Nimvastid 6 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Nimvastid 1.5 mg hard capsules EFG

Nimvastid 3 mg hard capsules EFG

Nimvastid 4.5 mg hard capsules EFG

Nimvastid 6 mg hard capsules EFG

rivastigmine

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

• Keep this leaflet. 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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Nimvastid is and what it is used for

The active substance in Nimvastid is rivastigmine.

Rivastigmine belongs to a group of medicines called cholinesterase inhibitors. In patients with Alzheimer's dementia or dementia associated with Parkinson's disease, certain nerve cells in the brain die, resulting in low levels of the neurotransmitter acetylcholine (a substance that enables nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.

By inhibiting these enzymes, Nimvastid increases the levels of acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.

Nimvastid is used to treat adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual capacity, and behaviour. The capsules and orodispersible tablets can also be used to treat dementia in adult patients with Parkinson's disease.

2. What you need to know before starting Nimvastid

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 that spreads beyond the size of the patch, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling), or if there is no improvement within 48 hours after removing the transdermal patch.

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

Warnings and precautions

Consult your doctor before starting to use Nimvastid:

• if you have or have ever had an irregular or slow heart rate (pulse).
• if you have or have ever had an active stomach ulcer.
• if you have or have ever had difficulty urinating.
• if you have or have ever had seizures.
• if you have or have ever had asthma or a serious respiratory disease.
• if you have or have ever had (impairment of) kidney function.
• if you have or have ever had (impairment of) liver function.
• if you suffer from tremors.
• if you have low body weight.
• if you have gastrointestinal reactions such as dizziness (nausea), vomiting, and diarrhea. You could become dehydrated (loss of large amounts of fluid) if vomiting or diarrhea are prolonged.

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

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

Children and adolescents

Nimvastid should not be used in the pediatric population for the treatment of Alzheimer's disease.

Other medicines and Nimvastid

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

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

Nimvastid should not be administered at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines together may cause problems such as stiffness in the limbs and hand tremors.

If you need to undergo surgery while taking Nimvastid, inform your doctor before receiving any anesthetic, as Nimvastid may enhance the effects of certain muscle relaxants used during anesthesia.

Caution is required when using Nimvastid together with beta-blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions). Taking both medicines together may cause complications such as a decrease in heart rate (bradycardia), which may lead to fainting or loss of consciousness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant, the benefits of using Nimvastid must be weighed against the potential adverse effects on the fetus. Nimvastid should not be used during pregnancy unless clearly necessary.

You must not breastfeed during treatment with Nimvastid.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Nimvastid 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 or use machinery or perform any tasks requiring your attention.

3. How to take Nimvastid

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

Starting treatment

Your doctor will tell you what dose of Nimvastid you should take.

• Treatment is usually started at a low dose.
• Your doctor will slowly increase your dose depending on how you respond to treatment.
• The highest dose you will take is 6.0 mg twice daily.

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

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

Taking this medicine

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

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 higher doses have experienced dizziness (nausea), vomiting, diarrhoea, high blood pressure, and hallucinations. Slowing of heart rate and fainting may also occur.

If you forget to take Nimvastid

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

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

4. Possible adverse effects

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

You may experience adverse effects more frequently when starting your treatment or when your dose is increased. Generally, adverse 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
• Restlessness
• 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
• Difficulty sleeping
• Fainting or accidental falls
• Changes in liver function

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

• Chest pain
• Skin rash, itching
• Epileptic seizures (fits)
• 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 heart rhythm such as fast or slow heartbeat
• Gastrointestinal bleeding – seen as blood in your stools or when vomiting
• Inflammation of the pancreas – signs include severe pain in the upper stomach, often with nausea or vomiting
• Worsening of signs of Parkinson’s disease or development of similar symptoms – such as muscle stiffness, difficulty moving

Not known (cannot be estimated from available data)

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

Patients with dementia or Parkinson’s disease

These patients experience some adverse effects more frequently and also have some additional adverse effects:

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

• Tremor
• Fainting
• Accidental falls

Common (may affect up to 1 in 10 people)

• Anxiety
• Feeling restless
• Slow and fast heartbeat
• Difficulty sleeping
• Excessive saliva and dehydration
• Abnormally slow movements or uncontrollable movements
• Worsening of signs of Parkinson’s disease 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 loss of movement control

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

Common (may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to properly control urination)

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity (high level of activity, restlessness)

Not known (cannot be estimated from available data)

• Allergic skin reaction at the site where the patch was applied, such as blisters or skin swelling

If you experience any of these adverse effects, contact your doctor, as medical attention may be required.

Reporting of adverse effects

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

5. Storage of Nimvastid

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the package and other information

Composition of Nimvastid

• The active substance is rivastigmine hydrogen tartrate.

Each capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg, 3 mg, 4.5 mg or 6 mg of rivastigmine.

• The other components of Nimvastid 1.5 mg hard capsules are microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate in the capsule contents, and titanium dioxide (E171), yellow iron oxide (E172) and gelatin in the capsule shell.

• The other components of Nimvastid 3 mg, 4.5 mg and 6 mg hard capsules are microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate in the capsule contents, and titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and gelatin in the capsule shell.

Appearance of the product and contents of the pack

Nimvastid 1.5 mg hard capsules contain a white to off-white powder in a capsule with yellow cap and body.

Nimvastid 3 mg hard capsules contain a white to off-white powder in a capsule with orange cap and body.

Nimvastid 4.5 mg hard capsules contain a white to off-white powder in a capsule with brownish-red cap and body.

Nimvastid 6 mg hard capsules contain a white to off-white powder in a capsule with brownish-red cap and orange body.

Pack sizes of blister packs (PVC/PVDC/Al-foil) available in boxes of 14 (only for 1.5 mg), 28, 30, 56, 60 or 112 hard capsules.

Plastic bottles: available in boxes of 200 or 250 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: {MM/YYYY}

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