REMINYL 4MG TABLETS

Active substance: GALANTAMINE HYDROBROMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

4 mg tablets
8 mg tablets
12 mg tablets

Read all of this leaflet carefully
before you start taking this
medicine.
• Keep this leaflet. You may need to read it
again.
• If you are a carer and will be giving
Reminyl to the person you look after, it is
also important that you read this leaflet on
their behalf.
• 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 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.

FPO

galantamine

GB - TBC

In this leaflet:
1 What Reminyl is and what it is used for
2 Before you take Reminyl
3 How to take Reminyl
4 Possible side effects
5 How to store Reminyl
6 Further information

1 What REMINYL is and what it is used for
Reminyl is an antidementia medicine used
to treat the symptoms of mild to moderately
severe dementia of the Alzheimer type, a
disease that alters brain function.
The symptoms of Alzheimer’s disease include
increasing memory loss, confusion and
behavioural changes. As a result, it becomes
more and more difficult to carry out normal
daily activities.

These symptoms are believed to be due
to a lack of acetylcholine, a substance
responsible for sending messages between
brain cells. Reminyl increases the amount
of acetylcholine in the brain and so could
improve the symptoms of the disease.

2 Before you take REMINYL




If you are allergic (hypersensitive) to
galantamine or to any of the other
ingredients listed in section 6 of this
leaflet
If you have severe liver and/or severe
kidney disease

FPO

Take special care with Reminyl
Reminyl should be used in Alzheimer’s
disease and not other forms of memory loss
or confusion.
Medicines are not always suitable for
everyone. Your doctor needs to know before
you take Reminyl if you suffer from or have
suffered in the past from any of the following
conditions:
• liver or kidney problems
• a heart disorder (e.g. angina, heart
attack, heart failure, slow or irregular
pulse)
• electrolyte disturbances (e.g. decreased/
increased blood potassium levels)
• peptic (stomach) ulcer disease
• acute abdominal pain
• a disorder of the nervous system (like
epilepsy or Parkinson’s disease)
• a respiratory disease or infection that
interferes with breathing (like asthma,
obstructive pulmonary disease or
pneumonia)
• if you recently had an operation on the
gut or bladder
• if you have difficulties passing urine
If you need an operation which requires a
general anaesthetic, you should inform the
doctor that you are taking Reminyl.
Your doctor will then decide whether
treatment with Reminyl is suitable for you or if
the dose needs to be changed.

Taking other medicines
You should always tell the doctor, nurse or
pharmacist if you are taking or have recently
taken any other medicines, including those
obtained without a prescription.
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 muscular
weakness)
• pilocarpine (for dry mouth or dry eyes) if
taken by mouth.
Some medicines can affect the way Reminyl
works, or Reminyl itself can reduce the
effectiveness of other medicines taken at the
same time. These include:
• paroxetine or fluoxetine (antidepressants)






quinidine (used for heart rhythm
problems)
ketoconazole (antifungal)
erythromycin (antibiotic)
ritonavir (antiviral - HIV protease
inhibitor).

Your doctor may prescribe a smaller dose
of Reminyl if you are also taking any of the
medicines listed above.
Some medicines can increase the number
of side effects caused by Reminyl, these
include:
• non-steroidal anti-inflammatory
painkillers (e.g. ibuprofen) which can
increase the risk of ulcers
• medicines taken for heart disorders
or high blood pressure (e.g. digoxin,
amiodarone, atropine, beta-blockers,
or calcium channel blocking agents).
If you take medicines for an irregular
heart-beat, your doctor may consider an
electrocardiogram (ECG).
If you need an operation which requires a
general anaesthetic, you should inform the
doctor that you are taking Reminyl.
If you have any questions, speak to your
doctor or pharmacist for advice.

Taking Reminyl with food and drink
Reminyl should be taken with food if
possible.
Drink plenty of liquids during your treatment
with Reminyl, to keep yourself hydrated. See
Section 3 of this leaflet for full details about
how to take this medicine.

Pregnancy and breast-feeding
Before taking Reminyl, speak to your doctor
for advice if you are pregnant, think you
could be pregnant, or you are planning a
pregnancy.
You should not breastfeed while you are
taking Reminyl.
Driving and using machines
Reminyl may cause dizziness or drowsiness,
especially during the first few weeks of
treatment. If you experience these symptoms,
do not drive or use any tools or machinery.

Important information about some of
the ingredients of Reminyl
The orange-brown (12 mg) tablets contain the
colouring agent orange-yellow S aluminium
lake (E110). In some people this colourant
may cause an allergic reaction.
This product contains lactose. 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
Always take Reminyl exactly as your doctor
has told you. You should check with your
doctor if you have any questions.

How to take Reminyl tablets
Reminyl tablets should be taken twice daily,
in the morning and evening, with water or
other liquids, and preferably with food.
Reminyl film-coated tablets are available
in three strengths: 4 mg, 8 mg and 12 mg.
Reminyl is started at a low dose. Your doctor
may then tell you to slowly increase the dose
(strength) of Reminyl that you take, to find the
most suitable dose for you.

FPO

1. The treatment is started at 4 mg (1 white
tablet) taken twice daily. After 4 weeks of
treatment, the dose is increased.
2. You would then take 8 mg (2 white
tablets or 1 pink tablet) twice daily.
After another 4 weeks of treatment at
the earliest, your doctor may decide to
increase the dose again.
3. You would then take 12 mg (3 white
tablets or 1 pink and 1 white tablet or 1
orange-brown tablet) twice daily.

