Xalacom

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Xalacom. If you are concerned about side effects, discuss the risks and benefits of Xalacom with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Dry Mouth
• dryness of eye
• feeling of something in the eye
• headache
• irritation, burning, or stinging of the eye when medication is applied
• itching eyes
• redness of the eyelid
• temporary blurred vision after putting in the eye drop
• temporary eye redness
• watery eye

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• back pain
• blurred vision
• coughing
• cloudiness of the eyeball
• darkening of eyelid skin colour
• Depression
• difficulty sleeping
• dizziness
• eye pain
• flu or cold-like symptoms
• hair loss
• increased blood pressure
• increased blood sugar
• increased brown colour in coloured part (iris) of eye
• increased tearing
• longer, thicker, and darker eyelashes
• muscle or joint pain
• muscle weakness
• prolonged blurred vision or other change in vision
• sensitivity of eye to light
• sinus pain and inflammation
• slowed heartbeat
• swelling, irritation, or inflammation of the eye or eyelid
• unusual fatigue

Stop taking the medication and seek immediate medical attention if any of the following occur:

• Angina pectoris or other chest pain
• symptoms of an allergic reaction (e.g., difficulty breathing, Hives, itchy skin rash, or swelling of the mouth and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Xalacom.

Each 1 mL of sterile, clear, colourless aqueous solution contains 50 µg of latanoprost and 5 mg of timolol. Each drop contains approximately 1.5 µg of latanoprost and 150 µg of timolol. Nonmedicinal ingredients: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous, water for injection, and benzalkonium chloride. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (acidity).

Do not use latanoprost - timolol eye drops if you:

• are allergic to latanoprost, timolol, benzalkonium chloride, or any ingredients of the medication
• have Asthma or have had asthma in the past
• have any of certain heart diseases or conditions:
• cardiogenic shock (heart cannot provide enough oxygen to the body)
• second-degree or third-degree atrioventricular (AV) block (electrical problems)
• sinus bradycardia (slow heartbeat)
• uncontrolled heart failure (heart cannot pump effectively)
• have severe COPD (Chronic Obstructive Pulmonary Disease) (COPD; e.g., emphysema, chronic Bronchitis)

There may be an interaction between latanoprost - timolol and any of the following:

• Abiraterone acetate
• Aldesleukin
• alpha blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• Amiodarone
• angiotensin converting enzyme inhibitors (ACEIs; e.g., Captopril, Enalapril, Ramipril)
• angiotensin receptor blockers (ARBs; e.g., candasartan, Irbesartan, Losartan)
• anti-psychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, olanzepine, Quetiapine, Risperidone)
• barbiturates (e.g., butalbital, pentobarbital, Phenobarbital)
• beta-adrenergic blockers in eye-drop or tablet form (e.g., betaxolol, Levobunolol, timolol, Propranolol)
• beta-2 agonists (e.g., salbutamol, formoterol, salmeterol, terbutaline)
• Bimatoprost
• brimonidine
• Bromocriptine
• Bupropion
• Cabergoline
• calcium channel blockers (e.g., Nifedipine, Diltiazem, Verapamil, Amlodipine)
• Celecoxib
• chloroquine
• Clobazam
• Clonidine
• Cinacalcet
• Cobicistat
• Darifenacin
• diabetes medications (e.g., chlorpropamide, glipizide, Glyburide, insulin, Metformin, Nateglinide, Rosiglitazone)
• Digoxin
• Diphenhydramine
• Dipyridamole
• Disopyramide
• diuretics (e.g., Amiloride, Furosemide, Hydrochlorothiazide)
• Donepezil
• Dronedarone
• Epinephrine
• ergot alkaloids (e.g., Dihydroergotamine, ergonovine, ergotamine, methylergonovine)
• Galantamine
• grass pollen extract
• Guanfacine
• HIV protease inhibitors (e.g., darunavir, indinavir, lopinavir, saquinavir, tipranavir)
• isoniazid
• Methotrimeprazine
• methyldopa
• nonsteroidal anti-inflammatory medications (e.g., Diclofenac, Ibuprofen, Ketoprofen, Naproxen)
• quinidine
• monoamine oxidase inhibitors (M.O.S. e.g., Phenelzine, Tranylcypromine, Selegiline)
• opiate medications (e.g., Codeine, Hydrocodone, Morphine)
• nitrates (e.g., isosorbide dinitrate, Nitroglycerin)
• Octreotide
• quinidine
• rifampin
• rifapentine
• Riociguat
• ritonavir
• Rivastigmine
• selective serotonin reuptake inhibitors (SSRI; e.g., Fluoxetine, Paroxetine, Sertraline)
• Stiripentol
• Theophylline
• Ticlopidine
• Tizanidine
• tofactitinb
• tricyclic antidepressants (e.g., Amitriptyline, Desipramine, Nortriptyline)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Xalacom. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Xalacom.

Allergy: If you are allergic to other prostaglandin analogues or beta-adrenergic receptor blockers, discuss the risks and benefits of using Xalacom with your doctor.

Asthma and respiratory disease: Although Xalacom is intended to be used as a topical (surface only) treatment for the eyes, it may be absorbed into the bloodstream and affect breathing if you have a history of breathing problems or difficulty breathing. If you have asthma or another respiratory condition, discuss with your doctor how Xalacom may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed.

Choroidal detachment: If you have chronic or recurrent choroidal detachment, talk to your doctor about further use of the eye drops.

Contact lenses: Contact lenses should be removed before latanoprost - timolol eye drops are applied and should not be reinserted for 15 minutes after application of the drops.

Depression: People with clinical depression should discuss with their doctor how Xalacom may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed. You may need to visit your doctor more often to ensure that Xalacom is not making your condition worse.

Diabetes: Although Xalacom is intended to be used as a topical treatment for the eyes, it may be absorbed into the bloodstream and affect blood sugar control if you have diabetes. People with diabetes should discuss with their doctor how Xalacom may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed. You may need to test your blood sugar more often while you are using Xalacom.

Drowsiness/reduced alertness: This medication may cause drowsiness and temporary blurring of your vision. Do not drive, operate machinery, or engage in any potentially hazardous activities until you determine how Xalacom affects you.

Eye changes: Latanoprost may gradually change the colour of the eye, increasing the amount of brown pigment in the iris (coloured part of the eye). The long-term effects on the eye and the chances of injury to the eye are currently unknown. The change in colour may be permanent and occurs slowly, and may not be noticeable for several months or years. Latanoprost has also been reported to cause darkening, thickening, and lengthening of eyelashes. Talk to your doctor if you have any concerns.

Eye conditions: If you have frequent or chronic inflammation of the eye, discuss with your doctor how Xalacom may affect your medical condition, howyour medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed.

Heart disease: Although Xalacom is intended to be used as a treatment applied directly to the eyes, it may be absorbed into the bloodstream and have an effect on heart disease or circulation problems such as Raynaud’s disease. If you have heart disease or circulation problems, discuss with your doctor how Xalacom may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed.

Kidney or liver disease: If you have decreased kidney or liver function, discuss with your doctor how Xalacom may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed.

Myasthenia Gravis: If you have myasthenia gravis, discuss with your doctor how Xalacom may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed.

Thimerosal: Any eye medication containing thimerosal should not be used within 5 minutes before or after using latanaprost, as solid particles may develop as a result of the two medications mixing together.

Thyroid disease: If you have thyroid disease, discuss with your doctor how Xalacom may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed.

Pregnancy: Xalacom should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Xalacom, contact your doctor immediately.

Breast-feeding: Xalacom may pass into breast milk. If you are a breast-feeding mother and are taking latanoprost - timolol, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Xalacom have not been established for children.