REMINYL 4 MG/ML ORAL SOLUTION

Active substance: GALANTAMINE

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PATIENT INFORMATION LEAFLET

2487
14.06.13[2]

Reminyl® 4 mg/ml Oral Solution
(galantamine hydrobromide)

 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.

You should not breastfeed while you are taking Reminyl.

Read all of this leaflet carefully before you start taking this medicine
 Keep this leaflet. You may need to read it again.
 If you are a carer and will be giving Reminyl to the person you look
after, it is also important that you read this leaflet on their behalf.
 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.

If you need an operation which requires a general anaesthetic, you
should inform the doctor that you are taking Reminyl.

Your medicine will be referred to as Reminyl throughout this leaflet.

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 muscular
weakness)
 pilocarpine (for dry mouth or dry eyes) if taken by mouth.

In this leaflet:
1. What Reminyl is and what it is used for
2. Before you take Reminyl
3. How to take Reminyl
4. Possible side effects
5. How to store Reminyl
6. Further information
1. What Reminyl is and what it is used for
Reminyl 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.
Reminyl increases the amount of acetylcholine in the brain and so could
improve the symptoms of the disease.
2. Before you take Reminyl
Do not take Reminyl
 If you are allergic (hypersensitive) to galantamine or to any of the other
ingredients listed in section 6 of this leaflet
 If you have severe liver and/or severe kidney disease
Take special care with Reminyl
Reminyl 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 Reminyl 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)

Pregnancy and breast-feeding
Before taking Reminyl, speak to your doctor for advice if you are
pregnant, think you could be pregnant, or you are planning a pregnancy.

Your doctor will then decide whether treatment with Reminyl is suitable
for you or if the dose needs to be changed.
Taking other medicines
You should always tell the doctor, nurse or pharmacist if you are taking or
have recently taken any other medicines, including those obtained without
a prescription.

Some medicines can affect the way Reminyl works, or Reminyl 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 Reminyl if you are also
taking any of the medicines listed above.
Some medicines can increase the number of side effects caused by
Reminyl, 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 Reminyl.
If you have any questions, speak to your doctor or pharmacist for advice.
Taking Reminyl with food and drink
Reminyl should be taken with food if possible.
Drink plenty of liquids during your treatment with Reminyl, to keep
yourself hydrated. See section 3 of this leaflet for full details about how to
take this medicine.

Driving and using machines
Reminyl 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.
Important information about some of the ingredients of Reminyl
This medicine contains methyl and propyl parahydroxybenzoates that can
sometimes cause allergic reactions, which may possibly be delayed.
3. How to take Reminyl
Always take Reminyl exactly as your doctor has told you. You should
check with your doctor if you have any questions.
How to take Reminyl oral solution
Reminyl oral solution should be taken twice daily, in the morning and
evening, with water or other liquids, and preferably with food.
Reminyl is started at a low dose. Your doctor may then tell you to slowly
increase the dose (strength) of Reminyl that you take, to find the most
suitable dose for you.
1. The treatment is started at 4 mg (1 millilitre of solution) taken twice
daily. After 4 weeks of treatment, the dose is increased.
2. You would then take 8 mg (2 millilitres of solution) twice daily. After
another 4 weeks of treatment at the earliest, your doctor may decide
to increase the dose again.
3. You would then take 12 mg (3 millilitres of solution) twice daily.
Your doctor will explain what dose to start with and when the dose should
be increased. If you feel that 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 for you and to discuss how you are feeling. Your doctor will also
check your weight regularly while you are taking Reminyl.
Liver or kidney disease
 If you have mild liver disease or mild to moderate kidney disease, the
above dosing instructions are followed.
 If you have moderate liver disease, treatment is started with 4 mg oral
solution once daily in the morning. After one week, begin taking the 4
mg oral solution twice daily for at least 4 weeks. Do not take more than
8 mg twice daily.
 If you have severe liver and/or kidney disease, do not take Reminyl.
The solution comes with a pipette which you should use to take the exact
amount needed from the bottle.

Directions for opening the bottle and using the pipette

If you stop taking Reminyl
You should consult your doctor before you stop taking Reminyl. It is
important to continue taking this medicine to treat your condition.
Children
Reminyl is not recommended for children.
4. Possible side effects
Like all medicines, Reminyl 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, swelling of your lips, face, throat or tongue
Side effects include:
Very Common: affects more than one user in 10.
 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.

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.
If you take more Reminyl than you should
If you take too much Reminyl, contact a doctor or hospital straight away.
Take along any remaining solution 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 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, you should contact your doctor.

Common: affects 1 to 10 users in 100.
 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).
Uncommon: affects 1 to 10 users in 1000
 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

Rare side effects: affects 1 to 10 users in 10000.
 Inflammation of the liver (hepatitis).
Tell your doctor or pharmacist if you are worried or think that
Reminyl is causing you a problem. If you notice any side effects not
listed in this leaflet, please tell your doctor.
5. How to store Reminyl
Keep out of the sight and reach of children.
Do not use Reminyl 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.
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
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 the inactive ingredients
methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate
(E216), sodium saccharin, sodium hydroxide, purified water.
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.
Manufacturer and Product Licence Holder
Manufactured by Janssen Pharmaceutica N.V., Turnhoutseweg 30, B2340 Beerse, Belgium. Procured from within the EU by Product Licence
holder Tenolol Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL No: 30900/2487

Leaflet revision and issue date (Ref) 14.06.13[2]
Reminyl is a trademark of Shire Pharmaceutical Development Ltd.

