Consumer Medicine Information
This leaflet answers some common questions about Gamine XR modified release capsules. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits this medicine is expected to have for you.
Ask your doctor or pharmacist if you have any concerns about taking Gamine XR.
Keep this leaflet with your medicine. You may need to read it again.
Gamine XR is used to treat mild to moderately severe dementia of the Alzheimer's type.
The symptoms of Alzheimer’s disease include confusion, memory loss or other changes in behaviour. As the disease progresses, patients find it more and more difficult to carry out their normal daily activities.
The symptoms of Alzheimer’s disease are thought to be due to a lack of acetylcholine, a substance which transmits messages between brain cells. Gamine XR increases the amount of this substance to help improve or stabilise the symptoms and therefore slow the progress of Alzheimer’s disease.
Your doctor may have prescribed this medicine for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Do not take Gamine XR if you have:
Do not take this medicine if the packaging is torn or shows signs of tampering.
Do not use it beyond the expiry date (month and year) printed on the pack.
You must tell your doctor if you are:
You must also tell your doctor if you have, or have had any of the following health problems:
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking or are given Gamine XR.
Your doctor will advise you whether or not to take Gamine XR or if you need to adjust the dose or alter your treatment. Since there may be other related conditions that this medicine is not intended to treat, you should verify with your doctor that you are taking it for the treatment of mild to moderate Alzheimer’s disease.
Initial results from clinical trials in patients with mild cognitive impairment of various causes have shown a slightly higher mortality rate (higher death rate) in those taking Gamine XR than those taking placebo (a pill without an active ingredient which is commonly used in clinical trials as a reference for comparison). The reason for this difference is currently not known and may just be due to chance. There is no evidence of increased risk of death in those with mild to moderately severe Alzheimer's disease taking Gamine XR.
Tell your doctor or pharmacist if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.
In particular, tell your doctor or pharmacist if you are taking any of the following:
These medicines may be affected by Gamine XR or may affect how well it works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
Effects on driving and operating machinery
Gamine XR modified release capsules should be taken once a day, preferably with food. Be sure to drink plenty of liquids during your treatment to keep yourself hydrated. The capsule must be swallowed whole. The contents should not be crushed and sprinkled on food.
The dose of Gamine XR is gradually increased to the most suitable dose. The necessary dosage steps should be determined by your doctor to suit your needs.
The following scheme is an example of how your doctor may increase the dose:
For long-term treatment, up to 24 mg a day is usually suitable but your doctor will determine the dose that is best for you.
If treatment is discontinued for more than several days, tell your doctor. Your doctor will need to restart your treatment at the lowest dose. This will minimise the chance of experiencing side effects.
Gamine XR is not recommended for children.
If you do not understand the instructions provided with this medicine, ask your doctor or pharmacist for help.
If you have missed more than one dose, or are not sure what to do, check with your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
Immediately telephone your doctor or the Poisons Information Centre for advice, or go to Accident and Emergency at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Poisons Information Centre telephone numbers:
Keep these telephone numbers handy .
If you take too much Gamine XR, you may experience vomiting or a feeling that you want to vomit, nausea,
stomach cramps, excessive production of saliva, tears or sweat, dry mouth, loss of control of your bladder or bowels, a slow or fast heart beat, low blood pressure, dizziness, light-headedness, muscle weakness or twitching, fits, breathing difficulties, chest pain, hallucinations or you may collapse.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects. Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you experience any of the following and they worry you:
Some of these side effects occur mainly during the early stages of treatment, or when the dose is increased. They usually disappear gradually over time. For example, nausea and vomiting tend to pass after a few days.
Always inform your doctor about any unwanted effect that has occurred while taking this medicine as some of these effects may be due to the Alzheimer’s disease.
Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following:
These may be serious side effects. You may need urgent medical attention. These are rare side effects.
Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.
Keep your tablets in the pack until it is time to take them.
Keep it in a cool dry place where the temperature is below 25°C.
Keep your medicines where children cannot reach them. A locked cupboard at least one-and-a-half metres (1.5 m) above the ground is a good place to store medicines.
Do not store Gamine XR, or any other medicine, in the bathroom or near a sink. Do not leave medicines in the car or on windowsills. Heat and dampness can destroy some medicines.
If your doctor tells you to stop taking Gamine XR, or your medicine has passed its expiry date, ask your pharmacist what to do with any medicine which may be left over.
There are 3 different types of Gamine XR modified release capsules:
Gamine XR modified release capsules are available in blister packs of 28 capsules.
The active ingredient of Gamine XR is galantamine hydrobromide.
Gamine XR modified release capsules contain either 8 mg, 16 mg or 24 mg of galantamine (as hydrobromide).
All capsules also contain microcrystalline cellulose
In addition, the 16 mg capsules contain iron oxide red and the 24 mg capsules contain indogo carmine, erythrosine, iron oxide red and iron oxide yellow.
Aspen Pharma Pty Ltd
34 - 36 Chandos Street
St Leonards NSW 2065
This leaflet was prepared in November 2011.
Australian Registration Number:
Gamine XR 8mg 182028
Gamine XR 16mg 182038
Gamine XR 24mg 182040
Published by MIMS August 2012