EXELON®

1.5mg, 3mg, 4.5mg and 6mg Capsules

Rivastigmine hydrogen tartrate

What Exelon is used for

Exelon is used to treat a condition called Alzheimer's disease.

Alzheimer's disease is a condition in which changes in the brain cause problems with memory, thinking and behaviour. These problems gradually become worse with time.

Exelon works by preventing the breakdown of a chemical in the brain called acetylcholine. This chemical is needed to help keep the brain working properly.

Exelon helps to slow down the mental decline that happens in people with Alzheimer's disease and it helps to improve the ability to cope with everyday activities. It does not cure the condition.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Exelon is only available with a doctor's prescription. It is not addictive.

Before you take Exelon

Do not take Exelon if you have had an allergic reaction to any of the following:

• rivastigmine, the active ingredient in Exelon
• any of the other ingredients of Exelon listed at the end of this leaflet.
• other related "carbamate" medicines (if you are unsure about these, ask your doctor or pharmacist).

Symptoms of an allergic reaction may include wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash or hives on the skin.

Do not take Exelon if you have a severe liver disorder. There is no information on the use of this medicine in people with severe liver problems.

Do not take Exelon after the expiry date printed on the pack. If you use it after the expiry date has passed, it may not work as well as it should.

Do not take Exelon if the packaging is torn or shows signs of tampering. In that case, return it to your pharmacist.

Do not give Exelon to children. It is not known how Exelon will affect children.

If you are not sure whether you should start taking Exelon, talk to your doctor or pharmacist.

Before you start to take it

Tell your doctor if you have any of the following conditions:

• a problem with your heart
• a history of stomach ulcer
• problems with your lungs such as asthma, bronchitis or emphysema
• difficulty passing urine (water)
• seizures (fits)
• problems with your kidneys or liver

If you have any of the above conditions, your doctor may want to take special precautions while you are taking Exelon.

Tell your doctor if you are pregnant or breast-feeding. Ask your doctor about the risks and benefits of taking Exelon in this case. It is not known whether taking Exelon during pregnancy may effect your baby. Breast-feeding is not recommended while you are taking this medicine. It is not known whether the active ingredient in Exelon passes into the breast milk and could affect your baby.

Tell your doctor if you smoke. Nicotine can affect the amount of Exelon that is in your body. A sudden change in your usual smoking habit can also change the effects of Exelon.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Other medicines may be affected by Exelon or they may affect how well Exelon works. These include:

• cholinergic medicines (e.g. bethanecol, medicines used during surgery)
• anticholinergic medicines (e.g. medicines for stomach cramps, medicines for travel sickness, many medicines used to treat mental illness)
• non-steroidal anti-inflammatory drugs (NSAIDs), which are medicines used to treat arthritis and other painful conditions such as muscle strains, back pain, menstrual cramps and migraine.

You may need to take different amounts of your medicines or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Exelon.

If you have not told your doctor about any of these things, tell him/her before you take Exelon.

How to take Exelon

Follow all directions given to you by your doctor and pharmacist carefully. These instructions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much to take

The usual starting dose is 1.5 mg twice a day. After two weeks, if you don't have any problems with the medicine, the dose may be gradually increased up to a maximum of 6 mg twice a day.

If for any reason you stop taking Exelon for more than several days, tell your doctor before you start taking Exelon again. Your doctor will restart you at the lowest dose to help prevent side effects such as nausea and vomiting.

How to take it

Swallow the capsules whole with a full glass of water or other liquid, with your morning and evening meals.

Do not open or crush the capsules.

Take Exelon at about the same time each day. Taking your capsules at the same time each day will have the best effect. It will also help you remember when to take the capsules.

How long to take it

Continue taking Exelon for as long as your doctor tells you to. This medicine helps to slow the progression of Alzheimer's disease but does not cure it. Your treatment can be continued for as long as it benefits your condition. Your doctor can give you more information.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the one that you missed. This may increase the chance of you getting an unwanted side effect.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Local Poisons Information Centre, or go to the Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Exelon. Do this even if there are no signs of discomfort or poisoning.

Keep the telephone numbers for these places handy.

Most people who have accidentally taken too much Exelon have not had any major problems and have not needed special treatment. A few people have had severe nausea (feeling sick), vomiting and diarrhoea. A slow heartbeat and breathing, excess saliva, sweating, low blood pressure, muscle weakness, fainting and seizures (fits) may also happen.

While you are taking Exelon

Things you must do

Be sure to keep all of your doctor's appointments so your progress can be checked. You and your caregiver can help to produce the maximum benefit from your treatment by keeping in close contact with your doctor.

Make sure you or your caregiver tell your doctor if you experience considerable nausea and vomiting with loss of appetite and weight loss.

If you become pregnant while taking Exelon, tell your doctor.

If you are going to have surgery, tell your doctor and anaesthetist that you are taking Exelon. Exelon may affect some medicines you receive during surgery.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Exelon.

Tell any other doctor, dentist or pharmacist who treats you that you are taking Exelon.

Things you must not do

Do not give this medicine to anyone else, even if their condition seems similar to yours.

Do not use Exelon to treat any other complaints unless your doctor tells you to.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Exelon, even if you do not think it is connected with the medicine. All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

• nausea (feeling sick) or vomiting
• diarrhoea
• loss of appetite
• stomach pains
• indigestion, burping, wind
• constipation
• weight loss
• dizziness or spinning sensation (vertigo)
• headache
• difficulty sleeping
• unusual tiredness or weakness, sleepiness, feeling generally unwell
• trembling or shakiness
• aches and pains
• mood changes such as anxiety, agitation, nervousness, depression or aggressive feelings
• hallucinations (hearing or seeing things that are not there)
• confusion
• unusual thinking (e.g. delusions, feeling paranoid)
• increased sweating
• runny or blocked nose
• increase in blood pressure
• slow heart beat
• symptoms of flu or chest infections such as shortness of breath, chest congestion, cough or sore throat
• frequent urge to urinate, pain on urination, loss of bladder control
• swelling of lower legs and hands due to fluid build up

The above side effects usually happen at the start of treatment when the dose is being increased. They are not usually serious and may gradually disappear as your body gets used to the medicine.

Women are more likely than men to get some side effects (e.g. nausea, vomiting, loss of appetite, weight loss).

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

• signs of allergy such as rash or hives on the skin; swelling of the face, lips, tongue or other parts of the body; wheezing or difficulty breathing
• chest pain
• severe dizziness, fainting or fits (seizures)
• vomiting blood or material that looks like coffee grounds
• bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea

The above side effects may be serious. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor if you notice anything else that is making you unwell. Other side effects not listed above may happen in some people.

After using Exelon

Storage

Keep your capsules in the original container until it is time to take them.

Store the capsules in a cool dry place where the temperature stays below 30°C or 86°F.

Do not store Exelon or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines. Exelon will keep well if it is cool and dry.

Keep the medicine where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Exelon or the capsules have passed their expiry date, ask your pharmacist what to do with any medicine you have left over.

Product description

What it looks like

Exelon is available in four strengths, in packs of 28 capsules.

• Exelon 1.5 mg: yellow capsules printed with "EXELON" and "1.5 mg" in red.
• Exelon 3.0 mg: orange capsules printed with "EXELON" and "3 mg" in red.
• Exelon 4.5 mg: red capsules printed with "EXELON" and "4.5 mg" in white.
• Exelon 6.0 mg: orange and red capsules printed with "EXELON" and "6 mg" in red.

Ingredients

Exelon capsules contain 1.5, 3.0, 4.5 or 6.0 mg of the active ingredient, rivastigmine (as the hydrogen tartrate salt).

They also contain:

• magnesium stearate
• hypromellose
• silica-colloidal anhydrous
• cellulose-microcrystalline
• gelatin
• iron oxide red (CI77491)
• iron oxide yellow (CI77492)
• titanium dioxide

   Inhouse Pharmacy Europe