PACKAGE LEAFLET: INFORMATION FOR THE USER

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

dorzolamide / timolol

In this leaflet:

1.    What Dorzolamide/Timolol Eye Drops, Solution is and what it is used for

2.    Before you use Dorzolamide/Timolol Eye Drops, Solution

3.    How to use Dorzolamide/Timolol Eye Drops, Solution

4.    Possible side effects

5.    How to store Dorzolamide/Timolol Eye Drops, Solution

6.    Further information

1. WHAT DORZOLAMIDE / TIMOLOL EYE DROPS, SOLUTION IS AND WHAT IT IS USED FOR

Dorzolamide/Timolol contains two active substances: dorzolamide and timolol.

•    Dorzolamide belongs to a group of medicines known as “carbonic anhydrase inhibitors”,

•    Timolol belongs to a group of medicines known as “beta-blockers”.

Both active substances reduce pressure within the eye in different ways.

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

2. BEFORE YOU USE DORZOLAMIDE/TIMOLOL EYE DROPS, SOLUTION

Do not use Dorzolamide/Timolol Eye Drops, Solution

•    if you are allergic to dorzolamide, timolol, beta-blockers or any of the other ingredients

•    if you have now, or have had in the past respiratory problems such as asthma, or if you have severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough)

•    if you suffer from certain heart conditions, including certain heart rhythm disorders with an unusually slow heart rate or severe heart failure

•    if you suffer from severe kidney problems

•    if you suffer from a condition where the blood turns acidic, due to high chloride levels (hyperchloraemic acidosis).

If you are not sure whether you should use Dorzolamide/Timolol, ask your doctor or pharmacist.

Take special care with Dorzolamide/Timolol Eye Drops, Solution

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), 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 or Timolol may mask signs and symptoms of low blood sugar

•    overactivity of the thyroid gland as Dorzolamide or Timolol may mask signs and symptoms

•    muscle weakness or myasthenia gravis (a skeletal muscle disorder)

•    liver problems

•    any allergies or allergic reaction

•    kidney stones.

Tell your doctor before you have an operation that you are using Dorzolamide/Timolol Eye Drops, Solution as Dorzolamide or Timolol may change effects of some medicines used during anaesthesia.

Contact your doctor immediately if you have any eye problems, such as:

•    eye irritation

•    any other eye problems, such as eye redness or swollen eyelids.

Tell your doctor if:

•    you develop an eye infection

•    you receive an eye injury

•    you are undergoing eye surgery

•    you have any new or worsening symptoms.

Use of Dorzolamide/Timolol in the eye can affect the whole body.

If you wear soft contact lenses, consult your doctor before using Dorzolamide/Timolol. See also “Important information about some of the ingredients of Dorzolamide/Timolol” at the end of section 2.

Use in children

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

Use in elderly patients

The effect of Dorzolamide/Timolol is similar among elderly and younger patients.

Effects when misused for doping purposes

In doping tests, use of Dorzolamide/Timolol may lead to positive results.

Using other medicines

Dorzolamide/Timolol Eye Drops, Solution 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, quinidine (used to treat heart conditions and some types of malaria), antidepressants known as fluoxetine and paroxetine.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,

including medicines obtained without a prescription.

This is particularly important if you are taking / using any of the following:

•    medicines to lower your blood pressure or to treat a heart condition (such as calcium channel blockers, beta-blockers or digoxin)

•    medicines to treat disturbed or irregular heartbeat such as calcium channel blockers, beta-blockers or digoxin

•    other eye drops that contain beta-blockers to lower pressure within the eye

•    other carbonic anhydrase inhibitors (such as acetazolamide) to lower pressure within the eye

•    medicines called monoamine oxidase inhibitors (MAO inhibitors) to treat depression or another disease

•    parasympathomimetic medicines, which may be prescribed to help you pass urine. Some parasympathomimetics medicines are also sometimes used to restore normal bowel movements.

•    narcotics such as morphine, used to treat moderate to severe pain

•    large doses of aspirin

•    medicines for the treatment of diabetes

•    antidepressants

Pregnancy and breast-feeding

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

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

Do not use Dorzolamide/Timolol Eye Drops, Solution if you are breast-feeding. Dorzolamide/Timolol may get into your milk. Ask your doctor for advice before taking any medicine during breast-feeding.

