Bimatoprost and timolol Mylan

Package leaflet: Information for the user

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

Bimatoprost/timolol
Generic Medicine
Please read this leaflet carefully before using this medicine because 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 Bimatoprost and Timololo Mylan is and what it is used for

Bimatoprost and Timololo Mylan contains two different active substances (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, watery fluid that nourishes its internal structures. This fluid is constantly drained from the eye, and new fluid is produced to replace the drained fluid. If the fluid is not drained quickly enough, the pressure inside the eye increases and, over time, this may damage vision (a condition known as glaucoma).
Bimatoprost and Timololo Mylan works by reducing the production of fluid and also increasing the amount of fluid that is drained. In this way, it reduces the pressure inside the eye.
The eye drops Bimatoprost and Timololo Mylan are used to treat elevated eye pressure in adults, including elderly patients. This increased pressure may lead to glaucoma. Your doctor will prescribe Bimatoprost and Timololo Mylan if other eye drops containing beta-blockers or prostaglandin analogues have not been effective.

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 have or have previously had respiratory problems such as asthma, or severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, breathing difficulties, 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:

• heart disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, low blood pressure
• heart rhythm disorders such as slow heartbeat
• respiratory problems, asthma, or chronic obstructive pulmonary disease
• conditions caused by poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• overactivity of the thyroid gland, as timolol may mask signs and symptoms of thyroid disorders
• diabetes, as timolol may mask signs and symptoms of low blood sugar levels
• severe allergic reactions
• liver or kidney problems
• problems affecting the surface of the eye
• separation of one of the layers inside the eyeball following surgery to reduce intraocular pressure
• known risk factors for macular edema (swelling of the retina inside the eye leading to worsening vision), for example cataract surgery.

Before undergoing surgical anesthesia, inform your doctor that you are using Bimatoprost and Timololo Mylan, as timolol may alter the effects of certain medicines used during anesthesia.
Bimatoprost and Timolol Mylan may cause darkening and lengthening of 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 treated.
Bimatoprost and Timolol Mylan may cause hair growth if it comes into contact with the skin surface.

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

Other medicines and Bimatoprost and Timolol Mylan
Bimatoprost and Timolol Mylan may affect or be affected by other medicines you are taking, including other eye drops used to treat glaucoma. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Inform your doctor if you are using or intend to use:

• medicines for heart and blood vessel conditions, such as hypertension (high blood pressure), angina, and certain antiarrhythmics (e.g. guanethidine, amiodarone)
• medicines for diabetes
• quinidine (used to treat heart conditions and certain types of malaria)
• medicines for 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, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not use Bimatoprost and Timolol Mylan during pregnancy unless specifically instructed by your doctor.
Do not use Bimatoprost and Timolol Mylan if you are breastfeeding. Timolol may be excreted in breast milk. Consult your doctor before taking any medicines while breastfeeding.

Driving and using machines
In some patients, Bimatoprost and Timolol Mylan may cause blurred vision. Do not drive or operate machinery until symptoms have resolved.

Bimatoprost and Timolol Mylan contains phosphates and benzalkonium chloride
This medicine contains 0.95 milligrams of phosphates and 0.05 milligrams of benzalkonium chloride per millilitre.
If you have severe damage to the transparent layer at the front of the eye (the cornea), phosphates may very rarely cause cloudy spots on the cornea due to calcium deposits during treatment.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Remove your contact lenses before using this medicine and wait at least 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially in case of dry eyes or corneal disorders (the transparent layer at the front of the eye). Consult your doctor if you experience abnormal eye sensations, a prickly sensation, or eye pain.

3. How to use Bimatoprost and Timolol Mylan

Use Bimatoprost and Timolol Mylan exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one drop daily, in the morning or evening, in each eye requiring treatment. Instill the dose at the same time every day.
Instructions for use
Do not use the bottle if the tamper-evident seal on the cap is not intact before first use.

1. Wash your hands. Tilt your head backward and look upward.
2. Gently pull down the lower eyelid to create a small pocket.
3. Invert the bottle and gently squeeze to release one drop of eye drops into each eye being treated.
4. Release the lower eyelid and close the eye.
5. While keeping the eye closed, press a finger against the inner corner of the eye (where the eye meets the nose) and hold for 2 minutes. This helps prevent Bimatoprost and Timolol Mylan from being absorbed into the rest of the body. If the drop did not enter the eye, repeat the procedure.

To avoid contamination, the tip of the bottle must not touch the eye or come into contact with any other surface. After using the bottle, close it tightly by screwing the cap back on.
If you are using Bimatoprost and Timolol Mylan together with other eye medications, wait at least 5 minutes between applying Bimatoprost and Timolol Mylan and the other medicine. Ocular 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 intended, it is unlikely to cause serious problems. Take the next dose at your usual time. If you are concerned, 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, apply one drop and then continue with your regular dosing schedule. Do not use a double dose to make up for the missed dose.
If you stop using Bimatoprost and Timolol Mylan
To work properly, Bimatoprost and Timolol Mylan must be used every day.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. You may continue using the eye drops normally unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using Bimatoprost and Timololo Mylan without first talking to your doctor.

The following side effects may occur with Bimatoprost and Timololo Mylan:

Very common side effects (may affect more than 1 in 10 people)
Eye-related:

• Redness of the eye

Common side effects (may affect up to 1 in 10 people)
Eye-related:

• Burning sensation,
• Itching,
• Stinging sensation,
• Conjunctival irritation (irritation of the transparent membrane of the eye),
• Light sensitivity,
• Eye pain, sticky eyes, dry eyes, sensation of a foreign body in the eye,
• Small ulcers on the surface of the eye, with or without inflammation,
• Blurred vision,
• Redness and itching of the eyelids,
• Increased growth of eyelashes,
• Darkening of the eyelids,
• Darkening of the skin around the eyes,
• Eyelash lengthening,
• Eye irritation,
• Tearing,
• Swollen eyelids,
• Reduced vision.

Other body parts:

• Runny nose,
• Headache.

Uncommon side effects (may affect up to 1 in 100 people)
Eye-related:

• Abnormal sensation in the eyes,
• Iritis (inflammation of the iris),
• Swollen conjunctiva (the transparent membrane of the eye),
• Painful eyelids,
• Tired eyes,
• Eyelashes growing inward,
• Darkening of the iris,
• Sunken eyes,
• Eyelid retraction (eyelid pulling away from the eye surface),
• Darkening of eyelashes.

Other body parts:

• Shortness of breath.

Side effects with unknown frequency (frequency cannot be estimated from available data)
Eye-related:

• Cystoid macular edema (swelling of the retina inside the eye causing worsening of vision),
• Eye swelling,
• Blurred vision,
• Eye discomfort.

Other body parts:

• Breathing difficulties/wheezing,
• Symptoms of allergic reaction (swelling, eye redness, skin rash),
• Skin hyperpigmentation (periocular),
• Taste disturbances,
• Dizziness,
• Slowed heart rate,
• High blood pressure,
• Sleep disturbances,
• Nightmares,
• Asthma,
• Hair loss,
• Fatigue.

Additional side effects have been observed in patients treated with eye drops containing timolol or bimatoprost, and therefore may also occur with Bimatoprost and Timololo Mylan. As with other topical ophthalmic medicines, timololo may be absorbed into the bloodstream. This may cause side effects similar to those seen with intravenous and/or oral beta-blockers. The likelihood of side effects after administration of eye drops is lower than that associated with oral or injectable medicines.

The listed side effects include reactions reported with bimatoprost and timololo when used to treat eye diseases:

• Severe allergic reactions with swelling and breathing difficulties, which could potentially be life-threatening,
• 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 eye surface; double vision; drooping eyelid; retinal detachment (separation of layers within the eyeball) following eye pressure-lowering surgery; eye surface inflammation; retinal haemorrhage (bleeding in the retina); intraocular inflammation; frequent blinking,
• Heart failure; irregular or stopped heartbeat; slow or rapid heartbeat; fluid retention, mainly water, in the body; chest pain,
• Low blood pressure; swollen or cold hands, feet, and extremities due to blood vessel constriction,
• Cough; worsening of asthma; worsening of chronic obstructive pulmonary disease (COPD),
• Diarrhoea; stomach ache; nausea and vomiting; indigestion; dry mouth,
• Red, scaly skin patches; skin rash,
• Muscle pain,
• Decreased sexual desire; sexual dysfunction,
• Weakness,
• Increased levels in certain blood tests indicating liver function abnormalities,
• Hallucinations.

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 stated on the label of the bottle and on the
package after Exp. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Once opened, the solutions may become contaminated, which could lead to eye infections.
For this reason, even if you have not used all the solution, you must discard the bottle 4 weeks
after first opening. To help you remember, write the date of opening in the space provided on the
package.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bimatoprost and Timolol Mylan contains
The active substances 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 adjust the solution to the correct pH (acidity) (see section 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 ranging 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 approximately half full 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 Milan, Italy
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 European Economic Area countries under the
following names:
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