Tadilecto 10 mg. 4 tablets
Tadilecto contains the active substance tadalafil, which belongs to the group of medicines called phosphodiesterase type 5 inhibitors.
Tadilecto 10 mg is intended for the treatment of elderly 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. 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 for the treatment of erectile dysfunction 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.
urinary symptoms associated with a commonly observed condition, called benign prostatic hyperplasia. This is a condition where the prostate gland increases with age. Symptoms include difficulty in starting urination, feeling uncomfortably emptying the bladder, and more urgency to urinate even at night, tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms of benign hyperplasia (increase) of the prostate. Tadalafil has been shown to improve these urinary symptoms 1-2 weeks after the start of treatment.
2. What you need to know before you take Tadelecto
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 angina 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.
Because benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will check for prostate cancer before starting Tadelecto for benign prostatic hyperplasia. Tadilecto does not cure prostate cancer.
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 for treatment 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 Tadleeco
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 Tadelecto, or they may have an impact on how well Tadelecto will work. Tell your doctor or pharmacist if you have
Some medications may be affected by Tadilecto, or they may have an impact on how well Tadelecto 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 (to treat 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 treatment for erectile dysfunction.
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 receiving tadalafil have 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 Tadilecto
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.
Alcohol use may temporarily lower your blood pressure. If you have taken or plan to take Tadelecto, avoid excessive alcohol consumption (blood alcohol level of over and above 0.08%), as this may increase the risk of dizziness when standing up.
For treatment of erectile dysfunction
The recommended dose is one 5 mg tablet once a day at approximately the same time of day. Your doctor may adjust the dose to 2.5 mg depending on Tadylecto's effect. Then one tablet of 2.5 mg may be given. Alternatively, the 2.5 mg dose can be obtained by dividing one 5 mg tablet into two equal parts.
Do not take Tadilecto more than once a day.
Taking once a day Tadelecto allows you to get an erection in sexual stimulation at any time, 24 hours a day. Tajilecto once daily dosing may be useful for men who expect sexual activity two or more times a week.
It is important to note that Tadilecto does not work without sexual stimulation. You and your partner will need to join a pre-game as you would if you did not take a medicine for erectile dysfunction. Alcohol use may affect your ability to get an erection.
For the treatment of benign prostatic hyperplasia
The recommended dose is one 5 mg tablet once a day at approximately the same time of day.
If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet once a day.
Do not take Tadelecto more than once a day.
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 forgot to take Tadilecto
Take the dose as soon as you remember, but do not take a double dose to make up for the missed dose.
Do not take Tadelecto more than once a day.
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 including rash (frequency - uncommon).
Chest pain - Do not use nitrates, and seek immediate medical attention (frequency - uncommon).
Priapism - prolonged and possibly painful erection after intake (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):
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 commonly in men over 75 years of age receiving tadalafil. Diarrhea is reported more commonly in men over the age of 65 who are taking tadalafil.
5. How to store 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 the blister after EXP. The deadline is 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 5 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
Tadelecto 5 mg film-coated tablets: Light yellow, biconvex, oblong, film-coated tablets with a line on one side and a 5 on the other side. The tablet can be divided into equal doses. Tablet dimensions: Length 9 mm and Width 6 mm.
Tadelecto 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.