Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Brolene Antibiotic 0.5%w/v Eye Drops

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Chloramphenicol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Chloramphenicol

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for Brolene Antibiotic Eye Drops contain a medicine called chloramphenicol. This belongs to a group of medicines called antibiotics. It works by stopping the growth of bacteria, allowing your body to fight off the infection. Brolene Antibiotic Eye Drops are used to treat minor infections of the eye or eyelid caused by bacteria (bacterial conjunctivitis). Signs include sore, red or inflamed eyes, sticky discharge or crust on the lids. 2. Before you use Brolene Antibiotic Eye Drops Do not use this medicine and tell your doctor if: Ñ You are allergic (hypersensitive) to chloramphenicol or any of the other ingredients of Brolene Antibiotic Eye Drops (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, tongue and worsening of redness, itching or swelling of the eye or eyelid. Ñ You or anyone in your family have had any problems with your blood, including 'aplastic anaemia' Do not use this medicine if the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Brolene Antibiotic Eye Drops. Warnings and precautions Take special care with Brolene Antibiotic Eye Drops Check with your doctor before taking your medicine if:  You have problems with your eyesight  You have severe pain within the eye  Your eyes are sensitive to light  You have eye inflammation and a rash on your face or scalp  Your eye looks cloudy  The pupil of your eye looks unusual

 You think that you have a foreign object in your eye  You have recently had conjunctivitis  You have glaucoma  Your eyes produce fewer tears (dry eye syndrome)  You have had eye surgery or laser treatment in the last 6 months  You have an eye injury  You are using other eye drops or eye ointment  You wear contact lenses. You should not wear contact lenses while using these eye drops and for at least 24 hours after completing your treatment. If you are not sure if the above apply to you, talk to your doctor or pharmacist before using Brolene Antibiotic Eye Drops. Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Brolene Antibiotic Eye Drops can affect the way some other medicines work. Also some medicines can affect the way Brolene Antibiotic Eye Drops work. In particular, tell your doctor if you are taking any of the following:

  • Medicines for cancer
  • Medicines for the immune system such as azathioprine. Pregnancy and breast-feeding Talk to your doctor before using this medicine if you are pregnant, might become pregnant, or think you may be pregnant. You should not breast-feed if you are taking Brolene Antibiotic Eye Drops. This is because small amounts may pass into mothers' milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking or using any medicine. Driving and using machines You may have blurred eyesight straight after using this medicine. If this happens, do not drive or use any tools or machines until you can see clearly.

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Brolene Antibiotic Eye Drops contains Boric acid 3. How to use Brolene Antibiotic Eye Drops Always use Brolene Antibiotic Eye Drops exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Using this medicine

  • Use the eye drops during waking hours only
  • Do not use for more than 5 days without talking to your doctor

How to take it

this medicine

  • Wash your hands
  • Remove the cap from the bottle
  • Tilt your head back
  • Squeeze one drop inside the lower lid without touching your eye with the bottle
  • Close your eye
  • Wipe away any excess liquid from the eyes with a clean tissue
  • Always put the cap back on the bottle as soon as you have used it How much to use Adults, Elderly and Children over 2 years of age
  • One drop in the affected eye every two hours for the first 2 days (48 hours)
  • After the first 2 days, one drop in the affected eye every four hours
  • Talk to your doctor or pharmacist if your symptoms do not improve within 2 days or if your eyes get worse
  • Keep using the eye drops for 5 days even if your symptoms improve If you forget to use Brolene Antibiotic Eye Drops If you forget a dose, use your drops as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose.

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4. Possible side effects Like all medicines, Brolene Antibiotic Eye Drops can cause side effects, although not everybody gets them. Stop using Brolene Antibiotic Eye Drops and see a doctor as soon as possible if:

  • You get any kind of skin problem, such as a rash or itching around your eyes or they become more red
  • You bruise more easily than usual or you get infections more easily or frequently than usual. You may also feel tired or weak
  • You notice any swelling of your face, lips or tongue, itching or rash with swelling of skin. Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
  • Stinging or burning in your eyes. This should only last for a short time and occurs immediately after using the eye drops Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report

Possible side effects

directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Brolene Eye Drops Keep this medicine in a safe place where children cannot see or reach it. Do not use Brolene Antibiotic Eye Drops after the expiry date which is stated on the label and carton.

5. Fonts Used: Proof Number: 5

If you stop using Brolene Antibiotic Eye Drops Keep using the eye drops for 5 days even if your symptoms improve. Do not stop using Brolene Antibiotic Eye Drops just because your eye(s) feel better. If you stop, your infection may come back. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Date:

By joannearmitage at 12:11 pm, Dec 23, 2021

The expiry date refers to the last day of that month. Store in the fridge (between 2°C and 8°C) and protect from light. Brolene Antibiotic Eye Drops are sterile when you buy them. Discard any drops remaining after 5 days of use. 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 protect the environment.

