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PACKAGE LEAFLET

Uprima® 3 mg
apomorphine hydrochloride

Read all of this leaflet carefully before you start taking this medicine.
* Keep this leaflet. You may need to read it again.
* If you have further questions, please ask your doctor or your pharmacist.
* This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.


In this leaflet:

1. What Uprima is and what it is used for
2. Before you take Uprima
3. How to take Uprima
4. Possible side effects
5. Storing Uprima

Uprima 3 mg sublingual tablets
apomorphine hydrochloride

Each tablet contains 3 mg of apomorphine hydrochloride, equivalent to 2.56 mg of apomorphine.

The other ingredients are: microcrystalline cellulose, hypromellose, citric acid, magnesium stearate, ascorbic acid, disodium edetate, silicon dioxide, red iron oxide (E172), acesulfame potassium, Orange mint flavour (WONF WL-28499) and mannitol.

The Marketing Authorisation holder and the manufacturer of Uprima is Abbott Laboratories
Ltd, Queenborough, Kent ME11 5EL, United Kingdom

1. WHAT UPRIMA IS AND WHAT IT IS USED FOR

Uprima tablets are sub-lingual tablets each containing 3 mg of apomorphine (as hydrochloride). The 3 mg tablet is available in packs of 2 and 4 sublingual tablets.

Uprima 3 mg tablets are brick red in colour and are triangle shaped embossed with 3 on one side and the Abbott logo on the other side.

Uprima is a medicine known as a dopaminergic agonist which helps men achieve an erection by stimulating the region of the brain, called the hypothalamus, thereby helping to produce the natural signals which start the erection process in the penis. Sexual stimulation is necessary for Uprima to work. Uprima is different to morphine and has no morphine-like properties.

Uprima is a therapy for the treatment of men with erectile dysfunction (sometimes called ED or impotence). This is a condition in which a man cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual performance.

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2. BEFORE YOU TAKE UPRIMA

Do not take Uprima if:

* You have ever had an allergic reaction to apomorphine or any of the ingredients in Uprima. Possible signs of an allergic reaction include rash, itching, swollen face or lips and shortness of breath. Tell your Doctor if you get any of these.
* You have severe unstable angina, recent myocardial infarction, severe heart failure or hypotension, and other medical conditions which could make sexual activity dangerous. Always consult your Doctor about your medical history.
* Your partner is pregnant or breastfeeding

You should tell your Doctor if:

* You have a deformity or disease of the penis as these may require special care when using medicines such as Uprima.
* You experience severe dizziness/lightheadedness or feel faint after taking Uprima, especially if you also have severe nausea or vomiting, sweating, become pale or become unusually hot. In these cases you should not attempt to stand up. If you experience these symptoms or feel faint for any reason you should lie down and raise your legs. The feeling of faintness should go away.
* You are taking nitrates (often used for the relief of angina or chest pains) or any medicines for hypertension (high blood pressure).
* You have liver or kidney problems. Your suitability for Uprima and/or the appropriate dose may need to be considered by your doctor.
* You have abnormally high or low blood pressure or are prone to dizzy spells or fainting.
* You are taking any other treatment for erectile dysfunction. Uprima should not be used with any other treatment for erectile dysfunction.

Uprima should not be given to children under the age of 18. No dose adjustment is required for the elderly.

Taking alcohol with Uprima can increase any undesirable effects, in particular low blood
pressure. In addition, taking alcohol can make it more difficult to obtain an erection. .

Not for use in women.

Driving and using machines:

Because some patients can experience dizziness, lightheadedness and, uncommonly fainting, it is recommended that you do not drive or operate machinery for at least 2 hours after taking Uprima or until any such symptoms are fully resolved.

Taking other medicines: Please inform your doctor if:

* You are taking nitrates (often used for the relief of angina or chest pains) or any medicines for hypertension (high blood pressure).
* You are taking drugs which affect the dopamine system (often used to treat Parkinson's disease, disturbances of the mind or to prevent vomiting).

You should also inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

| Back |

3. HOW TO TAKE UPRIMA

Your Doctor will decide the dose of Uprima which is suitable for you. Do not take more tablets than your Doctor has prescribed. All patients should begin with the 2 mg tablet. If your erection is not sufficient for satisfactory sexual activity at this dose and you have not experienced side effects, you may increase the dose to the 3 mg tablet following consultation with your doctor. You should not take more than 3 mg in any 8 hour period.

When taking Uprima:

* Swallow a small amount of water to help moisten your mouth
* Place one tablet of Uprima under your tongue. The tablet will not work if you swallow it.
* Let the tablet dissolve under your tongue - this usually takes about 10 minutes (if any tablet residue is left after 20 minutes it may be swallowed).
* Sexual activity may begin as soon as the Uprima is placed under your tongue and you may proceed with intercourse when you and your partner are ready.
* Typically erections may be achieved in under 20 minutes, although this varies from person to person.

You should not take more than 3 mg Uprima in any 8 hour period.

If Uprima does not help you get a satisfactory erection tell your Doctor as your dose may need adjustment.

You should only take Uprima as directed. If you take too many tablets or the wrong dose, contact your Doctor.

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4. POSSIBLE SIDE EFFECTS

Like all medicines, Uprima can have side effects. These are generally mild and transient in nature.

Common undesirable effects are nausea, headache, dizziness, yawning, sleepiness, infection, sore throat, pain, increased cough, rhinitis, flushing, taste disorder and sweating.

Uncommonly, fainting has occurred. If you feel faint, follow the instructions given under 'Do not take Uprima:'

If you have chest pains during intercourse, you should stop immediately and contact your doctor.

If you have any undesirable effect which is severe or prolonged you should tell your Doctor. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. STORING UPRIMA

Keep out of the reach and sight of children

Store your Uprima in the original package. Do not use this medicine after the expiry date shown on the pack, or if the pack has been damaged or tampered with.

Further information

| Back |

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.



This leaflet was last approved in May 2001.

100-264-201






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