Bisantim

PACKAGE LEAFLET: INFORMATION FOR

THE USER
BIMATOPROST and TIMOLOL DOC 0.3 mg/ml + 5 mg/ml eye drops, solution
Equivalent medicine
Please read all of 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 they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What BIMATOPROST and TIMOLOL DOC is and what it is used for

BIMATOPROST and TIMOLOL DOC 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 aqueous 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 drainage of the fluid is too slow, pressure inside the eye increases and, over time, this may damage vision (a condition called glaucoma). BIMATOPROST and TIMOLOL DOC works by reducing the production of fluid and also by increasing the amount of fluid that is drained. This way, it reduces the pressure inside the eye.
The eye drops BIMATOPROST and TIMOLOL DOC are used to treat elevated eye pressure in adults, including the elderly. This elevated pressure may lead to glaucoma. Your doctor will prescribe BIMATOPROST and TIMOLOL DOC 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 DOC eye drops, solution

Do not use BIMATOPROST and TIMOLOL DOC eye drops, solution

• 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, severe chronic obstructive pulmonary disease (severe lung disease that may cause shortness of breath, breathing difficulties, and/or persistent cough);
• if you have heart problems, such as slow heartbeat, heart block, or heart failure.

Warnings and precautions
Talk to your doctor or pharmacist before using BIMATOPROST and TIMOLOL DOC if you have or have previously had:

• coronary artery disease (symptoms may include chest pain or tightness, shortness of breath, or choking);
• heart failure, low blood pressure;
• heart rhythm disorders, such as slow heartbeat;
• respiratory problems, asthma, or chronic obstructive pulmonary disease;
• poor blood circulation (such as Raynaud’s disease or Raynaud’s syndrome);
• overactive 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;
• retinal detachment (separation of layers within 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 TIMOLOL DOC, as timolol may alter the effects of certain medicines used during anesthesia.

BIMATOPROST and TIMOLOL DOC 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 treated. BIMATOPROST and TIMOLOL DOC may cause increased hair growth if it comes into contact with the skin surface.

Children and adolescents
BIMATOPROST and TIMOLOL DOC must not be used in children and adolescents under 18 years of age.

Other medicines and BIMATOPROST and TIMOLOL DOC
BIMATOPROST and TIMOLOL DOC may affect or be affected by other medicines you are taking, including other eye drops for glaucoma treatment. 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 plan to use medicines to lower blood pressure, heart medications, diabetes medications, quinidine (used to treat heart conditions and certain types of malaria), or antidepressants such as fluoxetine and paroxetine.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not use BIMATOPROST and TIMOLOL DOC during pregnancy unless specifically recommended by your doctor.
Do not use BIMATOPROST and TIMOLOL DOC if you are breastfeeding. Timolol may pass into breast milk. Consult your doctor before taking any medicine during breastfeeding.

Driving and using machines
In some patients, BIMATOPROST and TIMOLOL DOC may cause blurred vision. Do not drive or operate machinery until symptoms have resolved.

BIMATOPROST and TIMOLOL DOC contains benzalkonium chloride
BIMATOPROST and TIMOLOL DOC contains a preservative called benzalkonium chloride. Benzalkonium chloride may cause eye irritation and is known to discolor soft contact lenses. Do not use the drops while wearing contact lenses. After using the eye drops, wait at least 15 minutes before reinserting your contact lenses.

3. How to use BIMATOPROST and TIMOLOL DOC

Use BIMATOPROST and TIMOLOL DOC exactly as instructed 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 drop every day at the same time.

Instructions for use

Do not use the bottle if the tamper-evident seal is damaged before first use.

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 the 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 TIMOLOL DOC from being absorbed into 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 any other surface. Immediately after using the medicine, close the bottle tightly by screwing the cap back on.

If you are using BIMATOPROST and TIMOLOL DOC together with other eye medicines, wait at least 5 minutes between applying BIMATOPROST and TIMOLOL DOC and the other medicine. Ointments or ocular gels should be used last.

If you use more BIMATOPROST and TIMOLOL DOC than you should

If you have instilled more BIMATOPROST and TIMOLOL DOC than recommended, it is unlikely to cause serious problems. Take the next dose at the usual time. If you are concerned, consult your doctor or pharmacist.

If you forget to use BIMATOPROST and TIMOLOL DOC

If you forget to use BIMATOPROST and TIMOLOL DOC, instill one drop in the affected eye as soon as you remember, 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 DOC

To work properly, BIMATOPROST and TIMOLOL DOC 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 everybody gets 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 DOC without talking to your doctor.

The following side effects may occur with BIMATOPROST and TIMOLOLO DOC:

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

• Redness

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

• Burning;
• Itching;
• Stinging sensation;
• Conjunctival irritation (the transparent membrane of the eye);
• Light sensitivity;
• Eye pain, sticky eyes, dry eyes, sensation of 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 hair growth around the eyes;
• Darkening of the eyelids;
• Darkening of the skin around the eyes;
• Eyelash lengthening;
• Eye irritation;
• Watery eyes;
• Swollen eyelids;
• Reduced vision.

Other parts of the body

• Runny nose;
• Dizziness;
• Headache.

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

• Abnormal sensation in the eye;
• Iritis (inflammation of the iris);
• Conjunctival swelling (swelling of the transparent layer of the eye);
• Painful eyelids;
• Tired eyes;
• Ingrown eyelashes;
• Darkening of the iris colour;
• Sunken eyes;
• Eyelid pulling away from the surface of the eye;
• Darkening of eyelashes.

Other parts of the body

• Shortness of breath.

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

• Cystoid macular edema (swelling of the retina inside the eye leading to worsening of vision);
• Swelling of the eyes;
• Blurred vision.

Other parts of the body

• Breathing difficulties / shortness of breath;
• Symptoms of allergic reaction (swelling, eye redness, skin rash);
• Taste disturbances;
• Slowing of the heartbeat;
• Difficulty sleeping;
• 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 DOC. Like other topical ophthalmic medicines, timolol is absorbed and passes 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 using eye drops is lower than when medicines are taken orally or by injection. The listed side effects include reactions reported with bimatoprost and timololo 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, separation of one of the layers inside the eyeball after eye pressure-lowering surgery, inflammation of the eye surface, retinal haemorrhage (bleeding of the retina), intraocular inflammation, frequent blinking;
• Heart failure, irregular or stopped heartbeat, slow or rapid heartbeat, fluid accumulation, mainly water, in the body, chest pain;
• Low blood pressure, high 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 phosphate-containing eye drops
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 spots 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, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at http://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 DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After opening, the solution 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 vial 4 weeks after first opening. To help you remember, write down the date of opening in the space provided 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 TIMOLOLO DOC 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 excipients 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) level.

Description of the appearance of BIMATOPROST and TIMOLOLO DOC and contents of the pack
BIMATOPROST and TIMOLOLO DOC 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.
This quantity is sufficient for 4 weeks of use.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici Srl
Via Turati 40
20121 Milan
Italy

Manufacturer
S.C. ROMPHARM COMPANY S.R.L.
Eroilor Street, no. 1A
075100 Otopeni, Ilfov
Romania

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands: bimatoprost/timolol DOC oogdruppels, oplossing
Italy: BIMATOPROST and TIMOLOLO DOC