Ibandrocare is intended to treat and prevent osteoporosis in postmenopausal women. Ibandrocare works directly on your bones to make them stronger and therefore less likely to break. Ibandrocare indicated for:

Treatment of Osteoporosis in Postmenopausal Women For the treatment of osteoporosis, Ibandrocare increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).
Treatment to Increase Bone Mass in Men with Osteoporosis.

Osteoporosis (porous bone disease) is a disease that causes bones to become weaker. Weak bones break (fracture) more easily. Osteoporosis is common in women after menopause and is also more likely to occur in women who have reached menopause early. Osteoporosis can also occur in women who have not yet reached menopause, and in men.

Long term steroid treatment can also lead to osteoporosis in both men and women. Ibandrocare works by slowing down the process of old bone being removed. This process allows the bone-forming cells time to rebuild normal bone. Ibandrocare also helps to rebuild bone mass. This creates stronger bone which is less likely to fracture.

Composition

Each tablet contains: Active ingredient:

Ibandrocare 150 mg tablets: lbandronate sodium monohydrate 168.8 mg Eq. to lbandronic acid 150 mg.

PHARMACEUTICAL FORM: Film coated tablets.

Indications

Treatment and Prevention as Postmenopausal Osteoporosis: Ibandrocare is indicated for the treatment and prevention of osteoporosis in posmenopausal women. Ibandrocare increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

Dosage

The dose of Ibandrocare is either one 150 mg tablet taken once monthly on the same date each month.

Dosing Instructions

Always use according to the physician’s instructions. Check with your physician or pharmacist if you are not sure. Only your physician will determine your dose and how you should take the medicine. The recommended dose is usually.
Take Ibandrocare on the same day each month. Choose a day of the month that suits you best. Do not exceed the recommended dose.
Take Ibandrocare with a full glass of tap water first thing when you wake up in the morning, and at least 30 minutes before breakfast, before drinking anything (except for tap water), or before taking any medicine.
Ibandrocare is most effective when your stomach is empty.
Mineral water and other drinks, including fruit juices, soda, coffee and tea, will reduce the effect of Ibandrocare.
Take your Ibandrocare tablet while sitting or standing upright.
Do not lie down for 30 minutes after taking the medicine.
It is important to stay upright, for example. sitting, standing or walking around, for at least 30 minutes after swallowing your tablet. It is also very important to stay upright until after you have eaten your first food of the day. This will help make sure the tablet reaches your stomach quickly and helps avoid irritation to your esophagus.
Do not chew or suck the tablet.
While under treatment with this medicine, be sure to eat foods rich in calcium and vitamin D, such as dairy products.
Take this medicine separately from calcium supplements.
Do not hold this medicine in your mouth longer than the time needed to swallow it.
Failing to follow the instructions for taking this medicine may increase the risk of injury to your esophagus.
If you have accidentally taken a higher dose, or if a child has accidentally swallowed some medicine, go immediately to a hospital emergency room and bring the medicine package with you. If you or somebody else has accidentally taken a large number of tablets, drink a full glass of milk or take antacids. Do this even If there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you forget to take the medicine at the scheduled time and the time remaining until your next monthly dose is longer than 7 days – take a tablet the next morning.
If you forget to take the medicine at the scheduled time and the time remaining until your next monthly dose is 7 days or less – do not take this dose. You must wait and take a tablet on the day of the month you chose to take your monthly treatment.
Persist the treatment as recommended by your physician.
If you are not sure what you should do, consult your physician or pharmacist. If you have trouble remembering to take your medicine, consult your pharmacist.

How long you should take the medicine

Continue taking Ibandrocare for as long as your physician recommends it.
Do not stop treatment with this medicine without consulting your physician or pharmacist.
Do not take medicines in the dark! Check the label and the dose each time you take the medicine. Wear glasses if you need them.
If you have any further questions regarding the use of this medicine, consult your physician or pharmacist.

Recommendations for Calcium and Vitamin D Supplementation:

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

Use in Specific Populations:

Ibandrocare is not recommended for use in patients with severe renal Impairment (creatinine clearance of <30 ml/min).
No dose adjustment is necessary for patients with mild or moderate renal impairment.
No dose adjustment is necessary for the elderly, or for patients with hepatic Impairment.

Side effects

Like all medicines, Ibandrocare may cause side effects in some users. Do not be alarmed by this list of side effects. You may not experience any of them. Tell your physician or pharmacist as soon as possible if you do not feel well while you are taking Ibandrocare.

Stop treatment and immediately see a physician or go to a hospital emergency room if you notice:

Severe skin reactions that can include blistering of the skin.
Symptoms of severe allergic reaction, such as:

1. swelling of the face, lips, mouth, throat or tongue.
2. difficulty swallowing.
3. hives and difficulty breathing.

These side effects could be serious. You may need urgent medical attention.

Stop treatment and refer immediately to the physician if you notice:

Rare side effects:

Difficulty or pain in swallowing.
Chest pain.
New or worsening heartburn. These side effects may be due to irritation or ulcers in the esophagus. They may get worse if you continue taking the tablets.

Refer immediately to the physician if you notice:

Rare side effects

Skin irritation or rash.
Eye inflammation usually accompanied by pain, red eyes and sensitivity to light, blurred vision.
Jaw or teeth problems, associated with delayed healing and/or infection, usually following tooth extraction or an invasive dental procedure.

Unusual fracture of the thigh bone, particularly in patients on long-term treatment for osteoporosis, may occur rarely. Contact your physician if you experience pain, weakness or discomfort in the thigh, hip or groin area as these signs may indicate a fracture of the thigh bone.

Additional side effects

Tell your physician or pharmacist if you notice any of the following:

Very common side effects:

Gastrointestinal problems such as: indigestion, abdominal pain or discomfort, heartburn, diarrhea, bloating, nausea and constipation, feeling of fullness.
Pain, including back and joint pain.

Side effects reported during marketing (unknown frequency):

Hypersensitivity reactions.
Digestive tract side effects: effects related to irritation of the upper digestive tract, such as inflammation of the esophagus, ulcers in the esophagus or stomach.
Muscle and bone pain.
Eye inflammations.
Necrosis of the jaw bone.
Lung problems.

If you experience a side effect, if any side effect gets worse, or if you experience a side effect not mentioned in this leaflet, consult your physician.

Ibandrocare – Information Leaflet

	Ibandrocare tablets – English Information Leaflet.
	Ibandrocare tablets – Simplified Arabic Information from Pharmacia group.

Ibandrocare- Product Information

Produced by: PHARMACARE – Egypt.
ATC code: M05BA06 / ibandronic acid .

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