COSOPT iMulti 20 mg/ml + 5 mg/ml eye drops, solution

• 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 side effects not listed in this leaflet. See section 4.

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

• 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, dificulty 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 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 COSOPT iMulti if 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 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.
• any allergies or anaphylactic reactions.
• muscle weakness or have been diagnosed as having myasthenia gravis.
• if you wear soft contact lenses, COSOPT iMulti has not been studied in patients wearing contact lenses.

If you have a history of contact hypersensitivity to silver, you should not use this medicine as dispensed drops may contain traces of silver from the container closure.

Tell your doctor before you have an operation that you are using COSOPT iMulti as timolol may change effects of some medicines used during anaesthesia.

When COSOPT iMulti is instilled into the eye it may affect the entire body.

Talk to your doctor if during the treatment with COSOPT iMulti you:

• develop any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids.
• suspect that COSOPT iMulti 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.
• develop an eye infection, receive an eye injury, have eye surgery or develop a reaction including new or worsening symptoms.

Use in children

There is limited experience with COSOPT (preserved formulation) in infants and children.

Use in elderly

In studies with COSOPT (preserved formulation), the effects were similar in both elderly and younger patients.

Use in patients with liver impairment

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

COSOPT iMulti 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 medicine 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).
• 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).

Ask your doctor or pharmacist for advice before taking any medicine.

Use in pregnancy

Do not use COSOPT iMulti if you are pregnant unless your doctor considers it necessary.

Use in breast-feeding

Do not use COSOPT iMulti if you are breast-feeding. Timolol may get into your milk. Ask your doctor for advice before taking any medicine during breast-feeding.

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

1. Hold the bottle directly below the cap and turn the cap to open the bottle. Do not touch anything with the tip of the bottle to avoid contamination of the solution.

2. Tilt your head backwards and hold the bottle above your eye.

3. Pull the lower eyelid down and look up. Squeeze the bottle gently in the middle and let a drop fall into your eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. Do not squeeze too hard.

4. 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.

5. Repeat instructions 2 – 4 to deliver a drop into the other eye, if your doctor has instructed you to do this. Sometimes only one eye needs to be treated and your doctor will advise if this applies to you and which eye needs treatment.

6. After each use and prior to recapping, the bottle should be shaken once in a downwards direction, without touching the dropper tip, in order to remove any residual liquid from the tip.

This is necessary in order to ensure delivery of subsequent drops.

7. Wipe off any excess solution from the skin around the eye.

8. At the end of the 2 months in-use shelf life of the medicine, there will be some COSOPT iMulti left in the bottle. Do not attempt to use the excess medicine remaining in the bottle after you have completed the course of treatment. Do not use the eye drops for longer than 2 months after first opening the bottle.

If you are not sure how to administer your medicine, ask your doctor, pharmacist or nurse.

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 COSOPT iMulti 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 want to stop using this medicine talk to your doctor first.

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.

• The active substances are dorzolamide and timolol.
  Each ml contains 20 mg of dorzolamide (as 22.26 mg dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg timolol maleate).
• The other ingredients are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide, and water for injections.

COSOPT iMulti is a clear, colourless to nearly colourless slightly viscous solution, practically free from visible particles provided in a white plastic bottle with a white Novelia dropper applicator and a white plastic tamper-proof screw cap.

Pack sizes: 1, 2 or 3 bottles in a carton

Not all pack sizes may be marketed.

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