Rivastigmine Sandoz

Package leaflet: Information for the patient

Rivastigmine Sandoz 1.5 mg hard capsules, 3 mg hard capsules, 4.5 mg hard capsules, 6 mg hard capsules

rivastigmine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Rivastigmine Sandoz is and what it is used for
2. What you need to know before taking 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

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

The active substance of Rivastigmina Sandoz is rivastigmine.
Rivastigmine belongs to a class 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 low levels of the neurotransmitter called acetylcholine (a substance that enables nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine, namely acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, Rivastigmina Sandoz helps increase acetylcholine levels in the brain, thereby helping to alleviate 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 dementia: this is 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 had a skin reaction due to allergic contact dermatitis caused by rivastigmine.

If this applies to you, inform your doctor and do not take Rivastigmina Sandoz.
Warnings and precautions
Talk to your doctor before taking Rivastigmina Sandoz

• if you have or have previously had a heart condition such as irregular or slow heartbeat, QTc prolongation, family history of QTc prolongation, torsades de pointes, or low levels of potassium or magnesium in the blood.
• if you have or have previously had an active stomach ulcer
• if you have or have previously had difficulty urinating
• if you have or have previously had seizures
• if you have or have previously had asthma or severe respiratory disorders
• if you have or have previously had impaired renal function
• if you have or have previously had impaired liver function
• if you suffer from tremors
• if you are underweight
• if you experience gastrointestinal disorders such as nausea, vomiting, and diarrhea. If vomiting and diarrhea are persistent, you may become dehydrated (excessive loss of fluids). If any of these apply to you, your doctor may monitor you more frequently during treatment with this medicine.

If you have not taken Rivastigmina Sandoz for more than three days, consult your doctor before
resuming treatment.
Children and adolescents
There is no indication for the specific use of Rivastigmina Sandoz in the pediatric population for the
treatment of Alzheimer's disease.
Other medicines and Rivastigmina Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Rivastigmina Sandoz must not be administered concomitantly with other medicines that have similar
effects. 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 must not be administered at the same time as metoclopramide (a medicine used
to relieve or prevent nausea and vomiting). Taking these two medicines together may cause symptoms
such as stiffness of the limbs and hand tremors.
If you are scheduled for surgery and are being treated with Rivastigmina Sandoz, inform your doctor
before receiving anesthesia, as Rivastigmina Sandoz may increase the effects of certain muscle
relaxants during anesthesia.
Caution is recommended when Rivastigmina Sandoz is taken together with beta-blockers (medicines
such as atenolol, used to treat hypertension, angina, and other heart conditions).
Taking these two medicines together may cause symptoms such as slowing of the heartbeat
(bradycardia), which may lead to fainting or loss of consciousness.
Caution is recommended when Rivastigmina Sandoz is taken together with other medicines that may
affect heart rhythm or the heart's electrical system (QT prolongation).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
If you are pregnant, the benefit of using Rivastigmina Sandoz must be weighed against the possible
risks to the unborn child. Rivastigmina Sandoz must not be used during pregnancy unless clearly
necessary.
You must not breastfeed during treatment with Rivastigmina Sandoz.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive and use machines 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 drowsy, do not drive, do not operate machinery, and do
not perform any other activity requiring alertness.

3. How to take Rivastigmina Sandoz

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Starting treatment
Your doctor will tell you what dose of Rivastigmina Sandoz to take.

• Treatment usually starts with a low dose.
• Your doctor will gradually increase the dose according to your response to treatment.
• The highest dose that may be taken is 6 mg twice daily. Your doctor will regularly check whether the medicine is working. 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, consult your doctor before restarting treatment.
Taking the medicine

• Inform the person caring for you that you are being treated with Rivastigmina Sandoz.
• To benefit from treatment, take the medicine every day.
• Take Rivastigmina Sandoz twice daily, in the morning and evening, with food.
• Swallow the capsules whole with a drink.
• Do not open or break the capsules.

If you take more Rivastigmina Sandoz than you should
If you accidentally take more Rivastigmina Sandoz than you should, inform your doctor. You may need medical treatment. Some people who accidentally took too much Rivastigmina Sandoz experienced feeling unwell (nausea) or actual illness (vomiting), diarrhoea, high blood pressure, and hallucinations. Slowing of the heartbeat and fainting may also occur.

