Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 20/5/12.5 Mg (Page 8 of 9)

16 HOW SUPPLIED/STORAGE AND HANDLING

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP, amlodipine besylate, USP at a dose equivalent to 5 or 10 mg amlodipine, and hydrochlorothiazide, USP in the strengths described below.

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are differentiated by tablet color/size. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are supplied for oral administration in the following strength and package configurations:

20/5/12.5 mg tablets are orange white colored, round, biconvex, film coated debossed with ’26’ on one side and plain on the other side.

Bottles of 30 NDC 13668-397-30

Bottles of 90 NDC 13668-397-90

Bottles of 500 NDC 13668-397-05

40/5/12.5 mg tablets are light yellow to yellow colored, round, biconvex, film coated debossed with ‘1386’ on one side and plain on the other side.

Bottles of 30 NDC 13668-386-30

Bottles of 90 NDC 13668-386-90

Bottles of 500 NDC 13668-386-05

40/5/25 mg tablets are light yellow to yellow colored, oval shaped, biconvex, film coated debossed with ‘1385’ on one side and plain on the other side.

Bottles of 30 NDC 13668-385-30

Bottles of 90 NDC 13668-385-90

Bottles of 500 NDC 13668-385-05

40/10/12.5 mg tablets are grayish red colored, round, biconvex, film coated, debossed with ‘1383’ on one side and plain on the other side.

Bottles of 30 NDC 13668-383-30

Bottles of 90 NDC 13668-383-90

Bottles of 500 NDC 13668-383-05

40/10/25 mg tablets are grayish red colored, oval shaped, biconvex, film coated, debossed with ‘1382’ on one side and plain on the other side.

Bottles of 30 NDC 13668-382-30

Bottles of 90 NDC 13668-382-90

Bottles of 500 NDC 13668-382-05

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Pregnancy: Tell female patients of childbearing age about the consequences of exposure to olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions ( 5.1) and Use in Specific Populations ( 8.1)] .

Lactation: Advise nursing women not to breastfeed during treatment with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets [see Use in Specific Populations ( 8.2)] .

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

Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.

Potassium Supplements: Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider.

Acute myopia and secondary angle-closure glaucoma: Advise patients to discontinue olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets and seek immediate medical attention if they experience symptoms of acute myopia or secondary angle-closure glaucoma [see Warnings and Precautions (5.9)] .

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Torrent Pharmaceuticals Limited.

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Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured for:

TORRENT PHARMA INC., Basking Ridge, NJ 07920

8093143 May 2023

FDA-Approved Patient Labeling

PATIENT INFORMATION

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide

(OL-me-SAR-tan me-DOX-oh-mil, am-LOE-di-peen and HYE-droe-KLOR-oh-THYE-a-zide) Tablets

Read the Patient Information that comes with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets before you take them and each time you get a a refill. There may be new informaton. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.

What is the most important information I should know about olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets?

  • Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets can cause harm or death to an unborn baby.
  • Talk to yourdoctor abut other ways to lower your blood pressure if you plan to become pregnant.
  • If you get pregnant while taking olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets tell your doctor right away.

What are olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets?

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a prescription medicine used to lower blood pressure (hypertension). Medicines that lower blood pressure lower your chance of having a stroke or heart attack. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are not for use as the first medicine to treat your high blood pressure.

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain 3 different prescription medications:

  1. amlodipine, a calcium channel blocker
  2. olmesartan medoxomil, an angiotensin receptor blocker, and
  3. hydrochlorothiazide, a diuretic (water pill)

It is not known if olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are safe and work in children.

Who should not take olmesartan medoxomil, amlodipine and hydrochlorthiazide tablets?

Do not take olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets if you:

  • have low or no urine output
  • are allergic to other Sulfonamide type medicines. Ask your doctor if you are not sure.
  • are taking aliskiren and have diabetes.

What should I tell my doctor before taking olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets?

Before taking olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, tell your doctor if you:

  • are pregnant or plan to become pregnant. See “What is the most important information I should know about olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets?
  • are breast feeding or plan to breast feed. One of the medicines in olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets can pass into your breast milk and may harm your baby. You and your doctor should decide if you will take olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets or breastfeed. You should do both.
  • are allergic to any of the ingredients in olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. See the end of the leaflet for a list of the ingredients in olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets.
  • have liver problems
  • have heart problems
  • have kidney problems
  • have lupus
  • are vomiting or have a lot of diarrhea
  • have any other medical conditions.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Some of your other medicines and olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets could affect each other, causing serious side effects.
Especially tell your doctor if you are taking:

  • water pills (diuretic)
  • other medicines for high blood pressure or a heart problem
  • potassium supplements or using salt substitute containing potassium
  • diabetes medicine including insulin
  • narcotic pain medicine sleeping pills and anti-seizure medicines called barbiturates
  • lithium, a medicine used to treat certain kinds of depression
  • medicines used to treat pain or arthritis such as aspirin or non-steroidal anti-inflammatory drugs (NSAIDs)
  • steroids
  • cholesterol lowering medicines
  • tacrolimus and cyclosporine (medicines used to alter the way your immune system works)

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.

