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REMINYL XL 8 MG PROLONGED RELEASE CAPSULES

Active substance(s): GALANTAMINE

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1515VTBC
Reminyl PIL Ireland UK 8mg_16mg_24mg 28ct 14071611152866
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466789A09
14-0046
6
160x600mm
23-07-15

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Package leaflet: Information for the user
Profile

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galantamine

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24mg prolonged-release capsules, hard

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you
• 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
only. Do not pass it on to others. It may
harm them, even if their signs of illness
are the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.

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Fonts used:
Helvetica Neue LT Std-55 Roman

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8mg prolonged-release capsules, hard
16mg prolonged-release capsules, hard

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

1. What Reminyl XL is and what it is used for

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Reminyl XL contains the active substance
‘galantamine’ an antidementia medicine. It is
used in adults to treat the symptoms of mild
to moderately severe Alzheimer’s disease,
a type of dementia that alters brain function.

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Alzheimer’s disease causes increasing
memory loss, confusion and behavioural
changes which make it increasingly
difficult to carry out normal daily activities.

Average Text Size (Body Text):
9.0 pt

These effects are thought to be caused
by a lack of ‘acetylcholine’, a substance
responsible for sending messages between
brain cells. Reminyl increases the amount
of acetylcholine in the brain and treats the
signs of the disease.
The capsules are made in a ‘prolongedrelease’ form. This means that they release
the medicine slowly.

2. What you need to know before you take Reminyl XL
Do not take Reminyl XL
• if you are allergic to galantamine or
to any of the other ingredients of this
medicine (listed in section 6)
• if you have severe liver or severe kidney
disease
Warnings and precautions
Talk to your doctor or pharmacist before
taking Reminyl XL. This medicine is only
used in Alzheimer’s disease, and is not
recommended for other types of memory
loss or confusion.
Serious side effects
Reminyl XL can cause serious skin
reactions, heart problems, fits (seizures).
You must be aware of these side effects
while you are taking Reminyl. See ‘Look
out for serious side effects’ in section 4.
Before you take Reimyl XL, your doctor
needs to know if you have, or have had,
any of the following:

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• liver or kidney problems
• a heart condition (such as chest
discomfort that is often brought on by
physical activity, a heart attack, heart
failure, slow or uneven heart beat)
• changes in ‘electrolyte’ levels ( naturally
occurring chemicals in the blood, such
as potassium)
• a peptic (stomach) ulcer
• blockage of the stomach or intestines
• a disorder of the nervous system (such
as epilepsy or Parkinson’s disease)
• a respiratory disease or infection that
affects breathing (such as asthma,
obstructive pulmonary disease, or
pneumonia)
• problems passing urine
Your doctor will decide if Reminyl XL is
suitable for you, or if the dose needs to be
changed
Also tell your doctor if you recently had
an operation on the stomach, intestines
or bladder. Your doctor may decide that
Reminyl XL is not suitable for you.
Reminyl XL can cause weight loss.
Your doctor will check your weight regularly
while you are taking Reminyl XL.
Children and adolescents
Reminyl XL is not recommended for
children and adolescents.
Other medicines and Reminyl XL
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.

Reminyl XL should not be used with
medicines that work in a similar way.
These include:
• donepezil or rivastigmine (for Alzheimer’s
disease)
• ambenonium, neostigmine or
pyridostigmine (for severe muscle
weakness)
• pilocarpine (when taken by mouth for
dry mouth or dry eyes)
Some medicines can make side effects
more likely in people taking Reminyl XL.
These include:
• paroxetine or fluoxetine
(antidepressants)
• quinidine (for uneven heart beat)
• ketoconazole (an antifungal)
• erythromycin (an antibiotic)
• ritonavir (for human immunodeficiency
virus or ‘HIV’).
• non-steroidal anti-inflammatory
painkillers (such as ibuprofen) which
can increase the risk of ulcers.
• medicines taken for heart conditions or
high blood pressure (such as digoxin,
amiodarone, atropine, beta-blockers,
or calcium channel blocking agents).
If you take medicines for an uneven
heart-beat, your doctor may check
your heart using an electrocardiogram
(ECG).
Your doctor may give you a lower dose of
Reminyl XL if you are also taking some of
these medicines.
Reminyl XL may affect some anaesthetics.
If you are going to have an operation under
a general anaesthetic, tell the doctor that
you are taking Reminyl, well in advance.
If you have any questions, talk to your
doctor or pharmacist for advice.
Pregnancy and breast-feeding
If you are pregnant, think you may be
pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice
before taking this medicine.
You should not breastfeed while you are
taking Reminyl XL.
Driving and using machines
Reminyl XL may make you feel dizzy or
sleepy, especially during the first few weeks
of treatment. If Reminyl XL affects you,
do not drive or use any tools or machinery.
Reminyl XL contains Sucrose
If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicine.

3. How to take Reminyl XL capsules
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.

DO NOT take more than one capsule in
a day. While you are taking once daily
Reminyl XL capsules, Do NOT take
Reminyl tablets or oral solution.

If you are currently taking Reminyl tablets
or oral solution and have been told by
your doctor to switch to Reminyl XL
prolonged-release capsules, carefully read
the instructions under ‘Switching from
taking Reminyl tablets or oral solution to
Reminyl capsule in this section.
How much to take
You will start treatment with Reminyl XL
at a low dose. The usual starting dose
is 8 mg, taken once a day. Your doctor
may gradually increase your dose, every
4 weeks or more until you reach a dose
that is suitable for you. The maximum dose
is 24 mg, taken once day.

How to take
Reminl XL capsules must be swallowed
whole and NOT chewed or crushed.
Take your dose of Reminyl XL once a day
in the morning, with water or other liquids.
Try to take Reminyl XL with food.

Your doctor will explain what dose to
start with and when the dose should be
increased. If you are not sure what to
do, or find the effect of Reminyl XL is too
strong or too weak, talk to your doctor or
pharmacist.
Your doctor will need to see you regularly,
to check that this medicine is working and
to discuss how you are feeling.

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If you have a liver or kidney problem,
your doctor may give you a reduced dose
of Reminyl XL, or may decide this medicine
is not suitable for you.
Switching from taking Reminyl tablets
or oral solution to Reminyl XL capsules
If you are currently taking Reminyl tablets
or oral solution, your doctor may decide you
should switch to Reminyl XL prolongedrelease capsules. If this applies to you:
• Take your last dose of Reminyl tablets
or oral solution in the evening.
• The next morning, take your first dose of
Reminyl XL prolonged-release capsule.

Drink plenty of liquids while you are taking
Reminyl XL, to keep yourself hydrated.
If you take more Reminyl XL than you
should
If you take too much Reminyl XL, contact a
doctor or hospital straight away. Take any
remaining capsules and the packaging with
you. The signs of overdose may include,
• severe nausea and vomiting.
• weak muscle, slow heart beat, fits
(seizures) and loss of consciousness.
If you forget to take Reminyl XL
If you forget to take one dose, miss out the
forgotten dose completely and take the next
dose at the normal time. Do not take a
double dose to make up for a forgotten
dose.
If you forget to take more than one dose,
contact your doctor.
If you stop taking Reminyl XL
Check with your doctor before you stop
taking Reminyl XL. It is important to
continue taking this medicine to treat your
condition.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

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Technical Info

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1515VTBC
Reminyl PIL Ireland UK 8mg_16mg_24mg 28ct 14071611152866
N/A
466789A09
14-0046
6
160x600mm
23-07-15

XXXXXX

Black

Technical Info

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4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

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Look out for serious side effects

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Stop taking Reminyl and see a doctor
or go to your nearest emergency
department immediately if you notice any
of the following.
Skin reactions, including:
• Severe rash with blisters and peeling
skin, particularly around the mouth,
nose, eyes and genitals (Stevens
Johnson syndrome).
• Red rash covered with small pusfilled bumps that can spread over the
body, sometimes with a fever (acute
generalized exanthematous pustulosis).
• Rash that may blister, with spots that
look like small targets.
These skin reactions are rare in people
taking Reminyl (may affect up to 1 in
1,000 people).

