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REMINYL 4MG TABLETS

Active substance: GALANTAMINE HYDROBROMIDE

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1516v4
Reminyl PIL Ireland UK MultiS 56ct 14021407262662 J&J
1172
441555A12
14-0011
7
160 x 800mm
01-12-14

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galantamine

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4 mg tablets
8 mg tablets
12 mg tablets

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GB - 996065

Package leaflet: Information for the user

Regulatory Responsible Person Approval:
Signature:

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

Marketing Responsible Person Approval:
Signature:

GFW-045 00

Fonts used:
Arial-Regular

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.

What is in this leaflet:
1.  hat Reminyl is and what it is used for
W
2.  hat you need to know before you take
W
Reminyl
3.  ow to take Reminyl
H
4.  ossible side effects
P
5.  ow to store Reminyl
H
6.  ontents of the pack and other
C
information

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

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.

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

2. What you need to know before you take Reminyl
Do not take Reminyl
•• 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.
Warning and precautions
Talk to your doctor or pharmacist before
taking Reminyl. 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 can cause 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 Reminyl, your doctor
needs to know if you have, or have had,
any of the following
•• 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 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 is not suitable for you
Reminyl can cause weight loss. Your
doctor will check your weight regularly
while you are taking Reminyl.
Children and adolescents
Reminyl is not recommended for children
and adolescents.
Other medicines and Reminyl
Tell your doctor or pharmacist if you are
taking or have recently taken or might take
any other medicines.
Reminyl 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. 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 if you are taking any of these
medicines.
Reminyl 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.
Driving and using machines
Reminyl may make you feel dizzy or sleepy,
especially during the first few weeks of
treatment. If Reminyl affects you, do not
drive or use any tools or machinery.
Reminyl tablets contain lactose
If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicine.
Reminyl 12 mg (orange –brown) tablets
contain orange-yellow S aluminium lake
The colouring in these tablets may cause
allergic reaction.

3. How to take Reminyl
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
How much to take
You will start treatment with Reminyl at a
low dose. The usual starting dose is 4mg,
taken twice a day (a total of 8 mg 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 12 mg, taken twice a day
(a total of 24mg a day).
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 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.

Drink plenty of liquids while you are taking
Reminyl, to keep yourself hydrated.
If you take more Reminyl than you
should
If you take too much Reminyl, contact a
doctor or hospital straight away. Take any
remaining tablets 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
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 have a liver or kidney problem,
your doctor may give you a reduced dose
of Reminyl, or may decide this medicine is
not suitable for you.

If you stop taking Reminyl
Check with your doctor before you stop
taking Reminyl. It is important to continue
taking this medicine to treat your condition.

How to take
Take your dose of Reminyl twice a day, in
the morning and evening, with water or
other liquids. Try to take Reminyl with food.

If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Look out for serious side effects
Stop taking Reminyl and see a doctor
immediately if you notice any of the
following:
•• 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 (may
affect up to 1 in 10 people).
•• Fits (seizures). These are uncommon in
people taking Reminyl (may affect up to
1 in 100 people).
Other Side effects:
Very Common side effects (may affects
up to 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 up 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 ear that does not go
away (tinnitus)
•• low blood pressure
•• Flushing
•• Feeling the need to vomit (retch)
•• Excessive sweating
•• Weak muscle
•• Increased level of liver enzymes

1516v4
Reminyl PIL Ireland UK MultiS 56ct 14021407262662 J&J
1172
441555A12
14-0011
7
160 x 800mm
01-12-14

Black

Technical Info

1st AW Person Approval:
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Regulatory Responsible Person Approval:

Profile

GB - 996065

4. Possible side effects
(continued)
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

Signature:
Marketing Responsible Person Approval:
Signature:

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

GFW-045 00

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.

This medicine does not require any special
storage conditions.

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Smallest point sized used:
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Average Text Size (Body Text):
9.0 pt

6. Contents of the pack and other information
What Reminyl contains:
•• The active substance is galantamine.
Each tablet contains 4mg, 8mg
or 12 mg of galantamine (as
hydrobromide).
•• The other ingredients are:
Colloidal anhydrous silica, crospovidone,
lactose monohydrate, magnesium
stearate and microcrystalline cellulose,
hypromellose, propylene glycol, talc and
titanium dioxide (E171).
The 4mg tablet also contain yellow ferric
oxide (E172),
The 8mg tablets also contains red ferric
oxide (E172),
The12 mg tablets also contain red
ferric oxide (E172) and orange-yellow S
aluminium lake (E110).
What Reminyl looks like and contents of
the pack
Reminyl 4 mg tablets are off-white, round
tablets and marked ‘G4’ on one side and
‘JANSSEN’ on the other side. Each pack
contains blisters of 14 or 56 tablets.
Reminyl 8 mg tablets are pink, round
tablets marked ‘G8’ on one side and
‘JANSSEN’ on the other side. Each pack
contains blisters of 14, 56, or 112 tablets.
Reminyl 12 mg tablets are orange-brown,
round and marked ‘G12’ on one side and
‘JANSSEN’ on the other side. Each pack
contains blisters of 56, 112 or 168 tablets.
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, 04010
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 
Reminyl 4 mg, 8 mg, 12 mg
- Filmtabletten
Belgium 
Reminyl 4 mg, 8 mg, 12 mg
omhulde tabletten
Denmark 
Reminyl 4 mg, 8 mg, 12 mg
filmovertrukne tabletter
Finland 
Reminyl 4 mg, 8 mg, 12 mg
kalvopäällysteiset tabletit
France 
Reminyl 4 mg, 8 mg, 12 mg
comprimé pelliculé
Greece 
Reminyl 4mg, 8 mg, 12 mg
επικαλυμμένα με λεπτό
υμένιο δισκία

Iceland 
Reminyl 4 mg, 8 mg, 12 mg
filmúhuðaðar töflur
Ireland 
Reminyl 4 mg, 8 mg, 12 mg
tablets
Italy Reminyl 4 mg, 8 mg, 12 mg
compresse rivestite con film
Luxembourg 
Reminyl 4 mg, 8 mg, 12 mg
comprimé pelliculé
Netherlands 
Reminyl 4 mg, 8 mg, 12 mg,
filmomhulde tabletten
Norway 
Reminyl 4 mg, 8 mg, 12 mg
filmdrasjerte tabletter
Portugal 
Reminyl 4 mg, 8 mg 12 mg
comprimidos revestidos
Sweden 
Reminyl 4 mg, 8 mg, 12 mg
filmdragerade tabletter
UK 
Reminyl 4 mg, 8 mg, 12 mg
tablets
This leaflet was last revised in November
2014.
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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