Folic Acid + Zinc & B12 - 30

PROFESSIONAL INFORMATION
Folic Acid + Zinc & B12

SCHEDULE STATUS:
To be allocated by Council upon registration.

PROPRIETARY NAME AND DOSAGE FORM
Folic acid + Zinc &B12 (Tablet)

COMPOSITION:

Each daily dosage contains
Folic acid 499 mcg
Zinc 12 mg
Vitamin B12 2.4 mcg


Other ingredients: Spherolac, Microcrystalline Cellulose, Sugar Refined, Disintegrant, Glidant (E551), Magnesium Stearate. Contains sugar.

PHARMACOLOGICAL CLASSIFICATION:
D34.12 Multiple Substance Formulation, Complementary Medicines: Health Supplements

PHARMACOLOGICAL ACTION:
Pharmacokinetic properties:
Absorption of folic acid is predominantly from the duodenum and jejunum. Folic acid is converted in the liver and plasma to the active form 5-methyltetrahydrofolate. The metabolites of folic acid and excess folate are excreted unchanged in the urine. Folic acid is actively excreted in breastmilk (see HUMAN REPRODUCTION).

Vitamin B12 is actively absorbed in the gastrointestinal tract after binding to intrinsic factor. The absorption of vitamin B12 is impaired in patients with a malabsorption syndrome or gut abnormality or disease or after gastrectomy, or with an absence of intrinsic factor. Little vitamin B12 can also be absorbed in the gastrointestinal tract by means of passive diffusion. Vitamin B12 is protein bound to transcobalamins and stored in the liver. Vitamin B12 is excreted in the bile and urine and undergoes enterohepatic circulation. Vitamin B12 crosses the placenta and is excreted in breastmilk (see HUMAN REPRODUCTION).

Zinc intestinal absorption is incomplete. The presence of dietary constituents, like phytates, reduces absorption of zinc. Zinc bioavailability ranges between 20%-30% depending on the source. Zinc distribution throughout the body is highest in bone, muscle, eye, skin and prostatic fluids. The excretion of zinc is primarily through feces and small amounts are excreted via perspiration and urine. Zinc is predominantly protein bound in serum.

Pharmacodynamic properties:
A deficiency in folic acid and vitamin B12 impairs the synthesis of DNA in any cell where chromosomal replication and division takes place. The most dramatic changes are seen in tissues with a high cell turnover and therefore the hematopoietic system is very sensitive to folic acid and vitamin B12 deficiencies. Vitamin B12 is intracellularly maintained as methylcobalamin and deoxyadenosylcobalamin, two active coenzymes. Deoxyadenosylcobalamine plays an important role in the metabolism of lipids and carbohydrates whereas methylcobalamin plays a role in the methionine synthetase reaction during normal folate metabolism. The interaction of folate and vitamin B12 donates a methyl group during the conversion of homocysteine to methionine which is essential in the synthesis of pyrimidines and purines; thus DNA synthesis. Folic acid and vitamin B12 play an important regulating role in the metabolic process of homocysteine. Low levels of Folic acid and Vitamin B12 is associated with high homocysteine concentrations which may lead to health complications.

Zinc is a present in all tissues and a constituent of several enzymatic systems and transcription and replication factors. Zinc is important for the normal functioning of the immune system. Zinc plays a role in innate immunity. Zinc directly induces chemotactic activity in polymorphonuclear leukocytes. Zinc is also important for lymphocyte activity, phagocytosis of neutrophils and macrophages and generation of the oxidative bursts. The number of granulocytes is also dependent on the level of zinc. Zinc also plays a role in proliferation. Zinc plays a role in specific immunity and in the production of B-lymphocyte antibodies and influences cytolytic T cell activity and development. Zinc is an essential cofactor for thymulin which is an important immunity regulating hormone.

INDICATIONS:
Folic Acid + Zinc & B12 plays an important role in prenatal development. When taken daily before and during early pregnancy, Folic Acid + Zinc & B12 may help to reduce the risk of neural tube defects. Folic Acid + Zinc & B12 supports red blood cell formation and helps to maintain a good health. Folic Acid + Zinc & B12 plays an essential role during cell replication and division and homocysteine regulation. Vitamin B12 contributes to the normal nervous system and psychological function. Zinc helps to maintain immune function.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.

