B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Rivastigmine 1 A Pharma 1.5 mg hard capsules Rivastigmine 1 A Pharma 3 mg hard capsules Rivastigmine 1 A Pharma 4.5 mg hard capsules Rivastigmine 1 A Pharma 6 mg hard capsules 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 1 A Pharma is and what it is used for

• 2. What you need to know before you take Rivastigmine 1 A Pharma

• 3. How to take Rivastigmine 1 A Pharma

• 4. Possible side effects

• 5. How to store Rivastigmine 1 A Pharma

• 6. Contents of the pack and other information

1. What Rivastigmine 1 A Pharma is and what it is used for

The active substance of Rivastigmine 1 A Pharma is rivastigmine.

Rivastigmine 1 A Pharma 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 1 A Pharma 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 1 A Pharma 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.

2. What you need to know before you take Rivastigmine 1 A Pharma

Do not take Rivastigmine 1 A Pharma

• – if you are allergic to rivastigmine (the active substance of Rivastigmine 1 A Pharma) 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 1 A Pharma.

Warnings and precautions

Talk to your doctor before taking Rivastigmine 1 A Pharma

• – 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.

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 1 A Pharma 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 1 A Pharma in the paediatric population in the treatment of Alzheimer’s di­sease.

Other medicines and Rivastigmine 1 A Pharma

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

Rivastigmine 1 A Pharma should not be given at the same time as other medicines with similar effects to Rivastigmine 1 A Pharma. Rivastigmine 1 A Pharma might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).

Rivastigmine 1 A Pharma 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 1 A Pharma, you should tell your doctor before you are given any anaesthetics, because Rivastigmine 1 A Pharma may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Rivastigmine 1 A Pharma is taken together with beta-blockers (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 1 A Pharma must be assessed against the possible effects on your unborn child. Rivastigmine 1 A Pharma should not be used during pregnancy unless clearly necessary.

You should not breast-feed during treatment with Rivastigmine 1 A Pharma.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Rivastigmine 1 A Pharma 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.

3. How to take Rivastigmine 1 A Pharma

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 1 A Pharma 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 1 A Pharma 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 1 A Pharma.
• To benefit from your medicine, take it every day.
• Take Rivastigmine 1 A Pharma 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 1 A Pharma than you should

If you accidentally take more Rivastigmine 1 A Pharma than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Rivastigmine 1 A Pharma 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 1 A Pharma

If you find you have forgotten to take your dose of Rivastigmine 1 A Pharma, 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. 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
• Chest pain
• Rash, itching
• Fits (seizures)
• Ulcers in your stomach or intestine

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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rivastigmine 1 A Pharma

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

Do not use Rivastigmine 1 A Pharma 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 store above 30°C.

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.

• 6. Content of the pack and other information

What Rivastigmine 1 A Pharma 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 1 A Pharma 1.5 mg capsule contains 1.5 mg of rivastigmine.

Each Rivastigmine 1 A Pharma 3 mg capsule contains 3 mg of rivastigmine.

Each Rivastigmine 1 A Pharma 4.5 mg capsule contains 4.5 mg of rivastigmine.

Each Rivastigmine 1 A Pharma 6 mg capsule contains 6 mg of rivastigmine.

What Rivastigmine 1 A Pharma looks like and contents of the pack

• – Rivastigmine 1 A Pharma 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 1 A Pharma 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 1 A Pharma 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 1 A Pharma 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.

Marketing Authorisation Holder

1 A Pharma GmbH

Industriestraße 18

83607 Holzkirchen

Germany

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Efc^rapufl CaHgo3 Btarapua KHT By.vHnKO.ia Banuapoß“ No. 55 crp. 4, em. 4 1407 Co$ua Ten.: + 359 2 970 47 47	Magyarország Sandoz Hungária Kft. Bartók Béla út 43–47 H-1114 Budapest Tel.: + 36 1 430 2890 E-mail:
Česká republika Sandoz s.r.o. Na Pankráci 1724/129 CZ-14000 Praha 4 – Nusle E-mail: Tel: +420 225 775 111	Malta V.J. Salomone Pharma Limited Upper Cross Road Marsa MRS 1542 Malta Tel: 00356 22983143
Danmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 K0benhavn S E-mail:	Nederland Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere Tel: + 31 36 5241600 E-mail:
Deutschland 1 A Pharma GmbH Industriestraße 18 D-83607 Holzkirchen Tel: +49 8024 908–3030 E-mail:	Norge Sandoz A/S Edvard Thomsens Vej 14 DK-2300 K0benhavn S E-mail:
Eesti Sandoz d.d. Eesti filiaal Pärnu mnt 105 EE-11312 Tallinn Tel: +372 6652400	Österreich 1A Pharma GmbH Stella-Klein-Löw-Weg 17 A-1020 Wien Tel: +43 (0)1 480 56 03
EZZáSa Novartis (Hellas) S.A.C.I./Sandoz division E0vik^ 05óg No 1 (12o km) MsTa^óppoon GR-144 51 A0pva Tql: +30 210 2811712	Polska Sandoz Polska Sp.z o.o. ul. Domaniewska 50 C PL-02–672 Warszawa Tel: + 48 22 549 15 00
España Sandoz Farmacéutica, S.A Centro Empresarial Parque Norte C/ Serrano Galvache N° 56, Edificio Roble E-28033 Madrid Tel: +34 91 602 30 62	Portugal Sandoz Farmacéutica Lda. Avenida Professor Doutor Cavaco Silva, n° 10E Taguspark 2740–255 Porto Salvo Portugal Tel: +351 211 964 000
France Sandoz SAS 49, avenue Georges Pompidou F-92593 Levallois-Perret Cedex Tél: + 33 1 4964 4800	Romania SC Sandoz S.R.L. Str Livezeni nr. 7A, Targu Mures, 540472 Romania Phone: +40 21 310 44 30

