Reminyl Xl 24mg Capsules
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Reminyl® XL 24mg Capsules
(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 Reminyl XL 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.
The name of your medicine is Reminyl XL 24mg Capsules but will be referred to as Reminyl XL throughout this leaflet. Please note that this leaflet also contains information about other strengths such as Reminyl XL 8mg and 16mg Capsules.
In this leaflet:
1 What Reminyl XL is and what it is used for
2 Before you take Reminyl XL
3 How to take Reminyl XL
4 Possible side effects
5 How to store Reminyl XL
6 Further information
1 What Reminyl XL is and what it is used for
Reminyl XL 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 XL increases the amount of acetylcholine in the brain and so could improve the symptoms of the disease.
The capsules are made in a ‘prolonged-release' form. This means that they release the medicine more slowly.
2 Before you take Reminyl XL
Do not take Reminyl XL
• 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 XL
Reminyl XL should be used in Alzheimer's disease and not other forms of memory loss or confusion.
Medicines are not always suitable for everyone. Your doctor needs to know before you take Reminyl XL if you suffer from or have suffered in the past from any of the following conditions:
• liver or kidney problems
• a heart disorder (e.g. angina, heart attack, heart failure, slow or irregular pulse)
• electrolyte disturbances (e.g. decreased/ increased blood potassium levels)
• peptic (stomach) ulcer disease
• acute abdominal pain
• a disorder of the nervous system (like epilepsy or Parkinson’s disease)
• a respiratory disease or infection that interferes with breathing (like asthma, obstructive pulmonary disease, or pneumonia)
• if you recently had an operation on the gut or bladder
• if you have difficulties passing urine
If you need an operation which requires a general anaesthetic, you should inform the doctor that you are taking Reminyl XL.
Your doctor will then decide whether treatment with Reminyl XL 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.
Reminyl 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 muscular weakness)
• pilocarpine (for dry mouth or dry eyes) if taken by mouth.
Some medicines can affect the way Reminyl XL works, or Reminyl XL itself can reduce the effectiveness of other medicines taken at the same time. These include:
• paroxetine or fluoxetine (antidepressants)
• quinidine (used for heart rhythm problems)
• ketoconazole (antifungal)
• erythromycin (antibiotic)
• ritonavir (antiviral - HIV protease inhibitor). Your doctor may prescribe a smaller dose of Reminyl XL if you are also taking any of the medicines listed above.
Some medicines can increase the number of side effects caused by Reminyl XL, these include:
• non-steroidal anti-inflammatory painkillers (e.g. ibuprofen) which can increase the risk of ulcers
• medicines taken for heart disorders or high blood pressure (e.g. digoxin, amiodarone, atropine, beta-blockers, or calcium channel blocking agents). If you take medicines for an irregular heart-beat, your doctor may consider an electrocardiogram (ECG).
If you need an operation which requires a general anaesthetic, you should inform the doctor that you are taking Reminyl XL.
If you have any questions, speak to your doctor or pharmacist for advice.
Taking Reminyl XL with food and drink
Reminyl XL should be taken with food if possible.
Drink plenty of liquids during your treatment with Reminyl XL, to keep yourself hydrated. See section 3 of this leaflet for full details about how to take this medicine.
Pregnancy and breast-feeding
Before taking Reminyl XL, 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 Reminyl XL.
Driving and using machines
Reminyl XL may cause dizziness or drowsiness, especially during the first few weeks of treatment. If you experience these symptoms, do not drive or use any tools or machinery.
Important information about some of the ingredients of Reminyl XL
This product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3 How to take Reminyl XL
Always take Reminyl XL exactly as your doctor has told you. You should check with your doctor if you have any questions.
If you are currently taking Reminyl tablets or oral solution and have been told by your doctor to switch to Reminyl XL prolonged-release capsules read the instructions at the end of this section carefully.
How to take Reminyl XL
Reminyl XL should be swallowed whole, NOT chewed or crushed. Reminyl XL should be taken in the morning, with water or other liquids, and preferably with food.
Reminyl XL prolonged-release capsules are available in three strengths: 8mg, 16mg and 24mg. Reminyl XL is started at a low dose. Your doctor may then tell you to slowly increase the dose (strength) of Reminyl XL that you take to find the most suitable dose for you.
1. The treatment is started with the 8mg capsule taken once daily. After 4 weeks of treatment, the dose is increased.
2. You would then take the 16mg capsule once daily. After another 4 weeks of treatment at the earliest, your doctor may decide to increase the dose again.
3. You would then take the 24mg capsule once 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 XL 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 XL.
• If you have mild liver or kidney disease, treatment is started with the 8mg capsule once daily in the morning.
• If you have moderate liver or kidney disease, treatment is started with the 8mg capsule once every other day in the morning. After one week, begin taking the 8mg capsule once daily in the morning. Do not take more than 16mg once daily.
• If you have severe liver and/or kidney disease, do not take Reminyl XL.
If you take more Reminyl XL than you should
If you take too much Reminyl XL, contact a doctor or hospital straight away. Take along any remaining capsules and the packaging with you. Signs or symptoms of overdose may include, among others: severe nausea, vomiting, muscle weakness, slow heart beat, seizures and loss of consciousness.
If you forget to take Reminyl 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, you should contact your doctor.
You should consult your doctor before you stop taking Reminyl XL. It is important to continue taking this medicine to treat your condition.
How do I switch from taking Reminyl tablets or oral solution to Reminyl XL prolonged-release capsules?
If you are currently taking Reminyl tablets or oral solution, your doctor may decide to switch you to Reminyl XL prolonged-release capsules.
• Take your last dose of Reminyl tablets or oral solution in the evening
• The next morning, take your first dose of Reminyl XL prolonged-release capsules.
DO NOT take more than one capsule in a day. While you are taking once-daily Reminyl XL capsules, DO NOT take Reminyl tablets or oral solution.
Children
Reminyl XL is not recommended for children.
A translation of the days of the week as they appear on the blister strips is as follows:
French: LUN MAR MER JEU VEN SAM DIM English: MON TUE WED THU FRI SAT SUN
4 Possible side effects
Like all medicines, Reminyl XL 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.
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
• Fit (Seizures)
• 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).
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 XL
Keep out of the sight and reach of children. If the capsules become discolored or show
Do not store above 30°C. signs of ^i^ratoiT you should seek the
advice of your pharmacist.
Do not use your medicine after the expiry date on the carton and blister foil.
Always return any leftover medicines to your pharmacist.
6 Further information
What Reminyl XL contains:
Reminyl XL contains 24mg of the active ingredient galantamine in the form of galantamine hydrobromide. Reminyl XL is presented as prolonged-release hard capsules.
Other ingredients in the capsules are: diethyl phthalate, ethylcellulose, hypromellose, macrogol, maize starch, sucrose, gelatin, titanium dioxide, red ferric oxide, yellow ferric oxide, black printing ink.
What Reminyl looks like and contents of the pack
Reminyl XL capsules are available in three strengths, each of which can be recognized by its colour and lettering:
The caramel opaque capsules contain 24 mg galantamine, and are marked G24
Manufactured by: Janssen-Cilag SpA, Via C Janssen, 04010 Borgo San Michelle, Latina, Italy.
Procured from within the EU and repackaged by the Product Licence holder: B&S
Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK
Reminyl XL 24mg Capsules I POM
PL No: 18799/1771
Leaflet date: 07.03.2014
Reminyl is a registered trademark of Shire Pharmaceutical Development Ltd. in the UK and Ireland.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Galantamine hydrobromide 24mg Capsules
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.
The name of your medicine is Galantamine hydrobromide 24mg Capsules but will be referred to as Galantamine throughout this leaflet. Please note that this leaflet also contains information about other strengths such as Galantamine hydrobromide 8mg and 16mg Capsules.
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.
The capsules are made in a ‘prolonged-release' form. This means that they release the medicine more slowly.
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)
• a respiratory disease or infection that interferes with breathing (like asthma, obstructive pulmonary disease, or pneumonia)
• if you recently had an operation on the gut or bladder
• if you have difficulties passing urine
If you need an operation which requires a general anaesthetic, you should inform the doctor that you are taking Galantamine.
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.
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.
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.
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.
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.
Important information about some of the ingredients of Galantamine
This product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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.
If you are currently taking Reminyl 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 to take Galantamine
Galantamine should be swallowed whole, NOT chewed or crushed. Galantamine should be taken in the morning, with water or other liquids, and preferably with food.
Galantamine prolonged-release capsules are available in three strengths: 8mg, 16mg and 24mg. Reminyl XL 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 with the 8mg capsule taken once daily. After 4 weeks of treatment, the dose is increased.
2. You would then take the 16mg capsule once daily. After another 4 weeks of treatment at the earliest, your doctor may decide to increase the dose again.
3. You would then take the 24mg capsule once 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.
• If you have mild liver or kidney disease, treatment is started with the 8mg capsule once daily in the morning.
• If you have moderate liver or kidney disease, treatment is started with the 8mg capsule once every other day in the morning. After one week, begin taking the 8mg capsule once daily in the morning. Do not take more than 16mg once daily.
• If you have severe liver and/or kidney disease, do not take Galantamine.
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 capsules 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.
You should consult your doctor before you stop taking Galantamine. It is important to continue taking this medicine to treat your condition.
How do I switch from taking Reminyl tablets or oral solution to Galantamine prolonged-release capsules?
If you are currently taking Reminyl tablets or oral solution, your doctor may decide to switch you to Galantamine prolonged-release capsules.
• Take your last dose of Reminyl 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 Reminyl tablets or oral solution.
Children
Galantamine is not recommended for children.
A translation of the days of the week as they appear on the blister strips is as follows:
French: LUN MAR MER JEU VEN SAM DIM English: MON TUE WED THU FRI SAT SUN
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.
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
• Fit (Seizures)
• 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).
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 store above 30°C.
Medicines can be kept for a limited period only. Therefore, do not use Galantamine after the date printed on the packaging.
Always return any leftover medicines to your pharmacist.
If the capsules become discolored or show signs of deterioration, you should seek the advice of your pharmacist.
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:
Galantamine contains 24mg of the active ingredient galantamine in the form of galantamine hydrobromide. Galantamine is presented as prolonged- release hard capsules.
Other ingredients in the capsules are: diethyl phthalate, ethylcellulose, hypromellose, macrogol, maize starch, sucrose, gelatin, titanium dioxide, red ferric oxide, yellow ferric oxide, black printing ink .
What Galantamine looks like and contents of the pack
Galantamine capsules are available in three strengths, each of which can be recognized by its colour and lettering:
Manufactured by: Janssen-Cilag SpA, Via C Janssen, 04010 Borgo San Michelle, Latina, Italy.
Procured from within the EU and repackaged by the Product Licence holder: B&S
Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK Galantamine hydrobromide 24mg Capsules PL No: 18799/1771
Leaflet date:07.03.2014
The caramel opaque capsules contain 24 mg galantamine, and are marked G24
The capsules are supplied in blister packs of 28.