Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
ts of the pack and other information
Bimatoprost/Timolol contains two different active substances (bimatoprost and timolol) that both reduce pressure in the eye. Bimatoprost belongs to a group of medicines called prostamides, a prostaglandin analogue. Timolol belongs to a group of medicines called beta-blockers. Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly enough, the pressure inside the eye builds up and could eventually damage your sight (an illness called glaucoma). Bimatoprost/Timolol works by reducing the production of liquid and also increasing the amount of liquid that is drained. This reduces the pressure inside the eye. Bimatoprost/Timolol eye drops are used to treat high pressure in the eye in adults, including the elderly. This high pressure can lead to glaucoma. Your doctor will prescribe
worsening vision), for example, cataract surgery
you Bimatoprost/Timolol when other eye drops containing beta-blockers or prostaglandin analogues have not worked sufficiently on their own.
Do not use Bimatoprost/Timolol eye drops, solution - if you are allergic to bimatoprost, timolol, beta-blockers or any of the other ingredients
of Bimatoprost/Timolol (listed in section 6) - if you have now or have had in past respiratory problems such as asthma and/or severe
chronic obstructive pulmonary disease (lung disease which may cause wheeziness, difficulty in breathing and/ or long-standing cough) or other types of breathing problems - if you have heart problems such as low heart rate, heart block, or heart failure
Warnings and precautions 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) - overactivity of the thyroid gland as timolol may mask signs and symptoms of thyroid
disease - diabetes as timolol may mask signs and symptoms of low blood sugar - severe allergic reactions - liver or kidney problems - eye surface problems - separation of one of the layers within the eyeball after surgery to reduce the pressure in
the eye - known risk factors for macular oedema (swelling of the retina within the eye leading to
Tell your doctor before surgical anaesthesia that you are using Bimatoprost/Timolol as timolol may change effects of some medicines used during anaesthesia. Bimatoprost/Timolol may cause your eyelashes to darken and grow, and cause the skin around the eyelid to darken too. The colour of your iris may also go darker over time. These changes may be permanent. The change may be more noticeable if you are only treating one eye. Bimatoprost/Timolol may cause hair growth when in contact with the skin surface.
Children and adolescents Bimatoprost/Timolol should not be used in children and teenagers under 18. Other medicines and Bimatoprost/Timolol Bimatoprost/Timolol can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor if you are using or intend to use medicines to lower blood pressure, heart medicine, medicines to treat diabetes, quinidine (used to treat heart conditions and some types of malaria) or medicines to treat depression known as fluoxetine and paroxetine. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not use Bimatoprost/Timolol if you are pregnant unless your doctor still recommends it. Do not use Bimatoprost/Timolol if you are breast-feeding. Timolol may get into your breast milk. Ask your doctor for advice before taking any medicine during breast-feeding. Driving and using machines Bimatoprost/Timolol may cause blurred vision in some patients. Do not drive or use machines until the symptoms have cleared. Bimatoprost/Timolol contains Benzalkonium chloride Bimatoprost/Timolol contains a preservative called benzalkonium chloride. This medicine contains 0.15 mg benzalkonium chloride in each 3 ml of solution which is equivalent to 0.05 mg/ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
The usual dose is one drop once a day, either in the morning or in the evening in each eye that needs treatment. Use at the same time each day. Instructions for use You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.
1. Wash your hands. Tilt your head back and look at the ceiling. 2. Gently pull down the lower eyelid until there is a small pocket. 3. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment. 4. Let go of the lower lid, and close your eye. 5. Whilst keeping the eye closed, press your finger against the corner of the closed eye (the site where the eye meets the nose) and hold for 2 minutes. This helps to stop Bimatoprost/Timolol getting into the rest of the body. If a drop misses your eye, try again. To avoid contamination, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle straight after you have used it. If you use Bimatoprost/Timolol with another eye medicine, leave at least 5 minutes between putting in Bimatoprost/Timolol and the other medicine. Use any eye ointment or eye gel last. If you use more Bimatoprost/Timolol than you should If you use more Bimatoprost/Timolol than you should, it is unlikely to cause you any serious harm. Put your next dose in at the usual time. If you are worried, talk to your doctor or pharmacist.
Affecting other parts of the body runny nose, headache.
