GLAUCOPT 20 MG / ML + 5 MG / ML EYE DROPS SOLUTION IN SINGLE-DOSE-CONTAINER - Patient leaflet, side effects, dosage

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 or pharmacist.

• – 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Glaucopt single-dose is and what it is used for

• 2. What you need to know before you use Glaucopt single-dose

• 3. How to use Glaucopt single-dose

• 4. Possible side effects

• 5. How to store Glaucopt single-dose

• 6. Contents of the pack and other information

1. what glaucopt single-dose is and what it is used for

Glaucopt single-dose contains two active substances: dorzolamide and timolol

• Dorzolamide belongs to a group of medicines called “carbonic anhydrase inhibitors”.
• Timolol belongs to a group of medicines called “beta blockers”.

These medicines lower the pressure in the eye in different ways.

Glaucopt single-dose is prescribed to lower raised pressure in the eye in the treatment of glaucoma when beta-blocker eyedrop medicine used alone is not adequate.

2. what you need to know before you use glaucopt single-dose- if you are allergic to the active substances (dorzolamide hydrochloride, timolol maleate) or any of the other ingredients of this medicine (listed in section 6)

• – if you have now or had in the past respiratory problems, such as asthma or severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or longstanding cough)

• – if you have a slow heart beat, heart failure or disorders of heart rhythm (irregular heart beats)

• – if you have severe kidney problems or severe kidney impairment, or a prior history of kidney stones

• – if you have excess acidity of the blood, caused by a build up of chloride in the blood (hyperchloraemic acidosis)

Warnings and precautions

Talk to your doctor or pharmacist before using Glaucopt single-dose if you have now or have had in the past:

• cardiovascular diseases/coronary heart disease (symptoms can include chest pain or tightness, breathlessness, or choking), heart failure, low blood pressure; abnormalities of heart rate such as

slow heart beat

• breathing problems, asthma or chronic obstructive pulmonary disease
• poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syn­drome).
• diabetes as timolol, one of the active substances of Glaucopt , may mask signs and symptoms of low

blood sugar (hypoglycaemia)

• overactivity of the gland called thyroid as timolol may mask signs and symptoms

Tell your doctor:

• if you are using Glaucopt single-dose and you need to have surgery as timolol may change effects of some medicines used during anaesthesia
• if you have been diagnosed as having myasthenia gravis (muscle weakness)
• if you develop any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids, in this case contact your doctor immediately
• if you develop an eye infection, receive an eye injury, have eye surgery, or experience other reactions including new or worsening of pre-existing symptoms

When Glaucopt single-dose is instilled into the eye it may affect the entire body.

Use in children and adolescents

There is limited experience with Glaucopt single-dose in infants and children.

Use in elderly

In studies with dorzolamide/ti­molol, the effects of the combination of the two active substances were similar in elderly and younger patients.

Use in patients with altered liver function (liver impairment)

Tell your doctor about any liver problems you now have or have suffered from in the past.

Anti-doping test

The use of this medicine may produce positive results in doping controls.

Other medicines and Glaucopt single-dose

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

Glaucopt single-dose 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, to treat heart diseases (cardiac disease) or to treat diabetes.

Tell your doctor:

• if you are taking medicines to lower blood pressure or to treat heart disease (such as calcium channel blockers, beta-blockers or digoxin).
• if you are taking medicines to treat heart disorders or abnormalties of the hear beat (such as calcium channel blockers, beta-blockers or digoxin).
• if you are using another eye drop that contains an active substance belonging to the class of “betablocker”, ask your doctor for further information.
• if you are taking another medicine used for high eye pressure (carbonic anhydrase inhibitor, such as acetazolamide).
• if you are taking medicines called “monoamine oxidase inhibitors (MAOIs)”, used to treat depression.
• if you are taking a medicine belonging to the class of “parasympatho­mimetics” prescribed to help you pass urine. Parasympathomi­metics are also a particular type of medicine which is sometimes used to help restore normal movements through the bowel.
• if you are taking “narcotics” such as morphine, used to treat severe pain.
• if you are taking medicines to treat diabetes.
• if you are taking antidepressants known as fluoxetine and paroxetine.
• if you are taking “sulfa medicines.”
• if you are taking “quinidine” used to treat heart conditions and some types of malaria.

