Rivanex 4.6 mg/24 h transdermal patches EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Rivanex 4.6 mg/24h transdermal patches EFG
Rivastigmine
Read the entire leaflet carefully before you start using 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Rivanex is and what it is used for
- What you need to know before using Rivanex
- How to use Rivanex
- Possible side effects
- How to store Rivanex
- Contents of the pack and other information
1. What Rivanex is and what it is used for
The active substance in Rivanex patches is rivastigmine.
Rivastigmine belongs to the class of cholinesterase inhibitors. In patients with Alzheimer's dementia, certain nerve cells in the brain die, resulting in low levels of the neurotransmitter acetylcholine (a substance that enables nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, Rivanex increases acetylcholine levels in the brain, helping to reduce the symptoms of Alzheimer's disease.
Rivanex is used to treat adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual capacity, and behaviour.
2. What you need to know before using Rivanex
Do not use Rivanex:
- if you are allergic to rivastigmine or to any of the other ingredients of this medicine (listed in section 6).
- if you have ever had an allergic reaction to a similar medicine (carbamate derivatives).
- if you develop a skin reaction that spreads beyond the size of the patch, if you experience a more intense local reaction (such as blisters, increased 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 use rivastigmine.
Warnings and precautions
Talk to your doctor before starting to use this medicine:
- 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 urinating.
- if you have or have ever had seizures.
- if you have or have ever had asthma or a serious respiratory disease.
- if you suffer from tremors.
- if you have a low body weight.
- if you experience gastrointestinal reactions such as nausea, vomiting, and diarrhea. You may become dehydrated (loss of large amounts of fluids) if vomiting or diarrhea are prolonged.
- if you have liver problems (hepatic insufficiency).
If you are in any of these situations, your doctor may consider it necessary to carry out closer monitoring while you are on treatment.
If you have not used the patches for several days, do not apply a new one without first consulting your doctor.
Children and adolescents
Rivastigmine must not be used in the pediatric population for the treatment of Alzheimer's disease.
Other medicines and Rivanex
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Rivastigmine may interfere with anticholinergic medicines, some of which are used to relieve stomach cramps or spasms (e.g. dicyclomine), for the treatment of Parkinson's disease (e.g. amantadine), or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).
This medicine must not be administered at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines together may cause problems such as stiffness in the limbs and hand tremors.
If you need to undergo surgery while using rivastigmine, inform your doctor that you are taking it, as it may excessively enhance the effects of certain muscle relaxants used during anesthesia.
Caution is required when using this medicine together with beta-blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions). Taking both medicines together may cause complications such as a decreased heart rate (bradycardia), which may lead to fainting or loss of consciousness.
Use of Rivanex with food, drinks, and alcohol
This medicine may be used with food, drinks, and alcohol.
Pregnancy, breast-feeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
If you are pregnant, the benefits of using rivastigmine must be weighed against the potential adverse effects on the fetus. This medicine should not be used during pregnancy unless clearly necessary.
You must not breast-feed while being treated with rivastigmine.
Driving and using machines
Your illness may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor tells you it is safe to do so.
Rivanex patches may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you must not drive or operate machinery.
3. How to use Rivanex
Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.
Important:
- Remove the previous patch before applying a new one.
- One patch only per day.
- Do not cut the patch into pieces.
- Press the patch firmly onto the skin with the palm of your hand for at least 30 seconds.
Starting treatment
Your doctor will determine the most appropriate rivastigmine dose for your individual case.
- Treatment is usually started with rivastigmine 4.6 mg/24 h.
- The usual recommended daily dose is rivastigmine 9.5 mg/24 h. If this dose is well tolerated, your treating doctor may consider increasing it to 13.3 mg/24 h.
- Wear only one rivastigmine patch at a time and replace the patch with a new one every 24 hours.
During treatment, your doctor may adjust the dose according to your individual needs.
If you have not used the patches for three days, do not apply a new one without first consulting your doctor. Treatment with the transdermal patch may be restarted at the same dose if the interruption did not exceed three days. Otherwise, your doctor will instruct you to restart treatment with rivastigmine 4.6 mg/24 h.
