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REMINYL XL 8 MG PROLONGED RELEASE CAPSULES

Active substance(s): GALANTAMINE / GALANTAMINE / GALANTAMINE

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Package leaflet: Information for the user

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02-03-17

8mg prolonged-release capsules, hard
16mg prolonged-release capsules, hard

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Technical Info

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galantamine

24mg prolonged-release capsules, hard

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.

What is in this leaflet:
1. What Reminyl XL is and what it is
used for
2. What you need to know before you take
Reminyl XL
3. How to take Reminyl XL
4. Possible side effects
5. How to store Reminyl XL
6. Contents of the pack and other
information

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

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. These effects are thought to be

The capsules are made in a ‘prolonged-release’
form. This means that they release the medicine
slowly.

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Average Text Size (Body Text):
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2. What you need to know before you take Reminyl XL
Do not take Reminyl XL



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 XL. 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 XL 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 XL, 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 XL is suitable for
you, or if the dose needs to be changed

Reminyl XL should not be used with medicines
that work in a similar way. These include:




Some medicines can make side effects more likely
in people taking Reminyl XL. These include:











Also tell your doctor if you recently had an
operation on the stomach, intestines or bladder.
Your doctor may decide that Reminyl XL is not
suitable for you.
Reminyl XL can cause weight loss. Your doctor
will check your weight regularly while you are
taking Reminyl XL.
Children and adolescents
Reminyl XL is not recommended for children and
adolescents.

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)

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 XL if you are also taking some of these
medicines.
Reminyl XL 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 XL.
Driving and using machines
Reminyl XL may make you feel dizzy or
sleepy, especially during the first few weeks
of treatment. If Reminyl XL affects you,
do not drive or use any tools or machinery.
Reminyl XL 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.

Other medicines and Reminyl XL
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

3. How to take Reminyl XL capsules
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

release capsules. If this applies to you:

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,
carefully read the instructions under ‘Switching
from taking Reminyl tablets or oral solution to
Reminyl capsule in this section.
How much to take
You will start treatment with Reminyl XL at a low
dose. The usual starting dose is 8 mg, taken once
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 24 mg, taken once 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 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 and to
discuss how you are feeling.
If you have a liver or kidney problem,
your doctor may give you a reduced dose of
Reminyl XL, or may decide this medicine is
not suitable for you.
Switching from taking Reminyl tablets or
oral solution to Reminyl XL capsules
If you are currently taking Reminyl tablets
or oral solution, your doctor may decide you
should switch to Reminyl XL prolonged-



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 capsule.

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.
How to take
Reminyl XL capsules must be swallowed whole
and NOT chewed or crushed. Take your dose of
Reminyl XL once a day in the morning, with water
or other liquids. Try to take Reminyl XL with food.
Drink plenty of liquids while you are taking
Reminyl XL, to keep yourself hydrated.
If you take more Reminyl XL than you should
If you take too much Reminyl XL, contact a doctor
or hospital straight away. Take any remaining
capsules 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 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, contact
your doctor.

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

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

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Technical Info

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4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.

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Look out for serious side effects.

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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 (Stevens-Johnson 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).

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Average Text Size (Body Text):
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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 XL (may affect up to1 in
10 people).
Fits (seizures). These are uncommon in
people taking Reminyl XL (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 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.
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 more than
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 in the blood
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

5. How to Store Reminyl XL
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 carton and blister foil after
EXP. The expiry date refers to the last day of that
month.

Do not store above 30°C.
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.

6. Contents of the pack and other information
What Reminyl XL contains:




The active substance is galantamine.
Each prolonged release capsule contains
8mg, 16mg or 24 mg of galantamine (as
hydrobromide)
The other ingredients are:
Diethyl phthalate, ethylcellulose, hypromellose,
macrogol 400, maize starch and sucrose,
gelatine, titanium dioxide (E171), iron oxide
black (E172), shellac, propylene glycol (E1520)
The 16 and 24 mg capsules also contain iron
oxide red (E172)
The 24 mg capsule also contain iron oxide
yellow (E172)

What Reminyl XL looks like and contents of
the pack
Reminyl XL 8 mg capsules are white
and marked ‘G8’. Each pack contains blisters of
7 or 28 capsules or bottles of 300 capsules.
Reminyl XL 16 mg capsules are pink and marked
‘G16’. Each pack contains blisters of 7, 28, 56 or
84 capsules.
Reminyl XL 24 mg capsules are caramel and
marked ‘G24’. Each pack contains blisters of 7,
28, 56 or 84 capsules or bottles of 300 capsules.
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, 04100 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
Germany
Greece

Reminyl 8 mg, 16 mg, 24 mg
Retardkapseln
Reminyl 8 mg, 16 mg, 24 mg harde
capsules met verlengde afgifte
Reminyl 8 mg, 16 mg, 24 mg
depotkapsler, hårde
Reminyl 8 mg, 16 mg, 24 mg
depotkapseli, kova
Reminyl LP 8 mg, 16 mg, 24 mg,
gélule à libération prolongée
REMINYL 1x täglich 8 mg, 16 mg,
24 mg Hartkapseln, retardiert
Reminyl 8mg, 16 mg, 24 mg
καψάκια παρατεταμένης
αποδέσμευσης, σκληρά

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
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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