Amlodipine and Valsartan (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Amlodipine and Valsartan is available as tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.

All strengths are packaged in bottles of 30, 90 and 500 count, and unit dose blister packages.

5/160 mg Tablets – Mustard coloured, capsule shaped, film coated, biconvex tablets debossed ‘LU’ on one side and ‘Q12’ on the other side.

Bottles of 30 NDC # 68180-764-06

Bottles of 90 NDC # 68180-764-09

Bottles of 500 NDC # 68180-764-02

Unit Dose 100 tablets (10 x 10 tablets blister cards) NDC # 68180-764-13

10/160 mg Tablets — Yellow, capsule shaped, film coated, biconvex tablets debossed ‘LU’ on one side and ‘Q14’ on the other side.

Bottles of 30 NDC # 68180-765-06

Bottles of 90 NDC # 68180-765-09

Bottles of 500 NDC # 68180-765-02

Unit Dose 100 tablets (10 x 10 tablets blister cards) NDC # 68180-765-13

5/320 mg Tablets — Mustard coloured, capsule shaped, film coated, biconvex tablets debossed ‘LU’ on one side and ‘Q13’ on the other side.

Bottles of 30 NDC # 68180-766-06

Bottles of 90 NDC # 68180-766-09

Bottles of 500 NDC # 68180-766-02

Unit Dose 100 tablets (10 x 10 tablets blister cards) NDC # 68180-766-13

10/320 mg Tablets — Yellow, capsule shaped, film coated, biconvex tablets debossed ‘LU’ on one side and ‘Q15’ on the other side

Bottles of 30 NDC # 68180-767-06

Bottles of 90 NDC # 68180-767-09

Bottles of 500 NDC # 68180-767-02

Unit Dose 100 tablets (10 x 10 tablets blister cards) NDC # 68180-767-13

Store at 25⁰ C (77⁰ F); excursions permitted to 15 to 30⁰ C (59 to 86⁰ F). [See USP Controlled Room Temperature.] Protect from moisture.

17 PATIENT COUNSELING INFORMATION

Information for Patients

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

Pregnancy

Female patients of childbearing age should be told about the consequences of exposure to amlodipine and valsartan tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.

^# The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Goa — 403722

India

Revised: October 2015 ID#: 242870

FDA-APPROVED PATIENT LABELING

PATIENT INFORMATION

Amlodipine (am-LOE-di-peen) and Valsartan (val-SAR-tan) Tablets

Rx only

Read the Patient Information that comes with amlodipine and valsartan tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about amlodipine and valsartan tablets, ask your doctor or pharmacist.

What are amlodipine and valsartan tablets?

Amlodipine and valsartan tablets contain 2 prescription medicines:

1. amlodipine, a calcium channel blocker

2. valsartan, an angiotensin receptor blocker (ARB).

Amlodipine and valsartan tablets may be used to lower high blood pressure (hypertension) in adults

• when 1 medicine to lower your high blood pressure is not enough
• as the first medicine to lower high blood pressure if your doctor decides you are likely to need more than 1 medicine.

Amlodipine and valsartan tablets have not been studied in children under 18 years of age.

What should I tell my doctor before taking amlodipine and valsartan tablets?

Tell your doctor about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. See “What is the most important information I should know about amlodipine and valsartan tablets?”
• are breastfeeding or plan to breastfeed. Amlodipine and valsartan tablets may pass into your milk. Do not breastfeed while you are taking amlodipine and valsartan tablets.
• have heart problems
• have liver problems
• have kidney problems
• are vomiting or having a lot of diarrhea
• have ever had a reaction called angioedema, to another blood pressure medicine. Angioedema causes swelling of the face, lips, tongue, throat, and may cause difficulty breathing.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines and amlodipine and valsartan tablets could affect each other, causing serious side effects.

