Agobrim 0.15 % Drops

The active substance is brimonidine tartrate which belongs to a group of medicines called alpha-2 adrenergic receptor agonists. AGOBRIM 0.15% w/v EYE DROPS is indicated for the lowering of pressure within the eyeball in patients with open angle glaucoma or ocular hypertension.

Do not use AGOBRIM 0.15% w/v EYE DROPS:

• If you are hypersensitive (allergic) to brimonidine tartrate or any of the ingredients of AGOBRIM 0.15% w/v EYE DROPS (listed in section 6).
• AGOBRIM 0.15% w/v EYE DROPS should not be used in neonates and infants under the age of 2 years.

Warnings and precautions

Take special care with AGOBRIM 0.15% w/v EYE DROPS:

• If you have any diseases associated with the heart.
• If you have any diseases that affect the kidney or liver.
• If you suffer or have suffered from depression, reduced mental capacity, reduced blood supply to the brain, Raynaud’s phenomenon (a condition resulting in painful discolouration of the fingers and/or the toes after exposure to changes in temperature or emotional events), or have orthostatic hypotension and thromboangiitis obliterans (a condition resulting in blockage of blood vessels).
• If you are scheduled to have surgery using a general anaesthetic.
• AGOBRIM 0.15% w/v EYE DROPS should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.
• If allergic reactions are observed, treatment with AGOBRIM 0.15% w/v EYE DROPS should be discontinued.

Children and Adolescents:

Children 2 years of age and above, especially those weighing ≤ 20 kg, should be treated with caution and closely monitored due to the high incidence and severity of drowsiness and/or strong desire to fall asleep.

Other medicines and AGOBRIM 0.15% w/v EYE DROPS:

Always tell your health care provider if you are taking any other medicines (This includes all complementary or traditional medicines). The following medicine should be used with caution:

• Medicines used in the treatment of high blood pressure;
• Digoxin, used in the treatment of heart conditions;
• Beta-blockers e.g. atenolol, sotalol used to treat a heart condition and beta-blocker eye drops e.g., timolol used to lower pressure inside the eyeball.
• Tricyclic antidepressants e.g. amitriptyline, imipramine etc.;
• Monoamine oxidase (MAO) inhibitors used in the treatment of depression e.g. moclobemide, selegiline etc.

Do not share medicines prescribed for you with any other person. Always use AGOBRIM 0.15% w/v EYE DROPS exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose is one drop in the eye(s) every twelve hours.

Helpful hints:

• Open the eye(s) needing the drops, tilt your head back and look upward.
• Gently pull down the lower eyelid.
• Bring the eye drops near the eye and squeeze one drop into the eye.
• Avoid touching the eye, eyelids or lashes with the dropper.
• Close your eyes and blink; this helps distribute the drops in the eye chamber.
• While your eyes are closed, gently press your fingers on the inner corner(s) of your eye(s).
• Wipe any excess away with a clean tissue.
• Replace cap on the dropper bottle.

Method of administration if you are using other medicines with AGOBRIM 0.15% w/v EYE DROPS

• If you have glaucoma which is difficult to control, certain other medicines or drops may be added to the existing treatment with AGOBRIM 0.15% w/v EYE DROPS ophthalmic solution.
• The length of treatment with these eye drops depends on your condition, and will be determined by your doctor.
• The dose of the eye drops may be changed by your doctor to best treat your condition.
• If you use AGOBRIM 0.15% w/v EYE DROPS ophthalmic solution with another eye medicine, apply AGOBRIM 0.15% w/v EYE DROPS ophthalmic solution first and wait five minutes before applying the second eye medicine.

Use in children

AGOBRIM 0.15% w/v EYE DROPS should not be used in children below the age of 2 years. Children 2 years of age and above or weighing ≤ 20 kg should be treated with caution.

Things to be careful of

• Keep enough eye drops to last weekends and holidays.
• If not handled properly, eye drops can become contaminated by germs which can cause eye infections. This may cause serious damage to your eye and loss of vision. To help prevent infections, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle straight after you have used it. Do not use if the solution changes colour or becomes cloudy. Do not use after the expiry date marked on the bottle.
• Tell your doctor immediately if you develop an eye infection, if you hurt your eye, or if you have to go for an eye operation.

Duration of treatment: Your doctor will tell you how long your treatment with AGOBRIM 0.15% w/v EYE DROPS will last. Do not stop using AGOBRIM 0.15% w/v EYE DROPS even if you feel well unless instructed by your doctor.

AGOBRIM 0.15% w/v EYE DROPS can have side effects. Not all side effects reported for AGOBRIM 0.15% w/v EYE DROPS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking AGOBRIM 0.15% w/v EYE DROPS, please consult your doctor, pharmacist, or other healthcare professional for advice. Do not stop using AGOBRIM 0.15% w/v EYE DROPS without speaking to your doctor.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice or experience any of the following:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to AGOBRIM 0.15% w/v EYE DROPS. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• High levels of cholesterol in the blood
• Allergic reaction
• Dizziness, headache
• Eye allergy, red eye, itchy eyes, itchy eyelids, burning sensation (eyes), small bumps inside the eyelid, eye swelling, eye surface bleeding, eye surface inflammation, watery eyes, sticky eyes, dry eyes, eye irritation, eye pain, small bumps on the eye surface, a feeling that something in is your eye, light sensitivity, stinging, visual disturbance, abnormalities in the field of view, eye floaters, eye sight worsening, eyelid and eye surface irritations, blurred vision, inflammation of the central front part of the eye, eyelid abnormalities, tearing,
• High blood pressure, low blood pressure
• Cough, shortness of breath
• Indigestion, dryness of the mouth, digestive disorder
• Bronchitis, flu syndrome, pharyngitis (sore throat), runny nose, sinus infection,
• Feeling weak, tiredness
• Rash

Less Frequent side effects:

• Difficulty in sleeping, feeling drowsy
• Distorted or abnormal sense of taste
• Superficial damage to the front part of the eye, styes
• Dryness of the nose
• Palpitations

Frequency not Known:

• Slower heart rate,
• Depression,
• Hypersensitivity,
• Inflammation of iris,
• Dry eye syndrome,
• Contraction of pupil of eye,
• Nausea,
• Skin reactions (including superficial reddening of the skin, Itchy eyes, rash and the widening of blood vessels),
• Fainting,
• Higher heart rate.

Ask your doctor or pharmacist for more information about the side effects. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (whoumc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of AGOBRIM 0.15% w/v EYE DROPS.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Store at temperature not exceeding 30°C. Protect from light.
• Keep away medicines from the reach of children.
• The EXPIRY date is marked on the bottle. Do not use the ophthalmic solution beyond the expiry date.
• Discard remaining contents 28 days after opening.
• Store in the original eye drop bottle.
• To avoid contamination of the solution, keep container tightly closed and do not touch dropper tip to any surface.
• Contents are sterile if seal is intact.

Do not put the eye drops in the freezer.

Return all unused medicines to your pharmacist.

Do not dispose of unused medicines in drains or sewerage systems (e.g. toilets).