What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 35533/0129.


Bimatoprost Aspire 0.1mg/ml, eye drops, solution

Package leaflet: Information for the user

Bimatoprost 0.1mg/ml, eye drops, solution

Bimatoprost

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • 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

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

1. What Bimatoprost is and what it is used for

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.

2. What you need to know before you use Bimatoprost

Do not use Bimatoprost:

  • if you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6);
  • if you have had to stop using eye drops in the past because of a side effect of the preservative benzalkonium chloride.

Warnings and precautions

Talk to your doctor or pharmacist before using Bimatoprost.

Talk to your doctor:

  • if you have any breathing problems;
  • if you have liver or kidney problems;
  • if you have had a cataract surgery in the past;
  • if you have dry eye;
  • if you have or have had any problems with your cornea (front transparent part of the eye);
  • if you wear contact lenses (see ‘Bimatoprost contains benzalkonium chloride’);
  • if you have or have had low blood pressure or low heart rate;
  • if you have had a viral infection or inflammation of the eye.

Bimatoprost 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

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.

Other medicines and Bimatoprost

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

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.

Driving and using machines

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.

Bimatoprost contains benzalkonium chloride

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.

Bimatoprost contains phosphate buffer

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.

3. How to use Bimatoprost

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.

Instructions for use:

You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.

  • Take the bottle (picture 1) out of the carton box.
  • Wash your hands. Tilt your head back and look at the ceiling (picture 2).
  • Gently pull down the lower eyelid until there is a small pocket (picture 3).
  • Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment (picture 4).
  • Let go of the lower lid and close your eye for 30 seconds (picture 5).

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

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

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.

If you stop using Bimatoprost

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.

4. Possible side effects

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 29% 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
  • Longer eyelashes
  • Irritation, when a drop is put in the eye
  • Eye pain

Affecting the skin

  • Red and itchy eyelids
  • Darker skin colour around the eye
  • Hair growth around the eye

Uncommon: may affect up to 1 in 100 people

Affecting the eye

  • Darker iris colour
  • Tired eye
  • Swelling of the surface of the eye
  • Blurred vision
  • Loss of eye lashes

Affecting the skin

  • Dry skin
  • Crusting on the edge of the eyelid
  • Swelling of the eyelid
  • Itching

Affecting the body

  • Headache
  • Feeling of sickness

Not known: frequency cannot be estimated from the available data

Affecting the eye

  • Macular oedema (swelling of the retina at the back of the eye which may lead to worsening vision)
  • Darker eyelid colour
  • Eyes appear sunken
  • Eye dryness
  • Sticky eyes
  • A feeling that something is in your eye
  • Swelling of the eye
  • Increasing tears
  • Ocular discomfort
  • Sensitivity to light

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 discolouration (periocular)

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):

  • Ocular burning
  • An allergic reaction in the eye
  • Inflamed eyelids
  • Difficulty in seeing clearly
  • Worsening of vision
  • Swelling of the see-through layer that covers the eye
  • Tears
  • Darker eyelashes
  • Retinal bleeding
  • Inflammation within the eye
  • Cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)
  • Eyelid twitching
  • Eyelid shrinking, moving away from the surface of the eye
  • Skin redness around the eye
  • Weakness
  • An increase in blood-test results that show how your liver is working

Reporting of 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: 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.

5. How to store Bimatoprost

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.

6. Contents of the pack and other information

What Bimatoprost contains

  • The active substance is bimatoprost. One ml of solution contains 0.1mg bimatoprost.
  • The other ingredients are benzalkonium chloride (preservative), sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and water for injections. Small amounts of hydrochloric acid or sodium hydroxide may be added to keep the level of acid (pH levels) normal.

What Bimatoprost looks like and contents of the pack

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 and Manufacturer

Marketing Authorisation Holder:

Aspire Pharma Ltd
Unit 4, Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom

Manufacturer:

BALKANPHARMA-RAZGRAD AD
68 Aprilsko vastanie Blvd.
Razgrad
7200 Bulgaria
Telephone: +359 84 613 318
Fax: +359 84 634 272

or

Pharmathen S.A.
6 Dervenakion Street
Pallini 15351
Athens
Greece
Tel: 0030 210 66 04 300
Fax: 0030 210 66 66 749

This leaflet was last revised in 02/2019

1010399-P4.1