Dantrolene sodium hemiheptahydrate
Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I taking Dantrium Capsules?
Dantrium contains an active ingredient dantrolene sodium hemiheptahydrate. It is used
to relax muscles which are in spasm as a result of spinal cord injury, stroke, cerebral
palsy or multiple sclerosis. It is of particular help to patients whose rehabilitation
is being slowed down by muscle spasm. For more information, see Section
1. Why am I taking Dantrium Capsules? in the full CMI.
2. What should I know before I take Dantrium Capsules?
Do not take Dantrium capsules if you have ever had an allergic reaction to any medicine
containing dantrolene sodium hemiheptahydrate or any of the ingredients listed at
the end of this leaflet; are lactose intolerant; have liver disease such as hepatitis
and cirrhosis; or your muscle spasms allow you to keep an upright position, to balance
during movement or for better physical function. Talk to your doctor if you have liver,
heart or kidney problems; breathing difficulty; are pregnant, or plan to become pregnant
or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Dantrium and affect how it works.
4. How do I take Dantrium Capsules?
Your doctor will decide how much Dantrium you should take each day and how long your
treatment with Dantrium should continue. More instructions can be found in Section
4. How do I take Dantrium Capsules? in the full CMI.
5. What should I know while taking Dantrium Capsules?
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Things you should do
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Keep all your doctor's appointments so that your progress and health can be monitored.
If you become pregnant while being treated with Dantrium, tell your doctor immediately.
Tell all doctors, dentists and pharmacists who are treating you that you are taking
Dantrium.
More information on "Things you should do" can be found in Section 5 in the full CMI.
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Things you should not do
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Do not take Dantrium to treat any other medical complaints unless your doctor tells
you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
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Driving or using machines
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Do not drive or operate machinery while you are taking Dantrium. It can cause drowsiness,
dizziness and weakness in some people and therefore may affect alertness.
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Drinking
alcohol
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Avoid drinking alcohol which may intensify drowsiness, dizziness and weakness.
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Looking after your medicine
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Store in original carton at below 30°C until ready for use.
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6. Are there any side effects?
Side effects of this medicine may include drowsiness; dizziness; weakness; fatigue;
diarrhoea; constipation; loss of appetite; difficulty swallowing; stomach cramps/pain;
indigestion; dry mouth; excessive saliva; vomiting; nausea; alteration of taste; swelling
of the face, lips, tongue or other parts of the body; shortness of breath; wheezing;
trouble breathing; chest pain; fits; speech problems; headache; light-headedness;
visual problems; trouble sleeping; depression; confusion; rashes; bleeding or bruising
more easily; sweating; backache; muscle pain; excessive tearing; chill; fever; frequent
urination; abnormal colouration of the urine; incontinence; difficulty passing urine;
erection problem; abnormal hair growth.
Dantrolene sodium hemiheptahydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Dantrium. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking Dantrium capsules.
Where to find information in this leaflet:
1. Why am I taking Dantrium Capsules?
Dantrium capsules contain the active ingredient dantrolene sodium hemiheptahydrate. The medicine is used to relax muscles which are
in spasm as a result of spinal cord injury, stroke, cerebral palsy or multiple sclerosis.
It is of particular help to those patients whose rehabilitation is being slowed down
by muscle spasm.
Your doctor may have prescribed it for another reason.
Ask your doctor if you have any questions about why Dantrium has been prescribed for
you.
2. What should I know before I take Dantrium Capsules?
Warnings
Do not take Dantrium if you are allergic to:
any medicine containing dantrolene sodium hemiheptahydrate
lactose
any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty
breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching
or hives on the skin.
Do not take Dantrium if you have or have had any of the following medical conditions:
liver disease such as hepatitis and cirrhosis
where your muscle spasms are used to allow you to keep an upright position, to balance
during movement or for better physical function.
Do not take Dantrium if:
the packaging is torn or shows signs of tampering
the expiry date printed on the pack has passed.
Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
you have liver problems.
It is essential to have your liver checked by your doctor before taking Dantrium,
to determine if you have any existing problems with your liver.
you have problems with your lungs and breathing
you have heart problems
you have kidney problems.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. Talk to your
doctor if you are breastfeeding or intend to breastfeed. Your doctor can discuss with
you the risks and benefits involved.
Dantrium should not be used while breastfeeding.
If you are not sure whether you should start taking this medicine, talk to your doctor.
This medicine is available only with a doctor's prescription.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including:
all prescription medicines
all medicines, vitamins, herbal supplements or natural therapies you buy without a
prescription from a pharmacy, supermarket, naturopath or health food shop.
Some medicines may be affected by Dantrium or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Your doctor will advise you.
Tell your doctor or pharmacist if you are taking any of the following:
medicines containing oestrogen, which include oral contraceptives and medicines used
to treat symptoms of menopause
calcium channel blockers such as verapamil, used to treat high blood pressure
other muscle relaxant medicines which work differently to Dantrium
CNS depressants (medicines to reduce anxiety or help you sleep).
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
4. How do I take Dantrium Capsules?
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
How much to take
Your doctor will decide how much Dantrium you should take each day and how long your
treatment with Dantrium should continue.
Take the capsules exactly as instructed by your doctor or pharmacist.
When to take
Your doctor will tell you how many times a day you should take Dantrium.
Always read the pharmacist's label to check the exact dose and how often to take it.
If you forget to take Dantrium
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
normally.
Do not take a double dose to make up for the dose that you have missed.
If you are not sure whether to skip the dose, ask your doctor or pharmacist for advice.
If you take too much Dantrium
Immediately telephone your doctor, or the Australian Poisons Information Centre (telephone
131 126), or go to Accident and Emergency at your nearest hospital, if you think you
or anyone else may have taken too much Dantrium.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
5. What should I know while taking Dantrium Capsules?
Things you should do
Keep all your doctor's appointments so that your progress and health can be monitored.
Dantrium can cause damage to your liver, so your liver function needs to be checked
regularly by your doctor to detect any abnormalities.
If you become pregnant while being treated with Dantrium, tell your doctor immediately.
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are being treated with Dantrium.
Tell all doctors, dentists and pharmacists who are treating you that you are taking
Dantrium.
Things you should not do
Do not take Dantrium to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Things to be careful of
Be careful of exposure to sunlight while being treated with Dantrium.
Dantrium may increase sensitivity of the skin to sun. Symptoms of sunburn (such as
redness, itching, swelling or blistering) may occur more quickly than normal.
Driving or using machines
Do not drive or operate machinery while you are taking Dantrium capsules.
Dantrium causes drowsiness, dizziness and weakness in some people and therefore may
affect alertness.
Drinking alcohol
Avoid drinking alcohol or taking medicines to reduce anxiety or help you sleep.
These may increase the drowsiness and dizziness effects of Dantrium and should be
avoided.
Looking after your medicine
Keep Dantrium in its original packaging until it is time to use it. If you take Dantrium
out of its packaging, it may not keep as well.
Keep your Dantrium in a cool, dry place where the temperature stays below 30°C.
Do not store Dantrium or any other medicine in the bathroom or near a sink. Do not
leave it in the car or on a window sill.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
When to discard your medicine
If your doctor tells you to stop taking this medicine, or it has passed its expiry
date, take it to any pharmacy for safe disposal.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below. Ask your doctor or pharmacist if you have any questions
about side effects.
Common side effects
Serious side effects
These are serious side effects. You may need urgent medical attention or hospitalisation.
These side effects are rare.
Some of these side effects (for example certain liver conditions, and blood abnormalities)
can only be found when your doctor does tests from time to time to check your progress.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
What Dantrium Capsules contain
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Active ingredient
(main ingredient)
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dantrolene sodium hemiheptahydrate
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Other ingredients
(inactive ingredients)
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gelatin
iron oxide red
iron oxide yellow
lactose monohydrate
magnesium stearate
maize starch
purified talc
sodium lauryl sulfate
sunset yellow FCF
TekPrint SW-9008 Black Ink
TekPrint SW-9010 Black Ink
titanium dioxide
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Do not take this medicine if you are allergic to any of these ingredients.
What Dantrium Capsules looks like
Dantrium 25 mg capsule (AUST R 42975): hard gelatin capsule with a tan opaque body and orange opaque cap, imprinted with
"Dantrium" "25 mg" on the cap and "0149" "0030" and single coding bars on the body
in black ink. Fill: deep orange cylindrical plug.
Dantrium 50 mg (AUST R 42976): hard gelatin capsule with a tan opaque body and orange opaque cap, imprinted with
the logo "Dantrium" "50mg" on the cap and "0149" "0031" and single coding bars on
the body in black ink. Fill: deep orange cylindrical plug.
Who distributes Dantrium Capsules
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in November 2024.
® Registered trademark