Rivaldo

Package leaflet: information for the patient

Rivaldo, 1.5 mg hard capsules
Rivaldo, 3.0 mg hard capsules
Rivaldo, 4.5 mg hard capsules
Rivaldo, 6.0 mg hard capsules
Rivastigmine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Rivaldo is and what it is used for

The active substance in Rivaldo is rivastigmine.
Rivastigmine belongs to a group of substances called cholinesterase inhibitors. In patients
with Alzheimer-type dementia or dementia caused by Parkinson's disease, certain brain cells
degenerate, leading to a reduction in 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 blocking these enzymes,
Rivaldo increases the concentration of acetylcholine in the brain, which helps to alleviate symptoms
of Alzheimer's disease and dementia associated with Parkinson's disease.
Rivaldo is used in the treatment of adult patients with mild to moderate Alzheimer-type dementia.
Rivaldo is used in the treatment of dementia in adult patients with Parkinson's disease.

2. Important information before using Rivaldo

When not to use Rivaldo

• if the patient is allergic to rivastigmine or any of the other ingredients of this medicine (listed in section 6).
• if the patient has experienced a skin reaction extending beyond the patch area while using rivastigmine transdermal patches, if the local reaction worsens (e.g. blisters, increased skin inflammation, swelling), or if these changes do not resolve within 48 hours after removing the patch.

If this situation applies to the patient, they should inform their doctor and must not use Rivaldo.
Warnings and precautions
Before starting treatment with Rivaldo, discuss the following with a doctor or pharmacist:

• if the patient currently has or has ever had irregular or slow heart rhythm;
• if the patient currently has or has ever had an active peptic ulcer;
• if the patient currently has or has ever had difficulty passing urine;
• if the patient currently has or has ever had seizures;
• if the patient currently has or has ever had bronchial asthma or severe respiratory disease;
• if the patient currently has or has ever had kidney function disorders;
• if the patient currently 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 symptoms 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 warnings apply, more frequent medical monitoring may be required during treatment.

If the patient has stopped taking Rivaldo for several days, they should not take another dose until they have spoken with their doctor.
Children and adolescents
Rivaldo is not indicated for the treatment of Alzheimer-type dementia in children and adolescents.
Rivaldo and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Rivaldo should not be used concomitantly with other medicines with similar mechanisms of action. Rivaldo may affect the action of anticholinergic medicines (medicines used to relieve stomach spasms, treat Parkinson's disease, or prevent motion sickness).
Rivaldo should not be used together with metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Concomitant use of these two medicines may cause adverse effects such as limb stiffness and hand tremors.
If surgery becomes necessary while taking Rivaldo, the patient must inform the doctor about using this medicine before receiving general anaesthesia, because Rivaldo may enhance the effects of certain muscle relaxants used during general anaesthesia.
Caution is advised when Rivaldo is used together with beta-adrenergic blocking agents (medicines such as atenolol, used in the treatment of hypertension, angina pectoris, and other heart conditions). Concomitant use of these two medicines may lead to adverse effects such as slowing of the heart rate (bradycardia), potentially resulting in 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 become pregnant, she should consult her doctor or pharmacist before using this medicine.
If the patient is pregnant, the benefits of using Rivaldo should be weighed against the potential risks to the unborn child. Rivaldo should not be used during pregnancy unless clearly necessary.
Breastfeeding is not recommended while taking Rivaldo.
Driving and operating machinery
The doctor will advise the patient whether their condition allows safe driving and operating machinery. Rivaldo may cause dizziness and drowsiness, particularly at the beginning of treatment or during dose escalation. If the patient experiences dizziness or drowsiness, they should not drive, operate machinery, or perform any tasks requiring concentration.

3. How to take Rivaldo

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Starting treatment
Your doctor will inform you of the dose of Rivaldo 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 that can be taken is 6.0 mg twice daily.

