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ALMURIVA 9.5 MG/24H TRANSDERMAL PATCH

Active substance(s): RIVASTIGMINE

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SZ00000LT000

PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT

Almuriva 4.6 mg/24 h
transdermal patch
Almuriva 9.5 mg/24 h
transdermal patch
rivastigmine
Read all of this leaflet carefully before you start
using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms of illness are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

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

1

What Almuriva is and what it is used
for

The active substance of Almuriva is rivastigmine.
Rivastigmine belongs to a class of substances
called cholinesterase inhibitors. In patients with
Alzheimer’s dementia, certain nerve cells die in the
brain, resulting in low levels of the neurotransmitter
acetylcholine (a substance that allows nerve cells to
communicate with each other). Almuriva works by
blocking the enzymes that break down acetylcholine:
acetylcholinesterase and butyrylcholinesterase. By
blocking these enzymes, Almuriva allows levels of
acetylcholine to be increased in the brain, helping to
reduce the symptoms of Alzheimer’s disease.
Almuriva is used for the treatment of adult patients
with mild to moderately severe Alzheimer’s dementia,
a progressive brain disorder that gradually affects
memory, intellectual ability and behaviour.

2

What you need to know before you
use Almuriva

Do not use Almuriva
• if you are allergic to rivastigmine (the active
substance in Almuriva or any of the other
ingredients of this medicine (listed in section 6).
• if you have ever had an allergic reaction to a similar
type of medicine (carbamate derivatives).
• if you have a skin reaction spreading beyond the
patch size, if there is a more intense local reaction
(such as blisters, increasing skin inflammation,

swelling) and if it does not improve within 48 hours
after removal of the transdermal patch.
If this applies to you, tell your doctor and do not apply
Almuriva transdermal patches.
Warnings and precautions
Talk to your doctor before using Almuriva:
• if you have, or have ever had, an irregular or slow
heartbeat.
• if you have, or have ever had, an active stomach
ulcer.
• if you have, or have ever had, difficulties in passing
urine.
• if you have, or have ever had, seizures.
• if you have, or have ever had, asthma or a severe
respiratory disease.
• if you suffer from trembling.
• if you have a low body weight.
• if you have gastrointestinal reactions such as
feeling sick (nausea), being sick (vomiting) and
diarrhoea. You may become dehydrated (losing too
much fluid) if vomiting or diarrhoea are prolonged.
• if you have impaired liver function.
If any of these apply to you, your doctor may need
to monitor you more closely while you are on this
medicine.
If you have not applied a patch for more than three
days, do not apply the next one before you have
talked to your doctor.
Children and adolescents
There is no relevant use of Almuriva in the paediatric
population in the treatment of Alzheimer’s disease.
Other medicines and Almuriva
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Almuriva might interfere with anticholinergic
medicines some of which are medicines used to
relieve stomach cramps or spasms (e.g. dicyclomine),
to treat Parkinson’s disease (e.g. amantadine) or
to prevent motion sickness (e.g. diphenhydramine,
scopolamine, or meclizine).
Almuriva Patch should not be given at the same
time as metoclopramide (a medicine used to relieve
or prevent nausea and vomiting). Taking the two
medicines together could cause problems such as
stiff limbs and trembling hands.
If you have to undergo surgery whilst using Almuriva
transdermal patches, tell your doctor that you are
using them because they may exaggerate the effects
of some muscle relaxants during anaesthesia.
Caution when Almuriva Patch is given together
with beta-blockers (medicines such as atenolol
used to treat hypertension, angina, and other heart
conditions). Taking the two medicines together
could cause problems such as slowing of the
heartbeat (bradycardia) leading to fainting or loss of
consciousness.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
If you are pregnant, the benefits of using Almuriva
transdermal patches must be assessed against
the possible effects on your unborn child. Almuriva
should not be used during pregnancy unless clearly
necessary.

