PRODUCT DESCRIPTION

This product is a brown, oblong-shaped soft gel capsule.


WHAT IS IN THE MEDICINE?

This product is a nutritional supplement which contains the natural substances ginseng and royal jelly, two widely used “tonics” to help build stamina and help enhance psychomotor performance. The revitalizing properties of both ginseng and royal jelly combined with the known biochemical effects of vitamins and minerals may help maintain the healthy state of body functions. B-complex vitamins and iron in particular, may help meet energy demands by facilitating conversion of food to utilizable energy. It also contains antioxidant nutrients (Vitamins A, C, E and Zinc) that protect cells from harmful free radicals and help enhance immune function.
 

STRENGTH OF THE MEDICINE

Please see formulation


WHAT IS THE MEDICINE USED FOR?

•    A nutritional supplement for the prevention and treatment of vitamin and mineral deficiency.


HOW MUCH AND HOW OFTEN SHOULD YOU USE THE MEDICINE?

Orally, 1 – 2 soft gel capsules daily.
    Or, as directed by a doctor.


WHEN SHOULD YOU NOT TAKE THIS MEDICINE?

•    If you are allergic to any ingredient in the product.
•    If you are pregnant or breastfeeding.



UNDESIRABLE EFFECTS

Nicotinamide: Dosages of nicotinamide in excess of 100 mg daily may cause flushing of the face, arms, and chest, itching, and nausea.

Iron: Doses of elemental iron greater than 120 mg per day may cause gastrointestinal side effects such as nausea, vomiting, bloating, and upper abdominal discomfort. Other undesirable effects may include black stools, diarrhea or constipation.

Ginseng: Ginseng when taken in high doses (>3 g daily) may cause hypertension, nervousness, insomnia, edema, diarrhea, and skin reactions.

Royal Jelly: Royal Jelly may cause hypersensitivity reactions such as eczema, rhinitis, urticaria, and bronchospasm.


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

•    Concomitant use of oral hypoglycemic agents (e.g., Glimepiride, Glipizide, etc.) and ginseng may enhance the effect of oral hypoglycemic agents.
•    Concomitant use of monoamine oxidase (MAO) inhibitors (e.g., Selegeline, Phenelzine, Moclobomide, etc.) and ginseng may result in decreased effect of MAO inhibitors.
•    Concomitant use of warfarin and ginseng may result in decreased blood prothrombin levels.


WHAT SHOULD YOU DO IF YOU MISS A DOSE?

If you miss a dose, just give the next dose and the subsequent doses at the usual recommended schedule.

Do not double the dose.


HOW SHOULD YOU KEEP THE MEDICINE?

•    Keep the product out of reach and sight of children.
•    Store at temperatures not exceeding 30ï‚°C.





SIGNS AND SYMPTOMS OF OVERDOSAGE

The B-complex vitamins (Vitamins B1, B2, B6, B12, and Nicotinamide) are relatively nontoxic.

However, long term (i.e., two months or longer) administration of large (megadose) dosages (e.g., usually 2 grams or more daily) of vitamin B6 can cause neurological symptoms manifested as paresthesia (more noticeable at night and limited to the extremities), bone pains, hyperesthesia (described as burning, pricking, stinging, or itching), muscle weakness, fasciculation (described as twitching, restlessness or fidgeting), and numbness on the limbs and face.

Vitamin A
Chronic daily vitamin A intakes in excess of 10,000 IU or weekly intakes in excess of 25,000 IU have resulted in hypervitaminosis A.

Excessive vitamin A intake (more than 10,000 IU daily) is hazardous when taken during the first and second trimesters of pregnancy. Excessive vitamin A intake during pregnancy may lead to birth defects such as cleft palate, heart abnormalities and brain malformations, e.g., hydrocephalus and microcephaly (baby with a very small head).

Iron
Acute iron overdosage (e.g., intake of ≥1,500 mg elemental iron for a 50 kg adult) can be divided into four stages:

Stage I – Occurs up to six hours after ingestion, the principal symptoms are vomiting and diarrhea. Other symptoms include hypotension (low blood pressure), tachycardia (rapid heartbeat) and central nervous system (CNS) depression ranging from lethargy (sleepiness) to coma (state of unconsciousness).

Stage II – May occur 6 to 24 hours after ingestion and is characterized by a temporary remission or signs of overdosage are decreased.

Stage III – Gastrointestinal symptoms recur accompanied by shock, metabolic acidosis (increased acid in the blood), coma, hepatic necrosis (death of liver tissue), jaundice (yellowish color of the skin, eyes and other tissues), hypoglycemia (low blood sugar), kidney failure, and pulmonary edema (fluid in the lungs).

Stage IV – Occurs several weeks after ingestion and is characterized by gastrointestinal obstruction (blockage) and liver damage.





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

If you have taken more than the recommended dosage, consult a doctor.


NAME/LOGO OF MANUFACTURER/IMPORTER/MARKETING AUTHORIZATION HOLDER





CARE THAT SHOULD BE TAKEN WHEN TAKING THIS MEDICINE

•      Do not take more than the recommended dose.
•      Do not use after the expiry date on the label.


WHEN SHOULD YOU CONSULT YOUR DOCTOR?

•      If any undesirable effect occurs.


DATE OF REVISION OF PATIENT INFORMATION LEAFLET (PIL)

Note to ULCH: PIL revision date should be the date when the PIL is approved by the Bureau of Food and Drugs (BFAD).