Fucithalmic 1% eye drops

Main information

  • Trade name:
  • Fucithalmic 1% eye drops
  • Dosage:
  • 10mg/1gram
  • Pharmaceutical form:
  • Modified-release drops
  • Administration route:
  • Ocular
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Fucithalmic 1% eye drops
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 11030100; GTIN: 5702191002041

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 20072/0242
  • Last update:
  • 30-01-2019

Summary of Product characteristics: dosage, interactions, side effects

Object 1

Fusidic Acid 1% Viscous Eye Drops

Summary of Product Characteristics Updated 12-Apr-2018 | Concordia International - formerly AMCo

1. Name of the medicinal product

Fucithalmic 1% w/w Viscous Eye Drops

Fusidic acid 1% w/w Viscous Eye Drops

2. Qualitative and quantitative composition

Each gram contains fusidic acid, hemihydrate 10mg.

Excipient with known effect: 0.01% w/w benzalkonium chloride

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Sterile viscous eye drops.

4. Clinical particulars

4.1 Therapeutic indications

Fusidic acid eye drops are indicated for the topical treatment of bacterial conjunctivitis where the

organism is known to be sensitive to the antibiotic.

4.2 Posology and method of administration

Posology:

For all ages: One Fusidic acid drop to be instilled into the eye twice daily. Treatment should be continued

for at least 48 hours after the eye returns to normal.

Method of administration:

For ophthalmic use only.

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Contact lenses should not be worn/used when Fusidic acid eye drops are used. The microcrystalline

fusidic acid may cause scratches in the contact lens or cornea. Contact lenses are kept out until all

symptoms of the infection have gone.

Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics,

extended or recurrent use may increase the risk of developing antibiotic resistance.

Excipients warning:

Fusidic acid eye drops contain benzalkonium chloride, which may cause eye irritation and discolour soft

contact lenses.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. Systemic interactions are unlikely since systemic exposure

after application of Fusidic acid eye drops is negligible.

4.6 Fertility, pregnancy and lactation

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to Fusidic acid eye drops is

negligible. Fusidic acid eye drops can be used during pregnancy.

Breast-feeding

No effects on the breast-fed new-born/infant are anticipated since the systemic exposure of the breast-

feeding woman to fusidic acid is negligible. Fusidic acid eye drops can be used during breast-feeding.

Fertility

There are no clinical studies with Fusidic acid eye-drops regarding fertility. No effects on women of

childbearing potential are anticipated, since systemic exposure to Fusidic acid eye-drops is negligible.

4.7 Effects on ability to drive and use machines

Fusidic acid eye drops has no or negligible influence on the ability to drive or use machines. Fusidic acid

eye drops may, however, cause a blurring of vision following application and patient should take this into

account.

4.8 Undesirable effects

The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical

trials and spontaneous reporting.

Based on pooled data from clinical studies, including 2,499 patients with eye infections including acute

conjunctivitis, who received Fucithalmic eye drops, the frequency of undesirable effects was 11.3%.

The most frequently reported adverse reactions during treatment are various application site reactions

such as pain, pruritus and irritation/discomfort in/around the eyes, which occurred in approximately 8.5%

of patients, followed by blurring of vision, which occurred in approximately 1.2% of patients.

Angioedema has been reported in a few patients post marketing.

Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting

with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the

order of decreasing seriousness.

Very common (≥1/10)

Common (≥1/100 and <1/10)

Uncommon (≥1/1,000 and <1/100)

Rare (≥1/10,000 and <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

System organ class

Frequency

Undesirable effects

Immune system disorders

Uncommon

Hypersensitivity

Eye disorders

Common

Vision blurred (transient)

Uncommon

Eyelid oedema, Lacrimation increased

Rare

Conjunctivitis aggravated

Skin and subcutaneous tissue

disorders

Uncommon

Rash

Angioedema

Rare

Urticaria

General disorders and

administration site conditions

Common

Application site pain (including eye burning and

eye stinging)

Application site pruritus

Application site discomfort/irritation

Paediatric population

The observed safety profile is similar in children and adults.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows

continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are

asked to report any suspected adverse reactions via the Yellow Card Scheme website:

www.mhra.gov.uk/yellowcard.

4.9 Overdose

The total quantity of fusidic acid in one 5 g tube of Fucithalmic eye drops (50 mg) does not exceed the

approved total daily oral dose of fusidic acid contain-ing products. The concentration of the excipients is

too low to constitute a safety risk. Therefore, overdose is unlikely to occur.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antimicrobial, ATC code: S01AA13

Fusidic acid eye drops are active against a wide range of gram-positive organisms, particularly

Staphylococcus aureus. Other species against which fusidic acid eye drops have been shown to have in

vitro activity include Streptococcus, Neisseria, Haemophilus, Moraxella and Corynebacteria.

5.2 Pharmacokinetic properties

The sustained release formulation of Fusidic acid eye drops ensures a prolonged contact with the

conjunctival sac. Twice daily application provides sufficient fusidic acid concentrations in all relevant

tissues of the eye. Fusidic acid penetrates well into the aqueous humour.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included

in other sections of the SPC.

6. Pharmaceutical particulars

6.1 List of excipients

Benzalkonium chloride, disodium edetate, mannitol, carbomer, sodium hydroxide, water for injections.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store below 25°C. Keep the tube tightly closed. The tube should be discarded one month after opening.

6.5 Nature and contents of container

Available in 5g tubes.

6.6 Special precautions for disposal and other handling

DIRECTIONS FOR USE FOR ADMINISTRATION

1. As with any eye preparation, wash your hands before you administer FUCITHALMIC viscous eye-

drops.

2. Remove the cap from the tube. To administer FUCITHALMIC viscous eye-drops, stand or sit

comfortably and tilt your head backwards. Hold the tube above your eye.

3. Gently pull down your lower eyelid and squeeze one drop from the tube into your lower eyelid as

shown in the picture. You may find a mirror useful when administering the drops.

4. Be careful not to touch the tip of the tube to your eye or other surface, so as to avoid contamination of

tube contents.

5. FUCITHALMIC viscous eye-drops comes out of the tube as a single viscous drop, which quickly turns

to liquid in your eye.

6. If the drops are for children, you may put the drops in their eyes when they are lying down or asleep.

Any unused medicinal product or waste material should be disposed of in accordance with local

requirements.

7. Marketing authorisation holder

Amdipharm UK Limited,

Capital House,

85 King William Street,

EC4N 7BL, London,

8. Marketing authorisation number(s)

PL 20072/0242

9. Date of first authorisation/renewal of the authorisation

United Kingdom 10.8.1987

10. Date of revision of the text

10/04/2018

Company Contact Details

Concordia International - formerly AMCo

Address

Capital House, 1st Floor, 85 King William Street, London, EC4N 7BL, UK

Telephone

+44 (0)208 588 9131

Medical Information Direct Line

08700 70 30 33

Customer Care direct line

+44 (0)208 588 9273

http://www.concordiarx.com

+44 (0)208 588 9200

Medical Information e-mail

[email

protected]

Medical Information Fax

+44 (0)20 8588 9200