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REMINYL XL 8MG CAPSULES

Active substance(s): GALANTAMINE HYDROBROMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

REMINYL® XL 8mg CAPSULES
(galantamine hydrobromide)
This product is available as the above name but will be referred to as Reminyl
XL throughout the remainder of this leaflet. Please note Reminyl XL Capsules
are also available in other strengths (Reminyl XL 16mg and 24mg Capsules).
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
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.

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, 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.

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 XL increases the amount of acetylcholine in the brain and treats
the signs of the disease.

Pregnancy and breast-feeding

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

Driving and using machines

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.

2. What you need to know before you take Reminyl XL

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.

Do not take Reminyl XL

Reminyl XL contains Sucrose




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 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

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.

Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.

Serious side effects

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.

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.

How much to take

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
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.

You will start treatment with Reminyl XL at a low dose. The usual starting
dose is 8mg, 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 a 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-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.

Children and adolescents
Reminyl XL is not recommended for children and adolescents.

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.




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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side
effects
directly
via
the
Yellow
Card
Scheme
at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety
of this medicine.

If you stop taking Reminyl XL
5. How to store 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

• Keep out of the sight and reach of children.
• Do not use after the expiry date printed on the carton label or blister strip.

The expiry date refers to the last day of that month.
• Do not store above 30°C.
• If the capsules have become discoloured or shows any other signs of

deterioration, you should ask your doctor or pharmacist for advice.
• Do not throw away any medicines via wastewater or household waste. Ask

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

your pharmacist how to throw away medicines you no longer use. These
measures will help to protect the environment.

Look out for serious side effects

6. Contents of the pack and other information

Stop taking Reminyl XL 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).

The name of this medicine is Reminyl XL.
Reminyl XL 8mg Capsules: Each prolonged release capsule contains 8mg of
galantamine (as hydrobromide). The capsules are white opaque, marked “G8”
and contain white to off white pellets.

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.

Reminyl XL Capsules also contain the inactive ingredients;
Diethyl phthalate, ethylcellulose, hypromellose, macrogol, sucrose, maize
starch, titanium dioxide (E171), black printing ink and gelatin.
The printing ink contains: benzoic acid (E210), black ferric oxide (E172),
dimethyl siloxanes, glycerides, lecithin (soya) (E322), methylcellulose,
polyethylene glycol (macrogol), polyethylene glycol stearate (macrogol
stearate), shellac, sorbic acid and xanthum gum.
Reminyl XL Capsules are available in blister packs of 28 capsules.
PL: 15814/0809 Reminyl® XL 8mg Capsules

POM

This product is manufactured by Janssen-Cilag SpA, Via C Janssen, Borgo
San Michelle, 04010 Latina, Italy and procured from within the EU and
repackaged by the Product Licence holder O.P.D. Laboratories Ltd., Watford,
Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 07.12.2016.
Reminyl is a registered trademark of Shire Pharmaceutical Development Ltd.



More Information

Common side effects (may affect more than 1 in 10 people):

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.
















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 1 in 100 people)



Allergic reaction
Not enough water in the body (dehydration)

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.
To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.

+ Expand Transcript

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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