BLUTIM 0.5% W/V EYE DROPS SOLUTION
Active substance(s): TIMOLOL MALEATE / TIMOLOL MALEATE / TIMOLOL MALEATE
Blutim 0.25% w/v Eye Drops Solution
Blutim 0.5% w/v Eye Drops Solution
Read all of this leaflet carefully before you start using this medicine.
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. Do not pass it on others. It may harm them, even if
their symptoms are the same as yours.
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.
In this leaflet you will find the following information:
What Blutim Eye Drops are and what they are used for
Before you use Blutim Eye Drops
How to use Blutim Eye Drops
Possible side effects
How to store Blutim Eye Drops
WHAT BLUTIM EYE DROPS ARE AND WHAT THEY ARE USED FOR
It is an eye drop and each bottle contains 5 ml of the medicine.
The active ingredient is timolol.
Timolol belongs to a group of medicines called ‘beta-blockers’ and is used to reduce pressure within
the eye in ocular hypertension (raised pressure in the eye) or glaucoma. It can be used either alone or
with another eye drop which lowers eye pressure.
BEFORE YOU USE BLUTIM EYE DROPS
Do not use Blutim Eye Drops if you
- are allergic to timolol, beta-blockers or to any of the ingredients.
- if you have now or have had in the past respiratory problems such as asthma, severe chronic
obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing
and/or long-standing cough)
Take special care with Blutim Eye Drops
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 cirulation 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 Blutim Eye Drops as timolol may
change effects of some medicines used during anaesthesia
141008 Blutim pl31103-0022-0023-1B-01
Using other medicines
Blutim 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 any prescription, in particular:
- a calcium antagonist (e.g. nifedipine, verapamil or diltiazem) often used to treat high blood
pressure, angina, or an abnormal heartbeat
- digoxin, often used to treat heart failure or an abnormal heartbeat
- a pressor amine (e.g. adrenaline) used to treat severe allergic reaction
- an SSRI (e.g. fluoxetine or paroxetine) often used to treat depression
- quinidine (used to treat heart conditions and some types of malaria)
- clonidine, a medicine used to treat high blood pressure
- other beta-blockers (e.g. other preparations of timolol both oral and/or ocular), which belong to the
same group of medicines as Blutim Eye Drops and could have an additive effect
- medicines to treat diabetes, e.g. insulin
- guanethidine, a medicine used to treat high blood pressure
Blutim eye drop solution should generally be used with caution in young patients. In newborns,
infants and younger children Timolol should be used with extreme caution. If coughing, wheezing,
abnormal breathing or abnormal pauses in breathing (apnoea) occur, the use of the medication should
be stopped immediately. Contact your doctor as soon as possible. A portable apnoea monitor may
also be helpful.
Blutim eye drop solution has been studied in infants and children aged 12 days to 5 years, who have
raised pressure in the eye(s) or have been diagnosed with glaucoma. For more information, talk to
Pregnancy and breast-feeding
Do not use Blutim Eye Drops if you are pregnant unless your doctor considers it necessary. Do not
use Blutim 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.
Driving and using machines
No effects on ability to drive and use machines have been reported. However do not drive or operate
machines if you experience any visual disturbance after using the product. Wait until this clears before
driving or using machines.
Important information about some of the ingredients of Blutim Eye Drops
Blutim Eye Drops contain the preservative benzalkonium chloride which may cause eye irritation.
Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15
minutes before reinsertion. Known to discolour soft contact lenses.
HOW TO USE BLUTIM EYE DROPS
Always use Blutim Eye Drops exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
The usual starting dose is one drop of 0.25% w/v solution in the affected eye(s) twice a day (e.g. once
in the morning and once in the evening). Some people need a stronger dose. Your doctor will change
your treatment as necessary.
If you use it with another eye drop, please wait at least 5 minutes before applying the second eye drop.
A detailed medical examination should precede the use of timolol. Your doctor will carefully evaluate
the risks and benefits when considering treatment with timolol. If the benefits outweigh the risks, it is
recommended to use the lowest active agent concentration available once daily. With regard to “the
use in children” the 0.25% solution may be sufficient to control pressure within the eye. If the
pressure is not sufficiently controlled with this dosage, a twice daily application at 12-hourly intervals
may be necessary. Patients, especially newborn, should be closely observed for one to two hours after
the first dose and careful monitoring for adverse events should be carried out until surgery is
Instructions for use
Always wash your hands before applying eye drops. Apply only one drop of Blutim Eye Drops in each
affected eye in the following way:
Tilt your head back and look at the ceiling.
Gently pull the lower eyelid down until there is a small pocket.
Squeeze the upturned dropper bottle to release a drop into your eye.
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 as long as possible (e.g. 3 – 5 minutes). This helps
to stop timolol getting into the rest of your body.
5. Replace and tighten the cap immediately after use.
Avoid touching the dropper tip against your eye or anything else.
If you use more Blutim Eye Drops than you should
There is no experience of an overdose with Blutim Eye Drops which is unlikely when used in the eye.
If it has been swallowed, then you should contact your doctor.
If you forget to use Blutim Eye Drops
If a dose has been forgotten treatment should continue with the next dose as planned for. The dose
should not exceed one drop 2 times daily in the affected eye(s).
If you stop using Blutim Eye Drops
Do not stop using this medine without talking to your doctor first.
Duration of treatment for Paediatric population
For a transient period only
POSSIBLE SIDE EFFECTS
Like all medicines, Blutim Eye Drops 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 Blutim Eye Drops without speaking to your doctor.
Like other medicines applied into eyes, timolol is absorbed into the blood. This may cause similar side
effects as seen with intravenous and/or 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 side effects include reactions seen within the class of beta-blockers when used for treating eye
If you develop 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, itchness, severe sudden life-threatening allergic reaction,
stop taking your eye drops and seek medical attention immediately.
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 tingling or 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, sensitivity to light, discharge from the
eye, pain in the eye.
Ringing sound in the ears.
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, fainting, interference with the blood supply to the brain which may lead to a
stroke, Raynaud's phenomenon, cold hands and feet, limping because there is a reduced blood supply
to your legs.
Constriction of the airways in the lungs (predominantly in patients with pre-existing disease),
difficulty breathing, shortness of breath, wheezing, cough.
Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
Sexual dysfunction, decreased sex drive, decreased libido. In men a condition which effects your penis
called Peyronie’s disease. The signs may be abnormal curve, pain or hardening of the tissue of your
Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of
psoriasis, skin rash, itching.
Muscle weakness/tiredness, muscle pain not caused by exercise.
A condition called lupus (systemic lupus erythematosus).
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 at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
HOW TO STORE BLUTIM EYE DROPS
Keep the bottle out of the reach and sight of children.
Do not use the bottle if the tamper-proof seal on the bottle is broken before first use.
Do not use Blutim Eye Drops after the expiry date which is stated on the label of the bottle and on the
Do not use the same bottle 4 weeks after opening even if the bottle is not empty.
Do not store the bottle at a temperature above 25˚C.
Store the bottle in the outer carton to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines that are no longer required. These measures will help to protect the environment.
What Blutim Eye Drops contain
The active ingredient is timolol. Blutim Eye Drops are available in two strengths as follows:
Blutim 0.25% w/v Eye Drops Solution. 1 ml of solution contains 2.5 mg timolol (as timolol
Blutim 0.5% w/v Eye Drops Solution. 1 ml of solution contains 5 mg timolol (as timolol
Other ingredients are benzalkonium chloride (preservative), disodium phosphate dodecahydrate,
sodium dihydrogen phosphate dihydrate and water for injection.
What Blutim Eye Drops look like and contents of the pack
A transparent plastic (LDPE) bottle containing 5 ml of a clear and colourless solution.
Blutim 0.25% w/v and 0.5% w/v Eye Drops
1 x 5 ml plastic bottle
3 x 5 ml plastic bottles
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Medicom Healthcare Ltd
235 Hunts Pond Road
27 Rue de la Lombardière
ZI la Lombardière
Hard to see or read the leaflet? Call 01489 574119 for help.
This leaflet was last revised - DRAFT May-2017
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.