If you forget to take Rivastigmina Sandoz
If you realize you have forgotten to take 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 dose.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects may be more frequent when you first start taking the medicine or when your dose is increased. Generally, side effects will gradually disappear as your body gets used to the medicine.

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

• Dizziness
• Loss of appetite
• Stomach problems such as nausea, vomiting, diarrhoea

Common (may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling restless
• Feeling tired or weak
• General feeling of being unwell
• Tremor or confusion
• Decreased appetite
• Nightmares

Uncommon (may affect up to 1 in 100 people)

• Depression
• Sleep disorders
• Fainting or accidental falls
• Changes in liver function

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

• Chest pain
• Rash, itching
• Seizures
• Stomach or intestinal ulcer

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

• High blood pressure
• Urinary tract infections
• Seeing things that are not there (hallucinations)
• Heart rhythm disorders, such as fast or slow heartbeat
• Bleeding in the intestine – shown by blood in stools or vomit
• Inflammation of the pancreas – shown by severe pain in the upper stomach, often accompanied by nausea or vomiting
• Worsening of Parkinson’s disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty in moving

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

• Severe vomiting which may lead to rupture of the tube connecting the mouth to the stomach (oesophagus)
• Dehydration (excessive loss of fluids)
• Liver problems (yellowing of the skin and whites of the eyes, abnormally dark urine, unexplained nausea, vomiting, tiredness and loss of appetite)
• Aggression, feeling restless
• Irregular heartbeat

Patients with dementia and Parkinson’s disease
These patients more frequently experience certain side effects. They may also experience additional side effects:

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

• Tremors
• Fainting
• Accidental falls

Common (may affect up to 1 in 10 people)

• Anxiety
• Feeling restless
• Slow and fast heartbeat
• Sleep disorders
• Excessive salivation and dehydration
• Unusual slowing of movements or uncontrollable movements
• Worsening of Parkinson’s disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty in moving, and muscle weakness

Uncommon (may affect up to 1 in 100 people)

• Irregular heartbeat and poor control of movements

Additional side effects reported with transdermal patches that could also occur with the hard capsules:

Common (may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to properly retain 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 at the site where the patch was applied, such as blisters or skin inflammation

If you experience any of these symptoms, contact your doctor, as you may require medical assistance.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivastigmina Sandoz

Keep this medicine out of the sight and reach of children.
Do not use Rivastigmina Sandoz after the expiry date stated on the blister, bottle, and carton after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Do not store above 30°C.

6. Package contents and other information

What Rivastigmina Sandoz contains

• The active substance is rivastigmine.
• The other ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica, gelatin, yellow iron oxide, red iron oxide, titanium dioxide and shellac. Each Rivastigmina Sandoz 1.5 mg capsule contains 1.5 mg of rivastigmine. Each Rivastigmina Sandoz 3 mg capsule contains 3 mg of rivastigmine. Each Rivastigmina Sandoz 4.5 mg capsule contains 4.5 mg of rivastigmine. Each Rivastigmina Sandoz 6 mg capsule contains 6 mg of rivastigmine.

Description of the appearance of Rivastigmina Sandoz and contents of the pack

• Rivastigmina Sandoz 1.5 mg hard capsules, containing a powder from almost white to slightly yellow, with a yellow cap and a yellow body, and a red print “RIV 1.5 mg” on the body.
• Rivastigmina Sandoz 3 mg hard capsules, containing a powder from almost white to slightly yellow, with an orange cap and an orange body, and a red print “RIV 3 mg” on the body.
• Rivastigmina Sandoz 4.5 mg hard capsules, containing a powder from almost white to slightly yellow, with a red cap and a red body, and a white print “RIV 4.5 mg” on the body.
• Rivastigmina Sandoz 6 mg hard capsules, containing a powder from almost white to slightly yellow, with a red cap and an orange body, and a red print “RIV 6 mg” on the body. Packaged in blisters available in three different carton packs (28, 56 or 112 capsules), although these may not be available in your country.

