ViloFane-Dp 7.5 (Oral, Injection)

Vitamins are substances your body needs for growth and health. You only need them in small amounts, and they usually come from the foods you eat. Folic acid (vitamin B 9) is important for healthy blood.

Not getting enough folic acid can cause anemia (weak blood). Your health care professional may give you a prescription for folic acid if this happens.

Some conditions can increase how much folic acid you need, including:

• Alcoholism
• Anemia, hemolytic
• Diarrhea (continuing)
• Fever (prolonged)
• Hemodialysis
• Illness (prolonged)
• Intestinal diseases
• Liver disease
• Stress (continuing)
• Surgical removal of stomach

Infants who are smaller than normal, breast-fed infants, or those on unfortified formulas (like evaporated milk or goat's milk) may also need extra folic acid.

Only your health care professional can determine if you need more folic acid.

Some studies suggest that women who take folic acid before and during early pregnancy may lower the risk of certain birth defects (neural tube defects).

Claims that folic acid and other B vitamins can prevent mental health issues have not been proven. Many treatments require large and costly amounts of vitamins.

Injectable folic acid should be given by or under the supervision of your health care professional. Another form of folic acid is available without a prescription.

To stay healthy, it's important to eat a balanced and varied diet. Follow any diet plan your health care professional recommends. If you have specific questions about your dietary vitamin and/or mineral needs, ask your health care professional for a list of suitable foods. If you believe you are not getting enough vitamins and/or minerals from your diet, you might consider taking a dietary supplement.

Folic acid is found in many foods, including vegetables, especially green ones; potatoes; cereals and cereal products; fruits; and organ meats (like liver or kidney). Try to eat fresh fruits and vegetables when you can, as they have the most vitamins. Food processing can reduce vitamins. For example, cooking can lower the amount of folic acid in foods.

Vitamins cannot replace a healthy diet and do not provide energy. Your body also needs other nutrients from food, such as protein, minerals, carbohydrates, and fats. Vitamins often need the presence of other foods to work properly.

The daily amount of folic acid needed is defined in a few ways.

• For U.S.—
• Recommended Dietary Allowances (RDAs) are the amounts of vitamins and minerals needed for good nutrition in most healthy people. RDAs can vary based on a person's age, sex, and physical condition (like pregnancy).
• Daily Values (DVs) are used on food and dietary supplement labels to show the percentage of the recommended daily amount of each nutrient that one serving provides. DV replaces the previous term, United States Recommended Daily Allowances (USRDAs).

• For Canada—
• Recommended Nutrient Intakes (RNIs) help determine how much vitamins, minerals, and protein are needed for adequate nutrition and to lower the risk of chronic disease.

Normal daily recommended intakes in micrograms (mcg) for folic acid are generally defined as follows:

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.

Geriatric

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

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

• Capecitabine
• Methotrexate
• Pafolacianine

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.

• Fosphenytoin
• Phenytoin
• Tea

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Pernicious anemia (a type of blood problem)—Taking folic acid while you have pernicious anemia may cause serious side effects. You should be sure that you do not have pernicious anemia before beginning folic acid supplementation.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

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

Rare

• Fever
• general weakness or discomfort
• reddened skin
• shortness of breath
• skin rash or itching
• tightness in chest
• troubled breathing
• wheezing

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.

In the U.S.

• FA-8
• Folacin-800
• Nature's Blend Folic Acid
• ViloFane-Dp 7.5

Available Dosage Forms:

• Capsule
• Solution
• Tablet

Therapeutic Class: Nutriceutical

Pharmacologic Class: Vitamin B (class)

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 dosage form (tablets): To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes: For the U.S. Adult and teenage males—150 to 400 micrograms (mcg) per day. Adult and teenage females—150 to 400 mcg per day. Pregnant females—400 to 800 mcg per day. Breast-feeding females—260 to 800 mcg per day. Children 7 to 10 years of age—100 to 400 mcg per day. Children 4 to 6 years of age—75 to 400 mcg per day. Children birth to 3 years of age—25 to 100 mcg per day. For Canada Adult and teenage males—150 to 220 mcg per day. Adult and teenage females—145 to 190 mcg per day. Pregnant females—445 to 475 mcg per day. Breast-feeding females—245 to 275 mcg per day. Children 7 to 10 years of age—125 to 180 mcg per day. Children 4 to 6 years of age—90 mcg per day. Children birth to 3 years of age—50 to 80 mcg per day. To treat deficiency: Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.

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.

• Why should I take folic acid with methotrexate?