How should I take olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets?

  • Take olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets exactly as prescribed by your doctor. Your doctor may change your dose if needed.
  • Take olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets one time a day.
  • Olmesartan medoxomil, amlodipine and hydrochlorothiazide 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 at your regular time.
  • If you take too much olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets call your doctor or Poison Control Center, or go to the nearest hospital emergency room.

What should I avoid while taking olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets?

Drinking alcohol. Drinking alcohol during treatment with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets can cause you to have low blood pressure. See “What are the possible side effects of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets?”

What are the possible side effects of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets?

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets may cause serious side effects, including:

  • Harm to your unborn baby causing injury or death. See “What is the most important information I should know abut olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets?”
  • Low Blood Pressure (hypotension). Low blood pressure may cause you to feel faint or dizzy. Lie down, if you feel faint or dizzy. Call your doctor right away.
  • Kidney problems. Kidney problems may get worse in people that already have kidney disease. Blood tests for kidney function may be done while you are taking olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets and the doctor may need to lower your dose of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Call your doctor if you nget 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 olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets.
  • Worsening chest pain or heart attack. Get medical help right away if you have chect pain that gets worse, or that does not go away, during treatment with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets.
  • Allergic reactions. Hydrochlorothiazide, one of the medicines in olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets can cause allergic reactions.
  • Changes in body salts (such as sodium and potassium), and body fluids. Tell your doctor if you have any of these signs or symptoms during treatment with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets:
  • Dry mouth
  • thirst
  • weakness
  • tiredness or sleepiness
  • restlessness
  • confusion
  • seizures
  • muscle pains or cramps
  • muscle tiredness
  • dizziness or fainting
  • low or not urine output
  • fast heartbeat
  • nausea and vomiting
  • Eye problems. One of the medicines in olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets can cause eye problems that may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Tell your doctor right away if you have:
  • decrease in vision
  • eye pain
  • Severe diarrhea and weight loss: Severe, chronic diarrhea with considerable weight loss may develop months to years after starting olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Tell your doctor if you are experiencing these symtoms.

The most common side effects of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets used to treat people with high blood pressure include:

  • dizziness
  • swelling (edema) of the ankles, feet, and hands
  • headache
  • tiredness
  • stuffy or runny nose or sore throat
  • muscle twitching (spasms)
  • nausea
  • upper respiratory tract infection
  • diarrhea
  • urinary tract infection
  • swelling (edema) of the joints

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

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

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

How do I store olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets?

  • Store olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
  • Keep olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets and all medicines out of the reach of children.

General Information about Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets for a condition for which it was not prescribed. Do not give olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about olmesartan medoxomil, amlodipine and hydrochlorothiazide tabvlets that is written for health professionals. For more information call Torrent Pharma Inc. at 1-800-912-9561.

What are the ingredients in olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets? Active ingredients: olmesartan medoxomil USP, amlodipine besylate USP, and hydrochlorothiazide USP

Inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc.

The color coating material contains the following ingredients.

Strength Ingredients

40/10/12.5 mg

and 40/10/25 mg

Polyvinyl alcohol, titanium

dioxide, polethylene glycol/macrogol,

talc, iron oxide yellow and iron oxide red

20/5/12.5 mg

Polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol, talc, iron oxide yellow, iron oxide red and iron

oxide black

40/5/12.5 mg

and 40/5//25 mg

Polyvinyl alcohol, titanium

dioxide, polyethylene glycol/macrogol,

talc and iron oxide yellow

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 forse is too much.

High blood pressure makes the heart work harder to pump blood through the body and causes damage to blood vessels. Olmesartan medoxomil, amlodipine and hydorchlorothiazide tablets can help your blood vessels relax so your blood pressure is lower.

The Patient Information has been approved by the U.S. Food and Drug Administratrion.

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Manufactured by:
TORRENT PHARMACEUTICALS LTD., INDIA

Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920

8090482 October 2022

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