If you forget to use Bimatoprost/Timolol If you forget to use Bimatoprost/Timolol, use a single drop as soon as you remember, and then go back to your regular routine. Do not use a double dose to make up for a forgotten dose. If you stop using Bimatoprost/Timolol Bimatoprost/Timolol should be used every day to work properly. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, Bimatoprost/Timolol 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 Bimatoprost/Timolol without speaking to your doctor. The following side effects may be seen with Bimatoprost/Timolol (multi-dose and/or single-dose): Very common side effects May affect more than 1 in 10 people. Affecting the eye redness.
Common side effects May effect up to 1 in 10 people Affecting the eye burning, itching, stinging, irritation of the conjunctiva (see-through layer of the eye), sensitivity to light, eye pain, sticky eyes, dry eyes, a feeling of something in the eye, small breaks in the surface of the eye with or without inflammation, difficulty in seeing clearly, redness and itching of the eyelids, hair growing around the eye, darkening of the eyelids, darker skin colour around the eyes, longer eyelashes, eye irritation, watery eyes, swollen eyelids, reduced vision.
Uncommon side effects May affect up to 1 in 100 people. Affecting the eye abnormal sensation in the eye, iris inflammation, swollen conjunctiva (see-through layer of the eye), painful eyelids, tired eyes, in-growing eyelashes, darkening of iris colour, eyes appear sunken, eyelid drooping, eyelid shrinking (moving away from the surface of the eye leading to incomplete closure of the eyelids), skin tightness of the eyelids, darkening of eyelashes. Affecting other parts of the body shortness of breath. Side effects where the frequency is not known Affecting the eye
cystoid macular oedema (swelling of the retina within the eye leading to worsening vision), eye swelling, blurred vision, ocular discomfort. Affecting other parts of the body difficulty breathing / wheezing, symptoms of allergic reaction (swelling, redness of the eye and rash of the skin), changes in your taste sensation, dizziness, slowing of heart rate, high blood pressure, difficulty sleeping, nightmare, asthma, hair loss, skin discolouration (periocular), tiredness. Additional side effects have been seen in patients using eye drops containing timolol or bimatoprost and so may possibly be seen with Bimatoprost/Timolol. 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. The chance of having side effects after using eye drops is lower than when medicines are for example, taken by mouth or injected. Listed side effects include reactions seen within bimatoprost and timolol when used for treating eye conditions:
• Severe allergic reactions with swelling and difficulty breathing which could be life-threatening • Low blood sugar • Depression; memory loss; hallucination • Fainting; stroke; decreased blood flow to the brain; worsening of myasthenia gravis (increased muscle weakness); tingling sensation • Decreased sensation of your eye surface; double vision; drooping eyelid; separation of one of the layers within the eyeball after surgery to reduce the pressure in the eye;
inflammation of the surface of the eye, bleeding in the back of the eye (retinal bleeding), inflammation within the eye, increased blinking • Heart failure; irregularity or stopping of the heartbeat; slow or fast heartbeat; too much fluid, mainly water, accumulating in the body; chest pain • Low blood pressure, swelling or coldness of your hands, feet and extremities, caused by constriction of your blood vessels • Cough, worsening of asthma, worsening of the lung disease called chronic obstructive pulmonary disease (COPD) • Diarrhoea; stomach pain; feeling and being sick; indigestion; dry mouth • Red scaly patches on skin; skin rash • Muscle pain • Reduced sexual urge; sexual dysfunction • Weakness • An increase in blood test results that show how your liver is working
Other side effects reported with eye drops containing phosphates This medicine contains 2.85 mg phosphates in each 3 ml of solution which is equivalent to 0.95 mg/ml. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.
Reporting 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 UK 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.
Bury street Ruislip, H4A 7TL United Kingdom
This leaflet was last revised in {09/2024}
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 to protect the environment.
• The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml corresponding to timolol maleate 6.8 mg/ml. • The other ingredients are benzalkonium chloride solution (a preservative), sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and water for injection. Small amounts of hydrochloric acid or sodium hydroxide may be added to bring the solution to the correct pH (acidity) level. What Bimatoprost/Timolol looks like and contents of the pack Bimatoprost/Timolol is a colourless to slightly yellow, clear eye drop solution in a plastic bottle. The pack contains 1 or 3 plastic bottles with a screw-cap. The bottle is about half full and contains 3 millilitres of solution. This is enough for 4 weeks' usage. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Brown & Burk UK Limited Micro House
Bimatoprost/Timolol 0.3 mg/ml + 5 mg/ml eye, drops solution comes as drops containing 0.3mg/ml / 5mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Bimatoprost/Timolol 0.3 mg/ml + 5 mg/ml eye, drops solution is bimatoprost, timolol maleate.
