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Logo OSTEOBON-70 Tablets

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

OSTEOBON-70 Tablets

COMPOSITION:
Each OSTEOBON-70 tablet contains
alendronate sodium trihydrate equivalent to 70 mg of alendronic acid.

PHARMACOLOGICAL CLASSIFICATION:
A 3.2. Connective tissue medicines, non-hormonal preparations.

PHARMACOLOGICAL ACTION:
Alendronate is an aminobisphosphonate, which is a synthetic analogue of pyrophosphate. Subsequent to binding to the hydroxyapatite found in bone, alendronate acts as a specific inhibitor of osteoclast-mediated bone resorption. Alendronate localises preferentially at sites of bone resorption and, more specifically, under osteoclasts. Alendronate has no direct effect on bone formation but definitely inhibits osteoclastic bone resorption. Bone formation is also reduced indirectly as a result of the coupling of bone formation and bone resorption, however, this is to a lesser extent than resorption. The overall effect is a progressive gain in bone mass. Alendronate is incorporated into the matrix of the new bone that is formed. Here it is pharmacologically inactive.
Pharmacokinetics:
Absorption:
The mean oral bioavailability in women is 0.57% for the 70 mg tablet when administered after fasting overnight and two hours before breakfast.
Bioavailability is decreased by 40% when alendronate is given either 30 minutes or one hour before breakfast, when compared to taking the tablets two hours before eating.
Whether alendronate is administered up to two hours after or with a standardised breakfast, the bioavailability in both instances is negligible.
When alendronate is taken with coffee or citrus juice, bioavailability is reduced by 60%.
Distribution:
Alendronate is transiently distributed to soft tissue and thereafter rapidly redistributed to bone or excreted in the urine. The volume of distribution is at least 28 L in humans.
Protein binding:
Approximately 78% in human plasma.
Elimination:
Following a single intravenous dose of 10 mg alendronate, the renal clearance is 71 mL per minute. The systemic clearance is approximately 200 mL/min. After 6 hours the plasma concentrations fall by more than 95%. The terminal half-life in humans is estimated to be more than 10 years, which reflects the release of alendronate from the skeleton. There is no evidence of alendronate metabolism in humans.

INDICATIONS:
OSTEOBON-70
is indicated for the treatment of postmenopausal osteoporosis in women to reduce the risk of fractures, including fractures of the spine (vertebral compression fractures) and hip.

CONTRA-INDICATIONS:
Hypersensitivity to alendronate or any other components of the formulation.
Severe renal function impairment when creatinine clearance is less than 35 mL/minute.
The risk factor should be considered when gastrointestinal problems, such as duodenitis, dysphagia, gastritis, ulcers or symptomatic oesophageal diseases, are present.
Oesophageal abnormalities, such as stricture or achalasia, which delay oesophageal emptying.
As alendronate may exacerbate hypocalcaemia or vitamin D deficiency, these conditions should be corrected before OSTEOBON-70 is administered.
The inability to stand or sit upright for 30 minutes after taking the medicine.
Paediatric age group: Safety and efficacy have not been established.

WARNINGS:
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates, including OSTEOBON-70, in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene).
While on OSTEOBON-70 treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw. Clinical judgement of the treating doctor should guide the management plan of each patient based on individual benefit/risk assessment.

INTERACTIONS:
Other oral medications, such as calcium supplements and antacids, will interfere with the absorption of OSTEOBON-70. Patients are advised to wait at least 30 minutes after OSTEOBON-70 before taking any other oral medication.
No adverse experiences attributable to the concomitant use of alendronate and oestrogen (intravaginal, transdermal, or oral) in postmenopausal women have been identified.

PREGNANCY AND LACTATION:
The safety of OSTEOBON-70 has not been established in pregnancy or lactation.

