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INTRODUCTION
HEADON 4IU INJECTION contains Somatropin which belongs to the group of medicines called Growth hormone agonists. It is used in children with growth failure due to growth hormone deficiency (GHD), idiopathic short stature (ISS), Turner syndrome (TS), Prader-Willi Syndrome, are too small or light at birth and in chronic kidney disease (CKD).

In adults it is used to treat either childhood-onset or adult-onset GHD. Growth hormone deficiency (GHD) is also called dwarfism or pituitary dwarfism. It is a disease characterized by low growth hormone levels in the body.

Your doctor might want you to take certain tests and follow a particular diet during treatment with HEADON 4IU INJECTION. HEADON 4IU INJECTION is not recommended for use if you have an active cancer, are seriously ill (like you need to get a surgery done) or if your growth has already stopped.

Before receiving HEADON 4IU INJECTION, inform your doctor if you have myalgia, diabetes, kidney or thyroid problem. HEADON 4IU INJECTION is not recommended for use in pregnant women and caution should be exercised while using it in breastfeeding women.

It should be used with caution in elderly patients above 80 years of age. The most common side effects of receiving HEADON 4IU INJECTION are joint pain, water retention (which shows as puffy fingers or swollen ankles), injection site reaction. Contact your physician for advice if any of the symptoms worsen.

USES OF HEADON 4IU INJECTION
Treats:

Children with growth failure due to growth hormone deficiency (GHD), idiopathic short stature (ISS), Turner syndrome (TS), Prader-Willi Syndrome and chronic kidney disease (CKD)
Children who are too small or light at birth
Childhood-onset or adult-onset GHD in adults
HOW HEADON 4IU INJECTION WORKS
HEADON 4IU INJECTION is a man-made form of growth hormone which resembles natural human growth hormone that stimulates the production of another growth hormone called insulin-like growth factor 1 or IGF-1. It helps the bones, muscles to grow and develop in the right amount.

DIRECTIONS FOR USE
HEADON 4IU INJECTION will be given to you only by a doctor or a nurse via subcutaneous injection that is injected into the fatty tissue just under the skin. The correct dose and duration will be decided by your physician for you depending on your age, body weight and disease condition.

SIDE EFFECTS OF HEADON 4IU INJECTION
COMMON
Joint pain
Water retention (which shows as puffy fingers or swollen ankles)
Injection site reaction (signs include temporary reddening, itchiness or pain)
Numbness / tingling
Stiffness in the legs and arms, muscle pain
Pain or burning feelings in the hands or underarms
UNCOMMON
Rash/itching
Breast enlargement (gynecomastia)
Leukemia
Increased intracranial pressure (symptoms such as strong headache, visual disturbances or vomiting)
Muscle pain
Raised itchy bumps on skin
RARE
Stop receiving HEADON 4IU INJECTION and contact your doctor immediately if you experience any of the following side effects:

Walk with a limp or start to limp during the treatment due to pain in the hip
Developing raised intracranial pressure (with symptoms like strong headache, visual disturbances or vomiting)
Experience worsening abdominal pain
Have headaches, changes in behavior, changes in vision, changes in moles, birthmarks or the color of the skin
Serious allergic reactions (symptoms include swelling of the face, lips, mouth or tongue, trouble breathing, wheezing, severe itching, skin rashes, redness or swelling, dizziness or fainting, fast heartbeat or pounding in the chest and sweating)
Body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in the joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet
Darkening of the skin, dizziness, weakness, severe fatigue or weight loss
Worsening of bend of the spine (scoliosis)
Severe and constant abdominal pain (may be a sign of pancreatitis)
WARNING & PRECAUTIONS
PREGNANCY
HEADON 4IU INJECTION is not recommended for use in pregnant women and women planning to have a baby as safety data has not been established yet. Consult your doctor before receiving HEADON 4IU INJECTION.

BREASTFEEDING
HEADON 4IU INJECTION should be used with caution in breastfeeding women as it is not known whether it passes through the breastmilk. Consult your doctor before receiving HEADON 4IU INJECTION.

DRIVING AND USING MACHINES
HEADON 4IU INJECTION does not affect the ability to drive and use machines.

