AZARGA Kolir 5 ml
AZARGA is used to lower intraocular pressure. This pressure can lead to a condition called glaucoma.
AZARGA is a combination of treatments for glaucoma.
It contains two active substances that act together to reduce intraocular pressure.
2. BEFORE YOU USE AZARGA
Do not use AZARGA:
if you are allergic to brinzolamide, carbonic anhydrase inhibitor, timolol, beta-blockers or any of the other ingredients. For a full list of ingredients see section 6;
if you have or have ever had breathing problems such as asthma, severe chronic obstructive bronchitis (severe lung condition which may cause wheezing, shortness of breath and / or prolonged cough) or other respiratory problems;
if you suffer from severe hay fever;
if you have a slow heart beat, heart failure or abnormal heart rhythm (irregular heartbeat);
if you have too much acidity in the blood (a condition called acidosis hyperchloraemic);
if you have severe kidney problems.
Take special care with AZARGA
Before using this medication, tell your doctor if you have or have had in the past:
Coronary heart disease (symptoms may include pain or tightness in the chest, shortness of breath or choking), heart failure, low blood pressure;
disturbances of heart rate such as slow heart rate;
breathing problems, asthma or chronic obstructive pulmonary disease;
disease with reduced blood circulation (such as Raynaud's disease or Raynaud's syndrome);
diabetes as timolol may mask signs and symptoms of low blood sugar;
increased activity of the thyroid gland, as timolol may mask the signs and symptoms of thyroid disease;
before surgery tell your doctor that you are using AZARGA, as timolol may change effects of some medicines used during anesthesia;
if you get any severe allergic reaction while using AZARGA, whatever the cause, adrenaline treatment may not be effective. So when receiving any other treatment please tell the doctor that you are using AZARGA;
if you have liver problems. Talk to your doctor;
if you have dry eyes or cornea problems. Talk to your doctor;
AZARGA is not recommended for children under 18 years.
Using other medicines
AZARGA can affect or be affected by other medicines you are taking, including other eye drops for treating glaucoma. Tell your doctor if you are taking or plan to take medicines to lower blood pressure, heart medicines including quinidine (used to treat heart disease and some types of malaria), medicines to treat diabetes or for the treatment of gastric ulcers, antifungal, antiviral or antibiotic drugs or antidepressants known as fluoxetine and paroxetine.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and lactation
You should not use AZARGA, if you are pregnant or might become pregnant, unless your doctor considers it necessary. Consult your doctor before you use AZARGA.
Do not use AZARGA, if you are breast feeding, timolol can pass into breast milk. Ask your doctor before taking any medicine while breastfeeding.
Driving and using machines
Do not drive or operate machinery until your vision is clear. You may find blurred vision after using AZARGA.
One of the active ingredients may impair the ability of elderly patients to perform tasks requiring mental alertness and / or physical coordination. If an affected, take care when driving or operating machinery.
Important information about some of the ingredients of AZARGA
In AZARGA is preservative (benzalkonium chloride) that can discolour soft contact lenses and cause eye irritation. Therefore, do not wear contact lenses whilst using AZARGA. Wait 15 minutes after using AZARGA, before putting your lenses back.
3. HOW TO USE AZARGA
Always use AZARGA exactly as your doctor has told you. If you're not sure, ask your doctor or pharmacist.
The usual dose is:
Adults: One drop in the affected eye / eyes twice daily - morning and evening.
Use AZARGA in both eyes if so you have been told by your doctor. Use it for as long as prescribed by your doctor.
Take a bottle with AZARGA and mirror.
Wash your hands.
Shake the bottle well before use.
Twist off the cap.
Hold the bottle, pointing down, between your thumb and fingers.
Tilt your head back. Pull down your eyelid with a clean finger, so that it forms a 'pocket' between him and the eye. The drop will go in this place.
Bring the bottle tip close to the eye. Use the mirror if it helps.
Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. There is a danger of contamination of the drops.
Gently press the base of the bottle to release one drop of AZARGA.
Do not squeeze the bottle: it is designed so that it only takes a little pressure on the bottom.
After inserting AZARGA, press a finger to the eye in the corner of the nose for 2 minutes. This will prevent AZARGA is to move to other parts of the body.
If you use drops in both eyes, repeat the steps for your other eye.
Close the bottle immediately after use.
Do not open a new bottle until you've used first.
If a drop misses your eye, try again.
If you use more than the amount of AZARGA, rinse your eye with warm water. Do not put in any more drops until it's time for your next regular dose.
If you forget to use AZARGA, continue with the next dose as planned. Do not take a double dose to make up for the forgotten. Do not put more than one drop in the affected eye / eyes twice daily.
If you stop using AZARGA, but do not coordinate with your doctor the pressure in your eye will not be controlled, and this can lead to vision loss.
If you use other eye drops, wait at least 5 minutes between putting of AZARGA and the other drops.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, AZARGA can cause side effects, although not everybody gets them.
You can usually carry on taking the drops, unless the effects are serious. If you're worried, ask your doctor or pharmacist. Do not stop using AZARGA, without talking to your doctor.
