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DANTRIUM CAPSULES 100MG

Active substance(s): DANTROLENE SODIUM

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PACKAGE LEAFLET : INFORMATION FOR THE USER

Dantrium Capsules 25 mg
Dantrium Capsules 100 mg
®
®

Dantrolene sodium
Read all of this leaflet carefully before you start taking
this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Dantrium Capsules is and what it is used for
2. Before you take Dantrium Capsules
3. How to take Dantrium Capsules
4. Possible side effects
5. How to store Dantrium Capsules
6. Further information
1. WHAT DANTRIUM CAPSULES IS AND WHAT IT IS
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. 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).
- have a known liver function impairment.
- have acute skeletal muscle spasms (your muscles go
rigid suddenly).
- need spasticity to stand up, walk or cope with daily
activities.
DO NOT give Dantrium Capsules to children.
Take special care with Dantrium Capsules if you:
- have heart or lung function impairment.
- 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.

Taking other medicines:
Please tell your doctor 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).
Taking Dantrium Capsules with food and drink
Avoid taking alcohol with this medicine as it may make
you feel dizzy or drowsy.
Pregnancy and breast-feeding
Do not take the capsules if pregnant or breast-feeding
unless advised otherwise by your doctor.
Ask your doctor or pharmacist for advice before taking
any 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.
Important information about some of the ingredients
of Dantrium Capsules
Lactose - if you know you have intolerance to some
sugars, speak to your doctor before taking this medicine.
Sunset yellow colouring (E110) - may cause allergic
reactions (Dantrium 25mg Capsules only).
3. HOW TO TAKE DANTRIUM CAPSULES
Always take Dantrium Capsules exactly as your doctor
has told you. You should check with your doctor or
pharmacist 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.
Children should NOT be given Dantrium Capsules.
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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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dantrium Capsules 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.
The following side effects have also been reported:
Most common side effects
- dizziness, drowsiness
- weakness, tiredness
- feeling generally unwell
- 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, Dantrium
Capsules is usually stopped permanently.
Less common side effects
- loss of appetite (anorexia)
- seizures
- speech or visual disturbance
- headache
- inflammation of the membrane around the heart,
sometimes accompanied by fluid in the lungs.
- feeling sick (nausea, vomiting)
- abdominal pain
- liver toxicity (characterised by inflammation of the
liver), problems with liver function.
- skin rash, acne
- fever, chills.
Rare side effects
- confusion, nervousness
- depression
- difficulty sleeping (insomnia)
- fast heartbeat
- worsening of heart problems
- unstable blood pressure
- difficulty in breathing
- difficulty in swallowing
- constipation (which may on rare occasions lead to a
blockage in bowel movement).
- 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.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor.
5. HOW TO STORE DANTRIUM CAPSULES
Keep out of the reach and sight 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. FURTHER 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 looks 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
DANTRIUM is a registered
trademark of the SpePharm AG
group of companies, licensed
to the Norgine group of
companies.
This leaflet was last revised in
11/2015

22201002
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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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