DEMELORA 4.6 MG/24 H Transdermal patch

Зміст інструкції

1. Demelora 4.6 mg/24 hours transdermal patch, 9.5 mg/24 hours transdermal patch
   1. What is Demelora and what is it 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

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

rivastigmine
Generic Medicine

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you use 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 is Demelora and what is it used for

Demelora contains the active ingredient rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients
with Alzheimer's dementia, some brain cells die, leading to low levels of acetylcholine
(a substance that allows nerve cells to communicate with each other). Rivastigmine works by blocking
the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these
enzymes, rivastigmine increases acetylcholine levels in the brain, improving the symptoms of Alzheimer's disease.
Demelora is used for the treatment of adult patients with Alzheimer's dementia of mild to
moderate severity, a progressive disorder of the central nervous system that gradually affects
memory, learning ability and behavior.

2. What you need to know before using Demelora

Do not useDemelora

• if you are allergic to rivastigmine (the active ingredient of Demelora) or to any of the other ingredients of this medicine (listed in section 6).
• if you have already had an allergic reaction to similar types of medicines (carbamate derivatives).
• if when using the patch you have had a skin reaction that spread beyond the area where the patch was applied, if you have had a local reaction more intense (such as blisters, increased skin inflammation, swelling) that did not improve within 48 hours of removing the patch. If this is the case, 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 irregular or slowed 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 convulsions.
• if you have or have previously had asthma or severe respiratory disorders.
• if you suffer from tremors.
• if you have a low body weight.
• if you experience gastrointestinal disorders such as nausea, vomiting and diarrhoea. If vomiting and diarrhoea are persistent, you may become dehydrated (excessive fluid loss).
• if you have impaired liver function. If you recognize yourself in any of these situations, your doctor may visit you more frequently during therapy 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 specific use of Demelora in the pediatric population in the
treatment of Alzheimer's disease.

Other medicinesand Demelora
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Demelora may interfere with anticholinergic medicines, including medicines used to relieve
stomach cramps or spasms (e.g. diciclomina), for the treatment of Parkinson's disease (e.g.
amantadine) or to prevent travel sickness (e.g. diphenhydramine, scopolamine or meclizine).
Demelora patch should not be administered simultaneously with metoclopramide (a
medicine used to relieve or prevent nausea and vomiting). Taking the two medicines
together may cause problems such as stiffness of the limbs and tremors in the hands.
If you are going to have surgery and are undergoing therapy with Demelora transdermal
patches, inform your doctor, as they may increase the effects of some
muscle relaxants during anesthesia.
Caution is necessary when Demelora patch is administered simultaneously with
beta-blockers (medicines such as atenolol used to treat hypertension, angina and other conditions
cardiac). Taking the two medicines together may cause problems such as slowed heartbeat
(bradycardia) leading to fainting or loss of consciousness.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, the benefits of using Demelora must be weighed against the possible effects on the
unborn child. Demelora should not be used during pregnancy unless
strictly necessary.
You should not breastfeed during treatment with Demelora transdermal patches.

Driving and using machines
Your doctor will tell you if your illness allows you to drive and operate machinery safely. Demelora transdermal patches may cause fainting or severe confusion. If you feel
faint or confused, do not drive, do not use machines and do not perform any other activity that
requires vigilance.

3. How to use Demelora

Use Demelora transdermal patches always exactly as your doctor has instructed. If you have
any doubts, consult your doctor, pharmacist or nurse.

IMPORTANT:

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

How to start 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 normal 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 h (The 13.3 mg/24 hour dosage is not available for this product. For conditions where this dosage needs to be used, please refer to other products containing rivastigmine for which 13.3 mg/24 h transdermal patches are available).
• Apply only one transdermal patch at a time and replace the patch with a new one every 24 hours. During treatment, your doctor may vary the dose to adjust it to your individual needs.

If you have not applied a patch for more than three days, do not apply the next one before consulting your
doctor. You can resume treatment with the transdermal patches at the same dose if the therapy has not
been interrupted for more than 3 days; alternatively, your doctor will start you on treatment again with
Demelora 4.6 mg/24 hours.
Demelora can be used at the same time as taking food, drinks and alcohol.

