VISUBLEND 0.3 MG / ML + 5 MG / ML EYE DROPS SOLUTION - patient leaflet, side effects, dosage

1. what visublend® is and what it is used for

VISUBLEND® 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. This liquid is constantly drained out of the eye and new liquid is made to replace it. 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). VISUBLEND® works by reducing the production of liquid and also increasing the amount of liquid that is drained. This reduces the pressure inside the eye.

VISUBLEND® 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 VISUBLEND® 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 visublend®

Do not use VISUBLEND® 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 currently have 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-lasting 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 VISUBLEND®, if you currently have 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 (such as Raynaud’s disease or Raynaud’s syn­drome),

• – overactive 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 a worsening vision), for example, cataract surgery.

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

VISUBLEND® 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 ifyou are only treating one eye. VISUBLEND® may cause hair growth when in contact with the skin surface.

Children and adolescents

VISUBLEND® should not be used in children and adolescents under 18 years of age.

Other medicines and VISUBLEND®

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

VISUBLEND® 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 VISUBLEND® if you are pregnant unless your doctor still recommends it.

Do not use VISUBLEND® 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

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

VISUBLEND® contains benzalkonium chloride

This medicine contains 0.05 mg benzalkonium chloride in each ml of solution.

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.

VISUBLEND® contains phosphates

This medicine contains 0.95 mg phosphates in each ml of solution.

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.

3. how to use visublend®

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-evident ring on the bottle neck is broken before you first use it.

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Wash your hands and sit or stand comfortably.

Unscrew the cap.

Remove the tamper-evident ring from the bottle.

Tilt your head back and look at the ceiling.

Gently pull down the lower eyelid until there is a small pocket (Figure 2).

Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment (Figure 3).

Let go of the lower lid and close your eye (Figure 4).

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 (Figure 5). This helps to stop VISUBLEND® 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 VISUBLEND® with another eye medicine, leave at least 5 minutes between putting in VISUBLEND® and the other medicine. Use any eye ointment or eye gel last.

If you use more VISUBLEND® than you should

If you use more VISUBLEND® 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 VISUBLEND®

If you forget to use VISUBLEND®, 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 VISUBLEND®

VISUBLEND® 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, this medicine can cause side effects, a lthough not everybody gets them. You can usually carry on taking the drops, unless the side effects are serious. If you’re worried, talk to a doctor or pharmacist. Do not stop using VISUBLEND® without speaking to your doctor.

The following side effects may be seen with VISUBLEND® (multi-dose and/or single-dose):

Very common side effects

These may affect more than 1 in 10 people

Affecting the eye redness.

Common side effects

These may affect up to 1 in 100 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 side effects

These may affect up to 1 in 1000 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.

Side effects where the frequency is not known

These cannot be estimated from the available data

Affecting the eye

cystoid macular oedema (swelling of the retina within the eye leading to a 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 skin rash), changes in your taste sensation, dizziness, slowing of heart rate, high blood pressure, difficulty sleeping, nightmare, bronchospasm, asthma, hair loss, skin discolouration around the eyes, tiredness.

Additional side effects have been seen in patients using eye drops containing timolol or bimatoprost, therefore they may possibly be seen with VISUBLEND®. 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 taken by mouth or injected. Listed side effects include reactions seen within bimatoprost and timolol when they were used for treating eye conditions:

• Severe allergic reactions with swelling and difficulty breathing which could be life-threatening;
• Low blood sugar;
• Depression; memory loss; hallucinations;
• 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 eye surface, 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;

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme

Website: 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 visublend®

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.

After first opening of the bottle:

Once opened, solutions may become contaminated, which can cause eye infections. Therefore, you must throw away the bottle 28 days 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 to protect the environment.

6. contents of the pack and other information

What VISUBLEND® contains

• The active substances are bimatoprost and timolol. Each ml ofsolution contains 0.3 mg bimatoprost and 5 mg timolol (corresponding to 6.8 mg timolol maleate).
• The other ingredients are benzalkonium chloride solution (50% aq.), sodium chloride, disodium phosphate, anhydrous, citric acid monohydrate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

What VISUBLEND® looks like and contents of the pack

VISUBLEND®is a clear, colourless to slightly yellow, eye drop solution that is practically free from foreign particles. It is available in a 5 mL white plastic dropper bottle with a white screw cap and a tamper evident ring. Each bottle contains 3 mL solution. This is enough for 4 weeks’ usage.

VISUBLEND® is supplied in a pack containing either 1 plastic bottle or 3 plastic bottles each with a screw cap.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

VISUfarma UK Ltd.

4230 Park Approach, Thorpe Park, Leeds, LS158GB, UK

Manufacturer

RAFARM S.A.

Thesi Pousi-Xatzi Agiou Louka,

Paiania, 19002, Attiki, Greece

This leaflet was last revised in: 09/2021

VISLJarma

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