REMINYL XL 16 MG PROLONGED RELEASE CAPSULES

Active substance: GALANTAMINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

TBC

galantamine

FPO

8mg prolonged-release capsules
16mg prolonged-release capsules
24mg prolonged-release capsules

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 XL
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.

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

1 What reminyl xl is and what it is used for
Reminyl XL 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 XL
increases the amount of acetylcholine in the brain
and so could improve the symptoms of the disease.
The capsules are made in a ‘prolonged-release’
form. This means that they release the medicine
more slowly.

2 Before you take REMINYL XL



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

Take special care with Reminyl XL

FPO

Reminyl XL 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
XL 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 XL.
Your doctor will then decide whether treatment with
Reminyl XL 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 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 muscular weakness)
• pilocarpine (for dry mouth or dry eyes) if taken
by mouth.
Some medicines can affect the way Reminyl XL
works, or Reminyl XL 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 XL if you are also taking any of the
medicines listed above.
Some medicines can increase the number of side
effects caused by Reminyl XL, 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 XL.
If you have any questions, speak to your doctor or
pharmacist for advice.

Taking Reminyl XL with food and drink

Reminyl XL should be taken with food if possible.
Drink plenty of liquids during your treatment with
Reminyl XL, 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 XL, 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 XL.

Driving and using machines

Reminyl XL 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 XL

This product 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
Always take Reminyl XL exactly as your doctor has
told you. You should check with your doctor if you
have any questions.
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,
read the instructions at the end of this section
carefully.

How to take Reminyl XL capsules

FPO

Reminyl XL capsules should be swallowed whole,
NOT chewed or crushed. Reminyl XL should be
taken in the morning, with water or other liquids,
and preferably with food.
Reminyl XL prolonged-release capsules are
available in 3 strengths: 8 mg, 16 mg and 24 mg.
Reminyl XL is started at a low dose. Your doctor
may then tell you to slowly increase the dose
(strength) of Reminyl XL that you take to find the
most suitable dose for you.
1. The treatment is started with the 8 mg capsule
taken once daily. After 4 weeks of treatment,
the dose is increased.
2. You would then take the 16 mg capsule once
daily. After another 4 weeks of treatment at the
earliest, your doctor may decide to increase the
dose again.
3. You would then take the 24 mg capsule once
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 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 for you and to discuss
how you are feeling. Your doctor will also check your
weight regularly while you are taking Reminyl XL.

Liver or kidney disease





If you have mild liver or kidney disease,
treatment is started with the 8 mg capsule once
daily in the morning.
If you have moderate liver or kidney disease,
treatment is started with the 8 mg capsule
once every other day in the morning. After one
week, begin taking the 8 mg capsule once daily
in the morning. Do not take more than 16 mg
once daily.
If you have severe liver and/or kidney disease,
do not take Reminyl XL.

If you take more Reminyl XL than
you should

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

FPO

Do not take Reminyl XL

TBC

3 How to take REMINYL XL (continued)
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, you
should contact your doctor.

If you stop taking Reminyl XL

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

How do I switch from taking Reminyl
tablets or oral solution to Reminyl XL
prolonged-release capsules?

If you are currently taking Reminyl tablets or oral
solution, your doctor may decide to switch you to
Reminyl XL prolonged-release capsules.
• 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 capsules.
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.

Children

Reminyl XL is not recommended for children.

4 Possible side effects
Like all medicines, Reminyl XL 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 XL 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 XL
Keep out of the reach and sight of children.
Do not use Reminyl XL 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.

Do not store above 30°C

6 Further information
What Reminyl XL contains:

The active substance is galantamine.
• Reminyl XL 8 mg prolonged-release capsules
contain 8 mg galantamine (as hydrobromide)
• Reminyl XL 16 mg prolonged-release capsules
contain 16 mg galantamine (as hydrobromide)
• Reminyl XL 24 mg prolonged-release capsules
contain 24 mg galantamine (as hydrobromide)
The other ingredients are:
Granules: Diethyl phthalate, ethylcellulose,
hypromellose, macrogol 400, maize starch and
sucrose.
Capsule shell: gelatin and titanium dioxide (E171).
There is also iron oxide red (E172) in the 16 mg and
24 mg capsules, and iron oxide yellow (E172) in the
24 mg capsule.
Printing ink: iron oxide black (E172), shellac, and
propylene glycol (E1520).

What Reminyl XL looks like and contents
of the pack

Reminyl XL prolonged-release capsules, hard are
available in three strengths, each of which can be
recognised by its colour and lettering:
8 mg: white capsules marked ‘G8’
16 mg: pink capsules marked ‘G16’
24 mg: caramel capsules marked ‘G24’

The capsules come in blister packs of 28 capsules.
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 8 mg, 16 mg, 24 mg
Retardkapseln
Belgium
Reminyl 8 mg, 16 mg, 24 mg harde
capsules met verlengde afgifte
Denmark
Reminyl 8 mg, 16 mg, 24 mg
depotkapsler, hårde
Finland
Reminyl 8 mg, 16 mg, 24 mg
depotkapseli, kova
France
Reminyl LP 8 mg, 16 mg, 24 mg,
gélule à libération prolongée
Germany
REMINYL 1x täglich 8 mg, 16 mg,
24 mg Hartkapseln, retardiert
Greece
Reminyl 8mg, 16 mg, 24 mg καψάκια
παρατεταμένης αποδέσμευσης, σκληρά

Iceland

Reminyl 8 mg, 16 mg, 24 mg
forðahylki, hörð
Ireland
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 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.
1515 (13061310152265)

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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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