Description
Latin name
cialis
Release form
Film-coated tablets.
Packing
In the package 1 pc.
Pharmacological action
Cialis is a treatment for erectile dysfunction (impotence, erectile dysfunction) in men and is part of a group of drugs called PDE-5 inhibitors (type 5 phosphodiesterase).
The drug dilates the blood vessels of the penis during sexual arousal.
As a result, blood circulation in the penis is enhanced, and this, in turn, contributes to the onset of a stable erection.
Indications
Erectile Dysfunction.
Contraindications
– Concomitant use of preparations containing any organic nitrates.
– Age to 18 years.
– Hypersensitivity to the drug.
Special instructions
Caution is required when prescribing Cialis to patients taking 1-blockers, for example, doxazosin, since the simultaneous use in some cases can lead to symptomatic arterial hypotension. In a clinical pharmacology study in 18 healthy volunteers who took a single dose of tadalafil, no symptomatic arterial hypotension was observed with the simultaneous administration of 1-adrenoblocker tamsulosin.
During treatment with Cialis, patients with moderate renal insufficiency (CC from 31 to 50 ml / min) were more likely to have back pain compared with patients with mild renal failure (CC from 51 to 80 ml / min) or healthy volunteers. To patients with QC 50 ml / min. The drug should be prescribed with caution.
Sexual activity has a potential risk for patients with cardiovascular disease. Therefore, the treatment of erectile dysfunction, including with the use of Cialis, should not be performed in men with heart diseases in which sexual activity is not recommended.
The potential risk of complications during sexual activity in patients with diseases of the cardiovascular system should be considered: myocardial infarction in the last 90 days, unstable angina or angina pectoris occurring during intercourse, chronic heart failure (NYHA class II functional class and above ), which has developed over the past 6 months, uncontrolled heart rhythm disturbances, arterial hypotension (blood pressure less than 90/50 mm Hg) or uncontrolled arterial hypertension I, stroke, transferred within the last 6 months.
Cialis should be used with caution in patients with a predisposition to priapism (e.g. with sickle cell anemia, multiple myeloma or leukemia) or in patients with anatomical deformation of the penis (for example, during angulation, cavernous fibrosis or Peyronie’s disease). The patient should be informed about the need to immediately consult a doctor in case of an erection lasting 4 hours or more.
Untimely treatment of priapism leads to damage to the tissues of the penis, resulting in long-term loss of potency. Against the background of the use of the drug Cialis, no cases of priapism were reported. The safety and effectiveness of the combination of Cialis with other treatments for erectile dysfunction have not been studied.
Therefore, the use of such combinations is not recommended. Like other PDE5 inhibitors, tadalafil has systemic vasodilating properties, which can lead to a transient decrease in blood pressure. Before prescribing Cialis, doctors should carefully consider whether patients with their cardiovascular disease will not be undesirable due to such vasodilating effects.
Patients with impaired liver function do not need a special dose selection. Since there are no data from controlled clinical trials on the safety and effectiveness of the use of Cialis in patients with severe hepatic insufficiency, the drug should be used in this category of patients with extreme caution and only if absolutely necessary.
For patients with impaired renal function (CC (creatinine clearance)> 30 ml / min), a special dose selection is not required. During treatment with Cialis, patients with moderate renal insufficiency (CC from 31 to 50 ml / min) were more likely to have back pain compared with patients with mild renal failure (CC from 51 to 80 ml / min) or healthy volunteers .
Patients with CC ² °Ò50 ml / min should be prescribed with caution. Since there are no data from controlled clinical trials on the safety and effectiveness of the use of Cialis in patients with severe renal insufficiency (CC> 30 ml / min), the drug should be used in this category of patients with extreme caution and only if absolutely necessary.
Cialis is not used in patients under 18 years of age.
Composition
In 1 film-coated tablet contains:
tadalafil 20 mg.
Excipients:
lactose monohydrate,
hyprolose (hydroxypropyl cellulose),
croscarmellose sodium,
microcrystalline cellulose,
magnesium stearate,
sodium lauryl sulfate.
Shell composition:
îpadry II yellow – lactose monohydrate, hypromellose, titanium dioxide, triacetin, yellow iron dye oxide.
Dosage and administration
The drug is taken orally.
The recommended maximum dose of the drug is 20 mg. The maximum recommended frequency of admission is 1 time / day.
Cialis is taken at least 16 minutes before the alleged sexual activity.
Patients may attempt intercourse at any time within 36 hours after taking the drug in order to to establish the optimal response time for taking the drug.
Side effects
Side effects are usually mild or moderate in severity, transient and decrease with continued use of the drug.
Most often: headache (11%), dyspepsia (7%).
Possibly: back pain, myalgia, nasal congestion, flushing of the face.
Rarely: edema of the eyelids, eye pain, conjunctival hyperemia. dizziness.
Very rare: hypersensitivity reactions (including rashes, hives and swelling of the face, Stevens-Johnson syndrome and exfoliative dermatitis), arterial hypotension (in patients who have already taken antihypertensive drugs), hypertension and syncope, abdominal pain and gastroesophageal reflux, hyperhidrosis (excessive sweating), priapism and delayed erection, blurry vision, non-arterial anterior ischemic optic neuropathy, retinal vein occlusion, visual field disturbance.
On the part of the cardiovascular system: in patients with cardiovascular risk factors – myocardial infarction, sudden cardiogenic death, stroke, chest pain, palpitations and tachycardia, however, it is not possible to accurately determine whether these phenomena are directly associated with these risk factors, with tadalafil , with sexual arousal, or with a combination of these or other factors.
Overdose
Symptoms: when administered once to healthy volunteers at a dose of 500 mg / day and to patients with erectile dysfunction – repeatedly up to 100 mg / day, the undesirable effects were the same as when using the drug in lower doses.
Treatment: conduct standard symptomatic therapy. With hemodialysis, tadalafil is practically not excreted.
Storage conditions
Do not store above 30 ° C.
Expiration
3 years.
Active ingredient
tadalafil
The dosage form of
tablet
Lilly del Caribe Inc.-Lilly S.A., USA
