RIVASTIGMINE SANDOZ 2 mg/ml ORAL SOLUTION

2. What you need to know before taking Rivastigmine Sandoz

Do not take Rivastigmine Sandoz

• if you are allergic to rivastigmine (the active ingredient of Rivastigmine Sandoz) or to any of the other ingredients 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 ever had a heart problem, irregular or slow heart rhythm (pulse), prolonged QTc interval, family history of prolonged QTc interval, Torsades de Pointesor low levels of potassium or magnesium in the blood.
• if you have or have ever had an active stomach ulcer
• if you have or have ever had difficulty urinating
• if you have or have ever had seizures
• if you have or have ever had asthma or severe respiratory disease
• if you have or have ever had kidney function impairment
• if you have or have ever 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 (nausea), vomiting, and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea is prolonged

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 consulted 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 (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 together may cause problems such as stiffness of the limbs and hand tremors.

In case 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 pectoris, and other heart conditions). Taking the two medications together may 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 weighed against the potential effects on the fetus. Rivastigmine Sandoz should not be used during pregnancy unless clearly necessary.

You should not breastfeed while being treated with 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 increasing the dose. If you feel dizzy or drowsy, do not drive or use machinery, or perform other tasks that require your attention.

Rivastigmine Sandoz contains sodium benzoate and sodium

This medication contains 1 mg of sodium benzoate in each ml of oral solution.

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

3. How to take Rivastigmine Sandoz

Follow your doctor's instructions for taking this medication exactly. If you are in doubt, consult your doctor or pharmacist.

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 (corresponding to 3 ml) 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.

How to use this medication

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 accidentally taken 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 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 everyone will experience them.

You may experience side effects more frequently when starting to take your medication or when the dose is increased. Normally, the side effects will disappear slowly as your body gets used to the medication.

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

• Nausea
• Loss 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 (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)
• 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 available data)

• Severe vomiting that can cause a tear in the tube that connects the mouth to the 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 uncontrollable 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 heartbeat and loss of movement control

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

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, restlessness)

Not known(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 you may need medical attention.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects 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 vial and carton after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C. Do not refrigerate or freeze.

Keep in an upright position.

Use Rivastigmine Sandoz oral solution within one month after opening the vial.

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.

6. Container contents and additional information

Composition of Rivastigmine Sandoz

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

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

Appearance of the product and container contents

Rivastigmine Sandoz oral solution is presented as a clear, yellow solution (2 mg/ml rivastigmine base) of 50 ml or 120 ml in amber glass bottles with a child-resistant closure, foam disk, dipping tube, and self-aligning stopper. Along with the oral solution, an oral dosing syringe is included in a plastic tube.

Marketing authorization holder

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

Manufacturer

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 medication by contacting the local representative of the marketing authorization holder:

This leaflet was last revised inNovember 2024

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