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Galantamine 4 Mg/ Ml Oral Solution

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Document: leaflet MAH BRAND_PLPI 20636-2658 change

2658

07.06.16[5]


PATIENT INFORMATION LEAFLET

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

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.

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.

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.

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).

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

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.

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

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.

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).

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

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.aov.uk/vellowcard. 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.

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.

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.

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.

2658

07.06.16[5]


PATIENT INFORMATION LEAFLET

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.

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 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

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.

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. 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 Galantamine.

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.

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.

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).

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.aov.uk/vellowcard. 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.

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.

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.

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]