E-400

Vitamins are compounds that you must have for growth and health. They are needed in only small amounts and are available in the foods that you eat. Vitamin E prevents a chemical reaction called oxidation, which can sometimes result in harmful effects in your body. It is also important for the proper function of nerves and muscles.

Some conditions may increase your need for vitamin E. These include:

• Intestine disease
• Liver disease
• Pancreas disease
• Surgical removal of stomach

Increased need for vitamin E should be determined by your health care professional.

Infants who are receiving a formula that is not fortified with vitamin E may be likely to have a vitamin E deficiency. Also, diets high in polyunsaturated fatty acids may increase your need for vitamin E.

Claims that vitamin E is effective for treatment of cancer and for prevention or treatment of acne, aging, loss of hair, bee stings, liver spots on the hands, bursitis, diaper rash, frostbite, stomach ulcer, heart attacks, labor pains, certain blood diseases, miscarriage, muscular dystrophy, poor posture, sexual impotence, sterility, infertility, menopause, sunburn, and lung damage from air pollution have not been proven. Although vitamin E is being used to prevent certain types of cancer, there is not enough information to show that this is effective.

Lack of vitamin E is extremely rare, except in people who have a disease in which it is not absorbed into the body.

Vitamin E is available without a prescription.

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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. You should check with your health care professional if you are giving your baby an unfortified formula. In that case, the baby must get the vitamins needed some other way. Some studies have shown that premature infants may have low levels of vitamin E. Your health care professional may recommend a vitamin E supplement.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 receiving this dietary supplement, 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 this dietary supplement 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.

• Dicumarol

Using this dietary supplement with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Warfarin

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 this dietary supplement. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems—Vitamin E, when taken in doses greater than 800 Units a day for long periods of time, may make this condition worse

This section provides information on the proper use of a number of products that contain vitamin e. It may not be specific to E-400. Please read with care.

Dosing

The dose of this medicine 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 this medicine. 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 solution dosage form:
  • To prevent the following deficiencies in infants:
    • Infants receiving a formula high in polyunsaturated fatty acids—15 to 25 Units per day or 7 Units per 32 ounces of formula.
    • Infants with certain colon problems—15 to 25 Units per kilogram (kg) (6.8 to 11 Units per pound) of body weight per day. The water-soluble form of vitamin E must be used.
    • Infants of normal birthweight—5 Units per 32 ounces of formula.
• For oral dosage forms (capsules, tablets, oral solution):
  • To prevent deficiency for individuals (other than infants), the amount taken by mouth is based on normal daily recommended intakes:
    For the U.S.
    • Adult and teenage males—10 milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) or 16.7 Units per day.
    • Adult and teenage females—8 mg alpha-TE or 13 Units per day.
    • Pregnant females—10 mg alpha-TE or 16.7 Units per day.
    • Breast-feeding females—11 to 12 mg alpha-TE or 18 to 20 Units per day.
    • Children 4 to 10 years of age—7 mg alpha-TE or 11.7 Units per day.
    • Children birth to 3 years of age—3 to 6 mg alpha-TE or 5 to 10 Units per day.
    For Canada
    • Adult and teenage males—6 to 10 mg alpha-TE or 10 to 16.7 Units per day.
    • Adult and teenage females—5 to 7 mg alpha-TE or 8.3 to 11.7 Units per day.
    • Pregnant females—8 to 9 mg alpha-TE or 13 to 15 Units per day.
    • Breast-feeding females—9 to 10 mg alpha-TE or 15 to 16.7 Units per day.
    • Children 7 to 10 years of age—6 to 8 mg alpha-TE or 10 to 13 Units per day.
    • Children 4 to 6 years of age—5 mg alpha-TE or 8.3 Units per day.
    • Children birth to 3 years of age—3 to 4 mg alpha-TE or 5 to 6.7 Units per day.
  • To treat deficiency:
    • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.

For individuals taking the oral liquid form of this dietary supplement:

• This preparation should be taken by mouth even though it comes in a dropper bottle.
• This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

• Vitamins are needed for growth and good health.

• If you have an allergy to E-400 (vitamin E capsules and tablets) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take E-400 with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using E-400 while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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.

Applies to vitamin e: oral capsule, oral capsule liquid filled, oral liquid, oral powder for solution, oral solution, oral tablet, oral tablet chewable

Along with its needed effects, vitamin e (the active ingredient contained in E-400 Clear) 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 while taking vitamin e:

• Blurred vision
• diarrhea
• dizziness
• headache
• nausea or stomach cramps
• unusual tiredness or weakness

Applies to vitamin e: compounding powder, oral capsule, oral liquid, oral solution, oral tablet, oral tablet chewable, oral and topical oil

Gastrointestinal

Gastrointestinal side effects associated with oral doses greater than 300 units daily have rarely included nausea, diarrhea, and intestinal cramps.[Ref]

Other

Other side effects associated with oral doses greater than 300 units daily have rarely included fatigue, emotional disturbances, weakness, and headache.[Ref]

Hematologic

Hematologic side effects associated with oral doses greater than 300 units daily have rarely included thrombophlebitis.[Ref]

Ocular

Ocular side effects associated with oral doses greater than 300 units daily have rarely included blurred vision.[Ref]

Dermatologic

Dermatologic side effects associated with oral doses greater than 300 units daily have rarely included rash.

Dermatologic side effects associated with topical application of vitamin E have included growth of white hair at site of alopecia and contact dermatitis.[Ref]

Genitourinary

Genitourinary side effects associated with oral doses greater than 300 units daily have rarely included gonadal dysfunction and breast soreness.[Ref]

Endocrine

Endocrine side effects associated with oral doses greater than 300 units daily have rarely included decrease in serum thyroxine and triiodothyronine.[Ref]

Metabolic

Metabolic side effects associated with oral doses greater than 300 units daily have rarely included creatinuria, increased serum creatinine kinase, increased serum cholesterol and triglycerides and increased urinary estrogens and androgens.[Ref]

Some side effects of E-400 Clear may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.