MAXITROL 0.1%w/v, 6000 IU/ml, 3500 IU/ml eye drops, suspension
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 19 February 2024
File name
Maxitrol_REG SPC_PF23-0205_February 2024_IPHA.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 May 2022
File name
Maxitrol_REG PIL_PF21-0116_clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 16 September 2020
File name
Maxitrol REG PIL PF 20-0143 TBI 10.5.2021.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 16 September 2020
File name
Maxitrol REG PIL PF 20-0143 TBI 10.5.2021IPHA.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 16 September 2020
File name
Maxitrol Eye Drops REG SPC PF 20-0143 Eye Drops September 2020 clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 May 2020
File name
Maxitrol REG PIL 670780 PF 20-0030 IPHA.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 10 December 2019
File name
Maxitrol REG PIL 647706 TBI 06 Jan 2019 IPHA.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 10 April 2019
File name
IPHAMaxitrol leaflet_ 647706_IE_TBI 06 Jan 2019.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 25 March 2019
File name
IPHA431205_R92_p1_LFT_TBI jan 2019.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to date of revision
Updated on 02 August 2018
File name
REG_SPC_Maxitrol Eye Drops_PF18-0221_clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 September 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 September 2017
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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 13 September 2017
File name
PIL_8797_409.pdf
Reasons for updating
- New PIL for new product
Updated on 13 September 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 31 May 2017
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 26 May 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 09 January 2017
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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.3, added untreated parasitic eye infections as contraindication
In section 4.4, added information on severity of hypersensitivity reaction and Cushing's syndrome
In section 4.5, added interaction with Ritonavir
In section 4.6, added information on fertility and pregnancy
In section 4.8, frequency of undesirable effects updated. Steven's-Johnson Syndrome and ulcerative keratitis added.
Updated on 09 January 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 10 December 2014
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 08 December 2014
Reasons for updating
- Change to side-effects
Updated on 30 June 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 26 June 2014
Reasons for updating
- Change to instructions about overdose
- Change to instructions about missed dose
- Change to warnings or special precautions for use
Updated on 09 April 2014
Reasons for updating
- Improved electronic presentation
Updated on 26 February 2014
Reasons for updating
- Change to section 4.3 - Contraindications
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 February 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 14 January 2014
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 13 January 2014
Reasons for updating
- Change to MA holder contact details
Updated on 04 April 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 15 November 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 2, Qualitative and quantitative composition, the text has been amended to QRD template.
In Section 4.1, Therapeutic indications, ‘Maxitrol Eye Drops’ is replaced with ‘Maxitrol Eye Drops, Suspension’
In Section 4.3, Contraindications, the whole section has been updated according to updated safety data, and is presented according to QRD.
In Section 4.4, Special warnings and precautions for use, the whole section has been updated according to updated safety data, and is presented according to QRD.
In Section 4.5, Interaction with other medicinal products and other forms of interaction, ‘None relevant to topical use’ is replaced by ‘No interaction studies have been performed.
Concomitant and/or sequential use of an aminoglycoside (neomycin) and other systemic, oral, or topical drugs that have neurotoxic, ototoxic, or nephrotoxic effects may result in additive toxicity and should be avoided, whenever possible.
If more than one ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.’
In Section 4.6, Pregnancy and lactation, the whole section has been updated according to updated safety data, and is presented according to QRD.
In Section 4.7, Effects on ability to drive and use machines, the whole section has been replaced with ‘MAXITROL eye drops, suspension has no or negligible influence on the ability to drive and use machines. As with any other eye drop, temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If transient blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery.’
In Section 4.8, Undesirable effects, the whole section has been rewritten to represent it in the MedRA format.
In Section 4.9, Overdose, the whole section is replaced with ‘No case of overdose has been reported. Signs and symptoms of an overdosage of MAXITROL eye drops, suspension may be similar to adverse reaction effects seen in some patients (punctuate keratitis, erythema, increased lacrimation, oedema and lid itching). A topical ophthalmic overdose of MAXITROL eye drops, suspension may be flushed from the eye(s) with lukewarm water.’
In Section 5.1, Pharmacodynamic properties, the whole section has been updated according to updated safety data, and is presented according to QRD.
In Section 5.3, Preclinical safety data, the whole section has been updated according to updated safety data, and is presented according to QRD.
In Section 6.3, Shelf life, ‘Once opened: Discard one month after first opening’ is replaced with ‘Discard one month after first opening.’
In Section 6.4, Special precautions for storage, the following storage condition has been added – ‘Store in the original package (to protect from light).’
In Section 7, Marketing Authorisation holder, ‘England’ in the address is replaced with ‘U.K.’
In Section 10, Date of revision of the text, the date is updated.
Updated on 13 August 2010
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 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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 renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2 - 'Also contains: Benzalkonium chloride w/v' is added.
Section 3 - 'A white and creamy homogeneous suspension' is replaced with 'White to pale yellow opaque suspension'.
Section 6.1 - '(for pH adjustment only)' is added against the excipient 'hydrochloric acid/sodium hydroxide'.
Section 6.3 - 'Unopened 24 months, after opening 28 days' is replaced with 'Unopened: 2 years. Once opened: Discard one month after first opening.'
Section 6.4 - 'Keep away from direct sunlight' removed, 'Do not refrigerate' is replaced with 'Do not refrigerate or freeze' and 'Store in the original package (to protect from light)' is added.
Section 6.5 - '5ml and 10ml Drop-Tainers, natural LDPE bottle and plug with a polystyrene or polypropylene cap' is changed to '5ml Drop-Tainers, natural or white low density poly-ethylene (LDPE) bottles fitted with a natural LDPE dispensing plugs and white polypropylene (PP) closures'.
Section 6.6 - Special precautions added.
Section 9 - Date of last renewal updated.
Section 10 - Date of revision updated.
Updated on 12 August 2010
Reasons for updating
- Change due to harmonisation of PIL
Updated on 10 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 20 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)