Brimonidine and timolol EG
Italy
Table of Contents
Package leaflet: Information for the patient
BRIMONIDINE AND TIMOLOL EG 2 mg/ml + 5 mg/ml eye drops, solution
Equivalent medicine (only for packages containing 1 and 3 vials of 5 ml)
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, because it could 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:
- What BRIMONIDINE AND TIMOLOL EG is and what it is used for
- What you need to know before using BRIMONIDINE AND TIMOLOL EG
- How to use BRIMONIDINE AND TIMOLOL EG
- Possible side effects
- How to store BRIMONIDINE AND TIMOLOL EG
- Contents of the pack and other information
1. What BRIMONIDINA E TIMOLOLO EG is and what it is used for
BRIMONIDINA E TIMOLOLO EG is an eye drop used to control glaucoma. It contains two different active substances (brimonidine and timolol), both of which reduce the elevated pressure inside the eye. Brimonidine belongs to a group of medicines called alpha-2 adrenergic receptor agonists. Timolol belongs to a group of medicines known as beta-blockers. BRIMONIDINA E TIMOLOLO EG is prescribed to reduce elevated intraocular pressure when beta-blocker eye drops used alone are not sufficient.
The eye contains a clear, watery fluid that nourishes its interior. This fluid is constantly 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 may eventually cause damage to vision.
BRIMONIDINA E TIMOLOLO EG works by reducing the amount of fluid produced and increasing the amount of fluid drained. This reduces the pressure inside the eye, while the eye continues to be nourished.
2. What you should know before using BRIMONIDINE AND TIMOLOL EG
Do not use BRIMONIDINE AND TIMOLOL EG:
-
If you are allergic to brimonidine tartrate, timolol, beta-blockers, or to 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 breathing problems such as asthma or severe chronic obstructive pulmonary disease (COPD) (a serious lung disease that may cause shortness of breath, difficulty breathing, and/or persistent cough).
-
If you have heart problems such as slow heartbeat, heart failure, or irregular heartbeat (unless controlled by a pacemaker).
-
If you are being treated with monoamine oxidase inhibitors (MAOIs) or certain other antidepressant medicines.
BRIMONIDINE AND TIMOLOL EG must not be used in children under 2 years of age and should generally not be used in children aged between 2 and 17 years.
If you think any of the above conditions apply to you, do not use BRIMONIDINE AND TIMOLOL EG before consulting your doctor again.
Warnings and precautions
Talk to your doctor or pharmacist before using BRIMONIDINE AND TIMOLOL EG if you:
- suffer or have previously suffered from:
- coronary 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;
- breathing problems, asthma, or chronic obstructive lung disease;
- a disease associated with reduced blood circulation (such as Raynaud's disease or Raynaud's syndrome);
- diabetes, as timolol may mask the signs and symptoms of low blood sugar levels;
- overactivity of the thyroid gland, as timolol may mask its signs and symptoms;
- kidney or liver problems;
- a tumour of the adrenal gland;
- eye surgery to reduce intraocular pressure;
- if you suffer or have suffered from any allergy (e.g. hay fever, eczema) or a severe allergic reaction, be aware that the usual dose of adrenaline used to treat a severe reaction may need to be increased;
- before undergoing surgery, inform your doctor that you are using BRIMONIDINE AND TIMOLOL EG, as timolol may alter the effects of certain medicines during anaesthesia.
Other medicines and BRIMONIDINE AND TIMOLOL EG
BRIMONIDINE AND TIMOLOL EG 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.
Some medicines may interfere with BRIMONIDINE AND TIMOLOL EG, so it is particularly important that you tell your doctor if you are taking:
- painkillers;
- medicines to help you sleep or for anxiety;
- medicines to treat high blood pressure (hypertension);
- medicines to treat heart conditions (e.g. irregular heartbeat), such as beta-blockers, digoxin, or quinidine (used to treat heart conditions and some types of malaria);
- medicines to treat diabetes or high blood sugar levels;
- medicines to treat depression such as fluoxetine and paroxetine;
- another eye drop to reduce high eye pressure (glaucoma);
- medicines 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 to treat stomach acidity or gastric ulcers.
Inform your doctor if the dose of any of your medicines has changed or if you regularly consume alcohol.
If you are due to undergo anaesthesia, inform your doctor or dentist that you are taking BRIMONIDINE AND TIMOLOL EG.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not use BRIMONIDINE AND TIMOLOL EG if you are pregnant, unless your doctor considers it necessary.
