Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Loteprednol etabonate
Bausch & Lomb UK Ltd
S01BA14
Loteprednol etabonate
5mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11040100; GTIN: 4030571002123
Eye Drops, Suspension Loteprednol Etabonate PACKAGE LEAFLET: INFORMATION FOR THE USER WHAT IS IN THIS LEAFLET 1. What Lotemax is and what it is used for 2. What you need to know before you use Lotemax 3. How to use Lotemax 4. Possible side effects 5. How to store Lotemax 6. Contents of the pack and other information 1. WHAT LOTEMAX IS AND WHAT IT IS USED FOR Lotemax is an eye drop suspension. Lotemax is used to treat inflammation of the eye, after surgery. Sometimes the eye may become inflamed (red and painful). Loteprednol etabonate is one of a group of medicines called corticosteroids. It acts by reducing inflammation and eases the symptoms. Because it is used in low doses directly where it is needed, its action is only at this place. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LOTEMAX DO NOT USE LOTEMAX: • if you are allergic to the active substance (loteprednol) or any of the other ingredients of this medicine (listed in section 6). • if you have been allergic to any other corticosteroid. • if you have eye diseases caused by viruses such as herpes simplex, vaccinia, and varicella. • if you have eye diseases caused by mycobacterium and fungi. • If you are breast-feeding. WARNINGS AND PRECAUTIONS • Tell your doctor if you already have glaucoma. • Contact your doctor if you experience blurred vision or other visual disturbances. • Tell your doctor if pain develops, or if redness, itching, or inflammation gets worse. • See your doctor if your symptoms do not get better within 2 days. He/she may want to re-evaluate your condition. • You should not use Lotemax longer than 10 days without having the pressure in your eye checked by your doctor. • Long-term use of Lotemax or other eye drops that contain steroids, may result in glaucoma or raised pressure in the eye, which can cause damage to the optic nerve, problems with vision, and cataracts. • Long-term use of Lotemax or other eye drops that contain steroids, may lower your ability to fight infections and may increase your chance of getting an e Read the complete document
OBJECT 1 LOTEMAX 0.5% EYE DROPS, SUSPENSION Summary of Product Characteristics Updated 09-Oct-2017 | Bausch & Lomb U.K Limited 1. Name of the medicinal product Lotemax 0.5% w/v Eye Drops_, _Suspension 2. Qualitative and quantitative composition The suspension contains 0.5%w/v loteprednol etabonate (5 mg/ml). Each drop contains 0.19 mg loteprednol etabonate. Excipient with known effect: Benzalkonium Chloride (0.01%) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Eye-drops, suspension Milky-white 4. Clinical particulars 4.1 Therapeutic indications Treatment of post-operative inflammation following ocular surgery. 4.2 Posology and method of administration Posology _Adults and elderly_ One to two drops four times daily beginning 24 hours after surgery and continuing throughout the post- operative period. The duration of treatment should not exceed 2 weeks. _Paediatric Population_ Lotemax should not be used in the paediatric age group until further data become available. Method of administration Ocular use Shake the bottle vigorously before using the eye drops. This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension. The bottle should be closed immediately after use. 4.3 Contraindications Lotemax is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures; untreated purulent acute infections which, similar to other infectious diseases, can be masked and worsened by corticoids, 'red eye' with unknown diagnosis and infection caused by amoeba. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to other corticosteroids. 4.4 Special warnings and precautions for use Prolonged use of corticosteroids may result in ocular hypertension or glaucoma with damage to the optic ner Read the complete document