This leaflet reproduces the patient information leaflet approved for Bimatoprost/Timolol 0.3 mg/ml + 5 mg/ml eye, drops solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
Posology
Recommended dosage in adults (including older people)
The recommended dose is one drop of Bimatoprost/Timolol in the affected eye(s) once daily, administered either in the morning or in the evening. It should be administered at the same time each day.
Existing literature data for bimatoprost/timolol suggest that evening dosing may be more effective in IOP lowering than morning dosing. However, consideration should be given to the likelihood of compliance when considering either morning or evening dosing (see section 5.1).
If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily.
Renal and hepatic impairment
Bimatoprost/Timolol has not been studied in patients with hepatic or renal impairment. Therefore caution should be used in treating such patients.
Paediatric population
The safety and efficacy of bimatoprost/timolol in children aged 0 to 18 years has not been established. No data are available.
Method of administration
If more than one topical ophthalmic medicinal product is to be used, each one should be instilled at least 5 minutes apart.
When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity.
▪ Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
▪ Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease.
▪ Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, not controlled with pace-maker. Overt cardiac failure, cardiogenic shock.
Like other topically applied ophthalmic medicinal products, the active substances (timolol/ bimatoprost) in Bimatoprost/Timolol may be absorbed systemically. No enhancement of the systemic absorption of the individual active substances has been observed. Due to the beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions as seen with systemic beta-blockers may occur. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. To reduce the systemic absorption, see section 4.2.
Cardiac disorders
Patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension therapy with beta-blockers should be critically assessed and therapy with other active substances should be considered. Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions.
Due to its negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block.
Vascular disorders
Patients with severe peripheral circulatory disturbance/disorders (i.e. severe forms of Raynaud's disease or Raynaud's syndrome) should be treated with caution.
Respiratory disorders
Respiratory reactions, including death due to bronchospasm in patients with asthma have been reported following administration of some ophthalmic beta-blockers.
Bimatoprost/Timolol should be used with caution, in patients with mild/moderate chronic obstructive pulmonary disease (COPD) and only if the potential benefit outweighs the potential risk.
Endocrine disorders
Beta-adrenergic blocking medicinal products should be administered with caution in patients subject to spontaneous hypoglycemia or to patients with labile diabetes as beta-blockers may mask the signs and symptoms of acute hypoglycemia.
Beta-blockers may also mask the signs of hyperthyroidism.
Corneal diseases
Ophthalmic β-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution
Other beta-blocking agents
The effect on intra-ocular pressure or the known effects of systemic beta-blockade may be potentiated when timolol is given to the patients already receiving a systemic beta-blocking agent. The response of these patients should be closely observed. The use of two topical beta-adrenergic blocking agents is not recommended (see section 4.5).
Anaphylactic reactions
While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergens and unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.
Choroidal detachment
Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide) after filtration procedures.
Surgical anaesthesia
β-blocking ophthalmological preparations may block systemic β-agonist effects e.g. of adrenaline. The anaesthesiologist should be informed when the patient is receiving timolol.
Hepatic
In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at baseline, bimatoprost had no adverse reactions on liver function over 24 months. There are no known adverse reactions of ocular timolol on liver function.
Ocular
Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid or periocular skin and increased brown iris pigmentation since these have been observed during treatment with bimatoprost and bimatoprost/timolol. Increased iris pigmentation is likely to be permanent, and may lead to differences in appearance between the eyes if only one eye is treated. After discontinuation of bimatoprost/timolol, pigmentation of iris may be permanent. After 12 months treatment with bimatoprost/timolol, the incidence of iris pigmentation was 0.2%. After 12 months treatment with bimatoprost eye drops alone, the incidence was 1.5% and did not increase following 3 years treatment. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. The long term effects of increased iridial pigmentation are not known. Iris colour changes seen with ophthalmic administration of bimatoprost may not be noticeable for several months to years. Neither nevi nor freckles of the iris appear to be affected by treatment. Periorbital tissue pigmentation has been reported to be reversible in some patients.
