Patient leaflet - Glaucopt 20 mg / ml + 5 mg / ml eye drops solution
1. What Glaucopt® is and what it is used for
Glaucopt® 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® 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®
Do not use Glaucopt®
- if you are allergic to 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 long-standing cough)
- if you have a slow heart beat, heart failure or disorders of heart rhythm (irregular heart beats)
- if you have severe kidney disease or problems, or 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)
If you are not sure whether you should use this medicine, contact your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before using Glaucopt®. Tell your doctor about any medical or eye problems you may have currently 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 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, may mask signs and symptoms of low blood sugar;
- overactivity of the thyroid gland as timolol may mask signs and symptoms.
Tell your doctor before you have an operation that you are using Glaucopt® as timolol may change effects of some medicines used during anaesthesia.
Also, tell your doctor about any allergies or allergic reactions including hives, swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing.
Tell your doctor if you have muscle weakness or have been diagnosed as having myasthenia gravis.
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 suspect that Glaucopt® is causing an allergic reaction or hypersensitivity (for example, skin rash, severe skin reaction, or redness and itching of the eye), stop using this medicine and contact your doctor immediately.
Tell your doctor if you develop an eye infection, receive an eye injury, have eye surgery, or develop a reaction including new or worsening of symptoms.
When Glaucopt® is instilled into the eye it may affect the entire body. Children
There is limited experience with Glaucopt® in infants and children. 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 liver impairment
Tell your doctor about any liver problems you now have or have suffered from in the past.
Other medicines and Glaucopt®
Glaucopt® 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 medicines or medicines to treat diabetes.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
This is particularly important if you are:
- taking medicines to lower blood pressure, or heart disease, (such as calcium channel blockers, beta-blockers or digoxin). • taking medicines to treat a disturbed or irregular heartbeat (such as calcium channel blockers, beta-blockers or digoxin). • using another eye drop that contains a beta-blocker. • taking anopther carbonic anhydrase inhibitor, such as acetazolamide. • taking monoamine oxidase inhibitors (MAOIs).
- taking a parasympathomimetic medicine, which may have been 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.
- taking narcotics such as morphine, used to treat severe pain. • taking medicines to treat diabetes.
- taking antidepressants known as fluoxetine and paroxetine. • taking sulfa medicines.
- taking quinidine (used to treat heart conditions and some types of malaria).
Pregnancy and breastfeeding
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 Glaucopt® if you are pregnant unless your doctor considers it necessary.
Do not use Glaucopt® if you are breast-feeding. Timolol may get into breast milk. Ask your doctor for advice before taking any medicine during breastfeeding.
Driving and using machines
No studies on the effects on the ability to drive or use machines have been performed. There are side effects associated with Glaucopt®, such as 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.
Glaucopt® contains benzalkonium chloride
This medicine contains the preservative benzalkonium chloride 0.075 mg per ml equivalent to 0.375 mg/5 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 of 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.
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 in the affected eye(s) in the morning and in the evening.
If you are using this medicine with another 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 tip of the container to touch the eye or the area around the eye. It may become contaminated with bacteria that can cause eye infections, leading to serious damage to the eye, even loss of vision. To
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avoid possible contamination of the container, wash your hands before using this medicine and keep the tip of the container away from contact with any surface. If you think your medication may be contaminated, or if you develop an eye infection, contact your doctor immediately concerning continued use of this bottle.
Instructions for use
Do not use the container if the plastic safety strip around the neck is missing or broken.When opening the container for the first time, tear off the plastic safety strip.
Every time you use Glaucopt®:
1.Wash your hands. 
2.Open the container.Take special care that the tip of the dropper container does not touch your eye, the skinaround your eye or your fingers. 3.Tilt your head backwards and hold the container upside down over the eye.
4.Pull the lower eyelid downwards and look up. Hold 
and gently squeeze the container on the flattened side of the container and let one drop fall into the space between the lower eyelid and the eye. 5.Close your eye and press the inner corner of the eye with your finger for about two minutes. This helps to stop the medicine from getting into the rest of the 
body.
