What is a Patient Information Leaflet and why is it useful?

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 can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 35533/0086 .

Dorzolamide/Timolol 20mg/ml + 5mg/ml eye drops, solution in single dose container

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dorzolamide/Timolol 20mg/ml + 5mg/ml eye drops, solution in single-dose container

dorzolamide/timolol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What this medicine is and what it is used for
2. What you need to know before you use this medicine
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 THIS MEDICINE IS AND WHAT IT IS USED FOR

This medicine 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 pressure in the eye in different ways.

This medicine 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 THIS MEDICINE

Do not use this medicine

  • if you are allergic to dorzolamide hydrochloride, timolol maleate or any of the other ingredients of this medicine (listed in section 6).
  • if you have now or had in the past respiratory problems, such as asthma, or severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough).
  • if you have a slow heartbeat, heart failure or disorders of heart rhythm (irregular heartbeats).
  • 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 this medicine, contact your doctor or pharmacist.

Warnings and precautions

Talk to your doctor before using this medicine.

Tell your doctor about any medical or eye problems you have now or have had in the past:

  • Coronary heart disease (symptoms can include chest pain or tightness, breathlessness, or choking), heart failure, low blood pressure.
  • Disturbances of heart rate such as slow heartbeat.
  • Breathing problems, asthma or chronic obstructive pulmonary disease.
  • Poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome).
  • Diabetes as timolol may mask signs and symptoms of low blood sugar.
  • Overactivity of the thyroid gland as timolol may mask signs and symptoms.

Tell your doctor before you have an operation that you are using this medicine as timolol may change effects of some medicines used during anaesthesia.

Also tell your doctor 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 this medicine is causing an allergic reaction or hypersensitivity (for example, skin rash, severe skin reaction, or redness and itching of the eye), stop using this medicine 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 this medicine is instilled into the eye it may affect the entire body.

This medicine has not been studied in patients wearing contact lenses. If you wear soft contact lenses, you should consult your doctor before using this medicine.

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 dorzolamide/timolol (preserved formulation) 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 this medicine

This medicine 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. Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This is particularly important if you are:

  • taking medicine to lower blood pressure or to treat heart disease (such as calcium channel blockers, beta-blockers or digoxin).
  • taking medicines to treat a disturbed or irregular heartbeat such as calcium channel blockers, beta-blockers or digoxin.
  • using another eye drop that contains a beta-blocker.
  • taking another carbonic anhydrase inhibitor such as acetazolamide.
  • taking monoamine oxidase inhibitors (MAOIs).
  • 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.
  • taking narcotics such as morphine used to treat moderate to severe pain.
  • taking medicines to treat diabetes.
  • taking antidepressants known as fluoxetine and paroxetine.
  • taking a sulfa medicine.
  • taking quinidine (used to treat heart conditions and some types of malaria).

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Use in pregnancy

Do not use this medicine if you are pregnant unless your doctor considers it necessary.

Use in breast-feeding

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

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 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.

3. HOW TO USE THIS MEDICINE

Always use this medicine exactly as your doctor has told you. 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 this medicine with another eye drop, the drops should be instilled at least 10 minutes apart.

Do not change the dose of the medicine without consulting your doctor.

If you have difficulty administering your eye drops, seek the assistance of a family member or carer.

Do not allow the single-dose container to touch the eye or areas around the eye. It could cause injury to your eye. It may also 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, wash your hands before using this medicine and keep the tip of the single-dose container away from contact with any surface. A new single-dose container should be opened immediately prior to each use; there is enough solution in each container for both eyes if your doctor has told you to use the drops in both eyes.

Discard the opened container with any remaining contents immediately after use.

Instructions for use:

Open the sachet which contains a strip of 5 individual single- dose containers.

1. Wash your hands.

2. Take the strip of containers from the sachet.

3. Detach one single-dose container from the strip.

4. Put the remaining strip back in the pouch and fold the edge to close the pouch.

5. To open the container, twist off the tab.

6. Hold the container between your thumb and index finger.

7. Tilt your head backwards or lie down. Look up and pull the lower eyelid downwards with the other hand. Do not allow any part of the container to touch your eye or any area around your eye. Gently squeeze the container to let one drop fall into the space between the lid and the eye. Do not blink while applying the drop to your eye. Each single-dose container contains enough solution for both eyes.

8. Close your eye and press the inner corner of the eye with your finger for about two minutes. This helps to stop the medicine from getting into the rest of the body.

9. Wipe off any excess solution from the skin around the eye.

If your doctor has told you to use drops in both eyes, repeat steps 7 to 9 for your other eye. After putting the drop into the eye(s), throw away the used single-dose container even if there is solution remaining to avoid contamination of the preservative free solution.

Store the remaining containers in the sachet; the remaining containers must be used within 7 days after opening of the sachet. If there are any containers left 7 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 are not sure how to administer your medicine, ask your doctor, pharmacist or nurse.

If you use more of this medicine 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 this medicine

It is important to take 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 take a double dose to make up for the forgotten dose.

If you stop using this medicine

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, this medicine 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 this medicine without speaking to your doctor.

Generalised allergic reactions including swelling beneath the skin 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, localised and generalised rash, itchiness, severe sudden life-threatening allergic reaction.

The following adverse reactions have been reported with this medicine or one of its components either during clinical trials or during post-marketing experience:

Very Common (may affect more than 1 in 10 people):

Burning and stinging of the eyes, taste perversion.

Common (may affect up to 1 in 10 people):

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 to the nose), nausea, weakness/tiredness and fatigue.

Uncommon (may affect up to 1 in 100 people):

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.

Rare (may affect up to 1 in 1,000 people):

Systemic lupus erythematosus (an immune disease which may cause an inflammation of internal organs), tingling or numbness of the hands or feet, insomnia, 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 (making the eye stay half closed), 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, respiratory failure, rhinitis, 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 (Stevens Johnson syndrome, toxic epidermal necrolysis).

Not known (frequency cannot be estimated from the available data):

Shortness of breath, foreign body sensation in eye (feeling that there is something in your eye).

Like other medicines applied into your eyes, timolol 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:

Not known (frequency cannot be estimated from the available data):

Low blood glucose levels, heart failure, a type of heart rhythm disorder, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction.

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 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 the unopened sachets of this medicine after the expiry date shown on the carton and sachet. 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.

Do not store above 25°C.

Do not refrigerate or freeze.

Store in the original package in order to protect from light.

You can use this medicine 7 days after first opening the sachet. Discard any unused single-dose containers after this time. Discard the opened single-dose container with any remaining solution immediately after first use.

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

  • The active substances are dorzolamide and timolol.
    Each ml contains 20mg of dorzolamide (as 22.26mg dorzolamide hydrochloride) and 5mg of timolol (as 6.83mg timolol maleate).
  • The other ingredients are hydroxyethyl cellulose, mannitol, sodium citrate, sodium hydroxide, and water for injections.

What this medicine looks like and contents of the pack

This medicine is a clear, colourless to nearly colourless slightly viscous solution. Each aluminium sachet contains 5 low density polyethylene single-dose containers containing 0.166ml of solution.

Pack sizes:

30 x 0.166ml (6 sachets with 5 single-dose containers)

60 x 0.166ml (12 sachets with 5 single-dose containers)

120 x 0.166ml (24 sachets with 5 single-dose containers)

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aspire Pharma Ltd
Unit 4
Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
UK

Manufacturer

Genetic S.p.A
Nucleo Industriale
Contrada Canfora
84084 Fisciano (SA)
Italy

This leaflet was last revised in June 2018

1010425 - P1.10