Blutim 0.5% W/V Eye Drops Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
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:
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
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.
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
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.
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 l2-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.
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.
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.
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.
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 Lombardiere, F-07104 Annonay Cedex, France
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This leaflet was last revised in 10/2014.