Tadalafil

• Long-acting erection pill
• Restores erectile function
• Effective within about 30 minutes
• Effect lasts about 36 hours
• Alcohol reduces the effect and may intensify side effects

Tadalafil contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafil comes in 2.5-mg, 5-mg, 10-mg and 20-mg tablets and is used to treat erectile dysfunction (ED) in adult men. 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 Tadalafil 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.

Tadalafil will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil does not work if there is no sexual stimulation.

Tadalafil is also used to treat other conditions (benign prostatic hyperplasia, pulmonary arterial hypertension). For more information, see the package leaflet.

Always use this medicine exactly as your doctor or pharmacist has told you. When in doubt, ask your doctor or pharmacist. The tablets should be swallowed whole with some water. Tadalafil 20-mg tablets can be spread out in equal doses. The tablets can be taken with or without food.

To treat erectile dysfunction ∙ Flexible dose, as needed:
The recommended starting dose is one 10-mg tablet before sexual activity. If the recommended dose of 10mg is too weak, your doctor may adjust the dose to 20 mg.
You may take a Tadalafil tablet at least 30 minutes before sexual activity. Tadalafil may still be effective up to 36 hours after taking the tablet. Tadalafil 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.

∙ Taken once daily:
If you take this medicine once daily, you will be able to get an erection 24 hours a day when sexually stimulated. Once-daily administration can be useful for men who expect to be sexually active at least twice a week.
The recommended dose is 5 mg once daily, taken every day at about the same time. Your doctor may adjust the dose to 2.5 mg depending on your response.
Do not take more than one dose per 24 hours. Drinking alcohol can temporarily impair your ability to get an erection.

If you have taken too little or too much of this ED medicine, talk to your doctor or pharmacist or read the package leaflet.

For the appropriate dose for other conditions (benign prostatic hyperplasia, pulmonary arterial hypertension), see the package leaflet.

When not to use this medicine

You should not use Tadalafil if:

• You are allergic to any of the ingredients in this medicine (see section 'What Tadalafil contains').
• You are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. Nitrates is a group of medicines used in the treatment of angina pectoris (chronic chest pain). Tadalafil has been shown to increase the effects of these medicines. You are taking any form of nitrate or are unsure, tell your doctor.
• You have serious heart disease or had a heart attack within the last 90 days.
• You have had a stroke within the last six months.
• You have low blood pressure or uncontrolled high blood pressure.
• You have ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as 'stroke of the eye'.
• You are taking riociguat. This drug is used to treat certain forms of high blood pressure in the lungs. PDE5 inhibitors, such as Tadalafil, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure, tell your doctor.

When should this medicine be used with caution?

Be aware that sexual activity carries a possible risk to patients with heart disease because it puts 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 or undesired or prolonged erections lasting more than four hours.
• A serious liver problem.
• A serious kidney problem.
• Any hereditary eye disease.
• Any heart problems other than your pulmonary hypertension.
• Problems with your blood pressure.

Tadalafil is not intended for use by women and adolescents under the age of 18.

Are you currently taking any medications? Some medicines may be affected by Tadalafil or they may affect how well Tadalafil 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.
• Nitrates (for chest pain).
• Riociguat.
• A 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• Protease inhibitors for treatment of AIDS or HIV infection (ritonavir).
• Phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
• Rifampicin, erythromycin or clarithromycin (used to treat infections).
• Medicines such as ketoconazole or itraconazole (antifungal medicines).
• Bosentan (another treatment for pulmonary arterial hypertension).
• Other treatments for erectile dysfunction (PDE5 inhibitors).

For more warnings about the use of Tadalafil, please see the package leaflet.

Tadalafil may 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.
• Chest pain - do not use nitrates but seek immediate medical assistance.
• Priapism, a prolonged and possibly painful erection after taking Tadalafil. If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
• Sudden loss of vision.

The most common side effects of Tadalafil are:

• Headache.
• Muscle ache.
• Pain in arms and legs.
• Facial flushing.
• Nasal congestion.
• Digestive problems.
• Dizziness (alcohol is likely to intensify this side effect).

For a complete list of side effects, see the package leaflet. Consult a doctor if you experience side effects, also if the side effects are not listed on the package leaflet.

The active ingredient is tadalafil. Each film-coated tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg of tadalafil.

The other ingredients are:

• Tablet core: lactose monohydrate, sodium laurilsulfate, povidone K12, crospovidone type B, sodium stearyl fumarate.
• Film coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, iron oxide yellow (E172).

The manufacturer of Tadalafil is:

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia

Read the package leaflet before use.