Ireland Rowex Ltd. Newtown IE-Bantry Co. Cork P75 V009 Tel: +353 27 50077	Slovenija Lek Pharmaceuticals d.d. Verovskova 57 SI-1526 Ljubljana Tel: + 386 1 5802111 E-mail:
Island Sandoz A/S Edvard Thomsens Vej 14 DK-2300 K0benhavn S E-mail:	Slovenská republika Sandoz d.d. – organizačná zložka Žižkova 22B SK-811 02 Bratislava Tel: +421 2 48 200 600
Italia Sandoz S.p.a Largo Umberto Boccioni 1 I-21040 Origgio (VA) Tel: + 39 02 96541	Suomi/Finland Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Kööpenhamina S/Köpenhamn S E-mail:
Knnpog n.T.XaiznYe^PYiou s-raipsia Ltd riXvTiZ31–3042 Aspsoog TnXepovo: 00357 25372425 Oa£ 00357 25376400 e-mail:	Sverige Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S E-mail:
Latvija Sandoz d.d. Latvia filiäle K.Valdemära Str. 33 – 29 LV-1010 Riga Tel: + 371 67892006	United Kingdom Sandoz Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR Tel: +44 1276 69 8020 E-mail:
Lietuva Sandoz Pharmaceuticals d.d., Branch Office Lithuania Seimyniskiu Str. 3A LT-09312 Vilnius Tel: + 370 5 2636037	Hrvatska Sandoz d.o.o. Maksimirska 120 10 000 Zagreb Tel: +38512353111 E-mail:

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency (EMA) website:

Package leaflet: Information for the patient

Rivastigmine 1 A Pharma 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 s 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 1 A Pharma is and what it is used for

• 2. What you need to know before you take Rivastigmine 1 A Pharma

• 3. How to take Rivastigmine 1 A Pharma

• 4. Possible side effects

• 5. How to store Rivastigmine 1 A Pharma

• 6. Contents of the pack and other information

1. What Rivastigmine 1 A Pharma is and what it is used for

The active substance of Rivastigmine 1 A Pharma is rivastigmine.

Rivastigmine 1 A Pharma 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 1 A Pharma 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 1 A Pharma 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.

2. What you need to know before you take Rivastigmine 1 A Pharma

Do not take Rivastigmine 1 A Pharma

• – if you are allergic to rivastigmine (the active substance in Rivastigmine 1A Pharma) 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 1 A Pharma.

Warnings and precautions

Talk to your doctor before taking Rivastigmine 1 A Pharma – 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.

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 1 A Pharma 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 1 A Pharma in the paediatric population in the treatment of Alzheimer’s di­sease.

Other medicines and Rivastigmine 1 A Pharma

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

Rivastigmine 1 A Pharma should not be given at the same time as other medicines with similar effects to Rivastigmine 1 A Pharma. Rivastigmine 1 A Pharma might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).

Rivastigmine 1 A Pharma 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 1 A Pharma, you should tell your doctor before you are given any anaesthetics, because Rivastigmine 1 A Pharma may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Rivastigmine 1 A Pharma is taken together with beta-blockers (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 1 A Pharma must be assessed against the possible effects on your unborn child. Rivastigmine 1 A Pharma should not be used during pregnancy unless clearly necessary.

You should not breast-feed during treatment with Rivastigmine 1 A Pharma.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Rivastigmine 1 A Pharma 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 1 A Pharma 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’.

3. How to take Rivastigmine 1 A Pharma

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 1 A Pharma 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 1 A Pharma 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 1 A Pharma.
• To benefit from your medicine, take it every day.
• Take Rivastigmine 1 A Pharma twice a day, in the morning and evening, with food.

How to use this medicine

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.

