Timolol Eye Drops Bp 0.25% W/V
Package leaflet: Information for the user
Vistatimol Eye Drops 0.25%w/v & 0.5%w/v
Timolol Maleate
Read all of this leaflet carefully before you start to use Vistatimol Eye Drops. It contains important information.
- 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 symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What is in this leaflet
1. What Vistatimol Eye Drops are and what they are used for
2. Before using Vistatimol Eye Drops
3. How to use Vistatimol Eye Drops
4. Possible side effects
5. How to store Vistatimol Eye Drops
6. Contents of the pack and other information
1. What Vistatimol Eye Drops are and what they are used for
The active ingredient in your eye drops is timolol maleate. This belongs to a group of medicines known as beta-blockers. Beta blockers reduce the pressure in the eye(s).
Because Vistatimol Eye Drops can reduce pressure in the eye, they are used to treat conditions where there is raised pressure in the eye(s). There are a number of these conditions, one example is a group of eye diseases that affect vision, called glaucoma.
Vistatimol Eye Drops Solution is available in two strengths: a 0.25% w/v solution containing the active ingredient timolol maleate equivalent to 2.5mg/ml timolol and a 0.5% w/v solution containing timolol maleate equivalent to 5 mg/ml timolol.
2. Before using Vistatimol Eye Drops Do not use Vistatimol Eye Drops:
• if you are allergic to timolol maleate beta-blockers or any of the other ingredients.
• you are allergic to other beta-blocking agents, such as atenolol.
• if you have now or have 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 heart beat, heart failure or disorders of heart rhythm, (irregular heart beats)
• you have heart disease (second and third degree AV block, or sinus bradycardia)
• you have an inadequate circulation of blood (cardiogenic shock)
Before you use this medicine, tell your doctor if 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 heart beat.
• breathing problems, asthma or chronic obstructive pulmonary disease.
• poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome)
• you have a condition called ‘angle closure glaucoma’ this medicine should be used with another that will make your pupil smaller (a miotic)
• you wear soft contact lenses. These should be removed before treatment with Vistatimol Eye Drops and not put back into your eyes until 15 minutes after using your eye drops.
• diabetes as Timolol may mask signs and symptoms of low blood sugar
• overactivity of the thyroid gland as Timolol may mask signs and symptoms
• you have a history of allergic reactions, as you may become more sensitive to the cause of the allergy
Tell your doctor before you have an operation that you are using Vistatimol Eye Drops as Timolol may change effects of some medicines used during anaesthesia.
If you are unsure about how to use Vistatimol Eye Drops talk to your doctor or pharmacist.
Using other medicines
Some medicines can interfere with your treatment.
Vistatimol Eye Drops 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.
You should consult your doctor if you are taking one or more of the following medicines or have recently stopped taking them:
• adrenaline (epinephrine), a medicine used to treat severe allergic reactions (anaphylaxis) and to restart the heart when it has stopped
• medicines used to treat an irregular heartbeat such as flecainide
• medicines used to treat depression known as SSRIs, such as citalopram
• medicines used to treat high blood pressure and heart problems (calcium antagonists, calcium channel blockers, calcium entry blockers, rauwolfia alkaloids and beta blockers) such as clonidine, nifedipine, verapamil, diltiazem and digitoxin
• medicines known as catecholamine depleting drugs such as reserpine, which is used to treat high blood pressure and certain mental disorders
• insulin, a medicine used to treat diabetes
• quinidine (used to treat heart conditions and some types of malaria), antidepressants known as fluoxetine and paroxetine.
Pregnancy & breast-feeding
Do not use Vistatimol Eye Drops if you are pregnant unless your doctor considers it necessary.
Do not use Vistatimol Eye Drops if you are breast-feeding. Timolol may get into your milk. Ask your doctor for advice before taking any medicine during breast-feeding.
Important information about some of the ingredients of Vistatimol Eye Drops
This medicine contains benzalkonium chloride as a preservative which may cause eye irritation and discolour soft contact lenses.
Effects on the ability to drive and use machines
Your sight may become blurred or you may become dizzy after using Vistatimol Eye Drops. Do not drive or operate machinery until any dizziness stops and your eyesight becomes clear.
3. How to use Vistatimol Eye Drops
Always use Vistatimol Eye Drops exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
After using Vistatimol Eye Drops, press a finger into the corner of your eye, by the nose (picture 1) for 2 minutes. This helps to stop Vistatimol getting into the rest of the body.
Picture 1
If you wear soft contact lenses they must be removed before treatment with Vistatimol Eye Drops.
Vistatimol Eye Drops are for external use only.
How much to use
Adults (including the elderly)
The usual dose is one drop in the affected eye(s) twice a day.
Your doctor will change your dosage as necessary.
Children
Not recommended for use in children
Instructions for use
1. Before opening a new bottle of ‘Vistatimol Eye Drops’ please check that the safety strip on the bottom of the outer cap is unbroken.
