Exelon 2 mg/ml solucion oral

Package Leaflet: Information for the User

Exelon 2 mg/ml Oral Solution

rivastigmina

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.See section4.

1.What Exelon is and what it is used for

2.What you need to know before you start taking Exelon

3.How to take Exelon

4.Possible side effects

5.Storage of Exelon

6.Contents of the pack and additional information

The active ingredient of Exelon is rivastigmine.

Rivastigmine belongs to a group of substances called cholinesterase inhibitors. In patients with Alzheimer's disease or Parkinson's disease-associated dementia, certain nerve cells die in the brain, resulting in low levels of acetylcholine neurotransmitters (a substance that allows nerve cells to communicate with each other). Rivastigmine acts by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Exelon allows for an increase in acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.

Exelon is used for the treatment of adult patients with mild to moderately severe Alzheimer's disease, a progressive brain disorder that gradually affects memory, intellectual capacity, and behavior. The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson's disease.

Do not take Exelon

• if you are allergic to rivastigmine (the active ingredient in Exelon) or to any of the other ingredients (listed in section 6).
• if you have a skin reaction that spreads beyond the size of the patch, if there is a more intense local reaction (such as blisters, increased skin inflammation, swelling) and if it does not improve within 48 hours after removing the transdermal patch.

If you are in any of these situations, inform your doctor and do not take Exelon.

Warnings and precautions

Consult your doctor before starting to take Exelon:

• if you have or have had any irregular or slow heart rhythm.

• if you have or have had any active stomach ulcer.
• if you have or have had any difficulty urinating.
• if you have or have had any seizures.
• if you have or have had any severe respiratory disease or asthma.
• if you have or have had any kidney function deterioration.
• if you have or have had any liver function deterioration.
• if you have tremors.
• if you have a low body weight.
• if you have gastrointestinal reactions such as dizziness (nausea), vomiting, and diarrhea. You may become dehydrated (loss of a large amount of fluid) if vomiting or diarrhea is prolonged.

If you are in any of these situations, your doctor may consider the need for closer monitoring while you are being treated.

If you have not taken Exelon for more than three days, do not take the next dose until you have consulted your doctor.

Children and adolescents

Exelon should not be used in pediatric patients for the treatment of Alzheimer's disease.

Other medications and Exelon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Exelon should not be administered at the same time as other medications with similar effects to Exelon. Exelon may interfere with anticholinergic medications (used to relieve stomach cramps or spasms, for the treatment of Parkinson's disease, or to prevent travel sickness).

Exelon should not be administered at the same time as metoclopramide (a medication used to relieve or prevent nausea and vomiting). Taking the two medications together may cause problems such as stiffness in the limbs and hand tremors.

If you need to undergo surgery while taking Exelon, inform your doctor before any anesthetic is administered, as Exelon may enhance the effects of some muscle relaxants during anesthesia.

Care should be taken when Exelon is used with beta blockers (medications such as atenolol used to treat hypertension, angina, and other heart conditions). Taking the two medications together may cause complications such as a decrease in heart rate (bradycardia) that may lead to dizziness or loss of consciousness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant, it is necessary to evaluate the benefits of using Exelon against the possible adverse effects on the fetus. Exelon should not be used during pregnancy unless it is clearly necessary.

You should not breastfeed during treatment with Exelon.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive or use machinery safely. Exelon may cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dose. If you feel dizzy or drowsy, do not drive, operate machinery, or perform other tasks that require your attention.

Exelon contains sodium benzoate

One of the inactive ingredients in Exelon oral solution is sodium benzoate. Benzoic acid is slightly irritating to skin, eyes, and mucous membranes.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor, pharmacist, or nurse again.

Starting treatment

Your doctor will tell you how much Exelon you should take.

• Normally, treatment starts with a low dose.
• Your doctor will gradually increase the dose depending on how you respond to treatment.
• The highest dose you should take is6.0mg twice a day.

Your doctor will regularly check if the medication is working for you. Your doctor will also monitor your weight while you are taking this medication.

If you have not taken Exelon for more than three days, do not take the next dose until you have consulted your doctor.