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Fonts used:
Helvetica Neue LT Std-55 Roman
Helvetica Neue LT Std-75 Bold
Myriad Pro-Bold
NimbusSanLOT-Bold
NimbusSanLOT-Regular
NimbusSanLOTBla-Regular
Smallest point sized used:
6.5 pt
Average Text Size (Body Text):
9.0 pt

Profile

Heart problems, including changes in
heart beat (such as a slow beat, extra
beats) or palpitations (heart beat feels
fast or uneven). Heart problems may
show as an abnormal tracing on an
electrocardiogram (ECG), and can be
common in people taking Reminyl XL (may
affect up to1 in 10 people).
Fits (seizures). These are uncommon in
people taking Reminyl XL (may affect up to
1 in 100 people).
You must stop taking Reminyl and get
help immediately if you notice any of the
side effects above.
Other Side effects:
Very Common side effects (may affects
more than 1 in 10 people):
• Nausea and vomiting. These side effects
are more likely to happen in the first few
weeks of treatment or when the dose
is increased. They tend to disappear
gradually as the body gets used to the
medicines and generally only last for
a few days. If you have these effects,
your doctor may recommend that you
drink more liquids and, may prescribe a
medicine to stop you being sick.
Common side effects (may affect more
than 1 in 10 people):
• Decreased appetite; weight loss
• Seeing, feeling, or hearing things that
are not there (hallucinations)

• Depression
• Feeling dizzy or fainting
• Muscle tremors or spasms
• Headache
• Feeling very tired ,weak or generally
unwell
• Feeling very sleepy with low energy
• High blood pressure
• Stomach pain or discomfort
• Diarrhoea
• Indigestion
• Falls
• Wounds
Uncommon side effects (may affect more
than to 1 in 100 people)
• Allergic reaction
• Not enough water in the body
(dehydration)
• Tingling or numb feeling of the skin
(pins and needles)
• Change in sense of taste
• Daytime sleepiness
• Blurred vision
• Ringing in the ears that does not go
away (tinnitus)
• Low blood pressure
• Flushing
• Feeling the need to vomit (retch)
• Excessive sweating
• Weak muscles
• Increased level of liver enzymes in the
blood
Rare side effects (may affect up to 1 in
1,000 people
• Inflamed liver (hepatitis)
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet.
You can also report side effects directly
(see details below). By reporting side
effects you help provide more information
on the safety of this medicine.
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5. How to Store Reminyl XL
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
blister foil after EXP. The expiry date refers
to the last day of that month.

Do not store above 30°C.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help to protect the environment.

6. Contents of the pack and other information
What Reminyl XL contains:
• The active substance is galantamine.
Each prolonged release capsule
contains 8mg, 16mg or 24 mg of
galantamine (as hydrobromide)
• The other ingredients are:
Diethyl phthalate, ethylcellulose,
hypromellose, macrogol 400, maize
starch and sucrose, gelatine, titanium
dioxide (E171), iron oxide black (E172),
shellac, propylene glycol (E1520)
The 16 and 24 mg capsules also
contain iron oxide red (E172)
The 24 mg capsule also contain iron
oxide yellow (E172)
What Reminyl XL looks like and
contents of the pack
Reminyl XL 8 mg capsules are white
and marked ‘G8’. Each pack contains
blisters of 7 or 28 capsules or bottles of
300 capsules.
Reminyl XL 16 mg capsules are pink and
marked ‘G16’. Each pack contains blisters
of 7, 28, 56 or 84 capsules.
Reminyl XL 24 mg capsules are caramel
and marked ‘G24’. Each pack contains
blisters of 7, 28, 56 or 84 capsules or
bottles of 300 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Shire Pharmaceuticals Limited, Hampshire
International Business Park, Chineham,
Basingstoke, Hampshire, RG24 8EP, UK.
Manufacturer
Janssen-Cilag SpA, Via C. Janssen, 04100
Borgo San Michele, Latina, Italy or
McGregor Cory Ltd, Exel, Site 1, Middleton
Close, Banbury, Oxfordshire, OX16 4RS,
UK.
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Austria
Belgium

