Pentasa Sachet 1g prolonged release granules

  • Name:

    Pentasa Sachet 1g prolonged release granules

  • Company:
    info
  • Active Ingredients:

    Mesalazine

  • Legal Category:

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

Summary of Product Characteristics last updated on medicines.ie: 18/9/2019

Click on this link to Download PDF directly

Ferring Ireland Limited

Ferring Ireland Limited

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Medicine Name Noqturina 25 microgram oral lyophilisate Active Ingredients Desmopressin Acetate
Medicine Name Noqturina 50 microgram oral lyophilisate Active Ingredients Desmopressin
Medicine Name Nordurine 0.1 mg Tablets Active Ingredients Desmopressin Acetate
Medicine Name Nordurine 0.2mg Tablets Active Ingredients Desmopressin Acetate
Medicine Name Pabal 100 micrograms/ml solution for injection Active Ingredients Carbetocin
Medicine Name Pentasa 1 g Prolonged-release Tablets Active Ingredients Mesalazine
Medicine Name Pentasa 1 g Suppositories Active Ingredients Mesalazine
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1 - 0 of 35 items.Total: Infinity pages

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 18 September 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Update to Section 4.2, to add sentence 'Alternatively the entire cotnent of the sachet can be taken with yogurt and consumed immediately.'

Updated on 3 August 2018 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

Section 4.8

Photosensitivity” added as a rare side effect with the footnote “More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema.

 

Other minor updates in the table in Section 4.8:

-          blood disorders” updated to “altered blood counts”

-          allergic exanthema” reworded to “dermatitis allergic” and relocated to section for skin and subcutaneous tissue disorders

-          “drug fever” moved to section for general disorders and administration site conditions.

Updated on 5 July 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 5 July 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

 

Section 4.2:

Added subheadings:

“Posology”

“Method of administration

Oral use”

 

New sentence: “The safety and efficacy in children below 6 years of age have not been established.”

 

Section 4.6:

Sentence update: “Mesalazine is known to cross the placental barrier and its concentration in umbilical cord plasma is lower than the concentration in maternal plasma.  The metabolite acetyl-mesalazine is found at similar concentrations in umbilical cord and maternal plasma. “

New sentence: “The underlying condition itself (Inflammatory bowel disease (IBD) may increase risks for adverse pregnancy outcome.”

New text:  “There are no adequate and well controlled studies of Pentasa use in pregnant women. Limited published human data on mesalazine show no increase in the overall rate of congenital malformations.  Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease. “

 

Section 4.8

Adverse events updated, see SPC for full updated list.

 

Section 4.9

New sentences:

“Since Pentasa is an amino salicylate, symptoms of salicylate toxicity may occur.  Symptoms of salicylate over dosage are well described in the literature.  “

“There is no specific antidote and the management of overdose is supportive and symptomatic. The treatment at hospital includes close monitoring of renal function.”

 

Deleted text:

“There is no specific antidote and treatment is symptomatic and supportive.”

Management of overdose in man:

Symptomatic treatment at hospital. Close monitoring of renal function. Intravenous infusion of electrolytes may be used to promote diuresis.”

 

Section 5.1

New sections:

“It has been established that mesalazine is the active component of sulphasalazine which is used for the treatment of ulcerative colitis and Crohn’s disease.  Based on clinical results, the therapeutic value of mesalazine after oral as well as rectal administration appears to be due to local effect on the inflamed intestinal tissue, rather than to systemic effect.  There is information suggesting that severity of colonic inflammation in ulcerative colitis patients treated with mesalazine is inversely correlated with mucosal concentrations of mesalazine. “

 

The mechanism of action of mesalazine is not fully understood although mechanisms such as activation of the γ-form of peroxisome proliferator-activated receptors (PPAR-γ) and inhibition of nuclear factor-kappa B (NF-κB) in the intestinal mucosa has been implicated. “

 

“It is currently unknown which, if any, of these mechanisms play a predominant role in the clinical efficacy of mesalazine.”

 

Sections 5.2 and 5.3

Full updates, see SPC for text.

 

Section 6.5:

Replaced “Aluminium foil single dose container.” with “Polyester/Aluminium/LD polyethylene sachet”

Updated on 5 July 2016 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

 

Section 4.2:

Added subheadings:

“Posology”

“Method of administration

Oral use”

 

New sentence: “The safety and efficacy in children below 6 years of age have not been established.”

 

Section 4.6:

Sentence update: “Mesalazine is known to cross the placental barrier and its concentration in umbilical cord plasma is lower than the concentration in maternal plasma.  The metabolite acetyl-mesalazine is found at similar concentrations in umbilical cord and maternal plasma. “

New sentence: “The underlying condition itself (Inflammatory bowel disease (IBD) may increase risks for adverse pregnancy outcome.”

