Mi-Omega NF

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Keep this and all medications out of the reach of children.

General

This product contains fish and soy which are potential allergens. Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pediatrics: Safety and effectiveness in pediatric patients have not been established.

Pregnancy

Pregnancy and Lactation: The safety of phytosterols has not been studied in pregnant or breastfeeding women. There is no evidence that dietary intakes of naturally occurring phytosterols, such as those consumed by vegetarian women, adversely affects pregnancy or lactation.

Applies to omega-3 polyunsaturated fatty acids: oral capsule liquid filled

Along with its needed effects, omega-3 polyunsaturated fatty acids (the active ingredient contained in Mi-Omega NF) 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 immediately if any of the following side effects occur while taking omega-3 polyunsaturated fatty acids:

• Bleeding gums
• cough
• coughing up blood
• difficulty with breathing or swallowing
• dizziness
• fast or irregular heartbeat
• headache
• hives, itching, or skin rash
• increased menstrual flow or vaginal bleeding
• nosebleeds
• paralysis
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red or black, tarry stools
• red or dark brown urine
• sweating
• tightness in the chest
• unusual tiredness or weakness

Some side effects of omega-3 polyunsaturated fatty acids 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:

• Acid or sour stomach
• bad, unusual, or unpleasant (after) taste
• belching
• bloated or full feeling
• change in taste
• excess air or gas in the stomach
• heartburn
• indigestion
• stomach discomfort, upset, or pain

• Diarrhea
• difficulty having a bowel movement (stool)
• loss of appetite
• nausea or vomiting
• passing of gas
• stomach fullness

Applies to omega-3 polyunsaturated fatty acids: oral capsule, oral delayed release capsule, oral kit, oral liquid, oral tablet chewable

Gastrointestinal

Common (1% to 10%): Eructation, dyspepsia, nausea, gastrointestinal disorders (including abdominal distension, abdominal pain, constipation, diarrhea, flatulence, gastroesophageal reflux disease, vomiting)
Uncommon (0.1% to 1%): Gastrointestinal hemorrhage, gastroenteritis
Rare (less than 0.1%): Gastrointestinal pain
Very rare (less than 0.01%): Lower gastrointestinal hemorrhage[Ref]

General

The most common adverse events were eructation, dyspepsia, and taste perversion[Ref]

Other

Common (1% to 10%): Infection, pain
Uncommon (0.1% to 1%): Death[Ref]

Dermatologic

Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Atopic dermatitis
Rare (less than 0.1%): Urticaria, acne, rash pruritic
Frequency not reported: Pruritus[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hypotension[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Metabolic

Uncommon (0.1% to 1%): Hyperglycemia, gout, high triglycerides
Very rare (less than 0.01%): Blood lactate dehydrogenase increased[Ref]

Nervous system

Common (1% to 10%): Taste perversion
Uncommon (0.1% to 1%): Dizziness, dysgeusia, headache, hyperactivity[Ref]

Respiratory

Uncommon (0.1% to 1%): Epistaxis
Very rare (less than 0.01%): Nasal dryness
Frequency not reported: Influenza[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity
Postmarketing reports: Anaphylactic reaction[Ref]

Hematologic

Very rare (less than 0.01%): White blood count increased,
Frequency not reported: Slight prolongation of bleeding time
Postmarketing reports: Hemorrhagic diathesis[Ref]

Psychiatric

Uncommon (0.1% to 1%): Tics, tantrum, insomnia[Ref]

Hepatic

Rare (less than 0.1%): Liver disorders (including increased ALT, increased AST, and transaminases increased)[Ref]

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