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«Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You ...»

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Glaucotima 50 microgram/5.0 mg per ml Eye Drops Solution

Latanoprost / Timolol

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.

What is in this leaflet:

1. What Glaucotima is and what it is used for

2. What you need to know before you use Glaucotima

3. How to use Glaucotima

4. Possible side effects

5. How to store Glaucotima

6. Contents of the pack and other information

1. WHAT GLAUCOTIMA IS AND WHAT IT IS USED FOR

Glaucotima is a combination of two different medicines that both contribute to lowering the pressure in the eye, but in different ways. Timolol is one of a group of medicines known as “beta-blockers” and lowers the pressure in the eye by reducing the inflow of fluid inside the eye. Latanoprost lowers the pressure by increasing the natural outflow of fluid from the inside of the eye.

Glaucotima is used for lowering increased pressure within the eye (called ocular hypertension) and for the treatment of glaucoma.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE GLAUCOTIMA

Do not use Glaucotima:

- if you have now or have had in past respiratory problems such as asthma, severe chronic obstructive bronchitis;

- if you have heart problems, such as heart failure or heart rhythm disorders;

- if you are allergic to timolol, beta-blockers or any of the other ingredients of the medicine (listed in section 6);

- if you are under eighteen years of age.

If you think any of these points apply to you, do not use Glaucotima until you have talked to your doctor.

Warnings and precautions Before you use this medicine, tell your doctor if you have now or have had in the past

- coronary heart disease, heart failure, hypotension

- breathing problems, asthma or chronic obstructive pulmonary disease

- peripheral arterial disease 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

- or allergies to other medicines that you have used.

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

If you have any heart problems your doctor will want to make sure that the situation is under control before you take your eye drops. Your doctor may want you to have extra checks on your heart and circulation whilst you are using Glaucotima.

If you have a coloured part of the eye (iris) that is a mixture of colours, i.e. blue/grey-brown, greenbrown or yellow-brown, you may find that you slowly and gradually develop an increase in the brown colour of the iris. Changes in purely blue, grey, green or brown eyes are rare. The brown colour change occurs slowly and is noticed only after months to years. If you are being treated with Glaucotima in one eye only, this can result in a difference in colour between eyes. The change in colour is harmless, but will probably be permanent.

If the coloured parts of your eyes are a mixture of colours or if you observe an increase in the brown colour of the iris, talk to your doctor.

Before surgery and anaesthesia, the doctor/dentist should know that you are being treated with Glaucotima, since there is a risk that blood pressure can suddenly fall in association with anaesthesia.

Other medicines and Glaucotima Glaucotima 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 or medicines to treat diabetes. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

You should consult your doctor if you are taking one or more of the following medicines:

- a calcium antagonist (e.g. nifedipine, verapamil or diltiazem) often used to treat high blood pressure, angina, an abnormal heartbeat or Raynaud’s syndrome;

- digoxin, a medicine used to relieve heart failure or treat abnormal heartbeat;

- anti-arrhythmic agents such as quinidine, medicines used to treat abnormal heartbeat;

- clonidine, a medicine used to treat high blood pressure;

- other beta-blockers (e.g. other preparations of timolol both oral and/or ocular), which belong to the same group of medicines as Timolol and could have an additive effect;

- medicine to treat diabetes;

- medicine to enable you to urinate more easily or in order to restore normal bowel movements;





- medicine to reduce swelling of the mucous membranes (for nasal congestion);

- medicine for asthma that contain adrenaline.

Pregnancy and breast-feeding Do not use Latanoprost / Timolol if you are pregnant unless your doctor considers it necessary.

Do not use Latanoprost / Timolol if you are breast-feeding. Timolol and latanoprost may get into your milk.

Ask your doctor for advice before taking any medicine during breast-feeding.

Driving and using machines Possible side effects e.g. blurred vision, can affect the ability to drive and/or operate machines. If you experience any problems, talk to your doctor.

Glaucotima contains benzalkonium chloride This medicinal product contains benzalkonium chloride which may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before putting them back in. Benzalkonium chloride is known to discolour soft contact lenses.

3. HOW TO USE GLAUCOTIMA Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

General instructions The usual dosage is 1 drop into the affected eye (eyes) once daily.

If Glaucotima is being used together with other eye drops, they should be put in at least 5 minutes apart.

If a dose is missed, you should wait until the next dose. Do not make up for a missed dose by putting an extra drop into the eye.

Instructions for use The following steps will help you to use Glaucotima

1. Wash your hands before using eye drops.

2. Twist off the colourless protective cap with the “wings”.

3. Unscrew the cap.

4. Using your forefinger, gently pull down the lower eyelid of the eye that is to be treated.

5. Place the tip close to the eye and squeeze gently, so that one drop falls into the eye.

6. Replace the cap after use.

After using Latanoprost / Timolol, press a finger into the corner of your eye, by the nose (picture 1) by 2 minutes. This helps to stop timolol getting into the rest of the body.

Picture 1 If you should accidentally use more Glaucotima then you should, always contact your doctor or hospital.

Use in children There is limited experience with Glaucotima in children and adolescents.

