Patient leaflet - BIMATOPROST BROWN & BURK 0.3 MG / ML EYE DROPS SOLUTION IN SINGLE-DOSE CONTAINER
4. Possible side effects
Package leaflet: Information for the user
Bimatoprost
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have further questions, ask your doctor or pharmacist.
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– This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
- if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. see section 4.
What is in this leaflet:
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1. What Bimatoprost Brown & Burk 0.3 mg/mL single-dose is and what it is used for
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2. What you need to know before you use Bimatoprost Brown & Burk 0.3 mg/mL single-dose
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3. How to use Bimatoprost Brown & Burk 0.3 mg/mL single-dose
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4. Possible side effects
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5. How to store Bimatoprost Brown & Burk 0.3 mg/mL single-dose
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6. Contents of the pack and other information
Bimatoprost Brown & Burk 0.3 mg/mL single-dose is an antiglaucoma preparation. It belongs to a group of medicines called prostamides.
Bimatoprost Brown & Burk 0.3 mg/mL single-dose eye drops are used to reduce high pressure in the eye. This medicine may be used on its own or with other drops called beta-blockers which also reduce pressure.
Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly enough, the pressure inside the eye builds up. This medicine works by increasing the amount of liquid that is drained. This reduces the pressure inside the eye. If the high pressure is not reduced, it could lead to a disease called glaucoma and eventually damage your sight.
This medicine does not contain a preservative.
Do not use this medicine:
If you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before you use Bimatoprost Brown & Burk 0.3 mg/mL singledose.
520 mm
Please tell your doctor or pharmacist, if:
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– You have any breathing problems
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– You have liver or kidney problems
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– You have had a cataract surgery in the past
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– You have or have had low blood pressure or low heart rate
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– You have had a viral infection or inflammation of the eye
Bimatoprost Brown & Burk 0.3 mg/mL single-dose may cause your eyelashes to darken and grow, and cause the skin around the eyelid to darken too. The colour of your iris may also go darker over time. These changes may be permanent. The change may be more noticeable if you are only treating one eye.
Children and adolescents
Bimatoprost Brown & Burk 0.3 mg/mL single-dose has not been tested in children under the age of 18 and therefore should not be used by patients under 18 years.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Bimatoprost Brown & Burk 0.3 mg/mL single-dose may get into breast milk so you should not breast-feed while you are taking this medicine.
Driving and using machines
Your sight may become blurred for a short time just after using Bimatoprost Brown & Burk 0.3 mg/mL single-dose.
You should not drive or use machines until your sight is clear again.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one drop once daily, in the evening, once daily in each eye that needs treatment. Bimatoprost Brown & Burk 0.3 mg/mL single-dose should only be applied to the eye
If you use Bimatoprost Brown & Burk 0.3 mg/mL single-dose with another eye medicine, wait at least 5 minutes between using Bimatoprost Brown & Burk 0.3 mg/mL single-dose and the other eye medicine.
Do not use more than once a day as the effectiveness of treatment may be reduced.
Wash your hands before use. Make sure that the single-dose container is intact before use. The solution should be used immediately after opening. To avoid contamination, do not let the open-end of the single-dose container touch your eye or anything else.
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1. Take one single-dose container from the pouch and hold it upright (with the cap pointing upwards) and twist off the cap.
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2. Gently pull down the lower eyelid to form a pocket. Turn the single-dose container upside down and squeeze it to release 1 drop into the affected eye(s).
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3. Throw away the single-dose container after you have used it, even if there is some solution left.
Wipe off any excess that runs down the cheek.
If you wear contact lenses, take your lenses out before using this medicine. Wait 15 minutes after using the drops, and before you put your lenses back in.
If you use more of this medicine than you should, it is unlikely to cause you any serious harm. Put your next dose in at the usual time. If you are worried, talk to your doctor or pharmacist.
If you forget to use this medicine, use a single drop as soon as you remember, and then go back to your regular routine. Do not take a double dose to make up for a forgotten dose.
Bimatoprost Brown & Burk 0.3 mg/mL single-dose should be used every day to work properly.
If you stop using Bimatoprost Brown & Burk 0.3 mg/mL eye drops, solution, in single-dose container the pressure inside your eye may go up, therefore talk to your doctor before stopping this treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1 in 10 people
Affecting the eye
- Slight redness (up to 24 % of people)
Common: may affect up to 1 in 10 people
Affecting the eye
- Small breaks in the surface of the eye, with or without inflammation
- Irritation
- Itchy eyes
- Pain
- Dryness
- A feeling that something is in your eye
- Longer eyelashes
- Darker skin colour around the eye
- Red eyelids
Uncommon: may affect up to 1 in 100 people
Affecting the eye
- Tired eyes
- Sensitivity to light
- Darker iris colour
- Itchy and swollen eyelids
- Tears
- Swelling of the see-through layer which covers the surface of the eye
- Blurred vision
Affecting the body
- Headaches
- Hair growth around the eye
Not known: frequency cannot be estimated from the available data
Affecting the eye
- Sticky eyes
- Ocular discomfort
Affecting the body
- Asthma
- Worsening of asthma
- Worsening of the lung disease called chronic obstructive pulmonary disease (COPD)
- Shortness of breath
- Symptoms of allergic reaction (swelling, redness of the eye and rash of the skin)
- Dizziness
- Increased blood pressure
- Skin discoloration (periocular)
In addition to the side effects for Bimatoprost Brown & Burk 0.3 mg/mL single-dose the following side effects have been seen with the preserved multi-dose formulation of Bimatoprost Brown & Burk 0.3 mg/mL single-dose and may occur in patients taking Bimatoprost Brown & Burk 0.3 mg/mL single-dose:
- Burning sensation in the eye
- An allergic reaction in the eye
- Inflamed eyelids
- Difficulty in seeing clearly
- Worsening vision
- Darker eyelashes
- Retinal bleeding
- Inflammation within the eye
- Cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)
- Iris inflammation
- Eyelid twitching
- Eyelid shrinking, moving away from surface of the eye
- Eyes appear sunken
- Nausea
- Skin redness around the eye
- Weakness
- An increase in blood-test results that show how your liver is working
Other side effects reported with eye drops containing phosphates
This medicine contains 0.949 mg phosphates in each mL which is equivalent to 0.379 mg/0.4 mL. In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.
Reporting 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 the Yellow Card Scheme, Website: 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.
By reporting side effects you can help provide more information on the safety of the medicine.
Keep this medicine out of the sight and reach of children.
This medicine is for single use only and does not contain preservatives. Do not keep any unused solution.
Do not use this medicine after the expiry date which is stated on the single-dose container and the carton after the expiry date (EXP):. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage condition. However, once the pouch is opened use within 30 days.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. contents of the pack and other information
The active substance is bimatoprost. One mL of solution contains 0.3 mg bimatoprost.
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– The other ingredients are sodium chloride, disodium phosphate heptahydrate (E339), citric acid monohydrate (E330) and water for injection. Small amounts of hydrochloric acid (E507) or sodium hydroxide (E524) may be added to keep the level of acid (pH levels) normal.