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AMLODIPINE AND VALSARTAN- amlodipine besylate and valsartan tablet, film coated


  1. Patient Information
  2. Pregnancy:
  3. What Is The Most Important Information I Should Know About Amlodipine And Valsartan Tablets?
  4. Amlodipine And Valsartan Tablets Contain 2 Prescription Medicines:
  5. Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  6. Especially Tell Your Doctor If You Take:
  7. How Should I Take Amlodipine And Valsartan Tablets?
  8. Tell All Your Doctors Or Dentist You Are Taking Amlodipine And Valsartan Tablets If You:
  9. What Should I Avoid While Taking Amlodipine And Valsartan Tablets?
  10. What Are The Possible Side Effects Of Amlodipine And Valsartan Tablets?
  11. The Most Common Side Effects Of Amlodipine And Valsartan Tablets Include:
  12. How Should I Store Amlodipine And Valsartan Tablets?
  13. What Are The Ingredients In Amlodipine And Valsartan Tablets?
  14. What Is High Blood Pressure (hypertension)?
  15. Distributed By:
  16. Revised: 8/2015document Id:

Patient 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.

T2016-30
August 2015

FDA-APPROVED PATIENT LABELING

PATIENT INFORMATION

AMLODIPINE AND VALSARTAN TABLETS

(am-LOE-dih-peen, val-SAR-tan)

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 Is The Most Important Information I Should Know About Amlodipine And Valsartan Tablets? 


Amlodipine and valsartan tablets can cause harm or death to an unborn baby.
Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
If you get pregnant while taking amlodipine and valsartan tablets, tell your doctor right away.

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.

Tell Your Doctor About All Of Your Medical Conditions, Including If You: 

are pregnant or plan to become pregnant.
are breastfeeding or plan to breastfeed.Amlodipine and valsartan 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 (cyclosporin) 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 many 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: 

are going to have surgery
go for kidney dialysis

What Should I Avoid While Taking Amlodipine And Valsartan Tablets? 

You should not take amlodipine and valsartan tablets during pregnancy.

What Are The Possible Side Effects Of Amlodipine And Valsartan Tablets? 

Amlodipine and valsartan tablets may causeserious side effectsincluding:

harm to an unborn baby causing injury and even death.
low blood pressure (hypotension). Low blood pressure is most likely to happen if you:
take water pills
are on a low-salt diet
get dialysis treatments
have heart problems
get sick with vomiting or diarrhea
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 amlodipine and valsartan tablets at room temperature between 59 F to 86 F (15 C to 30 C).
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 call Sandoz Inc., 1-800-525-8747.

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, crospovidone, magnesium stearate, and microcrystalline cellulose. Additionally, the 5/320 mg and 10/320 mg strengths contain iron oxide yellow and sodium starch glycolate. The film coating contains hypromellose, iron oxides, polyethylene glycol, talc, and titanium dioxide.

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.

*Norvascis a registered trademark of Pfizer, Inc.

**Viagrais a registered trademark of Pfizer, Inc.

Distributed By: 

Sandoz Inc.
Princeton, NJ 08540

T2016-30/T2016-31
August 2015/July 2015

PRINCIPAL DISPLAY PANEL

Package Label 5 mg*/160 mg

NDC 0781-5615-31

Amlodipine and Valsartan Tablets

5 mg*/160 mg

*each tablet contains 6.9 mg of amlodipine besylate

Rx Only

30 Tablets

Amlodipine and Valsartan Tablets 5mg/160mg label

PRINCIPAL DISPLAY PANEL

Package Label 10 mg*/160 mg

Rx Only NDC 0781-5628-31

Amlodipine and Valsartan Tablets

10 mg*/160 mg

*each tablet contains 13.9 mg of amlodipine besylate

30 Tablets

Amlodipine and Valsartan Tablets 10mg/160mg label

PRINCIPAL DISPLAY PANEL

Package Label 5 mg*/320 mg

NDC 0781-5639-31

Amlodipine and Valsartan Tablets

5 mg*/320 mg

*each tablet contains 6.9 mg of amlodipine besylate

Rx Only

30 Tablets

Amlodipine and Valsartan Tablets 5mg/320mg label

PRINCIPAL DISPLAY PANEL

Package Label 10 mg*/320 mg

NDC 0781-5643-31

Amlodipine and Valsartan Tablets

10 mg*/320 mg

*each tablet contains 13.9 mg of amlodipine besylate

Rx Only

30 Tablets

Amlodipine and Valsartan Tablets 10mg/320mg label
AMLODIPINE AND VALSARTAN
amlodipine besylate and valsartan tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0781-5615
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)AMLODIPINE5 mg
VALSARTAN(UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)VALSARTAN160 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
ColorYELLOW (dark yellow)Scoreno score
ShapeOVAL (ovaloid shaped)Size14mm
FlavorImprint CodeNVR;ECE
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0781-5615-3130 in 1 BOTTLE; Type 0: Not a Combination Product03/30/201509/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02199003/30/201509/30/2022
AMLODIPINE AND VALSARTAN
amlodipine besylate and valsartan tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0781-5628
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)AMLODIPINE10 mg
VALSARTAN(UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)VALSARTAN160 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
ColorYELLOW (light yellow)Scoreno score
ShapeOVAL (ovaloid shaped)Size14mm
FlavorImprint CodeNVR;UIC
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0781-5628-3130 in 1 BOTTLE; Type 0: Not a Combination Product03/30/201509/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02199003/30/201509/30/2022
AMLODIPINE AND VALSARTAN
amlodipine besylate and valsartan tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0781-5639
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)AMLODIPINE5 mg
VALSARTAN(UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)VALSARTAN320 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
ColorYELLOW (very dark yellow)Scoreno score
ShapeOVAL (ovaloid shaped)Size19mm
FlavorImprint CodeNVR;CSF
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0781-5639-3130 in 1 BOTTLE; Type 0: Not a Combination Product03/30/201509/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02199003/30/201509/30/2022
AMLODIPINE AND VALSARTAN
amlodipine besylate and valsartan tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0781-5643
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)AMLODIPINE10 mg
VALSARTAN(UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)VALSARTAN320 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
ColorYELLOW (dark yellow)Scoreno score
ShapeOVAL (ovaloid shaped)Size19mm
FlavorImprint CodeNVR;LUF
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0781-5643-3130 in 1 BOTTLE; Type 0: Not a Combination Product03/30/201509/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02199003/30/201509/30/2022
Labeler -Sandoz Inc (110342024)

Revised: 8/2015document Id: 

054546f4-f406-4a5c-91ba-d981071cf38bSet id: cc0fa546-063a-434f-b8c0-bfca5b34462cVersion: 2Effective Time: 20150820Sandoz Inc



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