Bimatoprost and timolol Teva

Package leaflet: Information for the user

Bimatoprost and Timolol Teva 0.3 mg/ml + 5 mg/ml eye drops, solution

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

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

Bimatoprost and Timolol Teva contains two different active substances (bimatoprost and timolol);
both reduce the pressure inside the eye. Bimatoprost belongs to a group of medicines called prostamides, which are 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 continuously 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, may damage vision (a condition known as glaucoma). Bimatoprost and Timolol Teva works by reducing the production of fluid and also increasing the amount of fluid that is drained. This way, it reduces the pressure inside the eye.
The eye drops Bimatoprost and Timolol Teva are used to treat elevated eye pressure in adults, including the elderly. This increased pressure may lead to glaucoma. Your doctor will prescribe Bimatoprost and Timolol Teva 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 Teva

Do not use Bimatoprost and Timolol Teva eye drops, solution

• if you are allergic to bimatoprost, timolol, or any of the other ingredients of this medicine (listed in section 6),
• if you currently have or have previously had respiratory problems such as asthma, severe chronic obstructive pulmonary disease (a serious lung condition that may cause shortness of breath, difficulty breathing, and/or persistent cough),
• if you have heart problems, such as slow heart rate, heart block, or heart failure.

Warnings and precautions
Before using this medicine, inform your doctor or pharmacist if you have or have ever had:

• heart conditions due to coronary artery 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 or mild to moderate 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 disease,
• diabetes, as timolol may mask signs and symptoms of low blood sugar,
• severe allergic reactions,
• liver or kidney problems,
• eye surface disorders,
• 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 leading to worsening vision), for example cataract surgery,
• intraocular inflammation (e.g., uveitis).

Before anesthesia, inform your doctor that you are using Bimatoprost and Timolol Teva, as
timolol may alter the effects of certain medicines used during anesthesia.
Bimatoprost and Timolol Teva may cause eyelash growth and may darken the eyelid or skin around the
eyelid. 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 Teva may cause hair growth if it comes
into contact with the skin surface.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive
anti-doping test.
Children and adolescents
Bimatoprost and Timolol Teva must not be used in children and adolescents under 18 years of age.
Other medicines and Bimatoprost and Timolol Teva
Bimatoprost and Timolol Teva 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 any of the following medicines:

• calcium channel blockers such as nifedipine, guanethidine, or other beta-blockers used to lower blood pressure,
• heart medications such as amiodarone or digoxin, as well as quinidine (also used to treat certain forms of malaria),
• cholinergic medicines such as bethanechol, used to tighten certain muscles in the bladder and intestines,
• fluoxetine and paroxetine, used to treat depression.

If you regularly use adrenaline, blurred vision may occur when ophthalmic beta-blockers are also used.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine. Do not use Bimatoprost and Timolol Teva
during pregnancy unless specifically recommended by your doctor.
Do not use Bimatoprost and Timolol Teva 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 Teva may cause blurred vision. Do not drive or operate
machinery until symptoms have resolved.
Bimatoprost and Timolol Teva contains benzalkonium chloride
This medicine contains 0.05 mg of benzalkonium chloride per ml. Benzalkonium chloride may be
absorbed by soft contact lenses and may cause discoloration. Remove contact lenses before using this
medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience an abnormal sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use Bimatoprost and Timolol Teva

Use Bimatoprost and Timolol Teva exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The usual dose is one drop daily, in the morning or evening, in each eye requiring treatment. Take 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 broken before use.

1. 2. 3. 4. 5.

1. Wash your hands. Tilt your head backward and look upward.
2. Gently pull down the lower eyelid to form a small pocket.
3. Invert the bottle and apply gentle pressure to release one drop of eye drops into each eye to be treated.
4. Release the lower eyelid and close your eye.
5. While keeping the eye closed, press a finger against the corner of the closed eye (where the eye meets the nose) and hold for 2 minutes. This helps prevent Bimatoprost and Timololo Teva from entering the rest of the body.

If the drop does 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 surfaces. After using the bottle, close it tightly by screwing the cap back on securely.
If you are using Bimatoprost and Timololo Teva together with other eye medications, wait at least 5 minutes between applying Bimatoprost and Timololo Teva and the other medication. Ocular ointments or gels should be used last.

If you use more Bimatoprost and Timololo Teva than you should
If you have instilled more Bimatoprost and Timololo Teva than you should, it is unlikely to cause serious problems. Use the next dose at the usual time. If you are concerned, consult your doctor or pharmacist.