6.Repeat steps 3 to 5 with the other eye if instructed to do so by your doctor.
7.Put the cap back on and close the container tightly.
If you use more Glaucopt® than you should
If you put too many drops in your eye or swallow any of the contents of the container, among other effects 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®
It is important to take Glaucopt® 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®
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.
Serious side effects:
If you experience any of the following side effects, stop using this medicine and seek immediate medical advice as these could be signs of a reaction to the medicine.
Generalised allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs, and can obstruct the airways, which may cause difficulty swallowing, shortness of breath, hives or itchy rash, localised and generalised rash, itchiness, severe sudden life-threatening allergic reaction.
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 Glaucopt® without speaking to your doctor.
The following side effects have been reported with dorzolamide/timolol eye drops or one the components either during clinical trials or during post-marketing experience:
Very common (may affect more than 1 in 10 people)
Burning and stinging of the eyes, taste perversion
Common (may affect up to 1 in 10 people)
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 eye(s), feeling of having something in the eye, decreased corneal sensitivity (not realising of getting something in the eye and not feeling pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or fullness in the nose), nausea, weakness/tiredness, and fatigue.
Uncommon (may affect up to 1 in 100 people)
Dizziness, depression, inflammation of the iris, visual disturbances, including refractive changes (due to withdrawal of miosis therapy in some cases), slow heartbeat, fainting, shortness of breath, indigestion, and kidney stones.
Rare (may affect up to 1 in 1000 people)
Systemic lupus erythematosus (an immune disease which may cause an inflammation of internal organs), tingling or numbness of the hands or
feet, insomnia, nightmares, memory loss, an increase in signs and symptoms of myasthenia gravis (muscle disorder), decreased sex drive, stroke, 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, drooping of the eyelids (making the eye stay half closed), double vision, eyelid crusting, swelling of the cornea (with symptoms of visual disturbances), low pressure in the eye, ringing noises in your ear, low blood pressure, 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), cerebral ischaemia (reduced blood supply to the brain), chest pain, forceful heartbeat that may be rapid or irregular (palpitations), heart attack, Raynaud's phenomenon, swelling or coldness of your hands and feet and reduced circulation in your arms and legs, leg cramps and/or leg pain when walking (claudication), shortness of breath, impaired lung function, runny or stuffed nose, nose bleed, constriction of the airways in the lungs, cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, hair loss, skin rash with white silvery coloured appearance (psoriasiform rash), Peyronie’s disease (which may cause a curvature of the penis), allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth, wheezing, or severe skin reactions (Stevens Johnson syndrome, toxic epidermal necrolysis). Like other medicines applied into your eyes, timolol is absorbed into the blood. This may cause similar side effects as seen with oral beta-blocking agents. Incidence of side effects after topical ophthalmic administration is lower than when medicines are, for example, taken by mouth or injected.
Listed additional side effects include reactions seen within the class ophthalmic beta-blockers when used for treating eye conditions: 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, hallucination, foreign body in the eye (feeling there is something in the eye), increased heart rate, increased blood pressure, and abnormal sensitivity of the eyes to light.
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 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 Glaucopt®
Keep this medicine out of the sight and reach of children. This medicinal product does not require any special temperature storage conditions. Keep in the original container in the outer carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the container label and the carton after “EXP”. The expiry date refers to the last day of that month.
After first opening the bottle, do not store the medicine above 25°C and use it within 28 days; after this period discard the residual medicine. Report the date of first opening in the appropriate 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 Each ml of the solution contains:
- 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, benzalkonium chloride, sodium hydroxide and water for injections.
What Glaucopt® looks like and contents of the pack
Glaucopt® is a clear, colourless solution in a polyethylene bottle. Each pack contains one bottle of 5 ml.
Marketing Authorisation Holder
VISUfarma UK Ltd.
4230 Park Approach, Thorpe Park,
Leeds, LS15 8GB, UK
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA), Italy