Tadilecto 20 mg. 4 tablets
Tadilecto is intended for the treatment of:
Adult men with erectile dysfunction. This is a condition where the male can not reach or hold a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability to produce a hard erect penis suitable for sexual activity.
Tadelecto contains the active substance tadalafil, which belongs to the group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadelecto works by helping the blood vessels in the penis relax and allow the blood flow to the penis. As a result, erectile function improves. Tadalafil will not help if you do not have erectile dysfunction.
It is important to note that Tadelecto does not work if there is no sexual stimulation. You and your partner will have to engage in the love game as you would if you do not take a medication for erectile dysfunction.
2. What you need to know before you take Tadilecto
Do not take Tadilecto:
if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6);
if you are taking any kind of nitrate or donor of nitric oxide, such as amyl nitrite. These are a group of drugs ("nitrates") used in the treatment of pectoris ("chest pain"). Tadalafil has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor;
if you have a serious heart disease or have had a heart attack in the last 90 days;
if you have suffered a stroke (stroke) in the last 6 months;
if you have low blood pressure or uncontrolled high blood pressure;
if you have ever had loss of vision as a result of non-arterial anterior ischemic optic neuropathy (NAION), a condition described as "eye stroke";
if you take rhizogyat. This medicine is used to treat pulmonary arterial hypertension (ie high blood pressure in the lungs resulting from blood clots). It has been shown that PDE5 inhibitors such as Tadelecto enhance the blood pressure lowering effect of this medicine. If you are taking rhizoglute or are not sure, tell your doctor.
Warnings and precautions
Talk to your doctor before taking Tadilecto
Note that sexual activity carries possible risks for patients with heart disease due to extra stress on your heart. If you have heart problems, you should tell your doctor.
Before taking the tablets, tell your doctor if you have:
sickle cell anemia (red blood cell anomaly);
multiple myeloma (bone marrow tumor);
leukemia (blood cell tumor);
some deformation of the penis;
serious liver problem;
serious kidney problem.
It is not known whether Tadelecto is effective in patients who have:
removal of all or part of the prostate gland, in which the nerve of the prostate is broken (radical, non-conservative nerve prostatectomy).
If you experience sudden decrease or loss of vision, stop taking Tadelecto and contact your doctor immediately.
Some patients taking tadalafil experience reduced hearing or sudden hearing loss. Although it is not known whether the event is directly related to tadalafil, if you have reduced hearing or sudden hearing loss, stop taking Tadelecto and contact your doctor immediately.
Tadelecto is not indicated for use in women.
Children and adolescents
Tadelecto is not intended for use by children and adolescents under 18 years of age.
Other drugs and Tadilecto
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take Tadelecto if you are already taking nitrate.
Some medications may be affected by Tadilecto, or they may have an impact on how well Tadilecto will work. Tell your doctor or pharmacist if you are already taking:
alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia);
other medicines to treat high blood pressure,
rhocigout (for the treatment of some forms of pulmonary arterial hypertension);
5-alpha reductase inhibitor (for the treatment of benign prostatic hyperplasia);
medicines such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection;
phenobarbital, phenytoin and carbamazepine (anti-inflammatory drugs);
rifampicillin, erythromycin, clarithromycin or itraconazole;
other types of erectile dysfunction treatment.
Tadylekt with drinks and alcohol
Information on the effect of alcohol is shown in point 3.
Grapefruit juice may affect the action of Tadelecto and should be taken with caution. Talk to your doctor for more information.
Lower sperm production in the testicles was observed with dogs. Reduction in sperm count is seen in some men. These effects are unlikely to result in loss of fertility.
Driving and using machines
In clinical trials, some men taking tadalafil reported dizziness. Check carefully how to take your medicines before driving or using machines.
Tadelecto contains lactose
If you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Tadelecto
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Tadelecto tablets are for oral use only by men. Swallow the tablet whole with some water. You can take the tablets with or without food.
The recommended starting dose is 10 mg before sexual activity. This dose can be given as one 10 mg tablet or by dividing one 20 mg tablet into two equal halves.
However, a single 20 mg tablet may be given if your doctor decides that the recommended dose of 10 mg is too weak.
You may take Tadelecto at the earliest 30 minutes before sexual activity.
Tadelecto may be effective up to 36 hours after taking the tablet.
Do not take Tadelecto more than once a day. Tadelecto 10 mg and 20 mg are intended for use before expected sexual activity and are not recommended for prolonged daily use.
It is important to note that Tadelecto does not work without sexual stimulation. You and your partner will need to join a pre-game as you would if you do not take a medication for erectile dysfunction.
Alcohol use may affect your ability to erect and may temporarily reduce your blood pressure. If you have taken or plan to take Tadelecto, avoid excessive alcohol consumption (blood alcohol level above and above 0.08%), as this may increase the risk of vertigo when standing up.
If you take more Tedlecto than you should
Contact your doctor. You may experience some of the side effects described in section 4.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them. These effects are usually mild to moderate in nature.
If you experience any of the following side effects, stop using the medicine and seek immediate medical attention:
Allergic reactions (frequency - uncommon).
Chest pain - Do not use nitrates, and seek immediate medical attention (frequency - uncommon).
Priapism - prolonged and possibly painful erection after taking Tadelecto (frequency - rare). If you have an erection that lasts for more than 4 hours, you should contact your doctor immediately.
Sudden loss of vision (frequency - rare).
Other reported side effects:
Common (may affect up to 1 in 10 people):
headache, back pain, muscle aches, pain in the hands and feet, facial flushing, nasal congestion and indigestion.
Uncommon (may affect up to 1 in 100 people):
dizziness, nausea, abdominal pain, heartburn, nausea (vomiting), blurred vision, eye pain, difficulty in breathing, blood in the urine, prolonged erection, feeling of palpitations, increased heart rate, increased blood pressure, decreased blood pressure, bleeding nose, tinnitus, swelling of the hands, legs or ankles and fatigue.
Rare (may affect up to 1 in 1,000 people):
fainting, loss of memory, swelling of the eyelids, redness of the eyes, sudden decrease or loss of hearing, urticaria (itchy red spots on the surface of the skin), increased sweating, bleeding from the penis, blood in the semen liquid.
In men receiving tadalafil, infarction and stroke were also rarely reported. Most of these men had known heart problems before taking this medicine.
Rarely, temporary or permanent decrease or loss of vision on one or both eyes has been reported rarely.
Some additional rare side effects have been reported in men taking tadalafil that have not been seen in clinical trials. They include:
migraine, facial swelling, serious allergic reaction causing facial or throat edema, severe skin rashes, some disorders affecting the blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
Adverse reaction dizziness is reported more frequently in men over 75 years of age. Diarrhea is reported more commonly in men over the age of 65 who are taking tadalafil.
How to Keep Tadilecto
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Tadilecto contains
The active substance is tadalafil (tadalafil). Each film-coated tablet contains 20 mg tadalafil.
Other ingredients are hypromellose phthalate, mannitol, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate (E470b) in the tablet core and lactose monohydrate, hypromellose, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172), and triacetin E1518) in the film coating.
See point 2 "Tadelecto contains lactose".
What Tadelecto looks like and contents of the pack
Tadilecto 20 mg film-coated tablets: Brown yellow, biconvex, oblong, film-coated, scored on one side and 20 on the other side. The tablet can be divided into equal doses. Tablet dimensions: Length about 14 mm and width - 9.5 mm.
Tadilecto is available in cartons containing: 2, 4, 8, 12, 14, 28, 56 and 84 film-coated tablets in blisters.
Not all pack sizes may be marketed.