Reminyl 8mg Tablets
Ref: 02745/220316/1/F
Reminyl 8mg Tablets / Reminyl 12mg Tablets
(galantamine hydrobromide)
Patient Information 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.
Your medicine is called Reminyl 8mg Tablets or Reminyl 12mg Tablets but will be referred to as Reminyl throughout this Patient Information Leaflet. Please note that this leaflet also contains information about other strengths of this medicine Reminyl 4mg Tablets.
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 How to take Reminyl Possible side effects How to store Reminyl
[ffl Contents of the pack and other information
^ 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.
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, 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 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 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 or 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 any 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 tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Reminyl 12 mg (orange -brown) tablets contain orange-yellow S aluminium lake
The colouring in these tablets may cause allergic reaction
[m 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, taken twice a day (a total of 8 mg 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 12 mg, taken twice a day (a total of 24mg 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 a 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.
If you take more Reminyl than you should
If you take too much Reminyl, contact a doctor or hospital straight away. Take any remaining tablets and the packaging with you. The signs of overdose may include,
* severe nausea and vomiting,
* weak muscles, 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.
Reminyl 8mg Tablets / Reminyl 12mg Tablets
(galantamine hydrobromide)
Patient Information Leaflet (continued)
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.
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 affectmore than1 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 ears that does not go away (tinnitus)
* Low blood pressure
* Flushing
* Feeling the need to vomit (retch)
* Excessive sweating
* Weak muscles
* Increased level of liver enzymes
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 (see details below). By reporting side effects you help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
[a How to store Reminyl
Expiry Date
Do not use this medicine after the expiry date shown on the carton label or blister strip.
If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to.
If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
Storing your medicine
* KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never give your medicine to other people. It may harm them, even if their symptoms are the same as yours.
This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). He/she will have additional information about this medicine and will be able to advise you.
^ Contents of the pack and other information
What Reminyl contains:
Each Reminyl 8mg tablet contains 8mg of the active ingredient galantamine (as galantamine hydrobromide) and each Reminyl 12mg tablet contains 12mg of the active ingredient galantamine (as galantamine hydrobromide). The other ingredients are:
colloidal anhydrous silica, crospovidone, lactose monohydrate, magnesium stearate and microcrystalline cellulose.
Film coat: hypromellose, propylene glycol, talc and titanium dioxide (E171). Red ferric oxide (E172) in the 8mg and 12mg tablets, and orange-yellow S aluminium lake (E110) in the 12mg tablet.
What Reminyl looks like and contents of the pack
The 8mg tablets are circular, pink film coated tablets marked ‘G 8' with a score line on one side and ‘JANSSEN' on the other side, and are available in packs of 56. (4 blister strips of 14 tablets).
The 12mg tablets are circular, orange-brown film coated tablets marked ‘G12' on one side and ‘JANSSEN' on the other side, and are available in packs of 56 (4 blister strips of 14 tablets) or 168 (12 blister strips of 14 tablets).
Manufacturer and Licence Holder
The tablets are manufactured by Janssen-Cilag SpA, Via C. Janssen -Borgo S. Michele, Latina, Italy, and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 15184/0274 Reminyl 8mg Tablet 1-1 PL 15184/0275 Reminyl 12mg Tablet
Reminyl is a registered trademark of Shire Pharmaceutical Development Limited.
Revision date: 22/03/16
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
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 SW1 P 1 PH. 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.