Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
e Mollifeye
Mollifeye eye drops are recommended for use in children aged 2 years and over, in adults and the elderly. A child below the age of 2 years with an eye infection should see a doctor. Do not use this medicine if:
6. R epeat the instructions 2 – 5 to deliver a drop into the other eye also, if your doctor has instructed you to do this. Sometimes only one eye needs to be treated and your doctor will advise if this applies to you and which eye needs treatment. 7. A fter each use and prior to recapping, the bottle should be shaken once in a downwards direction, without touching the dropper tip, in order to remove any residual liquid on the tip. This is necessary in order to ensure delivery of subsequent drops.
8. A fter you have used all doses there will be some Mollifeye left in the bottle. You should not be concerned since an extra amount of Mollifeye has been added and you will get the full amount of Mollifeye that your doctor has prescribed. Do not attempt to use the excess medicine remaining in the bottle after you have completed the course of treatment. Do not use the eye drops for longer than 28 days after first opening the bottle. Whilst applying the drops, do not:
How much to use Adults, the elderly and children over 2 years Put one drop into the affected eye(s) every 2 hours for the first 48 hours. After this you should reduce the dose to one drop every 4 hours. Use during waking hours only. Do not use this medicine just before you go to sleep. The course of treatment should be 5 days. Do not use this medicine for longer than 5 days at a time. Do not stop just because you feel better, this could make your condition worse. Seek further immediate medical advice at any time if symptoms worsen. Consult your doctor if your eye infection does not start to improve within 48 hours. If you use more Mollifeye than you should Mollifeye eye drops are for external use only. If you have swallowed or you suspect someone else has swallowed any Mollifeye eye drops, contact your doctor or go to the accident and emergency department of your local hospital at once. Always take the container with you, if possible, even if empty. If you accidentally apply too many drops, you should wash your eye with plenty of water, if any painful symptoms continue after this, you should tell your doctor immediately. If you forget to use Mollifeye Try not to miss doses. If you do miss a dose do not worry, take your next dose at the normal time. Never double up on a dose to make up for the one you have missed. Like all medicines, this medicine can cause side effects, although not everybody gets them. Some people may get one or more of these side effects. Some effects happen straight away but do not last long, others may only happen after several days of use. •A llergic reactions such as itching or rashes. If you get a severe allergic reaction, with swelling or breathing problems stop using the drops immediately and get medical help straight away. •C hanges in the blood (anaemia) leading to severe tiredness or easy bruising. If you experience these effects, stop using the drops immediately and tell your doctor. •T he use of topical chloramphenicol may occasionally result in the overgrowth of other non susceptible organisms including fungi. If any new infection appears during treatment you should tell your doctor. •B lurred vision or mild burning or stinging when you put the drops in. These should subside quickly.
Mollifeye 4. Possible side effects 5. How to store Mollifeye 6. C ontents of the pack and other information
2. T ilt your head backwards and hold the bottle above your eye. 3. P ull the lower eyelid down and look up. Squeeze the bottle gently in the middle and let a drop fall into your eye. Please note that there might be a few seconds 1. What Mollifeye is and what delay between squeezing and the it is used for drop coming out. Do not squeeze Mollifeye contains an antibiotic too hard. medicine called chloramphenicol. It is If you are not sure how to used in both adults and children aged administer your medicine, ask your 2 years and over to treat bacterial doctor or pharmacist. infections that affect the front surfaces of the eye. The most common type of infection in this area is called acute bacterial conjunctivitis. When you have this condition, the white part of one or both of your eyes will be red and/or your eyelids will be red or swollen. There will be a sticky discharge, 4. B link a few times so that the drop which can make the eye difficult to spreads over the eye. open in the morning and the eye may feel 'gritty or irritated'. This medicine is not suitable for treating eye infections that have spread to the deeper layers of the eye coverings or into the fluid within the eyeball. Antibiotic tablets or injections are needed to treat these deeper, more serious infections. 5. A fter using Mollifeye, press a This medicine does not contain a finger into the corner of your eye, preservative. by the nose for 2 minutes. This helps to stop the solution getting into the rest of your body.
Mollifeye
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date printed on the bottle label and on the carton after 'EXP'. The expiry date refers to the last day of that month. Once the bottle is opened use within 4 weeks. You are advised to dispose of the bottle once you have finished your five day course of treatment. This medicine needs to be stored upright between 2°C – 8°C (in a refrigerator). Protect from light. Do not allow it to freeze. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Mollifeye contains •T he active ingredient is chloramphenicol. Each multi-dose container contains approximately 10ml eye drops solution of chloramphenicol 5mg/ml. •T he other ingredients are borax, boric acid, sodium hydroxide or/and hydrochloric acid (for pH adjustment) and water for injection. What Mollifeye looks like and contents of the pack 10ml of Mollifeye eye drops is filled in a white opaque plastic bottle and white Novelia nozzle that is sealed with a white HDPE cap. Each carton contains 1 multi-dose container.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Aspire Pharma Ltd Unit 4, Rotherbrook Court Bedford Road Petersfield Hampshire GU32 3QG United Kingdom Manufacturer Pharmathen S.A. 6 Dervenakion 15351 Pallini Attiki Greece and EXCELVISION 27 st. La Lombardière Zl La Lombardière ANNONAY 07100 France This leaflet was last revised in: 03/2022 1010565-P2.9
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Mollifeye 5mg/ml Eye Drops, Solution comes as eye drops containing 5mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Mollifeye 5mg/ml Eye Drops, Solution is chloramphenicol.
Medicines with the same active substance, strength and form include: Eykappo (Chloramphenicol) 5mg/ml Eye Drops. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Mollifeye 5mg/ml Eye Drops, Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Chloramphenicol is indicated in adults and children aged 2 years and over for the treatment of acute bacterial conjunctivitis.
Considerations should be given to official guidance on the appropriate use of antibacterial agents.
Posology
Adults (including the elderly) and children aged 2 years and over:
• put one drop into the affected eye(s) every 2 hours for the first 48 hours and 4 hourly thereafter.
• To be used during waking hours only.
• The course of treatment should be 5 days.
Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute following instillation of the drops.
Method of administration
For ocular use.
Mollifeye 5 mg/ml eye drops solution is a sterile solution that does not contain a preservative.
Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures as this could cause injury to the eye.
Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Myelosuppression during previous exposure to chloramphenicol.
• Family or personal history of blood dyscrasias including aplastic anaemia.
Chloramphenicol is absorbed systemically from the eye and systemic toxicity has been reported. Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the naso lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)
In severe bacterial conjunctivitis and in cases where infection is not confined to the conjunctivae, the topical use of chloramphenicol should be supplemented with appropriate systemic treatment. Therefore, the patient should be referred to seek medical advice.
Prolonged use of chloramphenicol eye drops is not advisable. Prolonged or frequent intermittent topical application of chloramphenicol should be avoided since it may increase the likelihood of sensitisation and the emergence of resistant organisms.
Patients with a history of contact hypersensitivity to silver should not use this product as dispensed drops may contain traces of silver.
Do not use for more than 5 days without consulting your doctor.
The use of topical chloramphenicol may occasionally result in overgrowth of non-susceptible organisms including fungi. If any new infection appears during treatment, the patient should be referred to the doctor.
The label will state:
• Seek further immediate medical advice any time if symptoms worsen.
• Consult your doctor if your eye infection does not start to improve within 48 hours.
• Discard the medicine after a 5 day course of treatment.
• Do not use if you are allergic to chloramphenicol or any of the ingredients
• For external use/use in the eye only
• Keep all medicines out of the sight and reach of children.
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 period of treatment. Contact lens users may use glasses during treatment with chloramphenicol eye drops.
Soft contact lens wearers should wait 24 hours after completing a course of treatment before starting to use their lenses again.
The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.
The safety of chloramphenicol eye drops in pregnancy and lactation has not been established.
Pregnancy
As this product is for sale without prescription it is not recommended for use during pregnancy.
Breast-feeding
Chloramphenicol may appear in breast milk, use of the product during lactation should be avoided.
Fertility
No fertility data are available.
The use of the eye drops may cause transient blurring of vision. Patients should not drive or operate hazardous machinery unless vision is clear.
Eye disorders:
Transient irritation, burning, stinging and sensitivity reactions such as itching and dermatitis.
Immune System Disorders:
Hypersensitivity reactions including angioedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis. Treatment must be discontinued immediately in such cases.
Blood and lymphatic system disorders:
Bone marrow depression, including the idiosyncratic type of irreversible and fatal aplastic anaemia that is recognised to occur with systemic therapy, has been reported in association with topical administration of chloramphenicol.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store).
Accidental ingestion of the drops is unlikely to cause systemic toxicity due to the low content of the antibiotic in the product.
In view of the relatively small amount of chloramphenicol in Mollifeye, overdosage with this product is unlikely to constitute a hazard.
No specific treatment would be required. If irritation, pain, swelling, lacrimation or photophobia occur after undesired eye contact, the exposed eye(s) should be irrigated for at least 15 minutes. If symptoms persist after this, an ophthalmological examination should be considered.
Ask anything about Mollifeye 5mg/ml Eye Drops, Solution. 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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