Eyzeetan 0.3mg/ml + 5mg/ml Eye Drops, Solution

• 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.

Eyzeetan Eye Drops are contained within a novel multi-dose eye drop bottle, which allows for the solution not to contain any preservatives. Due to the design of the container, administration with these eye drops is not the same as standard eye drop bottles.

• Prior to first use, practice using the drops away from the eye. Slowly squeeze the bottle to deliver one drop in the air to get used to the pressure and time required to deliver one drop.
• Please note that there might be a few seconds delay between squeezing and the drop coming out. Do not squeeze too hard, or more than one drop may come out.
• After 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.
• If more than one type of eye drop is used, leave at least 5 minutes between administration of each eye drop solution.

Please read the full instructions on the correct use of this product in Section 3 of the leaflet (‘‘How to use Eyzeetan’’), before using these eye drops.

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

• if you are allergic to bimatoprost, timolol, beta-blockers or any of the other ingredients of this medicine (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

Talk to your doctor before using Eyzeetan 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

If you have a history of contact hypersensitivity to silver, you should not use this product as dispensed drops may contain traces of silver.

Tell your doctor before surgical anaesthesia that you are using Eyzeetan as timolol may change effects of some medicines used during anaesthesia.

During treatment, Eyzeetan 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 Eyzeetan. Eyzeetan may also cause your eyelashes to darken and grow, and cause the skin around the eye 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. Eyzeetan may cause hair growth when in contact with the skin surface.

Eyzeetan should not be used in children and teenagers under 18.

Eyzeetan can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. 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)
• 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 Eyzeetan if you are pregnant unless your doctor still recommends it.

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

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

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

Before instillation of the eye drops:

• Wash your hands before opening the bottle.
• Do not use this medicine if you notice that the tamper-proof seal on the bottle neck is broken before you first use it.
• When using for the first time, before delivering a drop to the eye, you should first of all practise using the dropper bottle by squeezing it slowly to deliver one drop into the air, away from the eye
• When you are confident that you can deliver one drop at a time, choose the position that you find most comfortable for the instillation of the drops (you can sit down, lie on your back, or stand in front of a mirror).

1. Hold the bottle directly below the cap and turn the cap to open the bottle. Do not touch anything with the tip of the bottle to avoid contamination of the solution.

2. Tilt your head backwards and hold the bottle above your eye.

3. Pull 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 delay between squeezing and the drop coming out. Do not squeeze too hard. If a drop misses your eye, try again.

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

4. Blink a few times so that the drop spreads over the eye.

5. After using Eyzeetan, press a finger into the corner of your eye, by the nose, for 2 minutes. This helps to stop Eyzeetan getting into the rest of your body.

6. Repeat 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. After 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. After you have used all doses there will be some Eyzeetan left in the bottle. You should not be concerned since an extra amount of Eyzeetan has been added and you will get the full amount of Eyzeetan 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.

If you use Eyzeetan with another eye medicine, leave at least 5 minutes between putting in Eyzeetan and the other medicine. Use any eye ointment or eye gel last.

If you use more Eyzeetan 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 Eyzeetan, 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.

Eyzeetan should be used every day to work properly.

This medicine contains 4.74mg phosphates in each 5ml 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 6.83mg/ml.
• The other ingredients are sodium chloride, disodium hydrogen phosphate heptahydrate, citric acid monohydrate, sodium hydroxide or/and hydrochloric acid (for pH adjustment) and water for injections.

Eyzeetan is presented as a clear, colourless aqueous solution filled in a white opaque 5ml LDPE bottle and white Novelia nozzle (HDPE and silicone) with a blue tip and sealed with a white HDPE cap.

Pack sizes: 1 or 3 bottles in a cardboard box.

Not all pack sizes may be marketed.

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