Your doctor will regularly check whether the medicine is working effectively for you. While taking this
medicine, your doctor will also monitor your body weight.
If you have stopped taking Rivaldo for more than three days, you should not take another dose
without first discussing it with your doctor.
Patients taking this medicine

• Should inform their caregiver that they are taking Rivaldo.
• Should take the medicine daily to achieve the desired therapeutic effect.
• Rivaldo 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 Rivaldo than prescribed
If you accidentally take more Rivaldo than prescribed, inform your doctor immediately, as medical
assistance may be required. In some people who have accidentally taken too much Rivaldo, symptoms such as nausea, vomiting, diarrhoea, high blood pressure, and hallucinations have been observed.
Slow heart rate and fainting may also occur.
If you miss a dose of Rivaldo
If you accidentally miss a dose of Rivaldo, 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 effects

Like all medicines, Rivaldo may cause adverse effects, although not everyone experiences them.
Adverse effects most commonly occur during the initial period of treatment or when the dose is being increased. These adverse effects will gradually subside as the body adjusts 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
• tremors or confusion
• reduced appetite
• nightmares

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 (convulsions)
• 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 appearance 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 rupture of the part of the gastrointestinal tract connecting the mouth to the stomach (oesophagus)
• dehydration (loss of excessive amounts of fluids)
• 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

Patients with dementia and Parkinson's disease
In these patients, certain adverse effects 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 appearance of similar symptoms – such as muscle stiffness, difficulty performing voluntary movements, and muscle weakness

Uncommon (may affect less than 1 in 100 people)

• irregular heartbeat and poor control over movements

Other adverse effects following administration of the medicinal product Rivaldo, 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 retain urine)

Uncommon (may affect less than 1 in 100 people)

• excessive motor activity (high level of activity, restlessness)

Frequency not known (cannot be estimated from available data)

• allergic reaction at the site of the patch, such as blisters or skin inflammation. If any of the above symptoms occur, contact a doctor, as medical help may be needed.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Effects 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, e-mail: [email protected]. Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Rivaldo

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton.
The expiry date refers to the last day of the specified month.
No special storage conditions required.
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 packaging and other information

What the medicine Rivaldo contains

• The active substance is rivastigmine. Each capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine.
• The other ingredients are:

Rivaldo 1.5 mg
Capsule contents: hypromellose, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate.
Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E 171), yellow iron oxide (E 172).
Red ink: shellac; red iron oxide (E 172); soybean lecithin; Antifoam DC; titanium dioxide (E 171); Allura Red AC, aluminium lake (E 129), propylene glycol.

Rivaldo 3.0 mg
Capsule contents: hypromellose, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate.
Capsule shell: gelatin, sodium lauryl sulfate, yellow iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171).
Red ink: shellac; red iron oxide (E 172); soybean lecithin; Antifoam DC; titanium dioxide (E 171); Allura Red AC, aluminium lake (E 129), propylene glycol.

Rivaldo 4.5 mg
Capsule contents: hypromellose, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate.
Capsule shell: gelatin, sodium lauryl sulfate, yellow iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171).
White ink: shellac, titanium dioxide (E 171).

Rivaldo 6.0 mg
Capsule contents: hypromellose, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate.
Capsule shell: gelatin, sodium lauryl sulfate, yellow iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171).
Red ink: shellac; red iron oxide (E 172); soybean lecithin; Antifoam DC; titanium dioxide (E 171); Allura Red AC, aluminium lake (E 129), propylene glycol.

What Rivaldo looks like and contents of the pack
Rivaldo 1.5 mg: yellow capsule with a red imprint "R 1.5" on the body, containing white or almost white powder.
Rivaldo 3.0 mg: orange capsule with a red imprint "R 3.0" on the body, containing white or almost white powder.
Rivaldo 4.5 mg: red capsule with a white imprint "R 4.5" on the body, containing white or almost white powder.
Rivaldo 6.0 mg: red-orange capsule with a red imprint "R 6.0" on the body, containing white or almost white powder.

Rivaldo is packed in blisters of 14 capsules.
Rivaldo 1.5 mg hard capsules
The unit pack contains 28 capsules.
Rivaldo 3 mg, 4.5 mg, 6 mg hard capsules
The unit pack contains 28 or 56 capsules.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Rivaldo