DORZOLAMIDE/TIMOLOL 20 MG / ML + 5 MG / ML EYE DROPS SOLUTION - patient leaflet, side effects, dosage

Dorzolamide/Timolol 20mg/ml + 5mg/ml Eye Drops, Solution

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.
• The full name of this medicine is Dorzolamide/Timolol 20mg/ml + 5mg/ml Eye Drops, Solution but within the leaflet it will be referred to as Dorzolamide/Timolol eye drops.

What is in this leaflet:

j What Dorzolamide/Timolol eye drops are and what they are used for

2l What you need to know before you use Dorzolamide/Timolol eye drops ^1 How to use Dorzolamide/Timolol eye drops

4l possible side effects

^1 How to store Dorzolamide/Timolol eye drops

^1 Contents of the pack and other information

l| What Dorzolamide/Timolol eye drops are and what they are used for

Dorzolamide/Timolol eye drops are a combination of two medicines: dorzolamide and timolol.

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

Dorzolamide/Timolol eye drops are prescribed to lower raised pressure within the eye in the treatment of glaucoma when beta-blocker eye drops used alone are not adequate.

^1 What you need to know before you use Dorzolamide/Timolol eye drops

• are allergic to dorzolamide or timolol, beta blockers or any of the other ingredients of this medicine (listed in section 6).
• have now or have had in the past respiratory problems such as asthma, severe chronic obstructive lung disease (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough),
• have severe kidney problems, or a prior history of kidney stones
• have a disturbance in the pH (acid/alkali balance) of your blood
• have certain heart problems, including certain heart rhythm disturbances producing an abnormally slow heart rate or severe heart failure.

If you think any of these apply to you, do not use Dorzolamide/Timolol eye drops until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before using Dorzolamide/Timolol eye drops.

• Before you use this medicine, tell your doctor if you have now or have had in the past coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), Prinzmental’s an­gina (chest pain while resting), 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 Dorzolamide/Timolol eye drops may mask signs and symptoms of low blood sugar.
• overactivity of the thyroid gland as Dorzolamide/Timolol eye drops may mask signs and symptoms.
• liver problems, if you have muscle weakness or have been diagnosed as having myasthenia gravis.
• any allergies to a medicine you have taken.

If you develop conjunctivitis (redness and irritation of the eyes), swelling of the eye or eyelids, skin rash or itching in and around the eye contact your doctor immediately. Such symptoms may be due to an allergic reaction or may be a side-effect of Dorzolamide/Timolol eye drops (See section 4).

Tell your doctor if you develop an eye infection, receive an eye injury, have eye surgery, develop other reactions or worsening of symptoms.

If you wear soft contact lenses , it is important that your lenses are removed before using your eye drops and not put back into your eyes until 15 minutes after using your eye drops as the preservative benzalkonium chloride may possibly discolour the contact lenses.

Before surgery and anaesthesia (even at the dentist), tell your doctor or dentist that you are using Dorzolamide/Timolol eye drops, as this medicine may change effects of some medicines used during anaesthesia and there may be a sudden fall in blood-pressure associated with the anaesthetic.

Children and adolescents

There is limited experience with Dorzolamide/ Timolol eye drops in infants and children.

Use in elderly

In studies with Dorzolamide/Timolol eye drops, the effects of Dorzolamide/Timolol eye drops were similar in both elderly and younger patients.

