Demelora

Package leaflet: Information for the user

Demelora 4.6 mg/24 hours transdermal patch, 9.5 mg/24 hours transdermal patch

rivastigmine
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Demelora is and what it is used for
2. What you need to know before using Demelora
3. How to use Demelora
4. Possible side effects
5. How to store Demelora
6. Contents of the pack and other information

1. What Demelora is and what it is used for

Demelora contains the active substance rivastigmine.
Rivastigmine belongs to a class of substances known as cholinesterase inhibitors. In patients with
Alzheimer's dementia, certain brain cells die, resulting in low levels of 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 inhibiting these
enzymes, rivastigmine increases acetylcholine levels in the brain, thereby improving the symptoms of
Alzheimer's disease.
Demelora is used for the treatment of adult patients with mild to moderate Alzheimer's dementia, a
progressive disorder of the central nervous system that gradually affects memory, learning ability, and
behaviour.

2. What you need to know before using Demelora

Do not use Demelora

• if you are allergic to rivastigmine (the active substance in Demelora) or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously had an allergic reaction to medicines of a similar type (carbamate derivatives).
• if, when using the patch, you have experienced a skin reaction extending beyond the area where the patch was applied, or if you had a more intense local reaction (such as blisters, increased skin inflammation, swelling) that did not improve within 48 hours after removing the patch. If this applies to you, inform your doctor and do not apply Demelora transdermal patches.

Warnings and precautions
Talk to your doctor before using Demelora:

• if you have or have previously had irregularities or slowing of the heartbeat.
• if you have or have previously had an active stomach ulcer.
• if you have or have previously had difficulty urinating.
• if you have or have previously had seizures.
• if you have or have previously had asthma or severe respiratory disorders.
• if you suffer from tremors.
• if you have low body weight.
• if you experience gastrointestinal disturbances such as nausea, vomiting, and diarrhea. If vomiting and diarrhea are persistent, you may become dehydrated (excessive loss of fluids).
• if you have impaired liver function. If any of these apply to you, your doctor may examine you more frequently during treatment with this medicine.

If you have not applied a patch for more than three days, consult your doctor before applying the next one.
Children and adolescents
There is no indication for the specific use of Demelora in the pediatric population for the treatment of Alzheimer's disease.
Other medicines and Demelora
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Demelora may interfere with anticholinergic medicines, including those 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).
Demelora patch must not be administered concurrently with metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking these two medicines together may cause problems such as stiffness of limbs and hand tremors.
If you are undergoing surgery and are being treated with Demelora transdermal patches, inform your doctor, as they may enhance the effects of certain muscle relaxants during anesthesia.
Caution is required when Demelora patch is administered concomitantly with beta-blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions). Taking both medicines together may cause problems such as slowing of the heartbeat (bradycardia), leading to fainting or loss of consciousness.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, the benefits of using Demelora must be weighed against possible risks to the unborn child. Demelora should not be used during pregnancy unless strictly necessary.
You must not breastfeed during treatment with Demelora transdermal patches.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Demelora transdermal patches may cause fainting or severe confusion. If you feel faint or confused, do not drive, operate machinery, or engage in any other activity requiring alertness.

3. How to use Demelora

Use Demelora transdermal patches exactly as prescribed by your doctor. If you have
any doubts, consult your doctor, pharmacist, or nurse.
IMPORTANT:

• Remove the previous day's patch before applying a NEW one.
• One patch per day only.
• Do not cut the patch into pieces.
• Press firmly on the patch with the palm of your hand for at least 30 seconds.

Starting treatment
Your doctor will tell you which Demelora transdermal patch is most suitable for you.

• Treatment usually starts with Demelora 4.6 mg/24 hours.
• The usual recommended daily dose is Demelora 9.5 mg/24 hours. If well tolerated, your doctor may consider increasing the dose to 13.3 mg/24 hours (The 13.3 mg/24-hour dosage is not available for this product. For conditions requiring this dosage, please refer to other products containing rivastigmine that offer transdermal patches delivering 13.3 mg/24 hours).
• Apply only one transdermal patch at a time and replace it with a new one every 24 hours. During treatment, your doctor may adjust the dose according to your individual needs.

