Bimatoprost/timolol Zentiva 0.3 mg / ml + 5 mg / ml eye drops solution – patient leaflet, side effects, dosage

1. What Bimatoprost/Timolol is and what it is used for

Bimatoprost/Timolol contains two different active substances (bimatoprost and timolol) that both reduce pressure in the eye. Bimatoprost belongs to a group of medicines called prostamides, a prostaglandin analogue. 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). Bimatoprost/Timolol works by reducing the production of liquid and also increasing the amount of liquid that is drained. This reduces the pressure inside the eye. Bimatoprost/Timolol 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 Bimatoprost/Timolol when other eye drops containing beta-blockers or prostaglandin analogues have not worked sufficiently on their own.

2. What you need to know before you use Bimatoprost/ Timolol

Do not use Bimatoprost/Timolol eye drops, solution

• 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 past respiratory problems such as asthma, 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

Warnings and precautions

Talk to your doctor before using Bimatoprost/Timolol 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 or spontaneous episodes of low blood sugar level, as timolol may mask signs and symptoms of low blood sugar
  • severe allergic reactions or a genetic disposition to develop an allergic reaction
  • liver or kidney problems
  • eye surface problems (such as dry eyes or corneal disease)
  • 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
  • inflammation of the eye which causes pain and redness (uveitis) Tell your doctor before surgical anaesthesia that you are using Bimatoprost/Timolol as timolol may change effects of some medicines used during anaesthesia.

Bimatoprost/Timolol 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. Bimatoprost/Timolol may cause hair growth when in contact with the skin surface.

Children and adolescents

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

Other medicines and Bimatoprost/Timolol

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

Bimatoprost/Timolol can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. 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.

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 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.

Driving and using machines

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

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

Bimatoprost/Timolol contains phosphates

This medicine contains 2.85 mg phosphates in each 3 ml of solution which is equivalent to 0.95 mg/ml.

3. How to use Bimatoprost/Timolol

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 usual 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.

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.

1. 1.

   Wash your hands. Tilt your head back and look at the

   ceiling.

2. 2.

   Gently pull down the lower eyelid until there is a small

   pocket.

3. 3.

   Turn the bottle upside down and squeeze it to release one

   drop into each eye that needs treatment.

4. 4. Let go of the lower lid, and close your eye.
5. 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 Bimatoprost/Timolol 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.

   If you stop using Bimatoprost/Timolol

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

   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. You can usually carry on taking the drops, unless the effects are serious. If you are worried, talk to a doctor or pharmacist. Do not stop using Bimatoprost/Timolol without speaking to your doctor. The following side effects may be seen with Bimatoprost/Timolol: Very common (may affect more than 1 in 10 people) Affecting the eye

• redness.
• 2. 3.
• 5.

Reporting 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 at: 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/Timolol

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. Once opened, solutions may become contaminated, which can cause eye infections. Therefore, you must throw away the bottle 4 weeks after you first opened it, even if some solution is left. To help you remember, write down the date that you opened it in the space on the carton.

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/Timolol contains

• The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml corresponding to timolol maleate 6.8 mg/ml.

• The other ingredients are benzalkonium chloride (a preservative), sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate and purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to bring the solution to the correct pH (acidity) level.

  • The product contains benzalkonium chloride and phosphates, please refer to section 2.

What Bimatoprost/Timolol looks like and contents of the pack

Bimatoprost/Timolol is a colourless to slightly yellow 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.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Zentiva Pharma UK Limited,

12 New Fetter Lane,

London,

EC4A 1JP

United Kingdom

Manufacturer

S.C. Rompharm Company S.R.L.

1A Eroilor Street

075100 Otopeni

Romania

This leaflet was last revised in December 2022 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,
• 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 drooping,
  • eyelid shrinking (moving away from the surface of the eye leading to incomplete closure of the eyelids)
  • skin tightness of the eyelids,
  • darkening of eyelashes.

Affecting other parts of the body

• shortness of breath.

Not known (frequency cannot be estimated from the 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,
• 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 with 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.

Other side effects reported with eye drops containing phosphates:

• 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. 1065034654

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