Other medicines and Dorzolamide/ Timolol eye drops

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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is particularly important if any of the following apply to you:

• You are taking antihypertensive medicines which are used to lower high blood pressure or medicines to treat heart disease such as calcium channel blockers and B-blockers or digoxin
• You are taking medicines to treat a disturbed or uneven heartbeat such as quinidine or digoxin
• You are using another eyedrop that contains a B-blocker
• You are taking another carbonic anhydrase inhibitor such as acetazolamide. You may be taking this type of medicine by mouth, as eye drops, or by some other method
• You are taking quinidine (used to treat heart conditions and some types of malaria)
• You are taking monoamine oxidase inhibitors (MAOIs) or selective serotonin reuptake inhibitors (SSRIs) (such as fluoxetine and paroxetine) both of which are used to treat depression or another illness
• You are taking a parasympathomimetic medicine which may have been prescribed to help you pass urine. Parasympathomi­metics are also a particular type of medicine which are sometimes used to help restore normal movements through the bowel
• You are taking narcotics such as morphine used to treat moderate to severe pain or if you are taking large doses of aspirin. Although there is no evidence that dorzolamide hydrochloride interacts with aspirin, some other medicines which are related to dorzolamide hydrochloride and which are taken by mouth, have been known to interact with aspirin
• You are taking medicines to treat diabetes or high blood sugar
• You are taking epinephrine (adrenaline).

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 Dorzolamide/Timolol eye drops if you are pregnant unless your doctor considers it necessary.

Do not use Dorzolamide/Timolol eye drops if you are breast-feeding. Timolol may get into your milk.

Driving and using machines

Dorzolamide/Timolol eye drops may cause side effects such as blurred vision in some patients. Do not drive or use any tools or machines until the symptoms have cleared.

Dorzolamide/Ti­molol eye drops contain benzalkonium chloride

Dorzolamide/Timolol eye drops contain the preservative benzalkonium chloride.

• Benzalkonium chloride may cause eye irritation.
• Benzalkonium chloride is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before re-insertion.

3l

How to use Dorzolamide/Timolol eye drops

Always use this medicine exactly as your doctor has 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) two times a day, for example in the morning and in the evening.

If you use Dorzolamide/Timolol eye drops with another eye drop, leave at least 10 minutes between putting in Dorzolamide/Timolol eye drops and the other medicine.

Do not change the dosage of the drug without consulting your doctor. If you must stop treatment, contact your doctor immediately.

Do not allow the tip of the container to touch your eye or areas around your 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, keep the tip of the container away from contact with any surface.

In order to secure correct dosage – the dropper tip should not be enlarged.

Instructions for use:

It is recommended that you wash your hands before putting in your eye drops.

It may be easier to apply your eye drops in front of a mirror.

• 1. Before using the medication for the first time, be sure that the tamper-proof seal on the bottle neck is unbroken. A gap between the bottle and the cap is normal for an unopened bottle.

• 2. Take off the cap of the bottle.

• 3. Tilt your head back and gently pull your lower eyelid down to form a small pocket between your eyelid and your eye (see picture 1).

• 4. Invert the bottle, and squeeze it until a single drop is dispensed into the eye as directed by your doctor. Do not touch your eye or eyelid with the dropper tip (see picture 1).

• 5. After using Dorzolamide/Timolol eye drops, press a finger into the corner of your eye, by the nose for 2 minutes (see picture 2). This helps to stop timolol 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 bottle straight after you have used it.

If you use more Dorzolamide/Timolol eye drops than you should

It is important to keep to the dose your doctor has prescribed. If you put too many drops in your eye or swallow any of the contents of the bottle, you may feel unwell, for example you may become light-headed, have difficulty breathing, or feel that your heart rate has slowed. If you feel any of the above effects you should seek medical attention immediately.

If you forget to use Dorzolamide/ Timolol eye drops

It is important to use Dorzolamide/Timolol eye drops as prescribed by your doctor.

If you miss a dose, apply 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 a forgotten dose.

If you stop taking Dorzolamide/Timolol eye drops

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4j

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 Dorzolamide/Timolol without speaking to your doctor.

If you experience any of the following serious side effects, stop using this medicine and tell your doctor immediately or go to the nearest hospital accident and emergency department.

• Generalized allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs, and can obstruct the airway which may cause difficulty swallowing or breathing, hives or itchy rash, localized and generalized rash, itchiness, severe sudden life-threatening allergic reaction.
• Serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes genitals and fever. Skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister.