Your doctor will explain what dose to start
with and when the dose should be increased.
If you feel that 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 for you
and to discuss how you are feeling. Your
doctor will also check your weight regularly
while you are taking Reminyl.

Liver or kidney disease


If you have mild liver disease or mild
to moderate kidney disease, the above
dosing instructions are followed.



If you have moderate liver disease,
treatment is started with the 4 mg tablet
once daily in the morning. After one
week of treatment, begin taking the 4 mg
tablet twice daily for at least 4 weeks.
Do not take more than 8 mg twice daily.



If you have severe liver and/or kidney
disease, do not take Reminyl.

FPO

Do not take Reminyl

GB - TBC

3 How to take REMINYL
(continued)
If you take more Reminyl than
you should

If you forget to take more than one dose, you
should contact your doctor.

If you take too much Reminyl, contact a
doctor or hospital straight away. Take along
any remaining tablets and the packaging
with you. Signs or symptoms of overdose
may include, among others: severe nausea,
vomiting, muscle weakness, slow heart beat,
seizures and loss of consciousness.

If you stop taking Reminyl

If you forget to take Reminyl

Reminyl is not recommended for children.

You should consult your doctor before
you stop taking Reminyl. It is important to
continue taking this medicine to treat your
condition.

Children

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.

4 Possible side effects
Like all medicines, Reminyl can cause side
effects, although not everybody gets them.
Some of these effects may be due to the
disease itself.
Stop taking your medicine and see a
doctor immediately if you experience;
• Heart problems including changes in
heart beat (slow or irregular)
• Palpitations (pounding heart beat)
• Conditions like blackout
• An allergic reaction. The signs may
include a rash, swallowing or breathing
problems, swelling of your lips, face,
throat or tongue
Side effects include:
Very Common: affects more than one user in 10.
• Feeling sick and/or vomiting. If these
undesired effects occur, they are mainly
experienced early on in the treatment or
when the dose is increased. They tend
to disappear gradually as the body gets
used to the treatment and generally
will not last for more than a few days.
If you have these effects, your doctor
may recommend that you drink more
liquids and, if necessary, may prescribe a
medicine to stop you being sick.
Common: affects 1 to 10 users in 100.
• Weight loss
• Loss of appetite
• Decreased appetite
• Slow heart beat
• Feeling faint
• Dizziness
• Trembling
• Headache
• Drowsiness
• Abnormally tired
• Stomach pain or discomfort
• Diarrhoea











Indigestion
Increased sweating
Muscle spasms
Falling
High blood pressure
Feeling weak
General feeling of discomfort
Seeing, feeling, or hearing things that are
not real (hallucinations)
Feeling sad (depression).

Uncommon: affects 1 to 10 users in 1000
• Increased liver enzymes in the blood
(laboratory test result that tells how well
your liver is working)
• Possible skipped heart beat
• Disturbance in the mechanism of
conducting impulses in the heart
• Sensation of abnormal heart beats
(palpitations)
• Tingling, pricking, or numbness of the
skin
• Change in the sense of taste
• Excessive sleepiness
• Fit (Seizures)
• Blurred vision
• Ringing or buzzing in the ears (tinnitus)
• Feeling the need to vomit
• Muscle weakness
• Excessive water loss in the body
• Low Blood Pressure
• Reddening of the face
• Allergic reaction
Rare side effects: affects 1 to 10 users
in 10000.
• Inflammation of the liver (hepatitis).
Tell your doctor or pharmacist if you are
worried or think that Reminyl is causing
you a problem. If you notice any side
effects not listed in this leaflet, please tell
your doctor.

5 How to store Reminyl
Keep out of the reach and sight of children.
Do not use Reminyl after the expiry date
which is stated on the carton and blister foil
after the letters 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.

This medicinal product does not require any
special storage conditions.

6 Further information
The active substance is galantamine.
• Reminyl 4 mg film-coated tablets contain
4 mg galantamine (as hydrobromide)
• Reminyl 8 mg film-coated tablets contain
8 mg galantamine (as hydrobromide)
• Reminyl 12 mg film-coated tablets
contain 12 mg galantamine (as
hydrobromide)
The other ingredients are:
colloidal anhydrous silica, crospovidone,
lactose monohydrate, magnesium stearate
and microcrystalline cellulose.
Film coat: hypromellose, propylene glycol,
talc and titanium dioxide (E171). There is also
yellow ferric oxide (E172) in the 4 mg tablet,
red ferric oxide (E172) in the 8 mg and 12 mg
tablets, and orange-yellow S aluminium lake
(E110) in the 12 mg tablet.

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:
4 mg: off-white, round tablets marked ‘G4’
on one side and ‘JANSSEN’ on the
other side
8 mg: pink, round tablets marked ‘G8’ on
one side and ‘JANSSEN’ on the other
side
12 mg: orange-brown, round tablets marked
‘G12’ on one side and ‘JANSSEN’ on
the other side
The tablets come in blister packs of 56
tablets.
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
Belgium
Denmark
Finland
France

Reminyl 4 mg, 8 mg, 12 mg
- Filmtabletten
Reminyl 4 mg, 8 mg, 12 mg
omhulde tabletten
Reminyl 4 mg, 8 mg, 12 mg
filmovertrukne tabletter
Reminyl 4 mg, 8 mg, 12 mg
kalvopäällysteiset tabletit
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 June 2013.

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.

1516 (13061310152265)

What Reminyl contains:

Expand view ⇕

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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