Amlodipine Besylate

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• AMLODIPINE BESYLATE DESCRIPTION
• CLINICAL PHARMACOLOGY
• PHARMACOKINETICS AND METABOLISM
• PHARMACODYNAMICS
• CLINICAL STUDIES
• INDICATIONS & USAGE
• AMLODIPINE BESYLATE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• DRUG INTERACTIONS
• DRUG & OR LABORATORY TEST INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE
• GERIATRIC USE
• AMLODIPINE BESYLATE ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• STORAGE AND HANDLING
• SPL PATIENT PACKAGE INSERT
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

AMLODIPINE BESYLATE DESCRIPTION

CLINICAL PHARMACOLOGY

PHARMACOKINETICS AND METABOLISM

PHARMACODYNAMICS

CLINICAL STUDIES

INDICATIONS & USAGE

AMLODIPINE BESYLATE CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

DRUG INTERACTIONS

DRUG & OR LABORATORY TEST INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

AMLODIPINE BESYLATE ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

SPL PATIENT PACKAGE INSERT

• ●     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.

• ●     Take amlodipine besylate tablets once a day, with or without food. You can take amlodipine besylate tablets with most drinks, including grapefruit juice.

• ●     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.

• ●     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.

• ●     headache

• ●     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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION