Summary of Product Characteristics
last updated on the eMC:
18/08/2010
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 18/08/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Oct-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 - Address of MAH has changed to The Heights, Brooklands, Weybridge, Surrey, KT13 0XP
Section 8 - Marketing Auhorisation Number has changed from PL 0364/0025 to PL 00129/0358
Section 9 - Date of First Authorisation has been added
Section 10 - Revision of text has been changed from 26/03/2009 to October 2009
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Updated on 28/08/2009 and displayed until 18/08/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 6. 3 - Shelf Life
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 26-Mar-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.8 Undesirable Effects
Very rarely (< 1/1000) the product may cause a temporary darkening of the tongue and/or stool.
4.9 Overdose
Bismuth
Bismuth intoxication may present as an acute encephalopathy with confusion, myoclonic movements, tremor, dysarthria and walking and standing disorders. Bismuth intoxication may also cause gastrointestinal disturbances, skin reactions, discolouration of mucous membranes, and renal dysfunction as a result of acute tubular necrosis. Treatment includes gastric lavage, purgation and hydration. Chelating agents may be effective in the early stages following ingestion and haemodialysis may be necessary.
Salicylate
Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (95.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.
Symptoms
Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.
A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of 4 years. In children aged 4 years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.
Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.
Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.
Management
Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.
Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under 10 years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
6.3 Shelf Life
36 months
10 DATE OF REVISION OF THE TEXT
26/03/2009
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Updated on 19/03/2009 and displayed until 28/08/2009
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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| Date of revision of text on the SPC: |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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