The active substance is tadalafil.
Each 5 mg film-coated tablet contains 5 mg of tadalafil.
Each 20 mg film-coated tablet contains 20 mg of tadalafil.
Excipients/Inactive Ingredients: The other ingredients are lactose monohydrate, sodium laurilsulfate, povidone, crospovidone and sodium stearyl fumarate.
The tablet coating is made of poly(vinyl alcohol), macrogol, titanium dioxide (E171), talc and iron oxide yellow (E172).
Tadafly Tablets contain the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil 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 if the patient do not have erectile dysfunction.
Tadafly Tablet is used to treat 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.
It is important to note that Tadalafil for the treatment of erectile dysfunction does not work if there is no sexual stimulation.
Always take this medicine exactly as advised by the doctor. Check with the doctor or pharmacist if not sure.
Tadafly tablets are for oral use in men only.
For the treatment of erectile dysfunction: Once-a-day dosing: The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. The doctor may adjust the dose to 2.5 mg* based on the response to Tadalafil. This will be given as a 2.5 mg* tablet. Do not take Tadalafil more than once a day.
*2.5 mg Tadalafil tablet can be offered by other brands.
Once-a-day dosing of Tadalafil may be useful to men who anticipate having sexual activity two or more times per week. When taken once a day Tadalafil allows to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day.
On-demand dosing: The recommended dose is 10 mg before sexual activity. If the effect of this dose is too weak, the doctor may increase the dose to 20 mg.
The patient may take the dose at least 30 minutes before sexual activity. Tadalafil may still be effective up to 36 hours after taking the dose. Do not take doses of 10 mg and 20 mg more than once a day. They are intended for use prior to anticipated sexual activity and is not recommended for continuous daily use. It is important to note that Tadalafil does not work if there is no sexual stimulation.
Drinking alcohol may affect the ability to get an erection and may temporarily lower the blood pressure. If the patient has taken or planning to take Tadalafil, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up.
If the patient forgets to take Tadalafil: Take the dose as soon as remembered but do not take a double dose to make up for a forgotten tablet. Tadalafil should not be taken more than once a day.
Method of administration: Depending on the dosage regimen (once-a-day or on-demand) Tadafly tablets can be divided in quarters (once-a-day) or halves (on-demand).
Tadalafil is for oral use and can be taken with or without food.
Swallow the tablet or part of the tablet with some water.
Dividing the 20-mg tablet into quarters (with 5 mg tadalafil for once-a-day dosing): Place the tablet with the score lines uppermost on a hard, level surface (e.g. tabletop).
Press down forcefully for a short time with thumb (or index finger) onto the scored upper side of the tablet until it breaks into four equal parts.
Dividing the 20-mg tablet into halves (with 10 mg tadalafil for on-demand dosing): Place the tablet with the score lines uppermost on a hard, level surface (e.g. tabletop).
Place the thumbs (or index fingers) of both hands at the same time on the left and right side of the shorter score line of the tablet.
Press down forcefully for a short time with both thumbs (or index fingers) on the left and right side of the outside of the tablet until it breaks into two equal parts.
Contact the doctor. The patient may experience side effects described in Side Effects.
Do not take Tadalafil if the patient is: Allergic to tadalafil or any of the other ingredients of this medicine (listed in Description).
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 are unsure, tell the doctor (see Interactions).
Have serious heart disease or recently had a heart attack within the last 90 days.
Recently had a stroke within the last 6 months.
Have low blood pressure or uncontrolled high blood pressure.
Ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
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 Tadalafil, have been shown to increase the hypotensive effects of this medicine. If the patient is taking riociguat or are unsure, tell the doctor.
Talk to the doctor before taking Tadalafil.
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, tell the doctor.
Before taking the tablets, tell the doctor if the patient has: Sickle cell anaemia (an abnormality of red blood cells); multiple myeloma (cancer of the bone marrow); leukaemia (cancer of the blood cells); any deformation of penis; a serious liver problem; a severe kidney problem.
It is not known if Tadalafil 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, stop taking Tadalafil 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, stop taking Tadalafil and contact the doctor immediately.
Tadalafil is not intended for use by women.
Tadalafil contains lactose: If the patient has an intolerance to some sugars, contact the doctor before taking the medicine.
Fertility: When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.
Driving and using machines: Some men taking Tadalafil in clinical studies have reported dizziness. Check carefully how the patient react to the tablets before driving or using machines.
Use in Children: Tadalafil is not intended for use by children and adolescents under the age of 18.
20-mg: Tadalafil contains sodium: This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially 'sodium-free'.
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, 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 Tadalafil (frequency rare) (if the patient has such an erection, which lasts continuously for more than 4 hours, contact a doctor immediately); sudden loss of vision (frequency rare); serious allergic reaction which causes swelling of the face or throat; blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).
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; indigestion.
Uncommon: seen in 1 to 10 in every 1,000 patients: Dizziness; stomach ache; feeling sick; being sick (vomiting); reflux; blurred vision; eye pain; difficulty in breathing presence of blood in urine; prolonged erection; pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure; nose bleeds and 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; passing memory loss; swelling of the eyelids, red eyes, sudden decrease or loss of hearing and hives (itchy red welts on the surface of the skin); penile bleeding; presence of blood in semen; increased sweating.
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 skin rashes; some disorders affecting blood flow to the eyes; irregular heartbeats; angina; 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, talk to the doctor or pharmacist.
This includes any possible side effects not listed.
By reporting side effects, it can help provide more information on the safety of this medicine.
Tell the doctor if the patient is taking, have recently taken or might take any other medicines.
Do not take Tadalafil if already taking any form of nitrates (see Contraindications).
Some medicines may be affected by Tadalafil or they may affect how well Tadalafil will work. Tell the doctor or pharmacist if 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; a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia); medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection; phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines); rifampicin, erythromycin, clarithromycin or itraconazole; other treatments for erectile dysfunction.
Tadalafil with drink and alcohol: Information on the effect of alcohol is in Dosage & Administration. Grapefruit juice may affect how well Tadalafil will work and should be taken with caution. Talk to the doctor for further information.
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.
G04BE08 - tadalafil ; Belongs to the class of drugs used in erectile dysfunction.
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