RIVASTIGMINE SANDOZ 1.5 MG HARD CAPSULES - patient leaflet, side effects, dosage

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

  A 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 Rivastigmine Sandoz

Do not take Rivastigmine Sandoz

• if you are allergic to rivastigmine (the active substance of 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 become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.

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.

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 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.
• Swallow the capsules whole with a drink.
• Do not open or crush the capsules.

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.

4

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 hard capsules:

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 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 blister, bottle and carton after “EXP”. The expiry date refers to the last day of that month.

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.

Do not store above 30°C.

Content of the pack and other information

What Rivastigmine Sandoz contains

• The active substance is rivastigmine
• The other ingredients are: hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous 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.

What Rivastigmine Sandoz looks like and contents of the pack

• Rivastigmine Sandoz 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with a red imprint “RIV 1.5 mg” on the body.
• Rivastigmine Sandoz 3 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “RIV 3 mg” on the body.
• Rivastigmine Sandoz 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “RIV 4.5 mg” on the body.
• Rivastigmine Sandoz 6 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “RIV 6 mg” on the body.
• They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) and plastic bottles of 250 capsules, but these may not all be available in your country.