• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Bimatoprost/Timolol single-dose is and what it is used for
2. What you need to know before you use Bimatoprost/Timolol single-dose
3. How to use Bimatoprost/Timolol single-dose
4. Possible side effects
5. How to store Bimatoprost/Timolol single dose
6. Contents of the pack and other information

• if you are allergic to bimatoprost, timolol, beta-blockers or any of the other ingredients of Bimatoprost/Timolol single-dose (listed in section 6).
• if you have now or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long standing cough)
• if you have heart problems such as low heart rate, heart block or heart failure.

Before you use this medicine, tell your doctor if you have now or have had in the past:

• coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure
• disturbances of heart rate such as slow heartbeat
• breathing problems, asthma or chronic obstructive pulmonary disease
• poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome)
• overactivity of the thyroid gland as timolol may mask signs and symptoms of thyroid disease
• diabetes as timolol may mask signs and symptoms of low blood sugar
• severe allergic reactions
• liver or kidney problems
• eye surface problems
• separation of one of the layers within the eyeball after surgery to reduce the pressure in the eye
• known risk factors for macular oedema (swelling of the retina within the eye leading to worsening vision), for example, cataract surgery

Tell your doctor before surgical anaesthesia that you are using Bimatoprost/Timolol single-dose as timolol may change the effects of some medicines used during anaesthesia.

During treatment, Bimatoprost/Timolol single-dose 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/ Timolol single-dose. This medicine 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 may cause hair growth when in contact with the skin surface.

This medicine should not be used in children and teenagers under 18.

Bimatoprost/Timolol single-dose can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor if you are using or intend to use medicines to lower blood pressure, heart medicine, medicines to treat diabetes, quinidine (used to treat heart conditions and some types of malaria) or medicines to treat depression known as fluoxetine and paroxetine.

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. Do not use this medicine if you are pregnant unless your doctor still recommends it.

Do not use this medicine if you are breast-feeding. Timolol may get into your breast milk.

Ask your doctor for advice before taking any medicine during breast-feeding.

This medicine may cause blurred vision in some patients. Do not drive or use machines until the symptoms have cleared.

Open the sachet which contains a strip of 5 individual single-dose containers.

1. Wash your hands.
2. Take the strip of containers from the sachet.
3. Detach one single-dose container from the strip.

4. Put the remaining strip back in the sachet and fold the edge to close the sachet.
5. To open the container, twist off the tab. Continue twisting until the lid detaches. Do not pull the lid to remove.

6. Hold the container between your thumb and index finger.
7. Check for any sharp edges or burrs around the container opening before administering a drop.
8. Tilt your head backwards or lie down. Look up and pull the lower eyelid downwards with the other hand. Do not allow any part of the container to touch your eye or any area around your eye. Gently squeeze the container to let one drop fall into the space between the lid and the eye. Do not blink while applying the drop to your eye. Each single-dose container contains enough solution for both eyes.

9. Close your eye and press the inner corner of the eye with your finger for about two minutes. This helps to stop the medicine from getting into the rest of the body.

10. Wipe off any excess solution from the skin around the eye.

If your doctor has told you to use drops in both eyes, repeat steps 7 to 10 for your other eye. After putting the drop into the eye(s), throw away the used single-dose container even if there is solution remaining to avoid contamination of the preservative free solution.

Store the remaining containers in the sachet; the remaining containers must be used within 7 days after opening of the sachet. If there are any containers left 7 days after opening the sachet they should be safely thrown away and a fresh sachet opened. It is important to continue to use the eye drops as prescribed by your doctor.

If you are not sure how to administer your medicine, ask your doctor, pharmacist or nurse.

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 Bimatoprost/Timolol single-dose with another eye medicine, leave at least 5 minutes between putting in Bimatoprost/Timolol single-dose and the other medicine. Use any eye ointment or eye gel last.

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 use a double dose to make up for a forgotten dose.

This medicine should be used every day to work properly.

This medicine contains 0.38mg phosphates in each 0.4ml of solution which is equivalent to 0.95mg/ml. 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.

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 (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.

• The active substances are bimatoprost 0.3mg/ml and timolol 5mg/ml corresponding to timolol maleate 6.8mg/ml.
• The other ingredients are: 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 bring the solution to the correct pH (acidity) level.

Bimatoprost/Timolol single-dose is a colourless to slightly yellow solution supplied in single-dose plastic (LDPE) containers, each containing 0.4ml of solution.

Pack contains 1, 6 or 18 foil sachets each containing 5 single-dose containers, for a total of 5, 30 or 90 single-dose containers in a carton, respectively.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer