FML

  • Name:

    FML

  • Company:
    info
  • Active Ingredients:

    Fluorometholone

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/12/17

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 6/12/2017
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Allergan Ltd

Allergan Ltd

Company Products

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Medicine Name Acular Active Ingredients Ketorolac Trometamol
Medicine Name Alphagan Active Ingredients brimonidine tartrate
Medicine Name Betagan Active Ingredients Levobunolol hydrochloride
Medicine Name Betagan Unit Dose Active Ingredients Levobunolol hydrochloride
Medicine Name BOTOX 100 Units Active Ingredients Botulinum Toxin Type A
Medicine Name BOTOX 200 Units Active Ingredients Botulinum Toxin Type A
Medicine Name BOTOX 50 Units Active Ingredients Botulinum Toxin Type A
Medicine Name Celluvisc 0.5% Active Ingredients Carmellose sodium
Medicine Name Celluvisc 1.0% w/v Eye drops, solution Active Ingredients Carmellose sodium
Medicine Name Combigan Active Ingredients brimonidine tartrate, Timolol Maleate
Medicine Name Exocin Active Ingredients Ofloxacin
Medicine Name FML Active Ingredients Fluorometholone
Medicine Name Ganfort Active Ingredients Bimatoprost, Timolol Maleate
Medicine Name Ganfort SD Active Ingredients Bimatoprost, Timolol Maleate
Medicine Name Lacri-Lube Active Ingredients No Active Ingredients
Medicine Name Liquifilm Tears Active Ingredients Polyvinyl Alcohol
Medicine Name Lumigan 0.1mg/ml Active Ingredients Bimatoprost
Medicine Name Ozurdex Active Ingredients Dexamethasone
Medicine Name Pred Forte Active Ingredients Prednisolone Acetate
Medicine Name Pred Mild Active Ingredients Prednisolone Acetate
Medicine Name Refresh Ophthalmic Active Ingredients Polyvinyl Alcohol, Povidone
Medicine Name Relestat 0.5 mg/ml, eye drops, solution Active Ingredients Epinastine Hydrochloride
Medicine Name Vistabel Active Ingredients Botulinum Toxin Type A
1 - 0 of 23 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 6 December 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 6 December 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

In section 4.4 (special warning and precaution for use), a visual disturbance warning was added.

In section 4.8 (undesirable effects), a note was added to see section 4.4 for further information on blurred vision.

In section 10 (date of the revision of the text), the revision date was updated to September 2017.

Updated on 4 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 December 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 17 February 2017 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

-In section 4.5 (Interaction with other medicinal products and other forms of interaction) - update to indicate the increased risk of systemic side effects from co-treatment with CYP3A inhibitors, including cobicistat-containing products, following PRAC recommendation on signals adopted at the PRAC meeting in October 2016 and published by EMA in November 2016. The following wording, as requested by PRAC, has been added:

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

-In section 10 (Date of revision of the text) - the date of revision of the text is February 2017

Updated on 16 February 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 20 October 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • 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

To update SPC in line with CCDS v3

Updated on 13 October 2014 PIL

Reasons for updating

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

Updated on 3 May 2012 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 4 - Clinical particulars
  • Change to section 5 - Pharmacological properties
  • 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

SPC & PIL updated to QRD reference standards.
Sections 4.2; 4.3; 4.4 & 4.8 updated with additional contraindications, warnings and precautions and undesirable effects.

Updated on 1 May 2012 PIL

Reasons for updating

  • Change to side-effects
  • Improved electronic presentation

Updated on 21 February 2011 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 5 January 2009 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 30 December 2008 SmPC

Reasons for updating

  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Summary of Changes to FMLTM Irish Summary of Product Characteristics (SPC)

 

The current FMLTM SPC is dated (December/2008)

This supersedes SPC dated (December/2004)

 

 

Section Number

Subject

Change

1

Name

FML Liquifilm Sterile Ophthalmic Suspension

 

FMLTM Liquifilm 0.1% w/v Sterile Eye Drops Suspension

 

2

Qualitative and quantitative composition

Revised text: Each millilitre contains 1 mg Fluorometholone (0.1% w/v).

 

Excipients: also includes Benzalkonium chloride, 0.0046% w/v.

For a full list of excipients, see section 6.1.

 

 

3

Pharmaceutical form

Eye Drops, Suspension. (Eye Drops).

           

A white, sterile homogeneous suspension microfine suspension

 

 

4.2

Posology and method of administration

General rewording of section and some more significant changes:

 

Adults and children over the age of 2 years only:

 

Topically as drops into the conjunctival sac.

