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 35533/0016.
Gatalin XL 8mg, 16mg, 24mg prolonged-release capsules, hard
Gatalin XL 8mg prolonged-release capsules, hard
Gatalin XL 16mg prolonged-release capsules, hard
Gatalin XL 24mg prolonged-release capsules, hard
1. What Gatalin XL is and what it is used for
2. What you need to know before you take Gatalin XL
3. How to take Gatalin XL
4. Possible side effects
5. How to store Gatalin XL
6. Contents of the pack and other information
Gatalin XL contains the active substance galantamine, an antidementia medicine. It is used in adults to treat the symptoms of mild to moderately severe Alzheimer’s disease, a type of dementia that alters brain function.
Alzheimer’s disease causes increasing memory loss, confusion and behavioural changes, which make it increasingly difficult to carry out normal daily activities. These effects are thought to be caused by a lack of acetylcholine, a substance responsible for sending messages between brain cells. Gatalin XL increases the amount of acetylcholine in the brain and treats the signs of the disease.
The capsules are made in a ‘prolonged-release’ form. This means that they release the medicine slowly.
Talk to your doctor or pharmacist before taking Gatalin XL. This medicine is only used in Alzheimer’s disease and is not recommended for other types of memory loss or confusion.
This medicine can cause serious skin reactions, heart problems and fits (seizures). You must be aware of these side effects while you are taking Gatalin XL. See ‘Look out for serious side effects’ in section 4.
Before you take Gatalin XL, your doctor needs to know if you have, or have had, any of the following:
Your doctor will decide if Gatalin XL is suitable for you, or if the dose needs to be changed.
Tell your doctor if you recently had an operation on the stomach, intestines or bladder. Your doctor may decide that this medicine is not suitable for you.
Gatalin XL can cause weight loss. Your doctor will check your weight regularly while you are taking this medicine.
This medicine is not recommended for children and adolescents.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Gatalin XL must not be taken with medicines that work in a similar way. These include:
Some medicines can make side effects more likely in people taking Gatalin XL. These include:
Your doctor may give you a lower dose of Gatalin XL if you are also taking any of these medicines.
This medicine may affect some anaesthetics.
If you are going to have an operation under a general anaesthetic, tell the doctor that you are taking Gatalin XL well in advance.
If you have any questions, talk to your doctor or pharmacist for advice.
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 Gatalin XL.
This medicine may make you feel dizzy or sleepy, especially during the first few weeks of treatment. If Gatalin XL affects you, do not drive or use any tools or machinery.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
If you are currently taking galantamine tablets or oral solution and have been told by your doctor to switch to Gatalin XL prolonged-release capsules, carefully read the instructions under ‘Switching from taking galantamine tablets or oral solution to galantamine capsules’ in this section.
You will start treatment with Gatalin XL at a low dose. The recommended starting dose is 8mg, taken once a day. Your doctor may gradually increase your dose, every 4 weeks or more, until you reach a dose that is suitable for you. The maximum dose is 24mg, taken once a day.
Your doctor will explain what dose to start with and when the dose should be increased. If you are not sure what to do or find that the effect of Gatalin XL 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 and to discuss how you are feeling.
If you have liver or kidney problems, your doctor may give you a reduced dose of Gatalin XL or may decide this medicine is not suitable for you.
If you are currently taking galantamine tablets or oral solution, your doctor may decide you should switch to Gatalin XL prolonged-release capsules. If this applies to you:
DO NOT take more than one capsule in a day. While you are taking once-daily Gatalin XL capsules, DO NOT take galantamine tablets or oral solution.
Gatalin XL is for oral use.
The capsules must be swallowed whole and NOT chewed or crushed. Take your dose of Gatalin XL once a day in the morning, with water or other liquids. Try to take this medicine with food.
Drink plenty of liquids while you are taking Gatalin XL, to keep yourself hydrated.
If you take too much Gatalin XL, contact a doctor or hospital straight away. Take any remaining capsules and the packaging with you. The signs of overdose may include: severe nausea and vomiting, weak muscles, slow heartbeat, fits (seizures) and loss of consciousness.
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, contact your doctor.
Check with your doctor before you stop taking Gatalin XL. 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.
Stop taking this medicine and see a doctor or go to your nearest emergency department immediately if you notice any of the following:
These skin reactions are rare in people taking Gatalin XL (may affect up to 1 in 1,000 people).
You must stop taking Gatalin XL and seek help immediately if you notice any of the side effects listed above.
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):
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 (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.
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 and blister after EXP.
The expiry date refers to the last day of that month.
This medicine 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.
The active substance is galantamine.
The other ingredients are:
Cellulose microcrystalline, Hypromellose, Ethylcellulose and Magnesium stearate.
8mg: Gelatin and Titanium dioxide (E171).
16mg: Gelatin, Titanium dioxide (E171) and Red iron oxide (E172).
24mg: Gelatin, Titanium dioxide (E171), Indigo carmine (E132), Erythrosin (E127), Red iron oxide (E172) and Yellow iron oxide (E172).
8mg: opaque, white size 2 hard gelatin capsules containing one round biconvex tablet
16mg: opaque, flesh-coloured size 2 hard gelatin capsules containing two round biconvex tablets
24mg: opaque orange size 2 hard gelatin capsules containing three round biconvex tablets
The capsules are made in a prolonged-release form. This means that they release the medicine slowly.
The capsules are available in transparent PVC/PE/PVDC-Aluminum blisters with 1, 7, 14, 28, 30, 56, 60, 84, 90, 300 prolonged release capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in 11/2022
1010067 - P9.1