CIALIS 20 mg. 4 tablets 

Each tablet contains 20 mg of tadalafil. 

For oral use. 

Keep out of reach of children. Contains lactose monohydrate.

Store in the original package to protect from moisture. Do not store above 30 º C.

CLINICAL DATA

Indications

  Treatment of erectile dysfunction. 

To be effective tadalafil, sexual stimulation is required.

Dosage and method of administration

For oral administration: CIALIS is available as film-coated tablets of 2.5, 5, 10, 20 mg 

Use in adults

In general, the recommended dose is 10 mg taken prior to anticipated sexual activity with or without food. In those patients in whom tadalafil 10 mg did not produce an adequate effect, you can try 20 mg. This dose may be taken at least 30 minutes before sexual aktivnost.Maksimalnata dose frequency is once dnevno.Tadalafil 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily upotreba.Pri patients who achieves the desired effect when used on demand, providing frequent use of CIALIS / as least twice a week / can be considered as an appropriate once daily regimen with the lowest doses of CIALIS, based on the choice of the patient and the physician's judgment. In these patients, the recommended dose is 5 mg, taken once a day at approximately the same time of day. The dose may be reduced to 2.5 mg once daily based on individual поносимостЦелесъобразността of prolonged daily use should be reassessed periodically.

Use in elderly men 

In elderly males do not require dose adjustment.

Use in men with impaired renal function

No reduction is required for patients with mild to moderate renal impairment. For patients with severe renal impairment, the maximum recommended dose is 10 mg. In patients with severe renal impairment dosing of tadalafil is not recommended.

Use in men with impaired hepatic function

The recommended dose of CIALIS is 10 mg, taken prior to anticipated sexual activity with or without food. There is limited clinical data on the safety of CIALIS in patients with severe hepatic impairment, if prescribed, the prescribing physician must make careful individual benefit / risk ratio. No data on the use of doses higher than 10 mg of tadalafil in patients with hepatic impairment. Dosed once daily has not been evaluated in patients with hepatic impairment, therefore, if prescribed, the prescribing physician must make careful individual benefit / risk assessment. 

Use in men with diabetes

In men with diabetes does not require a change in dosage 

Use in children and adolescents: 

CIALIS should not be administered to people aged under 18

CONTRAINDICATIONS

Hypersensitivity to the active substance or any of the other veshtestva.CIALIS and other agents for the treatment of erectile dysfunction should 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 preexisting 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 heart failure NYHA class 2 or higher in the last 6 months

 Patients with uncontrolled arrhythmias, hypotension 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 ischemic optic neuropathy, regardless of whether this episode was in connection or not with previous PDE5 inhibitor

Pregnancy and lactation

CIALIS is not indicated for use by women. No studies of tadalafil in pregnant zheni.Nyama clinical data on the use of tadalafil during бременност.Експерименталните Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

No studies on the effects on ability to drive and use machines. Although clinical trials the incidence of reports of dizziness in placebo and tadalafil arms was similar, patients should be aware of how they react to CIALIS before driving or operating machinery.

SIDE EFFECTS

The most commonly reported side effects were headache and dyspepsia. Reported adverse events were transient and mostly mild to moderate. Adverse reaction data are limited in patients over 75 years of age.

Immune System

 Hypersensitivity

Nervous System

 Headache, dizziness

 Rarely - stroke, syncope, migraine

Eye Disorders

  Blurred vision, sensations described as eye pain, eyelid edema, hyperemia of the conjunctiva, a breach of the field of non-arteritic anterior ischemic optic neuropathy, nasal retinal

Ear and labyrinth disorders

 Sudden deafness

Cardiac disorders

 Palpitations, tachycardia, myocardial infarction, unstable angina, ventricular arrhythmia

Vascular disorders:

Hypotension, flushing, hypertensi

Gastrointestinal Disorders

  Dyspepsia, abdominal pain

Skin and subcutaneous tissue disorders

  Rash, urticaria, hyperhidrosis, exfoliative dermatitis

Musculo-skeletal and connective tissue disorders

  Back pain, myalgia 

Reproductive system

  Swelling of the face