New text:  “There are no adequate and well controlled studies of Pentasa use in pregnant women. Limited published human data on mesalazine show no increase in the overall rate of congenital malformations.  Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease. “

 

Section 4.8

Adverse events updated, see SPC for full updated list.

 

Section 4.9

New sentences:

“Since Pentasa is an amino salicylate, symptoms of salicylate toxicity may occur.  Symptoms of salicylate over dosage are well described in the literature.  “

“There is no specific antidote and the management of overdose is supportive and symptomatic. The treatment at hospital includes close monitoring of renal function.”

 

Deleted text:

“There is no specific antidote and treatment is symptomatic and supportive.”

Management of overdose in man:

Symptomatic treatment at hospital. Close monitoring of renal function. Intravenous infusion of electrolytes may be used to promote diuresis.”

 

Section 5.1

New sections:

“It has been established that mesalazine is the active component of sulphasalazine which is used for the treatment of ulcerative colitis and Crohn’s disease.  Based on clinical results, the therapeutic value of mesalazine after oral as well as rectal administration appears to be due to local effect on the inflamed intestinal tissue, rather than to systemic effect.  There is information suggesting that severity of colonic inflammation in ulcerative colitis patients treated with mesalazine is inversely correlated with mucosal concentrations of mesalazine. “

 

The mechanism of action of mesalazine is not fully understood although mechanisms such as activation of the γ-form of peroxisome proliferator-activated receptors (PPAR-γ) and inhibition of nuclear factor-kappa B (NF-κB) in the intestinal mucosa has been implicated. “

 

“It is currently unknown which, if any, of these mechanisms play a predominant role in the clinical efficacy of mesalazine.”

 

Sections 5.2 and 5.3

Full updates, see SPC for text.

 

Section 6.5:

Replaced “Aluminium foil single dose container.” with “Polyester/Aluminium/LD polyethylene sachet”

Updated on 4 August 2015 SmPC

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Section 4.8: reporting of side effects text added

Updated on 4 August 2015 PIL

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Free text change information supplied by the pharmaceutical company

Section 4.8: reporting of side effects text added

Updated on 13 September 2013 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Free text change information supplied by the pharmaceutical company

Section 4.2 (updated for once daily dosing):

Ulcerative colitis

 

Adults

Active disease

Individual dosage, up to 4 g mesalazine once daily or divided into 2-4 doses.

Updated on 13 September 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Section 4.2 (updated for once daily dosing):

Ulcerative colitis

 

Adults

Active disease

Individual dosage, up to 4 g mesalazine once daily or divided into 2-4 doses.

Updated on 13 May 2013 PIL

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

Free text change information supplied by the pharmaceutical company

Section 5.1: new text added:
"The risk of colorectal cancer (CRC) is slightly increased in ulcerative colitis. Observed effects of mesalazine in experimental models and patient biopsies support the role of mesalazine in prevention of colitis-associated CRC, with down regulation of both inflammation dependent and non-inflammation dependent signalling pathways involved in the development of colitis-associated CRC. However data from meta-analyses, including both referral and non-referral populations, provide inconsistent clinical information regarding the benefit of mesalazine in the carcinogenesis risk associated with ulcerative colitis."

Section 5.3: new text added:
"Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryo-foetal development, parturition or postnatal development."

Updated on 13 May 2013 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Section 5.1: new text added:
"The risk of colorectal cancer (CRC) is slightly increased in ulcerative colitis. Observed effects of mesalazine in experimental models and patient biopsies support the role of mesalazine in prevention of colitis-associated CRC, with down regulation of both inflammation dependent and non-inflammation dependent signalling pathways involved in the development of colitis-associated CRC. However data from meta-analyses, including both referral and non-referral populations, provide inconsistent clinical information regarding the benefit of mesalazine in the carcinogenesis risk associated with ulcerative colitis."

Section 5.3: new text added:
"Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryo-foetal development, parturition or postnatal development."

Updated on 5 September 2012 PIL

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 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

Section 4.3: minor text change, no change to the content

 

Section 4.4:  full section update

 

Section 4.5:  updated sentence to: ‘Combination therapy with Pentasa and azathioprine or 6-mercaptopurine or thioguanine have shown a higher frequency of myelosuppressive effects, and an interaction cannot be ruled out, however, the mechanism behind the interaction is not established.’

 

Section 4.6: 

updated pregnancy section to:

‘Mesalazine is known to cross the placental barrier. Data on a limited number of exposed pregnancies indicate no adverse effect of mesalazine on the pregnancy or on the health of the fetus/newborn child. To date no other relevant epidemiologic data are available. Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition or postnatal development. Blood disorders (leucopenia, thrombocytopenia, anaemia) have been reported in new-borns of mothers being treated with Pentasa Sachet.

In one single case after long-term use of a high dose of mesalazine (2-4g, orally) during pregnancy, renal failure in a neonate was reported. .

 

Lactation section, new sentence: ‘If the infant develops diarrhoea, breast-feeding should be discontinued.’

 

New Fertility section: ‘Animal data on Mesalazine show no effect on male and female fertility’


Section 4.7: 
sentence updated from ‘None known’ to ‘Pentasa Sachet has no or negligible influence on the ability to drive or use machines.’

Section 4.8:
Changes to Rare events:

-         nervous system disorders: ‘dizziness’ added

-         gastrointestinal disorders: ‘flatulence’ added. ‘pancreatitis’ updated to ‘acute pancreatitis’

 

Changes to Very Rare events:

-         Blood and the lymphatic system disorders: ‘altered blood counts’ and ‘neutropenia’ added.

-         Immune system disorders: ‘hypersensitivity reactions such as allergic exanthema’ and ‘Pancolitis’ added

-         Respiratory, thoracic and mediastinal disorders: ‘bronchospasm’ added

-         Hepato-biliary disorders: ‘cholestasis parameters’ and ‘cholesttic hepatitis’ added

-         Reproductive system disorders: new section. ‘Oligospermia (reversible)’ added.

-         General disorders and administration site conditions: ‘Drug fever’ added

 

 

Section 5.1:  Update of Pharmacotherapeutic group to: ‘Pharmacotherapeutic groups: Intestinal anti-inflammatory agents, aminosalicylic acid and similar agents’

Updated on 5 September 2012 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 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Section 4.3: minor text change, no change to the content

 

Section 4.4:  full section update

 

Section 4.5:  updated sentence to: ‘Combination therapy with Pentasa and azathioprine or 6-mercaptopurine or thioguanine have shown a higher frequency of myelosuppressive effects, and an interaction cannot be ruled out, however, the mechanism behind the interaction is not established.’

 

Section 4.6: 

updated pregnancy section to:

‘Mesalazine is known to cross the placental barrier. Data on a limited number of exposed pregnancies indicate no adverse effect of mesalazine on the pregnancy or on the health of the fetus/newborn child. To date no other relevant epidemiologic data are available. Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition or postnatal development. Blood disorders (leucopenia, thrombocytopenia, anaemia) have been reported in new-borns of mothers being treated with Pentasa Sachet.

In one single case after long-term use of a high dose of mesalazine (2-4g, orally) during pregnancy, renal failure in a neonate was reported. .

 

Lactation section, new sentence: ‘If the infant develops diarrhoea, breast-feeding should be discontinued.’

 

New Fertility section: ‘Animal data on Mesalazine show no effect on male and female fertility’


Section 4.7: 
sentence updated from ‘None known’ to ‘Pentasa Sachet has no or negligible influence on the ability to drive or use machines.’

Section 4.8:
Changes to Rare events:

-         nervous system disorders: ‘dizziness’ added

-         gastrointestinal disorders: ‘flatulence’ added. ‘pancreatitis’ updated to ‘acute pancreatitis’

 

Changes to Very Rare events:

-         Blood and the lymphatic system disorders: ‘altered blood counts’ and ‘neutropenia’ added.

-         Immune system disorders: ‘hypersensitivity reactions such as allergic exanthema’ and ‘Pancolitis’ added

-         Respiratory, thoracic and mediastinal disorders: ‘bronchospasm’ added

-         Hepato-biliary disorders: ‘cholestasis parameters’ and ‘cholesttic hepatitis’ added

-         Reproductive system disorders: new section. ‘Oligospermia (reversible)’ added.

-         General disorders and administration site conditions: ‘Drug fever’ added

 

 

Section 5.1:  Update of Pharmacotherapeutic group to: ‘Pharmacotherapeutic groups: Intestinal anti-inflammatory agents, aminosalicylic acid and similar agents’

Updated on 11 October 2011 PIL

Reasons for updating

  • 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 4.9 - Overdose

Free text change information supplied by the pharmaceutical company

Section 4.5: section updated from "Concomitant treatment with mesalazine can increase the risk of blood dyscrasia in patients receiving azathioprine or 6-mercaptopurine" to "Combination therapy with Pentasa and azathioprine or 6-mercaptopurine has shown a higher frequency of leucopenia and an interaction cannot be ruled out, however, the mechanism behind the interaction is not established. Regular monitoring of white blood cells is recommended and the dosage regimen of thiopurine should be adjusted accordingly."

