Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - rivastigmine

Document Subject

Generated Narrative: MedicinalProductDefinition mpe0ec42c68686885cc176ad73b71e1d80

identifier: http://ema.europa.eu/identifier/EU/1/09/599/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Rivastigmine Sandoz 1.5 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-e0ec42c68686885cc176ad73b71e1d80

identifier: http://ema.europa.eu/identifier/EU/1/09/599/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - rivastigmine

Attesters

What is in this leaflet

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

The active substance of Rivastigmine Sandoz is rivastigmine.

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

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

Do not take Rivastigmine Sandoz

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

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

Warnings and precautions
Talk to your doctor before taking Rivastigmine Sandoz

• if you have, or have ever had irregular or slow heartbeat.
• if you have, or have ever had an active stomach ulcer.
• if you have, or have ever had, difficulties in passing urine.
• if you have, or have ever had, seizures.
• if you have, or have ever had, asthma or severe respiratory disease.
• if you have, or have ever had impaired kidney function.
• if you have, or have ever had, impaired liver function.
• if you suffer from trembling.
• if you have a low body weight.
• if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea. You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.

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

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

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

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

Rivastigmine Sandoz should not be given at the same time as other medicines with similar effects to Rivastigmine Sandoz. Rivastigmine Sandoz might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson s disease or to prevent travel sickness). Rivastigmine Sandoz should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together could cause problems such as stiff limbs and trembling hands.

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

Caution when Rivastigmine Sandoz is taken together with 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 Sandoz must be assessed against the possible effects on your unborn child. Rivastigmine Sandoz should not be used during pregnancy unless clearly necessary.

You should not breast-feed during treatment with Rivastigmine Sandoz.

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

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

How to start treatment Your doctor will tell you what dose of Rivastigmine Sandoz to take

Treatment usually starts with a low dose.

Your doctor will slowly increase your dose depending on how you respond to treatment.

The highest dose that should be taken is 6.0 mg twice a day.

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

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

Taking this medicine

Tell your caregiver that you are taking Rivastigmine Sandoz.

To benefit from your medicine, take it every day.

Take Rivastigmine Sandoz twice a day in the morning and evening with food.

Swallow the capsules whole with a drink.

Do not open or crush the capsules.

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

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

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

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

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

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

Feeling dizzy

Loss of appetite

Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea

Common (may affect up to 1 in 10 people)

Anxiety

Sweating

Headache

Heartburn

Weight loss

Stomach pain

Feeling agitated

Feeling tired or weak

Generally feeling unwell

Trembling or feeling confused

Decreased appetite

Nightmares

Uncommon (may affect up to 1 in 100 people)

Depression

Difficulty in sleeping

Fainting or accidentally falling

Changes in how well your liver is working

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

Chest pain

Rash, itching

Fits (seizures)

Ulcers in your stomach or intestine

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

High blood pressure

Urinary tract infection

Seeing things that are not there (hallucinations)

Problems with your heartbeat such as fast or slow heartbeat

Bleeding in the gut shows as blood in stools or when being sick

Inflammation of the pancreas the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)

The signs of Parkinson s disease get worse or getting similar signs such as stiff muscles, difficulty in carrying out movements

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

Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with your stomach (oesophagus)

Dehydration (losing too much fluid)

Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)

Aggression, feeling restless

Uneven heartbeat

Patients with dementia and Parkinson s disease These patients have some side effects more often. They also have some additional side effects:

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

Trembling

Fainting

Accidentally falling

Common (may affect up to 1 in 10 people)

Anxiety

Feeling restless

Slow and fast heartbeat

Difficulty in sleeping

Too much saliva and dehydration

Unusually slow movements or movements you cannot control

The signs of Parkinson s disease get worse or getting similar signs such as stiff muscles, difficulty in carrying out movements and muscle weakness

Uncommon (may affect up to 1 in 100 people)

Uneven heartbeat and poor control of movements

Other side effects seen with transdermal patches and which may occur with the 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.

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

Do not use Rivastigmine Sandoz after the expiry date which is stated on the blister, bottle and carton after EXP . The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Do not store above 30 C.

What Rivastigmine Sandoz contains

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

Each Rivastigmine Sandoz 1.5 mg capsule contains 1.5 mg of rivastigmine.
Each Rivastigmine Sandoz 3 mg capsule contains 3 mg of rivastigmine.
Each Rivastigmine Sandoz 4.5 mg capsule contains 4.5 mg of rivastigmine.
Each Rivastigmine Sandoz 6 mg capsule contains 6 mg of rivastigmine.

What Rivastigmine Sandoz looks like and contents of the pack

• Rivastigmine Sandoz 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with a red imprint RIV 1.5 mg on the body.

• Rivastigmine Sandoz 3 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint RIV 3 mg on the body.

• Rivastigmine Sandoz 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint RIV 4.5 mg on the body.