DOSAGE AND DIRECTIONS FOR USE:
It is important to take OSTEOBON-70 only as directed.
The recommended dosage is one OSTEOBON-70 tablet (70 mg alendronic acid) once weekly, taken by mouth with a glass of plain water, at least 30 minutes before any food, beverages or other medication is taken.
It is important to take OSTEOBON-70 with plain water only, as other beverages, including mineral water, are likely to reduce the absorption of alendronic acid.
All patients should take calcium and vitamin D supplements if their diet is inadequate. These should be taken at least 30 minutes after taking alendronic acid.
Remain in an upright position for 30 minutes after taking OSTEOBON-70 tablets.
To reduce the potential for oesophageal irritation and to ensure delivery to the stomach, it is important that OSTEOBON-70 is swallowed with a full glass of water and only upon arising for the day. Furthermore, it is important not to lie down for at least 30 minutes after taking OSTEOBON-70 and not until taking in the first food of the day. OSTEOBON-70 should not be taken before getting up for the day or at bedtime. The risk of oesophageal adverse experiences is increased if these instructions are not followed (see “Special Precautions”).
Elderly:
No dosage adjustment is necessary.
Renal impairment:
Patients with mild to moderate renal insufficiency (creatinine clearance 35 to 60 mL/min) do not require dosage adjustment (see “CONTRA-INDICATIONS”).
Missed dose:
Do not take the missed dose later in the day. Resume the usual schedule the next morning. Never take two tablets on the same day. Resume taking one tablet once weekly, on your chosen day according to the original schedule.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
The following adverse reactions have been reported with alendronate:
Nervous system disorders:
Frequently: Headache.
Eye disorders:
Less frequently: Uveitis.
Gastrointestinal disorders:
Frequently: Acid regurgitation, nausea, vomiting, oesophageal ulcer*, dysphagia*, oesophagitis*, oesophageal erosions*, dyspepsia, abdominal pain, abdominal distention, diarrhoea, flatulence, constipation, and melaena.
Less frequently: Oropharyngeal ulceration*, oesophageal stricture*, gastritis, gastric and duodenal ulcers, some severe and complicated, although a causal relationship has not been established. (*See “DOSAGE AND DIRECTIONS FOR USE” and “Special Precautions”).
Skin and subcutaneous tissue disorders:
Less frequently: Erythema and rash (occasionally with photosensitivity).
Musculoskeletal, connective tissue and bone disorders:
Frequently: Musculoskeletal (muscle, bone or joint) pain.
Less frequently: Osteonecrosis of the jaw (see “WARNINGS”).
General disorders:
Less frequently: Hypersensitivity reactions, including angioedema and urticaria.
Of the above adverse reactions, abdominal pain was reported most frequently and the prevalence of the other adverse reactions did not exceed 4.1%.
Laboratory test findings: Asymptomatic, mild and transient decreases in serum calcium and phosphate have been observed.

Special Precautions:
Hypocalcaemia and vitamin D deficiency should be corrected before starting OSTEOBON-70 therapy, as alendronic acid may exacerbate these conditions.
The risk benefit should be considered in patients suffering from upper gastrointestinal diseases, such as dysphagia, duodenitis, gastritis, ulcers or symptomatic oesophageal conditions, because of possible irritant effects of OSTEOBON-70 on the upper gastrointestinal mucosa and a potential for worsening of the underlying disease.
Adverse oesophageal experiences, including oesophagitis, oesophageal erosions and oesophageal ulcers, infrequently resulting in an oesophageal stricture, have previously been reported in patients receiving treatment with alendronate. In some instances these have been severe, requiring hospitalisation. It is therefore important that doctors are alert to any symptoms or signs signalling a possible oesophageal reaction. If patients develop retrosternal pain, dysphagia or odynophagia, the patients should be instructed to discontinue OSTEOBON-70 and consult their doctor.
It is extremely important that the full dosing instructions are made available to and clearly understood by the patient (see “DOSAGE AND DIRECTIONS FOR USE”), as the risk of severe oesophageal adverse experiences have been shown to be greater in patients who fail to swallow OSTEOBON-70 with a full glass of water, and/ or who lie down after taking OSTEOBON-70 and/or in patients who continue to take OSTEOBON-70 after experiencing symptoms suggestive of oesophageal irritation.
To reduce the potential for oesophageal irritation and to ensure delivery to the stomach, it is important that OSTEOBON-70 is swallowed with a full glass of water and only upon arising for the day. Furthermore, it is important not to lie down for at least 30 minutes after taking OSTEOBON-70 and not until taking in the first food of the day.
Patients should also not suck or chew the tablet because of the potential for oropharyngeal ulceration. Patients should get specific instructions not to take OSTEOBON-70 before getting up for the day or at bedtime. Patients should also be informed that the risk of oesophageal problems may increase if these instructions are not followed. They should be instructed that if they develop symptoms suggestive of oesophageal disease (such as new or worsening heartburn, retrosternal pain, or difficulty or pain upon swallowing), they should immediately discontinue taking OSTEOBON-70 and consult their doctor.
It is important to consider that osteoporosis may be due to causes other than aging, oestrogen deficiency, and glucocorticoid use.
Small, asymptomatic decreases in serum phosphate and calcium may occur, especially in patients receiving glucocorticoids, in whom calcium absorption may be decreased, due to the positive effects of OSTEOBON-70 to increasing bone mineral.
In patients receiving glucocorticoids, it is especially important to ensure adequate calcium and vitamin D intake.
Use in the Elderly: There is no age-related differences in the efficacy or safety profiles of alendronate.
Effects on ability to drive and use machines: Data do not suggest that OSTEOBON-70 affects the ability to drive or use machines.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Oral overdosage may result in hypophosphataemia, hypocalcaemia, and upper gastrointestinal adverse events, including oesophagitis, heartburn, upset stomach, gastritis, or ulcer.
The administration of milk and antacids may be of benefit.
Because of the risk of oesophageal irritation, vomiting should not be induced. Keep the patient in an upright position.

