Galantamine 12 Mg Film-Coated Tablets
TEVA UK Ref: 231-30-90040-C LEA GALANTAMINE A/S TABS TUK Version: 1 05 May 2015
PAGE 1: FRONT FACE (INSIDE OF REEL)
Pharma code 956 First bar is 105mm from top edge.
Package leaflet: Information for the 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.
• If you 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
• 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.
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
Galantamine is an antidementia medicine used to treat the symptoms of mild to moderately severe dementia of the 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 of the disease.
You must talk to a doctor if you do not feel better or if you feel worse.
Do not take Galantamine Film-coated Tablets
Some medicines can affect the way Galantamine Film-coated Tablets works, or Galantamine Film-coated Tablets 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 Film coated Tablets if you are also taking any of the medicines listed above.
Some medicines can increase the number of side effects caused by Galantamine Film-coated Tablets, 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 Film-coated Tablets.
If you have any questions, speak to 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 your treatment with Galantamine Film-coated Tablets to keep yourself hydrated. See section 3 of the leaflet for full details about how to take this medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 breast-feed while you are taking Galantamine Film-coated Tablets.
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.
Top of page cut-off to middle of registration mark: 44 mm.
• if you are allergic (hypersensitive) to galantamine or any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver and/or severe kidney disease.
Warnings and precautions
Talk to 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 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 potassium levels);
• peptic (stomach) ulcer disease;
• acute abdominal pain;
• a disorder of the 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);
• 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 Film-coated Tablets.
Your doctor will then decide whether treatment 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 if you 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) if taken by mouth.
Galantamine Film-coated Tablets contains lactose monohydrate
Warning: In addition to the active substance this product contains inactive ingredients necessary for the formulation. Some of these substances may, however, cause unwanted effects.
• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Galantamine Film-coated Tablets.
• 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).
Always this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you 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 and 12 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 four weeks of treatment the dose is increased. You would then take 8 mg (2 white tablets or 1 pink tablet) twice daily.
After another 4 weeks of treatment 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. If you feel that the effect of Galantamine Film-coated Tablets 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 Film-coated Tablets.
PAGE 2: REAR FACE (OUTSIDE OF REEL)
TEVA UK LIMITED
Liver or kidney disease
• If you have mild liver disease or mild to moderate kidney disease, the above dosing instructions are followed.
• If you 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.
• If you 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
If you have taken too 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
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 Galantamine Film-coated Tablets
You should consult your doctor before you stop taking Galantamine Film-coated Tablets. 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.
Like all medicines, this medicine 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 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. 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 side effects (may affect up to 1 in 10 people):
• Weight loss
• Loss of appetite
• Decreased appetite
• Slow heart beat
• Feeling faint
• Abnormally tired
• Stomach pain or discomfort
• Increased sweating
• Muscle spasms
• High blood pressure
• Feeling weak
• General feeling of discomfort
• 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 of abnormal heart beats (palpitations)
• Tingling, pricking or numbness of the skin
• Change in the sense of taste
• Excessive sleepiness
• 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
Rare side effects (may affect up to 1 in 1,000 people):
• Inflammation of the liver (hepatitis)
Tell your doctor or pharmacist if you are worried or think that Galantamine Film-coated Tablets is causing you a problem.
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.
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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the 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. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment
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 of tablets which can be identified by their colour and inscription:
Galantamine 4 mg Film-coated Tablets: Off white to light yellow
film coated capsule shaped tablet, debossed "602" on one side and "93" on the other side.
Galantamine 8 mg Film-coated Tablets: Pink, film coated capsule
shaped tablet, debossed "689" on one side and "93" on the other side.
Galantamine 12 mg Film-coated Tablets: 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
Marketing Authorisation Holder and manufacturer:
TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
This leaflet was last revised in April 2015
200 x 323