Where to apply the Demelora transdermal patch

• Before applying a patch, make sure the skin is clean, dry and hairless, free of dust, oils, moisturizers or lotions that may prevent the patch from adhering correctly to the skin, which must be without cuts, rashes and/or irritation.
• Carefully remove any patch before applying a new one.Having more patches on the skin may expose it to an excessive amount of medicine which could be potentially dangerous.
• Apply ONLY ONEpatch per day on ONLY ONEof the possible sites highlighted in the figures below:
• upper left arm orupper right arm
• upper left chest orupper right chest (avoid the breast)
• upper left back orupper right back
• lower left back orlower right back

Every 24 hours remove the previous patch before placing a NEW ONE on ONLY ONE
of the following possible sites.

When changing the patch, you must remove the patch from the previous day before applying a new one
each time in a different area (for example, on the right side of the body one day and on the left side the
next day, on the upper part of the body one day and on the lower part the next day). Do not re-apply a
new patch to the same area of skin before 14 days have passed.

How to apply the Demelora transdermal patch
Demelora patches are thin, light brown in color, made of plastic material that sticks to the skin.
Each patch is sealed in a sachet that protects it until it is time to use it. Do not open the
sachet or remove the patch until just before application.

Carefully remove any patch already present before
applying a new one.
For patients starting treatment for the first time and
for patients resuming treatment with rivastigmine
after an interruption, please start with the
instructions provided below next to the second image.
Each patch is sealed in its protective sachet. You must open the
sachet only when you are ready to apply the patch.
Cut the sachet along the scissor mark, without exceeding the
indicated line. Open the sachet by tearing it. Do not cut the sachet
along its entire length to avoid damaging the patch.
Remove the patch from the sachet.
Remove the protective film from the top, flesh-colored part of
the patch, and discard it.

A protective film covers the adhesive side of the patch.
Peel off one side of the protective film and do not touch the
adhesive part of the patch with your fingers.
Place the adhesive side of the patch on the upper or lower
back or on the upper arm or chest, then remove the second side of the protective film.

Press the patch firmly with the palm of your hand for at least
30 seconds, making sure the edges adhere well.
If it helps, you can write on the patch, for example, the day of the
week with a fine-tip ballpoint pen.
The patch must be worn continuously, until it is time to replace it with a new one. If you wish, when applying a new patch, you can try different areas to find those that are more
comfortable for you and where clothing does not rub against the patch.

How to remove the Demelora transdermal patch
Gently lift a corner of the patch to remove it slowly from the skin. If adhesive residue remains on the skin, wet the area thoroughly but gently with
lukewarm water and a mild soap, or use baby oil to remove it. Alcohol or
other solvents (for removing nail polish or other types) should not be used.
After removing the patch, wash your hands with soap and water. If your eyes come into contact with the patch or if
your eyes become red after handling the patch, rinse immediately with plenty of water
and consult a doctor if symptoms do not subside.

Can the Demelora transdermal patch be applied while bathing, swimming, or
sunbathing?

• Bathing, swimming or showering should not interfere with the patch. Make sure the patch does not come off during these activities.
• Do not expose the patch to external heat sources (e.g. excessive sunlight, sauna, solarium) for long periods of time.

What to do if a patch comes off?

If a patch comes off, apply a new one for the rest of the day, then replace the patch the
next day at the usual time.

When and for how long to apply the Demelora transdermal patch?

• To benefit from the treatment, you must 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 have
accidentally applied more than one patch. You may need medical attention. 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 one immediately. You can
apply the next patch the next day at the scheduled time. Do not apply two patches to
make up for the one you forgot.

If you stop using Demelora
If you stop treatment with the patch, inform your doctor or pharmacist.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Demelora transdermal patches can cause side effects
although not everybody gets them.
Side effects may be more frequent when you start taking the medicine or
when your dose is increased. Generally side effects will slowly disappear as
your body gets used to the medicine.