You should not breast-feed during treatment with
Almuriva transdermal patches.
Driving and using machines
Your doctor will tell you whether your illness allows
you to drive vehicles and use machines safely.
Almuriva transdermal patches may cause fainting or
severe confusion. If you feel faint or confused do not
drive, use machines or perform any other tasks that
require your attention.

3

How to use Almuriva






rivastigmine products for which transdermal
patches of the 13.3 mg/24 h strength are available).
Only wear one Almuriva patch at a time and
replace the patch with a new one after 24 hours.

During the course of the treatment your doctor may
adjust the dose to suit your individual needs.
If you have not applied a patch for three days, do not
apply the next one before you have talked to your
doctor. Transdermal patch treatment can be resumed
at the same dose if treatment is not interrupted for
more than three days. Otherwise your doctor will
restart your treatment on Almuriva 4.6 mg/24 h.

For patients starting treatment for
the first time and for patients
restarting Almuriva after
treatment interruption, please
begin with the second picture.

Every 24 hours take off the previous patch
before putting on ONE new patch. The new
patch should only be applied to one of the
following possible locations.
Front

or

or

or

or

Back

Almuriva can be used with food, drink and alcohol.
Always use Almuriva transdermal patches exactly
as your doctor has told you. Check with your doctor,
pharmacist or nurse if you are not sure.
IMPORTANT:
• Take off the previous patch before putting ONE
new patch on.
• Only one patch per day.
• Do not cut the patch into pieces.
• Press the patch firmly in place for at least 30
seconds using the palm of the hand.
How to start treatment
Your doctor will tell you which Almuriva transdermal
patch is most suitable for you.
• Treatment usually starts with Almuriva 4.6 mg/24 h.
• The recommended usual daily dose is Almuriva
9.5 mg/24 h. If well tolerated, the treating physician
may consider increasing the dose to 13.3 mg/24 h
(The 13.3 mg/24 h dose strength cannot be
achieved with this product. For conditions where
this strength should be used, please refer to other

Where to apply your Almuriva transdermal patch
• Before you apply a patch, make sure that your skin
is clean, dry and hairless, free of any powder, oil,
moisturiser or lotion that could keep the patch from
sticking to your skin properly, free of cuts, rashes
and/or irritations.
• Carefully remove any existing patch before
putting on a new one. Having multiple patches on
your body could expose you to an excessive
amount of this medicine which could be potentially
dangerous.
• Apply ONE patch per day to ONLY ONE of
the possible locations, shown in the following
diagrams:
• left upper arm or right upper arm
• left upper chest or right upper chest (avoid breast)
• left upper back or right upper back
• left lower back or right lower back

or

or

or

When changing the patch, you must remove the
previous day’s patch before you apply the new one to
a different location of skin each time (for example on
the right side of your body one day, then on the left
side the next day, and on your upper body one day,
then on your lower body the next day). Do not apply a
new patch to the same skin area twice within 14 days.
How to apply your Almuriva transdermal patch
Almuriva patches are thin, opaque, plastic patches
that stick to the skin. Each patch is sealed in a sachet
that protects it until you are ready to put it on. Do not
open the sachet or remove a patch until just before
you apply it.
Carefully remove the existing patch before putting on
a new one.










Each patch is sealed in its
own protective sachet.
You should only open the
sachet when you are ready to
apply the patch. Cut the
sachet along the dotted
line with scissors and remove
the patch from the sachet.








A protective liner covers the
sticky side of the patch.
Peel off one side of the
protective liner and do not
touch the sticky part of the
patch with the fingers.







Put the sticky side of the
patch on the upper or lower
back, upper arm or chest
and then peel off the second
side of the protective liner.







Then press the patch firmly in
place for at least 30 seconds
using the palm of the hand to
make sure that the edges stick
well.