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.

Use in pregnancy

Glaucopt single-dose should not be used during pregnancy.

Use in breast-feeding

Do not use Glaucopt single-dose if you are breast-feeding. Timolol may get into breast milk.

Driving and using machines

Glaucopt single-dose has minor influence on the ability to drive or use machines. However, there are side effects associated with the use of Glaucopt single-dose, such as transient blurred vision, which may affect your ability to drive and/or operate machinery. Do not drive or operate machinery until you feel well or your vision is clear.

3. how to use glaucopt

Always use this medicine exactly as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. The appropriate dosage and duration of treatment will be established by your doctor.

The recommended dose is one drop of Glaucoptsingle-dose in the affected eye(s) in the morning and in the evening.

If you are using Glaucopt single-dose concomitantly with other eye drops, the drops should be instilled at least 10 minutes apart.

Do not change the dose of the medicine without consulting your doctor.

Do not allow the cap of the container to touch the eye or areas around the eye. It 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 container, wash your hands before using this medicine and keep the container away from contact with any surface. A new single-dose should be opened immediately prior to each use; there is enough solution in each container for both eyes if your doctor has told you to use the drops in both eyes.

Instructions for use

Open the aluminium pouch which contains the individual single-dose containers. Write the date of first opening on the sachet.

• – Wash your hands and sit, or stand comfortably.

• – Take the strip of containers from the sachet.

• – Remove a single-dose container from the strip.

• – Put the remaining strip back in the pouch and fold the edge to close the pouch.

• – To open the container, twist off the tab.

  
  

• – Hold the container between your thumb and index finger. Note that the tip of the container must not show more than 5 mm above the edge of your index finger.

• – Tilt your head back or lie down and look up.

• – Pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.

• – Point the tip of the single-dose container close to the eye without touching it.

• – Press the single dose container lightly so that a single drop is dispensed into the eye as directed by your doctor. Do not blink while applying the drip to your eye. Release the lower eyelid.

  
  

• – Close your eye and press a finger into the inner corner of the concerned eye for a minute. This helps to stop the eye drop from being drained into the lacrimal duct.

  
  

• – Repeat in the other eye if instructed to do so by your doctor.

• – Throw away the single dose container and any residual content.

Store the remaining containers in the foil sachet, and the remaining containers must be used within 7 days after opening of the sachet. If there are are any containers left 7 days after opening the sachet they should be safely thrown away and a fresh sachet opened.

If you use more Glaucopt single-dose than you should

If you put too many drops in your eye or swallow any of the contents of the container, you may become light-headed, have difficulty breathing, or feel that your heart rate has slowed. Contact your doctor immediately.

If you forget to use Glaucopt single-dose

It is important to use Glaucopt single-dose as prescribed by your doctor. If you miss a dose, use it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not use a double dose to make up for the forgotten dose.

If you stop using Glaucopt single-dose

If you want to stop using this medicine talk to your treating doctor first.

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.

Timolol is absorbed by blood vessels that distribute it to the whole body, similar to other eye medicines.

This can cause undesirable effects similar to those observed with medicines of the same group (betablockers) taken orally. The incidence of undesirable effects after eye administration is lower than in oral administration.

If you experience allergic reactions including swelling of the face and limbs causing difficulty breathing or swallowing, hives or itchy rash, localised and generalised rash, itchiness, or a severe sudden life-threatening allergic reaction, stop using this medicine and seek medical advice immediately.

