Prospect: Patient Information

Rivastigmina Sandoz 1.5mg Hard EFG Capsules

Rivastigmina Sandoz 3mg Hard EFG Capsules

Rivastigmina Sandoz 4.5mg Hard EFG Capsules

Rivastigmina Sandoz 6mg Hard EFG Capsules

rivastigmina

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribedonlyto you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

The active ingredient of Rivastigmina Sandoz is rivastigmina.

Rivastigmina belongs to the group of substances known as cholinesterase inhibitors. In patients with Alzheimer's disease or dementia due to Parkinson's disease, certain nerve cells in the brain die, resulting in a reduction of the levels of acetylcholine neurotransmitter (a substance that allows communication between nerve cells). Rivastigmina blocks the enzymes that destroy acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Rivastigmina Sandoz allows increasing the levels of acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.

Rivastigmina Sandoz 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 Rivastigmina Sandoz

• if you are allergic to rivastigmine (the active ingredient in Rivastigmina Sandoz) or to any of the other ingredients (listed in section 6).

• if you have had a previous skin reaction suggestive of contact dermatitis with rivastigmine.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rivastigmina Sandoz.

• if you have or have had any heart problems, such as irregular or slow heart rhythm, prolonged QTc interval, family history of prolonged QTc interval, torsades de pointes, or low levels of potassium or magnesium in the blood.
• if you have or have had an active stomach ulcer
• if you have or have had difficulty urinating
• if you have or have had seizures
• if you have or have had asthma or a severe respiratory disease
• if you have or have had kidney function impairment
• if you have or have had liver function impairment
• if you suffer from tremors
• if you have a low body weight
• if you have gastrointestinal reactions such as dizziness (nausea), vomiting, and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea are prolonged
• if you experience skin reactions all over your body.

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 Rivastigmina Sandoz for more than three days, do not take the next dose until you have spoken with your doctor.

Rivastigmina Sandoz is not recommended for use in children or adolescents (under 18 years old).

Children and adolescents

There is no specific recommendation for the use of Rivastigmina Sandoz in the pediatric population for the treatment of Alzheimer's disease.

Use of other medicines and Rivastigmina Sandoz

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

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

Rivastigmina Sandoz should not be administered with metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together may cause problems such as stiffness of the limbs and tremor of the hands.

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

Be cautious when taking Rivastigmina Sandoz with beta-blockers (medicines, such as atenolol, used to treat hypertension, angina, and other heart conditions). Taking the two medicines together may cause problems such as bradycardia (slow heart rate), leading to dizziness or loss of consciousness.

Be cautious when taking Rivastigmina Sandoz with other medicines that may affect heart rhythm or the electrical system of the heart (prolongation of the QT interval).

Pregnancy, breastfeeding, and fertility

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

If you are pregnant, the benefits of using Rivastigmina Sandoz should be weighed against the possible effects on the fetus. Rivastigmina Sandoz should not be used during pregnancy, unless it is clearly necessary.

You should not breastfeed your children during treatment with Rivastigmina Sandoz.

Driving and operating machinery

Your doctor will tell you if your condition allows you to drive or use machinery safely. Rivastigmina Sandoz 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, use machinery, or perform other tasks that require your attention.

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

Starting treatment:

Your doctor will tell you what dose of Rivastigmina Sandoz you should take.

• Normally, treatment starts with a low dose.
• Your doctor will gradually increase the dose depending on how you respond to the treatment.
• The highest dose you should take is 6 mg 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 Rivastigmina Sandoz 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 Rivastigmina Sandoz.
• To benefit from your medication, take it every day.
• Take Rivastigmina Sandoz twice a day (in the morning and at night), with meals.
• Swallow the capsule whole with liquid.
• Do not open or crush the capsule.

If you take more Rivastigmina Sandoz than you should:

If you accidentally take more Rivastigmina Sandoz than you should, inform your doctor. You may require 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 Rivastigmina Sandoz:

If you forget your dose of Rivastigmina Sandoz, 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 doubts about using this medication, consult 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 first start taking your medicine or if your dose is increased. Side effects usually fade away as your body gets used to the medicine.

Very common(may affect more than 1 in 10 patients)

• Dizziness
• Loss of appetite
• Stomach problems such asdizziness (nauseas), vomiting, diarrhea

Common(may affect up to 1 in 10 patients)

• Anxiety
• Sweating
• Headache
• Heat
• Weight loss
• Stomach pain
• Feeling agitated
• Feeling tired or weak
• General feeling of discomfort
• Shakiness or feeling confused
• Loss of appetite
• Nightmares

Uncommon(may affect up to 1 in 100 patients)

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

Rare(may affect up to 1 in 1000 patients)

• Chest pain
• Cutaneous rash, itching
• Seizures (convulsions)
• Ulcersin the stomach or intestine

Very rare(may affect up to 1 in 10000 patients)

• High blood pressure
• Urinary tract infection
• Seeing things that do not exist (hallucinations)
• Problemswith heart rhythm such as rapid or slow heart rate
• Gastrointestinal bleeding – presents as blood in the stool or vomiting blood
• Pancreatitis – symptoms include severe pain in the upper abdomen, often with dizziness (nauseas) or vomiting
• Worsening of Parkinson's disease symptoms or development of similar symptoms–such as muscle stiffness, difficulty moving, and muscle weakness

Unknown(frequency cannot be estimated from available data)

• Intense vomiting that may cause tearing of part of the digestive tube that connects your mouth to your stomach (esophagus)
• Dehydration (loss of large amounts of fluid)
• Liver disorders (yellowing of the skin, yellowing of the white of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, fatigue, and loss of appetite)
• Aggression, feeling restless
• Irregular heart rhythm

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 than 1 in 10 patients)

• Tremor
• Fainting
• Accidental falls

Common(may affect up to 1 in 10 patients)

• Anxiety
• Feeling uneasy
• Irregular heart rhythm
• Difficulty sleeping
• Excessive saliva and dehydration
• Abnormally slow or uncontrolled movements
• Worsening of Parkinson's disease symptoms or development of similar symptoms–such as muscle stiffness, difficulty moving, and muscle weakness

Uncommon(may affect 1 in 100 patients)

• Irregular heart rhythm and loss of movement control

Other side effects observed in transdermal patches and that may appear with hard capsules:

Common(may affect up to 1 in 10 patients)

• Fever
• Severe confusion
• Urinary incontinence (inability to retain urine)

Uncommon(may affect up to 1 in 100 patients)

Unknown(frequency cannot be estimated from available data)

• Allergic reaction at the patch application site, 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 or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in Appendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use Rivastigmina Sandoz after the expiration date that appears on the blister pack, bottle, and box after “EXP” or “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Ask your pharmacist how to dispose ofthe packaging and the medicines that you no longerneed.By doing so, you will help protect the environment.

Do not store at a temperature above 30°C.

Composition of Rivastigmina Sandoz

• The active ingredient is rivastigmine.
• The other components are hypromellose, magnesium stearate, microcrystalline cellulose, colloidal silica, gelatin, yellow iron oxide, red iron oxide, titanium dioxide, and shellac.

Each capsule of Rivastigmina Sandoz 1.5 mg contains 1.5 mg of rivastigmine.

Each capsule of Rivastigmina Sandoz 3 mg contains 3 mg of rivastigmine.

Each capsule of Rivastigmina Sandoz 4.5 mg contains 4.5 mg of rivastigmine.

Each capsule of Rivastigmina Sandoz 6 mg contains 6 mg of rivastigmine.

Appearance of the product and contents of the package

• Rivastigmina Sandoz 1.5 mg hard capsules, contain a white to slightly yellowish powder, have a yellow cap and a yellow body with a red printed mark “RIV 1.5 mg” on the body.

• Rivastigmina Sandoz 3 mg hard capsules, contain a white to slightly yellowish powder, have a yellow cap and an orange body with a red printed mark “RIV 3 mg” on the body.

• Rivastigmina Sandoz 4.5 mg hard capsules, contain a white to slightly yellowish powder, have a red cap and a white printed mark “RIV 4.5 mg” on the body.

• Rivastigmina Sandoz 6 mg hard capsules, contain a white to slightly yellowish powder, have a red cap and an orange body with a red printed mark “RIV 6 mg” on the body.

It is packaged in blisters and is available in three different presentations (28, 56 or 112 capsules).

Marketing Authorization Holder

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

Responsible for manufacturing

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Salutas Pharma Gmbh

Otto-Von-Guericke-Allee 1, Barleben,

Saxony-Anhalt, 39179,

Germany

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

This leaflet has been revised in

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