Bimatoprost/Timolol 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.

1. What Bimatoprost/Timolol is and what it is used for
2. What you need to know before you use Bimatoprost/Timolol
3. How to use Bimatoprost/Timolol
4. Possible side effects
5. How to store Bimatoprost/Timolol
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 and/or severe chronic obstructive pulmonary disease (lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough) or other types of breathing problems
• 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 this medicine as timolol may change the effect of some medicines used during anaesthesia.

During treatment, this medicine 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 this medicine. Bimatoprost/Timolol 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. Bimatoprost/Timolol may cause hair growth when in contact with the skin surface.

Bimatoprost/Timolol should not be used in children and teenagers under 18.

Bimatoprost/Timolol 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 Bimatoprost/Timolol if you are pregnant unless your doctor still recommends it.

Do not use Bimatoprost/Timolol if you are breast-feeding. Timolol may get into your breast milk. Ask your doctor for advice before taking any medicine during breast-feeding.

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

This medicine contains 0.15mg benzalkonium chloride in each 3ml of solution which is equivalent to 0.05mg/ml.

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 2.94mg phosphate in each 3ml of solution which is equivalent to 0.98mg/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 (see section 4).

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

1. Wash your hands. Tilt your head back and look at the ceiling.
2. Gently pull down the lower eyelid until there is a small pocket.
3. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.
4. Let go of the lower lid, and close your eye.
5. Whilst keeping the eye closed, press your finger against the corner of the closed eye (the site where the eye meets the nose) and hold for 2 minutes. This helps to stop Bimatoprost/Timolol getting into the rest of the body.

If a drop misses your eye, try again.

To avoid contamination, 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 this medicine with another eye medicine, leave at least 5 minutes between putting in Bimatoprost/Timolol and the other medicine. Use any eye ointment or eye gel last.

If you use more Bimatoprost/Timolol 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/Timolol, 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.

Bimatoprost/Timolol should be used every day to work properly.

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
• dizziness
• slowing of heart rate
• high blood pressure
• difficulty sleeping
• nightmare
• asthma
• hair loss
• skin discolouration (periocular)
• tiredness.

Additional side effects have been seen in patients using eye drops containing timolol or bimatoprost and so may possibly be seen with Bimatoprost/Timolol.

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 bimatoprost and timolol 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
• 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; 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

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.

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 disodium phosphate anhydrous, benzalkonium chloride (a preservative), sodium chloride, citric acid monohydrate, hydrochloric acid, sodium hydroxide, water for injection.

Bimatoprost/Timolol is a colourless to slightly yellow, clear eye drop solution in a plastic bottle. Each pack contains either 1 or 3 plastic bottles each with a screw-cap.

Each bottle is about half full and contains 3 millilitres of solution. This is enough for 4 weeks usage. Not all pack sizes may be marketed.

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