10 mg / ml + 5 mg / ml eye drops , suspension
brinzolamide / timolol
1. What Brinzolamide / Timolol Accord is and what it is used for
Brinzolamide / Timolol Accord contains two ingredients, brinzolamide, and timolol, which together lower the pressure in the eye.
Brinzolamide / Timolol Accord is used to treat high pressure in the eyes, also called glaucoma or ocular hypertension, in adult patients over 18 years of age and in whom it is not possible to effectively control the high pressure in the eyes with just one drug.
Brinzolamide and timolol contained in Brinzolamide / Timolol Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before you use Brinzolamide / Timolol Accord
Do not use Brinzolamide / Timolol Accord
- if you are allergic to brinzolamide, medicines called sulphonamides (for example medicines used to treat diabetes, infections, and also diuretics ), timolol, beta-blockers (medicines used to lower blood pressure or to treat heart disease), or anything else ingredient of this medicinal product (listed in section 6)
- if you currently have or have ever had lung diseases such as asthma, severe long-term obstructive bronchitis (severe lung disease that may cause wheezing, difficulty breathing, and/or persistent cough), or other types of breathing problems
- if you have severe hay fever
- if you have a low heart rate, heart failure, or diseases that affect the heart rhythm (irregular heartbeat)
- if you have too acidic blood (a condition called hyperchloraemic acidosis)
- if you have severe kidney problems
Warnings and cautions
Use only Brinzolamide / Timolol Accord as eye drops.
If there are any signs of a serious reaction or hypersensitivity reaction, stop using the medicine and talk to your doctor.
Talk to your doctor or pharmacist before using Brinzolamide / Timolol Accord if you have or have ever had
- coronary heart disease (symptoms may include pain or tightness in the chest, shortness of breath, or suffocation), heart failure, low blood pressure
- heart rate disorders such as slow heartbeat
- respiratory problems, asthma, or chronic obstructive pulmonary disease
- disease with impaired blood circulation (eg Raynaud’s disease or Raynaud’s syndrome)
- diabetes because timolol can mask the signs and symptoms of low blood sugar
- overactive thyroid gland as timolol can mask signs and symptoms of thyroid disease
- muscle weakness (myasthenia gravis)
- Tell your doctor before surgery that you are using Brinzolamide / Timolol Accord as timolol may alter the effects of certain medicines during anesthesia
- if you have had atopy (a tendency to have an allergic reaction ) and severe allergic reactions, you may be more susceptible to having an allergic reaction while using Brinzolamide / Timolol Accord, and treatment with adrenaline may not be as effective in treating an allergic reaction; therefore, tell your doctor or nurse that you are using Brinzolamide / Timolol Accord when you receive any other treatment
- if you have liver problems
- if you have dry eyes or problems with the cornea ( the cornea )
- if you have kidney problems.
Children and young people
Brinzolamide / Timolol Accord is not recommended for children and adolescents under 18 years of age.
Other medicines and Brinzolamide / Timolol Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Brinzolamide / Timolol Accord can interact with other medications you are using, including other eye drops for the treatment of glaucoma ( glaucoma ). Tell your doctor if you are taking or plan to take medicines to lower your blood pressure, such as para sympathomimetics and guanethidine, or other heart medicines that contain quinidine (used to treat heart conditions and certain types of malaria ), amiodarone other medicines to treat heart rhythm disorders and glycosides to treat heart failure. Also tell your doctor if you are taking or intend to take medicines to treat diabetes or stomach ulcers, antifungals, antivirals or antibiotics or antidepressants such as fluoxetine and paroxetine.
If you are taking another carbohydrate inhibitor (acetazolamide or dorzolamide), talk to your doctor. Increases in pupil size during concomitant use of Brinzolamide / Timolol Accord and adrenaline ( epinephrine ) have been reported sporadically.
Pregnancy, breastfeeding and fertility
You should not use Brinzolamide / Timolol Accord if you are pregnant or likely to become pregnant unless your doctor considers it necessary. Talk to your doctor before using Brinzolamide / Timolol Accord.
Do not use Brinzolamide / Timolol Accord if you are breast-feeding, timolol may pass into breast milk. Consult a doctor before taking any medicine while breast-feeding
Driving and using machines
Do not drive or use any tools or machines until the vision is clear. You may experience blurred vision for a while just after using Brinzolamide / Timolol Accord.