KIDNEY
HEADON 4IU INJECTION should be used with caution in patients with kidney problems. It should not be used during kidney transplant. Consult your doctor before receiving HEADON 4IU INJECTION.

ALLERGY
Do not receive HEADON 4IU INJECTION if you are allergic to somatropin or any other ingredients of this medicine.

HEART DISEASE
HEADON 4IU INJECTION is not recommended for use in patients with open-heart surgery. Consult your doctor before receiving HEADON 4IU INJECTION.

OTHERS
HEADON 4IU INJECTION is not recommended for use if you:

Are seriously ill (for example, complications following open heart surgery, abdominal surgery, acute respiratory failure, accidental trauma or similar conditions)
Children with Prader-Willi syndrome who are severely obese
Have a history of severe upper airway obstruction
Have active cancer
Have severe non-proliferative or active proliferative diabetic retinopathy
Pediatric patients with closed epiphyses
If your growth has stopped
Before receiving HEADON 4IU INJECTION, inform your doctor if you have:

Myalgia
Diabetes
Thyroid problem
Use in Geriatrics:

HEADON 4IU INJECTION should be used with caution in elderly patients above 80 years of age. Consult your doctor before receiving HEADON 4IU INJECTION.

INTERACTIONS
A. Drug-Drug interactions:

Before receiving HEADON 4IU INJECTION, inform your doctor if you are taking any of the following medicine:

Replacement therapy with glucocorticoids (Ex. prednisone)
Medicine used to treat diabetes (Ex. glimepiride, metformin)
Medicine used as thyroid hormones (Ex. thyroxine)
Synthetic adrenal hormones (corticosteroids)
Medicines used for contraception (Ex. estrogen is taken orally or other sex hormones)
Medicine used to weaken the immune system after transplantation (Ex. ciclosporin)
Medicines used to control epilepsy (anticonvulsants) (Ex. carbamazepine, frisium)
Cytochrome P450- metabolized drugs (Ex. benzodiazepines, cyclosporine)
Overdosage:

HEADON 4IU INJECTION will be administered only by a doctor or a nurse in a hospital and so it is unlikely to receive an overdose. However, consult your doctor or nurse if there are any unusual symptoms of hypoglycemia, hyperglycemia, gigantism and/or acromegaly (excess growth hormone).

SYNOPSIS
Drug   :     Somatropin
Pharmacological Category   :     Growth Hormone Agonists
Therapeutic Indication   :     To increase growth
Dosage Forms   :     Injection
MORE INFORMATION
Keep HEADON 4IU INJECTION out of reach of children
Store in a refrigerator at a temperature of 2°C to 8°C
FAQs ABOUT HEADON 4IU INJECTION
Q: Is HEADON 4IU INJECTION safe to use in pregnancy?

A: HEADON 4IU INJECTION is not recommended for use in pregnancy as safety data has not been established yet. Consult your doctor before receiving HEADON 4IU INJECTION.

Q: Can HEADON 4IU INJECTION be used in diabetic patients?

A: Caution should be taken while using HEADON 4IU INJECTION if you are diabetic. If you have diabetes, constant monitoring of blood sugar levels is required while receiving HEADON 4IU INJECTION. Discuss with your doctor before receiving HEADON 4IU INJECTION.

Q: Can I receive HEADON 4IU INJECTION along with thyroid hormones?

A: Caution to be taken if HEADON 4IU INJECTION is used along with thyroid hormones because thyroid hormone dose may need to be adjusted. Your physician may adjust the dose of your thyroid hormone accordingly.

Q: How does HEADON 4IU INJECTION work?

A: HEADON 4IU INJECTION is a man-made form of growth hormone which resembles natural human growth hormone and is required for the growth of bones and muscles. It also helps the fat and muscle tissues to develop in the correct proportion.

Q: Who should not receive HEADON 4IU INJECTION?

A: HEADON 4IU INJECTION is not recommended for use in patients having an acute critical illness, pediatric with Prader-Willi syndrome who are severely obese, have a history of severe upper airway obstruction, active malignancy, severe non-proliferative or active proliferative diabetic retinopathy and in pediatric patients with closed epiphyses. Consult your doctor before receiving HEADON 4IU INJECTION.