Patient leaflet - Dorzolamide/timolol 20 mg / ml + 5 mg / ml eye drops solution in single dose Container
1. What Dorzolamide/Timolol is and what it is used for
aDorzolamide/Timolol contains two medicines: dorzolamide and timolol.
Dorzolamide belongs to a group of medicines called “carbonic
anhydrase inhibitors”.
- Timolol belongs to a group of medicines called “beta blockers”.
These medicines lower the pressure in the eye in different ways.
Dorzolamide/Timolol is prescribed to lower raised pressure in the eye in the treatment of glaucoma when beta-blocker eyedrop medicine used alone is not adequate.t COS
2. What you need to know before you use Dorzolamide/Timolol
Do not use Dorzolamide/Timolol
if you are allergic (hypersensitive) to dorzolamide hydrochloride, timolol maleate or any of the other ingredients of
Dorzolamide/Timolol.
- if you have respiratory disease, such as asthma, a history of asthma, or chronic obstructive lung disease · if you have certain heart diseases, including certain heart rhythm disturbances producing an abnormally slow heart rate or severe heart failure.
- if you have severe kidney disease or problems, or a prior history of kidney stones.
- if you have excess acidity of the blood caused by a build up of chloride in the blood (hyperchloraemic acidosis). If you are not sure whether you should use Dorzolamide/Timolol, contact your doctor or pharmacist.
Take special care with Dorzolamide/Timolol
Tell your doctor about any medical or eye problems you have now or have had in the past, especially asthma and other lung problems, heart problems, circulatory problems, low blood pressure, diabetes, low blood sugar (hypoglycemia), thyroid problems, and about any allergies or anaphylactic reactions.
Tell your doctor if you have muscle weakness or have been diagnosed as having myasthenia gravis. 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 dorzolamide/timolol is causing an allergic reaction or hypersensitivity (for example, skin rash, severe skin reaction, or redness and itching of the eye), stop using dorzolamide/timolol and contact your doctor immediately.
Tell your doctor if you develop an eye infection, receive an eye injury, have eye surgery, or develop a reaction including new or worsening symptoms.
When dorzolamide/timolol is instilled into the eye it may affect the entire body.
Dorzolamide/Timolol has not been studied in patients wearing contact lenses.
If you wear soft contact lenses, you should consult your doctor before using dorzolamide/timolol.
Use in children
There is limited experience with dorzolamide/timolol (preserved formulation) in infants and children.
Use in elderly
In studies with dorzolamide/timolol (preserved formulation), the effects of this medicine 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 or pharmacist if you are taking or have recently taken any other medicines, including other eye drops or medicines obtained without a prescription. This is particularly important if you are;
- a) taking medicine to lower blood pressure or to treat heart disease (such as calcium channel blockers, beta-blockers or digoxin)
- b) taking medicines to treat a disturbed or irregular heartbeat such as calcium channel blockers, beta-blockers or digoxin
- c) using another eye drop that contains a beta-blocker
- d) taking another carbonic anhydrase inhibitor such as acetazolamide
- e) taking monoamine oxidase inhibitors (MAOIs)
- f) taking a parasympathomimetic medicine which may have been prescribed to help you pass urine. Parasympathomimetics are also a particular type of medicine which is sometimes used to help restore normal movements through the bowel
- g) taking narcotics such as morphine used to treat moderate to severe pain.
- h) taking medicines to treat diabetes
- i) taking medicines to treat depression
- j) taking a sulfa drug
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Use in pregnancy
You should not use dorzolamide/timolol during pregnancy. Tell your doctor if you are pregnant or intend to become pregnant.
Use in breast-feeding
If treatment with dorzolamide/timolol is required, breast-feeding is not recommended. Tell your doctor if you are breast-feeding 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 dorzolamide/timolol, such as 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.
Sodium
This medicinal product contains less than 1 mmol (23 mg) sodium per ml, that is to say essentially ‘sodium-free’.
3. How to use Dorzolamide/Timolol
Always use dorzolamide/timolol 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.
The usual dose is one drop in the affected eye(s) in the morning and in the evening.
If you are using dorzolamide/timolol 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 single dose 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 of the single dose container, keep the tip of the single dose container away from contact with any surface.
Instructions for use
The solution from one individual single dose container of dorzolamide/timolol is to be used immediately after opening for administration to the affected eye(s). Since sterility cannot be maintained after the individual single dose container is opened, a new container must be opened prior to each use and must be discarded immediately after administration.
