- dorzolamide hydrochloride
- 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: PL01883/0358.
Dorzolamide / Timolol 20 mg/ml + 5 mg/ml eye drops, solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
Dorzolamide / Timolol 20 mg/ml + 5 mg/ml eye drops, solution
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 Dorzolamide / Timolol is and what it is used for
2. What you need to know before you use Dorzolamide / Timolol
3. How to use Dorzolamide / Timolol
4. Possible side effects
5. How to store Dorzolamide / Timolol
6. Contents of the pack and other information
1. WHAT DORZOLAMIDE / TIMOLOL IS AND WHAT IT IS USED FOR
Dorzolamide / Timolol contains two medicines: dorzolamide and timolol.
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 eye drop medicine used alone is not adequate.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DORZOLAMIDE / TIMOLOL
Do not use Dorzolamide / Timolol
If you are not sure whether you should use Dorzolamide / Timolol, contact your doctor or pharmacist.
Warnings and precautions:
Tell your doctor about any of the following medical or eye problems you have now or have had in the past:
Also tell your doctor:
When Dorzolamide / Timolol is instilled into the eye it may affect the entire body.
Children and adolescents
There is limited experience with Dorzolamide / Timolol in infants and children.
Use in elderly
In studies with Dorzolamide / Timolol, the effects of Dorzolamide / Timolol 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.
Other medicines and Dorzolamide / Timolol
Dorzolamide / Timolol can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Tell your doctor if you are using or intend to use medicines to lower blood pressure, heart medicine or medicines to treat diabetes. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
This is particularly important if you are:
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Use in pregnancy
Do not use Dorzolamide / Timolol if you are pregnant unless your doctor considers it necessary.
Use in breast-feeding
Do not use Dorzolamide / Timolol 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
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.
Dorzolamide / Timolol contains benzalkonium chloride
If you wear soft contact lenses, you should remove contact lenses before using Dorzolamide / Timolol and wait at least 15 minutes before reinsertion (the preservative benzalkonium chloride may possibly discolour the lenses).
Benzalkonium chloride may cause ocular irritation.
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 recommended 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 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 container, 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.
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 2 minutes. This helps to stop timolol getting into the rest of the body.
Avoid touching the dropper tip against your eye or anything else.
Replace and tighten the cap straight after use.
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 use 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
Like all medicines, Dorzolamide / Timolol can cause side effects, although not everybody gets them.
You can usually carry on taking the drops, unless the effects are serious. If you’re worried, talk to a doctor or pharmacist. Do not stop using Dorzolamide / Timolol without speaking to your doctor.
Serious side effects
If you develop generalized allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs, and can obstruct the airway which may cause difficulty swallowing or breathing, hives or itchy rash, localized and generalized rash, itchiness or a severe sudden life-threatening allergic reaction, you should stop using Dorzolamide / Timolol and seek medical advice immediately.
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Not known (frequency cannot be estimated from the available data)
The following adverse reactions have been reported with dorzolamide / timolol eye drops or one of its components either during clinical trials or during post marketing experience:
Burning and stinging of the eyes, taste perversion.
Redness in and around the eye(s), watering or itching of the eye(s), corneal erosion (damage to the front layer of the eyeball), swelling and/ or irritation in and around the eye(s), feeling of having something in the eye, decreased corneal sensitivity (not realising of getting something in the eye and not feeling pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or fullness in the nose), weakness/tiredness, and fatigue.
Dizziness, depression, inflammation of the iris, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), slow heartbeat, fainting, difficulty breathing (dyspnoea), indigestion, and kidney stones.
Systemic lupus erythematosus (an immune disease which may cause an inflammation of internal organs), tingling or numbness of the hands or feet, trouble sleeping, nightmares, memory loss, an increase in signs and symptoms of myasthenia gravis (muscle disorder), decreased sex drive, stroke, temporary short sightedness which may resolve when treatment is stopped, detachment of the layer below the retina that contains blood vessels following from filtration surgery which may cause visual disturbances drooping of the eyelids, double vision, eyelid crusting, swelling of the cornea (with symptoms of visual disturbances), low pressure in the eye, ringing noises in your ear, low blood pressure, changes in the rhythm or speed of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid build up), oedema (fluid build up), cerebral ischaemia (reduced blood supply to the brain),, chest pain, palpitations (a quicker and/or irregular heartbeat), heart attack, Raynaud’s phenomenon, 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, impaired lung function, runny or stuffed nose, nose bleed, constriction of the airways in the lungs, cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) , Peyronie’s disease (which may cause a curvature of the penis), allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth, wheezing, or severe skin reactions (Steven Johnson syndrome, toxic epidermal necrolysis).
Like other medicines applied into eyes, timolol maleate is absorbed into the blood. This may cause similar side effects as seen with oral beta-blocking agents. Incidence of side effects after topical ophthalmic administration is lower than when medicines are, for example, taken by mouth or injected.
Listed additional side effects include reactions seen within the class of beta-blockers when used for treating eye conditions:
Low blood glucose levels, heart failure, a type of heart rhythm disorder, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction.
If you get any side effects talk your doctor or pharmacist. This includes any side effects not listed in this leaflet.
5. HOW TO STORE DORZOLAMIDE / TIMOLOL
Keep out of the reach and sight of children.
Do not use this medicine after the date shown by the six digits following EX (or EXP) on the container and on the carton. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Keep the bottle in the outer carton in order to protect from light.
Discard Dorzolamide / Timolol 28 days after first opening.
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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dorzolamide / Timolol contains
What Dorzolamide / Timolol looks like and contents of the pack
Dorzolamide / Timolol is a clear, colourless to nearly colourless slightly viscous solution.
1 x 5 ml (single 5-ml containers)
3 x 5 ml (three 5-ml containers)
6 x 5 ml (six 5-ml containers)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
This medicinal product is authorised in the Member States of the EEA under the following names
Dorzolamide / Timolol 20 mg/ml + 5 mg/ml eye drops solution
Betaclar 20 mg/ml + 5 mg/ml collirio, soluzione
This leaflet was last revised in February 2019