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REMINYL 8MG TABLETS

Active substance(s): GALANTAMINE HYDROBROMIDE

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Transcript
UK PIL = June 2015

By shafia at

Package leaflet: Information for the user

Reminyl® 8mg Tablets
(galantamine hydrobromide)
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.

The name of your medicine is Reminyl
8mg Tablets but will be referred to as
Reminyl throughout this leaflet. Please
note that this leaflet also contains
information about other strengths such as
Reminyl 4mg and 12mg Tablets.
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
4. Possible side effects
5. How to store Reminyl
6. Contents of the pack and other
information

1. What Reminyl is and what it is used for
Reminyl contains the active substance
‘galantamine hydrobromide’, 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.
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
Reminyl 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 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 breast-feed 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 12mg (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 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, 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.

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

weak muscles, slow heart beat, fits
(seizures) and loss of consciousness.
If you forget to take Reminyl

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.
Drink plenty of liquids while you are
taking Reminyl, to keep yourself
hydrated.

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 take more Reminyl than you
should

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

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,

If you stop taking Reminyl

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.

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

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 pus-filled
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).

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 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

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 affect
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.

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, 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 at:
www.mhra.gov.uk/yellowcard
By reporting side effects you help provide
more information on the safety of this
medicine.

5. How to store Reminyl
There are no special storage conditions for
Reminyl.
Keep out of the sight and reach of
children.
Do not take your tablets after the expiry
date which is stated on the carton and
blister label after ‘Exp’. The expiry date
refers to the last day of that month.

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
to protect the environment.
If your tablets become discoloured or show
any signs of deterioration, you should seek
the advice of your pharmacist

6. Contents of the pack and other information
What Reminyl contains:
Reminyl contain 8mg galantamine (as
hydrobromide) as the active ingredient.
The tablets also contain the inactive
ingredients:
colloidal anhydrous silica, crospovidone,
lactose monohydrate, magnesium
stearate, microcrystalline cellulose,
hypromellose, propylene glycol, talc,
titanium dioxide (E171) and red ferric oxide
(E172).
What Reminyl looks like and contents
of the pack
Reminyl film-coated tablets are available in
three strengths, each of which can be
recognized by its colour and lettering:
The tablets are pink in colour and biconvex
with the inscription ‘JANSSEN’ on one side
and ‘G8’ on the other side. The tablets
come in blister packs of 56 tablets.

Manufactured by: Janssen-Cilag SpA, Via
C Janssen, 04010 Borgo San Michelle,
Latina, Italy.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK.
Reminyl® 8mg Tablets;
POM
PL 18799/0271
Leaflet date: 29.02.2016
Reminyl is a registered trademark of Shire
Pharmaceutical Development Ltd.

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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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