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DORZOLAMIDE PHARMASWISS 20 MG/ML EYE DROPS SOLUTION

Active substance(s): DORZOLAMIDE HYDROCHLORIDE

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Package leaflet: Information for the user
Dorzolamide PharmaSwiss 20 mg/ml, eye drops solution
Dorzolamide (as hydrochloride)
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
 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 symptoms 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.
What is in this leaflet
1. What Dorzolamide PharmaSwiss is and what it is used for
2. What you need to know before you use Dorzolamide PharmaSwiss
3. How to use Dorzolamide PharmaSwiss
4. Possible side effects
5. How to store Dorzolamide PharmaSwiss
6. Contents of the pack and other information
1. What Dorzolamide PharmaSwiss is and what it is used for
Dorzolamide PharmaSwiss contains dorzolamide which belongs to a group of medicines
called "carbonic anhydrase inhibitors".
This medicine is prescribed to lower raised pressure in the eye and to treat glaucoma. This
medicine can be used alone or in addition to other medicines which lower the pressure in the
eye (so called beta-blockers).
Dorzolamide PharmaSwiss eye drops solution is a sterile solution that does not contain a
preservative.

2. What you need to know before you take use Dorzolamide PharmaSwiss
Do not use Dorzolamide PharmaSwiss

if you are allergic to dorzolamide hydrochloride or any of the other ingredients of this
medicine.

if you have severe kidney impairment or problems, or a prior history of kidney
stones.
If you are not sure whether you should use this medicine, contact your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Dorzolamide PharmaSwiss
Tell your doctor or pharmacist about any medical problems you have now or have had in the
past, including eye problems and eye surgeries, and about any allergies to any medications.
If you develop any eye irritation or any new eye problems such as redness of the eye or
swelling of the eyelids, contact your doctor immediately.

If you suspect that this medicine is causing an allergic reaction (for example, skin rash, severe
skin reaction or itching) stop its use and contact your doctor immediately.
If you have a history of contact hypersensitivity to silver, you should not use this product.
If you wear contact lenses, you should consult your doctor before using Dorzolamide
PharmaSwiss.
Children and adolescents
Dorzolamide (preserved formulation) 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.
Use in elderly
In studies with Dorzolamide (preserved formulation), the effects of Dorzolamide (preserved
formulation) were similar in both elderly and younger patients.
Use in patients with liver impairment
Tell your doctor about any liver problems you now have or have suffered from in the past.
Other medicines and Dorzolamide PharmaSwiss
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor about all drugs (including eye drops) that you are using or plan to use,
including those obtained without a prescription, particularly another carbonic anhydrase
inhibitor such as acetazolamide, or a sulfa drug.
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.
Pregnancy
You should not use this medicine during pregnancy. Tell your doctor if you are pregnant or
intend to become pregnant.
Breast-feeding
You should not use this medicine during breast-feeding. Tell your doctor if you are breastfeeding or intend to breast-feed
Driving and using machines
No studies on the effects on the ability to drive or use machines have been performed. There
are side effects associated with this medicine, such as dizziness and blurred vision, which
may affect your ability to drive and/or operate machinery. Do not drive or operate machinery
until you feel well or your vision is clear.

3. How to use Dorzolamide PharmaSwiss
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 this medicine is used alone, the recommended dose is one drop in the affected eye(s)
in the morning, in the afternoon and in the evening.

If your doctor has recommended you use this medicine with a beta-blocker eye drop to lower
eye pressure, then the dose is one drop of Dorzolamide PharmaSwiss in the affected eye(s) in
the morning and in the evening.
If you are using this medicine with another eye drop, the drops should be instilled at least 10
minutes apart.
Do not change the dose of the drug without consulting your doctor.
Do not allow the tip of the multi dose container to touch the eye or areas around the eye. It
could cause injury to your eye. The eye drops solution 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 multi-dose container, keep the tip of the multi-dose
container away from contact with any surface.

Instructions for use:
Before instillation of the eye drops:
-

Wash your hands before opening the bottle.
Do not use this medicine if you notice that the tamper-proof seal on the bottle neck is
broken before you first use it.
When using for the first time, before delivering a drop to the eye, you should first of all
practise using the dropper bottle by squeezing it slowly to deliver one drop into the air,
away from the eye.
When you are confident that you can deliver one drop at a time, choose the position that
you find most comfortable for the instillation of the drops (you can sit down, lie on your
back, or stand in front of a mirror).

Instillation:
1. Hold the bottle directly below the cap and turn the cap to open the bottle. Do not touch
anything with the tip of the bottle to avoid contamination of the solution.

2. Tilt your head backwards and hold the bottle above your eye.

3. Pull the lower eyelid down and look up. Squeeze the bottle gently in the middle and let a
drop fall into your eye. Please note that there might be a few seconds delay between
squeezing and the drop coming out. Do not squeeze too hard.
If you are not sure how to administer your medicine, ask your doctor, pharmacist or nurse.

4. Blink a few times so that the drop spreads over the eye.
5. Repeat the instructions 2. – 4. to deliver a drop into the other eye also, if your doctor has
instructed you to do this. Sometimes only one eye needs to be treated and your doctor will
advise if this applies to you and which eye needs treatment.

6. After use and prior to recapping, the bottle should be shaken once in a downwards
direction, without touching the dropper tip, in order to remove any residual liquid on the tip.
This is necessary in order to ensure delivery of subsequent drops.
7. After you have used all doses there will be some Dorzolamide PharmaSwiss left in the
bottle. You should not be concerned since an extra amount of Dorzolamide PharmaSwiss has
been added and you will get the full amount of Dorzolamide PharmaSwiss that your doctor
has prescribed. Do not attempt to use the excess medicine remaining in the bottle after you
have completed the course of treatment.
Do not use the eye drops for longer than 28 days after first opening the bottle.
If you use more Dorzolamide PharmaSwiss than you should
If you put too many drops in your eye or swallow any of the contents of the container, you
should contact your doctor immediately.
If you forget to use Dorzolamide PharmaSwiss
It is important to take this medicine as prescribed by your doctor.
If you miss a dose, take 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 take a double dose to make up for the forgotten dose.
If you stop using Dorzolamide PharmaSwiss
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, this medicine 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 using this
medicine and seek immediate medical advice.
The following side effects have been reported with Dorzolamide Preservative free either
during clinical trials or during post-marketing experience:
Very Common (may affect more than 1 in 10 people)
 Burning and stinging of the eyes.
Common (may affect up to 1 in 10 people)








Disease of the cornea with sore eye and blurred vision (superficial punctuate keratitis)
Discharge with itching of the eyes (conjunctivitis)
Irritation/inflammation of the eyelid
Blurred vision
Headache, nausea
Bitter taste
Fatigue.

Uncommon (may affect up to 1 in 100 people)


Inflammation of the iris.

Rare (may affect up to 1 in 1,000 people)

















Tingling or numbness of the hands or feet
Temporary shortsightedness which may resolve when treatment is stopped
Development of fluid under the retina (choroidal detachment, following filtration surgery)
Eye pain
Eyelid crusting
Low pressure in the eye
Swelling of the cornea (with symptoms of visual disturbances)
Eye irritation including redness
Kidney stones
Dizziness
Nose bleed
Throat irritation
Dry mouth
Localized skin rash (contact dermatitis)
Severe skin reactions
Allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the
lips, eyes and mouth, shortness of breath, and more rarely wheezing

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: http://www.hpra.ie; E-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Dorzolamide PharmaSwiss
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
After first opening, the product may be stored for a maximum of 28 days. No special storage
conditions are required.
Do not use Dorzolamide PharmaSwiss after the expiry date which is stated on the carton and
the bottle after EXP. The expiry date refers to the last day of that month. Make sure the
container is properly closed.
Do not use this medicine if you notice that the seal is broken the first time you use the
container.
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. Contents of the pack and further information
What Dorzolamide PharmaSwiss contains




The active substance is dorzolamide.
Each ml contains 20 mg of dorzolamide (as dorzolamide hydrochloride).
The other ingredients are hydroxyethyl cellulose, mannitol, sodium citrate
dihydrate, sodium hydroxide, and water for injections.

What Dorzolamide PharmaSwiss looks like and contents of the pack
Dorzolamide PharmaSwiss eye drops solution is presented as a 5 ml clear, colorless aqueous,
slightly viscous solution, in white opaque 11 ml LDPE bottle and white Novelia nozzle
(HDPE and silicone) with a white HDPE cap.

Pack sizes: 1 or 3 bottles in cardbox
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2, 170 00 Praha 7, Czech Republic
Manufacturer:
EXCELVISION
27 st. La Lombardière, Zl La Lombardière,
ANNONAY 07100
France
And
PHARMATHEN S.A.
Dervenakion 6
Pallini Attikis 15351
Greece
This leaflet was last revised in June 2016.

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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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