Like other medicines applied into eyes, Dorzolamide/Timolol eye drops are absorbed into the blood. This may cause similar side effects as seen with ‘intraveneous’ and/or ‘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.

The following side effects may be seen with Dorzolamide/Timolol eye drops or one of its components:

Very common side effects (may affect more than 1 in 10 people):

Burning and stinging of the eyes, unusual taste

Common side effects (may affect up to 1 to 10 people):

Redness in and around the eye(s), watering or itching of the eye(s), and effects on the surface of the eye(s), swelling and/or irritation in and around the eye(s), feeling of having something in the eye (corneal erosion), 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), feeling sick, also called nausea, and fatigue.

Uncommon side effects (may affect up to 1 to 100 people):

Dizziness, depression, inflammation of the iris, blurred vision (in some cases due to withdrawal of medication to treat excessive contraction of the pupil of the eye), slow heartbeat, fainting, labored breathing, indigestion, and kidney stones (often marked by a sudden onset of continued top of next column

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excruciating, cramping pain in their low back and/or side, groin, or abdomen).

Rare side effects (may affect up to 1 in 1,000 people):

Systemic lupus erythematosus (an immune disease which may cause an inflammation of internal organs), tingling or numbness of the hands or feet, trouble sleeping, nightmares, memory loss, weakening of the muscles, decreased sex drive, stroke, temporary short sightedness which may resolve when treatment is stopped, development of fluid under the retina (choroidal detachment following filtration surgery), 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, low blood pressure, irregular heartbeat, chest pain, palpitations (a quicker and/or irregular heartbeat), oedema (fluid build up), heart attack, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build up), reduced blood flow to the brain, 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, feeling out of breath, runny or stuffed nose, nose bleed, difficulty in breathing, cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, hair loss, psoriasis or worsening of psoriasis, Peyronie’s disease (which may cause a curvature of the penis), weakness/tiredness, allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth, wheezing.

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

Low blood glucose levels, heart failure, a type of heart rhythm disorder, stomach pain and vomiting, muscle pain not caused by exercise, sexual dysfunction and decreased libido. Shortness of breath, foreign body sensation in the eye (feeling that there is something in your eye.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist, particularly if you experience any changes/visual disturbance when using Dorzolamide/Timolol eye drops after eye surgery.

Reporting of 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:

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

5|

How to store Dorzolamide/Timolol eye drops

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 medicinal product does not require any special temperature storage conditions.

Dorzolamide/Timolol eye drops should be used within 28 days after the bottle is first opened. 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.

^1

Contents of the pack and other information

What Dorzolamide/Timolol eye drops contain

• The active substances are Dorzolamide and Timolol. Each ml contains 20mg dorzolamide (as 22.26mg of dorzolamide hydrochloride) and 5mg timolol (as 6.83mg of timolol maleate).
• The other ingredients are Mannitol (E421), Hydroxy Ethyl Cellulose, Benzalkonium Chloride (as a preservative), Sodium Citrate (E331), Sodium Hydroxide (E524) for pH adjustment and Water for injection.

What Dorzolamide/Timolol eye drops look like and contents of the pack

Your medicine is in the form of a sterile, clear, slightly viscous, colourless aqueous eye drop solution.

Dorzolamide/Timolol eye drops are presented in a white opaque medium density polyethylene bottle with a sealed low density polyethylene dropper tip and a high density polyethylene cap with tamper proof seal, containing 5mL of the ophthalmic solution.

Pack size: 1 bottle of 5ml

Marketing Authorisation Holder

Actavis Group PTC ehf Reykjav^kurvegi 76–78 220 Hafnar­fjordur Iceland

Manufacturer

Famar S.A., Plant A 63 Agiou Dimitriou Street 174 56 Alimos

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This leaflet was last revised in April 2017.

Actavis, Barnstaple, EX32 8NS, UK