Denmark
Finland
France

Germany

Greece

Iceland
Ireland

Reminyl 8 mg, 16 mg, 24 mg
Retardkapseln
Reminyl 8 mg, 16 mg, 24 mg
harde capsules met verlengde
afgifte
Reminyl 8 mg, 16 mg, 24 mg
depotkapsler, hårde
Reminyl 8 mg, 16 mg, 24 mg
depotkapseli, kova
Reminyl LP 8 mg, 16 mg,
24 mg, gélule à libération
prolongée
REMINYL 1x täglich 8 mg,
16 mg, 24 mg Hartkapseln,
retardiert
Reminyl 8mg, 16 mg, 24 mg
καψάκια παρατεταμένης
αποδέσμευσης, σκληρά
Reminyl 8 mg, 16 mg, 24 mg
hörð forðahylki
Reminyl XL 8 mg, 16 mg,
24 mg prolonged release
capsules

Italy

Reminyl 8 mg, 16 mg, 24 mg
capsule rigide a rilascio
prolungato
Luxembourg Reminyl 8 mg, 16 mg, 24 mg,
gélules dures à libération
prolongée
Netherlands Reminyl retard capsules 1x
daags 8 mg, 16 mg, 24 mg,
harde capsules met verlengde
afgifte
Norway
Reminyl 8 mg, 16 mg, 24 mg
depotkapsler, hard
Portugal
Reminyl 8 mg, 16 mg, 24 mg
cápsulas de libertação
prolongada
Spain
Reminyl 8 mg, 16 mg, 24 mg
cápsulas duras de liberación
prolongada
Sweden
Reminyl 8 mg, 16 mg, 24 mg
depotkapslar, hårda
UK
Reminyl XL 8 mg, 16 mg,
24 mg prolonged release
capsules
This leaflet was last revised in June 2015.
More Information
If you are a person with Alzheimer’s
disease or are caring for someone, and
you are in England, Wales or Northern
Ireland, further information, advice and
support is available from the Alzheimer’s
Helpline 0845 300 0336 Monday - Friday
08.30 - 18.30. The helpline is provided by
the Alzheimer’s Society, Gordon House,
10 Greencoat Place, London SW1P 1PH.
Telephone: 020 7306 0606,
Fax: 020 7306 0808, e-mail:
info@alzheimers.org.uk.
If you are in Scotland, further information,
advice and support is available from
the 24 hour Dementia Helpline on
0808 808 3000. The helpline is provided
by Alzheimer Scotland - Action on
Dementia, 22 Drumsheugh Gardens,
Edinburgh EH3 7RN. Telephone (office):
0131 243 1453, Fax: 0131 243 1450,
email: alzheimer@alzscot.org.
If you live in the Republic of Ireland, further
information, advice and support is available
from: The Alzheimer Society of Ireland,
Alzheimer House, 43 Northumberland
Avenue, Dun Laoghaire, Co. Dublin.
Telephone: (01) 284 6616, Fax:
(01) 284 6030, e-mail: info@alzheimer.ie,
National Helpline (open Monday to Thursday
10am -4pm): 1 800 341 341 or
Western Alzheimer Foundation,
Mount Street, Claremorris, Co. Mayo.
Telephone: 094 624 80. Fax: 094 62560.
Reminyl is a registered trademark of
Shire Pharmaceutical Development Ltd.
in the UK and Ireland.

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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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