Marketing Authorisation 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 medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Luxembourg/Luxemburg
Sandoz N.V. Sandoz N.V.
Telecom Gardens, Medialaan 40 Telecom Gardens, Medialaan 40
B-1800 Vilvoorde B-1800 Vilvoorde
Tél/Tel: + 32 (0)2 722 97 97 Tél/Tel: + 32 (0)2 722 97 97
България Magyarország
Sandoz Bulgaria KTD Kft. Sandoz Hungária Kft.
Tel.: + 359 2 970 47 47 Bartók Béla út 43-47
[email protected] H-1114 Budapest
Tel.: + 36 1 430 2890
E-mail: [email protected]
Česká republika Malta
Sandoz s.r.o. Sandoz Pharmaceuticals d.d.
Na Pankráci 1724/129 Tel: +356 9964 4126
CZ-14000 Praha 4 - Nusle
E-mail: [email protected]
Tel: +420 225 775 111
Danmark Nederland
Sandoz A/S Sandoz BV
Edvard Thomsens Vej 14 Hospitaaldreef 29,
DK-2300 København S NL-1315 RC Almere
Denmark Tel: +31 36 5241600
Tlf: +45 6395 1000 E-mail: [email protected]
[email protected]
Deutschland Norge
Hexal AG Sandoz A/S
Industriestraße 25 Edvard Thomsens Vej 14
D-83607 Holzkirchen DK-2300 København S
Tel: + 49 8024 908 0 Denmark
E-mail: [email protected] Tlf: +45 6395 1000
[email protected]
Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Pärnu mnt 105 Biochemiestrasse 10
EE-11312 Tallinn A-6250 Kundl
Tel: +372 6652400 Tel: + 43 (0)53382000
Ελλάδα Polska
SANDOZ HELLAS MONOPROSOPIKI Sandoz Polska Sp.z o.o.
E.E. ul. Domaniewska 50 C
Tel: +30 216 600 5000 PL-02-672 Warszawa
Tel: + 48 22 549 15 00
España Portugal
Sandoz Farmacéutica, S.A Sandoz Farmacêutica, Lda.
Centro Empresarial Parque Norte Quinta da Fonte, Rua dos Malhões nº5,
Edificio Roble Edifício Q56 D. Pedro I, Piso 0
C/ Serrano Galvache Nº 56, 2770-071 Paço de Arcos
28033 Madrid Portugal
Tel: +34 900 456 856 Tel: +351 211 964 000
[email protected]
France România
Sandoz SAS Sandoz S.R.L.
49, avenue Georges Pompidou Str. Livezeni nr. 7A,
F-92593 Levallois-Perret Cedex Târgu Mureș, 540472
Tél: + 33 1 4964 4800 Romania
Tel: +40 21 310 44 30
Ireland Slovenija
Rowex Ltd. Lek Pharmaceuticals d.d.
Newtown Verovškova 57
IE-Bantry Co. Cork SI-1526 Ljubljana
P75 V009 Tel: + 386 1 5802111
Tel: +353 27 50077 E-mail: [email protected]
Ísland Slovenská republika
Sandoz A/S Sandoz d.d. - organizačná zložka
Edvard Thomsens Vej 14 Žižkova 22B
DK-2300 Copenhagen S SK-811 02 Bratislava
Denmark Tel: +421 2 48 200 600
Tlf: +45 6395 1000
[email protected]
Italia Suomi/Finland
Sandoz S.p.a Sandoz A/S
Largo Umberto Boccioni 1 Edvard Thomsens Vej 14
I-21040 Origgio (VA) DK-2300 Copenhagen S/Copenhagen S
Italy Denmark
Tel: + 39 02 96541 Puh: +358 010 6133 400
[email protected]
Κύπρος Sverige
Sandoz Pharmaceuticals d.d. Sandoz A/S
Tel: +357 22 69 0690 Edvard Thomsens Vej 14
DK-2300 Copenhagen S
Denmark
Tel: +45 6395 1000
[email protected]
Latvija United Kingdom (Northern Ireland)
Sandoz d.d. Latvia filiāle Sandoz Ltd
K. Valdemāra iela 33 – 29 Frimley Business Park
LV-1010 Riga Frimley Camberley Surrey GU16 7SR
Tel: + 371 67892006 Tel: +44 1276 69 8020
E-mail: [email protected]
Lietuva Hrvatska
Sandoz Pharmaceuticals d.d., Branch Office Sandoz d.o.o.
Lithuania Maksimirska 120
Seimyniskių g. 3A 10 000 Zagreb
LT-09312 Vilnius Tel: +385 1 2353111
Tel: + 370 5 2636037 E-mail: [email protected]
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Patient information leaflet

Rivastigmina Sandoz 2 mg/ml oral solution

rivastigmine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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 of Rivastigmina Sandoz is rivastigmine.
Rivastigmine belongs to a class 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 low levels of the neurotransmitter known as acetylcholine (a substance that enables nerve cells to communicate with each other). Rivastigmine works by inhibiting the enzymes that break down acetylcholine, namely acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, Rivastigmina Sandoz helps increase acetylcholine levels in the brain, thereby helping to alleviate 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 dementia: this is 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.