Contents of the pack and other information

What Brolene Antibiotic Eye Drops contains

  • The solution contains 0.5% w/v of the active substance, chloramphenicol
  • The other ingredients are borax, boric acid and water for injections What Brolene Antibiotic Eye Drops looks like and contents of the pack Brolene Antibiotic Eye Drops is a clear to light yellow liquid supplied in a 10 ml plastic dropper bottle. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder STADA, Linthwaite, Huddersfield, HD7 5QH, UK Email: [email protected] Manufacturer Zentiva k.s., U Kabelovny 130, 102 37 Prague 10, Czech Republic This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised October 2021 93030062109 1060031560 ZV/648 50

Frequently asked questions about Brolene Antibiotic 0.5%w/v Eye Drops

How do I take Brolene Antibiotic 0.5%w/v Eye Drops?

Brolene Antibiotic 0.5%w/v Eye Drops comes as eye drops containing 0.5%. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Brolene Antibiotic 0.5%w/v Eye Drops?

The active substance in Brolene Antibiotic 0.5%w/v Eye Drops is chloramphenicol.

Are there equivalent medicines to Brolene Antibiotic 0.5%w/v Eye Drops?

Medicines with the same active substance, strength and form include: Chloramphenicol Antibiotic 0.5%w/v Eye Drops. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Brolene Antibiotic 0.5%w/v Eye Drops, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Brolene Antibiotic 0.5%w/v Eye Drops without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Chloramphenicol (15 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Treatment of acute bacterial conjunctivitis.

4.2. Posology and method of administration

For ocular use.

The recommended dosage for adults (including the elderly) and children aged 2 years and over is one drop to be applied to the affected eye every two hours for the first 48 hours and 4 hourly thereafter. To be used during waking hours only.

Treatment should continue for 5 days, even if symptoms improve.

4.3. Contraindications

Chloramphenicol eye drops should not be administered to patients hypersensitive to chloramphenicol or any other ingredients in the formulation, or given to those with a known personal or family history of blood dyscrasias including aplastic anaemia.

4.4. Special warnings and precautions for use

Prolonged use of chloramphenicol eye drops should be avoided as it may increase the likelihood of sensitisation and emergence of resistant organisms.

Do not use for more than 5 days without consulting a doctor.

Medical advice should be sought if there is no improvement in the condition after 2 days or if symptoms worsen at any time.

Patients should be referred to their doctor if any of the following apply:

• Disturbed vision

• Severe pain within the eye

• Photophobia

• Eye inflammation associated with a rash on the scalp or face

• The eye looks cloudy

• The pupil looks unusual

• Suspected foreign body in the eye

Patients should also be referred to their doctor if any of the following in his/her medical history apply:

• Previous conjunctivitis in the recent past

• Glaucoma

• Dry eye syndrome

• Eye surgery or laser treatment in the last 6 months

• Eye injury

• Current use of other eye drops or eye ointment

• Contact lens use

If this product is used following advice from a contact lens practitioner or doctor, contact lenses should not be worn during the course of treatment. Soft contact lenses should not be replaced for 24 hours after completing treatment.

The labels will state:

• If symptoms do not improve within 48 hours talk to your doctor.

• Seek further immediate medical advice at any time if symptoms worsen.

• Discard any remaining eye drops after the five day course of treatment.

• Do not use if you are allergic to chloramphenicol or any of the other ingredients.

4.5. Interaction with other medicinal products and other forms of interaction

The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.

4.6. Pregnancy and lactation

The safety of Chloramphenicol Eye Drops during pregnancy and lactation has not been established.

Chloramphenicol may be absorbed systemically following the use of eye drops and may cross the placenta and appear in breast milk. Therefore this product is not recommended for use during pregnancy and lactation.

4.7. Effects on ability to drive and use machines

Chloramphenicol eye drops may cause transient blurring of vision when applied to the eye. Patients should be warned not to drive or operate hazardous machinery unless their vision is clear.

4.8. Undesirable effects

Eye disorders:

Chloramphenicol eye drops may cause transient stinging and irritation when applied to the eye.

Blood and lymphatic system disorder:

Bone marrow depression, including irreversible and fatal aplastic anaemia has been reported following topical use of chloramphenicol. Whilst the hazard is a rare one, it should be borne in mind when assessing the benefits expected from the use of this compound.

Immune system disorders:

Hypersensitivity reactions including angioedema.

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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Not applicable.

💬 Ask about this leaflet

Ask anything about Brolene Antibiotic 0.5%w/v Eye Drops. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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