Reminyl Xl 8mg Prolonged-Release Capsules
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Reminyl® XL 24mg Prolonged-Release Capsules
(Galantamine hydrobromide)
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 8mg Prolonged-Release Capsules or Reminyl XL 24mg Prolonged-Release capsules will be referred to as Reminyl XL throughout the remainder of this leaflet.
Your medicine is available in the above two strengths and also 16mg.
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 capsules
Reminyl XL capsules 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 3 strengths:
8 mg, 16 mg and 24 mg.
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 8 mg capsule taken once daily. After 4 weeks of treatment, the dose is increased.
2. You would then take the 16 mg 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 24 mg 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.
Liver or kidney disease
If you have mild liver or kidney disease, treatment is started with the 8 mg capsule once daily in the morning.
If you have moderate liver or kidney disease, treatment is started with the 8 mg capsule once every other day in the morning. After one week, begin taking the 8 mg capsule once daily in the morning. Do not take more than 16 mg 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.
If you stop taking Reminyl XL
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.
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).
Tell your doctor or pharmacist if you are worried or think that Reminyl XL is causing you a problem. If you notice any side effects not listed in this leaflet, please tell your doctor.
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 reach and sight of children.
Do not use after the expiry date shown on the blister pack and carton label. If the capsules show any sign of deterioration or discoloration, consult your pharmacist for advice. Always return any left over medicines to your pharmacist.
Do not store above 30°C.
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. FUTHER INFORMATION
Reminyl XL 8mg Capsules are white, opaque capsules marked ‘G8' in black ink on the cap. Each hard, prolonged-release capsule contains 8mg galantamine (as galantamine hydrobromide).
Reminyl XL 24mg Capsules are caramel, opaque capsules marked ‘G24' in black ink on the cap. Each hard, prolonged-release capsule contains 24mg galantamine (as galantamine hydrobromide).
The other ingredients in Reminyl XL Capsules are: diethyl phthalate, ethylcellulose, hypromellose, macrogol, maize starch, sucrose, gelatin, titanium dioxide (E171), benzoic acid (E210), black ferric oxide (E172), dimethyl siloxanes, glycerides, lecithin soya, methylcellulose, macrogol stearate, shellac, sorbic acid and xanthum gum.
Reminyl XL 24mg Capsules contain red ferric oxide (E172) and yellow ferric oxide (E172).
Reminyl XL capsules are available in aluminium calendar blister packs of 28 capsules.
Manufactured by Janssen-Cilag SpA, Via C Janssen, 04010 Borgo San Michele (Latina), Italy. Procured from within the EU. Product Licence Holder : Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by Maxearn Ltd, Bolton,
BL6 4SA.
PL 20774/0876 Reminyl XL 8mg Prolonged-Release Capsules PL 20774/0878 Reminyl XL 24mg Prolonged-Release Capsules
POM
Reminyl is a registered trademark of Janssen - Cilag Ltd Leaflet revision date: 13th November 2013 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.
PP6/0876/78/V2