The following side effects have been reported with dorzolamide timolol eye drops or one of its components either during clinical trials or during post-marketing experience:

Very common (may affect more than 1 in 10 patients)

-burning and stinging of the eyes

-altered taste

Common (may affect up to 1 in 10 patients)

-headache

-redness in and around the eye(s), watering or itching of the eye(s), corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation in and around the eyes, feeling of a foreign body in the eye, decreased corneal sensitivity (not realising of getting something in the eye and not feeling pain), eye pain, dry eyes, blurred vision

-sinusitis (feeling of tension or fullness in the nose)

-weakness/tiredness, and fatigue.

Uncommon (may affect up to 1 in 100 patients)

-depression

-dizziness, fainting

-inflammation of the part of the eye called the iris, visual disturbances (including refractive changes in some cases due to withdrawal of the miosis therapy)

-slow heartbeat

-difficulty breathing (dyspnoea)

-indigestion

-kidney stones

Rare (may affect up to 1 in 1000 patients)

-allergic type reactions such as rash, hives, itching, in rare cases swelling of the lips, eyes and mouth, wheezing, or severe skin reactions (Stevens Johnson syndrome, toxic epidermal necrolysis)

-trouble sleeping, nightmares, memory loss

-cerebral ischaemia (reduced blood supply to the brain), an increase in signs and symptoms of myasthenia gravis (muscle disorder), decreased sex drive, tingling or numbness of the hands or feet

-temporary short sightedness which may resolve when treatment is stopped, detachment of the layer below the retina that contains blood vessels following from filtration surgery which may cause visual disturbances due to fluid build up, drooping of the eyelids, double vision, eyelid crusting, swelling of the cornea (with symptoms of visual disturbances), low pressure in the eye

-ringing noises in your ear

-changes in the rhythm or speed of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid build up), oedema (fluid build up), chest pain, heart attack, low blood pressure, excessive tightening of blood vessels (Raynaud's phe­nomenon), swelling or coldness of your hands and feet, reduced circulation in your arms and legs, leg cramps and/or leg pain when walking

(claudication), stroke

-shortness of breath, impaired pulmonary function, runny or stuffed nose, nose bleed, constriction of the airways in the lungs, cough

-throat irritation, dry mouth, diarrhoea

-Skin inflammation due to contact with certain substances (contact dermatitis), hair loss, skin rash with white silvery coloured appearance (psoriasiform rash)

systemic lupus erythematosus (an immune disease which may cause an inflammation of internal organs)

-Peyronie’s disease (which may cause a curvature of the penis)

Listed additional side effects include reactions seen within the class ophthalmic beta-blockers:

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

-low blood glucose levels

-heart failure, a type of heart rhythm disorder

-abdominal pain, vomiting

-muscle pain not caused by exercise

-sexual dysfunction

-wheezing

-feeling of a foreign body in the eye (feeling there is something in the eye)

-strong heart beat that can be rapid and/or irregular (palpitations).

Reporting of 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 national reporting system. By reporting side effects you can help provide more information on the safety of this medicine.

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Keep this medicine out of the sight and reach of children.

Store in the original package in order to protect from light.

After first opening the aluminium pouch, do not store above 25°C and use within 7 days; residual containers must be discarded. Single-dose containers must be used immediately after opening; any residual medicine must be discarded.

Medicines should not be thrown in wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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– The active substances, dorzolamide 20 mg (corresponding to 22.26 mg dorzolamide hydrochloride) and timolol 5 mg (corresponding to 6.83 mg timolol maleate).

• – The other ingredients are mannitol, sodium citrate, hydroxyethylce­llulose, sodium hydroxide and water for injections.

What Glaucopt single-dose looks like and contents of the pack

Glaucopt single-dose is a clear, colourless solution.

Each pack contains 6 aluminium pouches where each pouch contains 5 polyethylene single-dose containers containing 0.166 ml of solution. Each carton contains 30 single-dose containers.

Marketing Authorisation Holder

TurnKey PharmaConsulting Ireland Limited

Ellerman House,

Cratloe Wood, Cratloe,

County Clare, V95 X925

Ireland

Manufacturer

Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)

This leaflet was last revised in May 2021

Confidential

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