Dorzolamide / Timolol 20mg/Ml + 5 Mg/Ml Eye Drops Solution
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PACKAGE LEAFLET: INFORMATION FOR THE USER
[Dorzolamide/Timolol] 20 mg/ml + 5 mg/ml eye drops, solution
Dorzolamide / 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] is and what it is used for
2. Before you use [Dorzolamide/Timolol]
3. How to use [Dorzolamide/Timolol]
4. Possible side effects
5. How to store [Dorzolamide/Timolol]
6. Further information
1. WHAT [Dorzolamide/Timolol] IS AND WHAT IT IS USED FOR
[Dorzolamide/Timolol] is a combination of 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.
[Dorzolamide/Timolol] is prescribed to lower raised pressure within the eye in the treatment of glaucoma when beta-blocker eye drops used alone are not adequate.
2. BEFORE YOU USE [Dorzolamide/Timolol]
Do not use [Dorzolamide/Timolol] eye drops, solution
■ if you are allergic to dorzolamide or timolol, beta-blockers or any of the other ingredients of this solution.
■ if you have now or have had in past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or longstanding cough).
■ if you have severe kidney problems, or a prior history of kidney stones.
■ if you have a disturbance in the pH (acid/alkali balance) of your blood.
■ if you have certain heart problems, including certain heart rhythm disturbances producing an abnormally slow heart rate or severe heart failure.
If you think any of these apply to you, do not use [Dorzolamide/Timolol] until you have consulted your
doctor.
Take special care with [Dorzolamide/Timolol]
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 [even while resting] 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 to a medicine you have taken.
Tell your doctor before you have an operation that you are using [Dorzolamide/Timolol] as dorzolamide/timolol may change effects of some medicines used during anaesthesia. There may be a sudden fall in blood-pressure associated with the anaesthetic.
Tell your doctor if you now have or have had liver problems, if you have muscle weakness or have been diagnosed as having myasthenia gravis.
If 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 contact your doctor immediately. Such symptoms may be due to an allergic reaction or may be a side-effect of [Dorzolamide/Timolol] (See ‘Possible Side Effects’).
Tell your doctor if you develop an eye infection, receive an eye injury, have eye surgery, develop other reactions or worsening of symptoms.
If you wear soft contact lenses, it is important that your lenses are removed before using your eye drops and not put back into your eyes until 15 minutes after using your eye drops as the preservative benzalkonium chloride may possibly discolour the contact lenses.
Use in children
There is limited experience with [Dorzolamide/Timolol] in infants and children.
[Dorzolamide/Timolol] eye drop solution should generally be used with caution in young patients. In newborns, infants and younger children
Timolol should be used with extreme caution. If coughing, wheezing, abnormal breathing or abnormal pauses in breathing (apnoea) occur, the use of the medication should be stopped immediately. Contact your doctor as soon as possible. A portable apnoea monitor may also be helpful.
Timolol has been studied in infants and children aged 12 days to 5 years, who have raised pressure in the eye(s) or have been diagnosed with glaucoma. For more information, talk to your doctor.
Use in elderly
In studies with Dorzolamide/Timolol eye drops solution, the effects of Dorzolamide/Timolol eye drops solution were similar in both elderly and younger patients.
Using other medicines
[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.
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 and B-blockers or digoxin
■ You are taking medicines to treat a disturbed or uneven heartbeat such as quinidine (use to treat some types of malaria as well) or digoxin
■ You are using another eyedrop that contains a B-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) or selective serotonin reuptake inhibitors (SSRIs, e.g. fluoxetine and paroxetine) both of which are used 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. 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).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breast-feeding.
Do not use [Dorzolamide/Timolol] if you are pregnant, unless your doctor considers it necessary.
Tell your doctor if you are pregnant or planning to become pregnant.
Do not use [Dorzolamide/Timolol] if you are breast-feeding. Timolol may get into your milk.
Tell your doctor if you are breast-feeding or intend to breast-feed.
Driving and using machines
[Dorzolamide/Timolol] may cause side effects such as blurred vision in some patients. Do not drive or use any tools or machines until the symptoms have cleared.
Important information about some of the ingredients of [Dorzolamide/Timolol]
[Dorzolamide/Timolol] contains the preservative benzalkonium chloride.
• Benzalkonium chloride may cause eye irritation
• Benzalkonium chloride is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait until 15 minutes before re-insertion.
3. HOW TO USE [Dorzolamide/Timolol]
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.
The appropriate dosage and duration of treatment will be established by your doctor.
Adults
The usual dose is one drop in the affected eye(s) two times a day, for example in the morning and in the evening.
If you use [Dorzolamide/Timolol] with another eye drop, leave at least 10 minutes between putting in [Dorzolamide/Timolol] and the other medicine.
Do not change the dosage of the drug without consulting your doctor. If you must stop treatment, contact your doctor immediately.
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.
In order to secure correct dosage - the dropper tip should not be enlarged.
Instructions for use:
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 medication 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. Invert the bottle, 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], press a finger into the corner of your eye, by the nose for 2 minutes. This helps to stop dorzolamide/timolol getting into the rest of the body.
6. Repeat steps 3 to 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.
Paediatric population
A detailed medical examination should precede the use of Timolol. Your doctor will carefully evaluate the risks and benefits when considering treatment with Timolol. If the benefits outweigh the risks, it is recommended to use the lowest active agent concentration available once daily. With regard to “the use in children”, the 0, 1% active agent concentration may be sufficient to control pressure within the eye. If the pressure is not sufficiently controlled with this dosage, a twice daily application at 12-hourly intervals may be necessary. Patients, especially newborn, should be closely observed for one to two hours after the first dose and careful monitoring for adverse events should be carried out until surgery is performed.
Method of administration (Illustration see above)
One drop only of [Dorzolamide/Timolol] should be instilled per dosing time.
After instillation keep the eyes closed for as long as possible (e.g. 3 - 5 minutes) and apply pressure to the corner of the eye closest to the nose to prevent [Dorzolamide/Timolol] eye drops spreading throughout the body.
Duration of treatment
For a transient treatment in the paediatric population.
If you use more [Dorzolamide/Timolol] 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, or feel that your heart rate has slowed. If you feel any of the above effects you should seek medical attention immediately.
If you forget to use [Dorzolamide/Timolol]
It is important to use [Dorzolamide/Timolol] as prescribed by your doctor.
If you miss a dose, apply 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 forgotten individual doses.
If you stop taking [Dorzolamide/Timolol]
If you want to stop using 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 you develop allergic reactions including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing, you should stop [Dorzolamide /Timolol] and talk to your doctor immediately.
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] 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)
Very Common:
Burning and stinging of the eyes, unusual taste Common:
Redness in and around the eye(s), watering or itching of the eye(s), and effects on the surface of the eye(s), swelling and/or irritation in and around the eye(s), feeling of having something in the eye(corneal erosion), decreased corneal sensitivity (not realising of getting something in the eye and not feeling pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or fullness in the nose), feeling sick, also called nausea, and fatigue
Uncommon:
Dizziness, depression, inflammation of the iris, blurred vision (in some cases due to withdrawal of medication to treat excessive contraction of the pupil of the eye) , slow heartbeat, fainting, indigestion, and kidney stones (often marked by a sudden onset of excruciating, cramping pain in their low back and/or side, groin, or abdomen).
Rare:
systemic lupus erythematosus (an immune disease which may cause an inflammation of internal organs), tingling or numbness of the hands or feet, trouble sleeping, nightmares, memory loss, weakening of the muscles, decreased sex drive, stroke, temporary shortsightedness which may resolve when treatment is stopped, development of fluid under the retina (choroidal detachment following filtration surgery), drooping of the eyelids, double vision, eyelid crusting, swelling of the cornea (with symptoms of visual disturbances), low pressure in the eye, ringing noises in your ear, low blood pressure, irregular heartbeat, chest pain, palpitations (a quicker and/or irregular heartbeat), heart attack, reduced blood flow to the brain, swelling or coldness of your hands and feet and reduced circulation in your arms and legs, leg cramps and/or leg pain when walking (claudication), shortness of breath, feeling out of breath, runny or stuffed nose, nose bleed, difficulty in breathing, cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, hair loss, psoriasis or worsening of psoriasis, Peyronie’s disease (which may cause a curvature of the penis), weakness/tiredness, allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth, wheezing.
Like other medicines applied into eyes, timolol is absorbed into the blood. This may cause similar side effects as seen with 'intraveneous' and/or 'oral' as applicable beta-blocking agents. Incidence of side effects after topical ophthalmic administration 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:
• 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 difficulty swallowing or breathing. Hives or itchy rash, localized and generalized rash, itchiness, severe sudden life-threatening allergic reaction.
• Low blood glucose levels.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss.
• Fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of myasthenia gravis (muscle disorder), dizziness, unusual sensations like pins and needles, and headache.
• Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), inflammation of the eyelid, inflammation in the cornea, blurred vision and detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye stay half closed), double vision.
• Slow heart rate, chest pain, palpitations, oedema (fluid build up), changes in the rhythm or speed of the heartbeat, 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, heart attack, heart failure.
• Low blood pressure, Raynaud's phenomenon, cold hands and feet.
• Constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough.
• Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
• Muscle pain not caused by exercise.
• Sexual dysfunction, decreased libido.
• Muscle weakness/tiredness.
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, particularly if you experience any changes/visual disturbance when using [Dorzolamide/Timolol] after eye surgery.
5. HOW TO STORE [Dorzolamide/Timolol]
Keep out of the reach and sight of children.
Do not use [Dorzolamide/Timolol] after the expiry date which is stated on the bottle label and the carton after EXP:. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions.
[Dorzolamide/Timolol] should be used within 28 days after the bottle is first opened. Therefore, you must throw away the bottle 4 weeks after you first opened it, even if some solution is left. To help you remember, write down the date that you opened it in the space on the carton.
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] contains
- The active substances are Dorzolamide and Timolol. Each ml contains 20 mg dorzolamide (as 22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (as 6.83 mg of timolol maleate).
- The other ingredients are Mannitol (E421), Hydroxy Ethyl Cellulose, Benzalkonium Chloride (as a preservative), Sodium Citrate (E331), Sodium Hydroxide (E524) for pH adjustment and Water for injection.
What [Dorzolamide/Timolol] looks like and contents of the pack
Your medicine is in the form of a sterile, clear, slightly viscous, colourless aqueous eye drop 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 cap with tamper proof seal, containing 5
mL of the ophthalmic solution.
Pack size: 1, 3 or 6 bottles of 5ml each.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany
Manufacturer
Pharmathen S.A.
6, Dervenakion str.,
153 51 Pallini, Attiki,
Greece
Or
Famar S.A.
63 Agiou Dimitriou Street,
174 56 Alimos Greece
Or
STADA Arzneimittel AG Stadastrasse 2 - 18, 61118 Bad Vilbel Germany
Or
Aliud Pharma GmbH
Gottlieb-Daimler-Str. 19, 89150 Laichingen Germany
This leaflet was last approved in 02/2011
Detailed information on this medicine is available on the web site of {MA/Agency}
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