What it is and what it is used for

for Minims® Chloramphenicol contains an antibiotic. It is used to treat infections of your eyes. Sometimes parts of the outer surface of the eye, such as the cornea (the transparent membrane covering the surface of the eye) or the conjunctiva (the lining of the inside of the eyelids and part of the eye), may become infected with bacteria. These eye drops can be used to treat this infection and are effective against many different types of bacteria. If the eye infection is very severe, your doctor may give you antibiotic tablets as well as this antibiotic eye drops. This medicine is indicated for children, adults and the elderly. 2. Before you use your eye drops Do not use these drops if

• you are allergic to the active substance (chloramphenicol) or any of the ingredients (refer to the end of this leaflet). Take special care If you use these eye drops over a long period of time they could possibly become less effective or produce allergic reactions. In order to prevent this, make sure that you stop using this medicine as soon as your doctor tells you to. Do you use any of these medicines? Chymotrypsin (solution used during cataract surgery) may not work properly when used at the same time as Minims® Chloramphenicol. Pregnancy, breast-feeding and fertility If you are pregnant, may be pregnant, or are breastfeeding tell your doctor or eye specialist, he/she may decide to use these drops or to prescribe you an alternative. Contact lenses Your doctor will ask you to remove your contact lenses prior to the administration of the drops. Do not wear your contact lenses throughout the entire treatment course. Driving and using machines

As with all eye drops, your vision may be blurred after putting the drops in. Wait until your vision is clear before driving or using machines. Minims® Chloramphenicol contains borax and boric acid This medicine contains borax (0.12mg per drop equivalent to 3.0 mg/ml) and boric acid (0.60 mg per drop equivalent to 15 mg/ml).

How to take it

your eye drops Do not use this product for longer than the time frame stated by your doctor or eye specialist, as it may become less effective at treating your eye infection. The drops are for single use only and provided in single use Minims units, to treat both eyes if both eyes are infected. Once opened, use immediately. Discard any unused portion. Dosage Adults (including the Elderly) The normal dose is 1 to 2 drops to each infected eye up to six times a day. If you have a severe infection your doctor or eye specialist may ask you to use this medicine more frequently at first, until the infection starts to get better. The frequency of treatment can then be gradually reduced. If your eyes get worse or are not better after a few days of using these eye drops, see your doctor or eye specialist or pharmacist. Children As for adults. The maximum duration of treatment is 10 – 14 days. Use in newborn infants: Your child's doctor may prescribe a lower dose to reduce the risk of side effects. The maximum duration of treatment is 10-14 days. Method of administration Make sure you follow these instructions carefully: 1. Wash your hands. 2. Use a mirror, this will help you to see what you are doing. 3. Carefully dry your eyes using a tissue, and twist off the cap from the Minims body of the unit. 4. Pull your lower eyelid down gently, and then carefully place 1 or 2 drops inside your lower eyelid. Make sure the dropper does not touch any parts of your eye. 5. Close your eye and blink a few times to make sure your eye is covered by the liquid. 6. Close the eyelids. It is advisable to press gently on the inner corner of your eyelid for 3 minutes. This will help stop the solution draining into your nose and throat. This is especially advisable in children, the elderly and population at risk. 7. Repeat steps 4, 5 and 6 for the other eye if necessary, then throw away the Minims unit, even if some solution remains. If you use more Minims® Chloramphenicol than you should, an overdose is very unlikely to occur. If you suddenly feel unwell after receiving the drops, tell your doctor or eye specialist or contact your nearest emergency department immediately. If you forget to use Minims® Chloramphenicol, you should take the missed dose as soon as you remember, unless it is nearly time for the next dose, but you should not take a double dose to make up for a missed dose.

Possible side effects

• Minims® Chloramphenicol may cause difficulty breathing or swallowing, swelling of the face, lips, throat or tongue (anaphylaxis), burning, stinging, itching or rash with swelling of skin (rash could be puffy (swollen) or blotchy or blister-like appearance) and skin irritation (including dermatitis) around the area it has been used on. These effects are not permanent.
• Swelling of the face, lips or tongue may also occur.
• Aplastic anaemia (condition in which the bone marrow is unable to produce blood cells) and bone marrow depression can occur but these are extremely rare and your doctor will have taken your medical history into account when deciding to prescribe Minims® Chloramphenicol. Pale skin, weakness, increased heart rate, out of breath, headache, pain, fever, infection, bruises may be a sign a severe blood disorder. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

How to store it

your eye drops Keep out of the sight and reach of children. Do not use the eye drops after the expiry date which is stated on the overwrap of each unit and on the carton after the letters "EXP". The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original package in order to protect from light. If necessary, the product may be stored at temperature not exceeding 25°C for up to 1 month only and then thrown away. In that case, affix a label bearing the relevant expiry date to the carton label. The drops are for single use only and provided in single use Minims units, to treat both eyes if both eyes are infected. Once opened, use immediately. Discard any unused portion. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Further information What do your eye drops contain

• The active ingredient is chloramphenicol. Each Minims unit contains approximately 0.5 ml eye drops solution of chloramphenicol 0.5% w/v (2.5 mg).
• The other ingredients are borax, boric acid and purified water. This medicine does not contain a preservative as it is a sterile single use unit. Contents of the pack Each carton contains 20 units.

Marketing Authorisation Holders: Bausch & Lomb UK Ltd. 106 London Road – Kingston-upon-Thames – KT2 6TN – UK Manufacturer:

Laboratoire Chauvin Zone Industrielle de Ripotier 50 Avenue Jean Monnet 07200 Aubenas France

DATE OF PREPARATION: November 2023