Brimonidine and timolol Mylan

Package leaflet: Information for the patient

Brimonidine and Timolol Mylan 2 mg/ml + 5 mg/ml eye drops

brimonidine tartrate and timolol maleate
Equivalent medicine (only for packages containing 1 and 3 bottles of 5 ml)
Please 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Brimonidina e Timololo Mylan is and what it is used for

Brimonidina e Timololo Mylan is an eye drop medicine used to control glaucoma. It contains two different active substances (brimonidine and timolol) that work together to reduce elevated pressure inside the eye. Brimonidine belongs to a group of medicines called alpha-2 adrenergic receptor agonists. Timololo belongs to a group of medicines called beta-blockers. Brimonidina e Timololo Mylan has been prescribed to reduce elevated intraocular pressure when beta-blocker eye drops used alone are not sufficient.
The eye contains a clear, aqueous fluid that delivers nutrients to the inner parts of the eye. This fluid is continuously drained from the eye and replaced by a constant production of new fluid. When this fluid cannot drain properly, pressure inside the eye increases, potentially impairing vision. Brimonidina e Timololo Mylan works by reducing the production of fluid in the eye and increasing the amount of fluid that drains out. This leads to a reduction in intraocular pressure, while the eye continues to receive its necessary nutrients normally.

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

Do not use Brimonidine and Timolol Mylan

• if you are allergic to brimonidine tartrate, timolol, beta-blockers, or any of the other components of this medicine (listed in section 6). Symptoms of an allergic reaction may include swelling of the face, lips, and throat, shortness of breath, feeling faint, difficulty breathing, itching, or redness around the eye.
• if you have or have previously had respiratory problems such as asthma, severe chronic obstructive pulmonary disease (COPD) (a severe lung disease that can cause shortness of breath, breathing difficulties, and/or long-lasting cough).
• if you have heart problems such as slow heart rate, heart failure, or irregular heartbeat (unless controlled by a pacemaker).
• if you are taking monoamine oxidase inhibitors (MAO inhibitors) or certain antidepressant medicines.

Brimonidine and Timolol Mylan must not be used in children under 2 years of age and should not normally be used in children aged between 2 and 17 years.
If you think any of the above points apply to you, do not use Brimonidine and Timolol Mylan before consulting your doctor again.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Warnings and precautions
Talk to your doctor or pharmacist before using Brimonidine and Timolol Mylan if you have or have previously 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
• a disease related to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• diabetes, as timolol may mask the signs and symptoms of low blood sugar
• overactive thyroid gland, as timolol may mask its signs and symptoms
• kidney or liver problems
• a tumor of the adrenal gland
• eye surgery to reduce eye pressure
• any allergies (e.g. hay fever, eczema) or a history of severe allergic reactions, as the usual dose of adrenaline used to treat severe allergic reactions may need to be increased.
• Before undergoing surgery, inform your doctor that you are using Brimonidine and Timolol Mylan, as timolol may alter the effects of certain medicines used during anesthesia.

Other medicines and Brimonidine and Timolol Mylan
Brimonidine and Timolol Mylan may affect or be affected by other medicines you are taking, including other eye drops used to treat glaucoma.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines for any condition—even those unrelated to eye disease—and those obtained without a prescription.
Some medicines may interact with Brimonidine and Timolol Mylan, so it is especially important to inform your doctor if you are taking:

• painkillers
• medicines to help you sleep or reduce anxiety
• medicines for high blood pressure (hypertension)
• medicines for heart problems (e.g. irregular heartbeat), such as beta-blockers, digoxin, or quinidine (used to treat heart conditions and some types of malaria)
• medicines for diabetes or high blood sugar
• medicines for depression such as fluoxetine and paroxetine
• another eye drop used to lower high eye pressure (glaucoma)
• medicines used to treat severe allergic reactions
• medicines that affect certain hormones in the body, such as adrenaline and dopamine
• medicines that act on the muscles in blood vessels
• medicines for treating heartburn or ulcers
  If the dose of any of your current medicines has changed or if you regularly consume alcohol, inform your doctor.
  If you are due to receive an anesthetic, inform your doctor or dentist that you are taking Brimonidine and Timolol Mylan.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use Brimonidine and Timolol Mylan during pregnancy unless your doctor considers it necessary.
Do not use Brimonidine and Timolol Mylan if you are breastfeeding. Timolol may be excreted in breast milk.
Ask your doctor for advice before taking any medicine while breastfeeding.

Driving and using machines
Brimonidine and Timolol Mylan may cause drowsiness, fatigue, or blurred vision in some patients.
Do not drive or operate tools or machinery until these symptoms have resolved. If you experience any problems, consult your doctor.

Brimonidine and Timolol Mylan contains phosphate buffer and benzalkonium chloride
This medicine contains 10.6 mg of phosphate buffer and 0.05 mg of benzalkonium chloride per 1 ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy corneal deposits due to calcium accumulation during treatment.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color. Remove your 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 (damage to the eye's superficial transparent layer). If you experience unusual sensations, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use Brimonidine and Timolol Mylan

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
Use in children and adolescents
Brimonidine and Timolol Mylan must not be used in children under 2 years of age. Brimonidine and Timolol Mylan is not normally used in children and adolescents (from 2 to 17 years of age).
Use in adults, including elderly patients
The recommended dose is one drop of Brimonidine and Timolol Mylan twice daily, approximately every 12 hours.
Do not change the dose or stop using the medicine without speaking to your doctor.
If you are using Brimonidine and Timolol Mylan with another eye drop, wait at least 5 minutes between applying Brimonidine and Timolol Mylan and the other eye drop.
Instructions for application
Do not use the bottle if the special tamper-evident seal on the neck of the bottle is already broken before you have used the eye drops for the first time.
Wash your hands before opening the bottle. Tilt your head backward and look upward.

1. Gently pull down the lower eyelid to form a pouch.
2. Invert the bottle and squeeze it until one drop falls into the eye to be treated.
3. Release the lower eyelid and close the eye.
4. Keep the eye closed and press with your finger at the inner corner of the eye, near the nose, for two minutes. This helps prevent Brimonidine and Timolol Mylan from spreading into the rest of the body.
   If the drop did not fall into the eye, try again.
   To prevent possible infections, avoid letting the tip of the bottle touch the eyes or any other object. Immediately after use, replace the protective cap to close the bottle.
   If you use more Brimonidine and Timolol Mylan than you should
   Adults
   If you have instilled more Brimonidine and Timolol Mylan than you should have, it is unlikely to cause serious consequences. Take the next dose at the usual time. If you are concerned, consult your doctor or pharmacist.
   Newborns and children
   Several cases of overdose have been reported in newborns and children who received brimonidine (one of the active substances in Brimonidine and Timolol Mylan) as part of glaucoma treatment. Symptoms of overdose include: drowsiness, weakness, low body temperature, pallor, and breathing difficulties. If any of these adverse effects occur, contact your doctor immediately.
   Adults and children
   If Brimonidine and Timolol Mylan has been accidentally swallowed, contact your doctor immediately.
   If you forget to use Brimonidine and Timolol Mylan
   If you forget to use Brimonidine and Timolol Mylan, apply one drop into 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 forgotten dose.
   If you stop using Brimonidine and Timolol Mylan
   To work properly, Brimonidine 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.
If you experience any of the following side effects, contact your doctor immediately:

• severe allergic reaction with symptoms including dizziness or fainting, rash, skin itching, and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing
• Heart failure (e.g., chest pain) or irregular heartbeat
• Increase or decrease in heart rate or low blood pressure

The following side effects may occur with Brimonidina e Timololo Mylan.
Eye disorders
Very common (may affect more than 1 in 10 people):

• eye redness or burning

Common (may affect up to 1 in 10 people):

• burning or pain in the eyes
• allergic reaction in the eye or skin around the eye
• small cracks on the surface of the eye (with or without inflammation)
• swelling, redness, or inflammation of the eyelid
• irritation, sensation of a foreign body in the eye
• itching of the eyes and eyelids
• follicles or white spots on the transparent layer covering the surface of the eye
• visual disturbances
• tearing
• dry eyes
• sticky eyes

Uncommon (may affect up to 1 in 100 people):

• difficulty seeing clearly
• swelling or inflammation of the transparent layer covering the surface of the eye
• tired eyes
• light sensitivity
• eyelid pain
• discolouration of the transparent layer covering the surface of the eye
• swelling or inflammation beneath the surface of the eye
• floaters in front of the eyes

Not known (frequency cannot be estimated from the available data):

• blurred vision

General disorders:
Common (may affect up to 1 in 10 people):