2. What you should 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 had a skin reaction due to allergic contact dermatitis caused by rivastigmine.

If this applies to you, inform your doctor and do not take Rivastigmina Sandoz.
Warnings and precautions
Talk to your doctor before taking Rivastigmina Sandoz

• if you have or have previously had a heart condition such as irregular or slow heartbeat, QTc prolongation, family history of QTc prolongation, torsades de pointes, or if you have low levels of potassium or magnesium in your blood.
• if you have or have previously had an active stomach ulcer.
• if you have or have previously had difficulty urinating.
• if you have or have previously had seizures.
• if you have or have previously had asthma or severe respiratory disorders.
• if you have or have previously had impaired kidney function.
• if you have or have previously had impaired liver function.
• if you suffer from tremors.
• if you are underweight.
• if you experience gastrointestinal disturbances such as nausea, vomiting, and diarrhoea. If vomiting and diarrhoea are persistent, you may become dehydrated (excessive loss of fluids). If any of these apply to you, your doctor may need to monitor you more frequently during treatment with this medicine.

If you have not taken Rivastigmina Sandoz for more than three days, consult your doctor before resuming treatment.
Children and adolescents
There is no indication for the specific use of Rivastigmina Sandoz in the paediatric population for the treatment of Alzheimer's disease.
Other medicines and Rivastigmina Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Rivastigmina Sandoz must not be administered concomitantly with other medicines that have similar effects. 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 must not be taken at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines together may cause side effects such as stiffness of the limbs and hand tremors.
If you are due to undergo surgery and are being treated with Rivastigmina Sandoz, inform your doctor before receiving anaesthesia, as Rivastigmina Sandoz may increase the effects of certain muscle relaxants during anaesthesia.
Caution is recommended when Rivastigmina Sandoz is taken together with beta-blockers (medicines such as atenolol, used to treat hypertension, angina, and other heart conditions).
Taking both medicines together may cause side effects such as slowing of the heartbeat (bradycardia), which may lead to fainting or loss of consciousness.
Caution is recommended when Rivastigmina Sandoz is taken together with other medicines that may affect heart rhythm or the heart's electrical system (QT prolongation).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, the benefit of using Rivastigmina Sandoz must be weighed against any possible risks to your unborn baby. 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 operate 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 drowsy, do not drive, operate machinery, or perform any other activity requiring alertness.
Rivastigmina Sandoz contains salt and sodium benzoate
This medicine contains 1 mg of sodium benzoate per ml of oral solution.
This medicine contains less than 1 mmol (23 mg) of sodium per ml of oral solution, i.e. it is essentially 'sodium-free'.

3. How to take Rivastigmina Sandoz

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Starting treatment
Your doctor will tell you what dose of Rivastigmina Sandoz to take.

• Treatment usually starts with a low dose.
• Your doctor will gradually increase the dose depending on your response to treatment.
• The highest dose that can be taken is 6 mg (equivalent to 3 ml) twice daily. Your doctor will regularly check whether the medicine is working. 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, consult your doctor before restarting treatment.
Taking the medicine

• Inform anyone caring for you that you are being treated with Rivastigmina Sandoz.
• To benefit from treatment, you must take it every day.
• Take Rivastigmina Sandoz twice a day, in the morning and in the evening, with food.

Instructions for use

1. Preparing the bottle and syringe

• Remove the syringe from the protective tube.
• To open the bottle, press down and turn the safety cap to remove it.

2. Inserting the syringe into the bottle

• Insert the tip of the syringe through the designated hole in the white seal.

3. Filling the syringe

• Pull the plunger up to the mark corresponding to the dose prescribed by your doctor.

4. Removing air bubbles

• Push and pull the plunger several times to remove any large air bubbles.
• Small air bubbles are not a concern and do not affect the accuracy of the dose.
• Check that the dose is still correct.
• Then remove the syringe from the bottle.

