Selectol Tablets 200mg

  • Name:

    Selectol Tablets 200mg

  • Company:
    info
  • Active Ingredients:

    Celiprolol hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/11/18

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 22/11/2018

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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 23 November 2018 PIL

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 22 November 2018 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

Concomitant use of fingolimod and beta blockers may potentiate bradycardia effects and is not recommended.  Where such co-administration is considered necessary, appropriate monitoring at treatment initiation, i.e. at least overnight monitoring, is recommended.

 

  

Floctafenine

In case of shock or hypotension due to floctafenine, beta-blockers make the drugs used for compensating these symptoms less effective.

 

Monoamineoxidase inhibitors (exception MOA-B inhibitors)

Combinations to be used with caution

Class I antiarrhythmic agents (disopyramide, quinidine) and amiodarone

 

Risk of disturbances in rhythm and atrioventricular conduction. Therefore, clinical and ECG monitoring must be performed.

 

Sympathomimetic agents

            Sympathomimetic agents may counteract the effects of beta blockers.

 

            Sinus arrest may occur when beta blockers, including Selectol, are used in combination with other drugs known to induce sinus arrest (see Section 4.8,             Undesirable effects).

 

4.6       Fertility, pregnancy and lactation

 

  • Cardiac disorders
    Uncommon: palpitations
    Not known: bradycardia;, cardiac failure and arrhytmias; sinus arrest in predisposed patients (e.g., elderly patients or patients with pre-existing bradycardia, sinus node dysfunction or atrioventricular block).
     
     
  • Vascular disorders

Symptoms

Bradycardia, hypotension, bronchospasm, and acute cardiac failure and sinus arrest have been reported with beta-blocker overdosage.

Updated on 27 July 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 26 July 2018 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.5 added

Diltiazem

An increased risk of depression has been reported when beta-blockers are co-administered with diltiazem (see section 4.8 Undesirable Effects).

Updated on 26 July 2018 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

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

Updated on 13 April 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 13 April 2015 SmPC

Reasons for 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
  • 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 4.2 - paragraphs updated include Elderly patients and Patients with renal disease
Section 4.3 - ≤50 beats per minute included with severe bradcardia, new points on hypotension and late stages of peripheral arterial occlusive disease and Raynaud’s syndrome
Section 4.4 - 1st paragraph updated regarding treatment in patients with coronary insufficiency and dosage. 
New paragraph: Patients with psoriasis should only be given beta-blockers after careful consideration, as psoriasis may be aggravated.
General Anaesthesia paragraph moved from section 4.5.
Updated paragraphs - Treated pheochromocytoma and Diabetes Mellitus
New paragraph on Thyrotoxicosis
Section 4.5 - new paragraphs
- Digitalis glycosides
- Fingloimod
- Clonidine
-
Interactions with organic anion-transporting polypeptides (OATPs) inhibitors
- Interactions with inhibitors/inducers of P-glycoprotein:
Calcium antagonists paragraph deleted
Section 4.6 - information on pregnancy and breast feeding updated.
Section 4.8 updated.

Updated on 1 April 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 April 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions

Updated on 13 September 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 28 August 2013 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 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Glucagons, 0.3 mg/kg
  • Hospitalization in an intensive care unit,
  • Isopenaline: treatment is generally needed at a high dosage, therefore patients monitoring in a specialized care unit is recommended
  • Glucagons, 0.3 mg/kg
  • Hospitalization in an intensive care unit,
  • Isopenaline: treatment is generally needed at a high dosage, therefore patients monitoring in a specialized care unit is recommended

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 as follows;-

 

 

In hypertensive patients, additional treatment with other anti-hypertensive agents according to clinical guidelines is possible, in particular with diuretics. When a combination is initiated an increased monitoring of the blood pressure is recommended.

 

Elderly patients: Although pharmacokinetics in elderly patients are not significantly different, due regard should be made for decreased renal and liver function in this age group.

 

Patients with renal disease: Celiprolol may be used in patients with mild to moderate degrees of reduced renal function. For patients with a creatinine clearance less than 40ml per minute, heart rate should be monitored and dosage should be decreased in case of bradycardia (less than 50-55 beats per minute at rest).

(Adjustment of dosage is unnecessary in patients with renal insufficiency with a creatinine clearance exceeding 30 ml/min.  However, cCareful surveillance of such patients is recommended until steady state blood levels are achieved.  A reduction in dosage may be necessary in patients with severe renal impairment), please see section 4.4.


 

4.6       Pregnancy and Lactation

No teratogenic effects have been shown in animals studies, but safety during human pregnancy has not been established   Celiprolol should not be used during pregnancy unless there is no safer alternative,  and the benefit outweighs the risk.

 

In neonates: In the newborn of treated mothers, beta-blocking activity persists for several days after birth. This residual effect is usually without clinical consequences, but there is a possibility of heart failure requiring hospitalization in an intensive care unit (see below section re case of cardiac decompensation on the neonate of mother treated with beta-blockers). 

In general beta blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries.  Plasma volume should not be increased as risk of acute pulmonary oedema may exist. In addition, bradycardia, respiratory distress, and hypoglycaemia have been reported. For these reasons, careful monitoring of the neonate (heart rate – glycemia) is recommended for the first 3 days of life.

 

When given within 48 hours of delivery of an obstetric patient, hypotension and bradycardia may be seen in the infant.

 

In the case of cardiac decompensation in the neonate of mother treated with beta-blockers, the following should be administered:

  • Glucagons, 0.3 mg/kg
  • Hospitalization in an intensive care unit,
  • Isopenaline: treatment is generally needed at a high dosage, therefore patients monitoring in a specialized care unit is recommended

The extent to which the drug is excreted in breast milk has not been established. It should not be given to mothers who are breast feeding their babies.

For treatment information on neonate, please refer to section 4.9.

Section 4.9 updated to include:-
In the case of cardiac decompensation in the neonate of mother treated with beta-blockers please refer to section 4.6.:

 

  • Glucagons, 0.3 mg/kg
  • Hospitalization in an intensive care unit,
  • Isopenaline: treatment is generally needed at a high dosage, therefore patients monitoring in a specialized care unit is recommended

 

 

Updated on 26 September 2012 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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 7 has been updated to include 'T/A SANOFI'

Updated on 12 May 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 27 August 2009 SmPC

Reasons for updating

  • 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

Correction of excipient name

Updated on 19 March 2009 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 27 August 2007 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 9 March 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 19 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 25 January 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 17 January 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 9 September 2004 PIL

Reasons for updating

  • Change to packaging

Updated on 19 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie