Skip to Content

OPTIPRES 20 MG/ML EYE DROPS SOLUTION

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET

Package leaflet: Information for the user

Optipres 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 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. This includes any possible side effects
not listed in this leaflet.

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

1. What Optipres is and what it is used for
Optipres is a sterile eye drop solution. Optipres 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). Optipres 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 take Optipres

Do not use Optipres
if you are allergic (hypersensitive) to dorzolamide or any of the other ingredients of this solution
(listed in section 6).
if you have severe kidney problems.
if you have a disturbance in the pH (acid/alkali balance) of your blood.

Warning and precautions
Before treatment with Optipres, 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
2

-

if you wear contact lenses (see the section ‘Important information about some of the ingredients of
Optipres).

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

Always use Optipres 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 Optipres 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 Optipres with a beta-blocker eye drop (medicines which lower the
pressure of the eye), then the usual dose is one drop of Optipres in the affected eye(s) two times a day, for
example in the morning and in the evening.
If you use Optipres with another eye drop, leave at least 10 minutes between putting in Optipres and the
other medicine. Alternatively if you are going to use Optipres 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 Optipres on the next day.
3

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 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 Optipres 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 Optipres
It is important to use Optipres 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 Optipres
Optipres 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, Optipres can cause side effects, although not everybody gets them.

4

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 using this medicine and seek immediate
medical advice.
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

The following side effects may be seen with Optipres.
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, Stevens-Johnson syndrome and toxic epidermal necrolysis
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 Optipres

5

Keep this medicine out of the sight and reach of children.
Do not use Optipres 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.
Optipres 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 or household waste. 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 Optipres 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 Optipres looks like and contents of the pack
Optipres 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.
Optipres is available in packs containing 1 bottle, 3 bottles or 6 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pharmaceutical Works Polpharma S.A,
19 Peplinska street, 83-200 Starogard Gdanski, Poland
Manufacturers:
FAMAR S.A., Alimos Plant
63 Agiou Dimitriou Street, 174 56 Alimos, Greece
Pharmathen S.A.,
Dervenakion 6, Pallini 153 51, Attiki, Greece
Pharmaceutical Works Polpharma S.A,
19 Peplinska street, 83-200 Starogard Gdanski, Poland

6

This medicinal product is authorised in the Member States of the EEA under the following names:
Estonia, Slovakia, United Kingdom: Optipres
Czech Republic: Optipres 20 mg/ml
Latvia: Optipres 20 mg/ml acu pilieni, šķīdums
Lithuania: Optipres 20 mg/ml akių lašai, tirpalas
Poland: Glautic
Romania: Dorzolamidă Polpharma 20 mg/ml picături oftalmice, soluţie

This leaflet was last approved in 09/2012.

Detailed information on this medicine is available on the web site of MHRA

7

Expand Transcript

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.

Hide