Ascenta 5mg Film Coated Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, or pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Ascenta is and what it is used for.
2. Before you use Ascenta
3. How to use Ascenta.
4. Possible side effects.
5 How to store Ascenta.
6. Further information.
1. What Ascenta is and what it is used for.
Ascenta contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
- Ascenta use for erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Ascenta has been shown to significantly improve the ability of obtaining a hard-erect penis suitable for sexual activity.
Following sexual stimulation Ascenta works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Ascenta will not help you if you do not have erectile dysfunction.
It is important to note that Ascenta for the treatment of erectile dysfunction does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
- urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is when the prostate gland gets bigger with age. Symptoms include difficulty in starting to pass water, a feeling of not completely emptying the bladder and a more frequent need to pass water even at night. Ascenta improves blood flow to, and relaxes the muscles of, the prostate and bladder which may reduce symptoms of benign prostatic hyperplasia. Ascenta has been shown to improve these urinary symptoms as early as 1-2 weeks after starting treatment.
2. What you need to know before you use Ascenta
Do not use Ascenta:
- If you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
- If you are 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”). Ascenta 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 serious heart disease or recently had a heart attack within the last 90 days.
- If you recently had a stroke within the last 6 months. – have low blood pressure or uncontrolled high blood pressure.
- If you ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
- If you are 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 Ascenta, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
Warnings and precautions
Talk to your doctor before taking Ascenta.
Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem, you should tell your doctor.
Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will check you for prostate cancer before starting treatment with Ascenta for benign prostatic hyperplasia. Ascenta does not treat prostate cancer.
Before taking the tablets, tell your doctor if you have:
- 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 your penis.
- a serious liver problem.
- a severe kidney problem.
It is not known if Ascenta 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 you experience sudden decrease or loss of vision, stop taking Ascenta and contact your 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 you experience decreased or sudden hearing loss, stop taking Ascenta and contact your doctor immediately.
Ascenta is not intended for use by women.
Talk to your doctor or, pharmacist or nurse before using Ascenta
Children and adolescents
Ascenta is not intended for use by children and adolescents under the age of 18.
Other medicines and Ascenta
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Do not take Ascenta if you are already taking nitrates.
Some medicines may be affected by Ascenta or they may affect how well Ascenta will work. Tell your doctor or pharmacist if you are 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.
- 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.
Amorya with food, drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Ascenta will work and should be taken with caution. Talk to your doctor for further information.
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 Ascenta in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.
Amorya contains lactose:
If you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Ascenta
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Ascenta tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.
Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Ascenta, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up.
For the treatment of erectile dysfunction, the recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg based on your response to Ascenta. This will be given as a 2.5mg tablet.
Do not take Ascenta more than once a day.
When taken once a day Ascenta allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day. Once a day dosing of Ascenta may be useful to men who anticipate having sexual activity two or more times per week.
It is important to note that Ascenta does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction. Drinking alcohol may affect your ability to get an erection.
For the treatment benign prostatic hyperplasia, the dose is one 5 mg tablet taken once a day at approximately the same time of the day. If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once a day.
Do not take Amorya more than once a day.
If you take more Ascenta than you should
Contact your doctor. You may experience side effects described in section 4.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
If you forget to take Ascenta
Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet. You should not take Ascenta 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 everybody gets them. These effects are normally mild to moderate in nature.
If you experience 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 Ascenta (frequency rare). If you have such an erection, which lasts continuously for more than 4 hours you 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, 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, 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), penile bleeding, presence of blood in semen and increased sweating.
Heart attack and stroke have also been reported rarely in men taking Ascenta. 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 Ascenta 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 Ascenta. Diarrhoea has been reported more frequently in men over 65 years of age taking Ascenta.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, health care provider or pharmacist.
5. How to store Ascenta
- Keep this medicine out of the sight and reach 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.
- Store in the original package in order to protect from moisture. store below 30°C.
- Do not use this medicine if you notice any visible signs of deterioration
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Further information
What Ascenta contains:
- The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
- The other ingredients are:
Tablet core: Lactose monohydrate, Croscarmellose sodium, Povidone, Sodium Lauryl sulfate, Colloidal anhydrous silica, Magnesium stearate.
Film-coat: Opadry yellow.
What Ascenta looks like and contents of the pack
Ascenta 5 mg Yellowish, almond shaped, biconvex, film coated tablet and has “JS9” marked on one side.
Ascenta 5 mg is available in blister packs containing 30 tablets.
Marketing Authorization Holder and Manufacturer
King Abdullah Economic City, Rabigh. Saudi Arabia
Tel: +966 12 21 29013