Sangobion Capsule

SANGOBION CAPSULES

(Iron + Folic Acid with Minerals)

COMPOSITION

Each soft-gelatin capsule contains:
Ferrous Gluconate Dihydrate, BP ........................ 250 mg
Manganese Sulfate Monohydrate, USP ............. 0.2 mg
Copper Sulphate Pentahydrate, BP ...................... 0.2 mg
Vitamin C (Ascorbic acid), USP ................................ 50 mg
Folic Acid, USP .................................................................. 1 mg
Vitamin B,.(Cyanocobalamin), USP .................... 7.5 mcg

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it onto others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

WHAT IS IN THIS LEAFLET?

1. What are Sangobion Capsule?
2. What are the indications for Sangobion Capsules?
3. What should be the dose of Sangobion Capsules?
4. What are the contraindications of Sangabion Capsules?
5. What are the adverse effects of Sangobion Capsules?
6. Other information for Sangobion Capsules?

WHAT ARE SANGOBION CAPSULES?

lron, an essential mineral, is a component of your blood and a number of your enzymes. The total body content of your iron is approximately 50 mi Xo in men and 35 mg/kg in women. This Iron is primarily stored in your body in the cells of your liver, spleen, and bone marrow. Sangobion is specially formulated so you can look and perform at your best every day. It is ferrous gluconate and not ferrous sulfate. This organic iron formulation allows for better absorption inside the body and has fewer gastrointestinal side effects than ferrous sulfate.

WHAT ARE THE INDICATIONS FOR SANGOBION CAPSULES?

Sangobion® is used if you have any condition such as traumatic endogenous bleeding and anemias during pregnancy, old age, and convalescence. You may also use Sangobion® Capsule in anemias that are due to certain infections, intoxications tumors. Due to general dietary insufficiency and poorly balanced food as well as you may use it as a prophylactic against anemia if you have donated blood.

WHAT SHOULD BE THE DOSE OF SANGOBION' CAPSULES?

The usual recommended dose of Sangobion capsule is one capsule daily or as prescribed by your physician as a prophylactic agent against iron deficiency anemias or certain B vitamins. If you have

iron deficiency, then the usual recommended dose is one capsule three times a day or as prescribed by your physician. The treatment should be continued until your red blood count or the iron content in the serum and/or the binding capacities of the iron have normalized. Afterward, you may continue the medication for additional 1-2 months to replenish the iron reserves.

WHAT ARE THE CONTRAINDICATIONS OF SANGOBION CAPSULES?

Do not take Sangobion® Capsule:

• If you are allergic to iron or any of the components of this capsule.
• If you have thalassemia, a blood disorder passes through families (inherited) in which the body makes an abnormal form of hemoglobin, the protein in red blood cells that carries oxygen. The disorder results in excessive destruction of red blood cells, which leads to anemia.
• If you have sideroblastic anemia, a blood disorder passes through families in which there is abnormal iron deposition in the red blood cells as the bone marrow is not able to manufacture normal red blood cells leading to anemia.
• If you nave hemochromatosis, a condition in which too much iron builds up in your body (iron overload).
• If you have hemosiderosis, a condition in which there is an abnormal accumulation of hemosiderin which is an insoluble form of tissue storage iron stored in the body tissue.
• If you are allergic to folic acid.

TAKE SPECIAL CARE WITH SANGOBION CAPSULE:

You should keep Sangobion capsules out of the reach of children. This is because an accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six years of age. Therefore, you are requested to please keep this product out of the reach of children. In case of accidental overdose, please call your doctor or seek medical advice immediately.

Iron therapy could induce relapse of erythropoietic protoporphyria, a condition in which you have excessive protoporphyrin in your blood, liver, and feces, commonly seen in young children.

Your doctor may advise concomitant parenteral therapy with vitamin B12 if you have a deficiency of vitamin B12. Pernicious anemia is rare in women of childbearing age, and the likelihood of its occurrence along with pregnancy is reduced by the impairment of fertility associated with vitamin B12 deficiency.

You are requested to inform your doctor/pharmacist if you are a patient of chronic renal failure or if you are receiving acetylsalicylic acid.

If you are an older patient or if you have conditions tending to lead to Vitamin B12 depletion, your doctor may regularly assess serum B12 levels during your treatment with Sangobion Capsules.

Taking other medicines

Medicines and other products that may affect or are affected by this product include magnesium trisilicate, antacids, or cholestyramine. You are advised not te consume alcchol during therapy with Sangobion® capsules as you might have a risk of toxic delirium and lactic acidosis.

Kindly inform the doctor if you are prescribed any blood thinner along with this capsule. Similarly inform your doctor or pharmacist accordingly if you are Prescribed any anti-infective drug-like ciprofloxacin, norfloxacin, ofloxacin along with Sangobion Capsule. Your doctor might advice not to take these medicines within two hours of a dose of oral anti-infective therapy.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Sangobion with food and drink

You are requested to avoid egg consumption during therapy with Sangobion therapy. as they may inhibit iron absorption. Similarly, coffee and tea consumed with a meal or one hour after a meal may significantly inhibit the absorption of dietary iron. However, its clinical significance has not been determined. Oral iron preparations should not be taken within one hour or two hours after ingestion of the above-mentioned food products.

Pregnancy and breast-feeding (lactation)

B-Complex vitamins are excreted in breast milk therefore you must tell your doctor or pharmacist regarding the use of Sangobion capsules if you are breastfeeding your baby.

WHAT ARE THE ADVERSE EFFECTS OF SANGOBION CAPSULES?

Like all medicines, Sangobion can cause side effects, although not everybody gets them.

If you experience any of the following side effects, tell your doctor or pharmacist immediately.

You might experience allergic sensitization following both oral and parenteral administration of folic acid. These allergic reactions, including rash, pruritus, and anaphylaxis. Some other rarely reported adverse effects include heartourn, eructation, abdominal pain and cramps, diarrhea, vomiting nausea, anorexia, abnormal liver function tests, stone formation, and black discoloration of your stool. Deterioration of acne-form Vulgaris, or eruption of acne-form exanthema, has been noted with several components.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

OTHER INFORMATION FOR SANGOBION® CAPSULES.

Presentation

Sangobion® Capsule: Available in a pack of 3 x 10 soft-gelatin capsules.

Special Precautions for storage

Store at 8° to 15 °C. Protect from light, heat and moisture. Keep all medicines out of the reach of children.

Innovator's Specs.

Manufactured by:
Martin Dow Marker Ltd
F-126,S.1.T.E., Karachi, Pakistan.
13003347