Especially tell your doctor if you take:

• simvastatin or other cholesterol-lowering medicine
• other medicines for high blood pressure or a heart problem
• water pills (diuretics)
• potassium supplements. Your doctor may check the amount of potassium in your blood periodically.
• a salt substitute. Your doctor may check the amount of potassium in your blood periodically.
• nonsteroidal anti-inflammatory drugs (like ibuprofen or naproxen)
• medicines used to prevent and treat fungal skin infections (such as ketoconazole, itraconazole)
• medicines used to treat bacterial infections (such as clarithromycin, telithromycin)
• certain antibiotics (rifamycin group), a drug used to protect against transplant rejection (cyclosporine) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of valsartan.
• lithium, a medicine used in some types of depression

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

How should I take amlodipine and valsartan tablets?

• Take amlodipine and valsartan tablets exactly as your doctor tells you.
• Take amlodipine and valsartan tablets once each day.
• Amlodipine and valsartan tablets 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 amlodipine and valsartan tablets, call your doctor or Poison Control Center, or go to the emergency room.
• Tell all your doctors or dentist you are taking amlodipine and valsartan tablets if you:

ο are going to have surgery

ο go for kidney dialysis

What should I avoid while taking amlodipine and valsartan tablets?

You should not take amlodipine and valsartan tablets during pregnancy. See “What is the most important information I should know about amlodipine and valsartan tablets.”

What are the possible side effects of amlodipine and valsartan tablets?

Amlodipine and valsartan tablets may cause serious side effects including:

• harm to an unborn baby causing injury and even death. See “What is the most important information I should know about amlodipine and valsartan tablets?”
• low blood pressure (hypotension). Low blood pressure is most likely to happen if you:

ο take water pills

ο are on a low salt diet

ο get dialysis treatments

ο have heart problems

ο get sick with vomiting or diarrhea

ο drink alcohol

Lie down if you feel faint or dizzy. Call your doctor right away.

• more heart attacks and chest pain (angina) in people that already have severe heart problems. This may happen when you start amlodipine and valsartan tablets or when there is an increase in your dose of amlodipine and valsartan tablets. Get emergency help if you get worse chest pain or chest pain that does not go away.
• kidney problems. Kidney problems may become worse in people that already have kidney disease. Some people will have changes in blood tests for kidney function and may need a lower dose of amlodipine and valsartan tablets. Call your doctor if you have swelling in your feet, ankles, or hands or unexplained weight gain. If you have heart failure, your doctor should check your kidney function before prescribing amlodipine and valsartan tablets.
• laboratory blood test changes in people with heart failure. Some people with heart failure who take valsartan, 1 of the medicines in amlodipine and valsartan tablets, have changes in blood tests including increased potassium and decreased kidney function.

The most common side effects of amlodipine and valsartan tablets include:

• swelling (edema) of the hands, ankles, or feet
• nasal congestion, sore throat, and discomfort when swallowing
• upper respiratory tract infection (head or chest cold)
• dizziness

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of amlodipine and valsartan tablets. For more information, ask your doctor or pharmacist.

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 amlodipine and valsartan tablets?

• Store at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF).
• Keep amlodipine and valsartan tablets dry (protect it from moisture).

Keep amlodipine and valsartan tablets and all medicines out of the reach of children.

General Information about amlodipine and valsartan tablets

Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflet. Do not use amlodipine and valsartan tablets for a condition for which it was not prescribed. Do not give amlodipine and valsartan tablets to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about amlodipine and valsartan tablets. If you would like more information about amlodipine and valsartan tablets, talk with your doctor. You can ask your doctor or pharmacist for information about amlodipine and valsartan tablets that is written for health professionals. For more information go to www.lupinpharmaceuticals.com or call 1-800-399-2561.

What are the ingredients in amlodipine and valsartan tablets?

Active ingredients: Amlodipine besylate and valsartan

The inactive ingredients of all strengths of the tablets are colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, iron oxide yellow and titanium dioxide. Additionally, the 5/160 mg and 5/320 mg strengths contain iron oxide red.

What is high blood pressure (hypertension)?

Blood pressure is the force of blood in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. Amlodipine and valsartan tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower blood pressure lower your chance of having a stroke or heart attack.