If you forget to use Bimatoprost and Timololo Teva
If you forget to use Bimatoprost and Timololo Teva, as soon as you remember, apply one single drop and then return to your regular dosing schedule. Do not use a double dose to make up for the missed dose.

If you stop using Bimatoprost and Timololo Teva
For Bimatoprost and Timololo Teva to work properly, it must be used every day.
If you have any doubts 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 gets them. You may continue to use the eye drops normally unless the side effects are serious. If you are concerned, consult your doctor or pharmacist. Do not stop using Bimatoprost and Timololo Teva without first talking to your doctor.

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

Very common side effects (may affect more than 1 in 10 people)
Eye disorders

• redness

Common side effects (may affect up to 1 in 10 people)
Eye disorders

• burning,
• 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,
• difficulty seeing clearly,
• redness and itching of the eyelids,
• increased eyelash growth, darkening of the eyelids,
• darkening of the skin around the eyes,
• eyelash lengthening,
• eye irritation,
• watery eyes,
• swollen eyelids,
• reduced vision.

Other body systems

• runny nose,
• headache.

Uncommon side effects (may affect up to 1 in 100 people)
Eye disorders

• abnormal sensation in the eye,
• iris inflammation,
• conjunctival swelling (swelling of the transparent membrane of the eye),
• painful eyelids,
• tired eyes,
• inward-growing eyelashes,
• darkening of the iris colour,
• sunken eyes,
• eyelid retraction (eyelid pulling away from the eye surface),
• darkening of eyelashes.

Other body systems

• shortness of breath.

Side effects with unknown frequency (frequency cannot be estimated from the available data)
Eye disorders

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

Other body systems

• breathing difficulties/wheezing,
• symptoms of allergic reaction (swelling, eye redness, skin rash),
• taste disturbances,
• dizziness, slowed heart rate,
• high blood pressure, sleep disturbances,
• nightmares,
• asthma,
• hair loss,
• skin discoloration (around the eye), fatigue.

Additional side effects have been observed in patients treated with eye drops containing timololo or bimatoprost, and therefore may also occur with Bimatoprost and Timololo Teva. Like other topical ophthalmic medicines, timolol is absorbed into the bloodstream. This may cause side effects similar to those seen with intravenously and/or orally administered beta-blockers. The likelihood of side effects after administration of eye drops is lower than with medicines taken by mouth or by injection. The listed side effects include reactions observed with bimatoprost and timololo used in the treatment of eye diseases:

• severe allergic reactions with swelling and breathing difficulties, which could potentially be life-threatening,
• low blood sugar levels,
• depression; memory loss, hallucinations,
• 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; separation of one of the layers inside the eyeball after eye pressure-lowering surgery; inflammation of the eye surface; retinal hemorrhage (bleeding in the retina); intraocular inflammation; frequent blinking,
• heart failure; irregular or stopped heartbeat; slow or fast heartbeats; fluid accumulation, mainly water, in the body; chest pain,
• low blood pressure; swollen or cold hands, feet, and extremities due to constriction of blood vessels,
• cough; worsening of asthma; worsening of chronic obstructive pulmonary disease (COPD),
• diarrhea; stomach ache; nausea and vomiting; indigestion; dry mouth,
• red, scaly skin patches; skin rash,
• muscle pain,
• reduced sexual desire; sexual dysfunction,
• weakness,
• increased levels in certain blood tests indicating liver function abnormalities.

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 or pharmacist. You can also report side effects directly via the national reporting system at 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 Timolol Teva

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 after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any 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 designated space on
the carton.
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 Teva contains

• The active substances are: bimatoprost 0.3 mg/ml and timolol 5 mg/ml, equivalent to 6.8 mg/ml of timolol maleate.
• The other ingredients are: benzalkonium chloride (a preservative), sodium chloride, disodium phosphate heptahydrate, 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).

What Bimatoprost and Timololo Teva looks like and contents of the pack
Bimatoprost and Timolol Teva is a colourless or slightly yellow solution in a plastic bottle.
Each pack contains 1 or 3 plastic bottles with screw caps.
Each bottle is approximately half full and contains 3 ml of solution, sufficient for 4 weeks of use.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milano, Italy

Manufacturer
S.C. ROMPHARM COMPANY S.R.L. - Eroilor Street 1A - 75100 Otopeni - Romania
Merckle GmbH Ludwig-Merckle-Straße 3 - 89143 Blaubeuren - Germany