• 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.

1. What Dorzolamide/Timolol is and what it is used for
2. What you need to know before you use Dorzolamide/Timolol
3. How to use Dorzolamide/Timolol
4. Possible side effects
5. How to store Dorzolamide/Timolol
6. Contents of the pack and other information

• if you are allergic to dorzolamide, timolol 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 heartbeat, heart failure or disorders of heart rhythm (irregular heartbeats).
• if you have severe kidney disease or problems, 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).

If you are not sure whether you should use this medicine, contact your doctor or pharmacist.

Talk to your doctor before using Dorzolamide/Timolol.

Tell your doctor about any medical or eye problems you have now 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 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 Dorzolamide/Timolol as timolol may change the 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, contact your doctor immediately.

If you suspect that Dorzolamide/Timolol 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 symptoms.

When Dorzolamide/Timolol is instilled into the eye it may affect the entire body.

If you wear soft contact lenses, you should consult your doctor before using this medicine.

There is limited experience with dorzolamide/timolol eye drops, solution in infants and children.

In studies with dorzolamide/timolol eye drops, solution the effects of this medicine were similar in both elderly and younger patients.

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

Dorzolamide/Timolol 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. 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 to treat 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 another carbonic anhydrase inhibitor such as acetazolamide.
• taking monoamine oxidase inhibitors (MAOIs) which are used to treat depression.
• 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 moderate to severe pain.
• taking medicines to treat diabetes.
• taking antidepressants known as fluoxetine and paroxetine.
• taking a sulfa medicine.
• taking quinidine (used to treat heart conditions and some types of malaria).

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.

Pregnancy

Do not use Dorzolamide/Timolol if you are pregnant unless your doctor considers it necessary.

Breast-Feeding

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

No studies on the effects on the ability to drive or use machines have been performed. There are side effects associated with Dorzolamide/Timolol, 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.

This medicine contains 0.075mg 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.

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 medicine 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.

4.Turn the bottle upside down 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.

5.After using Dorzolamide/ Timolol, 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 3-5 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 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.

It is important to use this medicine as prescribed by your doctor.

If you miss a dose, take 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 take a double dose to make up for a forgotten dose.

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

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 (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.

• The active substances are dorzolamide and timolol. Each ml contains 20mg dorzolamide (as dorzolamide hydrochloride) and 5mg timolol (as timolol maleate).
• The other ingredients are mannitol (E421), hydroxyethyl cellulose, benzalkonium chloride solution 50% (as a preservative), sodium citrate, sodium hydroxide for pH adjustment and water for injections.

Dorzolamide/Timolol is a sterile, clear, slightly viscous, colourless, aqueous solution.

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

Pack sizes: 1, 3 or 6 bottles of 5ml each.

Not all pack sizes may be marketed.

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