RIVASTIGMINE SANDOZ 1.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Rivastigmine Sandoz 1.5mg hard capsules EFG

Rivastigmine Sandoz 3mg hard capsules EFG

Rivastigmine Sandoz 4.5mg hard capsules EFG

Rivastigmine Sandoz 6mg hard capsules EFG

rivastigmine

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Rivastigmine Sandoz and what is it used for
2. What you need to know before taking Rivastigmine Sandoz
3. How to take Rivastigmine Sandoz
4. Possible side effects
5. Storage of Rivastigmine Sandoz
6. Package contents and additional information

1. What is Rivastigmine Sandoz and what is it used for

The active substance of Rivastigmine Sandoz is rivastigmine.

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

Rivastigmine Sandoz is used to treat adult patients with mild to moderately severe Alzheimer's disease, a progressive brain disorder that gradually affects memory, intellectual ability, and behavior. The capsules and oral solution can also be used to treat dementia in adult patients with Parkinson's disease.

2. What you need to know before taking Rivastigmine Sandoz

Do not take Rivastigmine Sandoz

• if you are allergic to rivastigmine (the active substance of Rivastigmine Sandoz) or to any of the other components of this medication (listed in section 6).
• if you have experienced a previous skin reaction suggestive of allergic contact dermatitis with rivastigmine.

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

Warnings and precautions

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

• if you have or have had a heart problem, irregular or slow heart rhythm, prolonged QTc interval, family history of prolonged QTc interval, torsades de pointesor low potassium or magnesium levels 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 low body weight
• if you have gastrointestinal reactions such as a feeling of nausea, vomiting, and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea is prolonged
• if you experience skin reactions all over your body.

If you are in one of these situations, your doctor may consider it necessary to monitor you more closely while you are being treated.

If you have not taken Rivastigmine Sandoz for more than three days, do not take the next dose until you have spoken to your doctor.

Rivastigmine Sandoz is not recommended for use in children or adolescents (under 18 years of age).

Children and adolescents

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

Use of other medications and Rivastigmine Sandoz

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

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

Rivastigmine Sandoz should not be administered with metoclopramide (a medication used to relieve or prevent nausea and vomiting). Taking the two medications at the same time could cause problems such as stiffness of the limbs and hand tremors.

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

Be cautious when taking Rivastigmine Sandoz with beta-blockers (medications, such as atenolol, used to treat high blood pressure, angina, and other heart conditions). Taking the two medications at the same time could cause problems such as a decrease in heart rate (bradycardia), leading to fainting or loss of consciousness.

Be cautious when taking Rivastigmine Sandoz with other medications that may affect heart rate or the heart's electrical system (prolongation of the QT interval).

Pregnancy, breastfeeding, and fertility

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

If you are pregnant, the benefits of using Rivastigmine Sandoz should be evaluated against the potential effects on the fetus. Rivastigmine Sandoz should not be used during pregnancy, unless clearly necessary.

You should not breastfeed while taking Rivastigmine Sandoz.

Driving and using machines

Your doctor will indicate whether your condition allows you to drive or use machinery safely. Rivastigmine Sandoz may cause dizziness and drowsiness, mainly at the start of treatment or when the dose is increased. If you feel dizzy or drowsy, do not drive or use machinery, and do not perform other tasks that require your attention.

3. How to take Rivastigmine Sandoz

Follow the administration instructions of this medication exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

How to start treatment:

Your doctor will indicate what dose of Rivastigmine Sandoz 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 is 6 mg twice a day.

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

If you have not taken Rivastigmine 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 Rivastigmine Sandoz.
• To benefit from your medication, take it every day.
• Take Rivastigmine Sandoz twice a day (in the morning and at night), with meals.
• Swallow the capsule whole with the help of a liquid.
• Do not open or crush the capsule.

If you take more Rivastigmine Sandoz than you should

If you accidentally take more Rivastigmine Sandoz than you should, inform your doctor. You may need medical attention. Some people who have taken accidentally higher doses have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. There may also be a slowing of the heart rate and fainting.

If you forget to take Rivastigmine Sandoz

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

If you have any doubts about the use of this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

You may experience side effects more frequently when you start taking your medication or when your dose is increased. Generally, side effects will disappear slowly as your body gets used to the medication.

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

• Nausea
• Lack of appetite
• Stomach problems such as nausea, vomiting, diarrhea

Common(may affect up to 1 in 10 patients)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Restlessness
• Feeling of fatigue or weakness
• Feeling of general discomfort
• Tremors or confusion
• Decreased 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 1,000 patients)

• Chest pain
• Skin rash, itching
• Seizures
• Ulcers in your stomach or intestine

Very rare(may affect up to 1 in 10,000 patients)

• High blood pressure
• Urinary tract infection
• Seeing things that do not exist (hallucinations)
• Heart rhythm problems such as fast or slow heart rate
• Gastrointestinal bleeding - manifested as blood in the stool or when vomiting
• Pancreatitis - signs include severe pain in the upper abdomen, often with nausea or vomiting
• Worsening of Parkinson's disease symptoms or development of similar symptoms - such as muscle stiffness, difficulty moving

Not known(frequency cannot be estimated from the available data)

• Severe vomiting that can cause a tear in 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 whites of the eyes, abnormal darkening of urine or unexplained nausea, vomiting, fatigue, and loss of appetite)
• Aggression, restlessness
• 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)

• Tremors
• Fainting
• Accidental falls

Common(may affect up to 1 in 10 patients)

• Anxiety
• Restlessness
• Fast or slow heart rate
• Difficulty sleeping
• Excessive saliva and dehydration
• Abnormally slow movements or movements that cannot be controlled
• Worsening of Parkinson's disease symptoms or development of similar symptoms - such as muscle stiffness, difficulty moving, and muscle weakness

Uncommon(may affect up to 1 in 100 patients)

• Irregular heartbeat and loss of movement control

Other side effects observed in transdermal patches and that may occur 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)

• Hyperactivity (high level of activity, agitation)

Not known(frequency cannot be estimated from the 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 you may need medical attention.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Rivastigmine Sandoz

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

Do not use Rivastigmine Sandoz after the expiration date stated on the blister, bottle, and carton after "EXP" or "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

Do not store above 30°C.

6. Package Contents and Additional Information

Rivastigmine Sandoz Composition

• 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 Rivastigmine Sandoz 1.5 mg capsule contains 1.5 mg of rivastigmine.

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

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

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

Product Appearance and Package Contents

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

• Rivastigmine Sandoz 3 mg hard capsules contain a white to slightly yellowish powder, with an orange cap and body, and a red printed mark "RIV 3 mg" on the body.

• Rivastigmine Sandoz 4.5 mg hard capsules contain a white to slightly yellowish powder, with a red cap and body, and a white printed mark "RIV 4.5 mg" on the body.

• Rivastigmine Sandoz 6 mg hard capsules contain a white to slightly yellowish powder, with a red cap and an orange body, and 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

Manufacturer

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 was last revised in

Detailed information on this medication is available on the European Medicines Agency website http://www.ema.europa.eu