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Dorzolamide 20mg/Ml Eye Drops Solution

Informations for option: Dorzolamide 20mg/Ml Eye Drops Solution, show other option
Document: leaflet MAH GENERIC_PL 04416-0757 change

PACKAGE LEAFLET: INFORMATION FOR THE USER SZ00000LT000

Dorzolamide 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


In this leaflet:

1.    What Dorzolamide is and what it is used for

2.    Before you use Dorzolamide

3.    How to use Dorzolamide

4.    Possible side effects

5.    How to store Dorzolamide

6.    Further information

A SANDOZ

What Dorzolamide is and what it is used for

Dorzolamide contains dorzolamide, a sulphonamide-related compound, as the active ingredient.

Dorzolamide is an opthalmic carbonic anhydrase inhibitor which lowers pressure in the eye.

Dorzolamide can be used alone or in addition to other medicines which lower the pressure in the eye (so-called beta-blockers).

Important information about some of the ingredients of Dorzolamide

Dorzolamide contains the

preservative benzalkonium chloride. If you wear soft contact lenses, you should consult your doctor before using Dorzolamide. The eye drops may cause eye irritation.

Avoid contact with soft contact lenses.

Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.

The preservative benzalkonium chloride is known to discolour soft contact lenses.

Before you use Dorzolamide

Your doctor can explain this to you.

Do not use Dorzolamide

3 How to use Dorzolamide

•    if you are allergic (hypersensitive) to dorzolamide or any of the other ingredients of Dorzolamide.

•    if you have severe kidney problems.

•    if you have a disturbance in the

Always use Dorzolamide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

pH (acid/alkali balance) of your blood.

Take special care with Dorzolamide

Before treatment with Dorzolamide, tell your doctor or pharmacist if

Dosage

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.

   you have or have had liver problems in the past.

   you have or have had renal calculi.

•    you have been told you have a corneal defect.

   you have had any allergies to any medicines.

   you have had, or are about to have

Using Dorzolamide with beta-blocker eye drops:

If your doctor has recommended you use Dorzolamide with a beta-blocker eye drop to lower eye pressure, then the usual dose is one drop of Dorzolamide in the affected eye(s) two times a day, for example in the morning and in the evening.

eye surgery.

•    you have suffered an eye injury or have an eye infection.

•    you wear contact lenses (see the section “Important information about some of the ingredients of Dorzolamide”).

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.

•    if you suspect that Dorzolamide is

Using Dorzolamide with another eye drop:

If you are using Dorzolamide as well as other eye drops, the different drops should be instilled at least 10 minutes apart.

If you are going to use Dorzolamide 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 Dorzolamide on the next day.

causing an allergic reaction (for example, skin rash or itching). Stop using Dorzolamide

Do not change the dosage of the drug without consulting your doctor.

immediately.

Use in children

Dorzolamide has been studied in infants and children less than six 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.

Instructions for use:

Please follow these instructions carefully when using Dorzolamide eye drops solution. It is recommended that you wash your hands before putting in your eye drops. 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.

• In particular you should tell your doctor if you are taking large doses of acetylsalicylic acid (medicine against pain, e.g. headache). Although there is no evidence that

1. You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.

Dorzolamide interacts with acetylsalicylic acid, some other medicines which are related to Dorzolamide and which are taken

2. To open the bottle unscrew the cap by turning it until the tamper-proof seal breaks.

by mouth, have been known to interact with acetylsalicylic acid.

• You should also tell your doctor if you are taking another carbonic anhydrase inhibitor such as

3. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye (Fig. 1).

acetazolamide (another medicine which lowers the eye pressure). You may be taking this type of medicine by mouth, as eye drops, or by some other method.

Pregnancy and breast-feeding

Pregnancy:

Tell your doctor if you are pregnant or intend to become pregnant. It is not recommended to use Dorzolamide during pregnancy.

Breast-feeding:

Tell your doctor if you are breast-feeding or intend to breast-feed. It is not recommended to use Dorzolamide while

4. Invert the container, and press gently as shown (Fig. 2) until a single drop as instructed by your doctor is dispensed into your eye. DO NOT TOUCH YOUR EYE OR EYELID WITH THE TIP OF THE CONTAINER.

breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Possible side effects such as dizziness and visual disturbances

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may affect your ability to drive or use machinery. If affected do not drive or operate machinery.(see section 4 “Possible side effects”).


5.    Repeat steps 3 and 4 with the other eye if instructed to do so by your doctor.

6.    Reclose the bottle by turning the cap firmly immediately after use and return the bottle to the original outer carton.

7.    The dispenser tip is designed to provide a pre-measured drop; therefore, do not enlarge the hole of the dispenser tip.

If you use more Dorzolamide than you should

If you put too many drops in your eye or swallow any of the contents, you should contact your doctor immediately.

Symptoms of overdose may include nausea, dizziness, headache, fatigue, abnormal dreams, problems swallowing; with oral ingestion somnolence can occur.

If you forget to use Dorzolamide

It is important to take Dorzolamide 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.

If you stop using Dorzolamide

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


6 Further information


4 Possible side effects


Like all medicines, Dorzolamide can cause side effects, although not everybody gets them.

Frequencies are defined as follows:

Very common side effects, may affect more than 1 in 10 people:

Burning and stinging of the eyes.

Common side effects, may affect up to 1 in 10 people:

Headache, superficial punctuate keratitis (eye pain, abnormal intolerance to light), tearing, inflammation of the conjunctiva, eyelid inflammation, eye itching, eyelid irritation, blurred vision, nausea, bitter taste, asthenia/fatigue.

Uncommon side effects, may affect up to 1 in 100 people:

Iridocyclitis (inflammation of the iris and the ciliary body).

Rare side effects, may affect up to 1 in 1,000 people:

Dizziness, numbness/tingling sensation, irritation including redness, pain, eyelid crusting, temporary shortsightedness (which stops when the medicine is discontinued), corneal oedema, ocular hypotony, choroidal detachment following filtration surgery (see section 2. “Take special care with Dorzolamide”), nose bleed, throat irritation, dry mouth, contact dermatitis, allergic skin reactions like urticaria, pruritus, rash (see section 2. “Take special care with Dorzolamide”), kidney and bladder stones, hypersensitivity: signs and symptoms of local reactions (palpebral reactions) and systemic allergic reactions including angioedema, shortness of breath, rarely bronchospasm (see section 2. “Take special care with Dorzolamide”).

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.


What Dorzolamide contains

The active substance is dorzolamide. Each ml contains 20.0 mg of dorzolamide equivalent to 22.3 mg of dorzolamide hydrochloride.

The other ingredients are: hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide/hydrochloric acid (for pH adjustment), benzalkonium chloride (as a preservative), water for injections.

What Dorzolamide looks like and contents of the pack

Dorzolamide is an isotonic, buffered, slightly viscous, aqueous solution. Dorzolamide is available in bottles containing 5 ml of solution.

Pack sizes

1 x 5 ml, 3 x 5 ml and 6 x 5 ml eye drops.

Not all pack sizes will be marketed.

LDPE bottle with LDPE dropper and HDPE cap.

Marketing Authorisation Holder

and Manufacturer

Marketing Authorisation Holder:

Sandoz Ltd,

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Aeropharm GmbH, Francois-Mitterrand-Allee 1

and

Theodor-Neubauer-StraGe 33/36, 07407 Rudolstadt,

Germany.

This leaflet was last revised in March 2013.


5 How to store Dorzolamide


Keep out of the sight and reach of children.

Do not use Dorzolamide after the expiry date which is stated on the carton and bottle. The expiry date refers to the last day of that month. Keep the bottle in the outer carton, in order to protect from light.

Do not store above 30°C!

Dorzolamide should be used within 4 weeks after the bottle is first opened.

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.


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