Where to apply your Rivanex transdermal patch
-
Before applying a patch, make sure the skin is clean, dry, and hair-free, without powders, oils, moisturizers, or lotions that could prevent the patch from adhering properly, and without cuts, redness, or irritation.
-
Carefully remove any existing patch before applying a new one. Wearing multiple patches on your body could expose you to an excessive amount of this medicine, which could be potentially dangerous.
-
Apply only one patch per day to one of the following areas, as shown in the diagrams below:
-
Upper left or upper right arm
-
Upper left or upper right chest (avoiding the breasts in women)
-
Upper left or upper right back
-
Lower left or lower right back
Every 24 hours, remove the previous patch before applying a new one to one of the following possible areas.
Each time you change the patch, remove the previous day's patch before applying the new one to a different skin site (for example, one day on the right side of the body and the next day on the left side; or one day on the upper part of the body and the next day on the lower part). Wait at least 14 days before reapplying a new patch to exactly the same skin area.
How to apply Rivanex transdermal patches
Rivanex patches are thin, opaque plastic patches that adhere to the skin. Each patch is contained in a protective pouch until ready for use. Do not open the pouch or remove the patch until it is time to apply it.
Carefully remove any existing patch before applying a new one.
Patients starting treatment for the first time, and patients restarting treatment with Rivanex after an interruption, should begin with the second figure.
Each patch is individually packaged in a protective pouch. Open the pouch only when you are ready to apply the patch. Cut along the dotted line with scissors and remove the patch from the pouch.
A protective liner covers the adhesive side of the patch. Remove the first part of the liner without touching the adhesive surface with your fingers.
Place the adhesive side of the patch on the upper or lower back, upper arm, or chest, then remove the second part of the protective liner.
Press the patch firmly onto the skin with the palm of your hand for at least 30 seconds, ensuring that the edges are well adhered.
If it helps, you may write on the patch (e.g., the day of the week) using a pen with a fine, rounded tip.
You should wear the patch continuously until it is time to replace it with a new one. When applying a new patch, try different sites to find the most comfortable areas where clothing does not rub against the patch.
How to remove Rivanex transdermal patches
Gently pull one edge of the patch to slowly peel it off the skin. If adhesive residue remains on the skin, soak the area with warm water and mild soap or use baby oil to remove it. Do not use alcohol or other solvent liquids (e.g., nail polish remover or other solvents).
After removing the patch, wash your hands with soap and water. If you accidentally touch your eyes or if your eyes become red after handling the patch, immediately rinse them thoroughly with plenty of water and seek medical advice if symptoms persist.
Can you wear Rivanex transdermal patches while bathing, swimming, or in the sun?
- Bathing, swimming, or showering should not affect the patch. Make sure it does not partially detach during these activities.
- Do not expose the patch to external heat sources (e.g., excessive sunlight, sauna, sunbed) for prolonged periods.
What to do if the patch falls off
If the patch falls off, apply a new one for the remainder of that day and change it the next day at the usual time.
When and for how long to use Rivanex transdermal patches
- To benefit from treatment, apply a new patch every day, preferably at the same time.
- Wear only one Rivanex patch at a time and replace it with a new one every 24 hours.
If you use more Rivanex than you should
If you accidentally applied more than one patch, remove all patches from the skin immediately and consult your doctor or pharmacist right away, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine used. Some people who have accidentally taken excessive amounts of rivastigmine have experienced discomfort (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. Slowing of heart rate and fainting may also occur.
If you forget to use Rivanex
If you realize you forgot to apply a patch, do so immediately. The next day, apply the following patch at your usual time. Do not apply two patches to make up for the missed one.
If you stop using Rivanex
Inform your doctor or pharmacist if you stop using the patches.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You may experience adverse effects more frequently when starting treatment or when your dose is increased. Generally, adverse effects will slowly disappear as your body gets used to the medicine.
