Rivastigmine neuropharma

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
Rivastigminum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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

The active substance in Rivastigmin NeuroPharma is rivastigmine.
Rivastigmine belongs to a group of substances called cholinesterase inhibitors. In patients with
Alzheimer's-type dementia or dementia caused by Parkinson's disease, certain brain cells degenerate,
leading to reduced levels of the neurotransmitter acetylcholine (a substance that enables nerve cells to
communicate with each other). Rivastigmine works by inhibiting the enzymes that break down
acetylcholine: acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes,
Rivastigmin NeuroPharma increases the concentration of acetylcholine in the brain, helping to
alleviate symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.
Rivastigmin NeuroPharma is used to treat adult patients with mild to moderate Alzheimer's-type
dementia, a progressive brain disorder causing gradual impairments in memory, intellectual
abilities, and behavior. Capsules and oral solution may also be used in the treatment of dementia in
adult patients with Parkinson's disease.

2. Important information before using Rivastigmin NeuroPharma

When not to use Rivastigmin NeuroPharma

• if the patient is allergic to rivastigmine (the active substance in Rivastigmin NeuroPharma) or to any of the other ingredients of this medicine (listed in section 6);
• if in the past, after using rivastigmine in patches, a reaction indicating allergic contact dermatitis occurred. If this applies to the patient, inform the doctor and do not use Rivastigmin NeuroPharma.

Warnings and precautions
Before starting treatment with Rivastigmin NeuroPharma, discuss the following with the doctor:

• if the patient has or has ever had heart conditions, such as irregular or slow heartbeat, QT interval prolongation, familial QT prolongation, torsade de pointes, or low blood potassium or magnesium levels;
• if the patient has or has ever had an active peptic ulcer;
• if the patient has or has ever had difficulties in urination;
• if the patient has or has ever had seizures;
• if the patient has or has ever had bronchial asthma or severe respiratory disease;
• if the patient has or has ever had kidney function disorders;
• if the patient has or has ever had liver function disorders;
• if the patient has muscle tremors;
• if the patient has low body weight;
• if the patient experiences gastrointestinal reactions such as nausea, vomiting, and diarrhoea. The patient may become dehydrated (lose too much fluid) if vomiting or diarrhoea persists for a prolonged period.

If any of the above apply, the doctor may decide to monitor the patient’s condition more closely during treatment with this medicine.
If the patient has stopped taking Rivastigmin NeuroPharma for more than three days, the next dose should not be taken without first discussing it with the doctor.

Children and adolescents
There is no justification for using Rivastigmin NeuroPharma in children and adolescents for the treatment of Alzheimer-type dementia.

Rivastigmin NeuroPharma and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Rivastigmin NeuroPharma should not be used concomitantly with other medicines with similar actions. Rivastigmin NeuroPharma may affect the action of anticholinergic medicines (medicines used to relieve stomach spasms, in Parkinson’s disease treatment, or to prevent motion sickness).
Rivastigmin NeuroPharma should not be used simultaneously with metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Concurrent use of these two medicines may cause adverse effects such as limb stiffness and hand tremors.
If surgery requiring general anaesthesia becomes necessary during treatment with Rivastigmin NeuroPharma, inform the doctor about taking this medicine beforehand, as Rivastigmin NeuroPharma may enhance the effect of certain muscle relaxants used during general anaesthesia.
Caution is advised when Rivastigmin NeuroPharma is used together with beta-adrenergic blocking agents (beta-blockers such as atenolol, used in the treatment of hypertension, angina pectoris, and other heart conditions). Concurrent use of these two medicines may cause adverse effects such as slowing of the heart rate (bradycardia), leading to fainting or loss of consciousness.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist.
If the patient is pregnant, the benefits of using Rivastigmin NeuroPharma should be weighed against the potential risks to the unborn child. Rivastigmin NeuroPharma should not be used during pregnancy unless absolutely necessary.
Breastfeeding is not recommended while taking Rivastigmin NeuroPharma.

Driving and operating machinery
The doctor will advise the patient whether their condition allows safe driving and operating of machinery. Rivastigmin NeuroPharma may cause dizziness and drowsiness, particularly during the initial phase of treatment or during dose escalation. If the patient experiences dizziness or drowsiness, they should not drive, operate machinery, or perform any other tasks requiring concentration.

3. How to use Rivastigmin NeuroPharma

This medicine should always be taken exactly as your doctor has told you.
If in doubt, consult your doctor, pharmacist, or nurse.
How to start treatment
Your doctor will inform you what dose of Rivastigmin NeuroPharma you should take.