• high blood pressure
• depression
• drowsiness
• headache
• dry mouth
• general weakness

Uncommon (may affect up to 1 in 100 people):

• heart failure
• irregular heartbeat
• feeling of emptiness in the head
• fainting
• itching, runny or blocked nose, sneezing
• dry nose
• altered taste
• nausea
• diarrhoea
• local allergic skin reaction to a material or substance (e.g., plants, jewellery)

Not known (frequency cannot be estimated from the available data):

• increase or decrease in heart rate
• low blood pressure
• facial flushing

Some of these effects may be due to an allergy to any of the components. Other side effects have been observed with brimonidine or timolol and may therefore also occur with Brimonidina e Timololo Mylan.
The following additional side effects have been observed with the use of brimonidine:

• inflammation inside the eye, pupil constriction, insomnia, feeling cold, shortness of breath, symptoms affecting the stomach and digestion, general allergic reactions, skin reactions including redness, facial swelling, itching, rashes, and dilation of blood vessels.

Like other eye medications, Brimonidina e Timololo Mylan (brimonidine/timololo) is absorbed into the bloodstream. The absorption of timolol, the beta-blocking component of Brimonidina e Timololo Mylan, may cause side effects similar to those observed with beta-blockers administered intravenously and/or orally. The incidence of side effects after topical ocular administration is lower than that following administration of medicines taken orally or by injection.
The listed side effects include reactions observed with the class of beta-blockers used in the treatment of ocular conditions:

• generalized allergic reactions, including swelling under the skin (which may occur in areas such as the face and limbs, and may obstruct the airways causing possible difficulty in swallowing or breathing), urticaria (or itchy rash), localized and generalized skin rash, itching, sudden severe allergic reaction that may be life-threatening
• low blood sugar levels
• difficulty sleeping (insomnia), nightmares, memory loss
• stroke, reduced blood flow to the brain
• worsening of signs and symptoms of drooping eyelids, double vision, difficulty speaking and swallowing, and sometimes muscle weakness in the arms or legs (caused by a muscle disease called myasthenia gravis)
• unusual sensations (such as tingling)
• corneal inflammation, detachment of the layer beneath the retina containing blood vessels following filtering surgery, which may cause visual disturbances, reduced corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (resulting in half-closure of the eye), double vision
• chest pain, oedema (fluid accumulation), changes in heart rhythm or rate, a type of heart rhythm disorder, heart attack, heart failure
• circulation problems causing finger pain and cold fingers (Raynaud's phenomenon), cold hands and feet
• narrowing of the airways in the lungs (mainly in patients with pre-existing lung disease), breathing difficulties, cough
• indigestion, abdominal pain, vomiting
• hair loss, skin rashes with silvery appearance (psoriasiform rash) or worsening of psoriasis, skin rash
• muscle pain not caused by physical exercise
• sexual dysfunction, reduced sexual desire
• fatigue
• hallucinations

Reporting of side effects
If you experience any side effect, 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 Brimonidine and Timolol Mylan

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Keep the bottle in the outer packaging to protect the medicine from light.
Use only one bottle at a time.
Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of that month.
If the medicine has discoloured or shows any other signs of deterioration, consult your pharmacist who will advise you on what to do.
The bottle must be discarded 4 weeks after first opening, even if there are still drops remaining. This will help prevent infections. To help you remember, write the opening date in the designated space on the packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Brimonidina e Timololo Mylan contains
The active substances are brimonidine tartrate and timolol maleate. Each 1 ml of solution contains 2 mg of
brimonidine tartrate and timolol maleate equivalent to 5 mg of timolol. The excipients are benzalkonium chloride
(a preservative), monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate (see section 2,
“Brimonidina e Timololo Mylan contains phosphate buffer and benzalkonium chloride”), and purified water.
Small amounts of hydrochloric acid or sodium hydroxide may be added to adjust the solution to the correct pH level (a measure of the acidity or alkalinity of the solution).

Description of the appearance of Brimonidina e Timololo Mylan and contents of the pack
Brimonidina e Timololo Mylan is a clear yellow-green solution in a pack containing 1, 3 or 6 plastic bottles, each with a cap. Each bottle contains 5 ml of solution.
Not all pack sizes may be marketed.

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

Manufacturer:
Akciju sabiedrība "Grindeks", Krustpils iela 53, Rīga (I vieta), LV-1057, Latvia