Dorzolamide/Timolol 20/5 Mg/Ml Eye Drops Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER szoyioiLrcm
Dorzolamide/Timolol 20/5 mg/ml Eye Drops, Solution
Active substances: Dorzolamide and Timolol
Read all of this leaflet carefully before you start using this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet:
1. What Dorzolamide/Timolol Eye Drops are and what they are used for
2. Before you use Dorzolamide/Timolol Eye Drops
3. How to use Dorzolamide/Timolol Eye Drops
4. Possible side effects
5. How to store Dorzolamide/Timolol Eye Drops
6. Further information
What Dorzolamide/Timolol 1 Eye Drops are and what they are used for
Dorzolamide/Timolol Eye Drops are a combination of dorzolamide hydrochloride, an ophthalmic carbonic anhydrase inhibiting active substance and timolol maleate, an ophthalmic beta-blocking active substance, both of which lower raised pressure in the eye in different ways.
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.
Before you use 2 Dorzolamide/Timolol Eye Drops
Do not use Dorzolamide/Timolol Eye Drops
• if you are allergic (hypersensitive) to
dorzolamide hydrochloride, timolol maleate, beta-blockers or any of the other ingredients
• if you have now or have had in the past respiratory problems such as asthma, 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 the heart rhythm (irregular heart beats)
• if you have severe kidney problems, or a disturbance in the pH (acid/alkali balance) of your blood.
If you think any of these apply to you, do not use Dorzolamide/Timolol Eye Drops until you have consulted your doctor.
Take special care with Dorzolamide/ Timolol Eye Drops
Before treatment with Dorzolamide/ Timolol Eye Drops, tell your doctor or pharmacist 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. Your doctor may wish to monitor your pulse rate and other signs of this disease while you are using Dorzolamide/ Timolol Eye Drops.
• disturbances of heart rate such as slow heartbeat.
• liver problems.
• muscle weakness or myasthenia gravis.
• breathing problems, asthma or chronic obstructive pulmonary disease.
• Prinzmetal’s angina (chest pains while resting).
• diabetes as timolol may mask signs and symptoms of low blood sugar.
• overactivity of the thyroid gland as timolol may mask signs and symptoms.
• poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome).
• allergies to a medicine you have taken.
• you wear contact lenses (see the section “Important information about some of the ingredients of Dorzolamide/Timolol Eye Drops”).
Contact your doctor immediately if:
• you develop an eye infection, receive an eye injury, have eye surgery, develop other reactions or worsening of symptoms.
• you develop conjunctivitis (redness and irritation of the eye[s]), swelling of the eye or eyelids, skin rash, or itching in and around the eye.
Such symptoms may be due to an allergic reaction or may be a side-effect of Dorzolamide/Timolol Eye Drops (see section 4. “Possible side effects”).
Before an operation, tell your doctor or dentist that you are taking Dorzolamide/ Timolol Eye Drops, as timolol may change effects of some medicines used during anaesthesia.
Use in children
There is limited experience with Dorzolamide/Timolol Eye Drops in infants and children.
Using other medicines
Dorzolamide/Timolol Eye Drops can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.
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 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,
catecholamine-depleting substances, beta-blockers, clonidine or digoxin
• you are taking medicines to treat a disturbed or uneven heartbeat such as amiodarone, quinidine (used to treat heart conditions and some types of malaria) or digoxin
• you are using another eye drop that contains a beta-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 monoamine oxidase inhibitors (MAOIs) 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 (acetylsalicylic acid). 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).
• you are taking antidepressants known as fluoxetine and paroxetine.
Pregnancy and breast-feeding
Pregnancy
Tell your doctor if you are pregnant, think you could be pregnant, or are planning to become pregnant. You should not use Dorzolamide/Timolol Eye Drops during pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or intend to breast-feed. Do not use Dorzolamide/Timolol Eye Drops if you are breast-feeding. Timolol and Dorzolamide may get into your milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Possible side effects such as blurred vision may affect your ability to drive and/or use machinery. If you experience any problems talk to your doctor, who will advise you (see the section 4. “Possible side effects”).
Important information about some of the ingredients of Dorzolamide/ Timolol Eye Drops
Dorzolamide/Timolol Eye Drops contain the preservative benzalkonium chloride,
which may cause eye irritation and is known to discolour soft contact lenses.
• If you wear soft contact lenses, you should consult your doctor before using Dorzolamide/Timolol Eye Drops.
• Avoid contact with soft contact lenses.
• Remove contact lenses prior to application and wait at least
15 minutes before reinsertion.
Your doctor can explain this to you.
How to use Dorzolamide/ Timolol Eye Drops
Always use Dorzolamide/Timolol Eye Drops exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dosage
The usual dose is:
One drop in the affected eye(s) two times a day, for example in the morning and in the evening.
Using Dorzolamide/Timolol Eye Drops with another eye drop:
If you are using Dorzolamide/Timolol Eye Drops as well as other eye drops, the different drops should be used at least ten minutes apart.
Do not change the dose of the medicinal product without consulting your doctor. If you must stop treatment, contact your doctor immediately.
Instructions for use:
Please follow these instructions carefully when using Dorzolamide/Timolol Eye Drops. It is recommended that you wash your hands before putting in your eye drops.
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.
1. You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.
2. To open the bottle, unscrew the cap by turning it until the tamper-proof seal breaks.
3. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye (Fig. 1).
4. Invert the bottle, and press gently as shown (Fig. 2 and 3) until a single drop as instructed by your doctor is dispensed into your eye. DO NOT TOUCH YOUR EYE OR EYELID WITH THE TIP OF THE CONTAINER.
5. Repeat steps 3 and 4 with the other eye if instructed to do so by your doctor.
6. Reclose the bottle by turning the cap firmly immediately after use and return the bottle to the original outer carton.
7. The dispenser tip is designed to provide a pre-measured drop; therefore, do not enlarge the hole of the dispenser tip.
After using Dorzolamide/Timolol Eye Drops press a finger into the corner of your eye, by the nose for 2 minutes. This helps to stop timolol getting into the rest of the body.
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, nausea, headache, fatigue or feel that your heartbeat is slower than usual. If you feel any of the above effects you should seek medical attention immediately.
If you forget to use Dorzolamide/ Timolol Eye Drops
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 a forgotten dose.
If you stop using Dorzolamide/Timolol Eye Drops
If you must stop or want to stop treatment, contact your doctor immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Dorzolamide/Timolol Eye Drops 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 Eye Drops without speaking to your doctor.
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)
The following side effects have been seen with the fixed combination of dorzolamide and timolol or one of its components:
Very common side effects (more than 1 of 10 patients)
• burning and stinging in the eye(s)
• bitter taste after putting in the eye drops
Common side effects (1 to 10 patients of 100)
• headache
• redness in and around the eye(s), blurred vision,
• watering or itching of the eye(s) and effects on the surface of the eye
• eyelid inflammation, irritation of the eye(s), e.g. dry eyes
• sinusitis
• feeling sick
• weakness/tiredness
• corneal erosion (damage to the front layer of the eyeball)
Uncommon side effects (1 to 10 patients of 1,000)
• dizziness
• depression
• inflammation of the iris and the ciliary body
• visual disturbances including blurred vision (in some cases due to withdrawal of medication to treat excessive contraction of the pupil of the eye)
• slowing of your heart rate
• fainting
• sudden loss of consciousness
• changes in the rhythm or speed of the heartbeat
• dyspnoea (shortness of breath)
• indigestion
• development of kidney stones
Rare side effects (1 to 10 patients of 10,000)
• unusual sensations like pins and needles
• difficulty sleeping (insomnia)
• nightmares
• decreased sex drive
• stroke (cerebrovascular accident)
• reduced blood supply to the brain
• irritation of the eye(s) including eyelid crusting and eye pain
• swelling and/or irritation in and around the eye(s)
• low pressure in the eye
• detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances
• ringing noises in the ear
• low blood pressure
• chest pain
• palpitations (rapid or strong heartbeat)
• heart failure
• congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build up)
• cardiac arrest
• Raynaud’s phenomenon (bluish hands and feet)
• swelling or coldness of your hands and feet and reduced circulation in your arms and legs
• oedema (fluid build up)
• rhinitis and breathing difficulties such as shortness of breath/breathlessness and more rarely wheezing
• coughing and nose bleed
• dry mouth
• (itchy) rash
• itchiness
• hair loss
• skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis
• Peyronie’s disease (which may cause a curvature of the penis)
• generalized allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs, and can obstruct the airways which may cause difficulty swallowing or breathing
• severe sudden life-threatening allergic reaction.
There are possible side effects of the components of Dorzolamide/Timolol Eye Drops, which may also be potential side effects of Dorzolamide/ Timolol Eye Drops in some patients. These include:
Common side effects (1 to 10 patients of 100)
• decreased sensitivity of the eye(s)
• inflammation in the cornea
• muscle weakness/tiredness
Uncommon side effects (1 to 10 patients of 1,000)
• fainting
Rare side effects (1 to 10 patients of 10,000)
• facial rash, joint pain, muscle disorder, fever (systemic lupus erythematosus)
• memory loss
• increases in signs and symptoms of myasthenia gravis (muscle disorder)
• temporary short sightedness which may stop when treatment is discontinued
• drooping of the upper eyelid (making the eye stay half closed) double vision
• stroke (cerebral ischemia)
• leg cramps and/or leg pain when walking (claudication)
• throat irritation
• diarrhoea
• constriction of the airways in the lungs (predominantly in patients with pre-existing disease)
Like other medicines applied into eyes, timolol is absorbed into the blood. This may cause similar side effects as seen with “intravenous” or “oral” beta-blocking agents. Incidence of side effects after application into the eyes is lower than when medicines are, for example, taken by mouth or injected. Listed side effects include reactions seen within the class of beta-blockers when used for treating eye conditions:
• localized and generalized rash
• low blood glucose levels
• a type of heart rhythm disorder
• heart attack
• taste disturbances
• abdominal pain
• vomiting
• muscle pain not caused by exercise
• sexual dysfunction
If any of the side effects happen to you, or you have any other unusual symptoms or feelings, contact your doctor immediately, particularly if you experience any changes/visual disturbance when using Dorzolamide/ Timolol Eye Drops after eye surgery.
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.
Keep out of the reach and sight of children.
Do not use Dorzolamide/Timolol Eye Drops after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
Keep the bottle in the outer carton, in order to protect from light.
Do not store above 30°C.
After first opening: use within 28 days. Discard any unused solution afterwards.
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.
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What Dorzolamide/Timolol Eye Drops contain
The active substances are: dorzolamide and timolol.
1 ml solution contains 20 mg of dorzolamide (as hydrochloride) and
5 mg of timolol (as maleate).
The other ingredients are: hydroxyethylcellulose, mannitol (E421), sodium citrate dihydrate, sodium hydroxide/hydrochloric acid (for pH-adjustment) and water for injection. Benzalkonium chloride (0.075 mg/ml) is added as a preservative.
What Dorzolamide/Timolol Eye Drops look like and contents of the pack
Eye drops, solution. Colourless to slightly yellowish, viscous solution.
Dorzolamide/Timolol Eye Drops are available in white coloured plastic 5 ml bottles (PE-bottles).
Pack sizes: 1 x 5 ml, 3 x 5 ml and
6 x 5 ml eye drops.
Not all pack sizes will be marketed.
Marketing authorization holder and manufacturer
Marketing Authorization Holder:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR.
Manufacturer:
Aeropharm GmbH, 07407 Rudolstadt, Frangois-Mitterrand-Allee 1, Germany or Salutas Pharma GmbH, 39179 Barleben, Otto-von-Guericke-Allee 1, Germany.
This leaflet was last approved in 02/2012.
46086640 SZ07101 LT03A