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

Your doctor will regularly check whether the medicine is working for you. While taking this medicine,
your doctor will also monitor your body weight.
If you have stopped taking Rivastigmin NeuroPharma for more than three days, you should not
take another dose until you have spoken to your doctor.
While taking this medicine

• Inform your caregiver that you are taking Rivastigmin NeuroPharma.
• Take the medicine every day to achieve the desired therapeutic effect.
• Rivastigmin NeuroPharma should be taken twice daily (in the morning and evening) with food.
• Capsules should be swallowed whole with liquid.
• Do not open or crush the capsules. Taking more Rivastigmin NeuroPharma than prescribed If you accidentally take more Rivastigmin NeuroPharma than prescribed, inform your doctor immediately, as medical assistance may be required. In some people who have accidentally taken too much Rivastigmin NeuroPharma, nausea, vomiting, diarrhoea, high blood pressure, and hallucinations have been observed. Slow heart rate and fainting may also occur. If you forget to take Rivastigmin NeuroPharma If you accidentally miss a dose of Rivastigmin NeuroPharma, wait and take the next dose at your usual scheduled time. Do not take a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions may occur more frequently during the initial period of treatment or during dose escalation. Adverse reactions usually gradually subside as the body adapts to the treatment.

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

• Dizziness
• Loss of appetite
• Stomach problems such as nausea or vomiting, diarrhoea

Common (may affect less than 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Abdominal pain
• Restlessness
• Feeling tired or weak
• General malaise
• Tremor or confusion
• Reduced appetite
• Nightmares
• Drowsiness

Uncommon (may affect less than 1 in 100 people)

• Depression
• Difficulty sleeping
• Fainting or accidental falls
• Changes in liver function

Rare (may affect less than 1 in 1,000 people)

• Chest pain
• Rash, itching
• Seizures (fits)
• Peptic ulcer of the stomach or intestines

Very rare (may affect less than 1 in 10,000 people)

• High blood pressure
• Urinary tract infections
• Seeing things that are not there (hallucinations)
• Heart rhythm disorders such as fast or slow heartbeat
• Gastrointestinal bleeding – blood in stool or vomit
• Pancreatitis – symptoms include severe pain in the upper abdomen, often with nausea or vomiting
• Worsening of Parkinson’s disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty performing voluntary movements

Frequency not known (cannot be estimated from available data)

• Severe vomiting, which may lead to oesophageal rupture (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, abnormally dark urine, or unexplained nausea, vomiting, fatigue and loss of appetite)
• Aggression, restlessness
• Irregular heartbeat
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal tilting of the body and head to one side)

Patients with dementia and Parkinson’s disease
In these patients, certain adverse reactions occur more frequently. Other additional symptoms may also occur:

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

• Tremor
• Fainting
• Accidental falls

Common (may affect less than 1 in 10 people)

• Anxiety
• Restlessness
• Slow and fast heartbeat
• Difficulty sleeping
• Excessive salivation and dehydration
• Abnormal slowness of movement or poor control over movements
• Worsening of Parkinson’s disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty performing voluntary movements, and muscle weakness
• Seeing things that are not there (hallucinations)
• Depression
• High blood pressure

Uncommon (may affect less than 1 in 100 people)

• Irregular heartbeat and poor control over movements
• Low blood pressure

Not known (frequency cannot be estimated from available data)

• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal tilting of the body and head to one side)
• Skin rash

Other adverse reactions observed after using rivastigmine patches, which may also occur after taking hard capsules.

Common (may affect less than 1 in 10 people)

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

Uncommon (may affect less than 1 in 100 people)

• Hyperactivity (excessive activity, restlessness)

Frequency not known (cannot be estimated from available data)

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

If any of the above symptoms occur, contact your doctor, as medical help may be needed.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:

Department for Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorisation holder.

By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Rivastigmin NeuroPharma

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the specified month.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps 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.
• Other ingredients include hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica. Capsule shell:
• Gelatin, yellow iron oxide (E 172), titanium dioxide (E 171), red iron oxide (E 172) (only in capsule shells of 3.0, 4.5 and 6.0 mg capsules), and printing ink.

The printing ink contains shellac, propylene glycol, concentrated ammonia solution, 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 hard gelatin capsules coloured yellow/yellow with a black print "RIVA 1.5mg", containing a white to off-white granular powder containing 1.5 mg of rivastigmine.
• Rivastigmin NeuroPharma 3.0 mg hard capsules are hard gelatin capsules coloured light orange/light orange with a black print "RIVA 3.0 mg", containing a white to off-white granular powder containing 3.0 mg of rivastigmine.
• Rivastigmin NeuroPharma 4.5 mg hard capsules are hard gelatin capsules coloured caramel/caramel with a black print "RIVA 4.5mg", containing a white to off-white granular powder containing 4.5 mg of rivastigmine.
• Rivastigmin NeuroPharma 6.0 mg hard capsules are hard gelatin capsules coloured light orange/caramel with a black print "RIVA 6.0 mg", containing a white to off-white granular powder containing 6.0 mg of rivastigmine.

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

Marketing Authorisation Holder
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld
Germany

For further information, please contact the local representative in Poland:
Neuraxpharm Polska sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
[email protected]

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 authorised in the European Economic Area countries 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