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: PL35533/0103.


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

Package leaflet: Information for the user

eyzeetan

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

Bimatoprost/Timolol

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, 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.

Important information about the administration of this product

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.

What is in this leaflet

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

1. What Eyzeetan is and what it is used for

Eyzeetan contains two different active substances (bimatoprost and timolol) that both reduce pressure in the eye. Bimatoprost belongs to a group of medicines called prostamides, which are prostaglandin analogues. Timolol belongs to a group of medicines called beta-blockers.

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 and could eventually damage your sight (an illness called glaucoma). Eyzeetan works by reducing the production of liquid and also increasing the amount of liquid that is drained. This reduces the pressure inside the eye.

Eyzeetan eye drops are used to treat high pressure in the eye in adults, including the elderly. This high pressure can lead to glaucoma. Your doctor will prescribe you Eyzeetan when other eye drops containing beta-blockers or prostaglandin analogues have not worked sufficiently on their own.

Eyzeetan eye drops solution is a sterile solution that does not contain a preservative.

2. What you need to know before you use Eyzeetan

Do not use Eyzeetan:

  • 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

Warnings and precautions

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.

Eyzeetan may 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 over time. 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.

Children and adolescents

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

Other medicines and Eyzeetan

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

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. 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.

Driving and using machines

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

3. How to use Eyzeetan

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 a day, either in the morning or in the evening in each eye that needs treatment. Use at the same time each day.

Do not allow the tip of the multi-dose container to touch the eye or areas around the eye. It could cause injury to your eye. The eye drops solution may become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision.

To avoid possible contamination of the multi-dose container, keep the tip of the multi-dose container away from contact with any surface.

Instructions for use

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).

Instillation:

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

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

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.

If you stop using Eyzeetan

Eyzeetan should be used every day to work properly.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, Eyzeetan can cause side effects, although not everybody gets them.

You can usually carry on taking the drops, unless the effects are serious. If you’re worried, talk to a doctor or pharmacist. Do not stop using Eyzeetan without speaking to your doctor.

The following eye side effects may be seen with Eyzeetan:

Very common (may affect more than 1 in 10 people):

Affecting the eye

  • redness

Common (may affect up to 1 in 10 people):

Affecting the eye

  • burning, itching, stinging
  • irritation of the conjunctiva (see-through layer of the eye)
  • sensitivity to light
  • eye pain
  • sticky eyes
  • dry eyes
  • a feeling of something in the eye
  • small breaks in the surface of the eye with or without inflammation
  • difficulty in seeing clearly
  • redness and itching of the eyelids
  • hair growing around the eye
  • darkening of the eyelids, darker skin colour around the eyes
  • longer eyelashes
  • eye irritation
  • watery eyes
  • swollen eyelids
  • reduced vision

Affecting other parts of the body

  • runny nose
  • dizziness
  • headache

Uncommon (may affect up to 1 in 100 people):

Affecting the eye

  • abnormal sensation in the eye
  • iris inflammation
  • swollen conjunctiva (see-through layer of the eye)
  • painful eyelids
  • tired eyes
  • in-growing eyelashes
  • darkening of iris colour
  • eyes appear sunken
  • eyelid has moved away from the surface of the eye
  • darkening of eyelashes

Affecting other parts of the body

  • shortness of breath

Not known (frequency cannot be estimated from available data):

Affecting the eye

  • cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)
  • eye swelling
  • blurred vision
  • ocular discomfort

Affecting other parts of the body

  • difficulty breathing / wheezing
  • symptoms of allergic reaction (swelling, redness of the eye and rash of the skin)
  • changes in your taste sensation
  • slowing of heart rate
  • difficulty sleeping
  • nightmare
  • asthma
  • hair loss
  • tiredness
  • skin discoloration (periocular)

Additional side effects have been seen in patients using eye drops containing timolol or bimatoprost and so may possibly be seen with Eyzeetan. Like other medicines applied into eyes, timolol is absorbed into the blood. This may cause similar side effects as seen with “intravenous” and/or “oral” beta-blocking agents.

The chance of having side effects after using eye drops is lower than when medicines are for example, taken by mouth or injected. Listed side effects include reactions seen within the class of beta-blockers when used for treating eye conditions:

  • severe allergic reactions with swelling and difficulty breathing which could be life-threatening
  • low blood sugar
  • depression; memory loss, hallucination (frequency not known)
  • fainting; stroke; decreased blood flow to the brain; worsening of myasthenia gravis (increased muscle weakness); tingling sensation
  • decreased sensation of your eye surface; double vision; drooping eyelid; separation of one of the layers within the eyeball after surgery to reduce the pressure in the eye; inflammation of the surface of the eye; bleeding in the back of the eye (retinal bleeding), inflammation within the eye, increased blinking
  • heart failure; irregularity or stopping of the heartbeat; slow or fast heartbeat; too much fluid, mainly water, accumulating in the body; chest pain
  • low blood pressure, high blood pressure, swelling or coldness of your hands, feet and extremities, caused by constriction of your blood vessels
  • cough, worsening of asthma, worsening of the lung disease called chronic obstructive pulmonary disease (COPD)
  • diarrhoea; stomach pain; feeling and being sick; indigestion; dry mouth
  • red scaly patches on skin; skin rash
  • muscle pain
  • reduced sexual urge; sexual dysfunction
  • weakness
  • an increase in blood test results that show how your liver is working

Other side effects reported with eye drops containing phosphates

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 of side effects

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.

5. How to store Eyzeetan

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.

Store below 30°C. After first opening, the product may be stored for a maximum of 28 days.

Do not use this medicine if you notice that the seal is broken the first time you use 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 Eyzeetan contains

  • 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.

What Eyzeetan looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

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

Manufacturer

Pharmathen S.A.
6 Dervenakion
15351 Pallini Attiki
Greece

And

EXCELVISION
27 st. La Lombardière
Zl La Lombardière
ANNONAY 07100
France

This leaflet was last revised in 12/2019

1010421-P5.3