Remove the patch and tell your doctor immediately if you notice any of the following
side effects becoming serious:
Common(may affect up to 1 in 10 people):

• Loss of appetite
• Feeling dizzy
• Feeling agitated or drowsy
• Urinary incontinence (inability to adequately control urination)

Uncommon(may affect up to 1 in 100 people)

• Heartbeat disturbances such as slow heartbeat
• Seeing things that are not really there (hallucinations)
• Stomach ulcer
• Dehydration (excessive fluid loss)
• Hyperactivity (elevated activity level, restlessness)
• Aggression

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

• Falls

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

• Stiffness in the arms or legs
• Tremors in the hands

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

• Allergic reactions at the patch application site, such as blisters or inflamed skin
• Symptoms of Parkinson's disease worsen - such as tremor, rigidity and shuffling gait
• Inflammation of the pancreas - manifests with severe pain in the upper abdomen, often accompanied by nausea or vomiting
• Fast or irregular heartbeat
• High blood pressure
• Convulsions Liver disorders (yellowing of the skin and whites of the eyes, abnormally dark urine or unexplained nausea, vomiting, fatigue and loss of appetite)
• Changes in test values indicating how your liver is working
• Feeling restless
• Nightmares Remove the patch and tell your doctor immediately if you notice any of the side effects described 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 unwellness
• Tremors or feeling confused
• Increased sweating

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

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

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

• Convulsions
• Ulcer in the intestine
• Chest pain - this may be caused by a cardiac spasm

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

• High blood pressure
• Inflammation of the pancreas - manifests with severe pain in the upper abdomen, often accompanied by nausea or vomiting
• Bleeding from the intestine - manifests with the presence of blood in the stool or vomit
• Seeing things that are not there (hallucinations)
• In some people who have had severe vomiting, rupture of the tract connecting the mouth to the stomach (esophagus) has occurred

Reporting suspected adverse reactions
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through 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 package and on the sachet after Scad./EXP. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage temperature.
• Store the transdermal patch in the sachet until the time of use.
• Do not use the patch if it is damaged or if it shows signs of tampering.
• After removing a patch, fold it in half with the adhesive sides inwards and press them together. Put the used patch back in its original sachet and dispose of it in such a way that children cannot reach it. Do not touch your eyes with your fingers and wash your hands with water and soap after removing the patch. If your municipality incinerates household waste, you can throw the patch with the household waste. Alternatively, return the used patches to the pharmacy, preferably in the original packaging.

6. Contents of the pack and other information

What Demelora contains

• The active ingredient is rivastigmine.
• Demelora 4.6 mg/24 hours transdermal patches: Each patch releases 4.6 mg of rivastigmine in 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 in 24 hours, measures 9.2 cm and contains 13.8 mg of rivastigmine.
• The other ingredients are:
• Matrix:
• poly [(2-ethylhexyl) acrylate, vinyl acetate]
• polyisobutene with intermediate and high molecular weight
• anhydrous colloidal silica
• light liquid paraffin Covering laminate: polyester film coated with polyethylene/thermoplastic resin/aluminium 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 layer is light brown and bears the inscription,
labeled with orange ink:

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

Each transdermal patch is sealed in a sachet. The patches are available in packs containing 7,
30 or 42 sachets and in multiple packs containing 60, 84 or 90 sachets. Not all pack sizes may be
marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:
Germany Rivastigmin Glenmark 4.6 mg/24 Stunden transdermales Pflaster
Germany Rivastigmin Glenmark 9.5 mg/24 Stunden transdermales Pflaster
Spain Rivastigmina Aristo 4.6 mg/24 h parches transdérmicos EFG
Spain Rivastigmina Aristo 9.5 mg/24 h parches transdérmicos EFG
France Rivastigmine Arrow 4.6 mg/24 heures, dispositif transdermique
France Rivastigmine Arrow 9.5 mg/24 heures, dispositif transdermique
Italy Demelora
Italy Demelora
Netherlands Rivastigmine Aurobindo 4.6 mg/24 uur Pleister voor transdermaal gebruik
Netherlands Rivastigmine Aurobindo 9.5 mg/24 uur Pleister voor transdermaal gebruik
Portugal Demelora
Portugal Demelora