Section 4.8:  Addition of very rare events: pericardial effusion, allergic and fibrotic lung reactions (incl....interstitial lung disease,...pleurisy), renal insufficiency (acute/chronic)

Section 4.9:  Update to human experience from "No experience" to "There are rare data on overdosage (e.g. intended suicide with high oral doses of mesalazine), which do not indicate renal or hepatic toxicity. There is no specific antidote and treatment is symptomatic and supportive. There have been reports of patients taking oral daily doses of 8 grams for a month without any adverse events"

Updated on 11 October 2011 SmPC

Reasons for updating

  • 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 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 4.5: section updated from "Concomitant treatment with mesalazine can increase the risk of blood dyscrasia in patients receiving azathioprine or 6-mercaptopurine" to "Combination therapy with Pentasa and azathioprine or 6-mercaptopurine has shown a higher frequency of leucopenia and an interaction cannot be ruled out, however, the mechanism behind the interaction is not established. Regular monitoring of white blood cells is recommended and the dosage regimen of thiopurine should be adjusted accordingly."

Section 4.8:  Addition of very rare events: pericardial effusion, allergic and fibrotic lung reactions (incl....interstitial lung disease,...pleurisy), renal insufficiency (acute/chronic)

Section 4.9:  Update to human experience from "No experience" to "There are rare data on overdosage (e.g. intended suicide with high oral doses of mesalazine), which do not indicate renal or hepatic toxicity. There is no specific antidote and treatment is symptomatic and supportive. There have been reports of patients taking oral daily doses of 8 grams for a month without any adverse events"

Updated on 7 July 2010 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Section 4.2: the licensed use in the paediatric population is reduced from 12 to 6 years of age. New dosing approved for active and maintenance treatments (please see SPC for further details).

Updated on 7 July 2010 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Free text change information supplied by the pharmaceutical company

Section 4.2: the licensed use in the paediatric population is reduced from 12 to 6 years of age. New dosing approved for active and maintenance treatments (please see SPC for further details).

Updated on 4 January 2010 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

Section 3:  Description of granules updated to 'White-grey to pale white-brown granules'
Section 6.1:  List of excipients updated to 'Ethylcellulose, Povidone'

Updated on 4 January 2010 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

Section 3:  Description of granules updated to 'White-grey to pale white-brown granules'
Section 6.1:  List of excipients updated to 'Ethylcellulose, Povidone'

Updated on 9 February 2009 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Free text change information supplied by the pharmaceutical company

Section 4.2: Change in Maintenance treatment to 'Recommened dosage, 2 g mesalazine once daily.'

Updated on 9 February 2009 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Section 4.2: Change in Maintenance treatment to 'Recommened dosage, 2 g mesalazine once daily.'

Updated on 19 August 2008 PIL

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 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

Section 4.4  Updated Special Warnings to include 'In case of acute symptoms of intolerance, i.e. cramps, abdominal pain, fever, severe headache and rash, the treatment should be discontinued immediately' and 'Blood tests (differential blood count; liver function parameters like ALT or AST) should be assessed prior to and during treatment, at the discretion of the treating physician'.
 
Section 4.5  'Concomitant treatment with mesalazine can increase the risk of blood dyscrasia in patients receiving azathioprine or 6-mercaptopurine' from section 4.4 to section 4.5.
 
Section 4.8  Added bilirubin, cirrhosis, hepatic failure, Quincke's oedema, renal impairment
 
Section 6.5  Updated pack sizes

Updated on 19 August 2008 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 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Section 4.4  Updated Special Warnings to include 'In case of acute symptoms of intolerance, i.e. cramps, abdominal pain, fever, severe headache and rash, the treatment should be discontinued immediately' and 'Blood tests (differential blood count; liver function parameters like ALT or AST) should be assessed prior to and during treatment, at the discretion of the treating physician'.
 
Section 4.5  'Concomitant treatment with mesalazine can increase the risk of blood dyscrasia in patients receiving azathioprine or 6-mercaptopurine' from section 4.4 to section 4.5.
 
Section 4.8  Added bilirubin, cirrhosis, hepatic failure, Quincke's oedema, renal impairment
 
Section 6.5  Updated pack sizes

Updated on 27 August 2007 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 27 August 2007 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 21 July 2005 SmPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 21 July 2005 PIL

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 5.1 - Pharmacodynamic properties

Updated on 4 July 2005 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Updated on 4 July 2005 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 27 June 2005 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

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

Updated on 27 June 2005 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 26 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie