Rivastigmin Neuropharma

PATIENT INFORMATION LEAFLET: USER INFORMATION

Rivastigmin NeuroPharma, 1.5 mg, hard capsules

Rivastigmin NeuroPharma, 3.0 mg, hard capsules

Rivastigmin NeuroPharma, 4.5 mg, hard capsules

Rivastigmin NeuroPharma, 6.0 mg, hard capsules

Rivastigmine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Rivastigmin NeuroPharma and what is it used for
• 2. Important information before taking Rivastigmin NeuroPharma
• 3. How to take Rivastigmin NeuroPharma
• 4. Possible side effects
• 5. How to store Rivastigmin NeuroPharma
• 6. Contents of the pack and other information

1. What is Rivastigmin NeuroPharma and what is it used for

The active substance of Rivastigmin NeuroPharma is rivastigmine.
Rivastigmine belongs to a group of substances called cholinesterase inhibitors. In patients with Alzheimer's disease or Parkinson's disease dementia, certain brain cells die, which reduces the level of the neurotransmitter acetylcholine (a substance that enables nerve cells to communicate with each other).
The action of rivastigmine is to block the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking the action of these enzymes, Rivastigmin NeuroPharma increases the level of acetylcholine in the brain, which helps to alleviate the symptoms of Alzheimer's disease and Parkinson's disease dementia.
Rivastigmin NeuroPharma is used to treat adult patients with mild to moderate Alzheimer's disease, a progressive brain disorder that causes gradual memory, intellectual, and behavioral disturbances. Capsules and oral solution may also be used to treat dementia in adult patients with Parkinson's disease.

2. Important information before taking Rivastigmin NeuroPharma

When not to take Rivastigmin NeuroPharma

Warnings and precautions

Before starting treatment with Rivastigmin NeuroPharma, discuss with your doctor:

If any of the above apply to you, your doctor may decide to monitor your condition more closely while taking this medicine.
If you have stopped taking Rivastigmin NeuroPharma for more than three days, do not take the next dose until you have talked to your doctor.

Children and adolescents

There is no justification for using Rivastigmin NeuroPharma in children and adolescents to treat Alzheimer's disease.

Rivastigmin NeuroPharma and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Rivastigmin NeuroPharma should not be taken with other medicines that have a similar effect. Rivastigmin NeuroPharma may affect the action of anticholinergic medicines (medicines used to relieve stomach cramps, treat Parkinson's disease, or prevent motion sickness).
Rivastigmin NeuroPharma should not be taken with metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking these two medicines together may cause disorders such as stiffness of the limbs and hand tremors.
If you need to undergo surgery during treatment with Rivastigmin NeuroPharma, tell your doctor about taking the medicine before undergoing general anesthesia, as Rivastigmin NeuroPharma may enhance the action of certain muscle relaxants used during general anesthesia.
Caution should be exercised when Rivastigmin NeuroPharma is taken with beta-adrenergic blockers (such as atenolol, used to treat high blood pressure, angina, and other heart conditions). Taking these two medicines together may cause disorders such as slow heart rate (bradycardia) leading to fainting or loss of consciousness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist.
If you are pregnant, your doctor will assess the benefits of taking Rivastigmin NeuroPharma against the possible effects of the medicine on the unborn child. Rivastigmin NeuroPharma should not be taken during pregnancy unless absolutely necessary.
Do not breastfeed while taking Rivastigmin NeuroPharma.

Driving and using machines

Your doctor will inform you whether your condition allows you to drive or use machines safely. Rivastigmin NeuroPharma may cause dizziness and drowsiness, mainly during the initial treatment period or when increasing the dose. If you experience dizziness or drowsiness, do not drive, operate machinery, or perform any other tasks that require concentration.

3. How to take Rivastigmin NeuroPharma

Always take this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor, pharmacist, or nurse.

How to start treatment

Your doctor will tell you what dose of Rivastigmin NeuroPharma to take.

• Treatment usually starts with a low dose.
• Your doctor will gradually increase the dose depending on your response to treatment.
• The maximum dose you can take is 6.0 mg twice a day.

Your doctor will regularly check if the medicine is working for you. During treatment with this medicine, your doctor will also monitor your weight.
If you have stopped taking Rivastigmin NeuroPharma for more than three days, do not take the next dose until you have talked to your doctor.

While taking this medicine

• Tell your caregiver that you are taking Rivastigmin NeuroPharma.
• Take the medicine every day to get the desired therapeutic effect.
• Take Rivastigmin NeuroPharma twice a day (morning and evening) with food.
• Swallow the capsules whole with a drink of water.
• Do not open or crush the capsules.

Taking a higher dose of Rivastigmin NeuroPharma than recommended

If you have accidentally taken a higher dose of Rivastigmin NeuroPharma than recommended, inform your doctor, as medical attention may be necessary. In some people who have accidentally taken too much Rivastigmin NeuroPharma, nausea (vomiting), vomiting, diarrhea, high blood pressure, and hallucinations have been observed. Slow heart rate and fainting may also occur.

Missing a dose of Rivastigmin NeuroPharma

If you have missed a dose of Rivastigmin NeuroPharma, 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 further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivastigmin NeuroPharma can cause side effects, although not everybody gets them.
Side effects may occur more frequently during the initial treatment period or when increasing the dose. Side effects usually disappear slowly as the body gets used to the treatment.

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

• Dizziness
• Loss of appetite
• Stomach problems, such as nausea (vomiting) or vomiting, diarrhea

Common (may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Abdominal pain
• Agitation
• 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
• Difficulty sleeping
• Fainting or accidental falls
• Changes in liver function

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

• Chest pain
• Rash, itching
• Seizures (epileptic fits)
• Stomach or intestinal ulcers

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 disturbances such as fast or slow heart rate
• Gastrointestinal bleeding - blood in stool or vomit
• Pancreatitis - severe pain in the upper abdomen, often with nausea or vomiting
• Worsening of Parkinson's disease symptoms or occurrence of similar symptoms - such as muscle stiffness, difficulty moving, and muscle weakness

Frequency not known (cannot be estimated from the available data)

• Sudden severe vomiting, which may lead to tearing of the esophagus (the part of the digestive tract connecting the mouth to the stomach)
• Dehydration (loss of too much fluid)
• Liver function disorders (yellowing of the skin, yellowing of the whites of the eyes, unusual dark color of urine or unexplained nausea, vomiting, fatigue, and loss of appetite)
• Aggression, restlessness
• Irregular heart rhythm
• Pisa syndrome (a condition characterized by involuntary muscle contraction with abnormal tilting of the body and head to one side)

Patients with dementia and Parkinson's disease

In these patients, some side effects occur more frequently. They may also experience additional symptoms:

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 heart rate
• Difficulty sleeping
• Excessive salivation and dehydration
• Abnormal slowing of movement or poor movement control
• Worsening of Parkinson's disease symptoms or occurrence of similar symptoms - such as muscle stiffness, difficulty moving, and muscle weakness

Uncommon (may affect up to 1 in 100 people)

• Irregular heart rhythm and poor movement control

Frequency not known (cannot be estimated from the available data)

• Pisa syndrome (a condition characterized by involuntary muscle contraction with abnormal tilting of the body and head to one side)

Other side effects observed after using rivastigmine patches, which may also occur after taking hard capsules.

Common (may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to properly hold urine)

Uncommon (may affect up to 1 in 100 people)

• Excessive restlessness (high level of activity, restlessness)

Frequency not known (cannot be estimated from the available data)

• Allergic reaction at the patch site, such as blisters or skin inflammation.

If you experience any of these symptoms, contact your doctor, as medical attention may be necessary.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to
Department for Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivastigmin NeuroPharma

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Rivastigmin NeuroPharma contains

Contents of the capsule:

• The active substance is rivastigmine hydrogen tartrate.
• The other ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide anhydrous Capsule shell:
• Gelatin, yellow iron oxide (E 172), titanium dioxide (E 171), red iron oxide (E 172) (only for 3.0, 4.5, and 6.0 mg capsules) and printing ink.

The printing ink contains shellac, propylene glycol, concentrated ammonia, black iron oxide, and potassium hydroxide.
Each Rivastigmin NeuroPharma 1.5 mg capsule contains 1.5 mg of rivastigmine.
Each Rivastigmin NeuroPharma 3.0 mg capsule contains 3.0 mg of rivastigmine.
Each Rivastigmin NeuroPharma 4.5 mg capsule contains 4.5 mg of rivastigmine.
Each Rivastigmin NeuroPharma 6.0 mg capsule contains 6.0 mg of rivastigmine.

What Rivastigmin NeuroPharma looks like and contents of the pack

• Rivastigmin NeuroPharma 1.5 mg hard capsules are yellow/yellow hard gelatin capsules with black printing "RIVA 1.5mg" containing white to off-white granular powder, equivalent to 1.5 mg of rivastigmine.
• Rivastigmin NeuroPharma 3.0 mg hard capsules are light orange/light orange hard gelatin capsules with black printing "RIVA 3.0 mg" containing white to off-white granular powder, equivalent to 3.0 mg of rivastigmine.
• Rivastigmin NeuroPharma 4.5 mg hard capsules are caramel/caramel hard gelatin capsules with black printing "RIVA 4.5mg" containing white to off-white granular powder, equivalent to 4.5 mg of rivastigmine.
• Rivastigmin NeuroPharma 6.0 mg hard capsules are light orange/caramel hard gelatin capsules with black printing "RIVA 6.0 mg" containing white to off-white granular powder, equivalent to 6.0 mg of rivastigmine.

The capsules are packaged in blisters, available in four different pack sizes (14, 28, 56, 112, or 560 capsules). Not all pack sizes may be marketed.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld
Germany
To obtain more detailed information, please contact the representative of the marketing authorization holder in Poland:
Neuraxpharm Polska sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
info-poland@neuraxpharm.com

Manufacturer

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23, 40764 Langenfeld
Germany
Genepharm S.A.
18th Marathonos Avenue, Pallini 15351, Attiki
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands:

Rivastigmine-neuraxpharm 1.5 mg / 3 mg / 4.5 mg / 6 mg hard capsules

Germany:

Rivastigmin-neuraxpharm 1.5 mg / 3 mg / 4.5 mg / 6 mg Hartkapseln

Poland:

Rivastigmin NeuroPharma

Date of last revision of the leaflet: