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DANTRIUM CAPSULES 100MG

Active substance(s): DANTROLENE SODIUM

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22226103
3
CR1723
DANTRIUM Capsules
04/11/16
UK
PIL 100mg
Rottendorf
NOR-LFT18-V1
148x280mm
181
309511
N/A

542983A03

Black

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

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

Page 1 of 2

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.
309511

22226103
3
CR1723
DANTRIUM Capsules
04/11/16
UK
PIL 100mg
Rottendorf
NOR-LFT18-V1
148x280mm
181
309511
N/A

542983A03

Black

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

Page 2 of 2

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).
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.
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.
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.
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.
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

22226103
309511

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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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