Galantamine 4 Mg Film-Coated Tablets
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GALANTAMINE 4 mg, 8 mg AND 12 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FORTHE USER
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.
• Ifyou are a carer and will be giving Galantamine Film-coated Tablets to the person you look after, it is also important that you read this leaflet on their behalf.
• Ifyou have any furtherquestions, askyourdoctor or pharmacist.
• This medicine has been prescribed foryou only. Do not pass it on to others. It may harm them, even iftheir signs of illness are the same as yours.
• Ifyou get any side effects, talkto 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 Film-coated Tablets are and what they are used for
2. What you need to know before you take Galantamine Film-coated Tablets
3. How to take Galantamine Film-coated Tablets
4. Possible side effects
5. How to store Galantamine Film-coated Tablets
6. Contents of the pack and other information
OWHAT GALANTAMINE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
symptoms of mild to moderately severe dementia ofthe Alzheimer type, a condition 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 ofthe disease.
You musttalkto a doctor ifyou do not feel better or ifyou feel worse.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GALANTAMINE FILM-COATED TABLETS
Do not use Galantamine Film-coated Tablets
• Ifyou are allergic (hypersensitive) to galantamine or any ofthe other ingredients ofthis medicine (listed in section 6)
• Ifyou have severe liver and/or severe kidney disease.
Warnings and precautions
Talkto your doctor or pharmacist before taking Galantamine Film-coated Tablets.
Galantamine Film-coated Tablets 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 Film-coated Tablets ifyou suffer from or have suffered in the past from any ofthe 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 potassium levels)
• peptic (stomach) ulcer disease
• acuteabdominalpain
• a disorder ofthe nervous system (e.g. epilepsy, Parkinson's disease)
• a respiratory disease or infection that interferes with breathing (e.g. asthma, obstructive pulmonary disease or pneumonia)
• ifyou recently had an operation on the gut or bladder
• ifyou have difficulties passing urine.
Ifyou need an operation which requires a general anaesthetic, you should inform the doctor that you are taking Galantamine Film-coated Tablets.
Yourdoctorwillthen decidewhethertreatment with Galantamine Film-coated Tablets is suitable for you or if the dose needs to be changed.
Other medicines and Galantamine Film-coated Tablets
Tell your doctor or pharmacist ifyou are taking, having 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 (for dry mouth or dry eyes) iftaken by mouth.
Some medicines can affect the way Galantamine Film-coated Tablets works, or Galantamine Film-coatedTablets themselves 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 medicines listed above.
Some medicines can increase the number of side effects caused by Galantamine Film-coatedTablets,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).
Ifyou need an operation which requires a general anaesthetic, you should inform the doctorthat you aretaking Galantamine Film-coatedTablets.
Ifyou have any questions, speakto your doctor or pharmacist for advice.
Galantamine Film-coated Tablets with food and drink
Galantamine should be taken with food if possible.
Drink plenty of liquids during yourtreatment with Galantamine Film-coatedTablets to keep yourself hydrated. See section 3 ofthe leaflet for full details about how to take this medicine.
Pregnancy and breast-feeding
Ifyou are pregnant or breast-feeding, thinkyou may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not breast-feed while you are taking Galantamine Film-coatedTablets.
Driving and using machines
Galantamine may cause dizziness or drowsiness, especially during the first fewweeks oftreatment. Ifyou experience these symptoms, do not drive or use any tools or machinery. Galantamine Film-coated Tablets contains lactose monohydrate Warning: In addition to the active substance this product contains inactive ingredients necessary for the formulation. Some ofthese substances may, however, cause unwanted effects.
• Ifyou have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Galantamine Film-coatedTablets
• The 12 mg tablets contain sunset yellow FCF (E110) and allura red AC aluminium lake (E129), which can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to acetylsalicylic acid (e.g. aspirin).
^ HOWTO TAKE GALANTAMINE FILM-COATEDTABLETS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist ifyou are not sure.
How to take Galantamine Film-coated Tablets
Galantamine should be taken twice daily, in the morning and evening, with water or other liquids, and preferably with food.The tablets must not be broken, crushed or chewed.
These film-coated tablets are available in three strengths: 4 mg,
8 mg and12 mg. Galantamine is started at a low dose.Your doctor may then tell you to slowly increase the dose (strength) of Galantamine Film-coated Tablets you take, to find the best most suitable dose for you.
• The treatment is started at 4 mg (1 white tablet) taken twice daily
• After fourweeks oftreatment the dose is increased. You would then take8mg(2 white tablets or 1 pink tablet) twice daily.
• After another 4 weeks oftreatment at the earliest, your doctor may decide to increase the dose again. You would then take 12 mg (3 white tablets or 1 pink and 1 white tablet or 1 orange tablet) twice daily.
Your doctor will explain what dose to start with and when the dose should be increased. Ifyou feel that the effect of Galantamine Film-coatedTablets is too strong or too weak, talkto your doctor or pharmacist.
