Dantrolene Sodium 25mg Capsules
Dantrium 25mg Capsules Ref: 1196/080616/1 /F
(dantrolene sodium)
Patient Information Leaflet
Your medicine is called Dantrium 25mg Capsules but will be referred to as Dantrium Capsules throughout this leaflet.
Please note that the leaflet also contains information about other strengths of this medicine, Dantrium 100mg Capsules.
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:
What Dantrium Capsules are and what they are used for Before you take Dantrium Capsules How to take Dantrium Capsules Possible side effects How to store Dantrium Capsules ^ Further information
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.
Before you take Dantrium Capsules
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 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 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 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 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.
(dantrolene sodium)
Patient Information Leaflet (continued)
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 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
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.
[p Further information
What Dantrium Capsules contain
Each capsule contains 25mg of dantrolene sodium as the active ingredient. Dantrium Capsules also has the following inactive ingredients: gelatin, wheat starch, talc, magnesium stearate, lactose monohydrate, erythrosine (E127), iron oxide (E172) and titanium dioxide (E171).
What Dantrium Capsules looks like and contents of the pack
Dantrium Capsules are a hard gelatine capsule with an opaque beige/peach body and an opaque orange cap containing a deep orange powder.
The capsules have no markings.
Dantrium Capsules comes in packs of 50 and 100 capsules.
Manufacturer and Licence Holder
The capsules are manufactured by Famar L'Aigle - Zone industrielle n°1 -Route de Crulai -61300 L'AIGLE, France and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 15184/1196
Dantrium is a registered trademark of Procter & Gamble Pharmaceuticals, Inc.
Revision date: 08/06/16
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
[p How to store Dantrium Capsules
Keep out of the sight and reach of children.
Do not store above 30°C.
Store in the original container.
Protect from light.
Protect from moisture.
Do not use Dantrium after the expiry date which is stated on the box/blisters/label. The expiry date refers to the last day of the month.
If your medicine becomes discoloured or shows any signs of deterioration, consult your pharmacist who will tell you what to do.
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.
Patient Information Leaflet
Your medicine is called Dantrolene Sodium 25mg Capsules but will be referred to as Dantrolene Sodium Capsules throughout this leaflet.
Please note that the leaflet also contains information about other strengths of this medicine, Dantrolene Sodium 100mg Capsules.
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:
^ What Dantrolene Sodium Capsules are and what they are used for Before you take Dantrolene Sodium Capsules [a How to take Dantrolene Sodium Capsules ^ Possible side effects
How to store Dantrolene Sodium Capsules [m Further information
* Products normally used to help doctors anaesthetise patients (e.g.products containing vecuronium).
Taking Dantrolene Sodium 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
Dantrolene Sodium 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 Dantrolene Sodium 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).
What Dantrolene Sodium Capsules are and what they are used for
Dantrolene Sodium 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.
[a Before you take Dantrolene Sodium Capsules
DO NOT take Dantrolene Sodium 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 spasms (your muscles go rigid suddenly)
* need spasticity to stand up, walk or cope with daily activities.
DO NOT give Dantrolene Sodium Capsules to children.
Take special care with Dantrolene Sodium 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 Dantrolene Sodium 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 Dantrolene Sodium 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)
[3) How to take Dantrolene Sodium Capsules
Always take Dantrolene Sodium 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:
Dantrolene Sodium 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 Dantrolene Sodium Capsules.
If you take more Dantrolene sodium 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 Dantrolene Sodium 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.
Patient Information Leaflet (continued)
[4 Possible side effects
Like all medicines, Dantrolene Sodium 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, Dantrolene Sodium 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
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.
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.
^ Further information
What Dantrolene Sodium Capsules contain
Each capsule contains 25mg of dantrolene sodium as the active ingredient. Dantrolene Sodium Capsules also has the following inactive ingredients: gelatin, wheat starch, talc, magnesium stearate, lactose monohydrate, erythrosine (E127), iron oxide (E172) and titanium dioxide (E171).
What Dantrolene Sodium Capsules looks like and contents of the pack
Dantrolene Sodium Capsules are a hard gelatine capsule with an opaque beige/ peach body and an opaque orange cap containing a deep orange powder.
The capsules have no markings.
Dantrolene Sodium Capsules comes in packs of 50 and 100 capsules.
Manufacture and Licence Holder
The capsules are manufactured by Famar L'Aigle - Zone industrielle n°1 -Route de Crulai -61300 L'AIGLE, France and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 15184/1196
Revision date: 08/06/16
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
[5) How to store Dantrolene Sodium Capsules
Keep out of the sight and reach of children.
Do not store above 30°C.
Store in the original container.
Protect from light.
Protect from moisture.
Do not use Dantrolene Sodium after the expiry date which is stated on the box/blisters/label. The expiry date refers to the last day of the month.
If your medicine becomes discoloured or shows any signs of deterioration, consult your pharmacist who will tell you what to do.