Dorzolamide 20 Mg/Ml Eye Drops Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER DORZOLAMIDE 20 mg/ml eye drops, solution
Dorzolamide 777193UK/1C
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 Dorzolamide 20 mg/ml eye drops solution is and what it is used for
2. Before you use Dorzolamide 20 mg/ml eye drops solution
3. How to use Dorzolamide 20 mg/ml eye drops solution
4. Possible side effects
5. How to store Dorzolamide 20 mg/ml eye drops solution
6. Further information
1. What Dorzolamide 20 mg/ml eye drops solution is and what it is used for
Dorzolamide 20 mg/ml eye drops solution 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).
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.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Use in pregnancy
You should not use this medicine during pregnancy. Tell your doctor if you are pregnant or intend to become pregnant.
Use in breast-feeding
If treatment with this medicine is required, breast-feeding is not recommended.
Tell your doctor if you are breast-feeding or intend to breast-feed.
Driving and using machines
The effects on the ability to drive or use machines has not been studied. However 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. If affected, do not drive or operate machinery until you feel well or your vision is clear.
Important information about some of the ingredients of Dorzolamide 20 mg/ml eye drops solution
Dorzolamide 20 mg/ml eye drops solution contains the preservative benzalkonium chloride which may cause irritation and discolour soft contact lenses. If you wear contact lenses, remove them prior to application and wait at least 15 minutes before reinsertion.
Apply your eye drops in the following way:
1. Remove protective cap.
2. Tilt your head back and look at the ceiling.
3. Gently pull the lower eyelid down until there is a small pocket.
4. Squeeze the upturned dropper bottle to release a drop into your eye.
5. Whilst keeping the affected eye closed, press your finger against the corner of the closed eye (the side where the eye meets the nose) and hold for 1 minute.
Avoid touching the dropper tip against your eye or anything else. Replace and tighten the cap straight after use.
If you use more Dorzolamide 20 mg/ml eye drops solution 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 20 mg/ml eye drops solution
It is important to use this medicine as prescribed by your doctor. If you miss a dose, apply 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 20 mg/ml eye drops solution
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.
or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.
5. How to store Dorzolamide 20 mg/ml eye drops solution
Keep out of reach and sight of children.
Store bottle in original carton, in order to protect from light.
Do not use Dorzolamide 20 mg/ml eye drops solution after the expiry date which is stated following EXP on the bottle and outer carton. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date refers to the last day of the month.
Dorzolamide 20 mg/ml eye drops solution should be used within 28 days after the bottle is opened.
Do not store above 25°C.
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
4. Possible side effects
2. Before you use Dorzolamide 20 mg/ml eye drops solution
Do not use Dorzolamide 20 mg/ml eye drops solution
• 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 of kidney stones.
Take special care with Dorzolamide 20 mg/ml eye drops solution
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, severe skin reaction or itching) stop its use and contact your doctor immediately.
Use in children
Dorzolamide 20 mg/ml eye drops solution 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 20 mg/ml eye drops solution, 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.
3. How to use Dorzolamide 20 mg/ml eye drops solution
Always use Dorzolamide 20 mg/ml eye drops solution 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(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 20 mg/ml eye drops solution 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 you 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:
Always wash your hands before applying eye drops.
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Like all medicines, Dorzolamide 20 mg/ml eye drops solution 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 20 mg/ml eye drops solution either during clinical trials or during post-marketing 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/inflammation 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 user 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 (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 reaction, 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,
What Dorzolamide 20 mg/ml eye drops solution contains
• The active substance is dorzolamide.
• Each ml contains 20 mg of dorzolamide (as 22.3 mg dorzolamide hydrochloride).
• The other ingredients are hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, and purified water. Benzalkonium chloride is added as a preservative.
What Dorzolamide 20 mg/ml eye drops solution looks like and contents of the pack
Dorzolamide 20 mg/ml eye drops solution is a clear, colourless to nearly colourless slightly viscous solution.
Pack sizes:
1 x 5.0 ml (single 5 ml container)
3 x 5.0 ml (three 5 ml containers)
6 x 5.0 ml (six 5 ml containers)
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Medicom Healthcare Ltd.,
235 Hunts Pond Road,
Titchfield Common, Fareham,
Hants, P014 4PJ, U.K.
Manufacturer
Tubilux Pharma S.p.A.
Via Costarica 20/22 00071 Pomezia (RM)
ITALY
This medicinal product is authorised in the Member States of the EEA under the following names
UK
Dorzolamide 20 mg/ml eye drops solution
Italy
Dorzolamide 20 mg/ml collirio, soluzione This leaflet was last revised on 10/2015
9-DORZPOM-11-GB-PV2
777193UK/1C
Medicom
Healthcare
JOB No: 0242
job name: Dorzolamide 2% Eye drops BAK 5ml (POM)
DIMENSIONS: 120 x 320 mm VERSION NO: PV2 COLOUR:
DATE: 15.9.15
PHASE 1
PHASE 2
□
JOB DESCRIPTION:
9-DORZPOM-11-GB-PV1