BIMATOPROST 0.3 mg/ml + 5 mg/ml Eye drops, solution

Зміст інструкції

1. Bimatoprost and Timolol Mylan 0.3 mg/ml + 5 mg/ml eye drops
   1. What is Bimatoprost and Timolol Mylan and what it is used for
   2. What you need to know before using Bimatoprost and Timolol Mylan
   3. How to use Bimatoprost and Timolol Mylan
   4. Possible side effects
   5. How to store Bimatoprost and Timololo Mylan
   6. Contents of the pack and other information

Bimatoprost and Timolol Mylan 0.3 mg/ml + 5 mg/ml eye drops

Bimatoprost/timolol

Generic Medicine
Read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Bimatoprost and Timolol Mylan is and what it is used for
• 2. What you need to know before using Bimatoprost and Timolol Mylan
• 3. How to use Bimatoprost and Timolol Mylan
• 4. Possible side effects 5 How to store Bimatoprost and Timolol Mylan
• 6. Contents of the pack and other information

1. What is Bimatoprost and Timolol Mylan and what it is used for

Bimatoprost and Timolol Mylan contains two different active ingredients (bimatoprost and timolol);
both reduce the pressure inside the eye. Bimatoprost belongs to a group of
medicines called prostamides, prostaglandin analogues. Timolol belongs to a group of
medicines called beta-blockers.
The eye contains a clear, aqueous liquid that nourishes it internally. This liquid is
constantly drained from the eye and new liquid is produced to replace it. If
the drainage of the liquid does not occur quickly enough, the pressure inside the eye
increases and over time can damage vision (a disease called glaucoma).
Bimatoprost and Timolol Mylan works by reducing the formation of the liquid and also increasing the
amount of liquid that is drained. In this way it reduces the pressure inside the eye.
The eye drops Bimatoprost and Timolol Mylan are used to treat high eye pressure
in adults, including the elderly .This high pressure can lead to glaucoma. Your doctor will
prescribe Bimatoprost and Timolol Mylan if other eye drops containing beta-blockers or analogues
of prostaglandin have not worked effectively.

2. What you need to know before using Bimatoprost and Timolol Mylan

Do not use Bimatoprost and Timolol Mylan

• if you are allergic to bimatoprost, timolol, beta-blockers or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from or have suffered in the past from respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that can cause wheezing, difficulty breathing and/or persistent cough)
• if you have heart problems, such as slow heart rate, heart block or heart failure.

Warnings and precautions
Talk to your doctor or pharmacist before using Bimatoprost and Timolol Mylan, if you have or have had:

• coronary problems (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure
• heart rate disorders such as slowed heartbeat
• respiratory problems, asthma or chronic obstructive pulmonary disease
• pathologies due to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• excessive activity of the thyroid gland, as timolol may mask signs and symptoms of thyroid diseases
• diabetes, as timolol may mask signs and symptoms of low blood sugar levels
• severe allergic reactions
• problems with the liver or kidneys
• problems with the surface of the eye
• separation of one of the layers inside the eyeball after surgery to reduce intraocular pressure
• known risk factors for macular edema (swelling of the retina inside the eye that leads to worsening vision), for example cataract surgery.

Before surgical anesthesia, tell your doctor that you are using Bimatoprost and Timolol Mylan in
as timolol may alter the effects of some medicines used during anesthesia.
Bimatoprost and Timolol Mylan may cause darkening and lengthening of the eyelashes; it may also
darken the skin around the eyelids. Over time, the color of the iris may also darken. These
changes may be permanent and are more noticeable if only one eye is being treated.
Bimatoprost and Timolol Mylan may cause hair growth if it comes into contact with the surface of the
skin.

Children and adolescents
Bimatoprost and Timolol Mylan should not be used in children and adolescents under 18 years of
age.

Other medicines and Bimatoprost and Timolol Mylan
Bimatoprost and Timolol Mylan can affect or be affected by other medicines you are taking,
including other eye drops for the treatment of glaucoma. Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicine. Tell your doctor if you are using
or intend to use

• medicines for the treatment of heart and blood vessel diseases, such as hypertension (high blood pressure), angina and some antiarrhythmics (e.g. guanethidine, amiodarone).
• medicines for the treatment of diabetes
• quinidine (used to treat heart conditions and some types of malaria).
• medicines for the treatment of depression known as fluoxetine and paroxetine.
• other medicines used to treat glaucoma (other beta-blockers).
• adrenaline (often used to treat severe allergic reactions).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine. Do not use
Bimatoprost and Timolol Mylan during pregnancy unless expressly indicated by your
doctor.
Do not use Bimatoprost and Timolol Mylan if you are breastfeeding. Timolol may be excreted
into breast milk. Consult your doctor before taking medicines while breastfeeding.

Driving and operating machinery
In some patients, Bimatoprost and Timolol Mylan may cause blurred vision. Do not drive vehicles or
operate machinery until the symptoms have disappeared.

Bimatoprost and Timolol Mylan contains phosphates and benzalkonium chloride
This medicine contains 0.95 milligrams of phosphates and 0.05 milligrams of benzalkonium chloride in each
millilitre.
If you suffer from severe damage to the transparent layer in front of your eye (the cornea), phosphates may
cause, in very rare cases, opaque spots on the cornea due to calcium deposits during
treatment.
Benzalkonium chloride can be absorbed by soft contact lenses and can change their color.
Remove contact lenses before using this medicine and wait at least 15 minutes before
re-applying the lenses.
Benzalkonium chloride can also cause irritation to the eye, especially in case of dry eyes
or corneal disorders (the transparent layer in front of the eye). See your doctor if you experience an
abnormal sensation in the eye, a feeling of pins and needles or eye pain.

3. How to use Bimatoprost and Timolol Mylan

Use Bimatoprost and Timolol Mylan following the instructions of your doctor or pharmacist exactly. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is one drop per day in the morning or evening in each eye that needs treatment. Instill the dose at the same time each day.

Instructions for use
Do not use the bottle if the tamper-evident seal on the cap is not intact before use.

• 1. Wash your hands. Tilt your head back and look up.
• 2. Gently lower the lower eyelid to form a small pocket.
• 3. Invert the bottle and apply gentle pressure to dispense one drop of eye drops into each eye to be treated.
• 4. Release the lower eyelid and close your eye.
• 5. Keeping your eye closed, press a finger against the corner of the closed eye (where the eye meets the nose) and hold for 2 minutes. This will help prevent Bimatoprost and Timolol Mylan from entering the rest of your body. If the drop does not enter the eye, repeat the operation.

To avoid contamination, the tip of the bottle must not touch the eye or come into contact with other surfaces. After using the bottle, close it tightly by screwing the cap back on.
If you are using Bimatoprost and Timolol Mylan at the same time as other eye medications, allow at least 5 minutes to pass between applying Bimatoprost and Timolol Mylan and applying the other medication. Ointments or gels should be used last.

If you use more Bimatoprost and Timolol Mylan than you should
If you have instilled more Bimatoprost and Timolol Mylan than you should, it is unlikely to cause serious consequences. Administer the next dose at the usual time. If this causes you concern, consult your doctor or pharmacist.

If you forget to use Bimatoprost and Timolol Mylan
If you forget to use Bimatoprost and Timolol Mylan, as soon as you remember, put in one drop and then return to your normal dosing schedule. Do not use a double dose to make up for a missed dose.

If you stop using Bimatoprost and Timolol Mylan
To work correctly, Bimatoprost and Timolol Mylan must be used every day.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
You can continue to use the eye drops normally unless the side effects are serious. If you are worried, consult your doctor or pharmacist. Do not stop using Bimatoprost and
Timolol Mylan without talking to your doctor.
The following side effects may occur with Bimatoprost and Timolol Mylan:

Very common side effects(may affect more than 1 in 10 people)
Related to the eye

• redness. Common side effects(may affect up to 1 in 10 people) Related to the eye
• burning,
• itching,
• stinging sensation,
• irritation of the conjunctiva (clear membrane of the eye),
• sensitivity to light,
• eye pain, sticky eyes, dry eyes, feeling of something in the eye,
• small ulcers on the surface of the eye, with or without inflammation,
• difficulty seeing clearly,
• redness and itching of the eyelids,
• growth of eyelashes around the eyes,
• darkening of the eyelids,
• darkening of the skin color around the eyes,
• lengthening of the eyelashes,
• eye irritation,
• tearing,
• swollen eyelids,
• reduced vision.

Related to other parts of the body

• runny nose,
• headache.

Uncommon side effects(may affect up to 1 in 100 people)
Related to the eye

• abnormal sensation in the eyes,
• inflammation of the iris,
• swollen conjunctiva (clear membrane of the eye),
• painful eyelids,
• tired eyes,
• eyelashes growing inwards,
• darkening of the iris,
• sunken eyes,
• loosening of the eyelid from the surface of the eye,
• darkening of the eyelashes.

Related to other parts of the body

• shortness of breath.

Side effects with unknown frequency(frequency cannot be estimated based on available data)
Related to the eye

• cystoid macular edema (swelling of the retina inside the eye that leads to worsening of vision),
• eye swelling,
• blurred vision
• eye discomfort.

Related to other parts of the body

• difficulty breathing/wheezing,
• symptoms of an allergic reaction (swelling, redness of the eye and skin rash),
• hyperpigmentation of the skin (periocular)
• altered taste,
• dizziness,
• slowing of the heart rate,
• high blood pressure,
• sleep disorders,
• nightmare,
• asthma,
• hair loss,
• fatigue.

Further side effects have been observed in patients treated with eye drops containing
timolol or bimatoprost and therefore may also occur with Bimatoprost and Timolol Mylan.
Like other ophthalmic medicines for topical use, timolol is absorbed and enters the bloodstream. This may
cause side effects similar to those observed with beta-blockers administered by
“intravenous” and/or “oral” route. The possibility of side effects after the administration of eye drops is
lower than that resulting from the administration of medicines by mouth or by injection.
Among the listed side effects are included reactions contemplated in bimatoprost and timolol used
for the treatment of eye diseases:

• severe allergic reactions with swelling and difficulty breathing that could be potentially fatal,
• low blood sugar levels,
• depression; memory loss,
• fainting; stroke; reduced blood flow to the brain; worsening of myasthenia gravis (increased muscle weakness); tingling sensation,
• reduced sensitivity of the surface of the eye; double vision; lowering of the eyelid, separation of one of the layers inside the eyeball after surgery to reduce pressure in the eye; inflammation of the surface of the eye; bleeding in the back of the eye (retinal bleeding), inflammation inside the eye; frequent blinking,
• heart failure; irregular or stopped heartbeat; slow or fast heartbeats; accumulation of fluids, mainly water, in the body; chest pain,
• low blood pressure; hands, feet and extremities swollen or cold due to constriction of the

blood vessels,

• cough; worsening of asthma; worsening of a lung condition called chronic obstructive pulmonary disease (COPD),
• diarrhea; stomach pain; nausea and vomiting; indigestion; dry mouth,
• red and scaly skin patches; rash,
• muscle pain,
• reduced sexual desire; sexual dysfunction,
• weakness,
• an increase in the levels of some blood tests that indicate liver function
• hallucinations.

Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the transparent layer of the front part
of the eye (the cornea) have developed opaque areas on the cornea due to the accumulation of calcium
during treatment.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Bimatoprost and Timololo Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the bottle and on the
pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Once opened, the solutions may become contaminated, which can cause eye infections.
For this reason, even if you have not used all of the solution, you must throw away the bottle 4 weeks
after first opening. To avoid forgetting, write the date of opening in the appropriate space on the
pack.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Bimatoprost and Timolol Mylan contains
The active ingredients are: bimatoprost 0.3 mg/ml and timolol 5 mg/ml, corresponding to 6.8 mg/ml of
timolol maleate.
The other excipients are: benzalkonium chloride (a preservative), disodium phosphate heptahydrate, sodium chloride,
citric acid monohydrate and purified water. Small amounts of hydrochloric acid or sodium hydroxide may have been added to bring the solution to the correct pH (acidity) (see paragraph
2 “ Bimatoprost and Timolol Mylan contains phosphates and benzalkonium chloride”).

Description of the appearance of Bimatoprost and Timolol Mylan and contents of the pack
Bimatoprost and Timolol Mylan is a solution from colourless to slightly yellow supplied in a plastic
bottle.
Each pack contains 1 plastic bottle or 3 plastic bottles each with a screw cap.
Each bottle is filled approximately halfway and contains 3 millilitres of solution, sufficient for 4 weeks of
use.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano

Manufacturer
S.C. Rompharm Company S.R.L., Eroilor Street no. 1A, Otopeni, Ilfov, 075100, Romania
Mylan UK Healthcare Limited, Building 20, Station Close, Potters Bar, EN6 1TL, United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Netherlands: Bimatoprost/Timolol Mylan 0.3 mg/ml + 5 mg/ml, oogdruppels, oplossing
Croatia: Bimatoprost/Timolol Mylan 0.3 mg/ml + 5 mg/ml kapi za oko, otopina
Estonia: Bimatoprost/Timolol Mylan
Finland: Bimatoprost/Timolol Mylan 0.3 mg/ml + 5 mg/ml silmätipat, liuos
France: Bimatoprost/Timolol Mylan 0.3 mg/ml + 5 mg/ml, collyre en solution
Italy: Bimatoprost e Timololo Mylan
Latvia: Bimatoprost/Timolol Mylan 0.3 mg/5 mg/ml acu pilieni, šķīdums
Lithuania: Bimatoprost/Timolol Mylan 0.3 mg/5 mg/ml akių lašai (tirpalas)
Portugal: Bimatoprost/timolol Mylan
Romania: Bimatoprost/Timolol Mylan 0.3 mg/5 mg/ml picături oftalmice, soluţie
United Kingdom: Bimatoprost/Timolol Mylan 0.3 mg/ml + 5 mg/ml eye drops, solution