Duralis®

Tadalafil

Read this entire leaflet carefully before you start taking this medicine.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor or pharmacist.
− This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as
yours.
− If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet?
1. What Duralis® is and what it is used for
2. What you need to know before you use Duralis®
3. How to use Duralis®
4. Possible side effects
5. How to store Duralis®
6. Contents of the pack and other information
1. What Duralis® is and what it is used for
Duralis® 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. Duralis® has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.
Duralis® contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Following sexual stimulation Duralis® 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. Duralis® will not help you if you do not have erectile dysfunction. It is important
to note that Duralis® 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.
2. What you need to know before you use Duralis®
Do not take Duralis® if you:
- Are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
- 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”). 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.
- 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”.
- 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
Duralis®, 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 Duralis®.
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.
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 Duralis® 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 nonnerve-sparing prostatectomy).
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 Duralis® and contact your doctor immediately.
Women: Duralis® is not intended for use by women.
Children and adolescents: Duralis® is not intended for use by children and adolescents under the age of 18.
Other medicines and Duralis®:
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take Duralis® if you are already taking nitrates.
Some medicines may be affected by Duralis® or they may affect how well Duralis® 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.
- 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.
Duralis® with drink and alcohol
PIL020/7

Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Duralis® will work and should be taken with
caution. Talk to your doctor for further information.
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 you react to the tablets before driving or
using machines.
Duralis® contains lactose:
If you have intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Duralis®
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Duralis® 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, you have been given the dose of one 20mg
tablet as your doctor has decided that the recommended dose of 10mg is too weak.
You may take a Duralis® tablet at least 30 minutes before sexual activity.
Duralis® may still be effective up to 36 hours after taking the tablet.
Do not take Duralis® more than once a day. Duralis® 10 mg and 20 mg is intended for use prior to anticipate sexual activity and is not
recommended for continuous daily use.
It is important to note that Duralis® 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 and may temporarily lower your blood pressure. If you have taken or are
planning to take Duralis®, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of
dizziness when standing up.
If you take more Duralis® than you should
Contact your doctor. You may experience side effects described in section 4.
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 Duralis® (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 Duralis®. 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.
Diarrhea has been reported more frequently in men over 65 years of age taking.
5. How to store Duralis®
Store below 30°C.
Keep in original pack in intact conditions.
6. Contents of the pack and other information
Duralis® film coated tablet; Box of 1 and 4 tablets.
Each film coated tablet contains Tadalafil 20 mg.
Excipients: Lactose, croscarmellose sodium, corn starch, povidone, colloidal silicon dioxide, magnesium stearate, microcrystalline
cellulose, polyvinyl alcohol, titanium dioxide, macrogol, talc, yellow iron oxide, FD&C yellow #5.
Date of revision: September 2017.

This is a medicament
- A medicament is a product which affects your health, and its consumption
contrary to instructions is dangerous for you
- Follow strictly the doctor’s prescription, the method of use, and the
instructions of the pharmacist who sold the medicament
- The doctor and the pharmacist are experts in medicine, its benefits and risks
- Do not by yourself interrupt the period of treatment prescribed for you
- Do not repeat the same prescription without consulting your doctor
- Medicament: keep out of reach of children Council of Arab Health Ministers
Union of Arab Pharmacists

Benta S.A.L.
Dbayeh - Lebanon