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 user in 10);
Common (affects 1 to 10 users in 100);
Uncommon (affects 1 to 10 users in 1000);
Rare (affects 1 to 10 users in 10,000);
Not known (from the available data can not be estimated).
Common side effects (affects 1 to 10 users in 100):
Ocular side effects: blurred vision, signs and symptoms of eye irritation (eg. A burning, stinging, itching, tearing, redness), eye pain, abnormal sensation in the eyes.
Common side effects: taste disturbances.
Uncommon side effects (affects 1 to 10 users in 1000):
Ocular adverse events: inflammation of the eye surface with a damage to the surface, inflammation within the eye, eye redness, itching of the eye; itching, redness, swelling of the eyelid or crusting of the eyelid; eye discharge, eye allergy, dry eye, tired eyes.
General side effects: chronic lung disease, reduced blood pressure, throat irritation, cough, difficulty sleeping (insomnia), skin inflammation, redness or itching, runny nose, abnormal hair.
Additional side effects:
AZARGA is a combination of two active substances. Like other medicines applied into eyes, brinzolamide and timolol (a beta blocker) are absorbed into the blood. This may cause similar side effects to those observed in intravenous and / or oral administration of beta-blockers. The incidence of adverse reactions after topical ophthalmic administration is lower than when administered orally or by injection.
Listed adverse reactions include reactions that are characteristic of the class beta-blockers, when used for the treatment of eye diseases are the following:
Ocular adverse events: damage to the optic nerve, increased pressure in the eye, deposits on the surface of the eye, corneal disorder, decreased sense of the eye, inflammation or infection of the conjunctiva, abnormal, double or reduced vision, increased pigmentation of the eye growth the surface of the eye, increased tear production, eye swelling, sensitivity to light, decreased growth or number of eyelashes, drooping of the upper eyelid (making the eye stay half closed), inflammation of the eyelid and the eyelid glands, inflammation of the cornea and detachment of the container layer blood vessels under the retina after filtration surgery, which may cause visual disturbances, decreased sensitivity of the cornea, corneal erosion (damage to the front layer of the eyeball).
Common side effects:
Heart and circulation: changes in rhythm or heart rate, slow heart rate, palpitations, a type of heart rhythm disorder, chest pain, reduced heart function, heart attack, heart failure, high blood pressure, decreased cerebral blood flow, stroke, edema ( fluid retention), congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid retention), swelling of the extremities, low blood pressure, Raynaud's phenomenon, cold hands and feet.
Respiratory: constriction of the airways in the lungs (predominantly in patients with pre-existing disease), shortness of breath or difficulty breathing, cold symptoms, fluid accumulation in the chest, sinus infection, sneezing, stuffy nose, dry nose, nosebleeds , asthma.
Nervous system and general disorders: nightmares, memory loss, headache, nervousness, irritability, fatigue, tremors, abnormal sensation, seizures, dizziness, drowsiness, or expressed general weakness, abnormal sensations such as numbness in the limbs.
Stomach: nausea, vomiting, diarrhea, intestinal gas or abdominal pain, sore throat, dry or abnormal sensation in the mouth, indigestion, pain in the stomach.
Blood: abnormal liver function tests, increased levels of chlorine in the blood or a reduced number of red blood cells in a blood test.
Allergy: increased allergic symptoms, generalized allergic reactions including swelling beneath the skin that can occur in areas like the face and lips and can clog the airways, causing difficulty swallowing or breathing, hives (urticaria), localized and generalized rash , itching, severe sudden life-threatening allergic reactions.
Ear, ringing in the ears, a feeling of vertigo or dizziness.
Skin: rash, abnormal or decreased skin sensation, hair loss, rash with white silvery coloring (psoriasiform rash) or worsening of psoriasis.
Muscular: generalized back pain, joint or muscle that is not caused by physical exertion, muscle spasms, pain in the extremities, muscle weakness / fatigue, increase in signs and symptoms of myasthenia gravis (muscle disorder).
Kidney: kidney pain, manifested as low back pain, frequent urination.
Play: sexual dysfunction, decreased libido, male sexual difficulty.
Metabolism: low blood sugar.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE AZARGA
Keep out of reach of children.
Do not use AZARGA after the expiry date stated on the bottle and carton after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Throw away the bottle 4 weeks after first opening to prevent infections and use a new bottle. Write the date you opened it in the space on the bottle label and carton.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
The active substances are brinzolamide and timolol. One ml of suspension contains 10 mg brinzolamide and 5 mg of timolol.
Other ingredients are: benzalkonium chloride, carbopol 974P, edetate disodium, mannitol (E421), purified water, sodium chloride, tyloxapol, hydrochloric acid and / or sodium
Added Tiny amounts of hydrochloric acid and / or sodium hydroxide to maintain a normal level of acidity (pH).
AZARGA looks like and contents of the pack
AZARGA is a liquid (white to off-white uniform suspension) supplied in a pack containing a plastic bottle of 5 ml with screw cap or in a pack containing three bottles of 5 ml.
He all pack sizes may be marketed.