• Rivastigmine Sandoz 6 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint RIV 6 mg on the body.

• They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) but these may not all be available in your country.

Marketing Authorisation Holder Sandoz GmbH
Biochemiestra e A-6250 Kundl
Austria

Manufacturer Novartis Farmac utica, S.A.
Gran Via de les Corts Catalanes, 08013 Barcelona
Spain

Novartis Pharma GmbH Roonstrasse 90429 N rnberg Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Sandoz N.V. Telecom Gardens, Medialaan B-1800 Vilvoorde T l/Tel: + 32 (0)2 722 97 Luxembourg/Luxemburg Sandoz N.V. Telecom Gardens, Medialaan B 1800 Vilvoorde T l/Tel: + 32 (0)2 722 97

Te .: + 359 2 970 47 Magyarorsz g Sandoz Hung ria Kft. Bart k B la t 43-H-1114 Budapest Tel.: + 36 1 430 2E-mail: info.hungary@sandoz.com

esk republika Sandoz s.r.o. Na Pankr ci 1724/CZ-14000 Praha 4 - Nusle E-mail: office.cz@sandoz.com Tel: +420 225 775 Malta Sandoz Pharmaceuticals d.d. Tel: +35699644126= Danmark Sandoz A/S Edvard Thomsens Vej DK-2300 K benhavn S Danmark Tlf: +45 6395 1info.danmark@sandoz.com

Nederland Sandoz B.V. Veluwezoom NL-1327 AH Almere Tel: + 31 36 5241E-mail: info.sandoz-nl@sandoz.com

Deutschland Hexal AG Industriestra e D-83607 Holzkirchen Tel: + 49 8024 908 0 E-mail: service@hexal.com

Norge Sandoz A/S Edvard Thomsens Vej DK-2300 K benhavn S Danmark Tlf: +45 6395 1info.norge@sandoz.com

Eesti Sandoz d.d. Eesti filiaal P rnu mnt EE-11312 Tallinn Tel: +372 6652 sterreich Sandoz GmbH Biochemiestrasse A-6250 Kundl Tel: + 43 (0)53382
Novartis (Hellas) A.E.B.E. : +30 210 281 17 Polska Sandoz Polska Sp.z o.o. ul. Domaniewska 50 C PL-02-672 Warszawa Tel: + 48 22 549 15 Espa a Sandoz Farmac utica, S.A
Centro Empresarial Parque Norte, Edificio Roble C/ Serrano Galvache N 56,
28033 Madrid Tel: +34 900 456 registros.spain@sandoz.com

Portugal Sandoz Farmac utica Lda. Avenida Professor Doutor Cavaco Silva, n. 10E Taguspark 2740-255 Porto Salvo Portugal Tel: +351 211 964 France Sandoz SAS 49, avenue Georges Pompidou F-92593 Levallois-Perret Cedex T l: + 33 1 4964 4Rom nia Sandoz S.R.L. Str Livezeni nr. 7A,
T rgu Mure , 540Rom nia Tel: +40 21 310 44 Ireland Slovenija Rowex Ltd. Newtown IE-Bantry Co. Cork P75 VTel: +353 27 50Lek Pharmaceuticals d.d. Verov kova SI-1526 Ljubljana Tel: + 386 1 5802E-mail: info.lek@sandoz.com

sland Sandoz A/S Edvard Thomsens Vej DK-2300 Kaupmannah fn S Danm rk S mi : +45 6395 1info.danmark@sandoz.com

Slovensk republika Sandoz d.d. - organiza n zlo ka i kova 22B SK-811 02 Bratislava Tel: +421 2 48 200 Italia Sandoz S.p.a
Largo Umberto Boccioni 1 I-21040 Origgio (VA) Tel: + 39 02 96Suomi/Finland Sandoz A/S Edvard Thomsens Vej DK-2300 K penhamina S/K penhamn S Tanska/Finland Puh: +358 010 6133 info.suomi@sandoz.com

Sandoz Pharmaceuticals d.d. : +357 22 69 0Sverige Sandoz A/S Edvard Thomsens Vej DK-2300 K penhamn S Danmark Tel: +45 6395 1info.sverige@sandoz.com

Latvija Sandoz d.d. Latvia fili le K.Valdem ra Str. 33 LV-1010 Riga Tel: + 371 67892United Kingdom (Northern Ireland) Sandoz GmbH Biochemiestr. A-6250 Kundl Tel: +43 5338 2uk.drugsafety@sandoz.com Lietuva Sandoz Pharmaceuticals d.d., Branch Office Lithuania Seimyniskiu Str. 3A LT-09312 Vilnius Tel: + 370 5 2636Hrvatska Sandoz d.o.o. Maksimirska 10 000 Zagreb Tel: +38512353E-mail: upit.croatia@sandoz.com

This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu

Package leaflet: Information for the patient

Rivastigmine Sandoz 2 mg/ml oral solution
rivastigmine

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

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