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GALANTAMINE 4 MG/ ML ORAL SOLUTION

Active substance(s): GALANTAMINE HYDROBROMIDE

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PATIENT INFORMATION LEAFLET

2658
07.06.16[5]

Reminyl® 4 mg/ml Oral Solution
(galantamine hydrobromide)
Your medicine will be referred to as Reminyl throughout this leaflet.
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 Reminyl is and what it is used for
2. What you need to know before you take Reminyl
3. How to take Reminyl
4. Possible side effects
5. How to store Reminyl
6. Contents of the pack and other information

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

1. What Reminyl is and what it is used for
Reminyl 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.

Your doctor may give you a lower dose of Reminyl if you are taking some
of these medicines.

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.
Reminyl increases the amount of acetylcholine in the brain and treats the
signs of the disease.

If you have any questions, talk to your doctor or pharmacist for advice.

2. What you need to know before you take Reminyl
Do not take Reminyl
 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 Reminyl. This medicine is
only used in Alzheimer’s disease and is not recommended for other types
of memory loss or confusion.
Serious side effects
Reminyl can cause serious skin reactions, heart problems and fits
(seizures). You must be aware of these side effects while you are taking
Reminyl. See ‘Look out for serious side effects’ in section 4
Before you take Reminyl, 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 intestine
 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 Reminyl 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 Reminyl is not suitable
for you.
Reminyl can cause weight loss. Your doctor will check your weight
regularly while you are taking Reminyl.
Children and adolescents
Reminyl is not recommended for children and adolescents.

Directions for opening the bottle and using the pipette
Fig. 1:
The bottle comes with a child-resistant cap, and should be
opened as follows:
- Push the plastic screw cap down while turning it counter
clockwise.
- Remove the unscrewed cap.
Fig. 2:
Insert the pipette into the bottle.
While holding the bottom ring, pull the top ring up to the mark
corresponding to the number of millilitres you want to give.
Fig. 3:
Holding the bottom ring, remove the entire pipette from the
bottle.
Empty the pipette into any non-alcoholic drink by sliding the
upper ring down and drink it immediately.
Close the bottle.
Rinse the pipette with some water.

Reminyl may affect some anaesthetics. If you are going to have an
operation under a general anaesthetic, tell the doctor that you are taking
Reminyl, well in advance.

Pregnancy and breast-feeding
If you are pregnant, 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 Reminyl.
Driving and using machines
Reminyl may make you feel dizzy or sleepy, especially during the first few
weeks of treatment. If Reminyl affects you, do not drive or use any tools
or machinery.
Reminyl contains methyl and propyl parahydroxybenzoates
These can sometimes cause allergic reactions, which may possibly be
delayed.
3. How to take Reminyl
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
How much to take
You will start treatment with Reminyl at a low dose. The usual starting
dose is 4mg (1ml of solution), taken twice a day (a total of 8mg 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
12mg (3ml of solution), taken twice a day (a total of 24 mg 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 the effect of Reminyl
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 Reminyl, or may decide this medicine is not suitable for
you.
How to take
Take your dose of Reminyl twice a day, in the morning and evening, with
water or other liquids. Try to take Reminyl with food.
Drink plenty of liquids while you are taking Reminyl, to keep yourself
hydrated.
The solution comes with a pipette which you should use to take the exact
amount needed from the bottle.

If you take more Reminyl than you should
If you take too much Reminyl, contact a doctor or hospital straight away.
Take any remaining solution and the packaging with you. The signs of
overdose may include:
 severe nausea and vomiting,
 weak muscle, slow heart beat, fits (seizures) and loss of
consciousness.
If you forget to take Reminyl
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 Reminyl
Check with your doctor before you stop taking Reminyl. 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 Reminyl 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 pusfilled 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 Reminyl (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 Reminyl (may affect up to 1
in 10 people).
Fits (seizures). These are uncommon in people taking Reminyl (may
affect up to 1 in 100 people).

6. Contents of the pack and other information
What Reminyl contains
It contains the active ingredient galantamine hydrobromide.
Each 1 ml of oral solution contains 4 mg galantamine (as hydrobromide).
Reminyl also contains methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), sodium saccharin, sodium hydroxide and
purified water.

You must stop taking Reminyl and get help immediately if you notice any
of the side effects above.

What Reminyl looks like and contents of the pack
Reminyl is available as clear colourless solution in a 100 ml amber glass
bottle with child-proof cap and a measuring pipette to take the exact
amount needed from the bottle.

Other side effects
Very Common side effects (may affects up to 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 more than 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 ear that does not go away (tinnitus)
 Low blood pressure
 Flushing
 Feeling the need to vomit (retch)
 Excessive sweating
 Weak muscle
 Increased level of liver enzymes
Rare side effects (may affect up to 1 in 1,000 people)
 Inflammation liver (hepatitis).
Reporting of side effects
If you get any side effects, talk to your doctor, 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 at:
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 Reminyl
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the packaging.
The expiry date refers to the last day of that month.
Do not freeze.
Reminyl should not be used for longer than 3 months after the bottle has
first been opened.
If the solution has become discoloured or shown any other signs of
deterioration please tell your doctor or pharmacist before taking your
medicine.
Do not throw away any medicine via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.

Manufacturer and Product Licence Holder
Manufactured by Janssen Pharmaceutica N.V., Turnhoutseweg 30,
B-2340 Beerse, Belgium. Procured from within the EU by Product
Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow,
Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2658

Leaflet revision and issue date (Ref) 07.06.16[5]
Reminyl is a trademark of Shire Pharmaceutical Development Ltd.

PATIENT INFORMATION LEAFLET

2658
07.06.16[5]

Galantamine 4 mg/ml Oral Solution
(galantamine hydrobromide)
Your medicine will be referred to as Galantamine throughout this leaflet.
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 Galantamine is and what it is used for
2. What you need to know before you take Galantamine
3. How to take Galantamine
4. Possible side effects
5. How to store Galantamine
6. Contents of the pack and other information
1. What Galantamine is and what it is used for
Galantamine 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.

Other medicines and Galantamine
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Galantamine 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
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 Galantamine if you are taking
some 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
Galantamine, well in advance.
If you have any questions, talk to your doctor or pharmacist for advice.

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.

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this
medicine.

2. What you need to know before you take Galantamine
Do not take Galantamine
 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

You should not breastfeed while you are taking Galantamine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Galantamine. 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
Galantamine. See ‘Look out for serious side effects’ in section 4
Before you take Galantamine, 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 intestine
 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 Galantamine 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 Galantamine.
Children and adolescents
Galantamine is not recommended for children and adolescents.

Directions for opening the bottle and using the pipette
Fig. 1:
The bottle comes with a child-resistant cap, and should be
opened as follows:
- Push the plastic screw cap down while turning it counter
clockwise.
- Remove the unscrewed cap.
Fig. 2:
Insert the pipette into the bottle.
While holding the bottom ring, pull the top ring up to the mark
corresponding to the number of millilitres you want to give.
Fig. 3:
Holding the bottom ring, remove the entire pipette from the
bottle.
Empty the pipette into any non-alcoholic drink by sliding the
upper ring down and drink it immediately.
Close the bottle.
Rinse the pipette with some water.

Driving and using machines
Galantamine may make you feel dizzy or sleepy, especially during the
first few weeks of treatment. If Galantamine affects you, do not drive or
use any tools or machinery.
Galantamine contains methyl and propyl parahydroxybenzoates
These can sometimes cause allergic reactions, which may possibly be
delayed.
3. How to take Galantamine
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
How much to take
You will start treatment with Galantamine at a low dose. The usual
starting dose is 4mg (1ml of solution), taken twice a day (a total of 8mg 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 12mg (3ml of solution), taken twice a day (a total of 24 mg 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 the effect of
Galantamine 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.
How to take
Take your dose of Galantamine twice a day, in the morning and evening,
with water or other liquids. Try to take Galantamine with food.
Drink plenty of liquids while you are taking Galantamine, to keep yourself
hydrated.
The solution comes with a pipette which you should use to take the exact
amount needed from the bottle.

If you take more Galantamine than you should
If you take too much Galantamine, contact a doctor or hospital straight
away. Take any remaining solution and the packaging with you. The
signs of overdose may include:
 severe nausea and vomiting,
 weak muscle, slow heart beat, fits (seizures) and loss of
consciousness.
If you forget to take Galantamine
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 Galantamine
Check with your doctor before you stop taking Galantamine. 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 Galantamine 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 pusfilled 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).

6. Contents of the pack and other information
What Galantamine contains
It contains the active ingredient galantamine hydrobromide.
Each 1 ml of oral solution contains 4 mg galantamine (as hydrobromide).
Galantamine also contains methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), sodium saccharin, sodium hydroxide and
purified water.

Other side effects
Very Common side effects (may affects up to 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.

What Galantamine looks like and contents of the pack
Galantamine is available as clear colourless solution in a 100 ml amber
glass bottle with child-proof cap and a measuring pipette to take the exact
amount needed from the bottle.

Common side effects (may affect more than 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 ear that does not go away (tinnitus)
 Low blood pressure
 Flushing
 Feeling the need to vomit (retch)
 Excessive sweating
 Weak muscle
 Increased level of liver enzymes
Rare side effects (may affect up to 1 in 1,000 people)
 Inflammation liver (hepatitis).
Reporting of side effects
If you get any side effects, talk to your doctor, 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 at:
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 Galantamine
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the packaging.
The expiry date refers to the last day of that month.
Do not freeze.
Galantamine should not be used for longer than 3 months after the bottle
has first been opened.
If the solution has become discoloured or shown any other signs of
deterioration please tell your doctor or pharmacist before taking your
medicine.
Do not throw away any medicine via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.

Manufacturer and Product Licence Holder
Manufactured by Janssen Pharmaceutica N.V., Turnhoutseweg 30,
B-2340 Beerse, Belgium. Procured from within the EU by Product
Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow,
Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2658

Leaflet revision and issue date (Ref) 07.06.15[5]

Expand view ⇕

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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