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Rosemont Pharmaceuticals Limited
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
Telephone: +44 (0)113 244 1400
Fax: +44 (0)113 246 0738
WWW: http://www.rosemontpharma.com
Customer Care direct line: +44 (0)800 919 312
Out of Hours Telephone: +44 (0)7836 557 879
Out of Hours contact: pharmacovigilance@rosemontpharma.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 16/04/2008
SPC Dexsol 2mg/5ml Oral Solution

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 16/04/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4: Psychiatric reaction warnings added.
Section 4.8: Psychiatric adverse reactions added
Updated on 26/09/2006 and displayed until 16/04/2008
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
  • Change to section 6. 6 - Instruction for Use/Handling
Date of revision of text on the SPC:   10/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1: Admin change
Section 2: Admin change
Section 3: added description
Section 4.1: Amended 'Endocirne disorders', 'allergy and anaphylaxis', 'haematological disorders',  'GI disorders', 'Neurological disorders', 'Ocular disorders', 'Respiratory disorders', 'Renal disorders', 'Rheumatic disorders', 'Skin disorders',  Added, 'Oncological disorders', 'various'.
Section 4.2: Info added re: raised intracranial pressure.
Section 4.3: Substantial changes
Section 4.4: Added info re: live vaccines, latent disease, ocular changes, ion imbalances, patients under stress, concomitant conditions requiring monitoring, fat embolism, left-ventricular free-wall rupture, anaphylaxis and hypersnesitivity, eosinophilia after withdrawal
Section 4.5: Extensive changes
Section 4.6: Extensive changes
Section 4.8: Added info under 'Musculoskeletal', 'Gastrointestinal', 'Deramtological', 'Anti-inflammatory/immunosuppressive', 'Endocrine/metabolic', 'General'.
Section 5.1: Added ATC code and Pharmacotherapeutic group
Section 5.2: Sentance structure changes
Section 5.3: Extensive changes
Section 6.1: Admin change
Section 6.3: Admin changes
Section 6.5: Removal of unused closure options
Section 6.6: Admin changes
Section 8: Change in MA number after Mutual Recognition Procedure
 
Updated on 21/09/2006 and displayed until 26/09/2006
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   10/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

Section 1 (Name of Medicinal Product): Removed 'Dexamethasone'

Section 2 (Qualitative and Quantitative composition): Added 'For excipients see 6.1'

Section 3 (Pharmaceutical form): Added description

Section 4.1 (Therapeutic indications): Amended endocrine disorders to just endocrine exaphthalamos., removed 'angioneurotic oedema', removed 'cardiovascular disorders', added idiopathic thrombocytopaenic pupura and reticulomphoproliferative disorders, indicated 'rectal only' for ulcerative colitis, added regional enteritis and certain forms of hepatitis. Removed sarcoidosis. Removed Miliary tuberculosis. Addedd acute exacerbations of multiple sclerosis. Added chorioretinitis, iridocyclitis, temporal arteritis, orbital pseudotumour.Removed 'lupus nephritis', added 'nephrotic syndrome'. Additional respiratory disorders. Additional rheumatic disorders. Aditional skin disorders. Added oncological disorders. Added 'Other' disorders.

Section 4.2 (Posology): Added dosing infomation in 'Raised Intracranial pressure'.

Section 4.3 (Contraindications): Added 'Infection with tropical worms'. Removed 'live vaccines, viral infections, uncontrolled psychotic status, glaucoma, osteoporosis, diabetes mellitus, hypertension (CHF), TB, Severe renal disease, Haemorrhage, gastroduodenal ulcer (replaced with stomach ulcer or duodenal ulcer.

Section 4.4 (Warnings and Precautions): Updated incformation on live vaccines (contraindicated). Added information on activation of latent disease. Added 'complication of fat embolism'. Added 'left-ventricular free-wall rupture after recent MI'. Added 'Anaphylactoid and hypersensitivity reactions'. Added decrease ot withdrawal of therapy may reveal underlying disease.

Section 4.5 (Interactions): Added info on cytochrome P450 3A4 metabolism, ketoconazole, ephedrine, incometacin (false-negative in supression tests), antibiotics, anticholinetserases, colestyramine, estrogens, aminoglutethimide, GI topicals, antacids, charcoal. Added antitubercular drugs, ciclosporin, thalidomide. Removed antacids. Added Praziquantel andoral anticoagulants. Added insulin, sulonylureas, metformin, isoniazid

Section 4.6 (Pregnancy): Added info on lack of reproductive studies therefore 'lowest effective dose needed' should be used', 'placental trnasfer is considerable', information on breast-feeding (removed advice not to breast-feed). Added 'Evidence of harmful effects on pregnancy in animals'.

Section 4.8 (Undesirable effects): Added muscle weakness, aseptic necrosis of femoral & humoral heads, los of muslce mass, perforation of the bowwl, thinning scalp hair, decreased resistance to infection, secondary adrenocortical and pituitary unresponsiveness, abnormal fat deposits, increased and decreased motility and number of spermatozoa. Removed Cardiovascular effects.

Section 5.1 (Pharmacodynamic properties):  Added ATC code and pharmacotherapeutic group.

Section 5.2 (Pharmacokinetic properties):  Added dexamethasone is bound to 'mainly albumins' (plasma proteins).Removed info about crossing the placenta and exretion into breast milk.

Section 5.3 (Preclinical safety data): Added info on toxicity (cleft palate, CNS and heart abnormalities in animal studies), inhibition in intrauterine growth (High dose). Added statement that no further safety info available.

Section 6.3 (Shelf life): Amended from 24months to 2 years.

Section 6.5 (Nature and contents of the container): Added 150 ml bottle. Removed closures apart from HDPE, EPE wadded, tamper evident , child resistant closure.

Section 6.6 (Instructions for use): Re-wording of exiting sentance.

Section 8 (MA number):  Amended to PL 00427/0137 (Mutual recognition licence)
Updated on 31/08/2005 and displayed until 21/09/2006
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change from BAN to rINN
Updated on 31/07/2002 and displayed until 31/08/2005
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 02/07/2001 and displayed until 31/07/2002
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  dexamethasone sodium phosphate