| teva UK Ret: 231-30-87796-G LEA DORZOLAMIDE/TIMOLOL 20mg/ml+5mg/ml SOL TUK<RUN Version: 1    11 November 2014

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

What Dorzolamide/Timolol is and what it is used for

Dorzolamide/Timolol eye drops contain 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'.These medicines lower the pressure in the eye in different ways.

This medicine is prescribed to lower raised pressure within the eye in the treatment ofglaucoma when beta-blockereye drops used alone are not adequate.

If left untreated this raised pressure in the eye may damage the optic nerve resulting in deterioration of vision and possible blindness. If your doctor has diagnosed raised pressure in your eye, regular eye examinations and measurements of the pressure within your eyes will be necessary.

0 What you need to know before you use Dorzolamide/Timolol

Do not use Dorzolamide/Timolol Single Dose Eye Drops, Solution

♦    Ifyou are allergicto dorzolamide hydrochloride timolol maleate, beta-blockers or any ofthe other ingredients of this medicine (listed in section 6)

♦    Ifyou have severe kidney impairment or problems, or have a disturbance in the pH (acid/alkali balance) ofyour blood

♦    Ifyou have now or have had in the past respiratory problems such as asthma, severe chronicobstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough)

♦    Ifyou have a slow heart beat, heart failure or disorders of heart rhythm (irregular heart beats).

Warning and precautions

| Talkto your doctoror pharmacist before using dorzolamide/timolol

S' Before you use this medicine, tell your doctor about any medical or ~ eye problems you have now or have had in the past, especially <5 * 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 (lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough)

♦    Poor blood circulation disease (such as Raynaud's disease or Raynaud's syndrome)

♦    Diabetes as timolol may maskthe signs and symptoms of low blood sugar(hypoglycemia)

♦    Overactivity ofthe thyroid gland as timolol may mask signs and symptoms.

You should also tell your doctor about any allergies or allergic reactions including hives, swelling ofthe face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing.

If you have a history of heart disease yourdoctor may wish to monitor your pulse rate and othersigns of this disease while you are using this medicine.

Tell yourdoctor if you have muscle weakness or have been diagnosed as having myasthenia gravis.

Ifyou develop conjunctivitis (redness and irritation ofthe eye[s]), swelling ofthe eye or eyelids, skin rash, severe skin reaction, or itching in and around the eye contact yourdoctor immediately. Such symptoms may be due to an allergic reaction or may be a side effect of this medicine (See 'Possible side effects').

Tell your doctor ifyou develop an eye infection, receive an eye injury, have eye surgery, develop other reactions orworsening of symptoms.

Dorzolamide/Timolol has not been studied in patients wearing contact lenses. If you wear soft contact lenses, you should consult your doctor before using Dorzolamide/Timolol.

Tell your doctor before you have an operation oran anaesthetic (even at the dentist) that you are using Dorzolamide/Timolol as timolol may change the effects of some medicines used during anaesthesia.

Children and adolescents

There is limited experience with this medicine in infants and children. Use in the elderly

In studies with this product (preserved formulation), its effects were similar in both elderly and younger patients.

Use in patients with liver impairment

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

Other medicines and Dorzolamide/Timolol

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 ifyou are using or intend to use medicines to lower blood pressure, heart medicine or medicines to

3.Twist open the top ofthe single dose container, as shown.

4. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and eye as shown.

5.    Put one drop in the affected eye(s) as directed by your doctor.

Each single dose container contains enough solution for both eyes.

6.    After putting the drop into the eye, throw away the used single dose containereven if there is solution remaining to avoid contamination ofthe preservative free solution.

7.    Store the remaining containers in the foil pouch; the remaining containers must be used within 15 days after opening of the pouch. Ifthere are any containers left 15 days after opening the pouch they should be safely thrown away and a fresh pouch opened. It is important to continue to use the eye drops as prescribed byyourdoctor.

After using Dorzolamide/Timolol, press a finger into the corner of your eye, by the nose (as in the picture below) for 2 minutes.This helps to stop timolol getting into the rest ofthe body.

If you use more Dorzolamide/Timolol than you should

It is important to keep to the dose yourdoctor has prescribed. Ifyou put too many drops in youreye orswallowany ofthe contents of the container, you may feel unwell, for example you may become light-headed, have difficulty breathing or a

headache, feel that your heart rate has slowed, feel sickortired. If you feel any of the above effects you should seekmedical attention immediately.

If you forget to use Dorzolamide/Timolol

It is important to use your medicine as prescribed by yourdoctor. If you miss a dose, apply it as soon as possible. However, if it is almost time forthe next dose, skip the missed dose and go back to your regular dosing schedule. Do not apply a double dose to make up forthe forgotten dose.

If you stop using Dorzolamide/Timolol

Ifyou want to stop using this medicine talkto your doctor first.

3 Never abruptly stop using this medicine since this may worsen 3 certain symptoms, especially if you have coronary heart disease or 5 an overactive thyroid.

♦    Numbness/tingling sensation, unusual sensations like pins and needles, stroke, reduced blood supply to the brain, difficulty sleeping (insomnia), nightmares, memory loss, decreased sex drive, increases in signs and symptoms of myasthenia gravis (muscle disorder)

♦    Swelling and/or irritation in and around the eye(s), drooping of the uppereyelid (making the eye stay half-closed), eyelid crusting, detachment ofthe layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, low pressure which may be accompanied by visual changes / disturbances, double vision

♦    Ringingnoisesinyourear

♦    Low blood-pressure, chest pain, palpitations, changes in the rhythm or speed ofthe heartbeat, heart attack, oedema (fluid build-up), congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build-up), a type of heart rhythm disorder, cold hands and feet, Raynaud's phenomenon (poor blood circulation which makes the toes and fingers numb and change colour), leg cramps and/or leg pain when walking (claudication)

♦    Shortness of breath, cough, difficulty breathing, constriction ofthe airways in the lungs (predominantly in patients with pre-existing disease), runny nose, nose bleed

♦    Throat irritation, dry mouth, diarrhoea

♦    Rash or inflammation ofthe skin, skin rash with white silvery coloured appearance (psoriasiform rash) orworsening of psoriasis, hair loss

♦    Peyronie's disease (which may cause a curvature of the penis)

♦    Unusual muscle weakness or pain not caused by exercise or tiredness

♦    Generalised 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, localised and generalised rash, itchiness, severe sudden life-threatening allergic reaction.

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

♦    Lowbloodglucoselevels

♦    Heartfailure

♦    Abdominalpain,vomiting

♦    Muscle pain not caused by exercise

♦    Sexualdysfunction.

In very rare cases, some patients with severe damage to the clear layer at the front ofthe eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

Reporting of side effects

Ifyou get any side effects, talkto your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directlyvia theYellow Card Scheme at: www.mhra.gov.uk/yellowcard

Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

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

^5 How to store Dorzolamide/Timolol

■J¹ Ifyou have any furtherquestions on the use of this product, ask ® yourdoctororpharmacist.

<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. Ifyou re worried, talkto a doctor or pharmacist. Do not stop using Dorzolamide/Timolol without speaking to yourdoctor.

Rarely (in 1 to 10 users in 10,000), allergic reactions such as swelling of the lips, eyes and mouth, wheezing orsevere skin reactions with blistering or peeling may occur. If you develop such effects, you should seek medical attention immediately.

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 container and carton.The expiry date refers to the last day of that month

Discard any unused single dose containers after 15 days of first opening the pouch

Discard the opened single dose container with any remaining

solution immediately after first use

Store below 25®C

Do not refrigerate orfreeze

Keep the containers in the outer carton in order to protect from light

Do not throw away any medicines via wastewateror household waste. Askyour pharmacist how to throw away medicines you no longer use.These measures will help protect the environment.

Tell your doctor ifyou develop an eye infection or develop other eye reactions orworsening of symptoms.

The following have been seen with Dorzolamide/Timolol. Like other medicines applied into the eyes, timolol is absorbed into the blood. This may cause similar side effects to those seen with intravenous and/or oral beta-blocking agents.The incidence of side effects after topical ophthalmic administration is lowerthan when medicines are, for example, taken by mouth or injected. Listed side effects include reactions seen within the class of beta-blockers when used fortreating eye conditions:

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

♦    Burning and stinging in and around the eye(s)

♦    Taste disturbances: some patients have reported a bittertaste after putting in their eye drops.

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

♦    Headache

♦    Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), inflammation ofthe eyelid, inflammation of the cornea, corneal erosion (damage to the front layer of the eyeball), decreased corneal sensitivity (not realising you have got something in your eye and not feeling pain), dry eye(s), eye pain, blurred vision

♦    Sinusitis

♦    Nausea

♦    Weakness/tiredness.

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Contents of the pack and other information

What Dorzolamide/Timolol contains

♦    The active substances are dorzolamide and timolol. Each millilitre contains 20 mg dorzolamide as 22.26 mg dorzolamide hydrochloride and 5 mg timolol as 6.83 mg timolol maleate.

♦    The other ingredients are hydroxyethylcellulose, mannitol, sodium citrate dihydrate, sodium hydroxide, and water for injections.

What Dorzolamide/Timolol looks like and contents of the pack

♦    Clear, colourless slightly viscous solution. Each foil pouch contains either 5 or 15 low-density polyethylene single dose containers containing 0.2 ml of solution.

♦    It is available in pack sizes of 5, 20, 30, 60 and 120 single dose containers. Not all packsizes may be marketed.

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG.

Manufacturer

Ivax Pharmaceuticals UK, Runcorn, WA7 3FA.

This leaflet was last revised in 11/2014.

PL 00289/1239

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

♦    Dizziness,depression

♦    Inflammation of the iris (the coloured part of the eye), changes in eyesight

♦    Slowingofyourheartrate,fainting

♦    Shortness of breath/breathlessness

♦    Indigestion

♦    Kidneystones.

Rare side effects (may affect up to 1 in 1000 people):

♦    Systemic lupus erythematosus (a red blotchy rash mainly on the face which may be accompanied by fatigue, fever, joint pain, muscle pain)

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