Dantrium Capsules 100mg

  • Name:

    Dantrium Capsules 100mg

  • Company:
    info
  • Active Ingredients:

    Dantrolene Sodium

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/01/19

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Summary of Product Characteristics last updated on medicines.ie: 22/1/2019

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Norgine Limited

Norgine Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Dantrium Capsules 100mg Active Ingredients Dantrolene Sodium
Medicine Name Dantrium Capsules 25mg Active Ingredients Dantrolene Sodium
Medicine Name Dantrium Intravenous 20 mg Powder for Solution for Injection Active Ingredients Dantrolene Sodium
Medicine Name MOVICOL 13.8g sachet, powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Medicine Name Movicol Liquid Orange Flavour Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
Medicine Name MOVICOL PAEDIATRIC PLAIN 6.9g sachet, powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
Medicine Name MOVIPREP Orange, powder for oral solution Active Ingredients Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
Medicine Name MOVIPREP, powder for oral solution Active Ingredients Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
Medicine Name NORMACOL Granules Active Ingredients Sterculia
Medicine Name NORMACOL PLUS Granules Active Ingredients Frangula, Sterculia
Medicine Name Plenvu powder for oral solution Active Ingredients Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
Medicine Name TARGAXAN 550mg film-coated tablets Active Ingredients Rifaximin
1 - 0 of 12 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 22 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 22 January 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 3 January 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 3 January 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The following changes have been made:

 

QRD updates throughout the SPC

 

Section 4.8 has been tabulated in line with QRD and additional ADRs have been listed as unknown

 

Revision date

Updated on 3 January 2017 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Free text change information supplied by the pharmaceutical company

The following changes have been made:

 

QRD updates throughout the SPC

 

Section 4.8 has been tabulated in line with QRD and additional ADRs have been listed as unknown

 

Revision date

Updated on 23 December 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 October 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

2.            QUALITATIVE AND QUANTITATIVE COMPOSITION

Dantrium capsules 100 mg Capsules contains 100 mg dantrolene sodium per capsules capsule.

Excipients: Contains Lactose Monohydrate 189.0 mg and Sunset Yellow (E110).

For a full list of excipients, see section 6.1.

 

3.        PHARMACEUTICAL form

Capsule, hard

Dantrium capsules are presented in orange/light brown hard capsules. The 100 mg capsule carries the monogram ‘Dantrium 100 mg’ on the cap and ‘0149’, ‘0033’ and triple coding bars on the body. white/green hard capsules.

 

4.2      Posology and method of administration

Each dosage level should be maintained for seven days in order to determine the patient's response. The maximum daily dose should not exceed 400 mg. In view of the potential for hepatoxicity hepatotoxicity in long term use, if no observable benefit is derived from the administration of Dantrium after a total of 45 days, therapy should be discontinued.

4.4         Special warnings and precautions for use

At the start of Dantrium therapy, liver function tests should be performed in all patients to establish a base-line, and exclude pre-existing liver disease. These tests should be repeated upon hospital discharge or at 6 six weeks after staring starting therapy. Further tests should may be carried out at appropriate intervals throughout treatment. Generally, if these studies reveal abnormal values, therapy should not be commenced or should be discontinued. In patients with symptoms compatible with hepatitis or where jaundice appears, Dantrium should be discontinued. If a decision is made to restart treatment after recovery from hepatic dysfunction, liver function should be monitored and the drug discontinued if abnormal values are observed.

4.5         Interaction with other medicinal products and other forms of interaction

 

The effects of non-depolarizing muscle relaxants may be potentiated in patients administered Dantrium. Hyperkalemia and myocardial depression have been observed in malignant hyperthermia-susceptible patients receiving intravenous dantrolene sodium and concomitant calcium channel blockers.

4.6      Pregnancy Fertility, pregnancy and lactation

Dantrolene sodium crosses the placenta, and has been detected in human milk. Although teratological studies in animals have proved satisfactory, the use of Dantrium is not advised in pregnant or nursing mothers.

 

4.8 Undesirable effects

 

Nervous system disorders:

Common: Seizure, visual disturbances, speech disturbance, headache

 

 

VasularVascular disorders:

Less common: Labile blood pressure

The colouring agent E110 can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

5.2      Pharmacokinetic properties

The absorption of Dantrium after oral administration in humans in is incomplete and slow but consistent, and dose-related blood levels are obtained. The duration and intensity of skeletal muscle relaxation is related to the dosage and blood levels. The mean biologic half-life of Dantrium in adults is 8.7 hours after a 100-mg dose. Specific metabolic pathways in the degradation and elimination of Dantrium in human subjects have been established.

 

 

6.1    List of excipients

 

Capsule Fill:Maize starch

Talc

Magnesium Stearate

Lactose monohydrate Monohydrate

 

Capsule Shell:

 

Sunset Yellow (E110)

Gelatin

Indigo Carmine (E132)

Titanium Dioxide (E171)

Iron Oxide (E172)

Edible Black Ink (Shellac, Iron Oxide E172).

