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REMINYL XL 24MG CAPSULES

Active substance(s): GALANTAMINE HYDROBROMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

REMINYL® XL 24MG CAPSULES
(galantamine hydrobromide)

This medicine is available using the name Reminyl XL 24mg
Capsules but will be referred to as Reminyl XL throughout this
leaflet.
Other strengths 8mg and 16mg are also available.

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.
2.
3.
4.
5.
6.

What Reminyl XL is and what it is used for
What you need to know before you take Reminyl XL
How to take Reminyl XL
Possible side effects
How to store Reminyl XL
Contents of the pack and other information

1. What Reminyl XL is and what it is used for
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.
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.
The capsules are made in a ‘prolonged-release’ form. This
means that they release the medicine slowly.

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

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.

Other medicines and Reminyl XL

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
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
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 XL.
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, betablockers, 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 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-release capsules. If this applies to you:

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

Your doctor may give you a lower dose of Reminyl XL if you
are also taking some of these medicines.

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.

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

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.

3. How to take Reminyl XL
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
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.
Page 1 of 2

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.
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.

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 (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).
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.

What Reminyl XL looks like and contents of the
pack

Reminyl XL are caramel, opaque, hard capsules, printed in
black with ‘G 24’, containing white to off-white pellets.
The capsules are available in calendar blister packs of
28 capsules.

Manufacturer

Manufacturer: Janssen-Cilag Spa, Latina, Italy.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0485

POM

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 Limited.
Leaflet revision and issue date (Ref): 21.04.16

Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

5. How to store Reminyl XL
Do not store above 30°C.
Keep out of the sight and reach of children.
Do not use after the expiry date on the carton and blister
labels. The expiry date refers to the last day of that month.
Always return any leftover medicines to your pharmacist.
If your capsules appear to be discoloured or show any other
signs of deterioration, take them to your pharmacist who will
advise you.
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.

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

Each prolonged-release capsule contains 24mg of the active
ingredient galantamine (as hydrobromide).
The other inactive ingredients are: diethyl phthalate,
ethylcellulose, hypromellose, macrogol, maize starch,
sucrose, gelatin, titanium dioxide (E171), red ferric oxide
(E172), yellow ferric oxide (E172) and printing ink.

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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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