- 1. Open the foil sachet which contains the 5 individual single dose containers. There is one strip of 5 single dose containers each in the sachet.
- 2. First wash your hands then break off one single dose container from the strip and twist open the top of the single dose container as shown.
- 3. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and eye as shown.
- 4. Put one drop in the affected eye(s) as directed by your doctor. Each single dose container contains enough solution for both eyes.
- 5. After putting the drop into the eye, throw away the used single dose container even if there is solution remaining to avoid contamination of the preservative free solution.
- 6. Store the remaining containers in the foil sachet; the remaining containers must be used within 15 days after opening of the sachet. If there are any containers left 15 days after opening the sachet they should be safely thrown away and a fresh sachet opened. It is important to continue to use the eye drops as prescribed by your doctor.
If you use more Dorzolamide/Timolol than you should
If you put too many drops in your eye or swallow any of the contents of the container, among other effects, you may become light-headed, have difficulty breathing, or feel that your heart rate has slowed. Contact your doctor immediately.
If you forget to use Dorzolamide/Timolol
It is important to take dorzolamide/timolol 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 take a double dose to make up for the forgotten dose.
If you stop using Dorzolamide/Timolol
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 it
Like all medicines, dorzolamide/timolol can cause side effects, although not everybody gets them.
If they do occur, you may need medical attention.
The following adverse reactions have been reported with dorzolamide/timolol or one of its components either during clinical trials or during post-marketing experience:
Very Common: (appearing in more than 1 of 10 treated patients)
Burning and stinging of the eyes, taste perversion
Common: (occurring in between 1 in 10 and 1 in 100 treated patients)
Redness in and around the eye(s), watering or itching of the eye(s), and effects on the surface of the eye(s), swelling and/or irritation in and around the eye(s), eyelid crusting, eye pain, dry eyes, blurred vision, headache, sinusitis, nausea and fatigue
Uncommon: (occurring in between 1 in 100 and 1 in 1,000 treated patients)
Dizziness, depression, inflammation of the iris, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), slow heartbeat, fainting, indigestion, and kidney stones
Rare: (occurring in between 1 in 1,000 and 1 in 10,000 treated patients)
Systemic lupus erythematosus, tingling or numbness of the hands or feet, insomnia, nightmares, memory loss, weakening of the muscles, decreased sex drive, stroke, temporary short sightedness which may resolve when treatment is stopped, choroidal detachment (following filtration surgery), drooping of the eyelids, double vision, ringing noises in your ear, low blood pressure, irregular heartbeat, chest pain, palpitations, heart attack, swelling or coldness of your hands and feet and reduced circulation in your arms and legs, leg cramps and/or leg pain when walking (claudication), shortness of breath, respiratory failure, rhinitis, nose bleed, bronchospasm (predominantly in patients with pre-existing bronchospastic disease), cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, psoriasis or worsening of psoriasis, Peyronie’s disease (which may cause a curvature of the penis), weakness/tiredness, allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth, wheezing, or severe skin reactions.
220101 V1
Insert R° (front side) 178 x 700 mm
folded 178x50 mm
INSERT 178 x 700 mm - folded 178x50 mm
MONO 7/MANUEL
PRODUCTION LINE(S) : MONO 7/MANUEL
KB SPEC. : 220101 V1
(30 mm maxi)
178 mm
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(123456) part number OCRB (AV-100) black
6 pts
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.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Dorzolamide/Timolol
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or sachet after EXP. The expiry date refers to the last day of that month.
Store below 25 °C.
Store in the original foil sachet in order to protect from light.
After First opening sachet: 15 days
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 protect the environment.
6. Contents of the pack and other information
What Dorzolamide/Timolol contains
The active substances is dorzolamide and timolol. Each ml contains 22.26 mg of dorzolamide hydrochloride is equivalent to 20 mg of dorzolamide.
Each ml contains 6.83 mg of timolol maleate is equivalent to 5 mg timolol.
The other ingredients are hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide and water for injection.
What Dorzolamide/Timolol looks like and contents of the pack
Clear, colorless to nearly colorless, slightly viscous aqueous solution, free from visible particles filled in LDPE single use containers.
Single-dose containers (LDPE) filled with 0.2 ml solution.
Packages of 30, 60 and 120 single-dose containers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Amarox Limited
Congress House, 14 Lyon Road
Harrow, HA1 2EN
United Kingdom
This leaflet was last revised in 09/2026.
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