If you have not applied a patch for more than three days, do not apply the next one without first consulting your
doctor. You may resume treatment with the same dose if the therapy has been interrupted for no more than 3 days; otherwise, your doctor will instruct you to restart treatment with Demelora 4.6 mg/24 hours.
Demelora may be used while eating, drinking, or consuming alcohol.
Where to apply the Demelora transdermal patch

• Before applying a patch, make sure the skin is clean, dry, and free of hair, powders, oils, moisturizers, or lotions, which may prevent proper adhesion of the patch. The skin should also be free of cuts, rashes, and/or irritation.
• Carefully remove any existing patch before applying a new one. Having more than one patch on the skin could expose you to an excessive amount of medication, which could be potentially dangerous.
• Apply ONE patch per day to ONE of the following application sites shown in the figures below:
• upper left arm or upper right arm
• upper left chest or upper right chest (avoid the breast area)
• upper left back or upper right back
• lower left back or lower right back

Every 24 hours, remove the previous patch before applying a NEW ONE to ONE of the following possible sites.

When changing the patch, remove the previous day's patch and apply the new one each time to a different site (for example, right side of the body one day and left side the next day, upper part of the body one day and lower part the next). Do not reapply a new patch to the same skin area until at least 14 days have passed.
How to apply the Demelora transdermal patch
Demelora patches are thin, light brown, plastic patches that adhere to the skin.
Each patch is sealed in a protective pouch to protect it until use. Do not open the pouch or remove the patch until just before application.

Carefully remove the existing patch before applying a new one.
For patients starting treatment for the first time and for patients restarting
rivastigmine treatment after an interruption, please follow the instructions
shown below next to the second image.

Each patch is sealed in its protective pouch. Open the pouch only when you are ready to apply the patch.
Cut the pouch along the scissors mark, without going beyond the indicated line. Open the pouch by tearing it open. Do not cut the pouch along its entire length to avoid damaging the patch.
Remove the patch from the pouch.
Peel off the protective film from the top (skin-colored) side of the patch and discard it.

A protective liner covers the adhesive side of the patch.
Peel off one side of the protective liner and avoid touching the adhesive surface of the patch with your fingers.

Place the adhesive side of the patch on the upper or lower back, upper arm, or chest, then remove the second side of the protective liner.

Press firmly on the patch with the palm of your hand for at least 30 seconds, ensuring the edges adhere well.
If helpful, you may write on the patch, for example, the day of the week, using a fine ballpoint pen.
The patch should be worn continuously until it is time to replace it with a new one. If desired, when applying a new patch, you may try different sites to find those most comfortable for you and where clothing does not rub against the patch.
How to remove the Demelora transdermal patch
Gently lift one corner of the patch to slowly remove it from the skin. If adhesive residue remains on the skin, moisten the area gently but thoroughly with warm water and mild soap, or use baby oil to remove it. Do not use alcohol or other solvents (such as nail polish remover or similar products).
After removing the patch, wash your hands with water and soap. If you get the medication in your eyes or if your eyes become red after handling the patch, rinse immediately with plenty of water and consult a doctor if symptoms do not improve.
Can you bathe, swim, or sunbathe while wearing the Demelora transdermal patch?

• Bathing, swimming, or showering should not interfere with the patch. Ensure the patch does not come loose during these activities.
• Do not expose the patch to external sources of heat (e.g., excessive sunlight, sauna, sunbed) for prolonged periods.

What to do if the patch comes loose
If the patch becomes detached, apply a new one for the remainder of the day, then replace the patch at the usual time the next day.
When and for how long to apply the Demelora transdermal patch?

• To benefit from treatment, apply a new patch every day, preferably at the same time.
• Apply only one Demelora patch at a time and replace it with a new one after 24 hours.

If you use more Demelora than you should
If you accidentally apply more than one patch, remove all patches from the skin and inform your doctor that you accidentally applied more than one patch. You may require medical treatment. Some people who accidentally took an excessive amount of rivastigmine experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. Slowing of the heart rate and fainting may also occur.
If you forget to use Demelora
If you realize you have forgotten to apply a patch, apply a new one immediately. You may apply the next patch at the usual time the following day. Do not apply two patches to make up for the missed one.
If you stop using Demelora
If you discontinue treatment with the patch, inform your doctor or pharmacist.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Demelora transdermal patches can cause side effects,
although not everybody will get them.
Side effects may be more common when you first start using the medicine or
when your dose is increased. Generally, side effects will gradually disappear as
your body gets used to the medicine.
Remove the patch and contact your doctor immediately if you notice that any of the following
side effects become severe:
Common (may affect up to 1 in 10 people):

• Loss of appetite
• Dizziness
• Feeling restless or drowsy
• Urinary incontinence (inability to properly retain urine)

Uncommon (may affect up to 1 in 100 people):

• Heart rhythm disorders, such as slow heartbeat
• Seeing things that are not really there (hallucinations)
• Stomach ulcer
• Dehydration (excessive loss of 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 in arms or legs
• Hand tremors

Not known (frequency cannot be estimated from the available data):

• Allergic reactions at the application site of the patch, such as blisters or inflamed skin
• Worsening of symptoms of Parkinson's disease – such as tremor, stiffness, and shuffling gait
• Inflammation of the pancreas – manifested by severe pain in the upper stomach, often accompanied by nausea or vomiting
• Fast or irregular heartbeat
• High blood pressure
• Seizures
• Liver disorders (yellowing of the skin and whites of the eyes, abnormally dark-coloured urine, or unexplained nausea, vomiting, tiredness, and loss of appetite)
• Changes in liver function test results
• Feeling restless
• Nightmares Remove the patch and contact your doctor immediately if you notice any of the side effects listed above.

