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ACUMOR XL 16 MG PROLONGED RELEASE CAPSULES

Active substance(s): GALANTAMINE HYDROBROMIDE

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Package leaflet:
Information for the patient

Acumor XL 8 mg
Prolonged Release
Capsules
Acumor XL 16 mg
Prolonged Release
Capsules
Acumor XL 24 mg
Prolonged Release
Capsules
(galantamine)

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 are a carer and will be giving
Acumor XL to the person you look
after, it is also important that you
read this leaflet on their behalf.
• 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 Acumor XL is and what it is used for
2. What you need to know before you take Acumor XL
3. How to take Acumor XL
4. Possible side effects
5. How to store Acumor XL
6. Contents of the pack and other information

This medicine can cause weight loss. Your doctor will check your
weight regularly while you are taking this medicine.

Serious side effects

This medicine can cause serious skin reactions, heart problems,
and fits (seizures). You need to be aware of these side effects whilst
you are taking this medicine. See section 4 for more information.

Children and adolescents

Acumor XL is not recommended for children and adolescents.

Other medicines and Acumor XL

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including those obtained
without a prescription.
Galantamine 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
muscular weakness)
• pilocarpine (for dry mouth or dry eyes) if taken by mouth
Some medicines can affect the way galantamine works, or
galantamine itself can reduce the effectiveness of other medicines
taken at the same time. Your doctor may prescribe a smaller
dose of Acumor XL if you are taking any of those medicines.
These include:
• paroxetine or fluoxetine (antidepressants)
• quinidine (used for heart rhythm problems)
• ketoconazole (antifungal)
• erythromycin (antibiotic)
• ritonavir (antiviral – HIV protease inhibitor)
Some medicines can increase the number of side effects caused by
galantamine, these include:
• non-steroidal anti-inflammatory painkillers (e.g. 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 irregular heartbeat, your doctor may consider an
electrocardiogram (ECG).
If you have any questions, speak to your doctor or pharmacist
for advice.

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

Pregnancy and breast-feeding

Acumor XL contains galantamine, which is an antidementia
medicine used to treat the symptoms of mild to moderately
severe dementia of the Alzheimer type, a disease that alters
brain function.

You should not breast-feed while you are taking Acumor XL.

The symptoms of Alzheimer’s disease include increasing memory
loss, confusion and behavioural changes. As a result, it becomes
more and more difficult to carry out normal daily activities. These
symptoms are believed to be due to a lack of acetylcholine, a
substance responsible for sending messages between brain cells.
Galantamine increases the amount of acetylcholine in the brain
and so could improve the symptoms of the disease.

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.

Driving and using machines

Galantamine may cause dizziness or drowsiness, especially
during the first few weeks of treatment. If you experience these
symptoms, do not drive or use any tools or machinery.

Acumor XL contains allura red (E129)

Allura red (E129, an azo colouring agent) may cause
allergic reactions.

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

3. How to take Acumor XL

2. What you need to know before you take
Acumor 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 Acumor XL:

• If you are allergic to galantamine or any of the other ingredients
of this medicine (listed in section 6).
• If you have severe liver and/or kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking Acumor XL.
This medicine is only used in Alzheimer’s disease, and is not
recommended for other forms of memory loss or confusion.
Before you take this medicine, your doctor needs to know if you
have, or have had, any of the following:
• other liver or kidney problems
• a heart condition (such as chest discomfort that is often brought
on by physical activity (angina), heart attack, heart failure, slow
or uneven heart beat)
• reduced blood flow to the brain, a stroke or a mini-stroke (also
known as a transient ischaemic attack or ‘TIA’)
• changes in “electrolyte” levels(if your blood potassium levels are
decreased or increased)
• a peptic (stomach) ulcer
• blockage of the stomach or intestines (which may cause
abdominal pain or severe constipation)
• 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 Acumor 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 this
medicine is not suitable for you.

During treatment

If you need an operation, which requires a general anaesthetic,
tell your doctor, or the hospital staff, that you are taking
Acumor XL.

Description Galantamine Hydrobromide 24 mg,16 mg,8 mg 28

If you are currently taking galantamine tablets or oral solution and
have been told by your doctor to switch to Acumor XL read the
instructions at the end of this section carefully.