5. Taking the medicine

• Drink the medicine directly from the syringe.
• Alternatively, you may mix the medicine in a glass with a small amount of water. Mix well and drink the entire mixture.

6. After using the syringe

• Wipe the outside of the syringe with a clean tissue.
• Place the syringe back into its protective tube.
• Replace the safety cap on the bottle to close it.

If you take more Rivastigmina Sandoz than you should
If you accidentally take more Rivastigmina Sandoz than you should, inform your doctor immediately. You may require medical treatment. Some people who have accidentally taken an excessive amount of Rivastigmina Sandoz have experienced feeling unwell (nausea) or actual illness (vomiting), diarrhoea, high blood pressure, and hallucinations. A slowed heartbeat and fainting may also occur.
If you forget to take Rivastigmina Sandoz
If you realize you have forgotten to take your dose of Rivastigmina Sandoz, wait and take the next dose at the usual scheduled time. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects may be more common when you first start taking the medicine or when the dose is increased. Generally, side effects will gradually disappear as your body gets used to the medicine.

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

• Dizziness
• Loss of appetite
• Stomach disturbances such as nausea, vomiting, diarrhoea

Common (may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach ache
• Feeling restless
• Feeling tired or weak
• General feeling of being unwell
• Tremors or confusion
• Decreased appetite
• Nightmares

Uncommon (may affect up to 1 in 100 people)

• Depression
• Sleep disorders
• Fainting or accidental falls
• Changes in liver function

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

• Chest pain
• Rash, itching
• Seizures
• Stomach or intestinal ulcer

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

• High blood pressure
• Urinary tract infections
• Seeing things that are not there (hallucinations)
• Heart rhythm disorders, such as fast or slow heartbeat
• Bleeding in the intestine –表现为 blood in the stool or vomit
• Inflammation of the pancreas –表现为 severe pain in the upper stomach, often accompanied by 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 the available data)

• Severe vomiting which may lead to rupture of the tube connecting the mouth to the stomach (oesophagus)
• Dehydration (excessive fluid loss)
• Liver problems (yellowing of the skin and whites of the eyes, unusually dark urine, unexplained nausea, vomiting, tiredness and loss of appetite)
• Aggression, restlessness
• Irregular heartbeat

Patients with dementia and Parkinson's disease
These patients more frequently experience certain side effects. They may also experience additional side effects:

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

• Tremors
• Fainting
• Accidental falls

Common (may affect up to 1 in 10 people)

• Anxiety
• Restlessness
• Slow and fast heartbeat
• Sleep disorders
• Excessive salivation and dehydration
• Unusual slowing of 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 people)

• Irregular heartbeat and poor control of movements

Additional side effects reported with transdermal patches that may also occur with the oral solution:

Common (may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to properly retain 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 at the site where the patch was applied (blisters or skin inflammation)

If you experience any of these symptoms, contact your doctor, as you may require medical attention.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivastigmina Sandoz

Keep this medicine out of the sight and reach of children.
Do not use Rivastigmina Sandoz after the expiry date 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 Rivastigmina Sandoz oral solution within 1 month after opening the bottle.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rivastigmina Sandoz contains

• The active substance is rivastigmine. Each ml contains an amount of rivastigmine hydrogen tartrate equivalent to 2 mg of rivastigmine base.
• The other components are sodium benzoate, citric acid, sodium citrate, quinoline yellow dye (E104), and purified water.

Description of the appearance of Rivastigmina Sandoz and contents of the pack
Rivastigmina Sandoz oral solution is available in amber glass bottles with child-resistant safety cap, seal, dip tube, and self-aligning plunger, containing 50 ml or 120 ml of a yellow, clear solution (2.0 mg/ml base). The oral solution is packaged with an oral dosing syringe contained 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

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

België/Belgique/Belgien Luxembourg/Luxemburg
Sandoz N.V. Sandoz N.V.
Telecom Gardens, Medialaan 40 Telecom Gardens, Medialaan 40
B-1800 Vilvoorde B-1800 Vilvoorde
Tél/Tel: +32 (0)2 722 97 97 Tél/Tel: +32 (0)2 722 97 97
E-mail: [email protected]

България Magyarország
Сандоз България КЧТ Sandoz Hungária Kft.
Tel.: +359 2 970 47 47 Bartók Béla út 43-47
H-1114 Budapest
Tel.: +36 1 430 2890
E-mail: [email protected]