If you notice any of the following adverse effects, which may be serious, remove the patch immediately and inform your doctor without delay:
Frequent (may affect up to 1 in 10 people)
- Loss of appetite
- Dizziness
- Feeling of restlessness or drowsiness
- Urinary incontinence (inability to properly control urination)
Uncommon (may affect up to 1 in 100 people)
- Heart rhythm problems such as slow heartbeat
- Seeing things that are not really there (hallucinations)
- Stomach ulcer
- Dehydration (loss of large amounts of body fluids)
- Hyperactivity (high level of activity, restlessness)
- Aggressiveness
Rare (may affect up to 1 in 1,000 people)
- Falls
Very rare (may affect up to 1 in 10,000 people)
- Stiffness of arms and legs
- Tremor in hands
Frequency not known (cannot be estimated from available data)
- Allergic reaction at the site of application, such as blisters or skin inflammation
- Worsening of signs of Parkinson's disease – such as tremor, stiffness, and difficulty in movement
- Inflammation of the pancreas – symptoms include severe pain in the upper part of the stomach, often accompanied by nausea or vomiting
- Fast or irregular heartbeat
- High blood pressure
- Epileptic seizures (convulsions)
- 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)
- Changes in blood tests indicating liver function abnormalities
- Feeling of restlessness
- Nightmares
- Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side)
If you notice any of the adverse effects listed above, remove the patch immediately and inform your doctor without delay.
Other adverse effects reported with rivastigmine capsules or oral solution, which may also occur with the patches:
Frequent (may affect up to 1 in 10 people)
- Excessive saliva
- Loss of appetite
- Feeling of restlessness
- General feeling of discomfort
- Tremor or confusion
- Increased sweating
Uncommon (may affect up to 1 in 100 people)
- Irregular heartbeat (e.g. fast heartbeat)
- Difficulty sleeping
- Accidental falls
Rare (may affect up to 1 in 1,000 people)
- Intestinal ulcer
- Epileptic seizures (convulsions)
- Chest pain – probably caused by spasm in the heart
Very rare (may affect up to 1 in 10,000 people)
- Gastrointestinal bleeding – manifested as blood in the stool or in vomit
- High blood pressure
- Inflammation of the pancreas – symptoms include severe pain in the upper part of the stomach, frequently accompanied by nausea or vomiting
- Gastrointestinal bleeding – manifested as blood in the stool or in vomit
- Seeing things that are not there (hallucinations)
- Some people who have experienced severe vomiting have developed a tear in part of the digestive tract connecting the mouth to the stomach (esophagus)
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Rivanex
This medicine does not require any special storage temperature conditions. Keep in the original packaging to protect it from light. Store the transdermal patch inside its pouch until use.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and pouch. The expiry date refers to the last day of the month indicated.
Do not use any patch if it appears damaged or shows signs of tampering.
After removing a patch, fold it in half with the adhesive side inwards and press firmly. After placing it into the original pouch, dispose of the patch safely, ensuring it remains out of the reach of children. After removing the patch, avoid touching the eyes and wash hands thoroughly with water and soap.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If in doubt, please ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Rivanex
The active substance is rivastigmine. Each patch releases 4.6 mg of rivastigmine over 24 hours, measures 5 cm² and contains 9 mg of rivastigmine.
The other components are: outer layer [polyester film, silicone-coated polyester film, fluoro-coated polyester film], adhesive matrix [acrylic adhesive (DURO-TAK 87-235A), acrylate copolymer (PLASTOID B) and ethyl acetate], adhesive layer [silicone adhesive (BIO-PSA 7-4302)] and ink.
Appearance of the medicinal product and contents of the pack
Rivanex 4.6 mg/24 h transdermal patches are presented as a transdermal patch composed of three layers. The outer layer has a rounded shape. Each sachet contains one transdermal patch.
Rivanex 4.6 mg/24 h transdermal patches are available in packs containing 30 or 60 sachets. Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEURAXPHARM SPAIN, S.L.U.
Avda. Barcelona, 69
08970 Sant Joan Despí - (Barcelona)
Spain
Manufacturer
Eurofins PHAST GmbH
Kardinal-Wendel-Strasse 16,
66424 Homburg,
Germany
Date of the most recent revision of this leaflet: January 2025
Other sources of information
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/