Modified Release Capsules
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about REMINYL 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
REMINYL against the benefits this medicine is expected to have for you.
If you have any concerns about taking REMINYL, ask your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What REMINYL is used for
REMINYL 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. REMINYL 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 REMINYL for another reason. Ask your doctor if you
have any questions about why this medicine has been prescribed for you.
Before you take REMINYL
When you must not take it
Do not take REMINYL if you have:
an allergy to REMINYL or any of the ingredients. See Product Description at the end
of this leaflet for a list of ingredients.
severe liver and/or kidney disease.
Do not take REMINYL if the packaging is torn or shows signs of tampering. Do not
use REMINYL beyond the expiry date (month and year) printed on the pack.
Before you start to take it
You must tell your doctor if you are:
pregnant, or planning to become pregnant
breastfeeding, or planning to breastfeed
planning to undergo surgery which will require anaesthesia.
You must also tell your doctor if you have, or have had any of the following health
liver and/or kidney disease
brain disorders, such as Parkinson's disease, fits
problems controlling movements of the body or limbs (extrapyramidal disorder)
breathing disorders, such as asthma, pneumonia
recent gut or bladder surgery
difficulties in passing urine
attacks of sudden abdominal pain
low potassium levels in the blood – weakness, muscle cramps, numbness and tingling
that begins in the lower extremities
If you have not told your doctor or pharmacist about any of the above, tell them before
you start taking or are given REMINYL.
Your doctor will advise you whether or not to take REMINYL or if you need to adjust
the dose or alter your treatment. Since there may be other related conditions that
REMINYL is not intended to treat, you should verify with your doctor that you are
taking REMINYL 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 REMINYL 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 REMINYL.
Taking other medicines:
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:
anticholinergic medicines (used to prevent travel sickness, relieve stomach cramps,
spasms or diarrhoea)
cholinergic medicines (e.g. bethanecol and certain medicines used during surgery)
medicines used to treat Parkinson's disease
medicines for certain heart problems (such as digoxin, quinidine) or to help lower
blood pressure (such as a class of medicine called beta blockers)
medicines used for breathing problems
certain medicines used to treat fungal infections (such as ketoconazole) or bacterial
infections (such as erythromycin)
certain medicines used to relieve pain, swelling and other symptoms of inflammation,
certain medicines used to treat depression, obsessive compulsive disorder (OCD), panic
disorder or anxiety (such as paroxetine, fluoxetine, fluvoxamine).
These medicines may be affected by REMINYL or may affect how well REMINYL 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
Alzheimer's disease may reduce your ability to drive or operate machines.
REMINYL may cause dizziness or drowsiness in some people, especially during initial
Discuss with your doctor whether it is safe for you to drive or operate machinery.
REMINYL modified release capsules should be taken once daily in the morning, preferably
with food. Be sure to drink plenty of liquids during your treatment with REMINYL to
keep yourself hydrated.
The dose of REMINYL 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:
Start with 8 mg a day.
After four weeks of treatment, raise the dose to 16 mg a day.
After at least another four weeks of treatment, raise the dose to 24 mg a day.
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 re-start your treatment at the lowest dose. This will minimise the chance
of experiencing side effects.
REMINYL is not recommended for children.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking it as you would
Do not take a double dose to make up for the dose you missed.
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
If you have taken too much (overdose)
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
Poisons Information Centre telephone numbers:
Australia: 13 11 26
New Zealand: 0800 764 766 or 0800 POISON
Keep these telephone numbers handy.
If you take too much REMINYL, you may experience nausea (feeling like you want to
vomit), vomiting, 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.
If you do not understand the instructions provided with this medicine, ask your doctor
or pharmacist for help.
While you are taking REMINYL
Things you must do
Always follow your doctor's instructions carefully.
Tell your doctor if you become pregnant while taking REMINYL.
Tell your doctor if you develop a rash or fever
If you are about to start taking a new medicine, tell your doctor and pharmacist that
you are taking REMINYL.
Things you must not do
Do not use REMINYL to treat any other complaint unless your doctor says so.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
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:
nausea, vomiting, diarrhoea, stomach pain or discomfort, indigestion, difficulty swallowing
distorted sense of taste
muscle spasm, tingling in the hands or feet
ringing in the ears
dehydration (sometimes severe) - thirst, lack of fluids
hallucinations (seeing, feeling or hearing things that are not there)
feeling depressed or having thoughts of harming yourself
low blood pressure - dizziness, light-headedness
slow, fast or irregular heart beat
trembling or shakiness
loss of appetite, weight loss
drowsiness, tiredness, weakness, feeling unwell, headache
falling (sometimes resulting in injury)
problems controlling movements of the body or limbs (extrapyramidal disorder)
high blood pressure
elevated liver enzymes
yellowing of the skin and eyes
light coloured bowel motions
dark coloured urine.
Some of these side effects occur mainly during the early stages of treatment, or when
the dose of REMINYL is increased. They usually disappear gradually over time. For
example, nausea and vomiting tend to pass after a few days.
Some of these effects may be due to the Alzheimer's disease but always inform your
doctor about any unwanted effect that has occurred while taking REMINYL.
Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital
if you notice any of the following:
signs of allergy such as rash or hives on the skin; swelling of the face, lips, tongue
or other parts of the body; wheezing or difficulty breathing.
vomiting blood or material that looks like coffee grounds
bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea
fainting, especially if you have a slow or irregular heart beat
widespread severe rash with peeling skin or white pus-filled spots which may be accompanied
by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson
syndrome or Acute generalized exanthematous pustulosis)
pain or tightness in the chest
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.
After taking REMINYL
Keep REMINYL in the pack until it is time to take them.
Keep REMINYL in a cool dry place where the temperature is below 30°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 REMINYL, 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
If your doctor tells you to stop taking REMINYL, or your medicine has passed its expiry
date, ask your pharmacist what to do with any medicine which may be left over.
What it looks like
There are 3 different types of REMINYL modified release capsules. Each capsule contains
a different amount of the active ingredient.
REMINYL 8 mg modified release capsules
White opaque capsules marked with 'G8', containing white to off-white pellets.
REMINYL 16 mg modified release capsules
Pink opaque capsules marked with 'G16', containing white to off-white pellets.
REMINYL 24 mg modified release capsules
Caramel opaque capsules marked with 'G24', containing white to off-white pellets.
Reminyl modified release capsules are available in blister pack of 28 capsules.
The active ingredient of REMINYL is galantamine hydrobromide.
REMINYL modified release capsules contain either 8 mg, 16mg or 24 mg of galantamine.
The capsules also contain:
non-pareil beads / sugar spheres (contains sucrose)
Opadry clear OY-7240 (PI 3234)
Opacode monogramming ink S-1-277002 Black (PI 107581) or TekPrint SW-9008 Black Ink
8 mg: empty hard gelatin capsules size 4 white Op. 44.000/44.000 pure bovine (ARTG
PI No 108031)
16 mg: Empty hard gelatin capsules size 2 37.024 Flesh Op.C024 pure bovine (ARTG PI
24 mg: Empty hard gelatin capsules size 1 36.092 Caramel Op.C024 pure bovine (ARTG
PI No 108030)
REMINYL modified release capsules do not contain gluten.
REMINYL modified release capsules contain sugars.
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Road
Macquarie Park NSW 2113
Telephone: 1800 226 334
NZ Office: Auckland, New Zealand
Telephone: 0800 800 806
The Australian Registration Numbers are:
REMINYL 8 mg capsules: AUST R 97883
REMINYL 16 mg capsules - AUST R 97885
REMINYL 24 mg capsules - AUST R 97887
This leaflet was prepared in April 2021.