GALSYA XL 8 MG PROLONGED-RELEASE CAPSULES HARD

Active substance: GALANTAMINE HYDROBROMIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

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.
• 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. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Galsya XL is and what it is used for
2. Before you take Galsya XL
3. How to take Galsya XL
4. Possible side effects
5. How to store Galsya XL
6. Further information

1. WHAT GALSYA XL IS AND WHAT IT IS
USED FOR


Galsya XL 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.
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. Galsya XL increases the amount of acetylcholine in the brain
and so could improve the symptoms of the disease.
The capsules are made in a ‘prolonged-release’ form. This means
that they release the medicine more slowly.


2. BEFORE YOU TAKE GALSYA XL


Do not take Galsya XL
• if you are allergic (hypersensitive) to galantamine or any of the
other ingredients of Galsya XL.
• if you have severe liver and/or severe kidney disease.
Take special care with Galsya XL
Galsya XL should be used in Alzheimer’s disease and not other
forms of memory loss or confusion.
Medicines are not always suitable for everyone. Your doctor needs
to know before you take Galsya XL if you suffer from or have
suffered in the past from any of the following conditions:
• liver or kidney problems
• a heart disorder (e.g. angina, heart attack, heart failure, slow or
irregular pulse)
• electrolyte disturbances (e.g. decreased/increased blood
potassium levels)
• peptic (stomach) ulcer disease









acute abdominal pain
a disorder of the nervous system (like epilepsy or Parkinson’s
disease)
a respiratory disease or infection that interferes with breathing
(like asthma, obstructive pulmonary disease, or pneumonia)
if you recently had an operation on the gut or bladder
if you have difficulties passing urine.

If you need an operation which requires a general anaesthetic, you
should inform the doctor that you are taking Galsya XL.
Your doctor will then decide whether treatment with Galsya XL is
suitable for you or if the dose needs to be changed.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
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
muscular weakness)
• pilocarpine (for dry mouth or dry eyes) if taken by mouth.
Some medicines can affect the way Galsya XL works, or Galsya XL
itself can reduce the effectiveness of other medicines taken at the
same time. These include:
• paroxetine or fluoxetine (antidepressants)
• quinidine (used for heart rhythm problems)
• ketoconazole (antifungal)
• erythromycin (antibiotic)
• ritonavir (antiviral - HIV protease inhibitor).
Your doctor may prescribe a smaller dose of Galsya XL if you are
also taking any of the medicines listed above.
Some medicines can increase the number of side effects caused
by Galsya XL, these include:








non-steroidal anti-inflammatory painkillers (e.g. ibuprofen)
which can increase the risk of ulcers
medicines taken for heart disorders or high blood pressure
(e.g. digoxin, amiodarone, atropine, beta-blockers, or calcium
channel blocking agents). If you take medicines for an irregular
heart-beat, your doctor may consider an electrocardiogram (ECG).

If you need an operation which requires a general anaesthetic, you
should inform the doctor that you are taking Galsya XL.
If you have any questions, speak to your doctor or pharmacist for
advice.
Taking Galsya XL with food and drink
Galsya XL should be taken with food if possible.
Drink plenty of liquids during your treatment with Galsya XL, to
keep yourself hydrated (see section 3).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
Before taking Galsya XL, speak to your doctor for advice if you are
pregnant, think you could be pregnant, or you are planning a
pregnancy.
You should not breastfeed while you are taking Galsya XL.
Driving and using machines
Galsya XL 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.

3. HOW TO TAKE GALSYA XL
Always take Galsya XL exactly as your doctor has told you. You
should 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 prolonged-

release capsules, read the instructions at the end of this section
carefully.
How to take Galsya XL
Galsya XL capsules should 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.
Galsya XL should be taken in the morning, with water or other
liquids, and preferably with food.
Galsya XL prolonged-release capsules are available in 3 strengths:
8 mg, 16 mg and 24 mg.
Galsya XL is started at a low dose. Your doctor may then tell you to
slowly increase the dose (strength) of Galsya XL that you take to
find the most suitable dose for you.
1. The treatment is started with the 8 mg capsule taken once daily.
After 4 weeks of treatment, the dose is 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 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 for you and to discuss how you are feeling.
Your doctor will also check your weight regularly while you are
taking Galsya XL.
Liver or kidney disease
If you have mild liver or kidney disease, treatment is started with
the 8 mg capsule once daily in the morning.

If you have moderate liver or kidney disease, 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 disease, do not take
Galsya XL.
Children
Galsya XL is not recommended for children and adolescents under
18 years of age.
If you take more Galsya XL than you should
If you take too much Galsya 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,
among others: severe nausea, vomiting, muscle weakness, slow
heart beat, 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.
If you forget to take more than one dose, you should contact your
doctor.
Do not take a double dose to make up for a forgotten dose.
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.
How do I switch from taking galantamine tablets or oral
solution to Galsya XL prolonged-release capsules?
If you are currently taking galantamine tablets or oral solution, your
doctor may decide to switch you to galantamine prolonged-release
capsules.
• 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.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.


4. POSSIBLE SIDE EFFECTS


Like all medicines, Galsya XL can cause side effects, although not
everybody gets them.
Some of these effects may be due to the disease itself.
Stop taking your medicine and see a doctor immediately if you
experience:
• Heart problems including changes in heart beat (slow or
irregular)
• Palpitations (pounding heart beat)
• Conditions like blackout
Side effects are classified into the following groups in order of
frequency:





Very common
Common
Uncommon
Rare

Affects more than 1 user in 10
Affects 1 to 10 users in 100
Affects 1 to 10 users in 1,000
Affects 1 to 10 users in 10,000

Very common
• Feeling sick and/or vomiting.
If these undesired effects occur, they are mainly experienced
early on in the 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, if necessary, may prescribe a medicine to stop you
being sick.

Common
• Weight loss, loss of appetite, decreased appetite, stomach pain
or discomfort, diarrhoea, indigestion
• Slow heart beat
• Feeling faint, dizziness, trembling, headache, drowsiness,
abnormally tired
• Increased sweating
• Muscle spasms
• Falling
• High blood pressure
• Feeling weak, general feeling of discomfort
• Seeing, feeling, or hearing things that are not real
(hallucinations)
• Feeling sad (depression)

5. HOW TO STORE GALSYA XL

Uncommon
• Increased liver enzymes in the blood (laboratory test result that
tells how well your liver is working)
• Possible skipped heart beat, disturbance in the mechanism of
conducting impulses in the heart, sensation of abnormal heart
beats (palpitations)
• 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
• Muscle weakness
• Excessive water loss in the body
• Low blood pressure
• Reddening of the face


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

Rare side effects
• Inflammation of the liver (hepatitis)
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.



Keep out of the reach and sight of children.
Do not use Galsya XL 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.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.


6. FURTHER INFORMATION

glycol, concentrated ammonia solution, black iron oxide (E172),
potassium hydroxide).
What Galsya XL looks like and contents of the pack
8 mg: White capsules with G8 imprinted on the capsule’s cap.
Content of capsule is one white oval, prolonged-release
tablet core.
16 mg: Pink capsules with G16 imprinted on the capsule’s cap.
Content of capsule are two white, oval, prolonged-release
tablet cores.
24 mg: Orange pink capsules 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., 500 Chiswick High Road, London,
W4 5RG


This leaflet was last approved revised in March 2011
P0110

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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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