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BLUTIM 0.25% W/V EYE DROPS SOLUTION

Active substance(s): TIMOLOL MALEATE

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eCTD Office [http://www.ectdoffice.com]

PACKAGE LEAFLET: INFORMATION FOR THE USER

BLUTIM 0.25% W/V EYE DROPS SOLUTION
BLUTIM 0.5% W/V EYE DROPS SOLUTION
Timolol
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:
1. What Blutim Eye Drops are and what they are used for
2. Before you use Blutim Eye Drops
3. How to use Blutim Eye Drops
4. Possible side effects
5. How to store Blutim Eye Drops
6. Further information

1. 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.

2. 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
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
Paediatric population
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 your doctor.
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.

3. 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.
Paediatric population:
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 performed.
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:
1. Tilt your head back and look at the ceiling.
2. Gently pull the lower eyelid down until there is a small pocket.
3. Squeeze the upturned dropper bottle to release a drop into your eye.

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4. 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.

4. 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 conditions.
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 penis.
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.

5. 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 carton.
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.

6. FURTHER INFORMATION
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 maleate)
• Blutim 0.5% w/v Eye Drops Solution. 1 ml of solution contains 5 mg timolol (as
timolol maleate)
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:
Blumont Pharma Ltd., 23 Moortown Close, Grantham, United Kingdom NG31 9GG
Manufacturer:
Excelvision, 27 rue de la Lombardière, F-07104 Annonay Cedex, France

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This leaflet was last revised in 10/2014.

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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.

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