Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - nimvastid

Document Subject

Generated Narrative: MedicinalProductDefinition mpbf180fec42e0c0b913e732d977364555

identifier: http://ema.europa.eu/identifier/14 hard capsules: EU/1/09/525/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Nimvastid 1.5 mg hard capsules

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-bf180fec42e0c0b913e732d977364555

identifier: http://ema.europa.eu/identifier/14 hard capsules: EU/1/09/525/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - nimvastid

Attesters

What is in this leaflet

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

The active substance of Nimvastid 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, Nimvastid 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. Nimvastid 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 orodispersible tablets can also be used for the treatment of dementia in adult patients with Parkinson s disease.

Do not take Nimvastid

if you are allergic to rivastigmine (the active substance in Nimvastid) or to any of the other ingredients of this medicine (listed in section 6).

if you have a skin reaction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the transdermal patch. If this applies to you, tell your doctor and do not take Nimvastid. Warnings and precautions Talk to your doctor before taking Nimvastid:

if you have, or have ever had, a heart condition such as an irregular or slow heartbeat, QTc prolongation, a family history of QTc prolongation, torsade de pointes, or have a low blood level of potassium or magnesium.

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 Nimvastid 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 Nimvastid in the paediatric population in the treatment of Alzheimer s disease. Other medicines and Nimvastid Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Nimvastid should not be given at the same time as other medicines with similar effects to Nimvastid. Nimvastid might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson s disease or to prevent travel sickness). Nimvastid 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 Nimvastid, tell your doctor before you are given any anaesthetics, because Nimvastid may exaggerate the effects of some muscle relaxants during anaesthesia. Caution when Nimvastid 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. Caution when Nimvastid is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation). 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 Nimvastid must be assessed against the possible effects on your unborn child. Nimvastid should not be used during pregnancy unless clearly necessary. You should not breast-feed during treatment with Nimvastid. Driving and using machines Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Nimvastid 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, pharmacist or nurse if you are not sure. How to start treatment Your doctor will tell you what dose of Nimvastid 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 Nimvastid 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 Nimvastid.

To benefit from your medicine, take it every day.

Take Nimvastid 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 Nimvastid than you should If you accidentally take more Nimvastid than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Nimvastid 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 Nimvastid If you find you have forgotten to take your dose of Nimvastid, 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 rivastigmine 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, pharmacist or nurse. 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 this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. 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.

What Nimvastid contains

The active substance is rivastigmine hydrogen tartrate. Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg, 3 mg, 4.5 mg or 6 mg rivastigmine.

The other ingredients for Nimvastid 1.5 mg capsules are microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate in the capsule content, and titanium dioxide (E171), yellow iron oxide (E172) and gelatine in the capsule shell.

The other ingredients for Nimvastid 3 mg, 4.5 mg and 6 mg capsules are microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate in the capsule content, and titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and gelatine in the capsule shell. What Nimvastid looks like and contents of the pack Nimvastid 1.5 mg hard capsules, which contain a white to almost white powder, have a yellow cap and yellow body. Nimvastid 3 mg hard capsules, which contain a white to almost white powder, have an orange cap and orange body. Nimvastid 4.5 mg hard capsules, which contain a white to almost white powder, have a brownish red cap and brownish red body. Nimvastid 6 mg hard capsules, which contain a white to almost white powder, have a brownish red cap and orange body. Blister pack (PVC/PVDC/Alu-foil): boxes of 14 (only for 1.5 mg), 28, 30, 56, 60 or 112 hard capsules are available. HDPE container: boxes of 200 or 250 hard capsules are available. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer KRKA, d.d., Novo mesto, marje ka cesta 6, 8501 Novo mesto, Slovenia For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien KRKA Belgium, SA. T l/Tel: + 32 (0) 487 50 73 Lietuva UAB KRKA Lietuva Tel: + 370 5 236 27

Te .: + 359 (02) 962 34 Luxembourg/Luxemburg KRKA Belgium, SA. T l/Tel: + 32 (0) 487 50 73 62 (BE) esk republika KRKA R, s.r.o. Tel: + 420 (0) 221 115 Magyarorsz g KRKA Magyarorsz g Kereskedelmi Kft. Tel.: + 36 (1) 355 8Danmark KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) Malta E.J. Busuttil Ltd. Tel: + 356 21 445 Deutschland TAD Pharma GmbH Tel: + 49 (0) 4721 606-0 Nederland KRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 Norge KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE)

KRKA
: + 30 2100101 sterreich KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 Espa a KRKA Farmac utica, S.L. Tel: + 34 911 61 03 Polska KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7France KRKA France Eurl T l: + 33 (0)1 57 40 82 Portugal KRKA Farmac utica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 Hrvatska KRKA - FARMA d.o.o. Tel: + 385 1 6312 Rom nia KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 Ireland KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3Slovenija KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 sland LYFIS ehf. S mi: + 354 534 3Slovensk republika KRKA Slovensko, s.r.o., Tel: + 421 (0) 2 571 04 Italia KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8Suomi/Finland KRKA Finland Oy Puh/Tel: +358 20 754 5 KI.PA. (PHARMACAL) LIMITED : + 357 24 651 Sverige KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE) Latvija KRKA Latvija SIA Tel: + 371 6 733 86 United Kingdom (Northern Ireland) KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. Package leaflet: Information for the patient Nimvastid 1.5 mg orodispersible tablets Nimvastid 3 mg orodispersible tablets Nimvastid 4.5 mg orodispersible tablets Nimvastid 6 mg orodispersible tablets 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.