Patient Leaflet Updated 13-Dec-2022 | Aspire Pharma Ltd
Bimatoprost Aspire 0.1mg/ml, eye drops, solution
Bimatoprost 0.1mg/ml, eye drops, solution
Bimatoprost
1. What Bimatoprost is and what it is used for
2. What you need to know before you use Bimatoprost
3. How to use Bimatoprost
4. Possible side effects
5. How to store Bimatoprost
6. Contents of the pack and other information
Bimatoprost is an anti-glaucoma preparation. It belongs to a group of medicines called prostamides.
Bimatoprost 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.
Talk to your doctor or pharmacist before using Bimatoprost.
Talk to your doctor:
During treatment, Bimatoprost may cause a loss of fat around the eye, which may cause your eyelid crease to deepen, your eye to appear sunken (enophthalmos), your upper eyelid to droop (ptosis), the skin around your eye to tighten (involution of dermatochalasis) and the lower white part of your eye to become more visible (inferior scleral show). The changes are typically mild, but if pronounced, they can affect your field of vision. The changes may disappear if you stop taking Bimatoprost. Bimatoprost may also 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. These changes may be permanent. The change may be more noticeable if you are only treating one eye.
This medicine has not been tested in children under the age of 18 and therefore Bimatoprost 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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not breast-feed while using Bimatoprost as this medicine may get into breast milk.
Your sight may become blurred for a short time just after using this medicine. You should not drive or use machines until your sight is clear again.
This medicine contains 0.2mg benzalkonium chloride in each ml of solution. 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.
This medicine contains 0.95mg phosphates in each ml of solution. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
This medicine should only be applied to the eye. The recommended dose is one drop of Bimatoprost in the evening, once daily in each eye that needs treatment.
If you use Bimatoprost with another eye medicine, wait at least five minutes between using Bimatoprost and the other eye medicine.
Do not use more than once a day as the effectiveness of treatment may be reduced.
You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.
Wipe off any excess that runs down the cheek.
If a drop misses your eye, try again.
To help prevent infections and avoid eye injury, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle straight after you have used it.
If you use more Bimatoprost 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 Bimatoprost, 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 should be used every day to work properly. If you stop using Bimatoprost 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
Common: may affect up to 1 in 10 people
Affecting the eye
Affecting the skin
Uncommon: may affect up to 1 in 100 people
Affecting the eye
Affecting the skin
Affecting the body
Not known: frequency cannot be estimated from the available data
Affecting the eye
Affecting the body
In addition to the side effects for Bimatoprost, the following side effects have been seen with another medicine containing a higher strength of bimatoprost (0.3 mg/ml):
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: 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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle label and the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After first opening of the container, the product may be stored for 4 weeks. You must throw away the bottle at the latest four weeks after you first opened it, even if there are still some drops left. This will prevent infections. To help you remember, write down the date you opened it in the space on the box and the bottle.
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 protect the environment.
Bimatoprost is a clear, colourless solution, free from visible particles in a white opaque low density polyethylene vial for eye drops containing 3ml of the ophthalmic solution sealed with a white opaque LDPE plug applicator and a white HDPE/LDPE cap with a tamper-proof seal.
The following pack sizes are available: cartons containing 1 or 3 bottles of 3ml solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
or
This leaflet was last revised in 05/2022
1010399-P5.4
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
+44 (0)1730 231148
http://www.aspirepharma.co.uk
+44 (0)1730 231148
+44 (0)1730 231148