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ALISKIREN tablet, film coated


  1. Patient Information
  2. What Is The Most Important Information I Should Know About Aliskiren Tablets?
  3. What Are Aliskiren Tablets?
  4. Do Not Take Aliskiren Tablet If:
  5. Especially Tell Your Doctor If You Are Taking:
  6. How Should I Take Aliskiren Tablets?
  7. Aliskiren Tablets May Cause Serious Side Effects, Including:
  8. How Should I Store Aliskiren Tablets?
  9. What Is High Blood Pressure (hypertension)?
  10. What Are The Ingredients In Aliskiren Tablets?

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Information for Patients

Pregnancy: Advise female patients of child bearing age about the consequences of exposure to aliskiren tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Advise patients to report pregnancies to their physicians as soon as possible.

Lactation

Advise nursing women that breastfeeding is not recommended during treatment with aliskiren tablets[see Use in Specific Populations (8.2)].

Anaphylactic Reactions and Angioedema: Advise patients to immediately report any signs or symptoms suggesting a severe allergic reaction (difficulty breathing or swallowing, tightness of the chest, hives, general rash, swelling, itching, dizziness, vomiting, or abdominal pain) or angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to take no more drug until they have consulted with the prescribing physicians. Angioedema, including laryngeal edema, may occur at any time during treatment with aliskiren tablets.

Symptomatic Hypotension: Advise patients that lightheadedness can occur, especially during the first days of aliskiren tablets therapy, and that it should be reported to the prescribing physician. Advise patients that if syncope occurs, aliskiren tablets should be discontinued until the physician has been consulted.

Caution patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

Potassium Supplements: Advise patients receiving aliskiren tablets not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician.

Relationship to Meals: Advise patients to establish a routine pattern for taking aliskiren tablets with regard to meals. High-fat meals decrease absorption substantially.

What Is The Most Important Information I Should Know About Aliskiren Tablets? 


Aliskiren tablets can cause harm or death to your unborn baby.

Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
If you become pregnant during treatment with aliskiren tablets, stop taking aliskiren tablets and tell your doctor right away.

What Are Aliskiren Tablets? 


Aliskiren tablet are a prescription medicine used to treat high blood pressure (hypertension) in adults to lower blood pressure.

It is not known if aliskiren tablets are safe and effective in children under 18 years of age.

Do Not Take Aliskiren Tablet If: 


you have diabetes and are taking a kind of medicine called an angiotensin receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEI).
you are allergic to any of the ingredients in aliskiren tablets.
are breastfeeding or plan to breastfeed. It is not known if aliskiren passes into your breast milk. You should not breastfeed during treatment with aliskiren tablets

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

Especially Tell Your Doctor If You Are Taking: 


a kind of medicine to control blood pressure called angiotensin receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEI).
water pills (also called diuretics ).
cyclosporine (Gengraf, Neoral, Sandimmune)
itraconazole (Onmel, Sporanox).
potassium-containing medicines, potassium supplements, or salt substitutes containing potassium.
nonsteroidal anti-inflammatory drugs (NSAIDs).

Ask your doctor if you are not sure if you are taking one of the medicines listed above.
Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine. Your doctor or pharmacist will know what medicines are safe to take together.

How Should I Take Aliskiren Tablets? 


Take aliskiren tablets exactly as your doctor tells you to take them.
Take aliskiren tablets 1 time a day, about the same time each day.
Your doctor may change your dose if needed.

Aliskiren Tablets May Cause Serious Side Effects, Including: 



Serious allergic reactions that can be life threatening. Stop taking aliskiren tablets and get emergency medical help right away and if you get any of these symptoms of a serious reactions during treatment with aliskiren tablets:
o trouble breathing or swallowing
o chest tightness
o raised bumps (hives)
o rash
o swelling of the face, lips, tongue, throat, arms, legs or the whole body
o itching
o dizziness
o vomiting
o stomach (abdomen) pain

Low blood pressure (hypotension).Your blood pressure may get too low if you also take water pills, are on a low-salt diet, sweat more than normal, receive dialysis treatments, have heart problems, or have vomiting or diarrhea. Lie down if you feel faint or dizzy and call your doctor right away.

Kidney problems, including kidney failure.Tell your doctor if you urinate less.

Increased potassium blood levels (hyperkalemia). Your doctor will check your potassium blood level during treatment with aliskiren tablets.

The most common side effect of aliskiren tabletsis diarrhea.

These are not all of the possible side effects of aliskiren tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Aliskiren Tablets? 


Store aliskiren tablets at room temperature between 68 to 77 F (20 to 25 C).
Keep aliskiren tablets in the original container it comes in. Do not remove the desiccant (drying agent) from the bottle.
Protect aliskiren tablets from moisture.

Keep aliskiren tablets and all medicines out of the reach of children.

General information about the safe and effective use of aliskiren tablets.

Medicines are sometimes prescribed for purpose other than those listed in the Patient Information leaflet. Do not take aliskiren tablets for a condition for which it was not prescribed. Do not give aliskiren tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information that is written for healthcare professionals.

What Is High Blood Pressure (hypertension)? 


Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too great. High blood pressure makes the heart work harder to pump blood through the body and causes damage to the blood vessels. Aliskiren tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack.

What Are The Ingredients In Aliskiren Tablets? 


Aliskiren is available as film-coated tablets, which contains 165.765 mg or 331.530 mg aliskiren hemifumarate (equivalent to 150 mg or 300 mg aliskiren).

Active ingredient: aliskiren hemifumarate

Inactive ingredients: calcium stearate, colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide. In addition, the 150 mg strength contains iron oxide black.

For more information about aliskiren tablets, call Par Pharmaceutical at 1-800-828-9393.

This Patient Information has been approved by the U.S. Food and Drug Administration.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Par Pharmaceutical.

Dist. by:
Par Pharmaceutical
Chestnut Ridge, NY 10977 U.S.A.

Mfg. by:
Par Formulations Private Limited,
9/215, Pudupakkam, Kelambakkam - 603 103
Made in India.

Mfg. Lic. No.: TN00002121
OS424-01-74-02

Revised: 02/2019



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