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DANTRIUM CAPSULES 25MG

Active substance(s): DANTROLENE SODIUM / DANTROLENE SODIUM / DANTROLENE SODIUM

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22201003
2
CR1723
DANTRIUM Capsules
07/11/16
UK
PIL (25mg)
Stradis
NOR-LFT64-V1
150 x 400mm
N/A
309510
N/A

542995A03

Black

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Arial Rounded MT-Bold
Myriad Pro-Bold
Myriad Pro-Regular
Average Text Size (Body Text):
10.0 pt

Page 1 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

DANTRIUM® 25 mg Capsules /
DANTRIUM® 100 mg Capsules
Dantrolene sodium
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read
it again.
- If you have any further questions, ask
your doctor, pharmacist or nurse.
- This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
- If you get any side effects, talk to
your doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Dantrium Capsules are and what
they are used for
2. What you need to know before you
take Dantrium Capsules
3. How to take Dantrium Capsules
4. Possible side effects
5. How to store Dantrium Capsules
6. Contents of the pack and other
information
1. What

Dantrium Capsules are and
what they are used for
Dantrium Capsules contain the active
substance dantrolene sodium – this
is a muscle relaxant which is used to
treat severe, long term muscle stiffness
(spasticity) in adults.
2. What

you need to know before you
take Dantrium Capsules
DO NOT take Dantrium Capsules if:
- you are allergic to any ingredients in
the product (see section 6 and end of
section 2).
- you have been told by your doctor that
you are unable to take some sugars
such as lactose.
- you have a known liver problem.
- you have acute skeletal muscle spasms
(your muscles go rigid suddenly).
- you need spasticity to stand up, walk or
cope with daily activities.
DO NOT give Dantrium Capsules to children.
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before taking Dantrium Capsules.
Take special care with Dantrium Capsules
if you:
- have heart or lung problems.
- have liver disorders or notice signs
or symptoms of liver toxicity (e.g.,
discoloured faeces, intense itching,
jaundice, anorexia, nausea, vomiting
during therapy) – contact your doctor
immediately.
- are elderly.
Liver function tests should be performed
frequently before start and during
Dantrium Capsules therapy as the risk of
liver toxicity appears to be greater in:
- females
- patients over 30 years old.
- patients taking other medication.
- females using oral oestrogen
contraception.
Other medicines and Dantrium Capsules
Please tell your doctor, pharmacist
or nurse if you are taking or have
recently taken any other medicines,

including medicines obtained without a
prescription. Talk to your doctor before
taking Dantrium Capsules if you are
already taking:
- Oestrogen (found in most oral
contraceptive pills and hormone
replacement therapy) or other drugs
which might affect the liver.
- Tranquillisers (e.g, diazepam,
lorazepam or temazepam).
- Medicines used to treat abnormal
heartbeat, angina or high blood
pressure (e.g.products containing
verapamil).
- Products normally used to help doctors
anaesthetise patients (e.g.products
containing vecuronium).
Dantrium Capsules with food, drink and
alcohol
Avoid taking alcohol with this medicine as
it may make you feel dizzy or drowsy.
Pregnancy, breast-feeding and fertility
Do not take the capsules if pregnant or
breast-feeding unless advised otherwise
by your doctor.
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor,
pharmacist or nurse for advice before
taking this medicine.
Driving and using machines
Dantrium Capsules may cause drowsiness
or dizziness. These symptoms may be
intensified if you have consumed alcohol.
Do not take the capsules without talking
to your doctor if you drive or are involved
in hazardous activities.
Dantrium Capsules contain Lactose.
If you have been told by your doctor that
you have an intolerance to some sugars,
speak to your doctor before taking this
medicine.
Dantrium 25 mg Capsules only, contain
Sunset yellow colouring (E110) and may
cause allergic reactions.
3. How to take Dantrium Capsules
Always take Dantrium Capsules exactly
as your doctor or pharmacist or nurse
has told you. You should check with your
doctor or pharmacist or nurse if you are
not sure. Your doctor will want to make
sure that the capsules do not affect your
liver. This will mean having blood tests
before you start and while you are taking
them.
Adults and Elderly:
Dantrium Capsules are to be taken by
mouth. Swallow the capsule with a glass
of water. The dose will vary from person to
person.
- The starting dose is usually one
25 mg capsule a day.
- If there is no improvement, your doctor
may increase your dose every week
until the right dose for you is reached.
- The normal maximum dose is one
100 mg capsule four times a day. It is
important to take the lowest dose
which works for you.
- If there is no improvement after about
6-8 weeks, your medication will be
stopped by your doctor.
Use in children
Children should NOT be given Dantrium
Capsules.
If you take more Dantrium Capsules
than you should
Do not exceed the recommended dose.
If you take too much medicine, tell your
doctor immediately or go to your nearest
Accident & Emergency Department (take
the pack with you if possible).
309510

