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GALANTAMINE 8 MG FILM-COATED TABLETS

Active substance(s): GALANTAMINE HYDROBROMIDE

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ZINC Ref:

Version:

EAS2105a LEA GALANTAMINE 8MG AND 12MG FC TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
200 mm
N/A
N/A

1

22 January 2018

Colours Used:

BLACK
PANTONE® GREEN C
Template

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 697
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
symptoms, do not drive or use any tools or machinery.

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.

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 two strengths: 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 taken twice daily.
should inform the doctor that you are taking Galantamine
• After four weeks of treatment the dose is increased. You would
Film-coated Tablets.
then take 8 mg (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
may decide to increase the dose again. You would then take 12 mg
Film-coated Tablets is suitable for you or if the dose needs to be
(1 orange tablet) twice daily.
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.

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Version 3.2

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.

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

Galantamine
8 mg & 12 mg
Film-coated Tablets

ZINC Ref:

Version:

EAS2105a LEA GALANTAMINE 8MG AND 12MG FC TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
200 mm
N/A
N/A

1

22 January 2018

Colours Used:

BLACK
PANTONE® GREEN C
Template

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.








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
If you take more Galantamine Film-coated Tablets than you should pharmacist.
If you have taken too much Galantamine Film-coated Tablets, contact Reporting of side effects
a doctor or hospital straight away. Take along any remaining tablets If you get any side effects, talk to your doctor, pharmacist or nurse.
and the packaging with you. Signs or symptoms of overdose may This includes any possible side effects not listed in this leaflet. You
include, among others, severe nausea, vomiting, muscle weakness, can also report side effects directly via the Yellow Card Scheme at:
slow heart beat, seizures and loss of consciousness.
www.mhra.gov.uk/yellowcard
Use in children
There is no use of Galantamine Film-coated Tablets in children.

By reporting side effects you can help provide more information
on the safety of this medicine.

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

5

How to store Galantamine Film-coated Tablets

Keep this medicine out of the sight and reach of children.

If you stop taking Galantamine Film-coated Tablets

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.

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.

This medicinal product does not require any special storage
conditions.

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

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

4

Possible side effects

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.
Each 8 mg film-coated tablet contains 8 mg galantamine (as
Stop taking your medicine and see a doctor immediately if you
galantamine hydrobromide).
experience:
Each 12 mg film-coated tablet contains 12 mg galantamine (as
• Heart problems including changes in heart beat (slow or irregular)
galantamine hydrobromide).
• Palpitations (pounding heart beat)
• The other ingredients are as follows:
• Conditions like blackout
Tablet
core: lactose monohydrate, microcrystalline cellulose,
• An allergic reaction. The signs may include a rash, swallowing
crospovidone, colloidal anhydrous silica, magnesium stearate
or breathing problems, swelling of your lips, face, throat or
Film-coating:
polyvinyl alcohol, titanium dioxide (E171),
tongue
macrogol 4000, talc and iron oxide yellow (E172).
In addition the tablets contain the following colouring agents:
Side effects include:
8 mg tablets: iron oxide red (E172) & iron oxide black (E172);
Very common side effects (may affect more than 1 in 10 people):
12 mg tablets: iron oxide red (E172), sunset yellow FCF
Feeling sick and/or vomiting. If these undesired effects occur, they
aluminium lake (E110) & allura red AC aluminium lake (E129).
are mainly experienced early on in the treatment or when the dose
What Galantamine Film-coated Tablets looks like and contents of
is increased. They tend to disappear gradually as the body gets
the pack
used to the treatment and generally will not last for more than a
few days. If you have these effects, your doctor may recommend
Galantamine comes in 2 different strengths of tablets which can be
that you drink more liquids and, if necessary, may prescribe a
identified by their colour and inscription:
medicine to stop you being sick.
Galantamine 8 mg Film-coated Tablets: Pink, film coated capsule
shaped tablet, debossed
Common side effects (may affect up to 1 in 10 people):
"689" on one side and "93"
• Weight loss
on the other side.
• Loss of appetite
Galantamine 12 mg Film-coated Tablets: Orange, film coated
• Decreased appetite
capsule shaped tablet,
• Slow heart beat
debossed "7417" on one
• Feeling faint
side and "93" on the other
• Dizziness
side.
• Trembling
• Headache
The 8 mg tablets come in packs of 14, 30, 56, 60, 100 and 112
• Drowsiness
film-coated
tablets.
• Abnormally tired
The 12 mg tablets come in packs of 14, 30, 56, 60, 100, 112 and 168
• Stomach pain or discomfort
film-coated tablets.
• Diarrhoea
Not all pack sizes may be marketed.
• 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)

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 February 2018

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

REG0065783

Version 3.2

Approved

EAS2105a
90040-D
200 x 323

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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
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APPROVALS
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REG0065783

Meaning of Signature

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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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