COMMON QUESTIONS

Blood pressure is the force that pushes the blood through your blood vessels to all the organs of your body. You have high blood pressure when the force of your blood moving through your blood vessels is too great. Renin (pronounced REE-nin) is an enzyme in the body that starts a process that makes blood vessels narrow, leading to high blood pressure.

High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.

High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.

Tekturna and Tekturna HCT are prescription medications that are approved to treat high blood pressure and are not approved to treat or prevent stroke, heart attack, heart failure, kidney failure, or vision problems resulting from high blood pressure.

Renin is an enzyme produced in the kidneys and is part of the renin system.

Fluid retention can happen when the kidneys aren’t working properly and it can lead to high blood pressure.

The kidneys regulate salt and water levels in the body. When salt and water levels increase around cells, the excess is drawn into our blood. Normally, the kidneys filter this salt and water from the blood, which are then excreted by the body as urine.

When kidneys don't work properly, fluid builds up around cells and in the blood. If there is more fluid in the blood, the heart, which pumps blood through the body, has to work harder. This can put more pressure on the walls of the blood vessels, resulting in high blood pressure.

High blood pressure causes damage to the blood vessels.

The renin system is a chemical system that works throughout your body. It plays a role in blood pressure rising and falling. Renin starts a chemical process that narrows blood vessels. In some people, the renin system is inappropriately activated.

Tekturna is a type of prescription medicine called a Direct Renin Inhibitor (DRI) that works in the body to help lower high blood pressure (hypertension).

Tekturna reduces the effect of renin and the harmful process that narrows blood vessels. Tekturna helps blood vessels relax and widen so blood pressure is lowered.

	If you get pregnant, stop taking Tekturna and call your doctor right away.
	If you plan to become pregnant, talk to your doctor about other treatment options for your high blood pressure.
	Do not take Tekturna if you are allergic to any of its ingredients.
	Do not take Tekturna if you take cyclosporine.

Aliskiren is the active ingredient in Tekturna. The inactive ingredients (the ingredients that bind the tablet together) are colloidal silicon dioxide, crospovidone, hypromellose, iron oxide colorants, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. These inactive ingredients are considered safe and are commonly used in many medications. Talk to your doctor if you have questions.

Tekturna has not been studied in children under 18 years of age.

Tell your doctor about all your medical conditions, including whether you:

	are pregnant or are planning to become pregnant.
	are breast-feeding. It is not known if Tekturna passes into your breast milk. You should choose either to take Tekturna or breast-feed, but not both.
	have kidney problems.
	are allergic to any of the ingredients in Tekturna.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

	other medicines for high blood pressure or a heart problem.
	water pills (also called diuretics).
	medicines for treating fungus or fungal infections.
	Cyclosporine (a medicine to suppress the immune system).
	potassium-containing medicines, potassium supplements, or salt substitutes containing potassium.

Your doctor or pharmacist will know what medicines are safe to take together.

	Take Tekturna once a day, at the same time each day. As with any blood pressure medication, it is important to take Tekturna on a regular daily basis exactly as prescribed by your doctor.
	Tekturna can be taken by itself or safely in combination with other medicines to lower high blood pressure. Tekturna can also be safely taken in combination with medications for other conditions, such as high cholesterol or diabetes. Your doctor may change your dose if needed.
	Tekturna can be taken with or without food.

If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time. If you take too much Tekturna, call your doctor or Poison Control Center, or go to the nearest hospital emergency room.

Tekturna (aliskiren) may cause the following serious side effect:

Low blood pressure (hypotension).

Your blood pressure may get too low if you also take water pills, are on a low-salt diet, get dialysis treatments, have heart problems, or get sick with vomiting or diarrhea. Lie down if you feel faint or dizzy.

Call your doctor right away.

Side effects were usually mild and brief. Few patients decided to stop taking Tekturna because of side effects. In clinical studies, the most common side effect experienced by more patients taking Tekturna than patients taking a sugar pill (placebo) was diarrhea. Other less common reactions to Tekturna include cough and rash.

If you develop an allergic reaction involving swelling of the face, lips, throat, and/or tongue which may cause difficulty in breathing and swallowing, stop taking Tekturna and contact your doctor immediately.

For a complete list of side effects, ask your doctor or pharmacist. Tell your doctor if you get any side effect that bothers you or will not go away.

	Store Tekturna tablets at room temperature between 59 to 86 degrees Fahrenheit.
	Keep Tekturna in the original prescription bottle in a dry place. Do not remove the desiccant (drying agent) from the bottle.
	Keep Tekturna and all medicines out of the reach of children.

Do not give Tekturna to other people, even if they have the same condition or symptoms you have. It may harm them.

Tekturna HCT contains two prescription medicines in one tablet that work together to lower blood pressure. It contains:

	aliskiren (Tekturna), a direct renin inhibitor (DRI).
	hydrochlorothiazide, a diuretic (water pill).

Tekturna HCT should not be the first medicine used to treat your high blood pressure.

Tekturna HCT has not been studied in children under 18 years of age.

Your doctor may prescribe other medicines for you to take along with Tekturna HCT to treat your high blood pressure. Blood pressure is reduced more with Tekturna HCT than when either Tekturna or hydrochlorothiazide is taken by itself.

The two medications in Tekturna HCT work to lower high blood pressure in two different ways.

1.	Here’s how the Tekturna component works:
	Renin is an enzyme in the body that can cause high blood pressure. It does this by starting a process that makes blood vessels narrow. Tekturna binds directly to renin and interrupts the process that narrows the blood vessels. Tekturna keeps blood vessels open so blood pressure is lowered.
2.	Here’s how the diuretic component works:
	Diuretics, also called water pills, cause sodium and water to move out of the body (through urination). This reduces blood volume, which can help lower blood pressure.

	If you get pregnant, stop taking Tekturna HCT and call your doctor right away.
	If you plan to become pregnant, talk to your doctor about other treatment options for your high blood pressure.
	Do not take Tekturna HCT if you make very little or no urine due to kidney problems.
	Do not take Tekturna HCT if you are allergic to any of its ingredients.

The active ingredients in Tekturna HCT are aliskiren and hydrochlorothiazide.

The inactive ingredients are: Colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide colorants, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide, and wheat starch.

Tell your doctor about all your medical conditions, including whether you:

	have any allergies or asthma.
	have kidney problems.
	have liver problems.
	have systemic lupus erythematosus (SLE). Tekturna HCT can make your SLE active or worse.
	have ever had a reaction called angioedema to an ACE Inhibitor medicine. Angioedema causes swelling of the face, lips, tongue, throat, arms, and legs, and may cause difficulty breathing.
	are pregnant or planning to become pregnant. See IMPORTANT WARNING.
	are breast-feeding. It is not known if Tekturna HCT passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you are taking:

	other medicines for high blood pressure or a heart problem.
	water pills (also called "diuretics").
	medicines for treating fungus or fungal infections.
	cyclosporine (a medicine used to suppress the immune system).
	potassium-containing medicines, potassium supplements, or salt substitutes containing potassium.
	cholestyramine (for example; Questran, Questran Light, Cholestyramine Light, Locholest Light, Locholest, Prevalite) (medicines to lower the cholesterol in your blood).
	Cholestipol (for example; Colestipol hydrochloride, Colestid, Flavored Colestid) (medicines to lower the cholesterol in your blood).
	potassium supplements.
	medicines to treat diabetes, including insulin.
	lithium, a medicine used in some types of depression. Do not take Tekturna HCT if you are taking lithium.
	nonsteroidal anti-inflammatory (NSAIDs) medicines. Ask your doctor if you are not sure if you are taking one of these medicines.
	blood thinners.
	barbiturate or narcotic medicines. Ask your doctor if you are not sure if you are taking one of these medicines.

Your doctor or pharmacist will know what medicines are safe to take together. Know your medicines. Keep a list of your medicines and show it to your doctor or pharmacist when you get a new medicine.

	Take Tekturna HCT exactly as prescribed by your doctor. It is important to take Tekturna HCT every day to control your blood pressure.
	Take Tekturna HCT once each day, about the same time each day.
	Take Tekturna HCT the same way every day, either with or without a meal.
	Your doctor may change your dose of Tekturna HCT if needed.
	If you miss a dose of Tekturna HCT, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time.
	If you take too much Tekturna HCT, call your doctor or Poison Control Center, or go to the nearest hospital emergency room.

Tekturna HCT may cause serious side effects:

	Injury or death to an unborn baby. See IMPORTANT WARNING.
	Low blood pressure (hypotension). Your blood pressure may get too low if you also take water pills, are on a low-salt diet, get dialysis treatments, have heart problems, or get sick with vomiting or diarrhea. Drinking alcohol and taking certain medicines (barbiturates or narcotics) can cause low blood pressure to get worse. Lie down if you feel faint or dizzy, and call your doctor right away.
	Angioedema. Aliskiren in Tekturna HCT can cause swelling of the face, lips, tongue, throat, arms, and legs, or the whole body. Get medical help right away and tell your doctor if you get any one or more of these symptoms. Angioedema can happen at any time while you are taking Tekturna HCT.
	Active or worsened Systemic Lupus Erythematosus (SLE). If you have SLE, tell your doctor right away if you get any new or worse symptoms.

Common side effects of Tekturna HCT include:

	dizziness.
	flu-like symptoms.
	diarrhea.
	cough.
	tiredness.

Other less common side effects include skin rash.

Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of Tekturna HCT. For a complete list of side effects, ask your doctor or pharmacist.

	Store Tekturna HCT tablets at room temperature between 59° F and 86° F (15° C-30° C).
	Keep Tekturna HCT in the original prescription bottle in a dry place. Do not remove the desiccant (drying agent) from the bottle.

Keep Tekturna HCT and all medicines out of the reach of children.

Medicines are sometimes prescribed for conditions not listed in the patient information. Do not take Tekturna HCT for a condition for which it was not prescribed. Do not give Tekturna HCT to other people, even if they have the same condition or symptoms you have. It may harm them.

This summarizes the most important information about Tekturna HCT. If you have questions about Tekturna HCT, talk with your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals.