with  sexual  activity.  Tadalafil  has  vasodilator  properties,  resulting  in  mild  and  transient  decreases  in  blood  pressure  (see  section Pharmacodynamic properties ) and as such potentiates the hypotensive effect of nitrates (see section Contraindications).
• The  evaluation  of  erectile  dysfunction  should  include  a  determination  of  potential  underlying  causes  and the  identification  of  appropriate  treatment  following  an  appropriate  medical  assessment.  It  is  not  known  if  Cialis is effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy.

Cardiovascular :

• Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia, have been reported  either  post  marketing  and/or  in  clinical  trials.  Most  of  the  patients  in  whom  these  events  have  been reported  had  pre-existing  cardiovascular  risk  factors.  However,  it  is  not  possible  to  definitively  determine whether these events are related directly to these risk factors, to Cialis, to sexual activity, or to a combination of these or other factors.
• In  patients  who  are  taking  alpha 1  blockers,  concomitant  administration  of  Cialis  may  lead  to  symptomatic  hypotension  in  some  patients  (see  section  Interaction  with  other  medicinal  products  and  other  forms  of interaction). The combination of tadalafil and doxazosin is not recommended.

Vision : Visual  defects  and  cases  of  NAION  have  been  reported  in  connection  with  the  intake  of  Cialis  and  other PDE5  inhibitors.  The  patient  should  be  advised  that  in  case  of  sudden  visual  defect,  he  should  stop  taking  Cialis and consult a physician immediately (see section Contraindications).
Hepatic impairment :

• There is limited clinical data on the safety of single-dose administration of Cialis  in patients with severe hepatic insufficiency (Child-Pugh Class C). If Cialis  is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
• Priapism and anatomical deformation of the Patients  who  experience  erections  lasting  4  hours  or  more  should  be  instructed  to  seek  immediate  medical  assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
• Cialis , should be used with caution in patients with anatomical deformation of the (such as angulation, cavernosal  fibrosis  or  Peyronie’s  disease),  or  in  patients  who  have  conditions  which  may  predispose  them  to  priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
• Use with CYP3A4 inhibitors Caution  should  be  exercised  when  prescribing  Cialis to  patients  using  potent  CYP3A4  inhibitors  (ritonavir,  saquinavir,  ketoconazole,  itraconazole,  and  erythromycin)  as  increased  tadalafil  exposure  (AUC)  has  been  observed  if  the  medicinal  products  are  combined  (see  section Interaction  with  other  medicinal  products  and other forms of interaction).
• Cialis and other treatments for erectile dysfunction The  safety  and  efficacy  of  combinations  of  Cialis and  other  PDE5  inhibitors  or  other  treatments  for  erectile dysfunction have not been studied. The patients should be informed not to take Cialis  in such combinations.
• Lactose Cialis contains  lactose.  Patients  with  rare  hereditary  problems  of  galactose  intolerance,  the  Lapp  lactase  deficiency or glucose-galactose malabsorption should not take this medicinal product. Cialis is not indicated for use by women.