Stemetil Tablets 5mg
- Name:
Stemetil Tablets 5mg
- Company:
SANOFI
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/09/18
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SANOFI
Company Products
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 19 September 2018 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 19 September 2018 SmPC
Reasons for updating
- Improved presentation of SmPC
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 17 September 2018 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.4.2 General information
General information relating to effects seen following administration of hypnotic agents which should be taken into account by the prescribing physician are described belowproducts and other forms of interaction and Ssection 4.8 Undesirable effects)
4.8 Undesirable effects
Uncommon: paraesthesia, tremor, disturbance in attention, speech disorder
Not knownRare: depressed level of consciousness, disturbance in attention, speech disorder.
Common: hHallucination, agitation, nightmare, depression (See Section 4.4)..
Uncommon: confusional state, irritability, restlessness, aggression, somnambulism (See Section 4.4), euphoric mood
Rare: libido disorder
Very rare: delusion, dependence (withdrawal symptoms, or rebound effects may occur after treatment discontinuation).
Not kKnown: restlessness, aggression, delusion, anger, abnormal behaviour, somnambulism, (See section 4.4 Special warnings and precautions for use: Somnambulism and associated behaviours),dependence (drug withdrawal syndrome, or rebound effects may occur after treatment discontinuation), libido disorder, depression (see section 4.4), euphoric mood
Not knownRare: gait disturbance, drug tolerance, fall (predominantly in elderly patients and
Not known: drug toleranc
Not KnownVery rare: respiratory depression (see section 4.4)
Not known: muscular weakness
Not knownUncommon: rash, pruritus, urticariam hyperhidrosis.
Rare: urticari
Not knownUncommon: liver enzymes elevated
Rare: , hepatocellular, cholestatic or mixed liver injury (see Sections 4.2, Section and 4.3 and Section 4.5).
Updated on 22 August 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 18 May 2018 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 29 March 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 29 March 2018 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 14 March 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 14 March 2018 SmPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Section 4.5 added:-
Phenothiazines are potent inhibitors of CYP2D6. There is a possible pharmacokinetic interaction between inhibitors of CYP2D6, such as phenothiazines, and CYP2D6 substrates. Co-administration of phenothiazines with amitriptyline/amitriptylinoxide, a CYP2D6 substrate, may lead to an increase in the plasma levels of amitriptyline/amitriptylinoxide. Monitor patients for dose-dependent adverse reactions associated with amitriptyline/amitriptylinoxide.
Updated on 8 November 2016 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 6 August 2014 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Bulk Type II C.I.4 No. variation to update the product information (SPC Section 4.8) following the publication of Prochlorperazine Global Labelling Update Version 7.
Updated on 30 July 2014 PIL
Reasons for updating
- Change to side-effects
Updated on 8 November 2013 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Type II No. C.I.4 to update the SPC section 4.8 in line with Prochlorperazine GLU v6. Section 4.8 is also updated in line with the implementation of the recent PV legislation
Updated on 6 November 2013 PIL
Reasons for updating
- Change to side-effects
Updated on 16 April 2013 PIL
Reasons for updating
- Change of manufacturer
Updated on 21 November 2012 PIL
Reasons for updating
- Improved electronic presentation
Updated on 26 September 2012 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)
Free text change information supplied by the pharmaceutical company
Updated on 15 February 2012 SmPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 17 November 2010 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 3 March 2010 SmPC
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 4.7 - Effects on ability to drive and use machines
- 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)
Free text change information supplied by the pharmaceutical company
Section 4.4 - warnings on use in patients with renal dysfunction, parkinsons disease, cardiac failure, myasthenia gravis, seizures, elderly patients with dementia, VTE etc.
Section 4.5 - additional interactions
Section 4.6 - warning on use in pregnancy
Section 4.7 - revision of statement on driving & drowsiness
Section 4.8 - revision of section on adverse reactions
Section 4.9 - administrative changes
Updated on 25 February 2010 PIL
Reasons for updating
- Improved electronic presentation
Updated on 11 November 2008 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 23 September 2008 SmPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 20 November 2007 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 10 - Date of revision of the text
- Change to section 6.1 - List of excipients
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 21 May 2007 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 17 November 2005 SmPC
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 14 February 2005 SmPC
Reasons for 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
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 7 December 2004 SmPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 6 October 2003 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 14 July 2003 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 23 June 2003 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 11 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)