Rivastigmine Sandoz 1.5 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Rivastigmina Sandoz 1.5 mg hard capsules EFG

Rivastigmina Sandoz 3 mg hard capsules EFG

Rivastigmina Sandoz 4.5 mg hard capsules EFG

Rivastigmina Sandoz 6 mg hard capsules EFG

rivastigmine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must 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 effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Rivastigmina Sandoz is and what it is used for
2. What you need to know before taking Rivastigmina Sandoz
3. How to take Rivastigmina Sandoz
4. Possible side effects
5. How to store Rivastigmina Sandoz
6. Contents of the pack and other information

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

The active substance in Rivastigmina Sandoz is rivastigmine.

Rivastigmine belongs to a group of substances known as cholinesterase inhibitors. In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells in the brain die, resulting in reduced levels of the neurotransmitter acetylcholine (a substance that enables communication between nerve cells). Rivastigmine blocks the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, Rivastigmina Sandoz helps increase acetylcholine levels in the brain, thereby helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.

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

2. What you need to know before taking Rivastigmina Sandoz

Do not take Rivastigmina Sandoz

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Rivastigmina Sandoz.

• if you have or have ever had a heart condition, irregular or slow heart rhythm (pulse), QTc interval prolongation, family history of QTc interval prolongation, torsades de pointes, or 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 a 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 tremors
• if you have low body weight
• if you have gastrointestinal reactions such as nausea, vomiting, and diarrhea. You may become dehydrated (loss of large amounts of fluid) if vomiting or diarrhea is prolonged
• if you experience skin reactions affecting the whole body.

If you are in any of these situations, your doctor may consider closer monitoring while you are on treatment.

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

Rivastigmina 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 Rivastigmina Sandoz in the pediatric population for the treatment of Alzheimer's dementia.

Taking other medicines and Rivastigmina Sandoz

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

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

Rivastigmina Sandoz should not be taken together with metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines together could 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 you are given any anesthetic, as Rivastigmina Sandoz may enhance the effects of certain muscle relaxants used during anesthesia.

Use caution when taking Rivastigmina Sandoz together with beta-blockers (medicines such as atenolol used to treat high blood pressure, angina, and other heart conditions). Taking both medicines together could cause problems such as a slowed heart rate (bradycardia), leading to fainting or loss of consciousness.

Use caution when taking Rivastigmina Sandoz together with other medicines that may affect heart rhythm or the heart's electrical system (QT interval prolongation).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become 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 risks to the fetus. Rivastigmina Sandoz should not be used during pregnancy unless clearly necessary.

You must not breastfeed while being treated with Rivastigmina Sandoz.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or use machinery safely. Rivastigmina Sandoz may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you feel dizzy or sleepy, do not drive or use machinery or perform any other tasks requiring your attention.

3. How to take Rivastigmina Sandoz

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How to start treatment:

Your doctor will tell you what dose of Rivastigmina Sandoz you should take.

• Treatment is usually started at a low dose.
• Your doctor will slowly increase your dose depending on how you respond to treatment.
• The highest dose you will take is 6 mg twice daily.

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

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

Taking this medicine:

• Inform your caregiver that you are taking Rivastigmina Sandoz.
• To benefit from your medicine, take it every day.
• Take Rivastigmina Sandoz twice daily (in the morning and in the evening), with meals.
• Swallow the capsule whole with liquid.
• Do not open or crush the capsule.

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 accidentally taken higher doses have experienced nausea, vomiting, diarrhoea, high blood pressure, and hallucinations. A slowing of the heart rate and fainting may also occur.

If you forget to take Rivastigmina Sandoz

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

If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

You may experience adverse effects more frequently when you first start taking this medicine or when your dose is increased. Generally, adverse effects gradually disappear as your body becomes used to the medicine.

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

• Dizziness
• Loss of appetite
• Stomach problems such as feeling sick (nausea), vomiting, diarrhoea

Common (may affect up to 1 in 10 patients)

• Anxiety
• Sweating
• Headache
• Burning sensation
• Weight loss
• Stomach pain
• Feeling restless
• Feeling tired or weak
• Feeling generally unwell
• Tremor 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
• Epileptic seizures (convulsions)
• 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 are not there (hallucinations)
• Problems with your heartbeat such as fast or slow heart rate
• Gastrointestinal bleeding – shown as blood in your stools or in vomit
• Inflammation of the pancreas – signs include severe pain in the upper part of the stomach, often with nausea or vomiting
• Worsening of signs of Parkinson’s disease or development of similar symptoms – such as muscle stiffness, difficulty with movement

Not known (frequency cannot be estimated from available data)

• Severe vomiting which may cause tearing of part of the digestive tube connecting your mouth to your stomach (oesophagus)
• Dehydration (loss of large amounts of fluid)
• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormal darkening of urine, or unexplained nausea, vomiting, tiredness and loss of appetite)
• Aggression, feeling restless
• Irregular heartbeat

Patients with dementia or Parkinson’s disease

These patients experience some adverse effects more frequently and also have some additional adverse 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 restlessness
• Slow and fast heartbeat
• Difficulty sleeping
• Excessive saliva and dehydration
• Abnormally slow movements or movements you cannot control
• Worsening of signs of Parkinson’s disease or development of similar symptoms – such as muscle stiffness, difficulty with movement and muscle weakness

Uncommon (may affect up to 1 in 100 patients)

• Irregular heartbeat and loss of movement control

Other adverse effects observed with transdermal patches and which may also occur with hard capsules:

Common (may affect up to 1 in 10 patients)

• Fever
• Severe confusion
• Urinary incontinence (inability to hold urine)

Uncommon (may affect up to 1 in 100 patients)

• Hyperactivity (high level of activity, agitation)

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 adverse effects, contact your doctor, as you may require medical attention.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmina Sandoz

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

Do not use Rivastigmina Sandoz after the expiry date which is stated on the blister, the bottle, and the carton after “EXP” or “CAD”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

Do not store above 30°C.

6. Contents of the pack and other information

Composition of Rivastigmina Sandoz

• The active substance is rivastigmine.
• The other components are hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, iron oxide yellow, iron oxide red, titanium dioxide, and shellac.

Each capsule of Rivastigmina Sandoz 1.5 mg contains 1.5 mg of rivastigmine.

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

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

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

Appearance of the product and contents of the pack

• Rivastigmina Sandoz 1.5 mg hard capsules contain a whitish to slightly yellow powder, with a yellow cap and body bearing a red imprint “RIV 1.5 mg” on the body.

• Rivastigmina Sandoz 3 mg hard capsules contain a whitish to slightly yellow powder, with an orange cap and body bearing a red imprint “RIV 3 mg” on the body.

• Rivastigmina Sandoz 4.5 mg hard capsules contain a whitish to slightly yellow powder, with a red cap and body bearing a white imprint “RIV 4.5 mg” on the body.

• Rivastigmina Sandoz 6 mg hard capsules contain a whitish to slightly yellow powder, with a red cap and an orange body bearing a red imprint “RIV 6 mg” on the body.

The capsules are packaged in blisters and available in three different pack sizes (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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

This leaflet has been reviewed in

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