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

^# The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Goa — 403722

India

Revised: October 2015 ID#: 242871

Strength: 5/160 mg Tablets

Container Label: 30s Pack

NDC 68180-764-06

5mg-160mg-30s-container

Strength: 5/160 mg Tablets

Carton Label: 100 Tablets

NDC 68180-764-13

5mg-160mg-carton

Strength: 5/160 mg Tablets

NDC 68180-764-11

Blister strip of 10’s

5mg-160mg-foil

Strength: 10/160 mg Tablets

Container Label: 30s Pack

NDC 68180-765-06

10mg-160mg-30s-container

Strength: 10/160 mg Tablets

Carton Label: 100 Tablets

NDC 68180-765-13

10mg-160mg-carton

Strength: 10/160 mg Tablets

NDC 68180-765-11

Blister strip of 10’s

10mg-160mg-foil

Strength: 5/320 mg Tablets

Container Label: 30s Pack

NDC 68180-766-06

5mg-320mg-30s-container

Strength: 5/320 mg Tablets

Carton Label: 100 Tablets

NDC 68180-766-13

5mg-320mg-carton

Strength: 5/320 mg Tablets

NDC 68180-766-11

Blister strip of 10’s

5mg-320mg-foil

Strength: 10/320 mg Tablets

Container Label: 30s Pack

NDC 68180-767-06

10mg-320mg-30s-container

Strength: 10/320 mg Tablets

Carton Label: 100 Tablets

NDC 68180-767-13

10mg-320mg-carton

Strength: 10/320 mg Tablets

NDC 68180-767-11

Blister strip of 10’s

10mg-320mg-foil

AMLODIPINE AND VALSARTAN amlodipine and valsartan tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-764 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg VALSARTAN (VALSARTAN) VALSARTAN 160 mg

Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED

Product Characteristics Color YELLOW (Mustard) Score no score Shape CAPSULE (capsule) Size 16mm Flavor Imprint Code LU;Q12 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57297-764-02 500 TABLET in 1 BOTTLE None 2 NDC:57297-764-11 10 TABLET in 1 BLISTER PACK None 3 NDC:57297-764-09 90 TABLET in 1 BOTTLE None 4 NDC:57297-764-06 30 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090245 03/30/2015

AMLODIPINE AND VALSARTAN amlodipine and valsartan tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-765 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg VALSARTAN (VALSARTAN) VALSARTAN 160 mg

Product Characteristics Color YELLOW (Yellow) Score no score Shape CAPSULE (capsule) Size 16mm Flavor Imprint Code LU;Q14 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57297-765-09 90 TABLET in 1 BOTTLE None 2 NDC:57297-765-02 500 TABLET in 1 BOTTLE None 3 NDC:57297-765-11 10 TABLET in 1 BLISTER PACK None 4 NDC:57297-765-06 30 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090245 03/30/2015

AMLODIPINE AND VALSARTAN amlodipine and valsartan tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-766 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg VALSARTAN (VALSARTAN) VALSARTAN 320 mg

Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED

Product Characteristics Color YELLOW (Mustard) Score no score Shape CAPSULE (capsule) Size 21mm Flavor Imprint Code LU;Q13 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57297-766-11 10 TABLET in 1 BLISTER PACK None 2 NDC:57297-766-06 30 TABLET in 1 BOTTLE None 3 NDC:57297-766-09 90 TABLET in 1 BOTTLE None 4 NDC:57297-766-02 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090245 03/30/2015

AMLODIPINE AND VALSARTAN amlodipine and valsartan tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-767 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg VALSARTAN (VALSARTAN) VALSARTAN 320 mg

Product Characteristics Color YELLOW (Yellow) Score no score Shape CAPSULE (capsule) Size 21mm Flavor Imprint Code LU;Q15 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57297-767-02 500 TABLET in 1 BOTTLE None 2 NDC:57297-767-11 10 TABLET in 1 BLISTER PACK None 3 NDC:57297-767-09 90 TABLET in 1 BOTTLE None 4 NDC:57297-767-06 30 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090245 03/30/2015

Labeler — LUPIN LIMITED (675923163)

Registrant — LUPIN LIMITED (675923163)

Establishment
Name	Address	ID/FEI	Operations
LUPIN LIMITED		677600414	manufacture (57297-764), manufacture (57297-765), manufacture (57297-766), manufacture (57297-767), pack (57297-764), pack (57297-765), pack (57297-766), pack (57297-767)

Revised: 02/2016 LUPIN LIMITED