Beef,Iron & Wine

In the U.S.

• Auryxia
• Beef,Iron & Wine
• Bifera
• Elite Iron
• Femiron
• Feosol
• Fergon
• Ferrex 150
• Hemocyte

In Canada

• Fer-In-Sol
• Palafer
• Pms-Ferrous Sulfate

Available Dosage Forms:

• Tablet, Chewable
• Tablet
• Liquid
• Capsule
• Solution
• Tablet, Enteric Coated
• Powder
• Tablet, Extended Release
• Suspension
• Capsule, Liquid Filled
• Syrup
• Capsule, Extended Release
• Elixir

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

Although many people in the U.S. get enough iron from their diet, some must take additional amounts to meet their needs. For example, iron is sometimes lost with slow or small amounts of bleeding in the body that you would not be aware of and which can only be detected by your doctor. Your doctor can determine if you have an iron deficiency, what is causing the deficiency, and if an iron supplement is necessary.

Lack of iron may lead to unusual tiredness, shortness of breath, a decrease in physical performance, and learning problems in children and adults, and may increase your chance of getting an infection.

Some conditions may increase your need for iron. These include:

• Bleeding problems
• Burns
• Hemodialysis
• Intestinal diseases
• Stomach problems
• Stomach removal
• Use of medicines to increase your red blood cell count

In addition, infants, especially those receiving breast milk or low-iron formulas, may need additional iron.

Increased need for iron supplements should be determined by your health care professional.

Injectable iron is administered only by or under the supervision of your health care professional. Other forms of iron are available without a prescription; however, your health care professional may have special instructions on the proper use and dose for your condition.

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Iron is found in the diet in two forms—heme iron, which is well absorbed, and nonheme iron, which is poorly absorbed. The best dietary source of absorbable (heme) iron is lean red meat. Chicken, turkey, and fish are also sources of iron, but they contain less than red meat. Cereals, beans, and some vegetables contain poorly absorbed (nonheme) iron. Foods rich in vitamin C (e.g., citrus fruits and fresh vegetables), eaten with small amounts of heme iron-containing foods, such as meat, may increase the amount of nonheme iron absorbed from cereals, beans, and other vegetables. Some foods (e.g., milk, eggs, spinach, fiber-containing, coffee, tea) may decrease the amount of nonheme iron absorbed from foods. Additional iron may be added to food from cooking in iron pots.

The daily amount of iron needed is defined in several different ways.

For U.S.—
• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).
• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

For Canada—
• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes in milligrams (mg) for iron are generally defined as follows (Note that the RDA and RNI are expressed as an actual amount of iron, which is referred to as “elemental”' iron. The product form [e.g., ferrous fumarate, ferrous gluconate, ferrous sulfate] has a different strength):

If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts. Iron supplements, when prescribed by your health care professional, are not expected to cause different side effects in children than they do in adults. However, it is important to follow the directions carefully, since iron overdose in children is especially dangerous.

Studies on sodium ferric gluconate have shown that this supplement is safe to use in children ages 6 to 15 years. The safety of sodium ferric gluconate has not been determined in patients who are younger than 6 years of age.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts. Elderly people sometimes do not absorb iron as easily as younger adults and may need a larger dose. If you think you need to take an iron supplement, check with your health care professional first. Only your health care professional can decide if you need an iron supplement and how much you should take.

Pregnancy

It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. Healthy fetal growth and development depend on a steady supply of nutrients from mother to fetus. During the first 3 months of pregnancy, a proper diet usually provides enough iron. However, during the last 6 months, in order to meet the increased needs of the developing baby, an iron supplement may be recommended by your health care professional.

However, taking large amounts of a dietary supplement in pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breast Feeding

It is especially important that you receive the right amounts of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. Iron normally is present in breast milk in small amounts. When prescribed by a health care professional, iron preparations are not known to cause problems during breast-feeding. However, nursing mothers are advised to check with their health care professional before taking iron supplements or any other medication. Taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or infant and should be avoided.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these dietary supplements, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using dietary supplements in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Altretamine
• Amygdalin
• Dasabuvir
• Deferoxamine
• Digoxin
• Dimercaprol
• Eltrombopag
• Elvitegravir
• Gefitinib
• Ketoconazole
• Ledipasvir
• Mefenamic Acid
• Pazopanib
• Phenytoin
• Rilpivirine
• Vismodegib

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Blood transfusions (with high red blood cell iron content) or
• Kidney infection or
• Liver disease or
• Porphyria cutaneous tarda—Higher blood levels of the iron supplement may occur, which may increase the chance of side effects.

• Arthritis (rheumatoid) or
• Asthma or allergies or
• Heart disease—The injected form of iron may make these conditions worse.

• Colitis or other intestinal problems or
• Iron overload conditions (e.g., hemochromatosis, hemosiderosis, hemoglobinopathies) or
• Stomach ulcer—Iron supplements may make these conditions worse.

• Other anemias—Iron supplements may increase iron to toxic levels in anemias not associated with iron deficiency.

This section provides information on the proper use of a number of products that contain iron supplement. It may not be specific to Beef,Iron & Wine. Please read with care.

After you start using this dietary supplement, continue to return to your health care professional to see if you are benefiting from the iron. Some blood tests may be necessary for this.

Iron is best absorbed when taken on an empty stomach, with water or fruit juice (adults: full glass or 8 ounces; children: ½ glass or 4 ounces), about 1 hour before or 2 hours after meals. However, to lessen the possibility of stomach upset, iron may be taken with food or immediately after meals.

For safe and effective use of iron supplements:

• Follow your health care professional's instructions if this dietary supplement was prescribed.
• Follow the manufacturer's package directions if you are treating yourself. If you think you still need iron after taking it for 1 or 2 months, check with your health care professional.

Liquid forms of iron supplement tend to stain the teeth. To prevent, reduce, or remove these stains:

• Mix each dose in water, fruit juice, or tomato juice. You may use a drinking tube or straw to help keep the iron supplement from getting on the teeth.
• When doses of liquid iron supplement are to be given by dropper, the dose may be placed well back on the tongue and followed with water or juice.
• Iron stains on teeth can usually be removed by brushing with baking soda (sodium bicarbonate) or medicinal peroxide (hydrogen peroxide 3%).

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, tablets, oral solution):
  • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
    For the U.S.
    • Adult and teenage males—10 milligrams (mg) per day.
    • Adult and teenage females—10 to 15 mg per day.
    • Pregnant females—30 mg per day.
    • Breast-feeding females—15 mg per day.
    • Children 7 to 10 years of age—10 mg per day.
    • Children 4 to 6 years of age—10 mg per day.
    • Children birth to 3 years of age—6 to 10 mg per day.
    For Canada
    • Adult and teenage males—8 to 10 mg per day.
    • Adult and teenage females—8 to 13 mg per day.
    • Pregnant females—17 to 22 mg per day.
    • Breast-feeding females—8 to 13 mg per day.
    • Children 7 to 10 years of age—8 to 10 mg per day.
    • Children 4 to 6 years of age—8 mg per day.
    • Children birth to 3 years of age—0.3 to 6 mg per day.
  • To treat deficiency:
    • Adults, teenagers, and children— The dose will be determined by your doctor, based on your condition.
• For injection dosage forms:
  • Adults, teenagers, and children— The dose will be determined by your doctor, based on your condition.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Backache , groin, side, or muscle pain
• chest pain
• chills
• dizziness
• fainting
• fast heartbeat
• fever with increased sweating
• flushing
• headache
• metallic taste
• nausea or vomiting
• numbness, pain, or tingling of hands or feet
• pain or redness at injection site
• redness of skin
• skin rash or hives
• swelling of mouth or throat
• troubled breathing

• Abdominal or stomach pain
• cramping (continuing) or soreness

• Double vision
• general unwell feeling
• weakness without feeling dizzy or faint

• Chest or throat pain, especially when swallowing
• stools with signs of blood (red or black color)

Symptoms of iron overdose may not occur for up to 60 minutes or more after the overdose was taken. By this time you should have had emergency room treatment. Do not delay going to emergency room while waiting for signs to appear.

• Diarrhea (may contain blood)
• fever
• nausea
• stomach pain or cramping (sharp)
• vomiting, severe (may contain blood)

• Bluish-colored lips, fingernails, and palms of hands
• convulsions (seizures)
• pale, clammy skin
• shallow and rapid breathing
• unusual tiredness or weakness
• weak and fast heartbeat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation
• diarrhea
• leg cramps
• nausea
• vomiting

Stools commonly become dark green or black when iron preparations are taken by mouth. This is caused by unabsorbed iron and is harmless. However, in rare cases, black stools of a sticky consistency may occur along with other side effects such as red streaks in the stool, cramping, soreness, or sharp pains in the stomach or abdominal area. Check with your health care professional immediately if these side effects appear.

If you have been receiving injections of iron, you may notice a brown discoloration of your skin. This color usually fades within several weeks or months.

• Darkened urine
• heartburn
• stained teeth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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