Bimatoprost and timolol Sandoz

Patient Information Leaflet

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

Equivalent medicine
Please read all of this leaflet carefully before you start 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 give it to others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Bimatoprost and Timolol Sandoz contains two different active substances (bimatoprost and timolol), both of which reduce the pressure inside the eye. Bimatoprost belongs to a group of medicines called prostamides, which are analogues of prostaglandin. 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 drainage of fluid occurs too slowly, the pressure inside the eye increases and, over time, this may damage vision (a condition known as glaucoma). Bimatoprost and Timolol Sandoz works by reducing the production of fluid and also increasing the amount of fluid that is drained. This reduces the pressure inside the eye.
The eye drops Bimatoprost and Timolol Sandoz 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 Timolol Sandoz 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 Sandoz

Do not use Bimatoprost and Timolol Sandoz eye drops solution
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• 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 breathing problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease 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 Bimatoprost and Timolol Sandoz, tell your doctor or pharmacist if you have, or have
had in the past

• heart disorders due to coronary problems (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, low blood pressure
• heart rhythm disorders such as slow heartbeat
• breathing 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 disease
• diabetes, as timolol may mask signs and symptoms of low blood sugar levels
• severe allergic reactions
• liver or kidney problems
• eye surface disorders
• 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 surgical anaesthesia, inform your doctor that you are using Bimatoprost and Timolol
Sandoz, as timolol may alter the effects of certain medicines used during anaesthesia.
Bimatoprost and Timolol Sandoz may cause darkening and lengthening of the eyelashes; it may
also darken the skin around the eyelid. Over time, the colour 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 Sandoz, if it comes into contact with the skin surface, may cause hair growth.
Children and adolescents
Bimatoprost and Timolol Sandoz must not be used in children and adolescents under
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18 years of age.
Other medicines and Bimatoprost and Timolol Sandoz
Bimatoprost and Timolol Sandoz 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 to lower blood pressure, medicines for the heart, medicines to treat diabetes, quinidine (used to treat heart conditions and some types of malaria), or medicines used to treat depression known as fluoxetine and paroxetine.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine. Do not use Bimatoprost and Timolol Sandoz during pregnancy unless specifically instructed to do so by your doctor.
Do not use Bimatoprost and Timolol Sandoz if you are breastfeeding. Timolol may be excreted in breast milk. Ask your doctor for advice before taking any medicines while breastfeeding.
Driving and using machines
In some patients, Bimatoprost and Timolol Sandoz may cause blurred vision. Do not drive or operate machinery until symptoms have resolved.
Bimatoprost and Timolol Sandoz contains benzalkonium chloride
Bimatoprost and Timolol Sandoz contains a preservative called benzalkonium chloride. Benzalkonium chloride may cause eye irritation and is known to cloud 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.
For those engaged in sports
Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use Bimatoprost and Timolol Sandoz

Use Bimatoprost and Timolol Sandoz exactly as directed 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
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Do not use the bottle if the tamper-evident seal on the cap is not intact 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. 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 Timololo Sandoz 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 surface. Immediately after using the bottle, close it tightly by screwing the cap back on.
If you use Bimatoprost and Timololo Sandoz together with other eye medications, wait at least 5 minutes between applying Bimatoprost and Timololo Sandoz and the other medication. Ocular ointments or gels should be used last.

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

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

If you stop using Bimatoprost and Timololo Sandoz
For Bimatoprost and Timololo Sandoz 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.
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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 Sandoz without first talking to your doctor.

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

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

• Redness.

Common side effects (may affect up to 1 in 10 people)
In the eye

• Burning,
• Itching,
• Stinging sensation,
• Conjunctival irritation (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,
• Growth of eyelashes around the eyes,
• Darkening of the eyelids,
• Darkening of the skin colour around the eyes,
• Lengthening of eyelashes,
• Eye irritation,
• Watery eyes,
• Swollen eyelids,
• Reduced vision.

In other parts of the body

• Runny nose,
• Dizziness,
• Headache.

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

• Abnormal sensation in the eye,
• Iritis (inflammation of the iris),
• Conjunctival swelling (swelling of the transparent layer 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.

In other parts of the body

• Shortness of breath.

Side effects with unknown frequency (frequency cannot be estimated from the available data)
In the eye

• Cystoid macular oedema (swelling of the retina inside the eye leading to worsening of vision),
• Eye swelling,
• Blurred vision,
• Ocular discomfort.

In other parts of the body

• Breathing difficulties/wheezing,
• Symptoms of allergic reaction (swelling, eye redness, skin rash),
• Taste disturbances,
• Slowed heart rate,
• Sleep disturbances,
• Nightmares,
• Asthma,
• Hair loss,
• Fatigue,
• Skin pigmentation changes (around the eye).

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 Sandoz. Like other 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 oral or injected medicines. 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,

• 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 glaucoma surgery; inflammation of the eye surface, retrobulbar haemorrhage (bleeding behind the eye), intraocular inflammation, frequent blinking,

• Heart failure; irregularities or arrest of heartbeat; slow or rapid heartbeat; fluid retention, 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),

• Diarrhoea; stomach ache; nausea and vomiting; indigestion; dry mouth,

• Red, scaly skin patches; skin rash,

• Muscle pain,

• Reduced sexual desire; sexual dysfunction,

• Weakness,

• Increased levels of certain liver function blood tests.

Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the transparent front layer 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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bimatoprost and Timolol Sandoz

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 carton 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

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What Bimatoprost and Timololo Sandoz 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).

Description of the appearance of Bimatoprost and Timololo Sandoz and package contents
Bimatoprost and Timololo Sandoz 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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy
Manufacturers
S.C. Rompharm Company S.R.L.
Strada Eroilor nr 1A
075100 Otopeni, Judet Ilfov
Romania
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
This medicinal product is authorised in the European Economic Area countries under the
following names:
Austria Bimatoprost/Timolol Sandoz 300 microgram/ml + 5 mg/ml –
Eye drops, solution
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Bulgaria Биматопрост+Тимолол Сандоз 0,3mg+5mg/1ml капки за очи,
разтвор
Estonia Bimatoprost/Timolol Sandoz
France BIMATOPROST/TIMOLOL SANDOZ
0.3 mg/ml + 5 mg/ml, eye drops, solution
Germany Bimatoprost comp – 1 A Pharma 0.3 mg/ml + 5 mg/ml
Eye drops, solution
Italy Bimatoprost e Timololo Sandoz
Latvia Bimatoprost/Timolol Sandoz 0.3 mg/5 mg/ml acu pilieni, šķīdums
Lithuania Bimatoprost/Timolol Sandoz 0.3 mg/5 mg/ml akių lašai (tirpalas)
Netherlands Bimatoprost/Timolol Sandoz 0.3 mg/ml + 5 mg/ml, eye drops,
solution
United Kingdom Bimatoprost/Timolol maleate 0.3 mg/ml + 5 mg/ml eye drops,
solution
Romania BIMATOPROST/TIMOLOL SANDOZ 0.3 mg/5 mg/ml picături
oftalmice, solutie
Slovenia Bimatoprost/timolol Sandoz 0.3 mg/5 mg v 1 ml kapljice za oko,
raztopina
Sweden Bimatoprost/Timolol Sandoz
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