Leaflet: information for the patient

Rivastigmina Farmalider 2 mg/ml oral solution EFG

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

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1. What is Rivastigmina Farmalider 2 mg/ml oral solution and what it is used for

2. What you need to know before you start taking Rivastigmina Farmalider 2 mg/ml oral solution

3. How to take Rivastigmina Farmalider 2 mg/ml oral solution

4. Possible side effects

5. Storage of Rivastigmina Farmalider 2 mg/ml oral solution

6. Contents of the pack and additional information

Rivastigmina Farmalider belongs to a group of substances known as cholinesterase inhibitors.

Rivastigmina Farmalider is used for the treatment of disorders in patients with Alzheimer's disease. It is also used for the treatment of dementia in patients with Parkinson's disease.

Do not take Rivastigmina Farmalider

- if you are allergic to rivastigmina or any of the other components of this medication (listed in section 6).

- if you have a skin reaction that extends beyond the size of the patch, if there is a more intense local reaction (such as blisters, increased skin inflammation, swelling) and 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 Rivastigmina Farmalider.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rivastigmina Farmalider 2 mg/ml oral solution.

- if you have or have had any irregular or slow heart rhythm.

- if you have or have had any active stomach ulcer.

- if you have or have had any difficulty urinating.

- if you have or have had any seizures.

- if you have or have had any severe respiratory disease.

- if you have or have had any kidney function deterioration.

- if you have or have had any liver function deterioration.

- if you suffer from tremors.

- if you have a low body weight.

- if you have gastrointestinal reactions such as dizziness (nausea), vomiting, and diarrhea. You may become dehydrated (loss of a large amount of fluid) if vomiting or diarrhea is prolonged.

If you are in any of these situations, your doctor may consider the need for closer monitoring while you are on treatment.

If you have not taken Rivastigmina Farmalider for several days, do not take the next dose until you have consulted your doctor.

Children and adolescents

Rivastigmina Farmalider is not recommended for use in children or adolescents (under 18 years old).

Taking Rivastigmina Farmalider 2 mg/ml oral solution with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

Rivastigmina Farmalider should not be administered at the same time as other medications with similar effects to Rivastigmina Farmalider. Rivastigmina Farmalider may interfere with anticholinergic medications (used to relieve cramps or stomach spasms, for the treatment of Parkinson's disease, or to prevent travel sickness).

If you need to undergo surgery while taking Rivastigmina Farmalider, inform your doctor before any anesthetic is administered, as Rivastigmina Farmalider may exaggerate the effects of some muscle relaxants during anesthesia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive or use machinery safely. Rivastigmina may cause dizziness and drowsiness, mainly at the beginning of treatment or when increasing the dose. If you feel dizzy or drowsy, do not drive, use machinery, or perform other tasks that require your attention.

Rivastigmina Farmalider contains propylparaben, sodium salt (E-217) and methylparaben, sodium salt (E-219)

It may cause allergic reactions (possibly delayed) because it contains propylparaben, sodium salt (E-217) and methylparaben, sodium salt (E-219)

Follow exactly the administration instructions for Rivastigmina Farmalider 2 mg/ml oral solution indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How to start treatment

Your doctor will tell you what dose of Rivastigmina Farmalider you should take.

• Treatment usually starts with a low dose.
• Your doctor will gradually increase the dose depending on how you respond to the treatment.
• The highest dose you should take is 6.0 mg twice a day.

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

If you have not taken Rivastigmina Farmalider for several days, do not take the next dose until you have consulted your doctor.

How to take this medicine

??Inform your caregiver that you are taking Rivastigmina Farmalider.

??To benefit from your medicine, take it every day.

??Take Rivastigmina Farmalider twice a day (in the morning and at night), with meals.

How to use this medicine

1. Preparation of the bottle and syringe

• Remove the syringe from its protective case.
• To open the bottle, press down and turn the child-resistant closure.

2. Syringe attachment to the bottle

• Press the syringe needle into the stopper.

3. Filling the syringe

• Pull the plunger up until it reaches the mark corresponding to the dose prescribed by your doctor.

4. Removal of bubbles

• Pull the plunger down and then pull it up a few times to remove large bubbles.
• The presence of some small bubbles is insignificant and does not affect the dose in any way.
• Check that the dose is still correct.
• Then separate the syringe from the bottle.

5. Taking your medicine

• Take your medicine directly from the syringe.
• You can also mix the medicine with a little water. Remove and drink the mixture completely.

6. After using the syringe

• Clean the outside of the syringe with a clean cloth.
• Then put the syringe back in its protective case.
• Put the child-resistant closure on the bottle to close it.

If you take more Rivastigmina Farmalider than you should

If you accidentally take more Rivastigmina Farmalider than you should, inform your doctor. You may need medical attention. Some people who have taken accidentally higher doses have experienced dizziness (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. A slowing of heart rate and fainting may also occur. In case of overdose or accidental ingestion, consult your doctor, pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Rivastigmina Farmalider

If you forget your dose of Rivastigmina Farmalider, wait and take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

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

Like all medications, Rivastigmina Farmalider may cause side effects, although not everyone will experience them.

You may experience side effects more frequently when starting treatment or when your dose is increased. Generally, side effects will slowly disappear as your body gets used to the medication.

Frequencies are defined as:

Very frequent (affects more than 1 in 10 patients)

Frequent (affects between 1 and 10 in 100 patients)

Infrequent (affects between 1 and 10 in 1,000 patients)

Rare (affects between 1 and 10 in 10,000 patients)

Very rare (affects fewer than 1 in 10,000 patients)

Frequency unknown (cannot be estimated from available data)

Very frequent

??Dizziness

??Loss of appetite

??Stomach problems such as dizziness (nauseas), vomiting, diarrhea

Frequent

??Anxiety

??Sweating

??Headache

??Heartburn

??Weight loss

??Stomach pain

??Restlessness

??Feeling tired or weak

??General feeling of discomfort

??Trembling or feeling confused

??Nightmares

Infrequent

??Depression

??Difficulty sleeping

??Fainting or accidental falls

??Changes in liver function

Rare

??Chest pain

??Rash, itching

??Seizures (convulsions)

??Ulcers in the stomach or intestine

Very rare

??High blood pressure

??Urinary tract infection

??Seeing things that are not there (hallucinations)

??Problems with heart rhythm such as rapid or slow heart rate

??Gastrointestinal bleeding – presents as blood in the stool or vomiting blood

??Pancreatitis – symptoms include severe pain in the upper abdomen, often with dizziness (nauseas) or vomiting

??Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty moving, and muscle weakness

Unknown frequency

??Intense vomiting that may cause tearing of part of the digestive tube that connects your mouth to your stomach (esophagus)

??Dehydration (loss of a large amount of fluid)

??Liver disorders (yellowing of the skin, yellowing of the white of the eyes, abnormal darkening of the urine, or inexplicable nausea, vomiting, fatigue, and loss of appetite)

??Aggression, feeling restless

??Irregular heart rhythm

?Pisa syndrome (condition involving involuntary muscle contraction and abnormal tilting of the body and head to one side)

Patients with dementia or Parkinson's disease

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

Very frequent

??Trembling

• Fainting
• Accidental falls

Frequent

??Anxiety

??Feeling uneasy

??Slow heart rate

??Difficulty sleeping

??Excessive saliva and dehydration

??Abnormally slow or uncontrolled movements

??Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty moving, and muscle weakness

Infrequent

??Irregular heart rhythm and loss of movement control

Unknown frequency

??Pisa syndrome (condition involving involuntary muscle contraction and abnormal tilting of the body and head to one side)

Other side effects observed in Rivastigmina Farmalider transdermal patches and that may appear with hard capsules:

Frequent

??Fever

??Severe confusion

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

No requires special conditions for conservation.

Once opened, do not conserve at a temperature above 30°C for a maximum of 2 months.

Keep in an upright position.

Keep out of sight and reach of children.

Do not use Rivastigmina Farmalider after the expiration date that appears on the packaging, after “CAD”. The expiration date is the last day of the month indicated.

Use Rivastigmina Farmalider oral solution in the month following the first opening of the bottle.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you do not need.This will help protect the environment.

Composition of Rivastigmina Farmalider 2 mg/ml oral solution

- The active ingredient is rivastigmine hydrogen tartrate. Each ml contains rivastigmine hydrogen tartrate equivalent to 2.0 mg of rivastigmine.

- The other components are sodium methylparaben (parahydroxybenzoate of methyl, sodium salt (E-219)), sodium propylparaben (parahydroxybenzoate of propyl, sodium salt (E-217)), sodium acetate trihydrate, glacial acetic acid, purified water.

Appearance of the product and contents of the packaging

Rivastigmina Farmalider is presented as a transparent, colorless (2.0 mg/ml rivastigmine base) solution in amber glass bottles of 125 ml, with 120 ml of solution per bottle, with a child-resistant closure. Along with the oral solution, a dosing oral device with a graduated cylinder and piston from 1.5 mg to 6 mg is included.

Holder of the marketing authorization and responsible for manufacturing

FARMALIDER S.A.

c/ Aragoneses 15

28108 Alcobendas- Madrid

Responsible for manufacturing

FARMALIDER, S.A:

C/ Aragoneses 2,

28108 Alcobendas, Madrid

Spain

or

EDEFARM, S.L.

Poligono Industrial Enchilagar del Rullo, 117

46191 Villamarchante (Valencia), Spain

Last review of this leaflet was in January 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.