If you use more Glaucotima than you should Immediately contact your doctor if you have used too much Glaucotima or if you have accidentally swallowed Glaucotima. If you have administer too many drops in the eye, you may feel a slight irritation in the eye. Your eyes may water and become red.

If you forget to use Glaucotima Carry on with the usual dose at the usual time. Do not take a double dose to make up for a forgotten dose. You should check with your doctor or pharmacist if you are not sure.

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're worried, talk to a doctor or pharmacist. Do not stop using Glaucotima without speaking to your doctor.

Very common side effects (more than 1 user in 10):

- Change in the coloured part of the eye (iris) which may be permanent. For more details refer to the earlier section of this leaflet under the heading “Warnings and precautions”.

Common side-effects (1 to 10 users in 100):

- Eye irritation (including stinging, burning and itching);

- Eye pain.

Uncommon side-effects (1 to 10 users in 1,000):

- Headache;

- Pink/Redness of the eye;

- Blurred vision;

- Watery eyes;

- Inflammation of the eyelids;

- Eye infection (conjunctivitis);

- Irritation or disruption of the surface of the eye;

- Skin rashes/itching.

Some side-effects have been seen with the two individual medicines (latanoprost and timolol

maleate) within Glaucotima. The following effects on the eye may occur with Glaucotima:

- Darker, thicker, longer and more eyelashes and fine (vellus) hair;

- Eyelashes growing in the “wrong” direction sometimes resulting in eye irritation;

- Swelling around the eyes;

- Small marks on the eye surface (punctate keratitis), eye discomfort;

- Inflammation and swelling in and around the eye/eyelid;

- Swelling at the back of the eye (macular oedema);

- Burning, stinging, itching, tearing and redness

- Eye becoming sensitive to light;

- Eye becoming less sensitive to other stimuli (eg. touch)

- Dry eyes;

- Corneal erosion;

- Visual disturbances (such as blurred or double vision);

- Drooping eyelid;

- Injury to the lining of the back of the eye (a condition known as choroidal detachment, but only seen when used following some kind of eye injury or filtration surgery).

When the Glaucotima is instilled into the eye, a small amount of active medicines (latanoprost and timolol maleate) in Glaucotima can be absorbed into the blood and may cause effects elsewhere in the body, not only in the eye.

Like other topically applied ophthalmic drugs, timolol is absorbed into the blood. This may cause similar side effects as seen with systemic beta-blocking agents. Incidence of side effects after topical ophthalmic administration is lower than for systemic administration. Listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers.

The following effects have been reported on the body for the individual medicines (latanoprost

and timolol maleate) within Glaucotima. These side effects may occur with Glaucotima:

- Asthma (acute and worsening of existing asthma), laboured breathing, shortness of breath, cough;

- Chest pain, fainting, a slowing of your heart rate;

- Worsening of angina in patients with pre-existing disease, awareness of heart rhythm (palpitations), changes in heart rhythm, slowing of the heart, heart failure (cardiac arrest, heart block or congestive heart failure);

- Fatigue (tiredness), dizziness, abnormal sensations, light-headedness, headache, ringing in the ears, abnormal skin sensations;

- Joint and muscle pain;

- Taste disturbances, nausea, diarrhoea, indigestion, dry mouth, abdominal pain, vomiting;

- Low blood pressure, stroke, swelling or coldness of your hands, feet and extremities, caused by constriction of the blood vessels in response to stimuli, including the cold;

- Depression, memory loss, nightmares, decreased sex drive and other sexual problems, difficulty in sleeping;

- Low blood sugar.

Hypersensitivity reactions such as skin rash (localised or generalised), urticaria (hives), itching, hair loss, darkening of the skin of the eyelid, psoriasis-like rash or exacerbation of psoriasis, swelling (oedema) and a worsening of myasthenia gravis (increased muscle weakness). A more severe allergictype reactions (angioedema, anaphylactic reaction) may cause sudden onset of breathing difficulty or wheezing, swollen mouth, face, hands or feet, fainting and rapid pulse.

If you experience any of these side effects and are concerned, please tell your doctor as soon as possible.

If you fget any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. HOW TO STORE GLAUCOTIMA Keep this medicine out of the sight and reach of children.

Before Glaucotima is first opened, it should be stored and transported refridgerated (2°C - 8°C).

Once the bottle has been opened, Glaucotima can be kept at room temperature (below 25°C) for up to 28 days. Keep the bottle in the outer carton in order to protect from light.

Do not use this medicine after the expiry date which is stated on the carton and the bottle after the EXP. The expiry date refers to the last day of that month.

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 Glaucotima contains

Each millilitre (1 ml) of Glaucotima contains:

Active substances: 50 microgram latanoprost and timolol maleate corresponding to 5 mg timolol.

Other ingredients: sodium dihydrogen phosphate, monohydrate, sodium chloride, disodium phosphate, anhydrous, benzalkonium chloride (preservative) and water for injections.

Each bottle of Glaucotima contains 2.5 ml eye drops.

What Glaucotima looks like and contents of the pack Glaucotima is a clear, colourless liquid. It is supplied in a bottle containing 2.5 ml eye drops solution.

The bottles are singly packed.



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