Ferrous gluconate

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use ferrous gluconate if you are allergic to it.

To make sure ferrous gluconate is safe for you, tell your doctor 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);

• liver or kidney disease;

• if you are an alcoholic; or

• if you receive regular blood transfusions.

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 ferrous gluconate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medication to anyone under 18 years old without medical advice.

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Take ferrous gluconate on an empty stomach, at least 1 hour before or 2 hours after a meal. Avoid taking antacids or antibiotics within 2 hours before or after taking ferrous gluconate .

Take this medication with a full glass of water.

Do not crush, chew, or break a ferrous gluconate tablet or capsule. Swallow the pill whole.

Measure the liquid medicine with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Ferrous gluconate can stain your teeth, but this effect is temporary. To prevent tooth staining, mix the liquid form of ferrous gluconate with water or fruit juice (not with milk) and drink the mixture through a straw. You may also clean your teeth with baking soda once per week to treat any tooth staining.

Ferrous gluconate is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat to make sure you get enough iron from both your diet and your medication.

Store at room temperature, away from moisture and heat. Keep the liquid medicine from freezing.

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.

Call your doctor at once if you have:

• bright red blood in your stools; or

• pain in your chest or throat when swallowing a ferrous gluconate tablet.

Common side effects may include:

• constipation, diarrhea;

• nausea, vomiting, heartburn;

• stomach pain, upset stomach;

• black or dark-colored stools or urine; or

• temporary staining of the teeth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. 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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about ferrous gluconate, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ferrous gluconate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using ferrous gluconate.

Review Date: October 4, 2017

Should be taken with water or juice on an empty stomach; may be administered with food to prevent irritation; however, not with cereals, dietary fiber, tea, coffee, eggs, or milk.

Elemental iron content of ferrous gluconate: 12%

Dietary sources of iron include beans, cereal (enriched), clams, beef, lentils, liver, oysters, shrimp, and turkey. Foods that enhance dietary absorption of iron include broccoli, grapefruit, orange juice, peppers and strawberries. Foods that decrease dietary absorption of iron include coffee, dairy products, soy products, spinach, and tea.

Disease-related concerns:

• Gastrointestinal disease: Avoid in patients with peptic ulcer, enteritis, or ulcerative colitis.

Special populations:

• Blood transfusion recipients: Avoid in patients receiving frequent blood transfusions.

• Elderly: Anemia in the elderly is often caused by “anemia of chronic disease” or associated with inflammation rather than blood loss. Iron stores are usually normal or increased, with a serum ferritin >50 ng/mL and a decreased total iron binding capacity. Hence, the “anemia of chronic disease” is not secondary to iron deficiency but the inability of the reticuloendothelial system to reclaim available iron stores.

• Pediatric: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of the reach of children. In case of accidental overdose call the poison control center immediately.

• Premature infants: Avoid use in premature infants until the vitamin E stores, deficient at birth, are replenished.

Other warnings/precautions:

• Duration of therapy: Administration of iron for >6 months should be avoided except in patients with continuous bleeding or menorrhagia.

Serum iron, total iron binding capacity, reticulocyte count, hemoglobin

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, constipation, stool discoloration, lack of appetite, or abdominal cramps. Have patient report immediately to prescriber black, tarry, or bloody stools; severe nausea; severe vomiting; severe abdominal pain; or vomiting blood (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.