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Dolmatil 400mg Tablets *

  • Company:

    SANOFI

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Sulpiride

    *Additional information is available within the SPC or upon request to the company

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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 29 January 2020

File name

1.3.1.1 Dolmatil 400mg tablets SmPC_1580323145.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Updated on 29 January 2020

File name

1.3.2.1 Dolmatil 200mg 400mg tablets PIL_1580323107.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 29 April 2019

File name

PIL Dolmatil 200mg 400mg tablets IE664_1556542523.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 29 April 2019

File name

SPC Dolmatil 400mg tablets IE664_1556543615.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

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 special precautions for use

Dolmatil should be used with caution in patients with a history of glaucoma, ileus, congenital digestive stenosis, urine retention or hyperplasia of the prostate.

           4.6       Fertility, pPregnancy and lactation

Pregnancy:

            There are only very limited data available from the use of sulpiride in pregnant       women. The safety of sulpiride during human pregnancy has not been established.

Sulpiride crosses the placenta. Studies in animals are insufficient with respect to reproductive toxicity (see section 5.3

The use of sulpiride is not recommended during pregnancy and in women of child bearing potential not using effective contraception, unless the benefits justify the potential risks.

A decrease in fertility linked to the pharmacological effects of the drug (prolactin mediated effect) was observed in treated animals.  Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, or and/or postnatal development.  In human, very limited clinical data on exposed pregnancies are available.  In most cases or foetal or neonatal disorders reported in the context of sulpiride use during pregnancy, alternative explanations can be suggested and seem more likely.  Therefore, the use of sulpiride is not recommended during pregnancy because of the limited experience.  If sulpiride is used during pregnancy, appropriate monitoring of the neonate should be considered in view of sulpiride safety profile.

Neonates exposed to antipsychotics, including Dolmatil, during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery (see Section 4.8). There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully

LactationBreastfeeding:

Sulpiride is excreted into breastmilk in rather large amounts, far above the accepted value of 10% of the maternal weight-adjusted dosage in some cases, but blood concentrations in breastfed infants have not been evaluated. There is insufficient information on the effects of sulpiride in newborns/ infants

A decision must be made whether to discontinue breast-feeding or to abstain from sulpiride therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Fertility

A decrease in fertility linked to the pharmacological effects of the drug (prolactin mediated effect) was observed in treated animals

Sulpiride has been found in breast milk in treated women. Therefore breast-feeding is not recommended during treatment.

 

Updated on 30 August 2017

Reasons for updating

  • New SPC for new product

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

Updated on 30 August 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 9 - Date of first authorisation/renewal of the 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

 

400mg tablets

 

4.4       Special warnings and special precautions for use

 

Minor typographical error – corrected

 

4.8       Undesirable effects - added

 

Hepatobiliary disorders

Common: hepatic enzyme increased

Not known: hepatocellular, cholestatic or mixed liver injury

 

4.9       Overdose

 

Minor typographical error – corrected

 

9.

 

DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION

 

Minor typographical error – corrected

 

 

10.       DATE OF REVISION OF THE TEXT - updated

Updated on 29 August 2017

File name

PIL_9163_658.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 August 2017

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 20 June 2017

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Type II C.I.4 variation to outline pneumonia aspiration and constipation as undesirable effects associated with Dolmatil (sulpiride) use, in both Section 4.8 and Section 4 in the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) respectively, for Dolmatil (sulpiride) 200mg and Dolmatil (sulpiride) 400mg tablets

Updated on 15 June 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 September 2016

Reasons for updating

  • Change of manufacturer

Updated on 03 August 2016

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

 

Metabolism and nutrition disorders:

Not known: hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Updated on 02 August 2016

Reasons for updating

  • Change to side-effects

Updated on 12 February 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • 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 4.4

Breast cancer
Sulpiride may increase prolactin levels. Therefore, caution should be exercised and patients with a history or a family history of breast cancer should be
closely monitored during sulpiride therapy (See Section 4.3).

Section 4.9

Fatal outcomes have been reported mainly in combination with other psychotropic agents.

Updated on 22 December 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose

Updated on 15 December 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to date of revision

Updated on 15 September 2014

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 4.8 - 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 No. C.1.4 to update the SPC as a result of the publication of the Sulpiride CCDS v8, 9, 10.

Updated on 11 September 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions

Updated on 01 March 2013

Reasons for updating

  • Change to marketing authorisation holder

Updated on 13 February 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Type II.C.I.3.b - SPC Update 4.4, 4.6, 4.8 to CCSIv6

Updated on 23 November 2010

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Section 4.4 & 4.8 of SPC updated with regard to warnings on the risk of venous thromboembolism and warnings on increased mortality in elderly people with dementia .

Updated on 22 November 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 09 August 2010

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Update Sections 4.4, 4.8, 4.9 of SPC to include information on:

Mortality in Elderly Demented Patients and Antipsychotic Benzamides

Venous Thromboembolic Events and Antipsychotic
Overdose section updated to include additional information on symptoms and treatment.

Updated on 22 March 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

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

Free text change information supplied by the pharmaceutical company

Update section 2
Addition of excipient amount

Updated on 14 December 2009

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Update Sections 4.4, 4.8, 4.9 with regard to use in patients with dementia and DVT.

Updated on 08 December 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 31 August 2009

Reasons for updating

  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Change to improve clarity and readability

Updated on 20 May 2008

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 31 March 2008

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

Update
Sections 4.3 - 4.9

Updated on 31 March 2008

Reasons for updating

  • Improved electronic presentation

Updated on 16 October 2007

Reasons for updating

  • Improved electronic presentation

Updated on 21 September 2007

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)

Free text change information supplied by the pharmaceutical company

Update sections
7- Change MA holder to sanofi-aventis Ireland Ltd.
8 - Change PA number
10 - Date of revision

Updated on 24 August 2007

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 18 December 2006

Reasons for updating

  • Improved electronic presentation

Updated on 02 December 2005

Reasons for updating

  • Improved electronic presentation

Updated on 02 December 2005

Reasons for updating

  • 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 29 August 2005

Reasons for updating

  • Improved electronic presentation

Updated on 29 August 2005

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 4.6 - 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 31 May 2005

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 21 October 2004

Reasons for updating

  • New PIL for medicines.ie