Reminyl Xl 24 Mg Prolonged-Release Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER REMINYL® XL 24 mg prolonged-release capsules
(galantamine hydrobromide)
This product is available as the above but will be referred to as Reminyl XL throughout the remainder of this leaflet.
This product is available in multiple strengths and other strengths will be referred to 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.
• 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 XL if you are taking some of these medicines.
Reminyl XL may affect some anaesthetics. If you are going to have an operation under a general anaesthetic, tell the doctor that you are taking Reminyl XL, well in advance.
If you have any questions, talk to your doctor or pharmacist for advice.
1. WHAT REMINYL XL IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REMINYL XL
3. HOW TO TAKE REMINYL XL CAPSULES
What is in this leaflet:
1. What Reminyl XL is and what it is used for
2. What you need to know before you take Reminyl XL
3. How to take Reminyl XL
4. Possible side effects
5. How to store Reminyl XL
6. Contents of the pack and other information
Reminyl XL contains the active substance 'galantamine', an antidementia medicine. It is used in adults to treat the symptoms of mild to moderately severe Alzheimer's disease, a type of dementia that alters brain function.
Alzheimer's disease causes increasing memory loss, confusion and behavioural changes which make it increasingly difficult to carry out normal daily activities.
These effects are thought to be caused by a lack of 'acetylcholine', a substance responsible for sending messages between brain cells. Reminyl XL increases the amount of acetylcholine in the brain and treats the signs of the disease.
The capsules are made in a 'prolonged release' form. This means that they release the medicine slowly.
Do not take Reminyl XL
• If you are allergic to galantamine or to any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver or severe kidney disease.
Warning and precautions
Talk to your doctor or pharmacist before taking Reminyl XL. This medicine is only used in Alzheimer's disease, and is not recommended for other types of memory loss or confusion.
Serious side effects
Reminyl XL can cause heart problems, fits (seizures). You must be aware of these side effects while you are taking Reminyl XL. See 'Look out for serious side effects' in section 4.
Before you take Reminyl XL, your doctor needs to know if you have, or have had, any of the following:
• liver or kidney problems
• a heart condition (such as chest discomfort that is often brought on by physical activity, a heart attack, heart failure, slow or uneven heart beat)
• change in 'electrolyte' levels (naturally occurring Chemicals in the blood, such as potassium)
• a peptic (stomach) ulcer
• blockage of the stomach or intestines
• a disorder of the nervous system (such as epilepsy or Parkinson's disease)
• a respiratory disease or infection that affects breathing (such as asthma, obstructive pulmonary disease or pneumonia)
• problems passing urine
Your doctor will decide if Reminyl XL is suitable for you, or if the dose needs to be changed.
Also tell your doctor if you recently had an operation on the
stomach, intestines or bladder. Your doctor may decide that Reminyl XL is not suitable for you
Reminyl XL can cause weight loss. Your doctor will check your weight regularly while you are taking Reminyl XL.
Children and adolescents
Reminyl XL is not recommended for children and adolescents. Other medicines and Reminyl XL
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
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 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 XL. These include:
• paroxetine or fluoxetine (antidepressants)
• quinidine (for uneven heart beat)
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 XL. Driving and using machines
Reminyl XL may make you feel dizzy or sleepy, especially during the first few weeks of treatment. If Reminyl XL affects you, do not drive or use any tools or machinery.
Reminyl XL 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.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
If you are currently taking Reminyl tablets or oral solution and have been told by your doctor to switch to Reminyl XL prolongedrelease capsules, carefully read the instructions under 'Switching from taking Reminyl tablets or oral solution to Reminyl capsule in this section.
How much to take
You will start treatment with Reminyl XL at a low dose. The usual starting dose is 8mg, taken once a day. Your doctor may gradually increase your dose, every 4 weeks or more, until you reach a dose that is suitable for you. The maximum dose is 24mg, taken once a day.
Switching from taking Reminyl tablets or oral solution to Reminyl XL capsules If you are currently taking Reminyl tablets or oral solutions, your doctor may decide you should switch to Reminyl XL prolongedrelease capsules. If this applies to you:
• 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 capsule.
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.
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 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 and to discuss how you are feeling.
If you have a liver or kidney problem,
your doctor may give you a reduced dose of Reminyl XL, or may decide this medicine is not suitable for you.
How to take
Reminyl XL capsules must be swallowed whole and NOT chewed or crushed. Take your dose of Reminyl XL once a day in the morning, with water or other liquids. T ry to take Reminyl XL with food.
