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GALANTAMINE 8 MG FILM-COATED TABLETS

Active substance(s): GALANTAMINE HYDROBROMIDE

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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)

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:

Pharma code 956
First bar is 105mm from top edge.

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

1

What Galantamine Film-coated Tablets are and what
they are used for

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.

2

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

What you need to know before you take Galantamine Galantamine may cause dizziness or drowsiness, especially during
Film-coated Tablets
the first few weeks of treatment. If you experience these

Do not take Galantamine Film-coated Tablets
• 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.

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 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).

3

How to take Galantamine Film-coated Tablets

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.

If you need an operation which requires a general anaesthetic, you • The treatment is started at 4 mg (1 white tablet) taken twice
should inform the doctor that you are taking Galantamine
daily.
Film-coated Tablets.
• After four weeks of treatment the dose is increased. You would
then take 8 mg (2 white tablets or 1 pink tablet) twice daily.
Your doctor will then decide whether treatment with Galantamine
• After another 4 weeks of treatment at the earliest, your doctor
Film coated Tablets is suitable for you or if the dose needs to be
may decide to increase the dose again. You would then take 12 mg
changed.
(3 white tablets or 1 pink and 1 white tablet or 1 orange tablet)
Other medicines and Galantamine Film coated Tablets
twice daily.
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.

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.

Top of page cut-off to middle of registration mark: 44 mm.

Galantamine
4 mg, 8 mg & 12 mg
Film-coated Tablets

TEVA UK Ref:

231-30-90040-C LEA GALANTAMINE A/S TABS TUK

Version:

1

05 May 2015

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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.








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
If you take more Galantamine Film-coated Tablets than you should effects not listed in this leaflet, please tell your doctor or
pharmacist.
If you have taken too much Galantamine Film-coated Tablets, contact
a doctor or hospital straight away. Take along any remaining tablets Reporting of side effects
and the packaging with you. Signs or symptoms of overdose may If you get any side effects, talk to your doctor, pharmacist or nurse.
include, among others, severe nausea, vomiting, muscle weakness, This includes any possible side effects not listed in this leaflet. You
slow heart beat, seizures and loss of consciousness.
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
If you forget to take Galantamine Film-coated Tablets
By reporting side effects you can help provide more information
on the safety of this medicine.
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
How to store Galantamine Film-coated Tablets
a double dose to make up for a forgotten dose.

5

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.

4

Possible side effects

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

6

Contents of the pack and other information

Like all medicines, this medicine can cause side effects, although
not everybody gets them. Some of these effects may be due to the What Galantamine Film-coated Tablets contains
disease itself.
• The active substance is galantamine.
Stop taking your medicine and see a doctor immediately if you
Each 4 mg film-coated tablet contains 4 mg galantamine (as
experience:
galantamine hydrobromide).
• Heart problems including changes in heart beat (slow or irregular)
Each 8 mg film-coated tablet contains 8 mg galantamine (as
• Palpitations (pounding heart beat)
galantamine hydrobromide).
• Conditions like blackout
Each 12 mg film-coated tablet contains 12 mg galantamine (as
• An allergic reaction. The signs may include a rash, swallowing
galantamine hydrobromide).
or breathing problems, swelling of your lips, face, throat or
• The other ingredients are as follows:
tongue
Tablet core: lactose monohydrate, microcrystalline cellulose,
crospovidone, colloidal anhydrous silica, magnesium stearate
Side effects include:
Film-coating: polyvinyl alcohol, titanium dioxide (E171),
macrogol 4000, talc and iron oxide yellow (E172).
Very common side effects (may affect more than 1 in 10 people):
In addition the tablets contain the following colouring agents:
Feeling sick and/or vomiting. If these undesired effects occur, they
8 mg tablets: iron oxide red (E172) & iron oxide black (E172);
are mainly experienced early on in the treatment or when the dose
12 mg tablets: iron oxide red (E172), sunset yellow FCF
is increased. They tend to disappear gradually as the body gets
aluminium lake (E110) & allura red AC aluminium lake (E129).
used to the treatment and generally will not last for more than a
few days. If you have these effects, your doctor may recommend
What Galantamine Film-coated Tablets looks like and contents of
that you drink more liquids and, if necessary, may prescribe a
the pack
medicine to stop you being sick.
Galantamine comes in 3 different strengths of tablets which can be
Common side effects (may affect up to 1 in 10 people):
identified by their colour and inscription:
• Weight loss
Galantamine 4 mg Film-coated Tablets: Off white to light yellow
• Loss of appetite
film coated capsule
• Decreased appetite
shaped tablet, debossed
• Slow heart beat
"602" on one side and "93"
• Feeling faint
on the other side.
• Dizziness
Galantamine 8 mg Film-coated Tablets: Pink, film coated capsule
• Trembling
shaped tablet, debossed
• Headache
"689" on one side and "93"
• Drowsiness
on the other side.
• Abnormally tired
Galantamine 12 mg Film-coated Tablets: Orange, film coated
• Stomach pain or discomfort
capsule shaped tablet,
• Diarrhoea
debossed "7417" on one
• Indigestion
side and "93" on the other
• Increased sweating
side.
• 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 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
• Fits
• Blurred vision

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
90040-C
200 x 323

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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