If it helps you, you may write, for example, the day of
the week, on the patch with a thin ball point pen.
The patch should be worn continuously until it is
time to replace it with a new one. You may wish to
experiment with different locations when applying a
new patch, to find ones that are most comfortable for
you and where clothing will not rub on the patch.
How to remove your Almuriva transdermal patch
Gently pull at one edge of the patch to remove it
slowly from the skin. In case the adhesive residue is
left over on your skin, gently soak the area with warm
water and mild soap or use baby oil to remove it.
Alcohol or other dissolving liquids (nail polish remover
or other solvents) should not be used.
You should wash your hands with soap and water
after removing the patch. In case of contact with eyes
or if the eyes become red after handling the patch,
rinse immediately with plenty of water and seek
medical advice if symptoms do not resolve.
Can you wear your Almuriva transdermal patch
when you are bathing, swimming, or in the sun?
• Bathing, swimming or showering should not affect
the patch. Make sure the patch does not loosen
during these activities.
• Do not expose the patch to any external heat
sources (e.g. excessive sunlight, saunas, solarium)
for long periods of time.
What to do if a patch falls off
If a patch falls off, apply a new one for the rest of the
day, then replace it at the same time as usual the
next day.
When and for how long to apply your Almuriva
transdermal patch







To benefit from treatment, you must apply a new
patch every day, preferably at the same time of
day.
Only wear one Almuriva patch at a time and
replace the patch with a new one after 24 hours.

If you use more Almuriva than you should
If you accidentally apply more than one patch,
remove all the patches from your skin, then inform
your doctor that you have accidentally applied more
than one patch. You may require medical attention.
Some people who have accidentally taken too much
Almuriva have experienced feeling sick (nausea),
being sick (vomiting), diarrhoea, high blood pressure
and hallucinations. Slow heartbeat and fainting may
also occur.
If you forget to use Almuriva
If you find you have forgotten to apply a patch, apply
one immediately. You may apply the next patch at the
usual time the next day. Do not apply two patches to
make up for the one that you missed.
If you stop using Almuriva
Tell your doctor or pharmacist if you stop using the
patch.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, Almuriva transdermal patches can
cause side effects, although not everybody gets them.

You may have side effects more often when you
start your medicine or when your dose is increased.
Usually, the side effects will slowly go away as your
body gets used to the medicine.

Common (may affect up to 1 in 10 people)
• Loss of appetite
• Feeling dizzy
• Feeling agitated or sleepy

Take off your patch and tell your doctor
immediately or go to the hospital if you
experience any of the following side effects which
could become serious:

Uncommon (may affect up to 1 in 100 people)
• Stomach ulcer
• Dehydration (losing too much fluid)
• Hyperactivity (high level of activity, restlessness)
• Aggression

Common (may affect up to 1 in 10 people)
• Urinary incontinence (inability to retain adequate
urine)
Uncommon (may affect up to 1 in 100 people)
• Problems with your heartbeat such as slow
heartbeat
• Seeing things that are not really there
(hallucinations)
Not known (frequency cannot be estimated from the
available data)
• Allergic reaction where the patch was used, such
as blisters or inflamed skin
• The signs of Parkinson’s disease get worse – such
as tremor, stiffness and shuffling
• Inflammation of the pancreas – signs include
serious upper stomach pain, often with feeling sick
(nausea) or being sick (vomiting)
• Liver disorders (yellow skin, yellowing of the
whites of the eyes, abnormal darkening of the urine
or unexplained nausea, vomiting, tiredness and
loss of appetite)
• Fast or uneven heartbeat
• Fits (seizures)
The following side effects have also been reported:

Rare (may affect up to 1 in 1,000 people)
• Falling
Very rare (may affect up to 1 in 10,000 people)
• Stiff arms or legs
• Trembling hands
Not known (frequency cannot be estimated from the
available data)
• High blood pressure
• Changes in tests which show how well the liver is
working
• Feeling restless
• Nightmares
Other side effects seen with rivastigmine
capsules or oral solution and which may occur
with the patch:
Tell your doctor immediately or go to the hospital
if you experience any of the following side effects
which could become serious:
Uncommon (may affect up to 1 in 100 people)
• Uneven heart rate (e.g. fast heart rate)