Macular oedema, including cystoid macular oedema, has been reported with bimatoprost/timolol. Therefore, Bimatoprost/Timolol should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular oedema (e.g. intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy). Bimatoprost/Timolol should be used with caution in patients with active intraocular inflammation (e.g. uveitis) because the inflammation may be exacerbated.
Skin
There is a potential for hair growth to occur in areas where bimatoprost/timolol solution comes repeatedly in contact with the skin surface. Thus, it is important to apply Bimatoprost/Timolol as instructed and avoid it running onto the cheek or other skin areas.
Excipients
The preservative in Bimatoprost/Timolol, benzalkonium chloride, may cause eye irritation. Contact lenses must be removed prior to application, with at least a 15-minute wait before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses. Contact with soft contact lenses must be avoided.
Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Therefore monitoring is required with frequent or prolonged use of Bimatoprost/Timolol in dry eye patients or where the cornea is compromised.
Other conditions
Bimatoprost/Timolol has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
In studies of bimatoprost 0.3 mg/ml in patients with glaucoma or ocular hypertension, it has been shown that more frequent exposure of the eye to more than 1 dose of bimatoprost daily may decrease the IOP-lowering effect. Patients using Bimatoprost/Timolol with other prostaglandin analogues should be monitored for changes to their intraocular pressure.
No specific interaction studies have been performed with the bimatoprost/timolol fixed combination.
There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral calcium channel blockers, guanethidine, beta-adrenergic blocking agents, parasympathomimetics, anti-arrhythmics (including amiodarone) and digitalis glycosides.
Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and timolol.
Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.
Pregnancy
There are no adequate data from the use of the bimatoprost/timolol fixed combination in pregnant women. Bimatoprost/Timolol should not be used during pregnancy unless clearly necessary. To reduce the systemic absorption, see section 4.2.
Bimatoprost
No adequate clinical data in exposed pregnancies are available. Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3).
Timolol
Epidemiological studies have not revealed malformative effects but shown a risk for intra uterine growth retardation when beta-blockers are administered by the oral route. In addition, signs and symptoms of beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery. If Bimatoprost/Timolol is administered until delivery, the neonate should be carefully monitored during the first days of life. Animal studies with timolol have shown reproductive toxicity at doses significantly higher than would be used in clinical practice (see section 5.3).
Breast-feeding
Timolol
Beta-blockers are excreted in breast milk. However, at therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant. To reduce the systemic absorption, see section 4.2.
Bimatoprost
It is not known if bimatoprost is excreted in human breast milk but it is excreted in the milk of the lactating rat. Bimatoprost/Timolol should not be used by breast-feeding women.
Fertility
There are no data on the effects of bimatoprost/timolol on human fertility.
Bimatoprost/Timolol has negligible influence on the ability to drive and use machines. As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machines.
Bimatoprost/Timolol
Summary of the safety profile
The adverse reactions reported in clinical studies using bimatoprost/timolol were limited to those earlier reported for either of the single active substances bimatoprost and timolol. No new adverse reactions specific for bimatoprost/timolol have been observed in clinical studies.
The majority of adverse reactions reported in clinical studies using bimatoprost/timolol were ocular, mild in severity and none were serious. Based on 12-month clinical data, the most commonly reported adverse reaction was conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in approximately 26% of patients and led to discontinuation in 1.5% of patients.
Tabulated list of adverse reactions
Table 1 presents the adverse reactions that have been reported during clinical studies with all bimatoprost/timolol formulations (multi-dose and single-dose) (within each frequency grouping, adverse reactions are presented in order of decreasing seriousness) or in the post-marketing period.
The frequency of possible adverse reactions listed below is defined using the following convention:
Very common
≥1/10
Common
≥1/100 to <1/10
Uncommon
≥1/1,000 to <1/100
Rare
≥1/10,000 to <1/1,000
Very rare
<1/10,000
Not known
Frequency cannot be estimated from available data
Table 1
System Organ class
Frequency
Adverse reaction
Immune system disorders
Not known
hypersensitivity reactions including signs or symptoms of allergic dermatitis, angioedema, eye allergy
Psychiatric disorders
Not known
Insomnia2, nightmare2
Nervous system disorders
Common
headache
Not known
Dysgeusia2, dizziness
Eye disorders
Very common
conjunctival hyperaemia.
Common
punctuate keratitis, corneal erosion2, burning sensation2, conjunctival irritation1, eye pruritus, stinging sensation in the eye2, foreign body sensation, dry eye, erythema of eyelid, eye pain, photophobia, eye discharge, visual disturbance2, eyelid pruritus, visual acuity worsened2, blepharitis2, eyelid oedema, eye irritation, lacrimation increased, growth of eyelashes.
Uncommon
iritis2, conjunctival oedema2, eyelid pain2, abnormal sensation in the eye1, asthenopia, trichiasis2, iris hyperpigmentation2, periorbital and lid changes associated with periorbital fat atrophy and skin tightness resulting in deepening of eyelid sulcus, eyelid ptosis, enophthalmos, lagophthalmos and eyelid retraction1&2, eyelash discolouration (darkening)1.
Not known
cystoid macular oedema2, eye swelling, vision blurred2, ocular discomfort
Cardiac disorders
Not known
Bradycardia
Vascular disorders
Not known
Hypertension
Respiratory, thoracic and mediastinal disorders
Common
Rhinitis2
Uncommon
Dyspnoea
Not known
bronchospasm (predominantly in patients with pre-existing bronchospastic disease)2, asthma
Skin andsubcutaneous tissue disorders
Common
blepharal pigmentation2, hirsutism2, skin hyperpigmentation (periocular).
Not known
Alopecia, skin discolouration (periocular)
General disorders and administration site conditions
Not known
fatigue
1adverse reactions only observed with bimatoprost/timolol single-dose formulation
2 adverse reactions only observed with bimatoprost/timolol multi-dose formulation
Like other topically applied ophthalmic drugs, Bimatoprost/Timolol (bimatoprost/timolol) is absorbed into the systemic circulation. Absorption of timolol may cause similar undesirable effects as seen with systemic beta-blocking agents. The incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. To reduce the systemic absorption, see section 4.2.
Additional adverse reactions that have been seen with either of the active substances (bimatoprost or timolol), and may potentially occur also with Bimatoprost/Timolol are listed below in Table 2:
Table 2
System Organ class
Adverse reaction
Immune system disorders
systemic allergic reactions including anaphylaxis1
Metabolism and nutrition disorders
Hypoglycaemia1
Psychiatric disorders
depression1, memory loss1, hallucination1
Nervous system disorders
syncope1, cerebrovascular accident1, increase in signs and symptoms of myasthenia gravis1, paraesthesia1, cerebral ischaemia1
Eye disorders
decreased corneal sensitivity1, diplopia1, ptosis1, choroidal detachment following filtration surgery (see section 4.4)1, keratitis1, blepharospasm2, retinal haemorrhage2, uveitis2,
Cardiac disorder
atrioventricular block1, cardiac arrest1, arrhythmia1, cardiac failure1, congestive heart failure1, chest pain1, palpitations1, oedema1
Vascular disorders
hypotension1, Raynaud's phenomenon1, cold hands and feet1
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation2, COPD exacerbation2,cough1
Gastrointestinal disorders
nausea1,2, diarrhoea1, dyspepsia1, dry mouth1, abdominal pain1, vomiting1
Skin and subcutaneous tissue disorders
psoriasiform rash1 or exacerbation of psoriasis1, skin rash1
Musculoskeletal and connective tissue disorders
Myalgia1
Reproductive system and breast disorders
sexual dysfunction1, decreased libido1
General disorders and administration site conditions
asthenia1,2
Investigations
liver function tests (LFT) abnormal2
1 adverse reactions observed with timolol
2 adverse reactions observed with bimatoprost
Adverse reactions reported in phosphate containing eye drops:
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the yellow card scheme, website:www.mhra.gov.uk/yellowcard
A topical overdose with bimatoprost/timolol is not likely to occur or to be associated with toxicity.
Bimatoprost
If Bimatoprost/Timolol is accidentally ingested, the following information may be useful: in two-week oral rat and mouse studies, doses of bimatoprost up to 100 mg/kg/day did not produce any toxicity. This dose expressed as mg/m2 is at least 70-times higher than the accidental dose of one bottle of bimatoprost/timolol in a 10 kg child.
Timolol
Symptoms of systemic timolol overdose include: bradycardia, hypotension, bronchospasm, headache, dizziness, shortness of breath, and cardiac arrest. A study of patients with renal failure showed that timolol did not dialyse readily.
If overdose occurs treatment should be symptomatic and supportive.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Bimatoprost/Timolol 0.3 mg/ml + 5 mg/ml eye, drops solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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