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REMINYL XL 16MG PROLONGED RELEASE CAPSULES

Active substance(s): GALANTAMINE HYDROBROMIDE

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Ref: 1439/240216/1/F

®

Reminyl XL 16mg prolonged-release capsules
(galantamine)
Patient Information Leaflet
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.
Your medicine is called Reminyl XL 16mg Prolonged-release capsules but
will be referred to as Reminyl XL throughout this Patient Information Leaflet.
Please note that this leaflet also contains information about other strengths
of this medicine Reminyl XL 8mg Prolonged-release capsules and
Reminyl XL 24mg Prolonged-release capsules
What is in this leaflet
1 What Reminyl XL is and what it is used for

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, 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).

2 What you need to know before you take Reminyl XL
3 How to take Reminyl XL

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

4 Possible side effects
5 How to store Reminyl XL

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.

6 Contents of the pack and other information

If you have any questions, talk to your doctor or pharmacist for advice.
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.

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.

Alzheimer’s disease causes increasing memory loss, confusion and
behavioural changes which make it increasingly
difficult to carry out normal daily activities.

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.

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.

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.

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

2

What you need to know before you take Reminyl XL

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.

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

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.

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.

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.

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.

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.

Before you take Reimyl 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

Your doctor will need to see you regularly, to check that this medicine is
working and to discuss how you are feeling.

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.

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.

Reminyl XL can cause weight loss.
Your doctor will check your weight regularly while you are taking Reminyl XL.

How to take
Reminl 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.

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.

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 prolongedrelease 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.

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.

Ref: 1439/240216/1/B

®

Reminyl XL 16mg prolonged-release capsules
(galantamine)
Patient Information Leaflet (continued)
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.
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 pusfilled 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).

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

How to store Reminyl XL

5

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 30°C.
Do not take this medicine after the expiry date shown on the blister and
carton label. If your doctor tells you to stop using this medicine, take any
remaining medicine back to the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration,
ask your pharmacist who will advise you what to do.
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 capsule contains 16mg galantamine (as hydrobromide).
The other ingredients are:
Granules: diethyl phthalate, ethylcellulose, hypromellose, macrogol 400,
maize starch, sucrose and netural pellets.
Capsule shell: gelatin, titanium dioxide E171 and red iron oxide E172.
Printing Ink: iron oxide black E172, shellac and propylene glycol E1520.
What Reminyl XL looks like and contents of the pack
Reminyl XL is pink, opaque, hard capsules marked with G16 in black ink,
containing white to off-white pellets.
Reminyl XL comes in blister packs containing 28 tablets
Manufacturer and Licence Holder
This medicine is manufactured by Janssen-Cilag SpA, Via C. Janssen,
04010 Borgo S. Michele, Latina, Italy and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1439

Reminyl XL 16mg Prolonged-release capsules

You must stop taking Reminyl and get help immediately if you notice
any of the side effects above.

Reminyl XL is a registered trademark of Shire Pharmaceutical Development
Limited.

Other Side effects:

Revision date: 24/02/16

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.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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)

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.

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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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