Dolmatil 200mg Tablets

  • Name:

    Dolmatil 200mg Tablets

  • Company:
    info
  • Active Ingredients:

    Sulpiride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/01/20

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Summary of Product Characteristics last updated on medicines.ie: 29/1/2020

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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

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

Updated on 29 January 2020 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 29 April 2019 PIL

Reasons for updating

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

Updated on 29 April 2019

Reasons for updating

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

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 humans, very limited clinical data on exposed pregnancies are available.  In most cases of 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 has been found in breast milk in treated women. Therefore breast-feeding is not recommended during treatment.

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.

Updated on 30 August 2017

Reasons for updating

  • New SmPC for new product

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

Updated on 30 August 2017 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

200mg tablets

 

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 – amended

 

 

10.       DATE OF REVISION OF THE TEXT - updated

Updated on 29 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 August 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 20 June 2017 SPC

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 PIL

Reasons for updating

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

Updated on 14 September 2016 PIL

Reasons for updating

  • Change of manufacturer

Updated on 3 August 2016 SPC

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 2 August 2016 PIL

Reasons for updating

  • Change to side-effects

Updated on 22 December 2015 PIL

Reasons for updating

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

Updated on 18 December 2015 SPC

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 15 December 2015 PIL

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 SPC

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 PIL

Reasons for updating

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

Updated on 1 March 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 13 February 2013 SPC

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 13 December 2010 SPC

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

Sections 4.4 & 4.8 udpated regarding warning on the risk of venous thromboembolism and warnings on increased mortality in elderly people with dementia .

Updated on 22 November 2010 PIL

Reasons for updating

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

Updated on 14 December 2009 SPC

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 8 December 2009 PIL

Reasons for updating

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

Updated on 31 August 2009 SPC

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 SPC

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 SPC

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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 19 November 2007 SPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Amend section 6.4 - storage conditions

Updated on 16 October 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 21 September 2007 SPC

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 1 August 2007 SPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 19 July 2007 SPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 18 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 2 December 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 2 December 2005 SPC

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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 29 August 2005 SPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie