PACKAGE INSERT FORMAT OF GLUCOSAMINE, CHONDROITIN, VITAMIN C, D3 AND PRO-BONE MINERALS TABLETS (SUBICART GC PLUS)

1.Product Name: 5.Indications:

Glucosamine, Chondroitin, Vitamin C, D3 & Pro-bone minerals Tablets( SUBICART GC PLUS) Osteoarthritis; Rheumatoid arthritis, Joint pain. Knee pain, back pain and disc swelling,osteoporosis.
2.Name and Strength of Active Ingredient Rickets, Osteomalacia.
Av. Per 2 tablets 6. Recommended Dose:
Glucosamine Sulphate 1500 mg Two tablets daily or as directed by physician.
Chondroitin Sulphate Sodium 400 mg 7. Mode of Administration:
Vitamin D3 400 IU SUBICART GC PLUS for oral administration it may be give with or without food. The tablets should
Vitamin C 100 mg be swallowed with water.
Zinc 6 mg 8. Contraindication:
Boron 1 mg Known sensitivity to glucosamine (or any of its derivatives), chondroitin sulfates or any of the other
Manganese 6 mg ingredients in Subicart GC Plus Tablets.
Copper 1 mg Patients taking blood-thinning medications or daily aspirin should not take chondroitin sulfate, as it
3. Product Description: may contribute to bleeding. Children, as well as women who are pregnant and/or nursing, or who
Brown color, caplet shaped, slightly biconvex film coated tablet plain on both sides. could become pregnant.
4. Pharmacokinetics: The relative contraindications include: erythrocyte G6PD- deficiency, hemochromatosis, thalassemia
Glucosamine sulphate: About 90% of glucosamine administered orally as a glucosamine salt gets and sideroblastanaemia, nephrolithiasis. Great care should be taken in case of toxicosis
absorbed from the small intestine, and from there it is transported via the portal circulation to the liver. It accompanying pregnancy.
appears that a significant fraction of the ingested glucosamine is catabolized by first-pass metabolism in Severe impaired renal function, Hypercalcemia, Severe hypercalciuria, copper metabolism
the liver. Free glucosamine is not detected in the serum after oral intake, and it is not presently known disorders, Kidney stones (nephrolitiasis, nephrocalcinosis) and Hyper-vitaminosis D. malabsorption
how much of an ingested dose is taken up in the joints in humans. should not take this medicine.
Chondroitin sulphate sodium: Absorption appears to occur from the stomach and small intestine. There 9. Warnings and Precautions:
is also an indication that some chondroitin sulphate, after absorption, does enter the joint space. Glucosamine sulphate and chondroitin sulphate: Glucosamine can thin the blood, so you might want
Vitamin C: About 70 – 90 % is absorbed from the lumen of small intestine, regarding metabolism, it is to ask your doctor or pharmacist before taking blood thinners, such as warfarin , enoxaparin,
oxidized to dehydroascorbic acid which can be either reduced back to ascorbic acid or hydrolyzed to apixaban, rivaroxaban, or dabigatran. People with diabetes should know that glucosamine might
diketogulonate & other metabolites, and the principal route of excretion of ascorbic acid & its raise blood sugar, since glucose is part of glucosamine structure. Taking glucosamine with an herbal
metabolites is via kidney. supplement that contains skullcap increases the risk of liver damage. If you want to take
Vitamin D3: Vitamin D3 is easily absorbed by the small intestine. Cholecalciferol and its metabolites glucosamine, discontinue using any supplement that contains skullcap. If you're allergic to shellfish,
circulate in the blood, linked to a specific alpha globulin. Cholecalciferol is metabolised in the liver by you still may be able to use glucosamine made from shellfish since shells themselves do not contain
hydroxylation to its active form, 25-hydroxycholecalciferol. It is then metabolised in the kidneys to 1, 25- the protein that causes an allergic reaction.
dihydroxycholecalciferol.1, 25-dihydroxycholecalciferol is the metabolite responsible for the increase in Vitamin C: Ascorbic acid should be used with caution (if contains Tartrazine) in patients with aspirin
calcium absorption. The vitamin D3 that is not metabolised is stored in adipose and muscle tissue. hypersensitivity, because it may cause allergic reactions (including bronchial asthma). Use with
Vitamin D3 is excreted via the faeces and urine. caution in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency. Avoid large dose
Zinc: zinc is completely absorbed from the small bowl with between 10 and 40% of an injested dose of ascorbic acid, because it may cause renal calcium oxalate calculi.
absorbed. Numerous dietary components can interfere with zinc absorption, particularly phytates and Vitamin D3: Care should be taken in following cases before taking Vitamin D3:
fiber bind to zinc, resulting in poorly absorbed zinc complexes. Approximately 60% of circulating zinc is - patients having problems with kidneys, sarcoidosis (inflammation that produces lumps of cells in
bound to albumin &roughly 30% is bound to macroglobulin. The majority of zinc is stored in liver and various organs in the body).
kidney, chiefly intra cellularly and bound to metalloproteins. In adults it has been estimated that If patients already taking other medicines or supplements containing vitamin D
approximately 0.5 to 1.5 mg/day secreted in the biliary tract and excreted in the stool, while 0.5 to if patients are taking medicines from a group known as cardiac glycosides used to treat heart
0.8mg/day is excreted in urine. conditions (e.g. digoxin, digitalis)
Boron: Boron take orally was completely absorbed by the gastrointestinal system of rats, rabbits and
human beings over every short period of time. Absorption of boron orally is very similar in both humans
and animals. Daily boron intake of 27.90mg/day Boric acid that is consumed by human and animals are
quickly distributed to body liquids.
Manganese: Oral absorption of manganese is found to be 26.5% ± 23.5. Renal excretion accounts for
very small.
Copper: After administration, Copper sulfate is mostly absorbed in the small intestine. Copper sulfate is
mostly eliminated via the biliary route and by kidneys to some extent.
Pharmacodynamics:
Glucosamine, chondroitin and Vitamin C: Glucosamine compound tablet is formulated to meet the
natural challenge of arthritis, its main components glucosamine sulphate and chondroitin sulphate are
combined in a therapeutic dosage for optimal conditions to reconstruct the cartilage matrix, while
ascorbic acid works by mopping free oxygen radicals thus aiding in the prevention of cartilage damage.
Glucosamine and chondroitin work synergistically to help stimulate cartilage production and control
cartilage damaging enzymes and therefore help maintain equilibrium between cartilage catabolic and
anabolic processes, Glucosamine compound tablet is thus effective in treating the disease at the
cellular level.
Vitamin D3: Cholecalciferol (vitamin D3) is a steroid hormone that has long been known for its important
role in regulating body levels of calcium and phosphorus, in mineralization of bone, and for the
assimilation of Vitamin A. The classical manifestation of vitamin D deficiency is rickets, which is seen in
children and results in bony deformities including bowed long bones. Deficiency in adults leads to the
disease osteomalacia. Both rickets and osteomalacia reflect impaired mineralization of newly
synthesized bone matrix, and usually result from a combination of inadequate exposure to sunlight and
decreased dietary intake of vitamin D. Common causes of vitamin D deficiency include genetic defects
in the vitamin D receptor, severe liver or kidney disease, and insufficient exposure to sunlight. Vitamin D
plays an important role in maintaining calcium balance and in the regulation of parathyroid hormone
(PTH). It promotes renal reabsorption of calcium, increases intestinal absorption of calcium and
phosphorus, and increases calcium and phosphorus mobilization from bone to plasma.
Copper: Elemental copper is essential for the functioning of metallo enzymes such as monoamine
oxidase, ceruloplasmin, Zn-Copper SOD, cytochrome-C oxidase, tyrosinase and ferroxidase. Elemental
copper is vital for catecholamine metabolism, oxidative phosphorylation, erythropoiesis and free radical
scavenging.
Zinc, Copper & Manganese: Multimineral preparations are indicated to prevent and correct nutritional
micronutrient deficiencies. Pregnancy and lactation represent periods with increased micronutrient
requirements and, as a consequence, increased risks of micronutrient deficiencies for both the mother
and the child. Especially during pregnancy, micronutrient deficiencies exhibit a more serious health risk,
as they may also impair the normal development of the unborn child.

- Copper: Copper is LIKELY SAFE when taken by mouth appropriately. Pregnant or breast-feeding

Boron: Hormone-sensitive condition such as breast cancer, uterine cancer, ovarian cancer, women should consume no more than 8 mg daily per day if they are 14 to 18 years old, and no more
endometriosis, or uterine fibroids: Boron might act like estrogen. If patient have any condition that might
be made worse by exposure to estrogen, avoid supplemental boron or high amounts of boron from
foods. Kidney disease or problems with kidney function: Do not take boron supplements if patient have
kidney problems. The kidneys have to work hard to flush out boron.
Zinc: Different zinc salts are used orally, parenterally and topically in different conditions and
deficiency. WHO recommends lower limits of safe ranges of population mean intakes of dietary zinc for
three categories of diets based on high, moderate and low zinc bioavailability; values are 4.0, 6.5 and
13.1 mg dietary zinc daily for women, and 5.6, 9.4 and 18.7mg dietary zinc daily for men respectively.
They recommend an upper limit of the safe range of population mean intakes of zinc of 35 mg daily for
women and 45 mg daily for men.
Manganese: It should be used cautiously in young children and pregnant females. In biliary tract or
hepatic dysfunction increased blood concentrations may result because manganese is normally
excreted in bile.
Copper: Taking copper in excess is poisonous and food cooked in copper vessels with poor tin-plating
can cause severe vomiting and diarrhea with abdominal pain. Drinking acid drinks in copper vessels
can also produce the same symptoms.
10. Interactions With Other Medicaments:
Glucosamine sulphate and Chondroitin sulphate:
Glucosamine and Chondroitin may increase the risk of bleeding when taken with drugs that increases
the risk of bleeding. Some examples are aspirin, anticoagulants such as warfarin or heparin, antiplatelet
drugs such as Clopidogrel and non-steroidal anti- Inflammatory drugs such as ibuprofen naproxen.
Glucosamine may affect insulin and blood sugar levels
Taking glucosamine along with etoposide, teniposide, and doxorubicin for cancer might decrease the
effectiveness of these medications for cancer. Chondroitin may affect blood pressure. Caution is
advised in people taking drugs that may also affect blood pressure. Chondroitin may also interact with
agents that may affect the immune system, agents that may affect the nervous system.
VitaminD3: Hypermagnesemia (high blood magnesium levels) may develop when magnesium-
containing antacids are used concurrently with vitamin D, particularly in patients with chronic renal
failure.
Vitamin C: Aspirin and NSAIDs can lower the amount of vitamin C in the body because they cause
more of the vitamin to be lost in urine. High doses of vitamin C may lower the amount of acetaminophen
passed in urine, which could cause the levels of this drug in your blood to rise. Barbiturates may
decrease the effects of vitamin C.As an antioxidant, vitamin C may interfere with the effects of some
drugs taken for chemotherapy. For patient undergoing chemotherapy, do not take vitamin C or any
other supplement without talking to your oncologist.
Boron: Boron might increase estrogen levels in the body. Taking boron along with estrogens might
cause too much estrogen in the body. Antibiotics (Quinolone antibiotics) interacts with manganese
might decrease how much antibiotic the body.
Copper, Zinc and Manganese: Products containing, manganese, copper or zinc may interact with orally
administered antacids, gastric acid suppressive medications, antibiotics (tetracycline’s,
fluoroquinolones), levodopa, bisphosphonates, penicillamine, thyroxine (levothyroxine), trientine,
digitalis, antiviral agents and thiazide diuretics, reducing the bioavailability of the medicinal product
and/or the minerals in Elevit Pronatal. If simultaneous use is necessary, administration of the two
products should be separated by at least 2 hours.
11. Pregnancy and Lactation
There is not enough reliable scientific information available to know if Subicart GC Plus is safe to take
during pregnancy or while breast-feeding. Until more is known, do not take take the tablet without
advice from physician while pregnant or breast-feeding.
Chondroitin sulfate: There is not enough reliable information about the safety of taking chondroitin
sulfate if you are pregnant or breast feeding. Stay on the safe side and avoid use.
Vitamin D 3: Vitamin D3 may be given during pregnancy in cases of calcium and vitamin D3 deficiency.
During pregnancy the daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D.
Animal studies have shown toxic effects on reproduction at high doses of vitamin D. In pregnant
women, all calcium or vitamin D overdoses must be avoided as prolonged hypercalcaemia in pregnancy
may lead to retardation of physical and mental development, supra-valvular aortic stenosis and
retinopathy in the child. There are no indications that Vitamin D3 at therapeutic doses is teratogenic in
man. Caltrate Vitamin D3 can be used during breastfeeding. Calcium and vitamin D3 pass into maternal
milk. This must be taken into consideration when vitamin D3 is given concomitantly to the child.
Vitamin C: Ascorbic acid crosses the placenta and is distributed in breast milk. It appears to be
reasonably safe in pregnancy in therapeutic doses.
Boron: Boron is likely safe for pregnant and breast-feeding women age 19-50 when used in doses less
that 20 mg per day. Pregnant and breast-feeding women age 14 to 18 should not take more than 17 mg
per day. Taking boron by mouth in high doses is possibly unsafe while pregnant and breast feeding.
Higher amounts may be harmful and should not be used by pregnant women because it has been
linked to birth defects. Intra vaginal boric acid has been associated with a 2.7- to 2.8-fold increased risk
of birth defects when used during the first 4 months of pregnancy.
Zinc: Zinc is LIKELY SAFE for most pregnant and breast-feeding women when used in the
recommended daily amounts (RDA). However, zinc is POSSIBLY UNSAFE when used in high doses by
breast-feeding women and LIKELY UNSAFE when used in high doses by pregnant women. Pregnant
women over 18 should not take more than 40 mg of zinc per day; pregnant women age 14 to 18 should
not take more than 34 mg per day. Breast-feeding women over 18 should not take more than 40 mg of
zinc per day; breast-feeding women age 14 to 18 should not take more than 34 mg per day.
Mangnese: Manganese is LIKELY SAFE in pregnant or breast-feeding adult women aged 19 or older
when taken by mouth in doses of less than 11 mg per day. However, pregnant and lactating women
under age 19 should limit doses to less than 9 mg per day. Manganese is POSSIBLY UNSAFE when
taken by mouth in higher doses. Doses over 11 mg per day are more likely to cause serious side
effects. Manganese is LIKELY UNSAFE when inhaled for long periods of time.
than 10 mg daily per day if they are 19 or older. Taking copper by mouth in higher doses
is POSSIBLY UNSAFE. Higher amounts can be dangerous.
12. Undesirable effects:
Glucosamine and Chondroitin: In general, glucosamine and chondroitin sulfate nutritional supplements
appear to be quite safe. The most common side effects occur that have been reported are
gastrointestinal in nature, such as upset stomach, nausea, heartburn, and diarrhea. Taking
glucosamine and/or chondroitin sulfate with food seems to reduce the incidence of the above side
effects.
Vitamin C: The preparation may cause headache, nausea, vomiting, diarrhea, gripes, skin redness,
increased diuresis.
Vitamin D3: Most people do not commonly experience side effects with vitamin D, unless too much is
taken. Some side effects of taking too much vitamin D include weakness, fatigue, sleepiness,
headache, and loss of appetite, dry mouth, metallic taste, nausea, vomiting, and others.
Boron, Zinc, manganese & Copper: The most common undesirable effects are gastrointestinal
disorders. Common effects are Abdominal discomfort, constipation, flatulence, vomiting, diarrhoea,
nausea.
13. Overdose and treatment
Glucosamine& Chondroitin: headache, dizziness, disorientation, arthralgia, nausea, vomiting,
Diarrhoea or constipation. In cases of overdose, treatment with SUBICART GC PLUS should be
discontinued and standard supportive measures should be adopted as required.
Vitamin C: High dose vitamin c administration may suppress insulin liberation in pancreas and also,
may bring about headache, nausea, vomiting, diarrhoea, colics, skin reddening; increased diuresis;
back pain. In case of sudden withdrawal of vitamin, especially after high dose administration,
symptoms of deficiency to scurvy may develope-hyperkeratosis, petechial, hemorrhagia, gum
inflammation, teeth falling, muscular weakness, anaemia.
Vitamin D3:Too much vitamin D can cause an abnormally high blood calcium level, which could
result in nausea, constipation, confusion, abnormal heart rhythm, and even kidney stones.
Boron: Overdose may be cause emesis, hypercalcemic states& polyuria, Polydipsia, elevated blood
urea nitrogen, albuminuria, hypercholesterolemia.
Zinc: Excessive intake of zinc leading to toxicity to the body. Zinc is a trace element required by the
body for many metabolic processes. The body does not tend to store zinc so regular dietary intake is
important. However, if excess zinc is consumed over a long period of time (as can occur in people
who work with the metal or breath its fumes) can affect how the body uses other trace elements and
result in gastrointestinal problems, anemia, poor immunity, dizziness, vomiting and other symptoms.
An acute overdose of zinc can cause symptoms such as vomiting, stomach pain, diarrhea and
fever.
Manganese: Some of the symptoms of Manganese overdose include: Cough Pleuritis, Pneumonia
Gastrointestinal irritation, Pancreatitis.
Copper: Excessive intake of Copper causes Abdominal pain, Diarrhea, Vomiting, Yellow skin.
14. Storage Condition
Store below 30°C & Protect from Sunlight. Keep out of reach of children
15. Dosage Forms and packaging available:
SUBICART GC PLUS are available in Blister pack of 15’s. Tablets are for Oral use.
16. Name and Address of Manufacturer/Marketing Authorization Holder
AEON FORMULATIONS PVT. LTD.,
R.S. No. 515/1, 515/2 & 514, No. 152/7,
VinayagarKoil street, Thirubuvanaipalayam,
Mannadipet Commune, Puducherry – 605 107.
17. Date of Revision of Package Insert
SUBICART GC PLUS Leaflet last revised on August 2016.