PHYLLOCONTIN CONTINUS Tablets

  • Name:

    PHYLLOCONTIN CONTINUS Tablets

  • Company:
    info
  • Active Ingredients:

    Aminophylline Hydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/07/18

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Summary of Product Characteristics last updated on medicines.ie: 23/5/2017
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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

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Company Products

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Medicine Name MST Continus Tablets Active Ingredients Morphine sulfate
Medicine Name Nyxoid 1.8 mg nasal spray Active Ingredients Naloxone Hydrochloride dihydrate
Medicine Name OxyContin prolonged release tablets Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm 10 mg/ml solution for Injection or Infusion Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm 50 mg/ml, solution for injection or infusion Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Capsules Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Concentrate Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Dispersa 5, 10, 20 mg orodispersible tablets Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm liquid 1 mg/ml oral solution Active Ingredients Oxycodone Hydrochloride
Medicine Name PALLADONE Capsules Active Ingredients Hydromorphone Hydrochloride
Medicine Name Palladone SR Capsules Active Ingredients Hydromorphone Hydrochloride
Medicine Name Pelmeg 6 mg solution for injection in pre-filled syringe Active Ingredients Pegfilgrastim
Medicine Name PHYLLOCONTIN CONTINUS Tablets Active Ingredients Aminophylline Hydrate
Medicine Name SEVREDOL Tablets Active Ingredients Morphine sulfate
Medicine Name Targin 15 mg/7.5 mg and 30 mg/15 mg prolonged-release tablets Active Ingredients Naloxone Hydrochloride dihydrate, Oxycodone Hydrochloride
Medicine Name Targin 5/2.5mg, 10mg/5mg, 20mg/10mg and 40/20mg prolonged release tablets Active Ingredients Naloxone Hydrochloride dihydrate, Oxycodone Hydrochloride
1 - 0 of 30 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 10 July 2018 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 23 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 23 May 2017 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - 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 4.8 – 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 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 2: $0Minor grammatical changes have been made.$0$0$0$0$0Section 3: $0$0Minor grammatical changes have been made. ‘Round’ has been added as a description of the tablet. ‘Film-coated’ has been moved from the first sentence to the second.$0$0$0$0$0Section 4.1: $0$0‘PHYLLOCONTIN CONTINUS tablets are indicated for use in adults and children aged 6 years and above. Aminophylline should not be used as the first drug of choice in the treatment of asthma in children.’ has been added.$0$0$0$0$0Section 4.2: $0$0The subtitle ‘Posology’ has been added.$0$0Information regarding route of administration has been moved to the end of this section.$0$0‘Children’ has been changed to ‘Paediatric population aged 6 years and above’.$0$0The usual paediatric maintenance dose has been changed from 12 mg/kg to 10 mg/kg.$0$0Information regarding increased clearance in children has been added.$0$0Information regarding use in children less than 6 years of age has been added.$0$0Information regarding theophylline distribution in body fat has been added.$0$0Information regarding ideal plasma theophylline concentrations has been added.$0$0The subtitle‘Missed dose’ has been added with the relevant information below.$0$0Information regarding the elderly and dose titration has been removed.$0$0$0$0$0Section 4.3:$0$0A reference to section 6.1 has been added.$0$0‘less than 6 years of age (or less than 22 kg).’ has been added in reference to children.$0$0‘Porphyria’ and ‘Aminophylline is contraindicated in children under 6 months of age’ have been added.$0$0$0$0$0Section 4.4:$0$0Information regarding increased and decreased clearance, the effects of aminophylline and when caution or particular care should be exercised has been added.$0$0$0$0$0Section 4.5:$0$0‘Ritonavir’ has been added and ‘moracizine’ has been removed as medicines that increase clearance.$0$0The repeated reference to St. John’s Wort has been removed.$0$0‘Aciclovir’ has been added and ‘ciprofloxacin’, ‘norfloxacin’, ‘ofloxacin’ and ‘viloxazine hydrochloride’ have been removed as medicines that reduce clearance.$0$0‘Pentoxifylline’ has replaced ‘oxpentifylline’.$0$0Information regarding theophylline interaction with quinolone antibiotics has been added.$0$0‘Reduced’ has replaced ‘halved’ in reference to aminophylline dose.$0$0‘resulting in increased serum theophylline levels’ has been added regarding interaction between theophylline and influenza vaccine.$0$0Information regarding concurrent administration of aminophylline has been added.$0$0‘Serum potassium concentrations’ has replaced ‘serum levels’.$0$0$0$0$0Section 4.6:$0$0The subtitles ‘Pregnancy’ and ‘Breast-feeding’ have been added.$0$0‘Preclinical safety data’ has been removed from the reference to section 5.3.$0$0$0$0$0Section 4.7:$0$0‘PHYLLOCONTIN CONTINUS tablets have no or negligible influence on the ability to drive and use machines’ has replaced ‘None known’.$0$0$0$0$0Section 4.8:$0$0Information about the assigned frequencies of the adverse drug reactions has been added.$0$0The adverse drug reactions have been inserted into a table, instead of their previous list format.$0$0System Organ Classes have been added to group the adverse drug reactions.$0$0A reference to section 4.4 has been added regarding urinary retention.$0$0Information regarding the reporting of adverse reactions has been added.$0$0$0$0$0Section 4.9:$0$0Information regarding theophylline toxicity has been added.$0$0Information regarding alimentary, neurological, cardiovascular and metabolic symptoms has been added.$0$0Information regarding the management of overdose has replaced the previous information on treatment of overdose.$0$0$0$0$0Section 5.1:$0$0‘Drugs for obstructive airways disease’ has been added to the pharmacotherapeutic group description.$0$0$0$0$0Section 5.2:$0$0Information regarding absorption, distribution and protein binding, biotransformation, elimination and factors affecting clearance has been added, under the relevant subtitles. This has replaced the previous information in this section.$0$0$0$0$0Section 5.3:$0$0Information regarding Genotoxicity and carcinogenicity and Reproductive and developmental toxicity has been added under the relevant subtitles. This has replaced the previous information in this section.$0$0$0$0$0Section 10:$0$0The date of revision has been updated to 10 May 2017.$0

Updated on 25 July 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 July 2016 PIL

Reasons for updating

  • Change of manufacturer

Updated on 24 August 2011 SmPC

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

Section 7

MA Holder is now

Mundipharma Pharamceuticals Ltd
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland

Section 8

PA number is now PA 1688/008/001

Updated on 23 August 2011 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 13 August 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 21 May 2007 PIL

Reasons for updating

  • Change to date of revision
  • Change to side-effects

Updated on 9 May 2007 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 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 1 updated to read name, strength and pharmaceutiacl form
Section 2 updated to include: for a full list of excipients, see 6.1
Section 4.2 updated with potential effects form chewing or crushing the tablets
Section 4.5 updated interactions
Section 4.8 updated undesirable effects
Section 4.9 added symptoms of overdose
Section 5.1 added pharmacotherapeutic group and ATC code
Section 6.5 updated to included: Not all pack sizes may be marketed
Section 6.6 updated to read: No special requirements
Section 10 date of revision of text updated.

Updated on 5 January 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 5 January 2006 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

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

Updated on 17 October 2005 PIL

Reasons for updating

  • Change of active ingredient
  • Change of inactive ingredient

Updated on 17 October 2005 SmPC

Reasons for updating

  • Change to separate SPCs covering individual presentations

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

Updated on 5 August 2005 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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

Updated on 18 May 2005 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

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

Updated on 31 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 24 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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