Your doctor will need to see you regularly to checkthat this medicine is working for you andto discuss how you are feeling. Your doctor will also check your weight regularly while you are taking Galantamine Film-coatedTablets.
Liver or kidney disease
• Ifyou have mild liver disease or mild to moderate kidney disease, the above dosing instructions are followed
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• Ifyou have moderate liver disease, treatment is started with the 4 mg tablet once daily in the morning. After one week, begin taking the 4 mg tablet twice daily for at least 4 weeks. Do not take more than 8 mg twice daily.
• Ifyou have severe liver and/or kidney disease, do not take Galantamine Film-coated Tablets.
Use in children
There is no use of Galantamine Film-coated Tablets in children.
If you take more Galantamine Film-coated Tablets than you should
Ifyou have takentoo much Galantamine Film-coated Tablets, contact a doctor or hospital straight away.Take along any remaining tablets 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 Film-coated Tablets
Ifyou 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.
Ifyou forget to take more than one dose, you should contact your doctor.
If you stop taking Galantamine Film-coated Tablets
You should consult your doctor before you stop taking Galantamine Film-coated Tablets. It is important to continuetaking this medicine to treat your condition.
Ifyou have any further questions on the use ofthis medicine, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some ofthese effects may be due to the disease itself.
Stop taking your medicine and see a doctor immediately ifyou 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 ofyour lips, face, throat or tongue.
Side effects include:
Very common side effects (may affect more than 1 in 10 people):
• 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. Ifyou 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 side effects (may affect uptol in 10 people):
• Weight loss
• Loss ofappetite
• Decreased appetite
• Slow heart beat
• Feeling faint
• Dizziness
• Trembling
• Headache
• Drowsiness
• Abnormallytired
• Stomach pain or discomfort
• Diarrhoea
• Indigestion
• Increased sweating
• Muscle spasms
• Falling
• High blood pressure
• Feeling weak
• General feeling ofdiscomfort
• Seeing, feeling or hearing things that are not real (hallucinations)
• Feeling sad (depression).
Uncommon side effects (may affect up to 1 in 100 people):
• 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 ofabnormal heart beats (palpitations)
• Tingling, pricking or numbness ofthe skin
• Changeinthesenseoftaste
• Excessive sleepiness
• Fits
• 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 ofthe face.
Rare side effects (may affect up to 1 in 1,000 people):
• Inflammation ofthe liver (hepatitis).
Tell your doctor or pharmacist ifyou are worried orthinkthat Galantamine Film-coatedTablets is causing you a problem.
Ifany ofthe side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
Ifyou get any side effects, talkto your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety ofthis medicine.
HOW TO STORE GALANTAMINE FILM-COATED TABLETS
Keep this medicine out of the sight and reach of children.
Do not use this medicine afterthe expiry date which is stated on the carton after "EXP'/The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Askyour pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Q CONTENTS OF THE PACK AND OTHER INFORMATION
What Galantamine Film-coated Tablets contains
• The active substance is galantamine.
Each 4 mg film-coated tablet contains 4 mg galantamine (as galantamine hydrobromide).
Each 8 mg film-coated tablet contains 8 mg galantamine (as galantamine hydrobromide).
Each 12 mg film-coated tablet contains 12 mg galantamine (as galantamine hydrobromide).
• The other ingredients are as follows:
Tablet core: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate Film-coating: polyvinyl alcohol,titanium dioxide (E171), macrogol 4000, talc and iron oxide yellow (E172).
In addition the tablets contain the following colouring agents:
8 mg tablets: iron oxide red (E172) & iron oxide black (E172);
12 mg tablets: iron oxide red (E172), sunset yellow FCF aluminium lake (E110) &allura red AC aluminium lake(E129). What Galantamine Film-coated Tablets looks like and contents of the pack
Galantamine comes in 3 different strengths oftablets which can be identified bytheircolourand inscription:
Galantamine 4 mg Film-coatedTablets:
Offwhite to light yellow film-coated capsule shaped tablet, debossed "602" on one side and "93" on the other side. Galantamine 8 mg Film-coatedTablets:
Pink, film-coated capsule shaped tablet, debossed "689" on one side and "93" on the other side.
Galantamine 12 mg Film-coatedTablets:
Orange, film-coated capsule shaped tablet, debossed "7417" on one side and "93" on the other side.
The 4 mg tablets come in packs of 14, 30, 56, 60 and 100 film-coated tablets.
The 8 mg tablets come in packs of 14, 30, 56, 60,100 and 112 film-coated tablets.
The 12 mg tablets come in packs of 14, 30, 56, 60,100,112 and 168 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer
TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne,
East Sussex, BN22 9AG.
This leaflet was last revised in October 2013.
TPTr77l
90040-B 200 x 323
REG0065783 Version 1.8 Approved 3of4 P age