2487
14.06.13[2]

 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.

Pregnancy and breast-feeding
Before taking Galantamine, 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 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 are a carer and will be giving Galantamine to the person you look
after, it is also important that you read this leaflet on their behalf.
 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.

If you need an operation which requires a general anaesthetic, you
should inform the doctor that you are taking Galantamine.

Driving and using machines
Galantamine 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.

Your medicine will be referred to as Galantamine throughout this leaflet.

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 muscular
weakness)
 pilocarpine (for dry mouth or dry eyes) if taken by mouth.

PATIENT INFORMATION LEAFLET

Galantamine 4 mg/ml Oral Solution
(galantamine hydrobromide)

In this leaflet:
1. What Galantamine is and what it is used for
2. Before you take Galantamine
3. How to take Galantamine
4. Possible side effects
5. How to store Galantamine
6. Further information
1. What Galantamine is and what it is used for
Galantamine 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.
Galantamine increases the amount of acetylcholine in the brain and so
could improve the symptoms of the disease.
2. Before you take Galantamine
Do not take Galantamine
 If you are allergic (hypersensitive) to galantamine or to any of the other
ingredients listed in section 6 of this leaflet
 If you have severe liver and/or severe kidney disease
Take special care with Galantamine
Galantamine 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 Galantamine 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)

Your doctor will then decide whether treatment with Galantamine is
suitable for you or if the dose needs to be changed.
Taking other medicines
You should always tell the doctor, nurse or pharmacist if you are taking or
have recently taken any other medicines, including those obtained without
a prescription.

Some medicines can affect the way Galantamine works, or Galantamine
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 Galantamine if you are also
taking any of the medicines listed above.
Some medicines can increase the number of side effects caused by
Galantamine, 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 Galantamine.
If you have any questions, speak to your doctor or pharmacist for advice.
Taking Galantamine with food and drink
Galantamine should be taken with food if possible.
Drink plenty of liquids during your treatment with Galantamine, to keep
yourself hydrated. See section 3 of this leaflet for full details about how to
take this medicine.

Important information about some of the ingredients of Galantamine
This medicine contains methyl and propyl parahydroxybenzoates that can
sometimes cause allergic reactions, which may possibly be delayed.
3. How to take Galantamine
Always take Galantamine exactly as your doctor has told you. You should
check with your doctor if you have any questions.
How to take Galantamine oral solution
Galantamine oral solution should be taken twice daily, in the morning and
evening, with water or other liquids, and preferably with food.
Galantamine is started at a low dose. Your doctor may then tell you to
slowly increase the dose (strength) of Galantamine that you take, to find
the most suitable dose for you.
1. The treatment is started at 4 mg (1 millilitre of solution) taken twice
daily. After 4 weeks of treatment, the dose is increased.
2. You would then take 8 mg (2 millilitres of solution) twice daily. After
another 4 weeks of treatment at the earliest, your doctor may decide
to increase the dose again.
3. You would then take 12 mg (3 millilitres of solution) twice daily.
Your doctor will explain what dose to start with and when the dose should
be increased. If you feel that 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 for you and to discuss how you are feeling. Your doctor will also
check your weight regularly while you are taking Galantamine.
Liver or kidney disease
 If you have mild liver disease or mild to moderate kidney disease, the
above dosing instructions are followed.
 If you have moderate liver disease, treatment is started with 4 mg oral
solution once daily in the morning. After one week, begin taking the 4
mg oral solution twice daily for at least 4 weeks. Do not take more than
8 mg twice daily.
 If you have severe liver and/or kidney disease, do not take
Galantamine.
The solution comes with a pipette which you should use to take the exact
amount needed from the bottle.

Directions for opening the bottle and using the pipette

If you stop taking Galantamine
You should consult your doctor before you stop taking Galantamine. It is
important to continue taking this medicine to treat your condition.
Children
Galantamine is not recommended for children.
4. Possible side effects
Like all medicines, Galantamine 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, swelling of your lips, face, throat or tongue
Side effects include:
Very Common: affects more than one user in 10.
 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.

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.
If you take more Galantamine than you should
If you take too much Galantamine, contact a doctor or hospital straight
away. Take along any remaining solution 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 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, you should contact your doctor.

Common: affects 1 to 10 users in 100.
 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).
Uncommon: affects 1 to 10 users in 1000
 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

Rare side effects: affects 1 to 10 users in 10000.
 Inflammation of the liver (hepatitis).
Tell your doctor or pharmacist if you are worried or think that
Galantamine is causing you a problem. If you notice any side effects
not listed in this leaflet, please tell your doctor.
5. How to store Galantamine
Keep out of the sight and reach of children.
Do not use Galantamine 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.
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
What Galantamine contains
It contains the active ingredient galantamine hydrobromide.
Each 1 ml of oral solution contains 4 mg of galantamine (as
hydrobromide).
Galantamine also contains the inactive ingredients
methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate
(E216), sodium saccharin, sodium hydroxide, purified water
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.
Manufacturer and Product Licence Holder
Manufactured by Janssen Pharmaceutica N.V., Turnhoutseweg 30, B2340 Beerse, Belgium. Procured from within the EU by Product Licence
holder Tenolol Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL No: 30900/2487

Leaflet revision and issue date (Ref) 14.06.13[2]

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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