RIVASTIGMINE SANDOZ 2 MG / ML ORAL SOLUTION - patient leaflet, side effects, dosage

Rivastigmine Sandoz 2 mg/ml oral solution

rivastigmine

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

• 2. What you need to know before you take Rivastigmine Sandoz

• 3. How to take Rivastigmine Sandoz

• 4. Possible side effects

• 5. How to store Rivastigmine Sandoz

• 6. Contents of the pack and other information

What Rivastigmine Sandoz is and what it is used for

The active substance of Rivastigmine Sandoz is rivastigmine.

Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with Alzheimer’s de­mentia or dementia due to Parkinson’s di­sease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholines­terase and butyrylcholines­terase. By blocking these enzymes, Rivastigmine Sandoz allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’s disease and dementia associated with Parkinson’s di­sease.

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

What you need to know before you take before you take Rivastigmine Sandoz

Do not take Rivastigmine Sandoz

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

If this applies to you, tell your doctor and do not take Rivastigmine Sandoz.

Warnings and precautions

• Talk to your doctor before taking Rivastigmine Sandoz if you have, or have ever had, irregular or slow heartbeat. if you have, or have ever had, an active stomach ulcer. if you have, or have ever had, difficulties in passing urine. 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 impaired kidney function.
• if you have, or have ever had, impaired liver function.
• if you suffer from trembling.
• if you have a low body weight.
• if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea. You may be come dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.

If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.

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

Children and adolescents

There is no relevant use of Rivastigmine Sandoz in the paediatric population in the treatment of Alzheimer’s di­sease.

Other medicines and Rivastigmine Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Rivastigmine Sandoz should not be given at the same time as other medicines with similar effects to Rivastigmine Sandoz. Rivastigmine Sandoz might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).

Rivastigmine Sandoz should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together could cause problems such as stiff limbs and trembling hands.

If you have to undergo surgery whilst taking Rivastigmine Sandoz, tell your doctor before you are given any anaesthetics, because Rivastigmine Sandoz may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Rivastigmine Sandoz is taken together with betablockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions). Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading to fainting or loss of consciousness.

Pregnancy, breast feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant, the benefits of using Rivastigmine Sandoz must be assessed against the possible effects on your unborn child. Rivastigmine Sandoz should not be used during pregnancy unless clearly necessary.

You should not breast feed during treatment with Rivastigmine Sandoz.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Rivastigmine Sandoz may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you feel dizzy or sleepy, do not drive, use machines or perform any tasks that require your attention.

Rivastigmine Sandoz contains benzoate salt and sodium

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

This medicine product contains less than 1 mmol (23 mg) sodium in each ml of oral solution, that is to say essentially ‘sodium-free’.

How to take Rivastigmine Sandoz

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How to start treatment

Your doctor will tell you what dose of Rivastigmine Sandoz to take.

• Treatment usually starts with a low dose.
• Your doctor will slowly increase your dose depending on how you respond to treatment.
• The highest dose that should be taken is 6.0 mg (corresponding to 3 ml) twice a day.

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

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

Taking this medicine

• tell your caregiver that you are taking Rivastigmine Sandoz
• to benefit from your medicine, take it every day
• take Rivastigmine Sandoz twice a day, in the morning and evening, with food.

How to use this medicine

• 1. Preparing the bottle and syringe

• take the syringe out of its protective case
• push down and turn the child resistant cap to open bottle.

2. Attaching the syringe to the bottle

• push the nozzle of the syringe into the hole in the white stopper.

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• 4. Removing bubbles

• push down and pull up the plunger a few times to get rid of any large bubbles
• a few tiny bubbles are not important and will not affect your dose in any way
• check the dose is still correct
• then, remove the syringe from the bottle.

• 5. Taking your medicine

• swallow your medicine straight from the syringe
• you can also mix your medicine with water in a small glass. Stir and drink all of the mixture.

• 6. After using the syringe

• wipe the outside of the syringe with a clean tissue
• then, put the syringe back in its protective case
• put the child resistant cap back on the bot tle to close it.

If you take more Rivastigmine Sandoz than you should

If you accidentally take more Rivastigmine Sandoz than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Rivastigmine Sandoz have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heartbeat and fainting may also occur.

If you forget to take Rivastigmine Sandoz

If you find you have forgotten to take 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 a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may have side effects more often when you start your medicine or when your dose is increased. Usually, the side effects will slowly go away as your body gets used to the medicine.

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

• feeling dizzy
• loss of appetite
• stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea.

Common (may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling agitated
• Feeling tired or weak
• Generally feeling unwell
• Trembling or feeling confused
• Decreased appetite
• Nightmares

Uncommon (may affect up to 1 in 100 people)

• depression
• difficulty in sleeping
• fainting or accidentally falling
• changes in how well your liver is working.

Rare (may affect up to 1 in 1,000 people)

• chest pain
• rash, itching
• fits (seizures)
• ulcers in your stomach or intestine.

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

• high blood pressure
• urinary tract infection
• seeing things that are not there (hallucinations)
• problems with your heartbeat such as fast or slow heartbeat
• bleeding in the gut – shows as blood in stools or when being sick
• inflammation of the pancreas – the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)
• the signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles, difficulty in carrying out movements.

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

• being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with your stomach (oesophagus)
• dehydration (losing too much fluid)
• Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)
• aggression, feeling restless
• uneven heartbeat.

Patients with dementia and Parkinson’s di­sease

These patients have some side effects more often. They also have some additional side effects:

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

• trembling
• fainting
• accidentally falling.

Common (may affect up to 1 in 10 people)

• anxiety
• feeling restless
• slow and fast heartbeat
• difficulty in sleeping
• too much saliva and dehydration
• unusually slow movements or movements you cannot control
• the signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles, difficulty in carrying out movements and muscle weakness.

Uncommon (may affect up to 1 in 100 people)

• Uneven heartbeat and poor control of movements

Other side effects seen with transdermal patches and which may occur with the oral solution:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity (high level of activity, restlessness)

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

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

If you get any of these side effects, contact your doctor as you may need medical assistance.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: or search for MHRA Yellow Card in Google play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Rivastigmine Sandoz

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

Do not use Rivastigmine Sandoz after the expiry date which is stated on the bottle and carton after “EXP”. The expiry date refers to the last day of that month.

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

Store in an upright position.

Use Rivastigmine Sandoz oral solution within 1 month of opening the bottle.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Content of the pack and other information

What Rivastigmine Sandoz contains

• The active substance is rivastigmine. Each ml contains rivastigmine hydrogen tartrate corresponding to rivastigmine base 2.0 mg.
• The other ingredients are: sodium benzoate, citric acid, sodium citrate, quinoline yellow WS dye (E104) and purified water.

What Rivastigmine Sandoz looks like and contents of the pack

Rivastigmine Sandoz oral solution is supplied as 50 ml or 120 ml of a clear, yellow solution (2.0 mg/ml base) in an amber glass bottle with a child resistant cap, foam liner, dip tube and self aligning plug. The oral solution is packaged with an oral dosing syringe in a plastic tube container.

Marketing Authorisation Holder

Sandoz GmbH

BiochemiestraBe 10

A-6250 Kundl

Austria

Manufacturer

Novartis Pharma GmbH,

Roonstrasse 25,

D-90429 Nuremberg, Germany.

This leaflet was last revised in 07/2021.

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