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REMINYL 4MG/ML ORAL SOLUTION

Active substance(s): GALANTAMINE / GALANTAMINE HYDROBROMIDE

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1510VTBC
Reminyl PIL Ireland UK 4mg 100ml 14071611182867
N/A
466954A07
14-0046
4
145x780mm

Package leaflet: Information for the user

25-06-15

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Technical Info

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galantamine

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GB - XXXXX

4mg/ml oral solution

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Read all of this leaflet carefully
before you start taking this medicine
because it contains important
information for you

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• Keep this leaflet. You may need to
read it again.

What is in this leaflet:
1. What Reminyl is and what it is used for
2. What you need to know before you take
Reminyl
3. How to take Reminyl

• If you have any further questions, ask
your doctor or pharmacist.

4. Possible side effects

• 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.

6. Contents of the pack and other
information

5. How to store Reminyl

• 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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Smallest point sized used:

1. What Reminyl is and what it is used for

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Average Text Size (Body Text):

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.

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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.
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.

FPO

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

Warnings 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

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 intestine
• 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, have recently taken or might take
any other medicines.

• 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 some 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 oral solution contains methyl
and propyl parahydroxybenzoates
These can sometimes cause allergic
reactions, which may possibly be delayed.

3. How to take Reminyl oral solution
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 (1ml of solution), taken twice a
day (a total of 8mg 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 12mg (3ml of solution), taken
twice a day (a total of 24 mg 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.

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 stop taking Reminyl

Check with your doctor before you
stop taking Reminyl. 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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If you have liver or kidney problems,
your doctor may give you a reduced dose
of Reminyl, or may decide this medicine
is not suitable for you.

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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.

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Drink plenty of liquids while you are
taking Reminyl, to keep yourself hydrated.
The solution comes with a pipette which
you should use to take the exact amount
needed from the bottle.

Directions for opening the bottle and
using the pipette
Fig. 1: The bottle comes with a
child-resistant cap, and should be
opened as follows:
- Push the plastic screw cap
down while turning it counter
clockwise.
- Remove the unscrewed cap.
Fig. 2: Insert the pipette into the bottle.
While holding the bottom ring,
pull the top ring up to the mark
corresponding to the number of
millilitres you want to give.
Fig. 3: Holding the bottom ring, remove
the entire pipette from the bottle.
Empty the pipette into any nonalcoholic drink by sliding the upper
ring down and drink it immediately.
Close the bottle.
Rinse the pipette with some water.

If you take more Reminyl than you
should

If you take too much Reminyl, contact a
doctor or hospital straight away. Take any
remaining solution 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.

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Reminyl can cause serious skin reactions,
heart problems and 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

Reminyl should not be used with
medicines that work in a similar way
these include:
• donepezil or rivastigmine
(for Alzheimer’s disease)

1510VTBC
Reminyl PIL Ireland UK 4mg 100ml 14071611182867
N/A
466954A07
14-0046
4
GB - XXXX

145x780mm
25-06-15

4. Possible side effects
Technical Info

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GFW-045 00

Fonts used:
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

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
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 (StevensJohnson 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).
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).
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
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 medicine 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 lever enzymes
Rare side effects (may affect up to 1 in
1,000 people
• Inflammation 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
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 label after
EXP. The expiry date refers to the last
day of that month.
Do not freeze.

Reminyl oral solution should not be used
for longer than 3 months after the bottle
has first been opened.
Do not throw away any medicine via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

6. Contents of the pack and other information
What Reminyl contains:
• The active substance is galantamine
1 ml of Reminyl oral solution contains
4 mg galantamine (as hydrobromide).
• The other ingredients are:
Methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216),
purified water, sodium saccharin and
sodium hydroxide.

What Reminyl looks like and
contents of the pack
Reminyl is a clear colourless oral solution
that comes in a 100ml bottle. The solution
comes with a pipette which you should
use to take the exact amount needed
from the bottle.
Marketing Authorisation Holder
Shire Pharmaceuticals Limited,
Hampshire International Business Park,
Chineham, Basingstoke, Hampshire,
RG24 8EP, UK.
Manufacturer
Janssen Pharmaceutica NV,
Turnhoutseweg 30, B2340 Beerse,
Belgium 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/ml Lösung
zum Einnehmen
Belgium
Reminyl 4 mg/ml, orale
oplossing
Denmark
Reminyl 4 mg/ml oral
opløsning
Finland
Reminyl 4 mg/ml oraaliliuos
France
Reminyl 4 mg/ml, solution
buvable
Germany
Reminyl 4mg/ml Lösung
zum Einnehmen
Greece
Reminyl 4mg/ml πόσιμο
διάλυμα
Iceland
Reminyl 4 mg/ml mixtúra,
lausn
Ireland
Reminyl 4 mg/ml oral
solution
Italy Reminyl 4 mg/ml soluzione
orale
Luxembourg Reminyl 4 mg/ml, soluté
buvable

Netherlands Reminyl 4 mg/ml, drank
Norway
Reminyl 4 mg/ml mikstur,
oppløsning
Portugal
Reminyl 4 mg/ml solução
oral
Spain
Reminyl 4mg/ml solución
oral
Sweden
Reminyl 4 mg/ml oral
lösning
UK
Reminyl 4 mg/ml oral
solution
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 0843 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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