Do not use BRIMONIDINE AND TIMOLOL EG if you are breastfeeding. Timolol may pass into breast milk. Consult your doctor before taking any medicine during breastfeeding.
Driving and using machines
BRIMONIDINE AND TIMOLOL EG 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 such problems, consult your doctor.
BRIMONIDINE AND TIMOLOL EG contains benzalkonium chloride.
Contact lenses
- Do not use BRIMONIDINE AND TIMOLOL EG while wearing contact lenses. Wait at least 15 minutes after administering BRIMONIDINE AND TIMOLOL EG before reinserting your contact lenses.
- A preservative contained in BRIMONIDINE AND TIMOLOL EG (benzalkonium chloride) may cause eye irritation and is known to discolour soft contact lenses.
3. How to use BRIMONIDINE AND TIMOLOL EG
Use this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
BRIMONIDINE AND TIMOLOL EG must not be used in children under 2 years of age.
BRIMONIDINE AND TIMOLOL EG should normally not be used in children and adolescents (from
2 to 17 years of age).
The recommended dose is one drop of BRIMONIDINE AND TIMOLOL EG twice daily,
maintaining an interval of approximately 12 hours. Do not change the dose or stop treatment
without first speaking to your doctor.
If you are using another eye drop in addition to BRIMONIDINE AND TIMOLOL EG, allow at least 5 minutes to pass
between the administration of BRIMONIDINE AND TIMOLOL EG and the other eye drop.
Instructions for use
Do not use the bottle if the tamper-evident seal on the cap is not intact when first used.
Wash your hands before opening the bottle. Tilt your head backward and look upward.
- Gently pull down the lower eyelid to create a small pocket.
- Invert the bottle and apply slight pressure to release one drop of eye drops into each eye to be treated.
- Release the lower eyelid and close the eye.
- Keep the eye closed and press your finger against the corner of the eye (the side where the eye meets the nose) for two minutes. This helps prevent BRIMONIDINE AND TIMOLOL EG from being absorbed into the rest of the body.
If the drop does not enter the eye, repeat the procedure.
To avoid contamination, do not let the tip of the bottle touch the eye or any other surface. Immediately after using the bottle, close it tightly by screwing the cap back on.
If you use more BRIMONIDINE AND TIMOLOL EG than you should
Adults
If you use more BRIMONIDINE AND TIMOLOL EG than prescribed, it is unlikely to cause serious consequences. Take the next dose at your usual time. If you are concerned, consult your doctor or pharmacist.
Infants and children
Several cases of overdose have been reported in infants and children receiving brimonidine
(one of the components of BRIMONIDINE AND TIMOLOL EG) as part of medical treatment for glaucoma. Symptoms include drowsiness, floppiness, low body temperature, paleness, and breathing difficulties. If this occurs, consult your doctor immediately.
Adults and children
If BRIMONIDINE AND TIMOLOL EG is accidentally swallowed, contact your doctor immediately.
If you forget to use BRIMONIDINE AND TIMOLOLOL EG
If you forget to use BRIMONIDINE AND TIMOLOL EG, instill one drop into each eye as soon as you remember, then continue treatment as usual. Do not use a double dose to make up for the missed dose.
If you stop using BRIMONIDINE AND TIMOLOL EG
You must use BRIMONIDINE AND TIMOLOL EG every day for it to work properly.
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.
If you experience any of the following side effects, contact your doctor immediately:
- heart failure (e.g. chest pain) or irregular heartbeat;
- fast or slow heartbeat or low blood pressure.
The following side effects may occur with BRIMONIDINE AND TIMOLOL EG:
Eye-related side effects
Very common (may affect more than 1 in 10 people):
- eye redness or burning.
Common (may affect up to 1 in 10 people):
- eye pain or stinging sensation,
- allergic reaction affecting the eye or skin around the eye,
- small ulcers on the surface of the eye (with or without inflammation),
- swelling, redness or inflammation of the eyelid,
- eye irritation or sensation of a foreign body in the eye,
- eye and eyelid itching,
- follicles or white spots on the transparent layer covering the surface of the eye,
- changes in vision,
- tearing,
- dry eyes,
- sticky eyes.
Uncommon (may affect up to 1 in 100 people):
- difficulty seeing clear images,
- swelling or inflammation of the transparent layer covering the surface of the eye,
- tired eyes,
- sensitivity to light,
- eyelid pain,
- whitening of the transparent layer covering the surface of the eye,
- swelling or inflammation beneath the eye surface,
- seeing floating spots in front of the eyes.
Frequency not known (frequency cannot be estimated from the available data):
- blurred vision.
