Tadilecto

Tadilecto

tadalafil

Manufacturer:

Krka

Distributor:

T-BOMA
Full Prescribing Info
Contents
Tadalafil.
Description
Each film-coated tablet contains 10 mg or 20 mg tadalafil.
Excipients/Inactive Ingredients: The other ingredients are: hypromellose phtalate, mannitol, croscarmellose sodium, sodium laurilsulfate, magnesium stearate (E470b), lactose monohydrate, hypromellose, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172) and triacetin (E1518).
Action
Tadilecto contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Indications/Uses
Tadilecto is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.
Following sexual stimulation Tadilecto works by helping the blood vessels in the penis to relax, allowing the flow of blood into the penis. The result of this is improved erectile function. Tadalafil will not help the patient if he does not have erectile dysfunction.
It is important to note that Tadilecto does not work if there is no sexual stimulation. The patient and his partner will need to engage in foreplay, just as the patient would if he were not taking a medicine for erectile dysfunction.
Dosage/Direction for Use
Always take this medicine exactly as advised by the doctor. Check with the doctor if not sure.
Tadilecto tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.
The recommended starting dose is one 10 mg tablet before sexual activity. However, the patient may be given the dose of one 20 mg tablet if the doctor has decided that the recommended dose of 10 mg is too weak. Tadilecto tablets are for oral use.
The patient may take Tadilecto at least 30 minutes before sexual activity. Tadilecto may still be effective up to 36 hours after taking the tablet.
Do not take Tadilecto more than once a day. Tadilecto 10 mg and 20 mg are intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tadilecto does not work if there is no sexual stimulation. The patient and his partner will need to engage in foreplay, just as the patient would if he were not taking a medicine for erectile dysfunction.
Drinking alcohol may affect the ability to get an erection and may temporarily lower the blood pressure. If the patient has taken or is planning to take Tadilecto, he should avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up.
Overdosage
If the patient takes more Tadilecto than he should: Contact the doctor. The patient may experience any of the side effects described in Side Effects.
If the patient has any further questions on the use of this medicine, he should ask the doctor or pharmacist.
Contraindications
Do not take Tadilecto: If the patient is allergic to tadalafil or any of the other ingredients of this medicine (listed in Description).
If the patient is taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of angina pectoris ("chest pain"). Tadalafil has been shown to increase the effects of these medicines. If the patient is taking any form of nitrate or is unsure tell the doctor.
If the patient has serious heart disease or recently had a heart attack within the last 90 days/3 months.
If the patient has recently had a stroke within the last 6 months.
If the patient has low blood pressure or uncontrolled high blood pressure.
If the patient has ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
If the patient is taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadilecto, have been shown to increase the hypotensive effects of this medicine. If the patient is taking riociguat or is unsure tell the doctor.
Special Precautions
Talk to the doctor or pharmacist before taking Tadilecto.
Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on the heart. If the patient has a heart problem he should tell the doctor.
Before taking the tablets, the patient should tell the doctor if he has: sickle cell anemia (an abnormality of red blood cells); multiple myeloma (cancer of the bone marrow); leukaemia (cancer of the blood cells); any deformation of the penis; a serious liver problem; a severe kidney problem.
It is not known if Tadilecto is effective in patients who have had: pelvic surgery; removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non-nerve-sparing prostatectomy).
If the patient experiences sudden decrease or loss of vision, he should stop taking Tadilecto and contact the doctor immediately.
Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if the patient experiences decreased or sudden hearing loss, he should stop taking Tadilecto and contact the doctor immediately.
Tadilecto is not intended for use by women.
Tadilecto with drink and alcohol: Information on the effect of alcohol is in Dosage & Administration.
Grapefruit juice may affect how well Tadilecto will work and should be taken with caution.
Talk to the doctor for further information.
Fertility: When dogs were treated there was reduced sperm development in the testicles. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.
Tadilecto contains lactose: If the patient has been told by the doctor that he has an intolerance to some sugars, the patient should contact the doctor before taking this medicine.
Driving and using machines: Some men taking tadalafil in clinical studies have reported dizziness. Check carefully how the patient reacts to the medicine before driving or using machines.
Use in Children: Tadilecto is not indicated for use by children and adolescents under the age of 18.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.
If the patient experiences any of the following side effects he should stop using the medicine and seek medical help immediately: Allergic reactions including rashes (frequency uncommon).
Chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).
Priapism, a prolonged and possibly painful erection after taking Tadilecto (frequency rare). If the patient has such an erection, which lasts continuously for more than 4 hours the patient should contact a doctor immediately.
Sudden loss of vision (frequency rare).
Other side effects have been reported: Common (seen in 1 to 10 in every 100 patients): headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.
Uncommon (seen in 1 to 10 in every 1,000 patients): dizziness, stomach ache, reflux, feeling sick, being sick (vomiting), blurred vision, eye pain, difficulty breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
Rare (seen in 1 to 10 in every 10,000 patients): fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), increased sweating, penile bleeding and presence of blood in semen.
Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men had known heart problems before taking this medicine.
Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.
Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical trials. These include: migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.
Reporting of side effects: If the patient gets any side effects, he should talk to the doctor or pharmacist. This includes any possible side effects not listed. By reporting side effects the patient can help provide more information on the safety of this medicine.
Drug Interactions
Tell the doctor if the patient is taking, has recently taken or might take any other medicines.
Do NOT take Tadilecto if the patient is already taking nitrates.
Some medicines may be affected by Tadilecto or they may affect how well Tadilecto will work. Tell the doctor or pharmacist if the patient is already taking: an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia); other medicines to treat high blood pressure; riociguat (to treat some forms of pulmonary hypertension); a 5-alpha reductase inhibitor (to treat benign prostatic hyperplasia); protease inhibitors for the treatment of AIDS or HIV infection (e.g. ritonavir); phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines); rifampicin, erythromycin, clarithromycin (to treat bacterial infections); medicines such as ketoconazole or itraconazole (to treat fungal infections); other treatments for erectile dysfunction.
Storage
Store below 25 °C. Protect from light and moisture.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
ATC Classification
G04BE08 - tadalafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
FC tab 10 mg (yellow, biconvex, oval, with sign 10 on one side, dimensions approximately 12 mm long and 7.5 mm wide) x 1 x 4's. 20 mg (brown yellow, biconvex, oval, scored on one side and with sign 20 on the other side, dimensions approximately 14 mm long x 9.5 mm wide) x 1 x 4's.
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