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.

← Back to all medicines

Brolene 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 Propamidine isetionate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Propamidine isetionate
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for 2. Before you use Brolene Eye Drops 3. How to use Brolene Eye Drops 4. Possible side effects 5. How to store Brolene Eye Drops 6. Further information

2. Fonts Used:

Proof Number: 4

Patient Information Leaflet Package leaflet: Information for the user

Date:

It is used for minor infections of the eye or eyelid. Signs include sore, red or inflamed eyes, stickiness or a crust on the eyelids. 2. Before you use Brolene Eye Drops Do not use this medicine and tell your doctor or pharmacist if: You are allergic (hypersensitive) to propamidine isetionate or any of the other ingredients of Brolene 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 or around the eyes. 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 Eye Drops. Take special care with Brolene Eye Drops if: You wear contact lenses. You should not wear contact lenses while using these drops. If you are not sure if the above apply to you, talk to your doctor or pharmacist before using Brolene Eye Drops.

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. 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. Important information about some of the ingredients of Brolene Eye Drops Brolene Eye Drops contains benzalkonium chloride This medicine contains 0,0025 mg benzalkonium chloride in each drop (0.05 ml), which is equivalent to 0.05 mg/ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor. 3. How to use Brolene Eye Drops Always use Brolene Eye Drops exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

How to use this m Wash your hand Remove the cap bottle Tilt your head b Squeeze one or drops inside the without touchin Close your eye Wipe away any with a clean tiss Always put the soon as you hav

How much to use One or two drop four times a day Use for at least If your symptom improve after 2 or pharmacist

If you forget to u If you forget a dos as you remember. time for your next dose. Do not use a for a forgotten dos

If you stop using Do not stop using because your eye(s your infection may

If you have a the use of th or pharmacis

4. Possible side e

Like all medicines, cause side effects, gets them.

Product Title: Brolene 0.1% w/v Eye Drops Pack Size: N/A CMU.No: 93030022109_PIL Dimensions: 180 x 140mm Component: Leaflet Barcode:

Verified

Pharmacode: reast-feeding r before using this Datamatrix: re pregnant, might become you may for be pregnant. Reason Change: eeding or planning Change of ownership from Sanofi to T&R k to your doctor or e taking or using any MOC-2021-1807 C

using machines e 1. blurred straight Black Colour:eyesight his medicine. If this 2. Colour: not drive or use Keyline any tools(Non-Printing) until you can seePANTONE clearly. Reflex Blue C + 5-75% 3. Colour:

Technical mation about some of theInfo (Non-Printing) 4. Colour: olene Eye Drops 5. Colour: Cirrus_Info_Box s contains benzalkonium 6. Colour: tains 0,0025 mg 7. Colour: oride in each drop (0.05 valent to 0.05 mg/ml. 8. Colour: oride may be absorbed nses and may change the 9. Colour: act lenses. You should 10.Colour: nses before using this them back 15 minutes 11.Colour:

oride may also cause eye 12.Colour: ly if you have dry eyes or Ocean 1. Fonts ornea (the Used: clear layer at Sans the Std f you feel abnormal eye 8pt Point Size Used: g or pain in the eye after ne,2.talk to your Fonts Used:doctor.

rolene EyeSize Drops Point Used:

If you forget to use Brolene Eye Drops If you forget a dose, use your drops as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose. If you stop using Brolene Eye Drops Do not stop using Brolene 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.

Like all medicines, Brolene Eye Drops can cause side effects, although not everybody gets them.

Point Size Used: 5. Fonts Used: Point Size Used: Date: 27.10.2021

Operator: GKE Artwork Number: 1249163 Approved by:

How much to use One or two drops in the affected eye up to four times a day Use for at least 2 days If your symptoms worsen or do not improve after 2 days, talk to your doctor or pharmacist

How to take it

this medicine Wash your hands Remove the cap from the bottle Tilt your head back Squeeze one or two drops inside the lower lid without touching your eye 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

Date:

Stop using Brolene 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 get a stinging or burning sensation in your eye 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 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.

Possible side effects

Used: e 3. EyeFonts Drops exactly as armacist has told you. You Point Size your doctor orUsed: pharmacist e. 4. Fonts Used:

Proof Number: 4

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 Eye Drops after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. Store below 25°C Brolene Eye Drops are sterile when you buy them, so you must not keep them for more than four weeks after opening the bottle (or if the drops are being used in a hospital environment, they should only be used for 7 days after first opening). 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.

6. Further information What Brolene Eye Drops contains The solution contains 0.1% w/v of the active substance, propamidine isetionate The other ingredients are ammonium chloride, sodium chloride, benzalkonium chloride, sodium hydroxide and water for injections What Brolene Eye Drops looks like and contents of the pack Brolene Eye Drops is a liquid supplied in a 10 ml plastic dropper bottle with a tamperproof cap. An auto-drop device may also be supplied as a separate item 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 September 2021

93030022109 1060031705 ZV/649 66

Frequently asked questions about Brolene Eye Drops

How do I take Brolene Eye Drops?

Brolene Eye Drops comes as eye drops. 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 Eye Drops?

The active substance in Brolene Eye Drops is propamidine isetionate.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Brolene 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 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: Propamidine isetionate (1 medicine)
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

Propamidine isetionate is an aromatic diamidine disinfectant which is active against Gram-positive non-spore forming organisms, but less active against Gram-negative bacteria and spore forming organisms. It also has antifungal properties. It may be used topically for the treatment of minor eye infections such as conjunctivitis and blepharitis.

4.2. Posology and method of administration

One or two drops up to four times daily. Medical advice should be obtained if there has been no significant improvement after two days.

4.3. Contraindications

Hypersensitivity to propamidine or any other component of the preparation.

4.4. Special warnings and precautions for use

If vision is disturbed or symptoms become worse during therapy, discontinue use and consult a physician.

If there is no significant improvement after two days' therapy, discontinue use and consult a physician.

The eye drops are unsuitable for use with hard or soft contact lenses.

The drops should be discarded 28 days after first opening for domiciliary use or, when used under hospital conditions, seven days after first opening.

Benzalkonium chloride

Brolene contains 0,0025 mg benzalkonium chloride in each drop (0.05 ml), which is equivalent to 0.05 mg/ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. The patient should be advised to remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Brolene should be used with caution in dry eye patients and in patients where the cornea may be compromised.

Patients should be monitored in case of prolonged use.

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

None known.

4.6. Pregnancy and lactation

Safety of use in pregnancy and lactation has not been established. Use during pregnancy and lactation only if considered essential by a physician.

4.7. Effects on ability to drive and use machines

May cause blurring of vision on instillation. Patients should not drive or operate hazardous machinery unless vision is clear.

4.8. Undesirable effects

Hypersensitivity may occur.

Eye pain or irritation, usually in the form of a stinging or burning sensation, may also occur. In such cases, use should be discontinued immediately and a physician should be consulted.

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

Topical overdosage not applicable. Oral ingestion of a full 10ml bottle is unlikely to cause any toxic effects.

💬 Ask about this leaflet

Ask anything about Brolene 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.

Pharmacies in major towns and cities — see the list
Pharmacies by county and region — see the full list

Browse all 2,009 towns and cities →