- timolol maleate
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL35533/0163.
Brinzolamide/Timolol Aspire 10mg/ml + 5mg/ml eye drops, suspension
PACKAGE LEAFLET: INFORMATION FOR THE USER
Brinzolamide/Timolol 10mg/ml + 5mg/ml eye drops, suspension
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Brinzolamide/Timolol is and what it is used for
2. What you need to know before you use Brinzolamide/Timolol
3. How to use this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. WHAT BRINZOLAMIDE/TIMOLOL IS AND WHAT IT IS USED FOR
Brinzolamide/Timolol contains two active substances, brinzolamide and timolol, which work together to reduce pressure within the eye.
Brinzolamide/Timolol is used to treat high pressure in the eyes, also called glaucoma or ocular hypertension, in adult patients that are more than 18 years of age and in whom high pressure in the eyes cannot be controlled effectively by one medicine alone.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BRINZOLAMIDE/TIMOLOL
Do not use this medicine:
Warnings and precautions
Only use this medicine for dropping in your eye(s).
If signs of serious reactions or hypersensitivity occur, discontinue the use of this product and talk to your doctor.
Talk to your doctor or pharmacist before using this medicine if you have or have had in the past:
Children and adolescents
This medicine is not recommended for children and adolescents under 18 years.
Other medicines and Brinzolamide/Timolol
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Brinzolamide/Timolol can affect, or be affected by, other medicines you are taking, including other eye drops for the treatment of glaucoma.
Tell your doctor if you are taking or intend to take medicines to lower blood pressure like parasympathomimetics and guanethidine, or other heart medicines including quinidine (used to treat heart conditions and some types of malaria), amiodarone or other medicines to treat heart rhythm disorders and glycosides to treat heart insufficiency. Also tell your doctor if you are taking or intend to take medicines to treat diabetes, or to treat gastric ulcers, antifungal, antiviral or antibiotic medicines, or antidepressants such as fluoxetine and paroxetine.
If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide), talk to your doctor.
Increase in pupil size when taking Brinzolamide/Timolol and adrenaline (epinephrine) together has been reported occasionally.
Pregnancy and breast-feeding
You should not use this medicine if you are pregnant or might get pregnant, unless your doctor considers it necessary. Talk to your doctor before you use Brinzolamide/Timolol.
Do not use this medicine if you are breast-feeding, timolol may get into your milk.
Ask your doctor for advice before taking any medicine during breast-feeding.
Driving and using machines
Do not drive or use machines until your vision is clear. You may find that your vision is blurred for some time just after using this medicine.
One of the active ingredients may impair the ability to perform tasks requiring mental alertness and/or physical coordination. If affected take care when driving or using machines.
Brinzolamide/Timolol contains benzalkonium chloride
This medicine contains 0.0033mg benzalkonium chloride in each drop which is equivalent to 0.01% or 0.1mg/ml.
Benzalkonium chloride is a preservative in Brinzolamide/Timolol that may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
3. HOW TO USE THIS MEDICINE
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
If you are changing from another eye drop medicine used to treat glaucoma to Brinzolamide/Timolol, you should stop using the other medicine and start using Brinzolamide/Timolol the following day. Check with your doctor or pharmacist if you are not sure.
To prevent contamination of the dropper tip and the suspension, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip. Keep the bottle tightly closed when not in use.
The following measure is useful to limit the amount of medicine that will come into the blood after application of eye drops:
The recommended dose is one drop in the affected eye or eyes, twice a day.
Only use this medicine in both eyes if your doctor told you to. Take it for as long as your doctor told you to.
How to use
If a drop misses your eye, try again.
If you are using other eye drop or eye ointment medicines leave at least 5 minutes between each medicine. Eye ointments should be administered last.
If you use more Brinzolamide/Timolol than you should
Rinse your eye with warm water. Do not put in any more drops until it is time for your next regular dose.
You may experience a decreased heart rate, decreased blood pressure, heart failure; difficulty breathing and your nervous system may be affected.
If you forget to use Brinzolamide/Timolol
Continue with the next dose as planned. Do not use a double dose to make up for the forgotten dose. Do not use more than one drop in the affected eye(s) twice daily.
If you stop using this medicine without speaking to your doctor, the pressure in your eye will not be controlled which could lead to loss of sight.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects although not everybody gets them.
Stop using this medicine and contact your doctor immediately if you develop a skin rash, severe skin reaction, or severe redness and itching of the eye. These could be the signs of an allergic reaction (frequency is not known).
You can usually carry on taking the drops, unless the effects are serious. If you are worried, talk to your doctor or pharmacist. Do not stop using this medicine without speaking to your doctor first.
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people):
Not known (frequency cannot be estimated from the available data):
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 the 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 THIS MEDICINE
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 bottle and the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Throw away the bottle 4 weeks after first opening to prevent infections, and use a new bottle. Write down the date of opening on the bottle label and carton label in the space provided.
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 this medicine contains
Tiny amounts of hydrochloric acid and/or sodium hydroxide are added to keep acidity levels (pH levels) normal.
What this medicine looks like and contents of the pack
Brinzolamide/Timolol is a liquid (white to off-white uniform suspension) supplied in a carton containing a 5ml low density polyethylene (LDPE) bottle with a LDPE insert dropper and a high density polyethylene (HDPE) cap containing 5ml suspension.
Cartons contain 1, 3 or 6 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
This leaflet was last revised in 12/2019
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
+44 (0)1730 231148
+44 (0)1730 231148
+44 (0)1730 231148