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

Treatment of Osteoporosis in Postmenopausal Women For the treatment of osteoporosis, Bonprove 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. Bonprove works by slowing down the process of old bone being removed. This process allows the bone-forming cells time to rebuild normal bone. Bonprove also helps to rebuild bone mass. This creates stronger bone which is less likely to fracture.

Composition

Each tablet contains: Active ingredient:

Bonprove 2.5 mg tablets: lbandronate sodium monohydrate 2.81 mg Eq. to lbandronic acid 2.5 mg.
Bonprove 150 mg tablets: lbandronate sodium monohydrate 168.8 mg Eq. to lbandronic acid 150 mg.
Inactive ingredients: Microcrystalline cellulose, lactose monohydrate, crospovidone, anhydrous colloidal silica, polyvinylpyrrolidone, stearic acid.

PHARMACEUTICAL FORM: Film coated tablets.

Indications

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

Dosage

The dose of Bonprove is either one 150 mg tablet taken once monthly on the same date each month or one 2.5 mg tablet taken once daily.

Dosing Instructions

To maximize absorption and clinical benefit, Bonprove should be taken at least 80 minutes before the first food or drink (other than water) of the day Or before taking any Oral medication or supplementation, including calcium, antacids. or vitamins.
To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, Bonprove tablets should be swallowed whole with a full glass of plain water while the patient is standing or siting in an upright position.
Patient should not lie down for 60 minutes after taking Bonprove.
Patients should not eat, drink anything except water, or take other medications for at least 60 minutes after taking Bonprove.
Plain water is the only drink that should be taken with Bonprove. Note that some mineral waters may have a higher concentration of calcium and therefore should not be used.
Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration.
The Bonprove 150 mg tablet should be taken on the same dale each month (i.e., the patient’s Bonprove day).
The patient must not take two 150 mg tablets within Mo same week.
If the once-monthly doss is missed, and the patients next scheduled Bonprove day is more than 7 days away, the patient should be Instructed to take one Bonprove 150 mg tablet in the morning following the date that it is remembered. The patient should than return to taking one Bonprove 150 mg tablet eveny month in the morning of their chosen day, according to their original schedule.
If the once-monthty dose is missed, and the patent’s next scheduled Bonprove day is only 1 to 7 days away, the patient must wait until the subsequent month’s scheduled Bonprove day to take their tablet. The patient should then return 50 taking one Bonprove 150 mg tablet every month in the morning of their chosen day, according to their original schedule.

Recommendations for Calcium and Vitamin D Supplementation:

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

Use in Specific Populations:

Bonprove 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, Bonprove 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 Bonprove.

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.

Bonprove – Information Leaflet

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

Bonprove- Product Information

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

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