Prospect: information for the patient

Rivastigmina Sandoz 2mg/ml oral solution EFG

rivastigmina

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

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

• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to other people, 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.

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

2.What you need to knowbefore starting totake Rivastigmina Sandoz

3.How to take Rivastigmina Sandoz

4.Possible adverse effects

5.Storage of Rivastigmina Sandoz

6.Contents of the package and additional information

The active ingredient of Rivastigmina Sandoz is rivastigmina.

Rivastigmina belongs to a group of substances called 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 acetylcholine neurotransmitter levels (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 acetylcholine levels in the brain to increase, 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 of 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.

Inform your doctor if you are in any of these situations 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 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 consulted your doctor.

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

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 (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 hand tremors.

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.

Rivastigmina Sandoz contains sodium benzoate and sodium

This medicine contains 1 mg of sodium benzoate per ml of oral solution.

This medicine contains less than 1 mmol of sodium (23 mg) per ml of oral solution; it is essentially "sodium-free".

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

Starting treatment:

Your doctor will indicate 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 treatment.
• The highest dose you should take is6mg (corresponding to 3 ml) 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 Sandozfor 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.

Using this medication:

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 high 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 the use of this medication, consult your doctor or pharmacist.

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

You may experience side effects more frequently when you first start taking your medicine or when the dose is increased. Normally, side effects will fade away gradually as your body gets used to the medicine.

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

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

Common(may affect up to 1 in 10 patients)

• Anxiety
• Sweating
• Headache
• Heat
• Weight loss
• Stomach pain
• Feeling of agitation
• Feeling of fatigue or weakness
• General feeling of discomfort
• Shakiness or feeling of 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
• Cutaneous rash, itching
• Seizures (convulsions)
• Ulcers in the 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)
• Problems with heart rhythm such as rapid or slow heart rate
• Gastrointestinal bleeding – presents as blood in stools or vomiting blood
• Pancreatitis – symptoms include severe pain in the upper abdomen, often with feeling of 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(the frequency cannot be estimated from the 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)
• Hepatic disorders (yellowing of the skin, yellowing of the white of the eyes, abnormal darkening of the urine or inexplicable nausea, vomiting, fatigue, and loss of appetite)
• Aggression, feeling of 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)

• Tremor
• Fainting
• Accidental falls

Common(may affect up to 1 in 10 patients)

• Anxiety
• Feeling of unease
• Irregular heart rhythm and loss of motor control
• 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 up to 1 in 100 patients)

• Irregular heart rhythm and loss of motor control

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

Common(may affect up to 1 in 10 patients)

• Fever
• Severe confusion
• Incontinence (inability to retain urine)

Uncommon(may affect up to 1 in 100 patients)

Unknown(the 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 they may require medical assistance.

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 the national notification system included in theAppendix 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 bottle and the box 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 Rivastigmina Sandoz oral solution within the month following the first opening of the bottle.

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.

Composition of Rivastigmina Sandoz

• The active ingredient is rivastigmine. Each ml contains rivastigmine hydrogen tartrate equivalent to 2 mg of rivastigmine base.

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

Appearance of the product and contents of the pack

Rivastigmina Sandoz oral solution is presented as a transparent, yellow (2 mg/ml rivastigmine base) solution of 50 ml or 120 ml in amber glass bottles with a child-resistant closure, foam disc, submerged tube and self-aligning stopper. Along with the oral solution, a dosing syringe for oral administration is included in a plastic tube.

Marketing Authorization Holder

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

Responsible for manufacturing

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nuremberg

Germany

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes 764,

08013 Barcelona

Spain

Salutas Pharma Gmbh

Otto-Von-Guericke-Allee 1, Barleben,

Saxony-Anhalt, 39179,

Germany

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

This leaflet was last revised inNovember 2024

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