How to take Acumor XL

Acumor XL should be swallowed whole, NOT chewed or crushed.
Acumor XL should be taken in the morning, with water or other
liquids, and preferably with food.
Acumor XL is available in 3 strengths: 8 mg, 16 mg and 24 mg.
Acumor XL is started at a low dose. Your doctor may then tell you
to slowly increase the dose (strength) of Acumor XL that you take
to find the most suitable dose for you.
1. The recommended starting dose is 8 mg capsule taken once
daily. After 4 weeks of treatment, the dose may be increased.
2. You would then take the 16 mg capsule once daily. After
another 4 weeks of treatment at the earliest, your doctor may
decide to increase the dose again.
3. You would then take the 24 mg capsule once daily.
Your doctor will explain what dose to start with and when the
dose should be increased. If you feel that the effect of Acumor 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 for you and to discuss how you are feeling.
Your doctor will also check your weight regularly while you are
taking galantamine.

If you have liver or kidney problems

• If you have mild liver or kidney problems, treatment is started
with the 8 mg capsule once daily in the morning.
• If you have moderate liver problems, treatment is started with
the 8 mg capsule once every other day in the morning. After
one week, begin taking the 8 mg capsule once daily in the
morning. Do not take more than 16 mg once daily.
• If you have severe liver and/or kidney problems, do not take
Acumor XL.

Date: 11 MAR 2016

Component Type Leaflet

Pharma Code N/A

No. of colours

Affiliate Item Code 843690

SAP No. N/A

Colours

Superceded Affiliate Item Code 539347
TrackWise PR No. 843690
MA No.

04569/1332,
1333, 1334

Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 276014
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Non-Print
Colours

1

Time: 10:07
Page Count

1/2

Black

Text Free
Area

Equate CMYK
with
Main Font Myriad Pro
Dimensions 210 x 420 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

If you take more Acumor XL than you should

If you take too much Acumor XL, contact a doctor or hospital
straight away. Take along any remaining capsules and the
packaging with you. Signs or symptoms of overdose may include:
severe nausea, vomiting, muscle weakness, slow heartbeat,
seizures and loss of consciousness.

If you forget to take Acumor 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, you should talk to
your doctor.

If you stop taking Acumor XL

You should talk to your doctor before you stop taking Acumor 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.

How do I switch from taking galantamine tablets or oral
solution to Acumor XL?
If you are currently taking galantamine tablets or oral solution,
your doctor may decide to switch you to Acumor XL.







muscle weakness
excessive water loss in the body
low blood pressure
reddening of the face
increased sweating

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.

5. How to store Acumor 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 label, carton and blister after the letters EXP. The expiry date
refers to the last day of that month.
If your medicine is packaged in aluminium blister packs:
Store in the original package in order to protect from moisture.

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

If your medicine is packaged in plastic blister packs with
aluminium foil lids:
Do not store above 25 ºC. Store in the original package in order to
protect from moisture.

DO NOT take more than one capsule in a day. While you are
taking once-daily Acumor XL, DO NOT take galantamine tablets
or oral solution.

If your medicine is packaged in a tablet container:
Do not store above 25 ºC. Keep the container tightly closed and
store in the original container in order to protect from moisture.

4. Possible side effects

If your medicine is packaged in a plastic bottle:
Keep the bottle tightly closed and store in the original bottle in
order to protect from moisture.

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

Look out for serious side effects

Stop taking this medicine and see a doctor immediately if
you experience:
• Heart problems including slow heart beat (common: may affect
up to 1 in 10 people). You may also notice other changes in
heart beat such as extra beats or palpitations (heart beat feels
fast or uneven), which may show as an abnormal tracking on
an electrocardiogram (ECG) (uncommon: may affect up to 1 in
100 people).
• Fits (seizures) (uncommon: may affect up to 1 in 100 people).
• Allergic reactions. You may notice a rash, itching or hives,
swelling of the face, lips, tongue, shortness of breath
(uncommon: may affect up to 1 in 100 people).
• Inflammation of the liver (hepatitis). You may notice stomach
pain, yellowing of the skin or eyes, pale stools or dark urine (rare:
may affect up to 1 in 1,000 people).
• Skin reactions (rare: may affect up to 1 in 1,000 people),
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 generalised
exanthematous pustulosis).
* Rash that may blister, with spots that look like small targets.

Other side effects:

Very common: may affect more than 1 in 10 people
• Feeling sick and/or vomiting. If these occur, they are mainly
experienced early on 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 medicine and generally will not last for
more than a few days. If you have these effects, your doctor may
recommend that you drink more liquids and, if necessary, may
prescribe a medicine to stop you being sick.
Common: may affect up to 1 in 10 people
• weight loss
• decreased appetite
• feeling faint, or fainting (blackout)
• dizziness
• trembling
• headache
• feeling very sleepy with low energy
• abnormally tired
• stomach pain or discomfort
• diarrhoea
• indigestion
• muscle spasms
• falling
• high blood pressure
• feeling weak
• general feeling of being unwell
• seeing, feeling, or hearing things that are not real
(hallucinations)
• feeling sad (depression)
• wounds (cuts)
Uncommon: may affect up to 1 in 100 people
• increased liver enzymes in the blood (laboratory test result that
tells how well your liver is working)
• tingling, pricking, or numbness of the skin
• change in the sense of taste
• excessive sleepiness
• blurred vision
• ringing or buzzing in the ears (tinnitus)
• feeling the need to vomit (retch)

Description Galantamine Hydrobromide 24 mg,16 mg,8 mg 28

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 protect the environment.

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

The active substance is galantamine
• Acumor XL 8 mg prolonged release capsules contains 8 mg
galantamine (as hydrobromide).
• Acumor XL 16 mg prolonged release capsules contains 16 mg
galantamine (as hydrobromide).
• Acumor XL 24 mg prolonged release capsules contains 24 mg
galantamine (as hydrobromide).
The other ingredients are:
Tablet core (contents of the capsule): Polyvinyl acetate, silica
colloidal anhydrous, povidone, hydrogenated vegetable oil,
sodium lauril sulfate and magnesium stearate.
Capsule Shell:
Gelatin, titanium dioxide (E171), allura red (E129)
Printing Ink: Shellac, propylene glycol, potassium hydroxide, black
iron oxide (E172).

What Acumor XL looks like and contents of the pack

Acumor XL is available in three strengths, each of which can be
recognised by its lettering:
Acumor XL 8 mg prolonged release capsules are hard gelatin
capsules with a white body and pink cap, printed in black ink
‘MYLAN’ over ‘GT8’ on the body and the cap.
Acumor XL 16 mg prolonged release capsules are hard gelatin
capsules with a white body and pale pink cap, printed in black ink
‘MYLAN’ over ‘GT16’on the body and the cap.
Acumor XL 24 mg prolonged release capsules are hard gelatin
capsules with a white body and pink cap, printed in black ink
‘MYLAN’ over ‘GT24’ on the body and the cap.
The 8 mg, 16 mg and 24 mg are available in:
• Plastic blister packs with an aluminium foil lid containing
7, 10, 28, 28 x 1 (unit dose), 30, 30 x 1 (unit dose), 56, 84,
98 or 100 capsules, or calendar packs containing 28 and
28 x 1 (unit dose) capsules.
• Aluminium blister packs containing 7, 10, 28, 28 x 1 (unit dose),
30, 30 x 1 (unit dose), 56, 84, 98 or 100 capsules, or calendar
blister packs containing 28 and 28 x 1 (unit dose) capsules.
• Tablet containers containing 500 capsules.
• Bottles containing 90 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire EN6 1TL, United Kingdom.

Manufacturers

Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
This leaflet was last revised in March 2016

843690

Date: 11 MAR 2016

Component Type Leaflet

Pharma Code N/A

No. of colours

Affiliate Item Code 843690

SAP No. N/A

Colours

Superceded Affiliate Item Code 539347
TrackWise PR No. 843690
MA No.

04569/1332,
1333, 1334

Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 276014
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Non-Print
Colours

1

Time: 10:07
Page Count

2/2

Black

Text Free
Area

Equate CMYK
with
Main Font Myriad Pro
Dimensions 210 x 420 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

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.

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