 

 

6.5         Nature and contents of container

 

Dantrium 100 mg Capsules are supplied in polypropylene or  polyethylene containers of 100 capsules, with a polyethylene screw cap and packaged in an outer carton.

 

7.        MARKETING AUTHORISATION HOLDER

 

SpePharm Holding Norgine B.V.

Kingsfordweg 1511043 GR Hogehilweg 7

1101CA  Amsterdam ZO

The Netherlands

 

8.        MARKETING AUTHORISATION NUMBER(S)

 

PA 1556/1/2 1336/004/002

 

 

10.      DATE OF REVISION OF THE TEXT

 

July 2010 September 2014

 

Updated on 28 October 2014 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to marketing authorisation holder

Free text change information supplied by the pharmaceutical company

2.            QUALITATIVE AND QUANTITATIVE COMPOSITION

Dantrium capsules 100 mg Capsules contains 100 mg dantrolene sodium per capsules capsule.

Excipients: Contains Lactose Monohydrate 189.0 mg and Sunset Yellow (E110).

For a full list of excipients, see section 6.1.

 

3.        PHARMACEUTICAL form

Capsule, hard

Dantrium capsules are presented in orange/light brown hard capsules. The 100 mg capsule carries the monogram ‘Dantrium 100 mg’ on the cap and ‘0149’, ‘0033’ and triple coding bars on the body. white/green hard capsules.

 

4.2      Posology and method of administration

Each dosage level should be maintained for seven days in order to determine the patient's response. The maximum daily dose should not exceed 400 mg. In view of the potential for hepatoxicity hepatotoxicity in long term use, if no observable benefit is derived from the administration of Dantrium after a total of 45 days, therapy should be discontinued.

4.4         Special warnings and precautions for use

At the start of Dantrium therapy, liver function tests should be performed in all patients to establish a base-line, and exclude pre-existing liver disease. These tests should be repeated upon hospital discharge or at 6 six weeks after staring starting therapy. Further tests should may be carried out at appropriate intervals throughout treatment. Generally, if these studies reveal abnormal values, therapy should not be commenced or should be discontinued. In patients with symptoms compatible with hepatitis or where jaundice appears, Dantrium should be discontinued. If a decision is made to restart treatment after recovery from hepatic dysfunction, liver function should be monitored and the drug discontinued if abnormal values are observed.

4.5         Interaction with other medicinal products and other forms of interaction

 

The effects of non-depolarizing muscle relaxants may be potentiated in patients administered Dantrium. Hyperkalemia and myocardial depression have been observed in malignant hyperthermia-susceptible patients receiving intravenous dantrolene sodium and concomitant calcium channel blockers.

4.6      Pregnancy Fertility, pregnancy and lactation

Dantrolene sodium crosses the placenta, and has been detected in human milk. Although teratological studies in animals have proved satisfactory, the use of Dantrium is not advised in pregnant or nursing mothers.

 

4.8 Undesirable effects

 

Nervous system disorders:

Common: Seizure, visual disturbances, speech disturbance, headache

 

 

VasularVascular disorders:

Less common: Labile blood pressure

The colouring agent E110 can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

5.2      Pharmacokinetic properties

The absorption of Dantrium after oral administration in humans in is incomplete and slow but consistent, and dose-related blood levels are obtained. The duration and intensity of skeletal muscle relaxation is related to the dosage and blood levels. The mean biologic half-life of Dantrium in adults is 8.7 hours after a 100-mg dose. Specific metabolic pathways in the degradation and elimination of Dantrium in human subjects have been established.

 

 

6.1    List of excipients

 

Capsule Fill:Maize starch

Talc

Magnesium Stearate

Lactose monohydrate Monohydrate

 

Capsule Shell:

 

Sunset Yellow (E110)

Gelatin

Indigo Carmine (E132)

Titanium Dioxide (E171)

Iron Oxide (E172)

Edible Black Ink (Shellac, Iron Oxide E172).

 

 

6.5         Nature and contents of container

 

Dantrium 100 mg Capsules are supplied in polypropylene or  polyethylene containers of 100 capsules, with a polyethylene screw cap and packaged in an outer carton.

 

7.        MARKETING AUTHORISATION HOLDER

 

SpePharm Holding Norgine B.V.

Kingsfordweg 1511043 GR Hogehilweg 7

1101CA  Amsterdam ZO

The Netherlands

 

8.        MARKETING AUTHORISATION NUMBER(S)

 

PA 1556/1/2 1336/004/002

 

 

10.      DATE OF REVISION OF THE TEXT

 

July 2010 September 2014

 

Updated on 25 March 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use

 

There are isolated cases of possibly significant effects of Dantrium on cardiovascular and respiratory systems and therefore Dantrium should be used with caution in patients with cardiovascular or respiratory disease.

 

Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with Dantrium therapy.

 

Patients should be instructed to contact their physician should signs or symptoms of hepatotoxicity (e.g., discoloured faeces, generalized pruritus, jaundice, anorexia, nausea, vomiting) occur during therapy. 

 

Factors that may increase the risk of developing hepatotoxicity include:

-                 Higher daily doses (doses exceeding 400 mg daily)

-                 Duration of therapy (most frequently reported between 2 and 12 months of treatment)

-                 Female gender

-                 Age greater than 30 years

-                 Prior history of liver disease/dysfunction

-                 Receiving other hepatotoxic therapies concomitantly

 

Spontaneous reports also suggest a higher proportion of hepatic events with fatal outcome in elderly patients.

 

At the start of Dantrium therapy, liver function tests should be performed in all patients to establish a base-line, and exclude pre-existing liver disease.  These tests should be repeated upon hospital discharge or at 6 weeks after staring therapy.  Further tests should be carried out at appropriate intervals throughout treatment.  Generally, if these studies reveal abnormal values, therapy should not be commenced or should be discontinued.  In patients with symptoms compatible with hepatitis or where jaundice appears, Dantrium should be discontinued.  If a decision is made to restart treatment after recovery from hepatic dysfunction, liver function should be monitored and the drug discontinued if abnormal values are observed.

 

Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.


6.1     List of excipients

 

Maize starch

Talc

Magnesium Stearate

Lactose monohydrate

Capsule shell

Sunset Yellow (E110)

Gelatin

Titanium Dioxide (E171)

Iron Oxide (E172)

Edible Black Ink (Shellac, Iron Oxide E172).


6.5         Nature and contents of container

 

Dantrium 100 mg Capsules are supplied in polypropylene or polyethylene containers of 100 capsules.



7.       MARKETING AUTHORISATION HOLDER

 

SpePharm Holding B.V.

Kingsfordweg 151

1043 GR Amsterdam

The Netherlands

 

 

8.       MARKETING AUTHORISATION NUMBER(S)

 

PA 1556/1/2

 

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 19 March 1975.

 

Date of last renewal: 19 March 2010.

 

 

10.     DATE OF REVISION OF THE TEXT

 

July 2010

Updated on 25 March 2011 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use

 

There are isolated cases of possibly significant effects of Dantrium on cardiovascular and respiratory systems and therefore Dantrium should be used with caution in patients with cardiovascular or respiratory disease.

 

Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with Dantrium therapy.

 

Patients should be instructed to contact their physician should signs or symptoms of hepatotoxicity (e.g., discoloured faeces, generalized pruritus, jaundice, anorexia, nausea, vomiting) occur during therapy. 

 

Factors that may increase the risk of developing hepatotoxicity include:

-                 Higher daily doses (doses exceeding 400 mg daily)

-                 Duration of therapy (most frequently reported between 2 and 12 months of treatment)

-                 Female gender

-                 Age greater than 30 years

-                 Prior history of liver disease/dysfunction

-                 Receiving other hepatotoxic therapies concomitantly

 

Spontaneous reports also suggest a higher proportion of hepatic events with fatal outcome in elderly patients.

 

At the start of Dantrium therapy, liver function tests should be performed in all patients to establish a base-line, and exclude pre-existing liver disease.  These tests should be repeated upon hospital discharge or at 6 weeks after staring therapy.  Further tests should be carried out at appropriate intervals throughout treatment.  Generally, if these studies reveal abnormal values, therapy should not be commenced or should be discontinued.  In patients with symptoms compatible with hepatitis or where jaundice appears, Dantrium should be discontinued.  If a decision is made to restart treatment after recovery from hepatic dysfunction, liver function should be monitored and the drug discontinued if abnormal values are observed.

 

Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.


6.1     List of excipients

 

Maize starch

Talc

Magnesium Stearate

Lactose monohydrate

Capsule shell

Sunset Yellow (E110)

Gelatin

Titanium Dioxide (E171)

Iron Oxide (E172)

Edible Black Ink (Shellac, Iron Oxide E172).


6.5         Nature and contents of container

 

Dantrium 100 mg Capsules are supplied in polypropylene or polyethylene containers of 100 capsules.



7.       MARKETING AUTHORISATION HOLDER

 

SpePharm Holding B.V.

Kingsfordweg 151

1043 GR Amsterdam

The Netherlands

 

 

8.       MARKETING AUTHORISATION NUMBER(S)

 

PA 1556/1/2

 

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 19 March 1975.

 

Date of last renewal: 19 March 2010.

 

 

10.     DATE OF REVISION OF THE TEXT

 

July 2010

Updated on 24 March 2006 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 24 March 2006 PIL

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Updated on 2 August 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 2 August 2005 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 7 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 7 July 2003 PIL

Reasons for updating

  • New SPC for medicines.ie