WARNINGS AND SPECIAL PRECAUTIONS:
Do not use this product if you are hypersensitive (allergic) to any of the ingredients. If you are on any medication or suffering from any medical condition, seek medical advice before taking this product. Do not exceed the recommended dosages unless on the advice of a healthcare practitioner. Use with caution in conjunction with other supplements containing folic acid, zinc or vitamin B12. Nutritional supplements should not replace a balanced diet. This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

INTERACTIONS:
Long term use of oral contraceptives, phenytoin, isoniazid, glucocorticosteroids, alcohol and high doses NSAIDs may cause folic acid deficiency. Antifolate agents such as methotrexate, pyrimethamine, sulfonamides and trimethoprim interfere with the metabolism of folic acid and may lead to a deficiency in patients with low stores of folic acid. Folic acid replacement therapy may be required to prevent the development of megaloblastic anemia. High doses of folic acid may counteract the effect of antiepileptikums such as phenobarbital, phenytoin and primidone. Large repeated doses of folic acid may lead to reduced levels of cyanocobalamin.

Large doses of ascorbic acid may destroy cyanocobalamin when ingested together. Gastrointestinal tract absorption of vitamin B12 may be reduced by histamine H2-antagonists, omeprazole, colchicine, neomycin and aminosalicylic acid. Oral contraceptives may decrease serum concentrations of vitamin B12. The effect of vitamin B12may be attenuated by parenteral chloramphenicol.

The absorption of tetracyclines, quinolones and penicillamine may be inhibited by Zinc. Zinc absorption van be inhibited by iron and phytates and should be taken at least two hours apart.

HUMAN REPRODUCTION:
Pregnancy:
The risk for neural tube defects in the fetus may be reduced by supplementing with folic acid prior to and during pregnancy. Consult a healthcare professional prior to use.

Lactation:
Folic acid, zinc and vitamin B12 are excreted in breastmilk. Consult a healthcare professional prior to use.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 14 years: Take one capsule daily, or as prescribed by a healthcare professional.

SIDE EFFECTS:
Rare: Gastrointestinal disturbances and hypersensitivity reactions; including skin rash and fever. Nausea, vomiting, metallic taste, abdominal cramping and diarrhea.

KNOWN SYMPTOMS OF OVERDOSE AND PARTICULARS OF ITS TREATMENT:
Excess folic acid and vitamin B12 are excreted in the urine. High doses of vitamin B12 do not pose any real danger. Excessive intake of zinc supplement can cause nausea, vomiting, metallic taste, abdominal cramping and diarrhoea. Chronic use of zinc above the tolerable upper intake level may decrease high-density lipoprotein, suppress immunity and cause copper deficiency and hypochromic microcytic anaemia. Contact a healthcare professional should an overdose be suspected.

IDENTIFICATION:
Off white tablet

PRESENTATION:
White polyvinyl chloride (PVC) bottles containing 30/60/90/120/180/1000 capsules.

STORAGE INSTRUCTIONS:
Store at or below 25˚C, in a dry place in original packaging. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
To be allocated by Council upon registration.

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
California Pharmaceuticals (Pty) Ltd, 179 Edison crescent, Hennopspark, Centurion, 0157 www.cntlabs.co.za

DATE OF PUBLICATION OF THE PACKAGE INSERT:
To be allocated by Council upon registration.

Comments

Company MAXXmarketing GmbH

DISCLAIMER:

All CNT Labs supplements are suitable for individuals 18 years and older, unless otherwise stated on the product. Should not be used by pregnant / lactating women without firstly consulting a healthcare practitioner. Individuals suffering from a medical condition or taking any prescription or over-the counter medication should consult their healthcare practitioner before using these products. Discontinue if you experience any adverse reaction. Products have not been evaluated by SAHPRA and do not intend to diagnose, treat, cure or prevent any form of illness or disease and should not replace any medication.

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