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OTINAN 20MG/ML EYE DROPS SOLUTION

Active substance(s): DORZOLAMIDE HYDROCHLORIDE

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PACKAGE LEAFLET

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 because it contains important
information for you.
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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 only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

In this leaflet:
1.
What Otinan is and what it is used for
2.
What you need to know before you use Otinan
3.
How to use Otinan
4.
Possible side effects
5.
How to store Otinan
6.
Contents of the pack and other 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.

WHAT YOU NEED TO KNOW BEFORE YOU USE OTINAN

Do not use Otinan
if you are allergic to dorzolamide or any of the other ingredients of this solution (listed in section 6).
if you have severe kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before using Otinan
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 ‘Otinan contains the preservative benzalkonium chloride’).

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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).
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.
Other medicines and OtinanTell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
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.
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 this medicine exactly as your doctor has told you. 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 to lower eye pressure, 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.

3

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 medicine, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects

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Stop using this medicine and seek immediate medical advice if you develop allergic reactions.
Symptoms of allergic reactions include the following:
• swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
• hives, itching, rash
• severe skin reactions with blistering of the skin which may affect the mouth, eyes and genitals
• inflammation of the eye and local reactions affecting the eye lids (palpebral reactions)
• shortness of breath and more rarely wheezing (bronchospasm)
Other side effects
Very common: may affect more than 1 in 10 people

burning and stinging
Common: may affect up to 1 in 10 people

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

nausea

bitter taste

asthenia/fatigue

headache
Uncommon: may affect up to 1 in 100 people

inflammation of the middle layer of the eye
Rare: may affect up to 1 in 1,000 people
• 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).
• throat irritation, dry mouth
• dizziness, numbness/tingling sensation
• formation of urinary calculi
• bleeding from the nose
• severe skin reactions, skin inflammation, localized skin rash (contact dermatitis)
Not known: (frequency cannot be estimated from the available data)
• shortness of breath
• foreign body sensation in eye (feeling that there is something in your eye)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.

5.

HOW TO STORE OTINAN

Keep out of the sight and reach of children.

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Do not use this medicine 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.
Do not throw away any medicines via wastewater . Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.

6.

CONTENTS OF THE PACK AND OTHER 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
6

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 revised in 08/20117.

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