Active ingredient
- galantamine hydrobromide
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00427/0237 .
Galantamine 4mg/ml Oral Solution
Package leaflet: Information for the user
Galantamine 4mg/ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Galantamine Oral Solution is and what it is used for
2. What you need to know before you take Galantamine Oral Solution
3. How to take Galantamine Oral Solution
4. Possible side effects
5. How to store Galantamine Oral Solution
6. Contents of the pack and other information
1. What Galantamine Oral Solution is and what it is used for
What your medicine is
The full name of your medicine is Galantamine 4mg/ml Oral Solution. In this leaflet the shorter name Galantamine is used. Galantamine belongs to a group of medicines known as ‘anti-dementia’ medicines.
What your medicine is used for
Galantamine is used in adults to treat the symptoms of mild to moderately severe Alzheimer’s disease. This is a type of dementia that alters the way the brain works. Alzheimer’s disease causes memory loss, confusion and changes in behaviour, which make it increasingly difficult to carry out normal daily tasks.
How your medicine works
The effects of Alzheimer’s disease on the brain are thought to be caused by a lack of ‘acetylcholine’. This is a substance which sends messages between brain cells. Galantamine increases the amount of ‘acetylcholine’ in the brain and helps more messages be sent.
2. What you need to know before you take Galantamine Oral Solution
Do not take Galantamine:
Do not take Galantamine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Galantamine.
Serious side effects
Galantamine can cause some side effects where you need to stop taking your medicine and tell your doctor straight away. These include heart problems and fits (seizures). See ‘Serious side effects’ at the top of section 4.
Warnings and precautions
Talk to your doctor or pharmacist before taking Galantamine. This medicine is only used for Alzheimer’s disease and is not recommended for other types of memory loss or confusion.
Before you take Galantamine, your doctor needs to know if you have, or have had, any of the following:
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Galantamine.
Operations or tests
Tell your doctor if you have recently had an operation on your stomach, intestines or bladder. Your doctor may decide that Galantamine is not suitable for you.
Galantamine may affect some medicines used during an operation (‘anaesthetics’). If you are going to have an operation, tell your doctor that you are taking Galantamine well in advance.
Galantamine and your weight
Your doctor will check your weight regularly when you take Galantamine. This is because Galantamine can cause weight loss.
Children and adolescents
Galantamine is not recommended for children or adolescents.
Other medicines and Galantamine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Galantamine can affect the way some other medicines work. Also, some other medicines can affect the way Galantamine works.
Galantamine should not be used with medicines that work in a similar way. These include:
Do not take Galantamine with any of the medicines above that work in a similar way.
Tell your doctor if you are taking any of the following medicines. They can make side effects more likely so your doctor may give you a lower dose of Galantamine. These include:
Tell your doctor if you are taking any of the medicines listed above. They can make side effects more likely so your doctor may give you a lower dose of Galantamine. If you have any questions, talk to your doctor or pharmacist for advice.
Pregnancy and breast-feeding
Driving and using machines
You may feel dizzy or sleepy while taking Galantamine, especially during the first few weeks of treatment. If this happens, do not drive, cycle, use any tools or machines.
Galantamine Oral Solution contains sodium methyl, sodium propyl parahydroxybenzoates, and sodium saccharin
3. How to take Galantamine Oral Solution
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
Your doctor will need to see you regularly, to check the medicine is working and to discuss how you are feeling.
People with liver or kidney problems
Your doctor may give you a lower dose of Galantamine, or they may decide this medicine is not suitable for you.
Taking this medicine
Measuring your dose
The solution comes with a syringe. This should be used to measure the exact amount of medicine you need.
1. Open the bottle by pressing the cap and turning it anticlockwise (Figure 1).
2. Insert the syringe adaptor into the bottle neck (Figure 2).
3. Take the syringe and put it in the adaptor opening (Figure 3).
4. Turn the bottle upside down (Figure 4).
5. Fill the syringe with a small amount of solution by pulling the piston down (Figure 4A). Then push the piston upward in order to remove any possible bubbles (Figure 4B). Finally, pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (Figure 4C).
6. Turn the bottle the right way up (Figure 5A).
7. Remove the syringe from the adaptor (Figure 5B). Empty the syringe into any non-alcoholic drink and use immediately.
8. Wash the syringe with water and let it dry before you use it again (Figure 6).
9. Close the bottle with the plastic screw cap - leave the syringe adaptor in the bottle.
If you take more Galantamine than you should
If you take too much Galantamine, contact a doctor or go to hospital straight away. Take any remaining solution and the packaging with you. The signs of an overdose may include:
If you forget to take Galantamine
If you stop taking Galantamine
Do not stop taking this medicine without talking to your doctor. Your signs may return. 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
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop taking Galantamine and tell your doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
Stop taking Galantamine and tell your doctor straight away if you notice any of the serious side effects above – you may need urgent medical treatment.
Other side effects
Tell your doctor or pharmacist if you notice any of the following side effects:
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Galantamine Oral Solution
6. Contents of the pack and other information
What Galantamine contains
What Galantamine looks like and contents of the pack
Galantamine is a clear colourless solution. It comes in a brown glass bottle holding 100ml of solution with a 3ml syringe and bottle adaptor.
The Marketing Authorisation Holder and Manufacturer is
This leaflet was last revised in 02/2021.
Other sources of information
This leaflet is also available in other formats for blind and partially-sighted patients. For large print and Braille, please go to www.xpil.medicines.org.uk
For an audio version, please go to www.rosemontpharma.com/products
D6W98RBJ2
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
+44 (0)113 244 1400
+44 (0)800 919 312
+44 (0)113 245 3567
+44 (0)7836 557 879