Taking this medication

• Inform your caregiver that you are taking Exelon.
• To benefit from your medication, take it every day.

• Take Exelon twice a day (morning and night), with meals.

How to use this medication

If you take more Exelon than you should

If you accidentally take more Exelon than you should, inform your doctor. You may need medical attention. Some people who have taken accidental higher doses have experienced dizziness (nausea), vomiting, diarrhea, high blood pressure, and hallucinations.It may also cause a slowing of heart rate and fainting.

If you forget to take Exelon

If you forget your Exelon dose, wait and take the next dose at the usual time. Do not take a double dose to make up for the missed doses.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You may experience side effects more frequently when you start treatment or when your dose is increased. Side effects usually disappear gradually as your body gets used to the medicine.

Very common(may affect more than1 in every10people)

• Dizziness
• Loss of appetite
• Stomach problems such as dizziness (nausea), vomiting, diarrhea

Common(may affect up to1in every10people)

• Anxiety

• Sweating
• Headache
• Heartburn
• Weight loss
• Abdominal pain
• Restlessness
• Feeling tired or weak
• General feeling of discomfort
• Trembling or feeling confused
• Loss of appetite
• Nightmares

Uncommon(may affect up to1in every100people)

• Depression
• Difficulty sleeping
• Fainting or accidental falls
• Changes in liver function

Rare(may affect up to1in every1,000people)

• Chest pain
• Rash, itching
• Seizures (convulsions)
• Ulcers in the stomach or intestine

Very rare(may affectup to1in every10,000people)

• High blood pressure
• Urinary tract infection
• Seeing things that are not there (hallucinations)
• Problems with your heart rhythm such as a fast or slow heart rate
• Gastrointestinal bleeding – presents as blood in the stool or vomiting blood
• Inflammation of the pancreas – symptoms include severe pain in the upper abdomen, often with dizziness (nausea) or vomiting
• Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty moving, and muscle weakness

Unknown(cannot be estimated from available data)

• Vomiting that can cause tearing of part of the digestive tube that connects your mouth to your stomach (esophagus)
• Dehydration (loss of a large amount of fluid)
• Liver disorders (yellowing of the skin, yellowing of the white of the eyes, abnormal darkening of the urine, unexplained nausea, vomiting, fatigue, and loss of appetite)
• Aggression, feeling restless
• Irregular heartbeat

Patients with dementia or Parkinson's disease

These patients experience some side effects more frequently and also have some additional side effects:

Very common(may affect more than1 in every10people)

Common(may affect up to1in every10people)

Uncommon(may affect up to1in every100people)

• Irregular heartbeat and loss of movement control

Other side effects observed with Exelon transdermal patches and may appear with oral solution:

Common(may affect up to1in every10people)

• Fever
• Severe confusion
• Urinary incontinence (inability to stop urinating properly)

Uncommon(may affect up to1in every100people)

• Hypervigilance (high level of activity, restlessness)

Unknown(cannot be estimated from available data)

• Allergic reaction where the patch was applied, such as blisters or skin inflammation

If you experience any of these side effects, contact your doctor as they may require medical attention.

Reporting side effects

If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through theAppendixV. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the reach and sight of children.
• Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.
• Do not store above 86°F (30°C). Do not refrigerate or freeze.
• Store in an upright position.
• Use Exelon oral solution within one month of the first opening of the bottle.
• Do not dispose of medications through drains or in the trash. Ask your pharmacist how to dispose of empty containers and unused medications. This will help protect the environment.

Exelon Composition

• The active ingredient is rivastigmine hydrogen tartrate. Each ml contains rivastigmine hydrogen tartrate equivalent to 2.0 mg of rivastigmine base.

• The other components are sodium benzoate, citric acid, sodium citrate, water-soluble quinoline yellow (E104) colorant, and purified water.

Appearance of the product and contents of the package

Exelon oral solution is presented as a transparent, yellow (2.0 mg/ml rivastigmine base) solution of 50 ml or 120 ml in amber glass bottles with a child-resistant closure, foam disk, submerged tube, and self-aligning stopper. Along with the oral solution, a syringe for oral dosing is included in a plastic tube.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Irlanda

Responsible for manufacturing

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Alemania

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu