Ferrous fumarate and folic acid

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

• iron overload syndrome;

• hemolytic anemia (a lack of red blood cells);

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• thalassemia (a genetic disorder of red blood cells);

• if you are an alcoholic; or

• if you receive regular blood transfusions.

If you have any of these conditions, you may not be able to use ferrous fumarate and folic acid, or you may need a dose adjustment or special tests during treatment.

It is not known whether this medication could be harmful to an unborn baby. Tell your doctor if you become pregnant during treatment.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give ferrous fumarate and folic acid to a child younger than 12 years old.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Do not take any vitamin or mineral supplements that your doctor has not prescribed or recommended.

Avoid taking an antibiotic medicine within 2 hours before or after you take ferrous fumarate and folic acid. This is especially important if you are taking an antibiotic such as ciprofloxacin (Cipro), demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), norfloxacin (Noroxin), ofloxacin (Floxin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

Certain foods can also make it harder for your body to absorb ferrous fumarate. Avoid taking this medication within 1 hour before or 2 hours after eating fish, meat, liver, and whole grain or "fortified" breads or cereals.

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb ferrous fumarate.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• sore throat, trouble swallowing;

• severe stomach pain; or

• blood in your stools.

Less serious side effects may include:

• diarrhea;

• constipation;

• nausea, vomiting, heartburn;

• leg pain; or

• darkened skin or urine color.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Black, tarry, or bloody stools.
• Fever.
• Very upset stomach or throwing up.
• Very bad belly pain.
• Throwing up blood or throw up that looks like coffee grounds.
• Stomach cramps.