Česká republika Malta
Sandoz s.r.o. Sandoz Pharmaceuticals d.d.
Na Pankráci 1724/129 Tel: +35699644126
CZ-14000 Praha 4 - Nusle
E-mail: [email protected]
Tel: +420 225 775 111

Danmark Nederland
Sandoz A/S Sandoz BV
Edvard Thomsens Vej 14 Hospitaaldreef 29,
DK-2300 København S NL-1315 RC Almere
Denmark Tel: +31 36 5241600
Tlf: +45 6395 1000 E-mail: [email protected]
[email protected]

Deutschland Norge
Hexal AG Sandoz A/S
Industriestraße 25 Edvard Thomsens Vej 14
D-83607 Holzkirchen DK-2300 København S
Tel: +49 8024 908 0 Denmark
E-mail: [email protected] Tlf: +45 6395 1000
[email protected]

Eesti Österreich
Sandoz d.d. Eesti filiaal Hexal GmbH
Pärnu mnt 105 Jakov-Lind-Straße 5, Top 3.05
EE-11312 Tallinn A-1020 Wien
Tel: +372 6652400 Tel: +43 (0)1 486 96 22

Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Sandoz Polska Sp.z o.o.
Α.Ε. ul. Domaniewska 50 C
Τηλ: +30 216 600 5000 PL-02-672 Warszawa
Tel: +48 22 549 15 00

España Portugal
Sandoz Farmacéutica, S.A Sandoz Farmacêutica, Lda.
Centro Empresarial Parque Norte Quinta da Fonte, Rua dos Malhões nº5,
C/ Serrano Galvache Nº 56, Edificio Roble Edifício Q56 D. Pedro I, Piso 0
E-28033 Madrid 2770-071 Paço de Arcos
Tel: +34 91 602 30 62 Portugal
[email protected] Tel: +351 211 964 000

France România
Sandoz SAS Sandoz S.R.L.
49, avenue Georges Pompidou Str Livezeni nr. 7A,
F-92593 Levallois-Perret Cedex Târgu Mureș, 540472
Tél: +33 1 4964 4800 Romania
Tel: +40 21 310 44 30

Ireland Slovenija
Rowex Ltd. Lek Pharmaceuticals d.d.
Newtown Verovskova 57
IE-Bantry Co. Cork SI-1526 Ljubljana
P75 V009 Tel: +386 1 5802111
Tel: +353 27 50077 E-mail: [email protected]

Ísland Slovenská republika
Sandoz A/S Sandoz d.d. - organizačná zložka
Edvard Thomsens Vej 14 Žižkova 22B
DK-2300 Kaupmannahöfn S SK-811 02 Bratislava
Denmark Tel: +421 2 48 200 600
Tlf: +45 6395 1000
[email protected]

Italia Suomi/Finland
Sandoz S.p.a Sandoz A/S
Largo Umberto Boccioni 1 Edvard Thomsens Vej 14
I-21040 Origgio (VA) DK-2300 Kööpenhamina S/Köpenhamn S
Tel: +39 02 96541 Denmark
Puh: +358 010 6133 400
[email protected]

Κύπρος
Π.Τ.Χατζηγεωργίου εταιρεία Ltd
Gildiz 31-3042 Limassol
Τηλέφωνο: 00357 25372425
Φαξ: 00357 25376400
e-mail: [email protected]

Sverige
Sandoz A/S
Edvard Thomsens Vej 14
DK-2300 Köpenhamn S
Denmark
Tel: +45 6395 1000
[email protected]

Latvija United Kingdom (Northern Ireland)
Sandoz d.d. Latvia filiāle Sandoz Ltd
K. Valdemāra Str. 33 – 29 Frimley Business Park
LV-1010 Riga Frimley Camberley Surrey GU16 7SR
Tel: +371 67892006 Tel: +44 1276 69 8020
E-mail: [email protected]

Lietuva Hrvatska
Sandoz Pharmaceuticals d.d., Branch Office Sandoz d.o.o.
Lithuania Maksimirska 120
Seimyniskiu Str. 3A 10 000 Zagreb
LT-09312 Vilnius Tel: +385 1 2353111
Tel: +370 5 2636037 E-mail: [email protected]

More detailed information on this medicinal product is available on the website of the European Medicines Agency: .