Systemic side effects:
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 light-headedness,
- fainting,
- dry nose,
- altered sense of taste,
- nausea,
- diarrhoea.
Frequency not known (frequency cannot be estimated from the available data):
- fast or slow heartbeat,
- low blood pressure,
- facial flushing.
Some of these effects may be due to an allergy to any of the components.
Additional side effects have been observed with brimonidine or timolol and may therefore potentially occur with BRIMONIDINE AND TIMOLOL EG.
The following additional side effects have been observed with brimonidine:
- inflammation inside the eye, constricted pupils, difficulty sleeping, cold-like symptoms, shortness of breath, gastrointestinal and digestive symptoms, systemic allergic reactions, skin reactions such as redness, facial swelling, itching, rashes, and dilation of blood vessels.
Like other ophthalmic medicines, BRIMONIDINE AND TIMOLOL EG is absorbed into the bloodstream.
The absorption of timolol, a beta-blocker contained in BRIMONIDINE AND TIMOLOL EG, may cause side effects similar to those observed with beta-blockers administered intravenously and/or orally. The incidence of side effects after topical ophthalmic administration is lower than when medicines are administered, for example, orally or by injection. The following side effects include reactions observed with medicines of the beta-blocker class when used to treat eye conditions:
- generalized allergic reactions, including subcutaneous swelling (which may occur in areas such as the face and limbs, and may obstruct airways causing difficulty in swallowing or breathing), urticaria (or itchy skin rash), localized or generalized skin rashes, itching, sudden potentially fatal allergic reaction;
- low blood glucose levels;
- difficulty sleeping (insomnia), nightmares, memory loss;
- stroke, reduced blood supply to the brain, worsening of signs and symptoms of myasthenia gravis (a muscle disorder), unusual sensations (such as pins and needles);
- 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 (causing the eye to appear half-closed), double vision;
- chest pain, oedema (fluid accumulation), changes in heart rate or rhythm, a type of heart rhythm disorder, heart attack, heart failure;
- Raynaud's phenomenon, cold hands and feet;
- narrowing of the airways in the lungs (especially in patients with pre-existing lung disease), breathing difficulties, cough;
- indigestion, abdominal pain, vomiting;
- hair loss, skin rash characterized by a silvery-white appearance (psoriasiform rash) or worsening of psoriasis, skin rash;
- muscle pain not related to physical exercise;
- sexual dysfunction, reduced sexual desire;
- muscle weakness/fatigue.
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 accumulation during treatment.
Reporting of side effects
If you experience any side effect, 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 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 EG
Keep this medicine out of the sight and reach of children.
Do not store at temperatures above 25°C.
Keep the bottle in the outer packaging to protect it from light.
Use only one bottle at a time.
Do not use this medicine after the expiry date stated on the bottle label and on the packaging after "EXP." The expiry date refers to the last day of that month.
If the medicine changes colour or shows any other signs of deterioration, consult your pharmacist for advice.
The bottle must be discarded 28 days after first opening, even if there are still eye drops remaining. This is to prevent the risk of infection. To help you remember, write the date of first opening in the space provided on the box.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What BRIMONIDINA E TIMOLOLO EG contains
The active substances are brimonidine tartrate and timolol maleate. 1 ml of solution contains 2 mg
of brimonidine tartrate and timolol maleate equivalent to 5 mg of timolol. The other components
are benzalkonium chloride (a preservative), monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, and purified water.
Small amounts of hydrochloric acid or sodium hydroxide may be added to adjust the pH of the solution (a measure of the solution's acidity or alkalinity).
Description of the appearance of BRIMONIDINA E TIMOLOLO EG and package contents
BRIMONIDINA E TIMOLOLO EG is available as a clear, particle-free solution of yellowish-green colour in packaging containing 1, 3 or 6 plastic bottles, each with a cap. Each bottle contains 5 ml of solution.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder
EG S.p.A., Via Pavia 6, 20136 Milano
Manufacturer
STADA Arzneimittel AG, Stadastrasse 2 – 18, Bad Vilbel (Germany)
JSC Grindeks, Krustpils iela 53, Riga 1057 (Latvia)
This medicinal product is authorised in the European Economic Area countries under the following names:
DE Brimonidin/Timolol AL 2 mg/ml + 5 mg/ml Augentropfen, Lösung
DK Brimonidine/Timolol STADA
ES Brimonidina/Timolol STADA 2 mg/ml + 5 mg/ml colirio en solución
FR BRIMONIDINE / TIMOLOL EG 2mg / 5mg, collyre en solution
IT BRIMONIDINA E TIMOLOLO EG