Last Updated on eMC 10-04-2017 View medicine  | E. R. Squibb & Sons Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 - Fertility, 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 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:04-01-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The main changes in relation to the CCDS are to sections 4.4, 4.6, 4.8 and 4.9. All other changes to other sections are QRD related

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-07-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 3, update to the use of the scoreline, section 10 update to date of revision

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC:01-10-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to SmPC in line with PRAC recommendations  for Renin-Angiotensin System (RAS) Acting Agents.

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC:12-08-2013

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • 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 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:12-08-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.1: correction of a typo: symptomatic to asymptomatic; remove of the following text after heart failure - "with reduction of systolic ventricular function, in combination with diuretics and, when appropriate, digilalis and beta-blockers.
Section 4.4: angioedema section updated and addition of risk of hypokalaemia and pregnancy
Section 4.5: addition of alpha blocking agents
Section 4.6: updated
Section 4.8: addition of intestinal angioedema

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • 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 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:12-08-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.1: remove of the follwoing thext after heart failure - "with reduction of systolic ventricular function, in combination with diuretics and, when appropriate, digilalis and beta-blockers.
Section 4.4: angioedema section updated and addition of risk of hypokalaemia and pregnancy
Section 4.5: addition of alpha blocking agents
Section 4.6: updated
Section 4.8: addition of intestinal angioedema

 

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:07-09-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The following text regarding pregnancy and lactation has been included:

4.4         Special Warnings and Special Precautions for Use

 

Pregnancy: ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).

 

4.6         Pregnancy and Lactation

 

Pregnancy:   Controlled studies with ACE inhibitors have not been done in humans, but limited number of cases of first trimester exposures have not shown malformations. Capoten The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 4.4). When a pregnancy is planned or confirmed, the switch to an alternative treatment should be initiated as soon as possible.   The use of ACE inhibitors is contraindicated during the second and third trimesters of pregnancy (see section 4.3 and 4.4).

Capoten is contraindicated during the second and third trimesters of pregnancy.   

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started. Prolonged captopril eExposure to ACE inhibitor therapy during the second and third trimesters is known to induce human feototoxicity in foetuses (decreased renal function, oligohydramnios, skull ossification retardation) and in neonates  neonatal toxicity (neonatal renal failure, hypotension, hyperkalaemia). (Ssee section also 5.3). Should exposure to ACE inhibitors have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension (see sections 4.3 and 4.4).

 

Lactation:   Capoten is contraindicated in the lactation period.

Limited pharmacokinetic data demonstrate very low concentrations in breast milk (see section 5.2). Although these concentrations seem to be clinically irrelevant, the use of Capoten in breastfeeding is not recommended for preterm infants and for the first few weeks after delivery, because of the hypothetical risk of cardiovascular and renal effects and because there is not enough clinical experience.

In the case of an older infant, the use of Capoten in a breast-feeding mother may be considered if this treatment is necessary for the mother and the child is observed for any adverse effect.

 

5.2         Pharmacokinetic Properties

 

Lactation:

In the report of twelve women taking oral captopril 100mg 3 times daily, the average peak milk level was 4.7μg/L and occurred 3.8 hours after the dose. Based on these data, the maximum daily dosage that a nursing infant would receive is less than 0.002% of the maternal daily dosage

 

10.         DATE OF REVISION OF THE TEXT

 

June 2010September 2012

 

Reasons for adding or updating:

  • Improved Electronic Presentation

Date of revision of text on the SPC:01-06-2010

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO