IXENSE ® 3-mg sublingual tablets

Apomorphine hydrochloride
The active ingredient is apomorphine.
Each tablet contains:
Apomorphine .... 2.56 mg
As apomorphine hydrochloride .... 3.00 mg
The other ingredients are microcrystalline cellulose, hypromellose, citric acid, magnesium stearate, ascorbic acid, disodium edetate, silicon dioxide, red iron oxide, (E172), acesulfame potassium, mint/orange aroma (WONF WL-28499) and mannitol.

WHAT IXENSE ® IS AND WHAT IT IS USED FOR

Ixense ® 3-mg tablets are sublingual tablets. Each tablet contains 3 mg of apomorphine (as hydrochloride). The 3-mg tablet is available in boxes of 2, 4, 8 and 12 sublingual tablets (as hydrochloride). Ixense ® 3-mg tablets are brick red in colour, triangular shaped with a "3" embossed on one side and the Takeda logo on the other side.

Ixense ® is a medicine known as a dopaminergic agonist, which helps men achieve erection by stimulating the region of the brain called the hypothalamus, thus facilitating the production of natural signals that initiate the process of penile erection. Sexual stimulation is necessary for Ixense ® to act. Ixense ® is different from morphine and does not have morphine-like properties.

Ixense ® is a pharmaceutical product designed to treat men who suffer from erection problems (at times referred to as erectile dysfunction or impotence). Men with this disorder cannot obtain or maintain a strong enough erection to experience satisfactory sexual performance.

WHAT YOU SHOULD KNOW ABOUT IXENSE ® BEFORE TAKING IT

Do not take Ixense ®:

• If you have ever previously had an allergic reaction to apomorphine or to any of the ingredients in Ixense ®. Possible signs of allergic reaction include skin rash, itchiness, swollen face or lips and shortness of breath. Notify your doctor if you notice any of these signs.
• If you have a cardiac problem, such as unstable angina, a recent case history of myocardial infarction, severe cardiac insufficiency or hypotension, or any other ailment that might make sexual activity dangerous. Always consult your doctor with regard to your medical history
• If your partner is pregnant or breast-feeding.

Special precautions when taking Ixense ®

Notify your doctor:

• If you have a deformity or disease of the penis which may require special care when using pharmaceutical products such as Ixense ®.
• If you suffer from severe dizziness/giddiness or feel unwell after taking Ixense ®, especially if, at the same time, you suffer severe nausea or vomiting, perspiration, pallor, or if you feel unusually hot. In such cases, do not attempt to stand up. If you experience these symptoms or feel at all unwell, lie down and raise your legs. The feeling of discomfort will disappear.
• If you are taking nitrate derivatives (often used for the treatment of angina or chest pains), or medication for the treatment of hypertension (high blood pressure).
• If you have liver or kidney problems. Your doctor may have to reconsider the suitability of your taking Ixense ® and/or if the dosage should be modified.
• If you have abnormally high or low blood pressure or are subject to dizziness or giddiness.
• If you are taking any other treatment for erectile dysfunction. Ixense ® must not be used together with other treatments for erectile dysfunction.

Ixense ® must not be administered to those under 18 years of age. In elderly patients, there is no need to modify the dosage.

Taking Ixense ® with food and drink

Alcohol consumption during Ixense ® treatment may intensify adverse side effects and, in particular, low blood pressure. Moreover, the consumption of alcohol can make achieving erection more difficult.

Pregnancy and breast-feeding

Not for use in women

Driving or operating machinery

Because certain patients may suffer dizziness, giddiness or, in rare cases, loss of consciousness, patients are recommended to wait at least two hours before driving or operating machinery, or until the symptoms have completely subsided.

Taking other pharmaceutical products

Please notify your doctor:

• If you are taking nitrate derivatives (often used to treat angina or chest pains) or medication for the treatment of hypertension (high blood pressure).
• If you are taking medication that acts on the dopaminergic system (often used to treat Parkinson's disease, psychological disturbances or to prevent vomiting).

Please also notify your doctor or chemist if you are taking, or have recently taken, any other medication, even if non-prescribed.

HOW TO TAKE IXENSE ®

Your doctor will decide the Ixense ® dosage that best suits your needs. Do not take more tablets than prescribed. All patients should begin treatment with a 2-mg tablet. Should your erection be insufficient for experiencing satisfactory sexual performance with this dosage, and you have not suffered adverse side effects, you may increase the dose to the 3-mg tablet, but only after consulting your doctor. Do not take more than 3 mg over an 8-hour period.

When taking Ixense ®:

• Drink a small amount of water to moisten the mouth area
• Place the tablet under your tongue. The tablet will not provide the desired results if swallowed.
• Let the tablet dissolve under the tongue. This will take approximately 10 minutes (any residue remaining after 20 minutes may be swallowed).
• Sexual activity may begin once Ixense ® is under your tongue and sexual intercourse may take place once you and your partner are ready.
• In general, erection is achieved in less than 20 minutes, although this can vary from one person to another.

Do not take more than 3 mg of Ixense ® in an 8-hour period.

If Ixense ® does not help you to achieve a satisfying erection, notify your doctor, since the dosage may need to be adjusted. Take Ixense ® only as prescribed. If you have taken too many tablets or the wrong dosage, contact your doctor.

POSSIBLE SIDE AFFECTS

Like all pharmaceutical products, Ixense ® can cause side effects.

In general, these are mild and temporary. The most frequent side effects are nauseas, headaches, dizziness, yawning, drowsiness, infection, sore throat, pain, increased cough, rhinitis, flushing, taste disorder and perspiration.

Rare cases have been reported of loss of consciousness. If you feel faint, follow the directions given in the section "Do not take Ixense ®".

If you feel chest pains during sexual intercourse, stop immediately and consult your doctor.

Should you have any adverse side effects that are severe or prolonged, notify your doctor. Also, if you notice any side effects not mentioned in this insert, report these to your doctor or chemist.

STORING IXENSE ®

Keep out of children's reach and sight. Store Ixense ® in its original packaging. Do not use Ixense ® after the expiry date marked on the box. Do not use Ixense ® if you believe the packaging to be damaged or tampered with.