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GALZEMIC XL16MG PROLONGED RELEASE CAPSULES

Active substance(s): GALANTAMINE HYDROBROMIDE

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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 Galzemic XL is and what it is used for
2. What you need to know before you take Galzemic XL
3. How to take Galzemic XL
4. Possible side effects
5. How to store Galzemic XL
6. Contents of the pack and other information
1. What Galzemic XL is and what it is used for
Galzemic 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 Galzemic XL
Do not take Galzemic 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 Galzemic 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
Galzemic XL. See ‘Look out for serious side effects’ in section 4.
Before you take Galzemic 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)
• changes 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 Galzemic 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 Galzemic XL.
Children and adolescents
Galantamine is not recommended for children and adolescents.
Other medicines and Galzemic XL
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Galzemic 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 lead to 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 Galzemic 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
Galzemic 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 breastfeed while you are taking Galzemic XL.
Driving and using machines
Galantamine may make you feel dizzy or sleepy, especially during the first few
weeks of treatment. If Galzemic XL affects you, do not drive or use any tools or
machinery.
3. How to take Galzemic 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 Galantamine
prolonged-release capsules, read the instructions at the end of this section
carefully.
How much to take
You will start treatment with Galzemic 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 Galzemic 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 Galzemic 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 Galzemic XL, to keep yourself
hydrated.
If you take more Galzemic XL than you should
If you take too much Galzemic 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 Galzemic 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 Galzemic XL
Check with your doctor before you stop taking Galzemic 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.

• 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).
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.

4. Possible side effects

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.

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)

5. How to store Galzemic XL

6. Contents of the pack and other information
What Galzemic XL contains
The active substance is galantamine.
• Galzemic XL 8 mg prolonged-release capsules contain 8 mg galantamine
(as hydrobromide)
• Galzemic XL 16 mg prolonged-release capsules contain 16 mg galantamine
(as hydrobromide)
• Galzemic XL 24 mg prolonged-release capsules contain 24 mg 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 Galzemic XL looks like and contents of the pack
Galzemic XL prolonged-release capsules are available in three strengths, each
of which can be recognised by its colour:
8 mg: Opaque white size 2 hard gelatine capsules containing one
round biconvex tablet
16 mg: Opaque, flesh size 2 hard gelatine capsules containing two
round biconvex tablets
24 mg: Opaque orange size 2 hard gelatine capsules containing
three round biconvex tablets
Pack sizes:
7, 28, 30, 56, 84, 90, 98, 250, 500 capsules or white opaque polyethylene high
density container with screw cap with 100 prolonged-release capsules.
Not all pack sizes may be marketed.
Marketing authorisation holder
Pharmathen S.A., Dervenakion 6, Pallini 15351, Attiki Greece
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
Distributed by:
Creo Pharma Ltd, Felsted Business Centre, Felsted, Essex CM6 3LY, UK
This leaflet was last revised in 03/2016

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Galzemic XL 8 mg prolonged-release capsules
Galzemic XL 16 mg prolonged-release capsules
Galzemic XL 24 mg prolonged-release capsules
Galantamine

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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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