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GAZYLAN XL 8MG PROLONGED RELEASE CAPSULES HARD

Active substance(s): GALANTAMINE HYDROBROMIDE

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TEVA UK Ref:

231-30-80029-A LEA GALANTAMINE (GAZYLAN) XL A/S CAPS TUK
Version:

4

19 March 2014

GAZYLAN XL 8 mg, 16 mg, 24 mg
PROLONGED-RELEASE CAPSULES,
HARD
galantamine

Your doctor will also check your weight regularly
while you are taking Gazylan XL.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gazylan XL with food and drink
Gazylan XL should be taken with food if possible.
See section 3 of this leaflet for full details about
how to take this medicine.

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

1

What Gazylan XL is and what it is
used for

2

What you need to know before you
take Gazylan XL

If you have any questions, speak 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
Gazylan XL.
Driving and using machines
Gazylan 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 Gazylan 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.

Gazylan XL is started at a low dose. Your doctor
may then tell you to slowly increase the dose of
Gazylan XL is an antidementia medicine used to Gazylan XL that you take to find the most
treat the symptoms of mild to moderately severe suitable dose for you.
dementia of the Alzheimer type, a disease that
1. The treatment is started with 8 mg taken once
alters brain function.
daily. After 4 weeks of treatment, the dose is
increased.
The symptoms of Alzheimer’s disease include
2. You would then take 16 mg once daily. After
increasing memory loss, confusion and
another 4 weeks of treatment at the earliest,
behavioral changes. As a result, it becomes more
your doctor may decide to increase the dose
and more difficult to carry out normal daily
again.
activities.
3. You would then take 24 mg once daily.
These symptoms are believed to be due to a lack
Your doctor will explain what dose to start with
of acetylcholine, a substance responsible for
sending messages between brain cells. Gazylan and when the dose should be increased.
XL increases the amount of acetylcholine in the
Your doctor will need to see you regularly to
brain and so could improve the symptoms of the
check that this medicine is working for you and
disease.
to discuss how you are feeling.

Do not take Gazylan 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 severe kidney
disease.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Gazylan XL.
Gazylan 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
Gazylan 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 Gazylan XL.
Your doctor will then decide whether treatment
with Gazylan XL is suitable for you or if the dose
needs to be changed.

Liver or kidney disease
• If you have mild liver or kidney disease,
treatment is started with 8 mg capsule once
daily in the morning
• If you have moderate liver or kidney disease,
treatment is started with 8 mg capsule once
every other day in the morning. After one
week, begin taking 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 Gazylan XL.
How do I switch from taking Galantamine
immediate release tablets or oral solution to
Galantamine prolonged-release capsules?
If you are currently taking Galantamine
immediate release tablets or oral solution, your
doctor may decide to switch you to Galantamine
prolonged-release capsules.
• Take your last dose of Galantamine immediate
release 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 Gazylan XL,
do not take Galantamine immediate release
tablets or oral solution.
Use in children
Gazylan XL is not recommended for children.
Method of administration
Gazylan XL should be swallowed whole, not
chewed or crushed. Gazylan XL should be taken
in the morning, with water or other liquids, and
preferably with food. Drink plenty of liquids
during your treatment with Gazylan XL, to keep
yourself hydrated.

Other medicines and Gazylan XL
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Gazylan XL should not be used with medicines
that work in a similar way, these include:

If you take more Gazylan XL than you should
If you take too much Gazylan 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 (feeling sick),
vomiting (being sick), muscle weakness, slow
heart beat, seizures and loss of consciousness.

• 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.

If you forget to take Gazylan 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.

Some medicines can affect the way Gazylan XL
works, or Gazylan 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).

If you forget to take more than one dose, you
should contact your doctor.

Your doctor may prescribe a smaller dose of
Gazylan XL if you are also taking any of the
medicines listed above.
Some medicines can increase the number of side
effects caused by Gazylan 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 Gazylan XL.

If you stop taking Gazylan XL
You should consult your doctor before you stop
taking Gazylan 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.
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
• An allergic reaction. The signs may include a
rash, swallowing or breathing problems, or
swelling of your lips, face, throat or tongue.

TEVA UK Ref:

231-30-80029-A LEA GALANTAMINE (GAZYLAN) XL A/S CAPS TUK
Side effects include:
Very common (may affect more than 1 in 10
people)
• 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 (may affect up to 1 in 10 people)





















Weight loss
Loss of appetite
Decreased appetite
Slow heart beat
Feeling faint
Dizziness
Trembling
Headache
Drowsiness
Abnormally tired
Stomach pain or discomfort
Diarrhoea
Indigestion
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).

Version:

4

19 March 2014

The capsules are available in the following
blister packs: 7, 10, 14, 28, 30, 56, 60, 84, 90, 98,
100, 112, 119, 120, 300 prolonged-release
capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Pharmathen International S.A.
Industrial Park Sapes, Rodopi Prefecture, Block
No 5, Rodopi 69300
Greece
This leaflet was last revised in 03/2014
PL 00289/1890-2

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)
• 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
• Allergic reaction
• Fits (seizures).
Rare (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 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 Gazylan 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 foil after
the letters 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.

6

Contents of the pack and other
information

What Gazylan XL contains:
The active substance is galantamine.
• Each Gazylan XL 8 mg Prolonged-release
Capsule, hard contains 8 mg galantamine (as
hydrobromide)
• Each Gazylan XL 16 mg Prolonged-release
Capsule, hard contains 16 mg galantamine (as
hydrobromide)
• Each Gazylan XL 24 mg Prolonged-release
Capsule, hard contains 24 mg galantamine (as
hydrobromide).
The other ingredients are:
Capsule content
Cellulose microcrystalline, Hypromellose,
Ethylcellulose, Magnesium stearate
Capsule shell
8 mg: Gelatin, Titanium dioxide (E171)
16 mg: Gelatin, Titanium dioxide (E171), red iron
oxide (E172).
24 mg: Gelatin, Titanium dioxide (E171), Indigo
carmine (E132), Erythrosin (E127), Red Iron Oxide
(E172), Yellow iron oxide (E172).
What Gazylan XL looks like and contents of the
pack
Gazylan XL Prolonged-release Capsules, hard are
available in three strengths, each of which can be
recognised by its colour:
8 mg: White capsules containing one round
biconvex prolonged-release tablet
16 mg: Pale pink capsules containing two round
biconvex prolonged-release tablet
24 mg: Orange capsules containing three round
biconvex prolonged-release tablets
The capsules are made in a ‘prolonged-release’
form. This means that they release the medicine
more slowly.

80029-A
248653.01-GB

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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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