One of the active substances may affect the ability of elderly patients to perform tasks that require mental alertness and/or physical coordination. If you are affected, you should be careful when driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Brinzolamide / Timolol Accord contains excipients
This medicine contains 0.0033 mg of benzalkonium chloride in each drop corresponding to 0.01% or 0.1 mg/ml.
Benzalkonium chloride is a preservative in Brinzolamide / Timolol Accord that can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before re-inserting the contact lenses.
Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using the medicine, consult a doctor.
3. How to use Brinzolamide / Timolol Accord
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
If you switch from other eye drops used to treat glaucoma and switch to Brinzolamide / Timolol Accord, stop using the other medicine and start using Brinzolamide / Timolol Accord the next day. If you are not sure, ask your doctor or pharmacist.
To prevent the tip and suspension of the dropper from contaminating, make sure that you do not touch the eyelids, surrounding areas, or other surfaces with the tip of the dropper. Keep the bottle tightly closed when not in use.
The following measures are helpful in limiting the amount of drug that enters the bloodstream after the application of eye drops:
- Close your eyes while gently pressing the inner corner of your eye with your finger for at least 2 minutes.
The recommended dose is one drop in the affected eye (s) twice daily.
Only use Brinzolamide / Timolol Accord in both eyes if your doctor prescribes it. Use Brinzolamide / Timolol Accord for as long as your doctor prescribes it.
To use the eye drops:
- Get the bottle and a mirror.
- Wash your hands.
- Shake the bottle carefully before use.
- Unscrew the cap on the bottle. If the safety collar is loose after removing the hat, remove the collar before using the product.
- Hold the bottle upside down between your thumb and forefinger.
- Tilt your head back. Pull the eyelid down with a clean finger, so that a pocket is formed between the eyelid and the eye. The drop should end up in the pocket (figure 1).
- Move the tip of the bottle close to the eye. Use the mirror if it facilitates.
- Do not touch the eye or eyelid, surrounding areas, or other surfaces with the bottle tip. This can contaminate the droplets.
- Squeeze a drop into the pocket formed between the eye and the eyelid (figure 2)
- After using Brinzolamide / Timolol Accord, press lightly with a finger against the corner of your eye at the nose for at least 1 minute. This prevents Brinzolamide / Timolol Accord from entering the rest of the body (Figure 3).
- If you use drops in both eyes, repeat the above steps in the other eye.
- Screw the cap onto the bottle firmly immediately after use.
- Use one bottle before opening the next.
If the drop misses the eye, try again.
If you use other eye drops or ointments, wait at least 5 minutes between each medicine. Eye ointments should be used last.
If you use more Brinzolamide / Timolol Accord than you should
If you use more Brinzolamide / Timolol Accord then you should rinse your eyes with lukewarm water. Do not drip in more drops until it is time for your next dose.
If you forget to use Brinzolamide / Timolol Accord
If you forget to use Brinzolamide / Timolol Accord, continue with the next dose as usual. Do not take a double dose to make up for a forgotten dose. Do not use more than one drop in the affected eye (s) twice daily.
If you stop using Brinzolamide / Timolol Accord
If you stop using Brinzolamide / Timolol Accord without talking to your doctor, the pressure in your eye will not be checked, which could lead to vision loss.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using this medicine and contact your doctor immediately if you get a rash, a severe skin reaction, or severe redness and itching in the eye. This may be a sign of an allergic reaction (frequency is unknown).
You can usually continue to use the drops unless the side effects are severe. If you are worried, talk to your doctor or pharmacist. Do not stop using Brinzolamide / Timolol Accord without talking to your doctor first.
Common side effects (may affect up to 1 in 10 people):
- Effects in the eye: Inflammation of the surface of the eye, blurred vision, signs, and symptoms of eye irritation (eg burning sensation, tingling, itching, tearing, redness ), eye pain.
- General side effects: Slower heart rate, taste changes.
Uncommon side effects (may affect up to 1 in 100 people):
- Effects in the eye: Erosion of the cornea (damage to the anterior layer of the eyeball), inflammation of the surface of the eye with surface damage, inflammation inside the eye, staining of the cornea, abnormal sensation in the eyes, discharge from the eye, dry eyes, tired eyes, itchy eyes, red eyes, eyelid redness.
- General side effects: Decreased white blood cell count, decreased blood pressure, cough, blood in the urine, weakness in the body.
Rare side effects (may affect up to 1 in 1,000 people)
- Effects in the eye: corneal problems, photosensitivity, increased tear production, crusting on the eyelid
- Common side effects: difficulty sleeping, sore throat, runny nose
Has been reported (occurs in the unknown number of users):
- Effects in the eye: Eye allergy, visual disturbance, damage to the optic nerve, increased pressure in the eye, deposits on the surface of the eye, decreased sensitivity in the eye, inflammation or infection in the conjunctiva (whites of the eyes), abnormal, double or impaired vision, increased pigmentation in the eye, growth on the surface of the eye, swollen eyes, photosensitivity, decreased growth of eyelashes or decreased number of eyelashes , drooping upper eyelids (keeps the eye half-closed), inflammation of the eyelids and eyelid glands, inflammation the cornea and loosening of the layer under the retina that contains blood vessels after filtration surgery, which can cause visual disturbances, decreased sensitivity of the cornea.
- Heart and blood circulation: Altered rhythm or rate of the heartbeat, slow heart rate, palpitations, a type of heart rhythm, abnormal increase of pulse a, chest pain, cardiac dysfunction, myocardial infarction, increased blood pressure, decreased blood supply to the brain, stroke, edema (fluid retention), chronic heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid retention), swollen extremities, low blood pressure , discoloration of fingers, toes and sometimes other parts of the body (Raynaud’s phenomenon), cold hands and feet.
- Lungs / Respiratory tract: Contraction of the airways in the lungs (especially in patients with pre-existing disease), shortness of breath or shortness of breath, cold symptoms, chest tightness, sinusitis, sneezing, nasal congestion, dry nose, nosebleeds, asthma, irritation of the throat.
- Nervous system and general disorders: Depression, nightmares, memory loss, headache, nervousness, irritation, fatigue, tremors, abnormal sensation, fainting, dizziness, drowsiness, general or severe weakness, unusual sensations such as. tingling in the skin, hallucination.
- Gastrointestinal disorders: Nausea, vomiting, diarrhea, flatulence, or uncomfortable feeling in the abdomen, sore throat, dry or abnormal sensation in the mouth, stomach upset, stomach pain.
- Blood: Abnormal liver function values, increased levels of chlorine in the blood, or decreased number of red blood cells during blood tests.
- Allergy: Increased allergic symptoms, generalized allergic reactions, including swelling under the skin that may occur in places such as. face arms and legs and may obstruct the airways which may cause difficulty in swallowing or breathing, hives, limited and generalized rash, itching, severe, sudden life-threatening allergic reaction.
- Ears: Ringing in the ears, feeling of rotation or dizziness
- Skin: Rash, redness or inflammation , abnormal or diminished sensation in the skin, hair loss, rash with white silvery appearance (psoriasis-like rash), or worsening of psoriasis.
- Muscles: General back, joint, or muscle pain not caused by exercise, muscle cramps, pain in the extremities, muscle weakness/muscle fatigue, increased signs and symptoms of myasthenia gravis (muscle disorder).
- Kidneys: Kidney pain such as back pain, frequent urination.
- Reproduction: Sexual dysfunction, decreased libido, sexual difficulties in men.
- Metabolism: Low blood sugar levels.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Brinzolamide / Timolol Accord
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
You must discard the bottle 4 weeks after opening it, to prevent infection, and use a new bottle. Write down the date when you opened it on the intended space on the bottle and carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substances are brinzolamide and timolol. One milliliter of suspensioncontains 10 mg brinzolamide and timolol maleate equivalent to 5 mg timolol.
- The other ingredients are benzalkonium chloride (see section 2, “Brinzolamide / Timolol Accord contains benzalkonium chloride”), carbomer, disodium edetate, mannitol (E421), purified water, sodium chloride, hydrochloric acid, and/or sodium hydroxide.
Small amounts of hydrochloric acid and/or sodium hydroxide are added to keep the acidity ( pH ) normal.
What the medicine looks like and the contents of the pack
Brinzolamide / Timolol Accord is a liquid (white to off-white even suspension ), supplied in a carton containing a 5 ml bottle of low-density polyethylene (LDPE) with a drop insert of LDPE and one with a lid of high-density polyethylene (HDPE) containing 5 ml of suspension.
Cartons containing 1, 3, or 6 bottles.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Manufacturer
Lusomedicamenta Sociedade Técnica Pharmacêutica SA
Rua Norberto De Oliveira 1-5
Povoa De Santo Adriao
Lisbon, 2620-111
Portugal