AMLODIPINE BESYLATE (Page 5 of 5)

16.2 5 mg Tablets

Amlodipine besylate tablets USP 5 mg (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are white to off-white, round, biconvex, uncoated tablets, debossed with “A5″ on one side and plain on the other side and supplied as follows:

NDC 16729-180-15 Bottle of 90

NDC 16729-180-43 Unit Dose package of 100

NDC 16729-180-58 Bottle of 300

16.3 10 mg Tablets

Amlodipine besylate tablets USP 10 mg (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are white to off-white, round, biconvex, uncoated tablets, debossed with “A10″ on one side and plain on the other side and supplied as follows:

NDC 16729-181-15 Bottle of 90

NDC 16729-181-43 Unit Dose package of 100

NDC 16729-181-58 Bottle of 300

16.4 Storage

Store bottles at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and dispense in tight, light-resistant containers (USP).

Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.

Manufactured By:
Intas Pharmaceuticals Limited,
Plot No. : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210,
INDIA.

10 9650 0 626072

Issued March 2013

Patient Information
Amlodipine Besylate Tablets USP

Read this information carefully before you start taking amlodipine besylate tablets and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor. If you have any questions about amlodipine besylate tablets, ask your doctor. Your doctor will know if amlodipine besylate tablets are right for you.

What are amlodipine besylate tablets?

Amlodipine besylate tablets are a type of medicine known as a calcium channel blocker (CCB). It is used to treat high blood pressure (hypertension) and a type of chest pain called angina. It can be used by itself or with other medicines to treat these conditions.

High Blood Pressure (hypertension)
High blood pressure comes from blood pushing too hard against your blood vessels. Amlodipine besylate tablets relax your blood vessels, which lets your blood flow more easily and helps lower your blood pressure. Drugs that lower blood pressure lower your risk of having a stroke or heart attack.

Angina
Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back. Amlodipine besylate tablets can relieve this pain.

Who should not use amlodipine besylate tablets?

Do not use amlodipine besylate tablets if you are allergic to amlodipine (the active ingredient in amlodipine besylate tablets), or to the inactive ingredients. Your doctor or pharmacist can give you a list of these ingredients.

What should I tell my doctor before taking amlodipine besylate tablets?

Tell your doctor about any prescription and non-prescription medicines you are taking, including natural or herbal remedies.

Tell your doctor if you:

  • ever had heart disease
  • ever had liver problems
  • are pregnant, or plan to become pregnant. Your doctor will decide if amlodipine besylate tablets are the best treatment for you.
  • are breast-feeding. Do not breast-feed while taking amlodipine besylate tablets. You can stop breast-feeding or take a different medicine.

How should I take amlodipine besylate tablets?

  • Take amlodipine besylate tablets once a day, with or without food.
  • It may be easier to take your dose if you do it at the same time every day, such as with breakfast or dinner, or at bedtime. Do not take more than one dose of amlodipine besylate tablets at a time.
  • If you miss a dose, take it as soon as you remember. Do not take amlodipine besylate tablets if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time.
  • Other medicines: You can use nitroglycerin and amlodipine besylate tablets together. If you take nitroglycerin for angina, don’t stop taking it while you are taking amlodipine besylate tablets.
  • While you are taking amlodipine besylate tablets, do not stop taking your other prescription medicines, including any other blood pressure medicines, without talking to your doctor.
  • If you took too much amlodipine besylate tablets, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.

What should I avoid while taking amlodipine besylate tablets?

  • Do not breast-feed. It is not known if amlodipine besylate tablets will pass through your milk.
  • Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.

What are the possible side effects of amlodipine besylate tablets?

Amlodipine besylate tablets may cause the following side effects. Most side effects are mild or moderate:

  • swelling of your legs or ankles
  • tiredness, extreme sleepiness
  • stomach pain, nausea
  • dizziness
  • flushing (hot or warm feeling in your face)
  • arrhythmia (irregular heartbeat)
  • heart palpitations (very fast heartbeat)

It is rare, but when you first start taking amlodipine besylate tablets or increase your dose, you may have a heart attack or your angina may get worse. If that happens, call your doctor right away or go directly to a hospital emergency room.

Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of amlodipine besylate tablets. For a complete list, ask your doctor or pharmacist.

How do I store amlodipine besylate tablets?

Keep amlodipine besylate tablets away from children. Store amlodipine besylate tablets at room temperature (between 59° and 86°F). Keep amlodipine besylate tablets out of the light. Do not store in the bathroom. Keep amlodipine besylate tablets in a dry place.

General advice about amlodipine besylate tablets

Sometimes, doctors will prescribe a medicine for a condition that is not written in the patient information leaflets. Only use amlodipine besylate tablets the way your doctor told you to. Do not give amlodipine besylate tablets to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or doctor for information about amlodipine besylate tablets.

Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.

Manufactured By:
Intas Pharmaceuticals Limited,
Plot No. : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210, INDIA.

10 9650 0 626072

Issued March 2013

PRINCIPAL DISPLAY PANEL

2.5 mg Tablets : 90 Tablets

Amlodipine
(click image for full-size original)

5 mg Tablets : 90 Tablets

Amlodipine
(click image for full-size original)

10 mg Tablets : 90 Tablets

Amlodipine
(click image for full-size original)
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-179
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amlodipine besylate (Amlodipine) Amlodipine 2.5 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, microcrystalline
Magnesium stearate
Sodium starch glycolate type A potato
Anhydrous trisodium citrate
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 5mm
Flavor Imprint Code A
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-179-15 90 TABLET (TABLET) in 1 BOTTLE None
2 NDC:16729-179-43 100 TABLET (TABLET) in 1 BOX, UNIT-DOSE None
3 NDC:16729-179-58 300 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202553 07/01/2013
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-180
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amlodipine besylate (Amlodipine) Amlodipine 5 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, microcrystalline
Magnesium stearate
Sodium starch glycolate type A potato
Anhydrous trisodium citrate
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code A5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-180-15 90 TABLET (TABLET) in 1 BOTTLE None
2 NDC:16729-180-43 100 TABLET (TABLET) in 1 BOX, UNIT-DOSE None
3 NDC:16729-180-58 300 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202553 07/01/2013
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-181
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amlodipine besylate (Amlodipine) Amlodipine 10 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, microcrystalline
Magnesium stearate
Sodium starch glycolate type A potato
Anhydrous trisodium citrate
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code A10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-181-15 90 TABLET (TABLET) in 1 BOTTLE None
2 NDC:16729-181-43 100 TABLET (TABLET) in 1 BOX, UNIT-DOSE None
3 NDC:16729-181-58 300 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202553 07/01/2013
Labeler — Accord Healthcare Inc. (604222237)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 725927649 manufacture (16729-179) (16729-180) (16729-181), analysis (16729-179) (16729-180) (16729-181)

Revised: 05/2013 Accord Healthcare Inc.

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