Dorzolamide 20mg/Ml Eye Drops Solution
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PACKAGE LEAFLET INFORMATION FOR THE USER | |
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Dorzolamide 20 mg/ml Eye Drops, Solution |
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.
I- 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
- Your medicine, Dorzolamide 20 mg/ml Eye Drops, Solution will be referred to as Dorzolamide in this leaflet.
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
1. WHAT DORZOLAMIDE IS AND WHAT IT IS USED FOR
Dorzolamide belongs to 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).
2. BEFORE YOU USE DORZOLAMIDE
Do not use Dorzolamide
- if you are allergic (hypersensitive) to Dorzolamide Hydrochloride or any of the other ingredients of this medicine.
- if you have severe kidney impairment or problems, or a prior history ofkidney stones.
Take special care with Dorzolamide
Tell your doctor 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 or itching) stop its use and contact your doctor immediately.
Use in children
Dorzolamide 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 far elderly
In studies with Dorzolamide, the effects of Dorzolamide 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 Using 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Uw In pregnancy
You should not use this medicine during pregnancy. Tell your doctor if you are pregnant or intend to become pregnant
If treatment with this medicine is required, breast-feeding is not recommended.
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. Important information about some of the Ingredients of Dorzolamide Dorzolamide 20 mg/ml Eye Drops, Solution contains the preservative preservative may cause eye irritation. This preservative may be deposited in soft contact leases and may possibly discolour the lenses. If you wear contact lenses, you should consult your doctor before using this medicine. Use with soft contact lenses should be avoided (Please also read the ‘Instructions for use’).
3. HOW TO USE DORZOLAMIDE
Always use Dorzolamide 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 this medicine is used alone, the dose is one drop in the affected eye(8) 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 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 allow the tip of the container to touch the eye or areas around the 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, wash your hands before using this medicine and keep the tip of the container away from contact with any surface. If yew think your medication may be contaminated, or if you develop an eye infection, contact your doctor immediately concerning continued use of this bottle Instructions for use:
• First wash your hands
• Avoid touching the eye (or any other surface) with the tip of the bottle
• If you wear soft contact lenses, they should be removed before using the eye drops and wait at least 15 minutes before reinserting
• These drops are supplied in a plastic bottle with an insert cap assembly, with a tamper proof dust cover. When using the bottle for the first time, snap off the dust cover by turning it clockwise to break the seal.
• Unscrew the inner cap
• Tilt your head back and look at the ceiling
• Pull the lower eyelid gently downwards
• Hold the bottle upside down above
the eye and gently squeeze the bottle to release a drop into your eye
• Keep the affected eye closed and press your fingertip against the inside comer of the closed eye, and hold for 1 minute
• Repeat for the other eye if necessary
• Recap the bottle after every use, tighten the inner cap on the nozzle
If you use more Dorzolamide than you should
If you put too many drops in your eye or the contents of the container are swallowed, you should contact your doctor immediately.
If you forget to use Dorzolamide It is important to use this medicine 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 the forgotten dose.
If you stop using Dorzolamide If you want to stop using this medicine talk to your doctor fust If you have any further questions on the use of this product, ask your doctor or pharmacist
4. POSSIBLE SIDE EFFECTS Like all medicines, Dorzolamide 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 tins medicine and seek jmrnrdi’atr medical advice.
The following side effects have been reported with Dorzolamide either during clinical trials or during postmarketing experience:
Very Common side effects:
(more than 1 user in 10)
Burning and stinging of the eyes. Common side effects:
(1 to 10 users in 100)
Disease of the cornea with sore eye and blurred vision (superficial punctuate keratitis), discharge with itching of the eyes (conjunctivitis), irritation/inflanimation of the eyelid, blurred vision, headache, nausea, bitter taste, and fatigue.
Uncommon side effects:
(1 to 10 users in 1,000)
Inflammation of the iris.
Rare side effects:
(1 to 10 users in 10,000)
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 (wife symptoms of visual disturbances), eye irritation including redness, kidney stones, dizziness, nosebleed, throat irritation, dry mouth, localized skin rash (contact dermatitis), 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.
If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE DORZOLAMIDE
Keep out of the reach and sight of children.
Do not store above 25°C.
Keep the bottle in the outer carton in order to protect from light.
Use the solution within 28 days after opening the bottle Do not use Dorzolamide after the expiry date which is stated on the bottle and on the carton the bottle is packed in. The expiry date refers to the last day of that month.
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 Dorzolamide contains
- The active substance is Dorzolamide.
- Each ml contains 22.26 mg of dorzolamide hydrochloride corresponding to 20 mg dorzolamide.
- The other ingredients are Hydroxyethyl Cellulose, Mannitol, Sodium Citrate, Sodium Hydroxide, and Water for Injections. Benzalkonium Chloride is added as a preservative.
What Dorzolamide looks like and contents of the pack
One bottle of Dorzolamide contains 5 ml solution.
Dorzolamide is a clear, colourless and slightly viscous solution filled in 5 mL labeled LDPE bottle with insert-cap assembly comprising of an orange colored, HDPE screw-cap over a LDPE nozzle with tamper-evident LDPE dust-cover sealing the bottle cap.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
FDC Pharma
Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire,
P015 7FE, UK
Tel: +44(0) 1489 565222
Fax:+44 (0)1489 565222
E-mail: fdcil@btconnect.com Manufacturer:
FDC International Ltd.,
Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire,
P015 7FE, UK PL number: 35638/0006 This leaflet was last approved in October 2013
COLOUR CHART
CMYK
D4
