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GATALIN XL 24 MG PROLONGED RELEASE CAPSULES HARD

Active substance(s): GALANTAMINE HYDROBROMIDE

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Package leaflet: Information for the user

Gatalin XL 8mg prolonged-release capsules, hard
Gatalin XL 16mg prolonged-release capsules, hard
Gatalin XL 24mg prolonged-release capsules, hard
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 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 Gatalin XL is and what it is used for
2. What you need to know before you take
Gatalin XL
3. How to take Gatalin XL
4. Possible side effects
5. How to store Gatalin XL
6. Contents of the pack and other information

1. What Gatalin XL is and what
it is used for
Gatalin 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. Galantamine increases the amount of
acetylcholine in the brain and treats the signs of
the disease.

2. What you need to know before you
take Gatalin XL
Do not take Gatalin 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
Gatalin 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
Galantamine can cause serious skin reactions,
heart problems and fits (seizures). You must be
aware of these side effects while you are taking
Gatalin XL. See ‘Look out for serious side
effects’ in section 4.
Before you take Gatalin 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).

c
• hanges 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 Gatalin 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 galantamine is not
suitable for you.
Galantamine can cause weight loss. Your
doctor will check your weight regularly while you
are taking Gatalin XL.
Children and adolescents
Galantamine is not recommended for children
and adolescents.
Other medicines and Gatalin XL
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Gatalin XL should not be used with medicines
that work in a similar way. These include:
• donepezil or rivastigmine (for Alzheimerʼs
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 galantamine.
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 Gatalin
XL if you are taking any of these medicines.
Galantamine may affect some anaesthetics.
If you are going to have an operation under a
general anaesthetic, tell the doctor that you are
taking Gatalin XL, well in advance.
If you have any questions, talk to your doctor or
pharmacist for advice.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 breast-feed
while you are taking Gatalin XL.
Driving and using machines
Gatalin XL may make you feel dizzy or sleepy,
especially during the first few weeks of
treatment.
If Gatalin XL affects you, do not drive or use any
tools or machinery.

3. How to take Gatalin XL
Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
If you are currently taking galantamine
immediate release tablets or oral solution and
have been told by your doctor to switch to
Gatalin XL prolonged-release capsules, read the
instructions at the end of this section carefully.
How much to take
You will start treatment with Gatalin XL at a low
dose. The recommended 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 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 that the effect of
Gatalin XL capsules 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 liver or kidney problems, your
doctor may give you a reduced dose of
galantamine, or may decide this medicine is not
suitable for you.
Switching from taking galantamine immediate
release tablets or oral solution to
galantamine prolonged release capsules
If you are currently taking galantamine tablets or
oral solution, your doctor may decide you should
switch to galantamine prolonged-release
capsules. If this applies to you:
• Take your last dose of galantamine tablets or
oral solution in the evening
• The next morning, take your first dose of
galantamine prolonged-release capsules.
DO NOT take more than one capsule in a day.
While you are taking once-daily galantamine
capsules, DO NOT take galantamine tablets
or oral solution.
How to take Gatalin XL
Galantamine capsules must be swallowed whole
and NOT chewed or crushed. Take your dose of
galantamine once a day in the morning, with
water or other liquids. Try to take galantamine
with food.
Drink plenty of liquids while you are taking
Gatalin XL, to keep yourself hydrated.
If you take more Gatalin XL than you should
If you take too much Gatalin XL, contact a doctor
or hospital straight away. Take along any
remaining capsules and the packaging with you.
The signs of overdose may include: severe
nausea and vomiting, weak muscles, slow heart
beat, fits (seizures) and loss of consciousness.
If you forget to take Gatalin 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 Gatalin XL
Check with your doctor before you stop taking
Gatalin 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 your medicine 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
galantamine (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 galantamine
(may affect up to 1 in 10 people)
• Fits (seizures). These are uncommon in
people taking galantamine (may affect up to 1
in 100 people).
You must stop taking galantamine and seek
help immediately if you notice any of the side
effects listed above.
Other side effects
Very common side effects
(may affect 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 medicine 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 up to 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 up 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).

6. Contents of the pack and
other information
What Gatalin XL contains:
The active substance is galantamine.
• Gatalin XL 8mg prolonged-release capsules
contain 8mg galantamine (as hydrobromide)

G
• atalin XL 16mg prolonged-release capsules
contain 16mg galantamine (as hydrobromide)
• Gatalin XL 24mg prolonged-release capsules
contain 24mg galantamine (as hydrobromide)
The other ingredients are:
Capsule contents: Cellulose microcrystalline,
Hypromellose, Ethylcellulose and Magnesium
stearate.
Capsule shell: Gelatin and Titanium dioxide
(E 171).
The 16 mg capsule also contains red iron oxide
(E 172).
The 24 mg capsule also contains Indigo carmine
(E 132), Erythrosin (E 127), Red Iron Oxide
(E 172) and Yellow iron oxide (E 172).
What Gatalin XL looks like and
contents of the pack
Gatalin XL prolonged-release capsules, hard are
available in three strengths, each of which can
be recognised by its colour:
8mg: Opaque white size 2 hard gelatine
capsules containing one round biconvex tablet
16mg: Opaque, flesh size 2 hard gelatine
capsules containing two round biconvex tablets
24mg: Opaque orange size 2 hard gelatine
capsules containing three round biconvex tablets
Pack sizes:
1, 7, 14, 28, 30, 56, 60, 84, 90, 300 prolonged
release capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aspire Pharma Limited
Bellamy House
Winton Road
Petersfield
Hampshire
GU32 3HA
United Kingdom
Manufacturers
Pharmathen S.A.
Dervenakion 6
Pallini 15351
Attiki
Greece
or
Pharmathen International S.A.
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece
This leaflet was last revised in 01/2016

Reporting of side effects
If you get any side effects, talk to your doctor or
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 (website: 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 Gatalin 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 carton and blister after EXP.
The expiry date refers to the last day of
that month.
This medicinal product does not require any
special storage conditions.
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.

1010067-P5.4

Artwork for:
Aspire Pharma Limited
Product name:
Gatalin XL
Size:
All strengths
PL/PA no:
Type: Leaflet
Artwork dimensions: 500mm x 170mm
Profile supplied:
Dimensions supplied
Date of first artwork: 5 July 2011
Reason for request: Artwork in Pharmathen User Tested style: text edits
Version no: 5.4
Date of revision:
18 January 2016
Colours:
As swatch(es)
Font(s):
9pt Helvetica
Artwork software:
InDesign CS6
BAC ref:
T911 (formerly R592)

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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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