Otinan 20mg/Ml Eye Drops Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
Otinan 20mg/ml Eye drops, solution
Dorzolamide
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 Otinan is and what it is used for
2. Before you use Otinan
3. How to use Otinan
4. Possible side effects
5. How to store Otinan
6. Further information
1. WHAT OTINAN IS AND WHAT IT IS USED FOR
Otinan is a sterile eye drop solution. Otinan contains dorzolamide, a sulphonamide-related compound, as the active ingredient.
Otinan is an ophthalmic carbonic anhydrase inhibitor which reduces high pressure in the eye.
It is indicated in the treatment of elevated intra-ocular pressure in conditions such as ocular hypertension and glaucoma (open-angle glaucoma, pseudo-exfoliative glaucoma). Otinan can be used alone or in addition to other medicines which lower the pressure in the eye (so-called beta-blockers).
2. BEFORE YOU USE OTINAN Do not use Otinan
- if you are allergic (hypersensitive) to dorzolamide or any of the other ingredients of this solution.
- if you have severe kidney problems.
Take special care with Otinan
Before treatment with Otinan, tell your doctor
- if you have or have had liver problems in the past
- if you have been told you have a corneal defect
- if you have had any allergies to any medicines
- if you have had, or are about to have eye surgery
- if you have suffered an eye injury or have an eye infection
- if you have a prior history of kidney stones
- if you are taking orally another carbonic anhydrase inhibitor
- if you wear contact lenses (see the section ‘Important information about some of the ingredients of Otinan’).
You should contact your doctor immediately if you develop any eye irritation or any new eye problems such as redness of the eye or swelling of the surface layer of the eye or eyelids.
Stop using Otinan and contact your doctor immediately if you suspect that Otinan is causing an allergic reaction (for example, skin rash or itching, inflammation of the eye).
Use in children
Otinan has been studied in infants and children less than 6 years of age who have raised pressure in the eye(s) or have been diagnosed with glaucoma. For more information, talk to your doctor.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular you should tell your doctor if 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.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor if you are pregnant or planning to become pregnant. Otinan should not be used during pregnancy unless your doctor still recommends it.
Otinan should not be used while breast-feeding.
Driving and using machines
Otinan may cause dizziness and visual disturbances 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 Otinan
Otinan 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 reinsertion.
3. HOW TO USE OTINAN
Always use Otinan 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.
When Otinan is used alone, the usual dose is one drop in the affected eye(s) three times a day, for example in the morning, in the afternoon and in the evening.
If your doctor has recommended you use Otinan with a beta-blocker eye drop (medicines which lower the pressure of the eye), then the usual dose is one drop of Otinan in the affected eye(s) two times a day, for example in the morning and in the evening.
If you use Otinan with another eye drop, leave at least 10 minutes between putting in Otinan and the other medicine. Alternatively if you are going to use Otinan to replace another eye drop medicine, used to lower eye pressure, you should stop using the other medicine after taking the proper dosing on one day, and start Otinan on the next day.
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.
Instructions for proper 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. Repeat steps 3 & 4 with the other eye if instructed to do so by your doctor.
6. Put the cap back on and close the bottle straight after you have used it.
If you use more Otinan than you should
If you put too many drops in your eye or swallow any of the contents, you should contact your doctor immediately.
If you forget to use Otinan
It is important to use Otinan 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 using Otinan
Otinan should be used every day to work properly. If you must stop treatment, contact your doctor immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Otinan can cause side effects, although not everybody gets them. The chance of having a side effect is described by the following categories:
|
Very common |
Occurs in more than 1 out of 10 patients |
|
Common |
Occurs in between 1 and 10 out of every 100 patients |
|
Uncommon |
Occurs in between 1 and 10 out of every 1,000 patients |
The following side effects may be seen with Otinan.
Eye disorders: Very common: Common:
Uncommon:
Rare:
burning and stinging
disease of the cornea with sore eye and blurred vision (superficial punctuate keratitis), inflammation or swelling of the surface layer of the eye(s) and possible inflammation of the eyelid(s) and/or skin around the eye(s), watering or itching of the eye(s), blurred vision, effects on the surface of the eye. inflammation of the middle layer of the eye.
swelling of the surface layer of the eye(s), choroidal detachment which may be accompanied by visual changes/disturbances (following eye surgery), ocular hypotony, redness of the eye(s), eye pain, crusting of the eyelid(s), temporary shortsightedness (which stops when the medicine is discontinued).
Gastrointestinal disorders:
Common: nausea, bitter taste
Rare: throat irritation, dry mouth
General disorders and administration site conditions:
Common: asthenia/fatigue
Rare: Hypersensitivity: signs and symptoms of local reactions (palpebral reactions) and
systemic allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing, hives and itching, rash, shortness of breath and more rarely bronchospasm (contraction of the smooth muscle in the bronchi)
Nervous system disorders:
Common: headache
Rare: dizziness, numbness/tingling sensation
Renal and urinary disorders:
Rare: formation of urinary calculi
Respiratory, thoracic, and mediastinal disorders: Rare: bleeding from the nose
Skin and subcutaneous tissue disorders:
Rare: skin inflammation
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.
5. HOW TO STORE OTINAN
Keep out of the reach and sight of children.
Do not use Otinan 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.
Keep the bottle in the outer carton in order to protect from light. Store below 30°C.
Otinan 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 Otinan contains
- The active substance is dorzolamide. Each ml contains 20 mg dorzolamide (as dorzolamide hydrochloride).
- The other ingredients are Mannitol, Hydroxy Ethyl Cellulose, Benzalkonium Chloride (as a preservative), Sodium Citrate, Sodium Hydroxide for pH adjustment and Water for injection.
What Otinan looks like and contents of the pack
Otinan is a sterile, isotonic, buffered, colourless, clear, slightly viscous solution in a white opaque medium density polyethylene bottle with a sealed dropper tip and a two-piece cap assembly. Each bottle contains 5 mL of the eye drop solution.
Otinan is available in packs containing 1 bottle, 3 bottles or 6 bottles.
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
Centrafarm Services B.V.
Nieuwe Donk 9, 4879 AC Etten Leur,
The Netherlands
Or
PharmaCoDane ApS Marielundvej 46A, 2730 Herlev,
Denmark
Or
Aliud Pharma GmbH
Gottlieb-Daimler-Str. 19, 89150 Laichingen, Germany
This leaflet was last approved in July 2011.
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Detailed information on this medicine is available on the web site of {MA/Agency}
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