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DANTROLENE SODIUM 25MG CAPSULES

Active substance(s): DANTROLENE SODIUM / 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 leaflet. Dantrium is
available in 100mg strength.
Patient Information Leaflet
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 and Wheat starch
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.

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).
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

5) How to store Dantrium capsules

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 the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

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) Contents of the pack and other 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: 22.03.2017
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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