Skip to Content

REMINYL XL 24 MG CAPSULES

Active substance(s): GALANTAMINE HYDROBROMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

REMINYL® XL 24MG CAPSULES
(Galantamine hydrobromide)
This product is available as the above but will be referred to as Reminyl®
• problems passing urine
XL throughout the remainder of this leaflet.
Your doctor will decide if Reminyl® XL is suitable for you, or if the dose
needs to be changed
Read all of this leaflet carefully before you start taking this medicine
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.

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.

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

What is in this leaflet:

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

1. What Reminyl® XL is and what it is used for
2. What you need to know before you take Reminyl® XL

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

®

3. How to take Reminyl XL

6. Contents of the pack and other information

• 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)

1. WHAT REMINYL® XL IS AND WHAT IT IS USED FOR

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

4. Possible side effects
5. How to store Reminyl® XL








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.

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

• 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

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.

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.

You should not breastfeed while you are taking Reminyl® XL.
Driving and using machines

Serious side effects

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 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.

Reminyl® XL contains Sucrose

Before you take Reimyl® XL, your doctor needs to know if you have, or
have had, any of the following:

If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

• 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)

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.
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.

1

How much to take

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).

®

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.

Fits (seizures). These are uncommon in people taking Reminyl® XL (may
affect up to 1 in 100 people).
You must stop taking Reminyl® XL and get help immediately if you
notice any of the side effects above.

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

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.

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:

Drink plenty of liquids while you are taking Reminyl® XL, to keep yourself
hydrated.

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

If you take more Reminyl® XL than you should

Uncommon side effects (may affect more than to 1 in 100 people)

• Take your last dose of Reminyl® tablets or oral solution in the evening.
• The next morning, take your first dose of Reminyl® XL prolongedrelease 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.















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.

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)

If you stop taking Reminyl® XL

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Reminyl® XL contains:
• The active substance is galantamine. Each prolonged release capsule
contains 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, iron oxide yellow (E172), iron oxide red (E172),
propylene glycol (E1520).
What Reminyl® XL looks like and contents of the pack
Reminy®l XL 24 mg capsules are caramel and marked ‘G24’. Each pack
contains blisters of 28 capsules.
Manufacturer and Product Licence Holder:
Janssen-Cilag SpA, Via C. Janssen, 04010 Borgo San Michele, Latina,
Italy. Procured from within the EU by Product Licence Holder:
Beachcourse Ltd., 20 Alliance Court, W3 0RB London.
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, email: 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® XL 24mg Capsules
PL16378/0566
Revision Date: 29.03.2016

POM
Ref: REXL24

Reminyl® is a registered trademark of Janssen-Cilag Ltd.

®

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

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 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 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.

5. HOW TO STORE REMINYL® XL

Look out for serious side effects

Keep this medicine out of the sight and reach of children.

Stop taking Reminyl and see a doctor or go to your nearest
emergency department immediately if you notice any of the following.

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.

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).

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.

2

3

Expand view ⇕

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.

Hide