Maxitrol Eye Drops

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/12/19

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Summary of Product Characteristics last updated on medicines.ie: 2/8/2018

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Novartis Ireland Limited

Novartis Ireland Limited

Company Products

Medicine NameActive Ingredients
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Medicine Name Atriance 5 mg/ml solution for infusion Active Ingredients Nelarabine
Medicine Name Azarga 10mg/ml + 5mg/ml eye drops, suspension Active Ingredients Brinzolamide, Timolol Maleate
Medicine Name Azopt 10mg/ml eye drops suspension Active Ingredients Brinzolamide
Medicine Name Cataflam 50 mg Coated Tablets Active Ingredients Diclofenac Potassium
Medicine Name Certican Tablets Active Ingredients Everolimus
Medicine Name CILOXAN 3 mg/ml ear drops, solution Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Co-Diovan 160 mg/12.5 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 160mg/25mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 320mg/12.5mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 320mg/25mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 80mg/12.5mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Cosentyx 150 mg solution for injection in pre-filled pen Active Ingredients secukinumab
Medicine Name Desferal 500mg Vials Active Ingredients Desferrioxamine Mesylate
Medicine Name Diovan 160 mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 320mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 3mg/ml Oral Solution Active Ingredients Valsartan
Medicine Name Diovan 40 mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 80 mg film-coated tablets Active Ingredients Valsartan
Medicine Name DuoTrav Eye Drops Solution Active Ingredients Timolol Maleate, Travoprost
Medicine Name Entresto 24mg/26mg, 49mg/51mg and 97mg/103mg film-coated tablets Active Ingredients Sacubitril, Valsartan
Medicine Name Estradot Transdermal Patches Active Ingredients Estradiol Hemihydrate
Medicine Name Eucreas 50mg / 850mg and 50mg / 1000mg film-coated tablets Active Ingredients Metformin Hydrochloride, Vildagliptin
1 - 0 of 116 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 December 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 10 April 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 25 March 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to date of revision

Updated on 2 August 2018 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 14 September 2017 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 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 5.3 and 4.8 updated.

Updated on 13 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 September 2017 PIL

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 SmPC

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

- sections 7,8 and 10 updated following approval of transfer of MAH from Alcon to Novartis.

Updated on 26 May 2017 PIL

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 9 January 2017 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 4.6 - 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 4.2, added information regarding hepatic and renal patients and method of administration

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 9 January 2017 PIL

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 SmPC

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

- IMB name change to HPRA

Updated on 8 December 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 30 June 2014 SmPC

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

- SPC updated in line with CCSI changes.

Updated on 26 June 2014 PIL

Reasons for updating

  • Change to instructions about overdose
  • Change to instructions about missed dose
  • Change to warnings or special precautions for use

Updated on 9 April 2014 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 26 February 2014 SmPC

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 SPC to align with core CCSI changes.

Updated on 21 February 2014 PIL

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 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

MAH address change.

Updated on 13 January 2014 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 4 April 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 15 November 2010 SmPC

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 SmPC

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 1 - Name of the product changed to 'Maxitrol 0.1% w/v, 6000IU/ml, 3500 IU/ml eye drops, suspension'.

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 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 10 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)