Consumer Information for: ACH-OLMESARTAN HCTZ

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ACH-Olmesartan HCTZ. Talk about any health conditions or problems you may have, including if you:

• Have a greater chance of developing skin cancer because you:
• had skin cancer or have a family history of skin cancer
• had light-coloured skin
• sunburn easily
• take drugs to suppress your immune system.
• Are allergic to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors,
• Are allergic to the penicillin (antibiotic drug).
• Have a narrow artery or a heart valve.
• Had a heart attack or have heart or blood vessel disease.
• Had a stroke or have a condition that affects the blood supply to the brain.
• Have liver or kidney disease.
• Have blocked bile ducts
• Are taking a medicine that contains aliskirin, such as Rasilez, used to lower high blood pressure. The combination with ACH-Olmesartan HCTZ is not recommended.
• Are taking an angiotensin converting enzyme inhibitor (ACE inhibitors). You can recognize ACE inhibitors because their medicinal ingredient ends in “-PRIL”.
• Have lupus or gout.
• Have diabetes
• Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
• Are taking a salt substitute that contains potassium, potassium supplements, or a potassiumsparing diuretic (a specific kind of “water pill”).
• Are on a low-salt diet.
• Are less than 18 years old.
• Have asthma
• Are taking any medication including non-prescription or herbal products.
• You have to undergo any kind of surgery and general anesthesia.

Other warnings you should know about

ACH-Olmesartan HCTZ can:

• cause severe chronic diarrhea with substantial weight loss (sprue-like enteropathy). It can take months to years for symptoms to develop.
• lower the levels of sodium, chloride and potassium in the blood.

Pregnancy

ACH-Olmesartan HCTZ can cause harm to your unborn baby. Taking ACH-Olmesartan HCTZ during pregnancy can:

• prevent the normal growth of your baby’s kidneys and skull if you take the drug during the second and third trimester. Your doctor may recommend an ultrasound.
• cause your baby’s eyes and skin to turn yellow after birth.
• lower the level of platelets in your baby’s blood.

Risk of skin cancer

ACH-Olmesartan HCTZ contains hydrochlorothiazide. Treatment with hydrochlorothiazide may increase the risk of developing non-melanoma skin cancer. The risk is higher if you have been taking ACH-Olmesartan HCTZ for many years (more than 3) or at a high dose.

While taking ACH-Olmesartan HCTZ:

• Make sure to regularly check your skin for any newlesions (such as a lump, bump, sore, or patch). Check areas that are most exposed to the sun, such as the face, ears, hands, shoulders, upper chest and back. Talk to your doctor immediately if you develop new skin lesions
• Limit your exposure to the sun and to indoor tanning.
• Always use sunscreen (SPF-30 or higher).
• Protect your skin when going outside by covering your skin with clothing and a hat.
• You may become sensitive to the sun. Talk to your doctor immediately if you get more sensitive to the sun or UV light.

Hydrochlorothiazide in ACH-Olmesartan HCTZ can cause Sudden Eye Disorders. These disorders can develop within hours to weeks of starting ACH-Olmesartan HCTZ:

• Sudden Myopia (nearsightedness): objects further away appear blurry.
• Sudden Glaucoma: blurred vision increased pressure in your eyes, and eye pain. It may lead to permanent vision loss if left untreated

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to ACH-Olmesartan HCTZ. Dizziness, lightheadedness, or fainting can occur when you take the drug for after the first time and when your dosage is increased.

Avoid drinking alcohol until you have discussed this with your doctor. Drinking alcohol may lower your blood pressure and may cause you to feel sudden dizziness when you stand up.

If you take ACH-Olmesartan HCTZ with medicines that reduce pain and swelling (Non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors), you may experience:

• A decline in kidney function or sudden kidney failure. Contact your doctor and go to the emergency department immediately if you notice:
• a decrease in the amount of urine you produce
• generalized swelling
• weakness
• shortness of breath, or irregular heartbeats
• loss of appetite
• lethargy and fatigue
• A decrease in the ability of ACH-Olmesartan HCTZ to lower your blood pressure. This means that ACH-Olmesartan HCTZ may not be able to lower your blood pressure as it is expected to do. If this happens, speak with your doctor or pharmacist.