• 3. Filling the syringe

• Pull the plunger upwards until it reaches the right mark for the dose that your doctor has prescribed.

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.

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.

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 bottle to close it.

If you take more Rivastigmine 1 A Pharma than you should

If you accidentally take more Rivastigmine 1 A Pharma than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Rivastigmine 1 A Pharma 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 1 A Pharma

If you find you have forgotten to take your dose of Rivastigmine 1 A Pharma, 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. 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.

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
• 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rivastigmine 1 A Pharma

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

Do not use Rivastigmine 1 A Pharma 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 1 A Pharma 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.

• 6. Content of the pack and other information

What Rivastigmine 1 A Pharma 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 1 A Pharma looks like and contents of the pack

• – Rivastigmine 1 A Pharma 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 1 A Pharma 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 1 A Pharma 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 1 A Pharma 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.

Marketing Authorisation Holder

1 A Pharma GmbH

Industriestraße 18

83607 Holzkirchen

Germany

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Efc^rapufl CaHgo3 Btarapua KHT By.vHnKO.ia Banuapoß“ No. 55 crp. 4, em. 4 1407 Co$ua Ten.: + 359 2 970 47 47	Magyarország Sandoz Hungária Kft. Bartók Béla út 43–47 H-1114 Budapest Tel.: + 36 1 430 2890 E-mail:
Česká republika Sandoz s.r.o. Na Pankráci 1724/129 CZ-14000 Praha 4 – Nusle E-mail: Tel: +420 225 775 111	Malta V.J. Salomone Pharma Limited Upper Cross Road Marsa MRS 1542 Malta Tel: 00356 22983143
Danmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 K0benhavn S E-mail:	Nederland Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere Tel: + 31 36 5241600 E-mail:
Deutschland 1 A Pharma GmbH Industriestraße 18 D-83607 Holzkirchen Tel: +49 8024 908–3030 E-mail:	Norge Sandoz A/S Edvard Thomsens Vej 14 DK-2300 K0benhavn S E-mail:
Eesti Sandoz d.d. Eesti filiaal Pärnu mnt 105 EE-11312 Tallinn Tel: +372 6652400	Österreich 1A Pharma GmbH Stella-Klein-Löw-Weg 17 A-1020 Wien Tel: +43 (0)1 480 56 03
EZZáSa Novartis (Hellas) S.A.C.I./Sandoz division E0vik^ 05óg No 1 (12o km) MsTa^óppoon GR-144 51 A0pva Tql: +30 210 2811712	Polska Sandoz Polska Sp.z o.o. ul. Domaniewska 50 C PL-02–672 Warszawa Tel: + 48 22 549 15 00
España Sandoz Farmacéutica, S.A Centro Empresarial Parque Norte C/ Serrano Galvache N° 56, Edificio Roble E-28033 Madrid Tel: +34 91 602 30 62	Portugal Sandoz Farmacéutica Lda. Avenida Professor Doutor Cavaco Silva, n° 10E Taguspark 2740–255 Porto Salvo Portugal Tel: +351 211 964 000
France Sandoz SAS 49, avenue Georges Pompidou F-92593 Levallois-Perret Cedex Tél: + 33 1 4964 4800	Romania SC Sandoz S.R.L. Str Livezeni nr. 7A, Targu Mures, 540472 Romania Phone: +40 21 310 44 30

Ireland Rowex Ltd. Newtown IE-Bantry Co. Cork P75 V009 Tel: +353 27 50077	Slovenija Lek Pharmaceuticals d.d. Verovskova 57 SI-1526 Ljubljana Tel: + 386 1 5802111 E-mail:
Island Sandoz A/S Edvard Thomsens Vej 14 DK-2300 K0benhavn S E-mail:	Slovenská republika Sandoz d.d. – organizačná zložka Žižkova 22B SK-811 02 Bratislava Tel: +421 2 48 200 600
Italia Sandoz S.p.a Largo Umberto Boccioni 1 I-21040 Origgio (VA) Tel: + 39 02 96541	Suomi/Finland Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Kööpenhamina S/Köpenhamn S E-mail:
Knnpog n.T.XaiznYe^PYiou s-raipsia Ltd riXvTiZ31–3042 Aspsoog TnXepovo: 00357 25372425 Oa£ 00357 25376400 e-mail:	Sverige Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S E-mail:
Latvija Sandoz d.d. Latvia filiäle K.Valdemära Str. 33 – 29 LV-1010 Riga Tel: + 371 67892006	United Kingdom Sandoz Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR Tel: +44 1276 69 8020 E-mail:
Lietuva Sandoz Pharmaceuticals d.d., Branch Office Lithuania Seimyniskiu Str. 3A LT-09312 Vilnius Tel: + 370 5 2636037	Hrvatska Sandoz d.o.o. Maksimirska 120 10 000 Zagreb Tel: +38512353111 E-mail:

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency (EMA) website:

Package leaflet: Information for the patient

Rivastigmine 1 A Pharma 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 s 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 1 A Pharma is and what it is used for

• 2. What you need to know before you take Rivastigmine 1 A Pharma

• 3. How to take Rivastigmine 1 A Pharma

• 4. Possible side effects

• 5. How to store Rivastigmine 1 A Pharma

• 6. Contents of the pack and other information

1. What Rivastigmine 1 A Pharma is and what it is used for

The active substance of Rivastigmine 1 A Pharma is rivastigmine.