Drink plenty of liquids while you are taking Reminyl XL, to keep yourself hydrated.
If you take more Reminyl XL than you should
If you take too much Reminyl XL, contact a doctor or hospital straight away. Take any remaining capsules 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 XL
If you forget to take one dose, miss out the forgotten dose completely and take the next dose at the normal time. Do not take a double dose to make up for a forgotten dose.
If you forget to take more than one dose, contact your doctor.
If you stop taking Reminyl XL
Check with your doctor before you stop taking Reminyl XL. It is important to continue taking this medicine to treat your condition.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
POM
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Look out for serious side effects
Stop taking Reminyl XL and see a doctor immediately if you
notice any of the following:
• 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 XL (may affect up to 1 in 10 people).
• Fits (seizures). These are uncommon in people taking Reminyl XL (may affect up to 1 in 100 people).
Other Side effects:
Very Common side effects (may affect 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 medicines 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
What Reminyl XL looks like and contents of the pack
Reminyl XL is presented as hard, prolonged release capsules. The capsules come in 3 different strengths:
• the white opaque capsules contain 8mg galantamine (as galantamine hydrobromide) and are marked G8.
• the pink opaque capsules contain 16mg galantamine (as galantamine hydrobromide) and are marked G16.
• the caramel opaque capsules contain 24mg galantamine (as galantamine hydrobromide) and are marked G24.
The capsules are supplied in blister packs of 28.
Manufacturer:
Reminyl XL are manufactured by Janssen-Cilag SpA, Via C. Janssen, 04010 Borgo San Michele, Latina, Italy and are procured from within the EU by the Parallel Import Product Licence holder: G. Pharma Ltd., Salford M50 2PU.
PL 16369/1322
Reminyl XL XL 24mg Prolonged Release Capsules
30/07/2015
More Information
If you are a person with Alzheimer's disease or are caring for someone, and you are in England, Wales or Northern Ireland, further information, advice and support is available from the Alzheimer's Helpline
0845 300 0336 Monday - Friday 08.30 - 18.30.
The helpline is provided by the Alzheimer's Society, Gordon House, 10 Greencoat Place, London SW1P 1PH. Telephone: 020 7306 0606,
Fax: 020 7306 0808, e-mail: info@alzheimers.org.uk.
If you are in Scotland, further information, advice and support is available from the 24 hour Dementia Helpline on 0808 808 3000. The helpline is provided by Alzheimer Scotland - Action on Dementia,
22 Drumsheugh Gardens, Edinburgh EH3 7RN. Telephone (office):
0131 243 1453, Fax: 0131 243 1450, email: alzheimer@alzscot.org.
If you live in the Republic of Ireland, further information, advice and support is available from:
The Alzheimer Society of Ireland, Alzheimer House, 43 Northumberland Avenue, Dun Laoghaire, Co. Dublin.
Telephone: (01) 284 6616, Fax: (01) 284 6030, e-mail: info@alzheimer.ie, National Helpline (open Monday to Thursday 10am—4pm): 1 800 341 341 or Western Alzheimer Foundation, Mount Street, Claremorris, Co. Mayo. Telephone: 094 624 80. Fax: 094 62560.
Reminyl XL is a registered trademark of Shire Pharmaceutical Development Limited.
Rare side effects (may affect up to 1 in 1,000 people: • Inflamed liver (hepatitis)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not store above 30°C
Do not use Reminyl XL after the expiry date which is stated on the carton and blister foil after the letters EXP.
The expiry date refers to the last day of that month.
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.
Remember
This medicine is for you. Only your doctor can prescribe Reminyl XL for you. Never give your medicine to anyone else. It may harm them even if their condition is the same as yours. If you have any further questions about your medicine or your treatment, ask your doctor or pharmacist.
What Reminyl XL contains:
• The active substance is galantamine.
• Other ingredients in the capsules are: diethyl phthalate, ethylcellulose, hypromellose, macrogol 400, maize starch and sucrose.
• There are 59mg sucrose in the 8mg capsule, 117mg in the 16mg capsule and 176mg in the 24mg capsule.
• The capsule shell contains: gelatin and titanium dioxide (E171).
• Colouring agents in the capsule shell are:
16mg capsule: red iron oxide (E172)
24mg capsule: red iron oxide (E172) and yellow iron oxide (E172).
• Printing ink contains: shellac, black iron oxide (E172) and propylene glycol.