Patient Leaflet Updated 06-Oct-2023 | Norgine Limited
Dantrium 25mg and 100mg Capsules
Dantrium® 25 mg Capsules / Dantrium® 100 mg Capsules
Dantrolene sodium
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
Dantrium is a medicine that reduces increased muscle tension.
Dantrium is used for spastic movement disorders with abnormally increased muscle tension due to various causes in adults and children over the age of 5 years old weighing 25 kg or more.
Talk to your doctor or pharmacist before taking Dantrium.
Take special care with Dantrium
Before and during treatment with Dantrium your doctor will carry out regular blood tests to check your liver function. If the values are outside the normal range, treatment with Dantrium must be discontinued.
If you notice any signs that might indicate liver damage, such as unusual fatigue, light stools, itching all over the body, yellowing of the skin or eyes, loss of appetite, nausea and vomiting, you should seek medical attention immediately.
The risk of liver damage appears to be particularly high at daily doses of more than 300 mg, with prolonged treatment, in female patients over 30 years of age, with a history of liver damage and concomitant use of other medicines that can cause liver damage. Liver damage can be life-threatening, especially in the elderly.
If you suffer from multiple sclerosis, the risk of serious liver damage appears to be even higher.
Dantrium may cause the skin to become sensitive to light (photosensitisation), so you should protect yourself from strong sunlight during treatment.
Administration of Dantrium must be discontinued if patients have developed cardiac and pleural reactions with fluid accumulation (pleural or pericardial effusion or pleuropericarditis).
Doses of more than 200 mg dantrolene per day are more likely to cause side effects.
This medicine contains only very low levels of gluten (from wheat starch). It is regarded as ‘gluten-free’ and is very unlikely to cause problems if you have coeliac disease.
One Dantrium 25mg capsule contains no more than 3.8 micrograms of gluten.
One Dantrium 100mg capsule contains no more than 3.3 micrograms of gluten.
Dantrium can be used in children over 5 years of age under supervision from your doctor.
Dantrium should not be given to children under 5 years of age as there is insufficient experience with the use of Dantrium in this patient group to determine tolerability.
Tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are not prescription medications.
If taken at the same time as
Simultaneous use of medicines that depress the central nervous system (sedatives, such as benzodiazepines, antihistamines) and alcohol is to be avoided as the side effects of Dantrium may be increased (in particular the central nervous system depressant effect and muscle weakness).
In patients predisposed to malignant hyperthermia (certain complications of anaesthesia) who received intravenous dantrolene, it has been observed that simultaneous administration of calcium antagonists and/or beta-blockers (antihypertensive/heart disease drugs) resulted in elevated potassium levels and cardiac insufficiency.
Do not drink alcohol while taking Dantrium.
Dantrium should not be used during pregnancy, as the safety of Dantrium for use during pregnancy has not been established.
The active substance of Dantrium passes into breast milk. Dantrium should not be used while breast-feeding, since adverse effects on the breastfed child cannot be excluded, particularly under long-term treatment with Dantrium. Breast-feeding must be discontinued if treatment is required while breast-feeding.
Ask your doctor or pharmacist for advice before taking/using any medicine.
You must not drive or operate machinery without consulting your doctor.
When Dantrium or other medicines that also affect the central nervous system are taken at the same time, central nervous system effects, such as drowsiness or confusion, can change the ability to react to such an extent that it reduces the ability to drive or operate tools and machines. This particularly applies at the start of treatment, when dosage is increased and when taken together with alcohol.
This medicine contains lactose and wheat starch. If you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor before taking this medicine.
Always take Dantrium exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will slowly adjust the number of capsules you take until the optimal dose required for your treatment is reached. The lowest dose compatible with optimal response is recommended.
Adults
Unless prescribed otherwise by your doctor, the usual dose for adults at the beginning of treatment is 1 capsule daily. This dose should be increased weekly until the optimal dose is reached.
The dose should not be increased faster than as per the following schedule:
Week 1: 1 Dantrium 25 mg capsule once a day
Week 2: 1 Dantrium 25 mg capsule two times a day
Week 3: 2 Dantrium 25 mg capsules two times a day
Week 4: 2 Dantrium 25 mg capsules three times a day
Once the optimal dose is reached, the patient should take their total daily dose subdivided between 2 to 4 individual doses.
Doses of more than 200 mg should not be given in long-term Dantrium treatment, as doses of more than 200 mg of dantrolene per day are more likely to result in side effects.
