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Bristol-Myers Squibb Pharmaceutical Limited
Watery Lane, Swords, Co. Dublin,
Telephone: 1 800 749 749
Medical Information Direct Line: Freephone: 1 800 749 749
Medical Information e-mail: Medical.information@bms.com
Summary of Product Characteristics last updated on medicines.ie: 25/11/2016
SPC Capoten 50mg Tablets

When a pharmaceutical company changes an SPC or PIL, 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 25/11/2016 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   22-Nov-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
 QRD updates and typos corrected throughout.
Update of the date of revision.
Undesirable effects updates:
- Inclusion of hyponatremia
- Amendment of sleep disorder to insomnia
- Frequency change for headache and paraethesia from common to uncommon
- Amendment of drowsiness to somnolence
- Update of Tachyarrhythmia to arrhythmia
- Inclusion of orthostatic hypotension as a vascular disorder
- Inclusion of dyspepsia as a gastrointestinal disorder
- Inclusion of asthenia as a general disorder
Updated on 22/09/2015 and displayed until 25/11/2016
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • 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 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   18-Sep-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
$0section 3 QRD alignment regarding the use of the scoreline; section 4.2 QRD alignment; section 4.4 QRDalignment and the following changes: Patients with heart failure are at a highrisk of hypotension and a lower starting dose is recommended when initiatingtherapy with an ACE inhibitor.  The magnitude of the decreaseis greatest early in the course of treatment; this effect stabilises within aweek or two, and generally returns to pre-treatment levels, without a decreasein therapeutic efficacy, within two months.  Cautionshould be used whenever the dose of captopril or diuretic is increased in patientswith heart failure.$0$0 Infants, especially newborns, may be more susceptible tothe adverse haemodynamic effects of captopril.  Excessive, prolongedand unpredictable decreases in blood pressure and associated complications,including oliguria and seizures have been reported.$0$0Anaphylactoid reactions during high-fluxdialysis/lipoprotein apheresis membrane exposure: Anaphylactoid reactionshave been reported in patients haemodialysed with high-flux dialysis membranesor undergoing low-density lipoprotein apheresis with dextran sulphate absorption adsorption.  Inthese patients, consideration should be given to using a different type ofdialysis; membrane or a different class of medication.$0$0Renal function in patients with Heart Failure:  About 20% of patients developstable elevations of BUN and serum creatinine  >20% above normalor baseline upon long-term treatment with captopril.  Less than 5% ofpatients, generally those with severe pre-existing renal disease, requireddiscontinuation of treatment due to progressively increasing creatinine.$0$0section 4.5 QRD alignment; section 4.6 alignment and thefollowing changes: Pregnancy: The use of ACE inhibitors is not recommended during thefirst trimester of pregnancy (see section 4.4).  The use of ACEinhibitors is contraindicated during the second and third trimesters ofpregnancy (see sections 4.3 and 4.4).  Controlledstudies with ACE inhibitors have not been done in humans, but limited numbersof cases of first trimester exposures have not shown malformations$0$0section 4.8 QRD alignment and multiple ADR changesin MedDRA term and frequency; section 4.9 the following changes: Captopril may be removed from adult circulation by, haemodialysis.  Captopril is not adequately cleared by peritoneal dialysis.$0$0section 5.2 QRD alignment; section 6.5 addition of "or 56"; section10 Update of revision date to "September 2015"$0
Updated on 10/08/2015 and displayed until 22/09/2015
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   22-Jan-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Submission of updated SmPC, "or 56 was deleted in error but has now been added back$0$0$0$06.5 Nature and contents of container$0$0The tablets are packaged in PVC/aluminium blisters or PVC/PVdC/aluminium blisters in packs of 28 or 56 tablets.$0$0$0$0$0$0$0
Updated on 29/01/2015 and displayed until 10/08/2015
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:   22-Jan-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
SPC update in line with PRAC recomendations
Updated on 31/10/2013 and displayed until 29/01/2015
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
None provided

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Active Ingredients

 
  Captopril