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ROZDOL 20MG/ML EYE DROPS SOLUTION

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Rozdol 20 mg/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 Rozdol is and what it is used for
2.
Before you use Rozdol
3.
How to use Rozdol
4.
Possible side effects
5.
How to store Rozdol
6.
Further information

1.

WHAT ROZDOL IS AND WHAT IT IS USED FOR

Rozdol is a sterile eye drops solution. Rozdol contains dorzolamide, a sulphonamide-related compound, as
the active ingredient.
Dorzolamide 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). Rozdol 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 ROZDOL

Do not use Rozdol
if you are allergic (hypersensitive) to dorzolamide or any of the other ingredients of this solution.
if you have severe kidney problems.
if you have a disturbance in the pH (acid/alkali balance) of your blood.

Take special care with Rozdol
Before treatment with Rozdol, 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 another carbonic anhydrase inhibitor
if you wear contact lenses (see the section ‘Important information about some of the ingredients of
Rozdol).

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 Rozdol and contact your doctor immediately if you suspect that Rozdol is causing an allergic
reaction (for example, skin rash or itching, inflammation of the eye).
Use in children
Rozdol should only be used in children if the benefits outweigh the risks. Your doctor will be able to advise
you.
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. Rozdol should not be used during pregnancy unless your doctor still
recommends it.
Rozdol should not be used while breast-feeding.
Driving and using machines
Rozdol 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 Rozdol
Rozdol 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 ROZDOL

Always use Rozdol 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 Rozdol 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 Rozdol with a beta-blocker eye drop (medicines which lower the
pressure of the eye), then the usual dose is one drop of Rozdol in the affected eye(s) two times a day, for
example in the morning and in the evening.
If you use Rozdol with another eye drop, leave at least 10 minutes between putting in Rozdol and the other
medicine. Alternatively if you are going to use Rozdol 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
Rozdol 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.

2

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 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 2 & 3 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 Rozdol 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 Rozdol
It is important to use Rozdol as prescribed by your doctor.
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 forgotten individual doses.
If you stop using Rozdol
Rozdol 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, Rozdol can cause side effects, although not everybody gets them.
The chance of having a side effect is described by the following categories:
Very common
Common
Uncommon
Rare

Occurs in more than 1 out of 10 patients
Occurs in between 1 and 10 out of every 100 patients
Occurs in between 1 and 10 out of every 1,000 patients
Occurs in between 1 and 10 out of every 10,000 patients
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The following side effects may be seen with Rozdol.
Eye disorders:
Very common:
Common:

Uncommon:
Rare:

burning and stinging
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:
formation of urinary calculi
Rare:
Respiratory, thoracic, and mediastinal disorders:
Rare:
bleeding from the nose
Skin and subcutaneous tissue disorders:
skin inflammation
Rare:
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 ROZDOL

Keep out of the reach and sight of children.
Do not use Rozdol 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.
Rozdol 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.

4

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 Rozdol 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 injections.
What Rozdol looks like and contents of the pack
Rozdol is a sterile, isotonic, buffered, colourless, 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.
Rozdol is available in packs containing 1 bottle, 3 bottles or 6 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
mibe GmbH Arzneimittel
Münchener Str. 15
06796 Brehna
Germany
tel: +49/34954/247-0
fax: +49/34954/247-100

Manufacturer
Pharmathen S.A.
6, Dervenakion str.,
15351 Pallini Attiki,
Greece
tel: +30/2106604300
fax: +30/2106666749

This leaflet was last approved in 03/2011.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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