Driving and using machines

During Dorzolamide/Timolol treatment, possible side effects such as blurred vision may affect your ability to drive and/or use machines. Do not drive and do not operate any tools or machinery until you feel better or your vision has cleared.

Important information about some of the ingredients of Dorzolamide/Timolol Eye Drops, Solution

Dorzolamide/Timolol contains benzalkonium chloride as a preservative, which may cause eye irritation.

If you wear contact lenses, they should be removed prior to use of the drops and should not be reinserted for at least 15 minutes post-administration, as benzalkonium chloride may lead to discolouration of soft contact lenses.

3. HOW TO USE DORZOLAMIDE/TIMOLOL EYE DROPS, SOLUTION

Always use Dorzolamide/Timolol Eye Drops, Solution exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will decide on the proper dose and length of treatment.

The usual dose is:

One Dorzolamide/Timolol drop into each affected eye, in the morning and evening.

If you are using Dorzolamide/Timolol together with other eye drops, the drops should be administered at least 10 minutes apart.

Do not change the prescribed dose of this medicine without asking your doctor first.

Do not touch your eyes - or the area around the eyes - with the dropper tip of the container. The eye drops may otherwise become contaminated with bacteria, which could lead to an eye infection, resulting in serious eye damage and even loss of vision. To avoid contamination of the container, wash your hands before using this medicine and prevent the tip of the container from coming into contact with any surfaces. If you think that your medicine is contaminated or if you develop an eye infection, contact your doctor immediately regarding further use of this bottle.

Instructions for use

1.    Wash your hands and sit or stand comfortably.

2.    Twist off the cap.

3.    Tilt the head back.

4.    Use your finger to gently pull down the lower eyelid of your affected eye.

5.    Invert the bottle and place the tip of the bottle close to, but not touching your eye. DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.

6.    Squeeze the bottle gently so that only one drop goes into your eye (Picture 1) , then release the lower eyelid.

7.    After using Dorzolamide/Timolol Eye Drops, Solution, press a finger into the corner of your eye, by the nose (Picture 2) for 2 minutes. This helps to prevent Dorzolamide/Timolol from being absorbed into the body.

8.    Repeat in your other eye if your doctor has told you to do this.

9.    Put the cap back on the bottle.

Picture 1:    Picture 2:

If you use more Dorzolamide/Timolol Eye Drops, Solution than you should

If you have put too many drops into your eye or have swallowed some of the container contents, you may -among other effects -start feeling dizzy, experience breathing difficulties or sense your heart rate slowing down. If you feel any of the above effects you should seek medical attention immediately.

If you forget to use Dorzolamide/Timolol Eye Drops, Solution

It is important that you use Dorzolamide/Timolol as directed by your doctor. If you forget a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not use a double dose to make up for a forgotten dose.

If you stop using Dorzolamide/Timolol Eye Drops, Solution

If you would like to stop treatment with this medicine, talk to your doctor first.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dorzolamide/Timolol Eye Drops, Solution can cause side effects, although not everybody gets them. If they do occur, you might need medical care.

You can usually carry on taking the drops, unless the effects are serious. If you experience any side effects, talk to a doctor or pharmacist. Do not stop using Dorzolamide/Timolol Eye Drops, Solution without speaking to your doctor.

Like other medicines applied into eyes, Dorzolamide/Timolol is absorbed into the blood. This may cause similar side effects as seen with ‘intravenous' and/or 'oral' as applicable beta-blocking agents. The rate of side effects is lower with eye drops than when drugs are taken by mouth or injected. Listed side effects include reactions seen within the class of beta-blockers when used for treating eye conditions.

Important side effects to look out for - and what to do if you are affected:

If you develop allergic reactions including

•    hives (nettle rash)

•    skin rash (localized or generalized rash)

•    itchiness

•    eye redness and itching

•    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 difficult swallowing or breathing.

•    severe sudden life-threatening allergic reaction.

Stop using this medicine and seek immediate medical advice.

The following side effects have been reported with Dorzolamide/Timolol or either of its active substances.

