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GALSYA XL 16 MG PROLONGED-RELEASE CAPSULES HARD

Active substance(s): GALANTAMINE HYDROBROMIDE

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PACKAGE LEAFLET:
Information for the patient

Galsya XL 8 mg
®

prolonged-release capsules, hard

Galsya® XL 16 mg

prolonged-release capsules, hard

Galsya® XL 24 mg

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 Galsya XL is and what it is used for
2. What you need to know before you take Galsya XL
3. How to take Galsya XL
4. Possible side effects
5. How to store Galsya XL
6. Contents of the pack and other information

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

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

Before you take Galsya 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, heart attack, heart failure, slow
or uneven heart beat)
• changes in ‘electrolyte’ levels (naturally occurring chemicals in
the blood, such as potassium)
• 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 Galsya XL is suitable for you, or if the
dose needs to be changed.

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

Also tell your doctor if you recently had an operation on
the stomach, intestines or bladder. Your doctor may decide that
Galsya XL is not suitable for you.

Do not take Galsya 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.

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Galsya XL.
This medicine is only used in Alzheimer’s disease and is not
recommended for other types of memory loss or confusion.

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

Galsya XL contains the active substance ‘galantamine’ that is 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. Galsya XL increases the amount of
acetylcholine in the brain and treats the signs of the disease.

Serious side effects
Galsya XL can cause serious skin reactions, heart problems, fits
(seizures). You must be
aware of these side effects while you are taking Galsya XL. See
‘Look out for serious side effects’ in section 4.

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

Galsya 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 Galsya 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 Galsya XL if you are
also taking any of these medicines.
Galsya XL may affect some anaesthetics. If you are going to have
an operation under a
general anaesthetic, tell the doctor that you are taking Galsya 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 for advice before
taking this medicine.
You should not breastfeed while you are taking Galsya XL.
Driving and using machines
Galsya XL may make you feel dizzy or sleepy, especially during
the first few weeks of treatment. If you experience these
symptoms, do not drive or use any tools or machinery.

3. How to take Galsya 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 tablets or oral solution and
have been told by your doctor to switch to galantamine prolongedrelease capsules, carefully read the instructions under ‘Switching
from taking galantamine tablets or oral solution to Galsya XL
capsules’ in this section.
How much to take
You will start treatment with Galsya 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 Galsya 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 Galsya XL, or may decide this medicine is not
suitable for you.
Switching from taking galantamine tablets or oral solution
to Galsya XL capsules
If you are currently taking galantamine tablets or oral solution, your
doctor may decide you
should switch to Galsya XL 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 Galsya XL prolonged release capsule.

DO NOT take more than one capsule in a day. While you
are taking once daily Galsya XL capsules, Do NOT take
galantamine tablets or oral solution.
How to take Galsya XL
Galsya XL capsules must be swallowed whole, NOT chewed or
crushed.
If you find the capsules difficult to swallow, you may empty the
capsule and swallow the content whole - DO NOT chew or crush
the contents.
Take your dose of Galsya XL once a day in the morning, with water
or other liquids. Try to take Galsya XL with food. Drink plenty of
liquids while you are taking Galsya XL, to keep yourself hydrated.
If you take more Galsya XL than you should
If you take too much Galsya XL, contact a doctor or hospital
straight away. Take any remaining capsules and the packaging
with you. Signs of overdose may include:
• severe nausea and vomiting,
• muscle weakness, slow heart beat, fits (seizures) and loss of
consciousness.
If you forget to take Galsya 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 contact your
doctor.
If you stop taking Galsya XL
You should consult your doctor before you stop taking Galsya
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 of the 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
Galsya XL (may affect up to1 in 10 people).
Fits (seizures). These are uncommon in people taking Galsya XL
(may affect up to 1 in 100 people).
You must stop taking Galsya XL and get help immediately if
you notice any of the side effects 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 treatment 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, may prescribe a medicine to stop you being sick.
Common side effects (may affect up to 1 in 10 people):
• Weight loss, decreased appetite
• Seeing, feeling, or hearing things that are not there
(hallucinations)
• Depression
• Feeling dizzy or fainting
• Muscle tremor 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 the 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):
• Inflammation of the liver (hepatitis)

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: 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 Galsya 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 blister and carton after EXP. The expiry date refers to the last
day of that month.
Do not store above 30°C. Store in the original package in order to
protect from moisture.
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 Galsya XL contains
• The active substance is galantamine.
8 mg: Each prolonged-release capsule, hard contains 8 mg
galantamine (as hydrobromide).
16 mg: Each prolonged-release capsule, hard contains 16 mg
galantamine (as hydrobromide).
24 mg: Each prolonged-release capsule, hard contains 24 mg
galantamine (as hydrobromide).
• The other ingredients in the prolonged-release tablet core are
sodium laurilsulfate, ammonio methacrylate copolymer (type B),
hypromellose, carbomers, hydroxypropylcellulose, magnesium
stearate and talc.





The other ingredients in the 8 mg capsule shell are gelatin,
titanium dioxide (E171) and black ink (shellac, propylene
glycol, concentrated ammonia solution, black iron oxide (E172),
potassium hydroxide).
The other ingredients in the 16 mg and 24 mg capsule shell
are gelatin, titanium dioxide (E171), red iron oxide (E172),
yellow iron oxide (E172) and black ink (shellac, propylene
glycol, concentrated ammonia solution, black iron oxide (E172),
potassium hydroxide).

What Galsya XL looks like and contents of the pack
8 mg: White capsules size 2 (capsule length: 17.6 - 18.4 mm)
with G8 imprinted on the capsule’s cap. Content of capsule is one
white oval, prolonged-release tablet core.
16 mg: Pink capsules size 1 (capsule length: 19.0 - 19.8 mm)
with G16 imprinted on the capsule’s cap. Content of capsule are
two white, oval, prolonged-release tablet cores.
24 mg: Orange pink capsules size 0 el (capsule length: 23.8 24.6 mm) with G24 imprinted on the capsule’s cap. Content of
capsule are three white, oval, prolonged-release tablet cores.
Capsules are available in cartons of 10, 14, 28, 30, 56, 60, 84, 90
and 100 prolonged-release capsules, hard in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto,
Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto,
Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven,
Germany
Distributed by
Consilient Health (UK) Ltd., No.1 Church Road, Richmond upon
Thames, Surrey. TW9 2QE.
This leaflet was last revised in 03/2016

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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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