RIVASTIGMINE FARMALIDER 2 mg/ml ORAL SOLUTION

2. What you need to know before taking Rivastigmine Farmalider 2 mg/ml Oral Solution

Do not take Rivastigmine Farmalider

• if you are allergic to rivastigmine or any of the other ingredients of this medication (listed in section 6).
• if you have a skin reaction that spreads beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if there is no improvement during the 48 hours after removing the transdermal patch.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rivastigmine Farmalider 2 mg/ml Oral Solution.

• if you have or have ever had an irregular or slow heart rate.
• 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 severe respiratory disease.
• if you have or have ever had kidney function impairment.
• if you have or have ever had liver function impairment.
• if you suffer from tremors.
• if you have low body weight.
• if you have gastrointestinal reactions such as a feeling of nausea, vomiting, and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea is prolonged.

If you are in any of these situations, your doctor may consider it necessary to monitor you more closely while you are being treated.

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

Children and adolescents

Rivastigmine Farmalider is not recommended for use in children or adolescents (under 18 years of age).

Taking Rivastigmine Farmalider 2 mg/ml Oral Solution with other medications

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

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

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

Pregnancy and breastfeeding

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

Driving and using machines

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

Rivastigmine Farmalider contains propylparaben sodium (E-217) and methylparaben sodium (E-219)

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

3. How to take Rivastigmine Farmalider 2 mg/ml Oral Solution

Follow the administration instructions for Rivastigmine Farmalider 2 mg/ml Oral Solution exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How to start treatment

Your doctor will indicate what dose of Rivastigmine Farmalider you should take.

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

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

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

Taking this medication

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

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

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

How to use this medication

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 cap.

1. Attaching the syringe to the bottle
   • Press the syringe nozzle into the opening of the stopper.

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

1. Removing air bubbles
   • Push the plunger down and pull it up several times to remove large air bubbles.
   • The presence of some small bubbles is of no importance and does not affect the dose in any way.
   • Check that the dose is still correct.
   • Then separate the syringe from the bottle.

1. Taking your medication
   • Take your medication directly from the syringe.
   • You can also mix the medication with a little water. Stir and drink the mixture completely.

1. 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 cap on the bottle to close it.

If you take more Rivastigmine Farmalider than you should

If you accidentally take more Rivastigmine Farmalider than you should, inform your doctor. You may need medical attention. Some people who have taken accidental overdoses have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. There may also be a slowing of the heart rate and fainting. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Rivastigmine Farmalider

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

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

4. Possible side effects

Like all medications, Rivastigmine Farmalider can cause side effects, although not everyone will experience them.

You may have side effects more frequently when starting your 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 common (affect more than 1 in 10 patients)

Common (affect between 1 and 10 in 100 patients)

Uncommon (affect between 1 and 10 in 1,000 patients)

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

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

Frequency not known (cannot be estimated from available data)

Very common

??Nausea

??Loss of appetite

??Stomach problems such as nausea, vomiting, diarrhea

Common

??Anxiety

??Sweating

??Headache

??Heartburn

??Weight loss

??Stomach pain

??Feeling of agitation

??Feeling of fatigue or weakness

??Feeling of general discomfort

??Tremor or feeling of confusion

??Nightmares

Uncommon

??Depression

??Difficulty sleeping

??Fainting or accidental falls

??Changes in liver function

Rare

??Chest pain

??Skin rash, itching

??Seizures (convulsions)

??Ulcers in your stomach or intestine

Very rare

??High blood pressure

??Urinary tract infection

??Seeing things that do not exist (hallucinations)

??Heart rate problems such as fast or slow heart rate

??Gastrointestinal bleeding - manifested as blood in the stool or when vomiting

??Pancreatitis - signs 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 moving

Not known

??Severe vomiting that can 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 whites of the eyes, abnormal darkening of urine or unexplained nausea, vomiting, fatigue, and loss of appetite)

??Aggression, feeling of restlessness

??Irregular heart rate

??Pisa syndrome (a condition that involves 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 common

??Tremor

• Fainting
• Accidental falls

Common

??Anxiety

??Feeling of restlessness

??Slow heart rate

??Difficulty sleeping

??Excessive saliva and dehydration

??Abnormally slow movements or movements that cannot be controlled

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

Uncommon

??Irregular heartbeat and loss of movement control

Not known

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

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

Common

??Fever

??Severe confusion

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

5. Conservation of Rivastigmine Farmalider 2 mg/ml Oral Solution

No special storage conditions are required.

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

Keep in a vertical position.

Keep out of sight and reach of children.

Do not use Rivastigmine Farmalider after the expiration date stated on the packaging, after "EXP". The expiration date is the last day of the month indicated.

Use Rivastigmine Farmalider Oral Solution within 1 month of opening the bottle.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Rivastigmine 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 ingredients are methylparaben sodium (methylparaben, sodium salt (E-219)), propylparaben sodium (propylparaben, sodium salt (E-217)), sodium acetate, trihydrate, glacial acetic acid, purified water.

Appearance of the product and contents of the pack

Rivastigmine Farmalider is presented as a clear, colorless solution (2.0 mg/ml rivastigmine base) in 125 ml amber glass bottles, with 120 ml of solution per bottle, with a child-resistant cap. The oral solution comes with an oral dosing device consisting of a cylinder and a graduated piston from 1.5 mg to 6 mg.

Marketing authorization holder and manufacturer

FARMALIDER S.A.

c/ Aragoneses 15

28108 Alcobendas- Madrid

Manufacturer

FARMALIDER, S.A:

C/ Aragoneses 2,

28108 Alcobendas, Madrid

Spain

or

EDEFARM, S.L.

Poligono Industrial Enchilagar del Rullo, 117

46191 Villamarchante (Valencia), Spain

This package leaflet was last revised in January 2025

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