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Product Details

Brand Name: Vitabolic

Iron + Folic Acid + Vitamin B-Complex

Capsule

Vitamins and Minerals

Each capsule contains:

Ferrous Sulfate Heptahydrate, USP...………….........…..455.50 mg

(equivalent to elemental Iron, 91.50 mg)

Folic Acid…...........……………………………………….…...…..1 mg

Thiamine Mononitrate (Vitamin B1)........................................15 mg

Riboflavin (Vitamin B2)……………...................….....….……..10 mg

(equivalent to Riboflavin 5’-Phosphate Sodium, 12.71 mg)

Pyridoxine Hydrochloride (Vitamin B6)……...............…...…..10 mg

Cyanocobalamin (Vitamin B12)………………..…….…….....10 mcg

 

DESCRIPTION

Iron + Folic Acid + Vitamin B-Complex (Vitabolic) is a capsule with brown cap and body.

WHAT IS IN THE MEDICINE?

Each capsule of Vitabolic contains Iron, Folic acid and Vitamins B1, B2, B6 and B12 and used at pre- and post-natal stages of a woman. These nutrients are necessary for healthy blood, to prevent iron-deficiency anemia and to prevent neural tube defects (or NTDs). NTDs are characterized by malformations of the baby’s brain and/or spinal cord which can be prevented by adequate folic acid intake particularly during the very early stages of pregnancy. Folic acid and Vitamins B6 and B12 are required in the metabolism of homocysteine to prevent its accumulation in the blood since elevated homocysteine in the blood may be a risk factor in the development of cardiovascular disease. Together, these nutrients may help maintain the normal homocysteine levels in the blood. In addition, thiamine (vitamin B1) and riboflavin (vitamin B2) are also included for prevention and/or treatment of thiamine and riboflavin deficiencies, respectively.

STRENGTH OF THE MEDICINE

See the formulation.

WHAT IS THIS MEDICINE USED FOR?

Iron + Folic Acid + Vitamin B-Complex (Vitabolic) is used for the prevention of iron-deficiency anemia and neural tube defects during the pre- and post-natal stages of a woman with the added supplements of Vitamin B-Complex (see previous statements for more information).

HOW MUCH AND HOW OFTEN SHOULD YOU USE THIS MEDICINE?

Take one capsule daily orally as soon as pregnancy is detected or as directed by physician. May be taken with or without food.

WHEN SHOULD YOU NOT TAKE THIS MEDICINE?

- If allergic to any component of this product.

- If the patient is receiving repeated blood transfusions; anemia not due to iron deficiency.

- If you have undiagnosed megaloblastic anemia, pernicious, aplastic or normocytic anemias, primary

hemochromatosis (a genetic condition characterized by excessive iron absorption), peptic ulcer (stomach sores), regional enteritis (inflammation of the intestines such as Crohn’s disease) or ulcerative (colitis).

- Never give folic acid alone or if with inadequate amounts of vitamin B12 for the treatment of undiagnosed megaloblastic anemia, since folic acid may produce a haematopoietic response in patients with a megaloblastic anemia due to vitamin B12 deficiency without preventing aggravation of neurological symptoms. This masking of the true deficiency state can lead to serious neurological damage,

such as subacute combined degeneration of the spinal cord.

- If any undesirable effects, previously mentioned or other undesirable effects are experienced while taking this medication.

CARE THAT SHOULD BE TAKEN WHEN TAKING THIS MEDICINE?

- Ask a physician before use of this medicinal product.

- Do not use more than the recommended dose unless recommended by a physician.

- Do not use this product after its expiration date.

UNDESIRABLE EFFECTS OF THIS MEDICINE

- With Folic acid, this may cause hypersensitivity reactions, gastrointestinal disturbances, bronchospasm and others.

- Stools may appear darker in color and discoloration of urine due to iron.

- Gastrointestinal side effects such as nausea, vomiting, bloating and upper abdominal discomfort are seen with high iron doses.

- With Vitamin B2, large doses of riboflavin results in a bright yellow discoloration of urine that may interfere with certain laboratory tests.

Pyridoxine (Vitamin B6) can cause severe peripheral neuropathies or adverse neurological effects upon long-term (2 months or longer) administration of large doses (e.g. 100-500 mg daily).

WHAT OTHER MEDICINE OR FOOD SHOULD BE AVOIDED WHILE TAKING THIS MEDICINE?

- Do not use together with chloramphenicol since it may cause delayed response to iron therapy.

- Do not use this medicinal product together with antacids and tetracyclines since they may result in reduced iron absorption.

- With Folic acid, do not take this medicine with antiepileptics, oral contraceptive, anti-TB drugs, alcohol, aminopterin, methotrexate, pyrimethamine, trimethoprim and sulphonamides since this may result to decrease in serum folate concentrations. On the other hand,

folic acid can decrease serum phenytoin concentrations.

- With Thiamine or Vitamin B1, the effect of neuromuscular blocking agents may be enhanced.

- Do not take this with propantheline bromide since the rate and extent of absorption of riboflavin may be affected. Food increases the extent of absorption of riboflavin.

- Greater requirement in pyridoxine dose may result if this is taken with isoniazid, penicillamine and oral contraceptives. Pyridoxine can

reduce the effects of levodopa, phenobarbitone, altretamine and phenytoin. Always tell your physician if what medicine/s you are currently taking.

WHAT SHOULD YOU DO IF YOU MISS A DOSE?

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose skip the missed dose and continue with your regular dosing schedule. Do not take a double dose.

SIGNS AND SYMPTOMS OF OVERDOSE

- With Iron, symptoms are nausea, vomiting, abdominal pain, diarrhea of green or tarry stools, haematemesis, seizures, drowsiness, metabolic acidosis, hepatic dysfunction, renal failure, coma.

Folic acid is generally well-tolerated but with overdosage exaggeration of gastrointestinal disturbances and hypersensitivity may occur.

- With Vitamin B2, large doses of riboflavin results in a bright yellow discoloration of urine that may interfere with certain laboratory tests.

- Long-term (2 months or longer) administration of large doses of Vitamin B6 (e.g. 2 grams or more daily) can cause neurological symptoms manifested as paresthesia, bone pains (as lightning, stabbing or shooting like a knitting needle or electric shocks), hyperesthesia (as burning, pricking, stinging or itching), muscle weakness, fasciculation (as twitching, restlessness or fidgeting) and numbness on the limbs and face.

WHAT TO DO WHEN YOU HAVE TAKEN MORE THAN THE RECOMMENDED DOSAGE?

If overdose is suspected, immediately consult a physician, other healthcare professionals or contact the nearest hospital.

HOW SHOULD YOU KEEP THIS MEDICINE?

Store at temperatures not exceeding 30OC.

KEEP OUT OF REACH OF CHILDREN

WHEN SHOULD YOU CONSULT YOUR DOCTOR?

- Consult your physician if you are pregnant or breastfeeding, before using this product.

- Women who are pregnant must have regular pre-natal check-up with their physician.

- If any of undesirable effects previously mentioned or new undesirable effects of this medicine are experienced while taking this medicine.

AVAILABILITY

Iron + Folic Acid + Vita B-Complex (Vitabolic) capsule is available in box of 10’s and 30’s (in blister pack of 10’s).

 

For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph

Seek medical attention at the first sign of any adverse drug reaction.

REGISTRATION NUMBER: DR-XY46166

INITIAL AUTHORIZATION DATE: DECEMBER 28, 2017

REVISION DATE OF PATIENT INFORMATION LEAFLET: FIRST EDITION

 

Additional Information
Vitabolic (Vitamin B Complex + Folic Acide + Iron )