Rivastigmine Farmalider 2 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rivastigmine Farmalider 2 mg/ml oral solution EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Leaflet contents:

1. What Rivastigmine Farmalider 2 mg/ml oral solution is and what it is used for
2. What you need to know before taking Rivastigmine Farmalider 2 mg/ml oral solution
3. How to take Rivastigmine Farmalider 2 mg/ml oral solution
4. Possible side effects
5. How to store Rivastigmine Farmalider 2 mg/ml oral solution
6. Contents of the pack and other information

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

Rivastigmina Farmalider belongs to a group of substances called cholinesterase inhibitors.

Rivastigmina Farmalider is used to treat cognitive impairment in patients with Alzheimer's disease. It is also used to treat dementia in patients with Parkinson's disease.

2. What you need to know before starting to take Rivastigmine Farmalider 2 mg/ml oral solution

Do not take Rivastigmine Farmalider

• if you are allergic to rivastigmine or to any of the other ingredients of this medicine (listed in section 6).
• if you have a skin reaction that spreads beyond the size of the patch, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling), or 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 Rivastigmine Farmalider.

Warnings and precautions

Talk to 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 (pulse).
• if you have or have ever had an active stomach ulcer.
• if you have or have ever had difficulties in urination.
• if you have or have ever had seizures.
• if you have or have ever had asthma or a serious respiratory disease.
• if you have or have ever had (impairment of) kidney function.
• if you have or have ever had (impairment of) liver function.
• if you suffer from tremors.
• if you have low body weight.
• if you experience gastrointestinal reactions such as dizziness (nausea), vomiting, and diarrhea. You could become dehydrated (loss of large amounts of fluid) if vomiting or diarrhea are prolonged.

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

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

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

Taking Rivastigmine Farmalider 2 mg/ml oral solution with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

If you need to undergo surgery while taking Rivastigmine Farmalider, inform your doctor before receiving any anesthetic, as Rivastigmine Farmalider may exaggerate the effects of certain muscle relaxants used during anesthesia.

Pregnancy and breastfeeding

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

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Rivastigmine may cause dizziness and somnolence, especially at the beginning of treatment or when the dose is increased. If you feel dizzy or sleepy, do not drive, operate machinery, or perform any other tasks requiring your attention.

Rivastigmine Farmalider contains propyl parahydroxybenzoate sodium salt (E-217) and methyl parahydroxybenzoate sodium salt (E-219)

It may cause allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate sodium salt (E-217) and methyl parahydroxybenzoate sodium salt (E-219).

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

Follow exactly the instructions for the use of Rivastigmina Farmalider 2 mg/ml oral solution provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Starting treatment

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

• Treatment is usually started at a low dose.
• Your doctor will gradually increase your dose depending on how you respond to treatment.
• The maximum dose you will take is 6.0 mg twice daily.

Your doctor will regularly monitor whether the medicine is working for you. Your doctor will also monitor 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.

Taking this medicine

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

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

??Take Rivastigmina Farmalider twice daily (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 cap.

2. Attaching the syringe to the bottle
   • Push the syringe tip firmly into the opening of the stopper.

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

4. Removing air bubbles
   • Push the plunger down and pull it up several times to remove large air bubbles.
   • The presence of a few small bubbles is unimportant and does not affect the dose in any way.
   • Check that the dose is still correct.
   • Then detach the syringe from the bottle.

5. Taking your medicine
   • Take your medicine directly from the syringe.
   • You may also mix the medicine with a small amount of water. Stir, and drink the mixture completely.

6. After using the syringe
   • Wipe the outside of the syringe with a clean cloth.
   • Then return the syringe to its protective case.
   • Replace the child-resistant cap 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 require medical attention. Some people who have accidentally taken higher doses have experienced nausea, vomiting, diarrhoea, high blood pressure, and hallucinations. Slowing of the heart rate and fainting may also occur. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone 91 562 04 20.

If you forget to take Rivastigmina Farmalider

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

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

4. Possible adverse effects

Like all medicines, Rivastigmina Farmalider can cause adverse effects, although not everyone experiences them.

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

Frequencies are defined as follows:

Very common (affects more than 1 in 10 people)
Common (affects between 1 and 10 in 100 people)
Uncommon (affects between 1 and 10 in 1,000 people)
Rare (affects between 1 and 10 in 10,000 people)
Very rare (affects fewer than 1 in 10,000 people)
Frequency not known (cannot be estimated from available data)

Very common

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

Common

??Anxiety
??Sweating
??Headache
??Heartburn
??Weight loss
??Stomach pain
??Feeling restless
??Feeling tired or weak
??General feeling of being unwell
??Tremor or confusion
??Nightmares

Uncommon

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

Rare

??Chest pain
??Skin rash, itching
??Epileptic 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 rate such as fast or slow heartbeat
??Gastrointestinal bleeding – manifested as blood in stools or vomit
??Inflammation of the pancreas – signs include severe upper abdominal pain, often with nausea or vomiting
??Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle rigidity, difficulty performing movements

Frequency not known

??Severe vomiting which may lead to a tear in the part of the digestive tract connecting the mouth to the stomach (oesophagus)
??Dehydration (loss of large amounts of fluid)
??Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormally dark urine, or unexplained nausea, vomiting, tiredness and loss of appetite)
??Aggression, restlessness
??Irregular heartbeat
? Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side)

Patients with dementia or Parkinson's disease

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

Very common

??Tremor

• Fainting
• Accidental falls

Common

??Anxiety
??Feeling restless
??Slow heart rate
??Difficulty sleeping
??Excessive salivation 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 rigidity, difficulty performing movements and muscle weakness

Uncommon

??Irregular heartbeat and impaired movement control

Frequency not known

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

Other adverse effects observed with Rivastigmina Farmalider transdermal patches and which may also occur with hard capsules:

Common

??Fever
??Severe confusion

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

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

No special storage conditions are required.

After opening, do not store above 30°C and keep for a maximum of 2 months.

Keep in an upright position.

Keep out of the sight and reach of children.

Do not use Rivastigmina Farmalider after the expiry date stated on the container, following “EXP”. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and any unused medicines at a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Rivastigmine Farmalider 2 mg/ml oral solution

• The active substance is rivastigmine hydrogen tartrate. Each ml contains rivastigmine hydrogen tartrate equivalent to 2.0 mg of rivastigmine.
• The other components are sodium methylparaben (methylparahydroxybenzoate, sodium salt (E-219)), sodium propylparaben (propylparahydroxybenzoate, sodium salt (E-217)), sodium acetate trihydrate, glacial acetic acid, purified water.

Appearance of the medicinal product and contents of the container

Rivastigmine Farmalider is presented as a clear, colourless solution (2.0 mg/ml rivastigmine base) in 125 ml amber glass bottles containing 120 ml of solution per bottle, with a child-resistant closure. An oral dosing device provided with a graduated cylinder and plunger, graduated from 1.5 mg to 6 mg, is included with the oral solution.

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.

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante (Valencia), Spain

The last revision of this leaflet was in January 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.