 

The safety and efficacy of FML has not been proven in children aged 2 years or less.

 

4.3

Contraindications

General rewording of section

 

4.4

Special warnings and precautions for use

General rewording of section and some more significant changes:

 

Steroid medication in the treatment of herpes simplex keratitis (involving the stroma) requires great caution, frequent slit-lamp microscopy is mandatory, in severe cases once a day.

 

A red eye, where the diagnosis is unconfirmed, may be due to herpes simplex virus, and a corticosteroid may aggravate the condition, leading to corneal ulceration, with possible damage to vision and even loss of the eye. 

 

Adverse topical effects of steroid treatment, such as skin atrophy, striae and teleangiectasia, may occur especially in the facial skin.

 

FML contains benzalkonium chloride which is irritant to the eye and could cause discoloration of soft contact lenses.  Avoid contact with soft contact lenses.  Remove contact lenses before FML is used and wait for at least 15 minutes before reinsertion.

 

Concomitant ocular medication should be administered 5 minutes prior to the instillation of FML.

 

 

 

4.6

Pregnancy and lactation

There is inadequate evidence of safety in human pregnancy.  Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation.  There may therefore be a very small risk of such defects in the human foetus.

 

 

Pregnancy

 

Fluorometholone should only be used during pregnancy if it is clearly necessary.  Fluorometholone is, as are other corticosteroids, teratogenic in animal studies.

 

Lactation

 

Fluorometholone may pass into breast milk so it is recommended that FML is not used in nursing mothers unless clearly necessary.

 

 

4.7

Effects on ability to drive and use machines

Instillation of any eye drop could result in transient blurring of vision.  If this occurs, the patient should wait for the blurring to subside before driving or operating machinery.

 

4.8

Undesirable effects

Glaucoma with optic nerve damage, visual acuity or field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens liberated from ocular tissues, perforation of the globe.

 

Local side-effects of steroid therapy, i.e. skin atrophy, striae and telangiectasia, are especially likely to effect facial skin.

 

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

 

The following undesirable effects have been reported since FML was marketed.

 

Frequency:

Common: affecting >1/100 and <1/10 patients

Not known: the incidence cannot be determined from available information.

 

Eye disorders

Not known: Eye irritation, conjunctival hyperaemia, eye pain, visual disturbance, foreign body sensation in eyes, eyelid oedema, blurred vision, eye discharge, eye pruritis, lacrimation increased, ocular hyperaemia, eye oedema, mydriasis, eye inflammation, corneal disorder, cataract (including subcapsular)

 

Immune system disorders

Not known: Hypersensitivity

 

Investigations

Common: Intraocular pressure increased

 

Nervous system disorders

Not known: Dysgeusia, headache, dizziness

 

Skin and subcutaneous tissue disorders

Not known: Rash

 

Vascular disorders

Not known: Hypertension

 

 

4.9

Overdose

No case of overdose has been reported.  Overdosage will not ordinarily cause acute problems. 

 

If accidental overdosage occurs in the eye, the eye should be flushed with water or normal saline.  If accidentally ingested, the patient should drink fluids to dilute.

 

5

Pharmacological properties

Pharmacotherapeutic group: Corticosteroids, plain

ATC code: S01BA07

 

5.1

Pharmacodynamic properties

General rewording of section

5.2

Pharmacokinetic properties

General rewording of section

5.3

Preclinical safety data

Any preclinical safety data relevant to the prescriber has been included in other sections of the Summary of Product Characteristics.

 

6.3

Shelf Life

Slight rewording of section

 

6.5

Nature and contents of container

Bottles and dropper tips composed of low density polyethylene containing either 5 or 10 ml of FML.  Screw caps are medium impact polystyrene.

 

A bottle and an applicator tip of low density polyethylene (LDPE).  A screw cap of high impact polystyrene (HIPS).

 

The bottle contains 5 ml or 10 ml of suspension.

 

Not all pack sizes may be marketed.

 

 

 

6.6

Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

This product is sterile when packaged.  To prevent contamination, care should be taken to avoid touching the applicator tip to the eye or to any other surface.  The use of the product by more than one person may spread infection.

 

Keep bottle tightly closed when not in use.

 

No special requirements.

 

 

Key:

 

Words added within the text are in red and underlined eg (Eye Drops).

 

Words deleted from the text are in black and are struck through eg sterile homogeneous suspension

 

Updated on 1 September 2008 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 28 August 2008 PIL

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 15 August 2005 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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)

Updated on 9 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 6 August 2004 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Updated on 29 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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