facebook
Subscribe50$/product give away!


Submit an Article to Pharmacy HQ     
Please include the author's name, title, and citations.     

FORTAMET- metformin hydrochloride tablet, film coated, extended release


  1. Lactic Acidosis:
  2. Hypoglycemia:
  3. Females Of Reproductive Age:
  4. Administration Information:
  5. Patient Information
  6. Fortamet Can Cause Serious Side Effects Including:
  7. Stop Taking Fortamet And Call Your Healthcare Provider Right Away If You Get Any Of The Following Symptoms Of Lactic Acidosis:
  8. You Have A Higher Chance Of Getting Lactic Acidosis If You:
  9. What Is Fortamet?
  10. Do Not Take Fortamet If You:
  11. What Should I Avoid While Taking Fortamet?
  12. Fortamet May Cause Serious Side Effects, Including:
  13. Common Side Effects Of Fortamet Include:
  14. How Should I Store Fortamet?

Lactic Acidosis: 

Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its development. Advise patients to discontinue FORTAMET immediately and to promptly notify their healthcare provider if unexplained hyperventilation, myalgias, malaise, unusual somnolence or other nonspecific symptoms occur. Counsel patients against excessive alcohol intake and inform patients about importance of regular testing of renal function while receiving FORTAMET. Instruct patients to inform their doctor that they are taking FORTAMET prior to any surgical or radiological procedure, as temporary discontinuation may be required [see Warnings and Precautions (5.1)].

Hypoglycemia: 

Inform patients that hypoglycemia may occur when FORTAMET is coadministered with oral sulfonylureas and insulin. Explain to patients receiving concomitant therapy the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development [see Warnings and Precautions (5.3)].

Vitamin B12Deficiency:

Inform patients about importance of regular hematological parameters while receiving FORTAMET [see Warnings and Precautions (5.2)].

Females Of Reproductive Age: 

Inform females that treatment with FORTAMET may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy [see Use in Specific Populations (8.3)].

Administration Information: 

Inform patients that FORTAMET must be swallowed whole and not crushed, cut, or chewed, and that the inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemble the original tablet.

Manufactured by:
Actavis Laboratories FL, Inc.
Fort Lauderdale, FL 33314 USA

Distributed by:
Shionogi Inc.
Florham Park, NJ 07932

Rev. C 11/2018

Patient Information 

FORTAMET(for-TAH-met)

(metformin hydrochloride)

extended-release tablets

Fortamet Can Cause Serious Side Effects Including: 

Lactic Acidosis.Metformin hydrochloride, the medicine in FORTAMET, can cause a rare, but serious side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Stop Taking Fortamet And Call Your Healthcare Provider Right Away If You Get Any Of The Following Symptoms Of Lactic Acidosis: 

  • feel very weak and tired
  • have unusual sleepiness or sleep longer than usual
  • have unusual (not normal) muscle pain
  • feel cold, especially in your arms and legs
  • have trouble breathing
  • feel dizzy or lightheaded
  • have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea
  • have a slow or irregular heartbeat

You Have A Higher Chance Of Getting Lactic Acidosis If You: 

  • have severe kidney problems.

What Is Fortamet? 

  • FORTAMET is a prescription medicine that contains metformin hydrochloride. FORTAMET is used with diet and exercise to help control high blood sugar (hyperglycemia) in adults with type 2 diabetes.
It is not known if FORTAMET is safe and effective in children under 18 years of age.

Do Not Take Fortamet If You: 

  • have severe kidney problems
  • are allergic to metformin HCl or any of the ingredients in FORTAMET.

    • Take FORTAMET exactly as your healthcare provider tells you.
    • FORTAMET should be taken with your evening meals to help decrease an upset stomach.
    • Swallow FORTAMET whole. Do not crush, cut, or chew the tablets.
    • You may sometimes pass a soft mass in your stools (bowel movement) that looks like FORTAMET. This is not harmful and will not affect the way FORTAMET works.
    • When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine that you need may change. Tell your healthcare provider right away if you have any of these problems.
    • Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with FORTAMET.
    • Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
    • Low blood sugar (hypoglycemia) can happen more often when FORTAMET is taken with certain other diabetes medicines.
      Talk to your healthcare provider about how to prevent, recognize and manage low blood sugar.
    • Check your blood sugar as your healthcare provider tells you to.
    • Stay on your prescribed diet and exercise program while taking FORTAMET.
    • If you take too much FORTAMET, call your healthcare provider or go to the nearest hospital emergency room right away.

What Should I Avoid While Taking Fortamet? 


Do not drink a lot of alcoholic drinks while taking FORTAMET. This means you should not binge drink for short periods, and you should not drink a lot of alcohol on a regular basis. Alcohol can increase the chance of getting lactic acidosis.

Fortamet May Cause Serious Side Effects, Including: 

  • Low vitamin B12(vitamin B12deficiency).Using FORTAMET may cause a decrease in the amount of vitamin B12in your blood, especially if you have had low vitamin B12levels before. Your healthcare provider may do blood tests to check your vitamin B12levels.
  • Low blood sugar (hypoglycemia).If you take FORTAMET with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take FORTAMET. Signs and symptoms of low blood sugar may include:
  • headache
  • hunger
  • dizziness
  • drowsiness
  • fast heartbeat
  • sweating
  • weakness
  • confusion
  • irritability
  • shaking or feeling jittery

Common Side Effects Of Fortamet Include: 

  • diarrhea
  • stomach-area (abdominal) pain and swelling
  • nausea and vomiting
  • headache
  • gassiness (flatulence)
  • taste disturbance (unpleasant metallic taste)
  • indigestion

These are not all the possible side effects of FORTAMET.

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 Fortamet? 

Store FORTAMET at room temperature between 68 F to 77 F (20 C to 25 C).

Active ingredients: metformin hydrochloride.

Inactive ingredients: candelilla wax, cellulose acetate, hypromellose, magnesium stearate, polyethylene glycols (PEG 400, PEG 8000), polysorbate 80, povidone, sodium lauryl sulfate, synthetic black iron oxides, titanium dioxide, and triacetin.

Manufactured by:
Actavis Laboratories FL, Inc.
Fort Lauderdale, FL 33314 USA

Distributed by:
Shionogi Inc.
Florham Park, NJ 07932

For more information call Teva Pharmaceuticals USA, Inc. at 1-888-838-2872

This Patient Information has been approved by the U.S. Food and Drug Administration

Revised: D 11/2018



Your use of this website constitutes your agreement to the terms and conditions linked below:
Terms and Conditions | Resources
2017 © Copyright PharmacyHQ.com. Questions?
Please contact: pharmacyhq.mail@gmail.com