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
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
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
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
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
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
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
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
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
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
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
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
- 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 02 December 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 29 August 2005
Reasons for updating
- Improved electronic presentation
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