Other side effects observed with rivastigmine capsules or oral solution and which may
occur with the patch:
Common (may affect up to 1 in 10 people):

• Excessive salivation
• Loss of appetite
• Feeling restless
• General feeling of being unwell
• Tremors or feeling confused
• Increased sweating

Uncommon (may affect up to 1 in 100 people):

• Irregular heartbeat (e.g. fast heartbeat)
• Sleep disorders
• Accidental falls

Rare (may affect up to 1 in 1,000 people):

• Seizures
• Intestinal ulcer
• Chest pain – this may be caused by cardiac spasm

Very rare (may affect up to 1 in 10,000 people):

• High blood pressure
• Inflammation of the pancreas – manifested by severe pain in the upper stomach, often accompanied by nausea or vomiting
• Intestinal bleeding – manifested by presence of blood in stools or vomit
• Seeing things that are not there (hallucinations)
• In some people who experienced severe vomiting, rupture of the tube connecting the mouth to the stomach (oesophagus) occurred

Reporting of suspected adverse reactions
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Demelora

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and on the sachet after "Exp./EXP". The expiry date refers to the last day of that month.
• This medicine does not require any special storage temperature.
• Keep the transdermal patch in its sachet until ready to use.
• Do not use the patch if it is damaged or shows signs of tampering.
• After removing a patch, fold it in half with the adhesive sides together and press them firmly. Return the used patch to its original sachet and dispose of it so that children cannot touch it. Avoid touching your eyes with your fingers and wash your hands thoroughly with water and soap after removing the patch. If your local waste disposal service incinerates household waste, you may dispose of the patch with household waste. Alternatively, return used patches to a pharmacy, preferably in their original packaging.

6. Package contents and other information

What Demelora contains

• The active substance is rivastigmine.
• Demelora 4.6 mg/24 hours transdermal patches: Each patch releases 4.6 mg of rivastigmine over 24 hours, measures 4.6 cm and contains 6.9 mg of rivastigmine.
• Demelora 9.5 mg/24 hours transdermal patches: Each patch releases 9.5 mg of rivastigmine over 24 hours, measures 9.2 cm and contains 13.8 mg of rivastigmine.
• The other components are:
• Matrix:
• poly[(2-ethylhexyl)acrylate, vinyl acetate]
• medium and high molecular weight polyisobutene
• anhydrous colloidal silica
• light liquid paraffin
  Cover layer: polyester film coated with polyethylene/thermoplastic resin/aluminum
  Release liner:
• polyester film coated with fluoropolymer
  Orange printing ink

Description of the appearance of Demelora and contents of the pack
Each transdermal patch is thin. The outer surface is light brown and bears the label printed in orange ink:

• “RIV-TDS 4.6 mg/24 h”
• “RIV-TDS 9.5 mg/24 h”

Each transdermal patch is sealed in a pouch. The patches are available in packs containing 7,
30 or 42 pouches, and in multiple packs containing 60, 84 or 90 pouches. Not all pack sizes may be marketed.
Marketing Authorization Holder
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 – Ascoli Piceno (AP)
Italy
Manufacturer
Luye Pharma AG - Am Windfeld 35, 83714 Miesbach - Germany
This medicinal product is authorized in the European Economic Area countries under the following names:
Germany Rivastigmin Glenmark 4.6 mg/24 hours transdermal patch
Germany Rivastigmin Glenmark 9.5 mg/24 hours transdermal patch
Spain Rivastigmina Aristo 4.6 mg/24 h transdermal patches EFG
Spain Rivastigmina Aristo 9.5 mg/24 h transdermal patches EFG
France Rivastigmine Arrow 4.6 mg/24 hours, transdermal system
France Rivastigmine Arrow 9.5 mg/24 hours, transdermal system
Italy Demelora
Italy Demelora
Netherlands Rivastigmine Aurobindo 4.6 mg/24 hours transdermal patch
Netherlands Rivastigmine Aurobindo 9.5 mg/24 hours transdermal patch
Portugal Demelora
Portugal Demelora