Rivastigmine 1 A Pharma 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 1 A Pharma 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 1 A Pharma 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.

2. What you need to know before you take Rivastigmine 1 A Pharma

Do not take Rivastigmine 1 A Pharma

• – if you are allergic to rivastigmine (the active substance in Rivastigmine 1A Pharma) 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 1 A Pharma.

Warnings and precautions

Talk to your doctor before taking Rivastigmine 1 A Pharma – 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.

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 1 A Pharma 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 1 A Pharma in the paediatric population in the treatment of Alzheimer’s di­sease.

Other medicines and Rivastigmine 1 A Pharma

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

Rivastigmine 1 A Pharma should not be given at the same time as other medicines with similar effects to Rivastigmine 1 A Pharma. Rivastigmine 1 A Pharma might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).

Rivastigmine 1 A Pharma 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 1 A Pharma, you should tell your doctor before you are given any anaesthetics, because Rivastigmine 1 A Pharma may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Rivastigmine 1 A Pharma is taken together with beta-blockers (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 1 A Pharma must be assessed against the possible effects on your unborn child. Rivastigmine 1 A Pharma should not be used during pregnancy unless clearly necessary.

You should not breast-feed during treatment with Rivastigmine 1 A Pharma.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Rivastigmine 1 A Pharma 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 1 A Pharma 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’.

3. How to take Rivastigmine 1 A Pharma

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 1 A Pharma 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 1 A Pharma 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 1 A Pharma.
• To benefit from your medicine, take it every day.
• Take Rivastigmine 1 A Pharma twice a day, in the morning and evening, with food.

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.

• 3. Filling the syringe

• Pull the plunger upwards until it reaches the right mark for the dose that your doctor has prescribed.

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.

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.

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 bottle to close it.

If you take more Rivastigmine 1 A Pharma than you should

If you accidentally take more Rivastigmine 1 A Pharma than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Rivastigmine 1 A Pharma 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 1 A Pharma

If you find you have forgotten to take your dose of Rivastigmine 1 A Pharma, 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. 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.

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
• 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rivastigmine 1 A Pharma

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

Do not use Rivastigmine 1 A Pharma 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 1 A Pharma 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.

• 6. Content of the pack and other information

What Rivastigmine 1 A Pharma 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 1 A Pharma looks like and contents of the pack

Rivastigmine 1 A Pharma 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

1 A Pharma GmbH

Industriestraße 18

83607 Holzkirchen

Germany

Manufacturer

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nuremberg

Germany

Efc^rapufl

CaHgo3 Ei.irapu;! KHT

Ey.vHnKO.ia BanuapoB“ No. 55

crp. 4, em. 4

1407 Co(|ih;i

Ten.: + 359 2 970 47 47

Česká republika

Sandoz s.r.o.

Na Pankráci 1724/129

CZ-14000 Praha 4 – Nusle

E-mail:

Tel: +420 225 775 111

Danmark

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 K0benhavn S

E-mail:

Luxembourg/Lu­xemburg

1 A Pharma GmbH

Industriestraße 18

D-83607 Holzkirchen

Tel: +49 8024 908–3030

E-mail:

Magyarország

Sandoz Hungária Kft.

Bartók Béla út 43–47

H-1114 Budapest

Tel.: + 36 1 430 2890

E-mail:

Malta

V.J. Salomone Pharma Limited

Upper Cross Road

Marsa

MRS 1542

Malta

Tel: 00356 22983143

Nederland

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

Tel: + 31 36 5241600

E-mail:

Deutschland

• 1 A Pharma GmbH

Industriestraße 18

D-83607 Holzkirchen

Tel: +49 8024 908–3030

E-mail:

Eesti

Sandoz d.d. Eesti filiaal

Pärnu mnt 105

EE-11312 Tallinn

Tel: +372 6652400

EZZáda

Novartis (Hellas) S.A.C.I./Sandoz division

E0vik^ 05óg No 1 (12o km)

MsTa^óppoon

GR-144 51 A0qva.

Tql: +30 210 2811712

España

Sandoz Farmacéutica, S.A

Centro Empresarial Parque Norte

C/ Serrano Galvache N° 56, Edificio Roble

E-28033 Madrid

Tel: +34 91 602 30 62

France

Sandoz SAS

• 49, avenue Georges Pompidou