The frequency of possible side effects listed below is defined using the following convention:

Very common (affects more than 1 user in 10)

Common (affects 1 to 10 users in 100)

Uncommon (affects 1 to 10 users in 1,000)

Rare (affects 1 to 10 users in 10,000)

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

Other possible side effects:

Very common (affect more than 1 in 10 people)

•    burning and stinging of the eyes

•    impaired taste

Common (affect less than 1 in 10 people)

•    headache

•    signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness, inflammation of the eyelid, inflammation in the cornea, blurred vision, decreased corneal

sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), a feeling as if something is in the eye (corneal impairment)

•    sinus inflammation (sinusitis)

•    nausea

•    tiredness

Uncommon (affect less than 1 in 100 people)

•    dizziness, depression

•    inflammation of the iris

•    slow heart rate, fainting

•    indigestion

•    kidney stones (often marked by a sudden onset of excruciating, cramping pain in their low back and/or side, groin, or abdomen)

Rare (affect less than 1 in 1.000 people)

•    difficulty sleeping (insomnia), depression, nightmares, memory loss

•    muscle weakness, increases in signs and symptoms of myasthenia gravis (muscle disorder), unusual sensations like pins and needles,

•    temporary short-sightedness which is reversible once treatment has finished, choroidal detachment(detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances), drooping of the upper eyelid (making the eye stay half closed) double vision, eyelid crusting, swelling of the cornea (together with symptoms of visual disturbances), low pressure within the eye

•    ringing in the ears

•    low blood pressure, irregular heartbeat, changes in the rhythm or speed of the heartbeat, chest pain, stroke, pounding of the heart (palpitations), heart attack, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build up), oedema (fluid build up), reduced blood circulation through the brain, swelling and feelings of coldness in the hands/feet and poor circulation in the arms and legs, Raynaud's phenomenon, leg cramps and/or pain on walking (claudication), tingling or numbness of the hands or feet

•    shortness of breath, difficulty breathing, impaired lung function, blocked/runny nose, nosebleeds, airway constriction (bronchospasm, mainly in patients with pre-existing bronchospastic disease), cough

•    throat irritation, dry mouth, taste disturbances, diarrhoea , vomiting, abdominal pain

•    allergic skin reaction (contact dermatitis), hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, skin rash

•    Peyronie’s disease (which can lead to curvature of the penis), sexual dysfunction, decreased libido, reduced sex drive

•    muscle pain not caused by exercise

•    low blood glucose levels

•    weakness/tiredness, allergic reactions such as skin rash, hives (nettle rash), itchy skin, in rare cases possible swelling of lips, eyes and mouth wheezing

•    systemic lupus erythematosus (an immune system disorder which can cause inflammation of the internal organs)

If any of the side effects get serious, or if you notice any side effects not mentioned in this leaflet,

please, tell your doctor or pharmacist.

5. HOW TO STORE DORZOLAMIDE/TIMOLOL EYE DROPS, SOLUTION Keep out of the reach and sight of children.

Do not use Dorzolamide/Timolol after the expiry date stated on the container (after “EXP”). The

expiry date refers to the last day of that month.

You can use Dorzolamide/Timolol for up to 28 days after opening the bottle.

Do not store above 25°C. Keep the bottle in the outer carton in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Dorzolamide/Timolol Eye Drops, Solution contains

•    The active substances are dorzolamide and timolol.

•    Each ml 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, sodium hydroxide, water for injection and benzalkonium chloride.

What Dorzolamide/Timolol Eye Drops, Solution looks like and contents of the pack

Dorzolamide/Timolol is a clear, colourless to light yellow, sterile eye drop solution.

Pack sizes

Dorzolamide/Timolol Eye Drops, Solution is available in the following pack sizes:

Pack of 1 bottle of 5 ml Pack of 3 bottles of 5 ml each Pack of 6 bottles of 5 ml each

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Bausch and Lomb (UK) Limited

106 London Road

Kingston-Upon-Thames

Surrey

KT2 6TN

United Kingdom

Manufacturer:

Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH Brunsbutteler Damm 165 - 173 13581 Berlin -GERMANY

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Belgium, Germany, Greece, Hungary, Italy, Lithuania, Luxembourg, The Netherlands, Poland:

ARUTIDOR

Czech Republic, Slovak Republic, Latvia: BATIDOR

Estonia, Spain, Portugal, Romania:

DORZOLAMIDE / TIMOLOL DR. GERHARD MANN

France:

DORZOLAMIDE / TIMOLOL DR. GERHARD MANN. CHEM.-PHARM. FABRIK GMBH

United Kingdom:

DORZOLAMIDE / TIMOLOL 20 MG/ML + 5 MG/ML EYE DROPS, SOLUTION This leaflet was approved in March 2012