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DANTROLENE SODIUM 25MG CAPSULES

Active substance(s): DANTROLENE SODIUM

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Dantrium® 25mg Capsules/Dantrolene sodium 25mg Capsules
(dantrolene sodium)

This product is available using any of the above names but will be referred
to as Dantrium Capsules throughout the following:
Patient Information Leaflet
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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

1) What Dantrium Capsules are and what they are 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 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) Before you take Dantrium Capsules

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 anesthetise 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.

DO NOT take Dantrium Capsules if you:
• are allergic to any of the ingredients in the product (see Section 6 and
end of Section 2)
• have a known liver function impairment
• have acute skeletal muscle spasm (your muscles go rigid suddenly)
• need spasticity to stand up, walk or cope with daily activities.
DO NOT give Dantrium Capsules to children.

Important information about some of the ingredients of Dantrium
Capsules
Lactose - if you know you have an intolerance to some sugars, speak to
your doctor before taking this medicine.
Wheat starch – suitable for people with coeliac disease. Patients with
wheat allergy (different from coeliac disease) should not take this
medicine.

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.

3) How to take Dantrium Capsules

Liver function tests should be performed frequently before start and
during Dantrium 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.

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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 25mg 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 100mg 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.
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; 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 sight and reach of children.
Store in the original packaging in order to protect from light and moisture.
Do not take the capsules after the expiry “exp” date printed on the label.
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. Each capsule contains 25mg
of the active ingredient dantrolene sodium.
Each capsule also contains: lactose monohydrate, wheat starch, talc,
magnesium stearate, gelatine, erythrosine (E127), titanium dioxide (E171)
and iron oxide (E172). (see also end of Section 2 “Important information
about some of the ingredients of Dantrium Capsules”).
What Dantrium Capsules looks like and contents of the pack
Dantrium Capsules are hard gelatine capsules with an opaque brown body
and an opaque orange cap containing a deep orange powder.
The capsules are available as 50 capsules in a carton.
Who makes and repackages your medicine
PL 10383/1427

Dantrium® 25mg Capsules/
Dantrolene sodium 25mg Capsules

POM

Your medicine is manufactured by Famar L’Aigle - Zone Industrielle n°1 Route de Crulai - 61300 L’AIGLE - France. Procured from within the EU by
the Product Licence holder: Primecrown Ltd., 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet Date: 17.05.2016
Dantrium® is a trademark of SpePharm Ip B.V., The Netherlands.

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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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