If it is foreseeable that the patient will face stress or stressful situations, the dose can be increased temporarily and gradually up to 400 mg per day. The increased dose should be titrated as follows:
Week 5: 75 mg three times a day
Week 6: 75 mg four times a day
Week 7: 100 mg four times a day
Doses of more than 200 mg per day should not be given for more than 2 months.
Children
Unless prescribed otherwise by your doctor, the following dosage should be used for children aged 5 years and older (from 25 kg body weight):
Week 1: 1 Dantrium 25 mg capsule once a day
Week 2: 1 Dantrium 25 mg capsule two times a day
Week 3: 1 Dantrium 25 mg capsule three times a day
Week 4: 2 Dantrium 25 mg capsules two times a day
Week 5: 2 Dantrium 25 mg capsules three times a day
Week 6: 3 Dantrium 25 mg capsules three times a day
Children weighing 50 kg or more:
See dosage for adults.
The dose can be gradually increased up to 200 mg daily.
Please take the capsules whole with plenty of liquid (preferably with a glass of water).
If no improvement is achieved after a total of 6-8 weeks, treatment should be discontinued by the doctor.
Please talk to your doctor or pharmacist if you feel that the effect of Dantrium is too strong or too weak.
Tell your doctor immediately. He or she will take the necessary measures. Signs of overdose may include disorders of consciousness (e.g. lethargy, coma), muscle weakness, fatigue, dizziness, weakness, impaired vision, rapid heartbeat, itching, loss of appetite, nausea, vomiting, diarrhoea, light stools, yellowing of the skin or eyes.
Do not take a double dose to make up for an omitted dose. Take the same number of capsules as prescribed, when your next dose is due. If you are unsure what to do, please talk to your doctor.
If you temporarily want to stop treatment or stop it early, e.g. because the side effects appear too severe, please talk to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequencies for the following list of adverse drug reactions are based on estimates after reports of adverse drug reactions to the approved drug.
Very common (may affect more than 1 in 10 people): Fatigue, weakness, malaise, dizziness, drowsiness and diarrhoea. In persistent diarrhoea, the medicinal product must be discontinued.
Common (may affect up to 1 in 10 people): In patients treated with Dantrium, the following occurred: Headache, speech disorders, seizures, loss of appetite, impaired vision, abdominal cramps, nausea, vomiting, skin rashes, acne-like skin reactions, muscle weakness, which may cause functional impairment and coordination disorders, chills, fever, depression, confusion, nervousness, insomnia, respiratory failure, abnormal liver function test, liver damage: even daily doses of up to 200 mg can cause liver-damaging side effects, usually as inflammation of the liver with jaundice.
Uncommon (may affect up to 1 in 100 people): In patients treated with Dantrium, the following occurred: Reduction of red blood cells due to impaired or lack of production (aplastic anaemia), reduction of white blood cells (leukopaenia), lymph node cancer (lymphocytic lymphoma), thrombocytopaenia, allergic reaction, acute allergic reaction (anaphylaxis), hallucinations, triggering of cerebral seizures, particularly in children with cerebral palsy; aggravation of paralysis in amyotrophic lateral sclerosis (ALS, a disorder of the nervous system) or presence of symptoms of bulbar paralysis (symptoms caused by damage to certain cranial nerves). Double vision, increased tear-flow, increased heart rate, insufficient cardiac output (heart failure); phlebitis, fluctuations in blood pressure, constipation, in rare cases including intestinal obstruction; difficulty swallowing, taste disorders, shortness of breath, bleeding in the gastrointestinal tract, abdominal pain, increased salivation.
Increased sweating, abnormal hair growth, itching, photosensitivity, muscle and back pain, excretion of crystals or red blood cells in the urine (crystalluria, haematuria), involuntary urinary incontinence, urinary retention or increased urinary frequency, Cardiac and pleural reactions with fluid accumulation (pleural or pericardial effusion or pleuropericarditis), accompanied by eosinophilia (proliferation of certain cells in the blood) has been reported, as well as respiratory disorders, presumably due to weakening of the respiratory muscles.
Very Rare
Feeling of suffocation, skin rash with red swollen bumps, eczema, Micturition disorder, erectile dysfunction.
Not known (frequency cannot be estimated from the available data):
Decreased heart rate, disorientation. Reduced muscle tone, dry mouth, nocturnal urination (nocturia), discoloured urine, indigestion.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 capsules in the blister and outer packaging away from light and moisture.
Do not take Dantrium Capsules after the expiry date which is stated on the outer carton and the blister 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.
Other sources of information
If you need further information on this leaflet in an alternative format please ring 0800 198 5000.
This leaflet was last revised in 08/2023
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+44 (0) 1895 826 606
