Combigan

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 Combigan. If you are concerned about side effects, discuss the risks and benefits of Combigan with your doctor.

The following side effects have been reported by at least 1% of people taking Combigan. 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.

• burning or stinging of your eye
• drowsiness
• dry eye
• Dry Mouth
• headache
• itchy eye
• red eyes (dilation of blood vessels in the membrane that lines the eyelid and surface of the eye, causing the eye to appear "red")

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

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

• vision changes
• slow or irregular heart beat
• Low Blood Pressure
• symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heart beat, weakness

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

• signs of breathing problems (e.g., shortness of breath, troubled breathing, wheezing, or tightness in chest, fast or irregular breathing)
• symptoms of a Anaphylaxis (severe allergic reaction) (e.g., difficulty breathing, Hives, swelling of the face or 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 Combigan.

Each mL of ophthalmic solution contains brimonidine tartrate 2 mg (0.2%) and timolol maleate 5 mg (0.5 %). Nonmedicinal ingredients: benzalkonium chloride 0.005% as preservative, purified water, sodium phosphate, monobasic monohydrate, sodium phosphate, and dibasic heptahydrate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

Do not use brimonidine - timolol eye drops if you:

• are allergic to brimonidine, timolol, or any ingredients of the medication
• are taking a monoamine oxidase (MAO) inhibitor, such as Phenelzine or Tranylcypromine
• have Asthma or have ever had asthma in the past
• have severe chronic obstructive lung disease (COPD (Chronic Obstructive Pulmonary Disease))
• have certain heart diseases or conditions:
• sinus bradycardia (slow heartbeat)
• sick sinus syndrome
• sino-atrial nodal block
• second- or third-degree atrioventricular (AV) block (electrical problems)
• uncontrolled heart failure (heart cannot pump effectively)
• cardiogenic shock (heart cannot provide enough oxygen to the body)

Do not give Combigan to children under 2 years of age.

There may be an interaction between brimonidine - timolol eye drops and any of the following:

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 Combigan. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, Nicotine from cigarettes, and 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 Combigan.

Absorption: Combigan is to be used only as a topical (surface-only) treatment for the eyes; however, as with many eye medications, it is absorbed into the bloodstream. The same side effects of systemic (oral) beta-adrenergic receptor blockers may occur with Combigan. These side effects include shortness of breath, dizziness, lightheadedness, skin rash, or slow heartbeat.

Allergy: Some people who are allergic to other alpha-agonists or beta-blockers experience allergic reactions to brimonidine - timolol. Before you use Combigan, inform your doctor about any previous adverse reactions you have had to medications.

Contamination: Eye drops can become contaminated with bacteria if the tip of the dropper touches any surface, including your eye. This can cause Eye Infections, which may lead to serious eye damage and loss of vision.

Contact lenses: The preservative in these eye drops may be absorbed by soft contact lenses. You should wait at least 15 minutes after using Combigan before putting in your soft contact lenses.

Drowsiness/reduced alertness: Combigan may cause fatigue and/or drowsiness. Avoid driving, using machinery, or doing hazardous activities until you determine how the medication affects you.

Heart disease: People with heart conditions, such as heart block, heart failure or Angina, may experience increased symptoms of their condition when using this eye drop. If you have any medical condition that may be affected by low blood pressure or reduced heart rate, discuss with your doctor how Combigan may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Combigan, and whether any special monitoring is needed. Medical conditions that may be affected include:

• orthostatic hypotension (low blood pressure upon standing up)
• Raynaud's disease
• reduced blood flow to the brain or heart
• severe cardiovascular disease or heart failure
• thromboangiitis obliterans (inflammation and destruction of blood vessels)

Medical conditions: If you have any of the following medical conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Combigan, and whether any special monitoring is needed.

• allergy to other alpha-adrenergic agonists or beta-adrenergic receptor blockers
• chronic obstructive pulmonary disease (COPD)
• Depression
• Diabetes
• liver or kidney impairment
• Myasthenia Gravis

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

Breast-feeding: Timolol passes into breast milk after being used as an eye drop. It is not known if brimonidine passes into human breast milk. If you are a breast-feeding mother and are taking brimonidine - timolol, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

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