Rare (may affect up to 1 in 1,000 people)
• Fits (seizures)
• Chest pain – this may be caused by heart spasm
Very rare (may affect up to 1 in 10,000 people)
• Inflammation of the pancreas – the signs include
serious upper stomach pain, often with feeling sick
(nausea) or being sick (vomiting)
• Some people who have been violently sick have
had tearing of the tube that connects your mouth
with your stomach (oesophagus)
• Bleeding in the gut – shows as blood in stools or
when being sick
Other side effects with rivastigmine capsules or oral
solution :
Common (may affect up to 1 in 10 people)
• Too much saliva
• Loss of appetite
• Feeling restless
• Generally feeling unwell
• Trembling or feeling confused
• Increased sweating
Uncommon (may affect up to 1 in 100 people)
• Difficulty sleeping
• Accidental falls
Rare (may affect up to 1 in 1,000 people)
• Ulcer in the intestine
Very rare (may affect up to 1 in 10,000 people)
• High blood pressure
• Seeing things that are not there (hallucinations)

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via the Yellow
Card Scheme: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine

5




















How to store Almuriva

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 sachet. The
expiry date refers to the last day of the month.
Do not store above 25°C.
Keep the transdermal patch in the sachet until use.
Do not use any patch that is damaged or shows
signs of tampering.
After removing a patch, fold it in half with the sticky
sides on the inside and press them together.
Return the used patch to its sachet and dispose
of it in such a way that children cannot handle it.
Do not touch your eyes with your fingers and wash
your hands with soap and water after removing the
patch. If your community burns domestic rubbish,
you can dispose of the patch with your domestic
rubbish. Otherwise, return used patches to a
pharmacy, preferably in the original packaging.

6

Contents of the pack and other
information

What Almuriva contains
• The active substance is rivastigmine.
- Almuriva 4.6 mg/24 h transdermal patches: Each
patch releases 4.6 mg of rivastigmine per 24
hours is 5 cm2 and contains 9 mg of
rivastigmine.
- Almuriva 9.5 mg/24 h transdermal patches: Each
patch releases 9.5 mg of rivastigmine per 24
hours is 10 cm2 and contains 18 mg of
rivastigmine.
- The other ingredients are: polyethylene
terephthalate film lacquered, all-rac-α
Tocopherol, poly(butylmethacrylate,
methyl-methacrylate) copolymer (3:1), acrylic
copolymer, silicone, dimeticone, polyester
film fluoropolymer-coated, resin, pigments,
organic polymers/resins.
What Almuriva looks like and contents of the pack
Almuriva 4.6 mg/24 h transdermal patches
Each transdermal patch is a thin, matrix-type
transdermal patch consisting of three layers. The
outside of the backing layer is beige and labelled with
“RIV”, 4.6 mg/24 h”
Almuriva 9.5 mg/24 h transdermal patches
Each transdermal patch is a thin, matrix-type
transdermal patch consisting of three layers. The
outside of the backing layer is beige and labelled with
“RIV”, 9.5mg/24 h”
One transdermal patch is sealed in one sachet. The
patches are available in packs containing 7, 30, 60 (2

packs of 30), 90 (3 packs of 30) sachets. Not all pack
sizes may be marketed in your country.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Limited,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR.
Manufacturer
Novartis Pharma GmbH,
Roonstrasse 25,
D-90429 Nürnberg
Germany
or
Hexal AG
Industriestrasse 25,
83607 Holzkirchen
Germany
or
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
39179 Barleben
Germany
or
Lek Pharmaceuticals d.d
Verovškova 57,
1526 Ljubljana
Slovenia.
This leaflet was last revised in 12/2015.
SZ00000LT000

Artwork Proof Box
Ref: V007 - PSUSA - SPC & PIL
Proof no.
004.0

Date prepared:
15/12/2015

Colours:
Black
Dimensions: 594 x 148 mm

Font size:
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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