2. Twist the outer cap to break the seal.
3. Wash your hands well before use.
4. Remove the outer cap. If you are putting in the eye drops yourself you should use a mirror.
5. Tilt your head back and look up at the ceiling.
6. Pull the lower lid of the eye out to form a small pocket between your eyelid and your eye.
7. Hold the container between the thumb and middle finger of the other hand, turn the bottle upside down near to the eye, try not to touch the eye with the nozzle.
8. Apply enough pressure to the bottle to release one to two drops, as directed by your doctor.
9. Immediately after putting in the drop place your finger into the corner of your eye and press down for two minutes. This is very important as it stops the Vistatimol Eye Drops being absorbed into the body which could cause serious side effects.
10. Blink the eye a few times.
11. If you think that you have missed the eye, then insert another drop.
12. Repeat steps 5-11 for the other eye if you have been told to use Vistatimol Eye Drops in both eyes.
13. Replace the outer cap on the bottle, trying not to touch the applicator tip with anything, including the eye or your fingers.
14. Wash your hands.
If you are unsure about how to use Vistatimol Eye Drops talk to your doctor or pharmacist.
If you are at all concerned that you have used or been given too much of this medicine please tell your doctor immediately.
If you have swallowed or you suspect someone else has swallowed any of this medicine contact your doctor or go to the accident and emergency department of your local hospital immediately. Take the container and this leaflet with you if possible, even if empty.
If you missed a dose of Vistatimol Eye Drops
If you miss a dose of Vistatimol Eye Drops use them as soon as you remember, unless it is nearly time for the next dose, then carry on using it as before. Do not take a double dose to make up for one you have missed.
If you stop using Vistatimol Eye Drops
You should keep using Vistatimol Eye Drops for as long as your doctor has asked. Your treatment is helping your condition, even if you have not noticed a difference in how you feel. Should you need to stop your treatment, your doctor will advise you how to do this.
4. Possible side effects
Like all medicines Vistatimol Eye Drops may 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 Vistatimol Eye Drops without speaking to your doctor.
Like other medicines applied into the eyes, Timolol is absorbed into the blood. This may cause similar side effects as seen with ‘intravenous’ and/or ‘oral’ as applicable 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 side effects include reactions seen within the class of beta-blockers when used for treating eye conditions:
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, severe sudden life-threatening allergic reaction.
Low blood glucose levels.
Difficulty sleeping (insomnia), depression, nightmares, memory loss.
Fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of myasthenia gravis (muscle disorder), dizziness, unusual sensations (like pins and needles), and headache.
Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), inflammation of the eyelid, inflammation in the cornea, blurred vision and detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye stay half closed), double vision.
Slow heart rate, chest pain, palpitations, oedema (fluid build up), changes in the rhythm or speed of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build up), a type of heart rhythm disorder, heart attack, heart failure.
Low blood pressure, Raynaud's phenomenon, cold hands and feet.
Constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough.
Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
Muscle pain not caused by exercise.
Sexual dysfunction, decreased libido.
Muscle weakness/tiredness.
Sensitivity to light
Discharge from the eye
Pain in your eye
Ringing in your ears
Interference with the blood supply to the brain which may lead to a stroke Limping because there is a reduced blood supply to your legs Wheezing
In men: a condition which affects your penis called Peyronie’s disease. The signs may be abnormal curve, pain or hardening of the tissue of your penis
A condition called lupus (systemic lupus erythematosus).
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.
5. Storing Vistatimol Eye Drops
Keep out of the reach and sight of children.
Make sure the container is properly closed after each use.
Do not use this medicine after the expiry date which is printed on the label. Once you have opened the bottle it should be thrown away after 4 weeks.
Store Vistatimol Eye Drops in their original container away from direct light.
Store below 30°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
What Vistatimol Eye Drops contain
The active substance is Timolol Maleate equivalent to 5mg/ml timolol (0.5%w/v) or 2.5mg/ml timolol (0.25%w/v). The other ingredients are potassium dihydrogen phosphate, disodium hydrogen phosphate, benzalkonium chloride and purified water.
What Vistatimol Eye Drops look like and the contents of the pack
Vistatimol Eye Drops are a clear, colourless solution supplied in a plastic bottle with a tamper proof cap.
Each bottle contains 5ml of sterile solution.
Marketing Authorisation Holder
Martindale Pharmaceuticals Ltd.,
Bampton Road, Romford, Essex RM3 8UG, UK.
Manufacturer
Farmigea S.p.A. Via G.B. Oliva 6/8, 56121 Pisa, Italy
If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.
Product licence numbers:
Vistatimol Eye Drops 0.25 %w/v PL 0156/0032 Vistatimol Eye Drops 0.5 %w/v PL 0156/0033
This leaflet was last updated January 2012