22201003
2
CR1723
DANTRIUM Capsules
07/11/16
UK
PIL (25mg)
Stradis
NOR-LFT64-V1
150 x 400mm
N/A
309510
N/A

If you forget to take Dantrium Capsules
If you miss a dose, do not take a double
dose to make up for a forgotten capsule;
continue taking your medicine as normal
at the correct time. If you have any further
questions on the use of this product, ask
your doctor or pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
You may suffer an allergic reaction,
symptoms of which include rash,
itching, difficulty in breathing or
swelling of the face, lips, throat or
tongue. If this happens to you, stop
taking the capsules immediately and
seek urgent medical attention.

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Immediately inform your health care
provider if you have discoloured stool,
generalised itch, yellowing of skin
and eyes, loss of appetite, feeling sick,
abnormal blood tests, as this may be signs
of a serious liver disorder.

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The following side effects have also been
reported:
Common: may affect up to 1 in 10 people
- drowsiness
- dizziness
- weakness
- feeling tired
- general feeling of uneasiness
- seizures
- speech or visual disturbance
- headache
- diarrhoea - if severe diarrhoea occurs,
your doctor may stop the capsules for
a short while. If you start taking them
again and the diarrhoea returns, the
use of Dantrium Capsules is usually
stopped permanently.
- loss of appetite (anorexia)
- confusion, nervousness
- depression
- difficulty sleeping (insomnia)
- inflammation of the membrane around
the heart, sometimes accompanied by
fluid in the lungs.
- difficulty in breathing, bluish colouration
in the skin, finger tips, or lips
- rapid shallow breathing
- chest pain
- feeling sick (nausea, vomiting)
- abdominal pain
- dry mouth
- abdominal fullness, heartburn
- fever, chills.
Uncommon: may affect up to 1 in
100 people
- worsening of heart problems
- difficulty in swallowing
- constipation (which may on rare
occasions lead to a blockage in bowel
movement).
- excessive sweating
- increased urinary frequency
- tiny crystals or traces of blood in the
urine, difficulty in controlling the
bladder (incontinence), being unable
to pass urine easily.

Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in
this leaflet. You can also report side
effects directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety of
this medicine.
5. How to store Dantrium Capsules
Keep out of the sight and reach of
children.
Store Dantrium Capsules below 30°C.
Do not take Dantrium Capsules after the
expiry date which is stated on the label
after “Exp”. The expiry date refers to the
last day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.
6. Contents of the pack and other
information
What Dantrium Capsules contain
- The active substance is dantrolene
sodium, 25 mg or 100 mg per capsule.
- The other ingredients are: lactose,
maize starch, talc and magnesium
stearate.
- The capsule shell of Dantrium
25mg capsules contains gelatin and
colouring agents E171 and E110
(see end of section 2).
- The capsule shell of Dantrium
100mg capsules contains gelatin and
colouring agents, E171, E172 and E132.
What Dantrium Capsules look like and
contents of the pack:
- Dantrium 25 mg Capsules: The capsules
are white/orange. The capsules are
supplied in plastic containers of
100 capsules.
- Dantrium 100 mg Capsules: The
capsules are white/green. The capsules
are supplied in plastic containers of
100 capsules.
Marketing Authorisation Holder and
Manufacturer:
Norgine BV
Hegehilweg 7
1101 CA Amsterdam ZO
The Netherlands
If you need further
information or this
leaflet in an alternative
format please ring
01895 246606.
This leaflet was last revised in 11/2016

Unknown: frequency cannot be estimated
from the available data
- yellowing of the skin (jaundice)
- hepatitis (symptoms include:
abdominal pain, joint pain, weakness
and fatigue)
- blood in the stool or black stool
- slow heartbeat
- fast heartbeat
If any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor.
22201003
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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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