IDENTIFICATION:
White, capsule-shaped, biconvex tablets, plain on one side and ‘3173’debossed on the other side.

PRESENTATION:
OSTEOBON-70
tablets are packed in a thermoformable PVC and aluminium foil blister strip of 4 tablets.

STORAGE INSTRUCTIONS:
Store in a dry place below 25°C.
Keep the blisters in the outer carton until required for use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
A39/3.2/0396

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
CIPLA MEDPRO (PTY) LTD
.
Rosen Heights, Pasita Street
Rosen Park, Bellville, 7530, RSA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 2005

© 2005 Cipla Medpro (Pty) Ltd
http://www.cipla.co.za/wp-content/uploads/2013/10/sep_osteobon-70mg.pdf

OSTEOBON-70
PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet, you may need to read it again.
• If you have further questions please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.
SCHEDULING STATUS: S3
PROPRIETARY NAME AND DOSAGE FORM:
OSTEOBON-70 Tablets.
Alendronate or alendronic acid is the active substance.

WHAT OSTEOBON-70 CONTAINS:
The active substance in OSTEOBON-70 is alendronate sodium trihydrate equivalent to 70 mg alendronic acid (alendronate).
The other inactive ingredients are magnesium stearate, maize starch, mannitol, microcrystalline cellulose and sodium starch glycolate.
OSTEOBON-70 is available as a 70 mg tablet.

WHAT OSTEOBON-70 IS USED FOR:
OSTEOBON-70 belongs to a class of medicines called aminobisphosphonates.
OSTEOBON-70 is not a hormone. OSTEOBON-70 has been prescribed by your doctor to treat a condition known as osteoporosis. When used for the treatment of osteoporosis, OSTEOBON-70 rebuilds bone and reduces the risk of developing fractures.

What is osteoporosis and why should this condition be treated?
Osteoporosis is a condition characterised by weakening and thinning of the bones which commonly occurs in women after menopause.
Earlier onset of menopause increases the risk of osteoporosis. In the beginning osteoporosis generally does not present with any symptoms, however, if it is not treated, osteoporosis can lead to fractures of bones. Generally fractures are painful and are easily diagnosed by a doctor, but fractures of the spine may not be noticed until they cause loss of height. Fractures due to osteoporosis is characterised by the fact that they often occur during normal, everyday activities, such as lifting objects, bumping a leg against a table, or other minor injuries that would not routinely cause fractures of bones. These fractures due to osteoporosis usually occur at the hip or spine where they not only cause considerable pain, but also deformities and, more importantly, disability, including loss of mobility and bedridden patients needing constant care.

Additional measures to prevent or treat osteoporosis:
In addition to OSTEOBON-70 your doctor may recommend one or more of the following lifestyle adjustments:
Follow a healthy balanced diet:
  Your doctor may advise on diet modifications or whether it is necessary to take any dietary supplements.
Avoid excessive alcohol:
  Alcohol increases the risk for osteoporosis.
Stop smoking:
  Smoking appears to increase the rate of bone loss and, therefore, the risk of osteoporosis.
Exercise regularly:
  Exercise promotes strong and healthy bones, but it is important to consult your doctor before you start any exercise program.

BEFORE YOU TAKE OSTEOBON-70:
Do not take OSTEOBON-70 if you:
Are hypersensitive (allergic) to alendronate or any of the other ingredients of OSTEOBON-70.
Have severe kidney problems.
Have stomach, intestinal or digestive problems associated with dyspepsia or heartburn, including inflammation of the stomach lining and/or ulcers.
Have disorders of the oesophagus (the tube that connects your mouth with your stomach), including difficulty in swallowing, narrowing of the oesophagus and ulcers.
Have been told by your doctor that you have low blood calcium or vitamin D deficiency.
If you are not able to sit or stand upright for at least 30 minutes after taking OSTEOBON-70.
Take special care with OSTEOBON-70:
If you require a serious dental procedure or invasive dental surgery. Should you have cancer or are on cancer treatment, or on steroids, or have poor oral hygiene, you should avoid serious dental procedures whilst on OSTEOBON-70. Before any dental procedure you should advise your dentist to contact your doctor about your OSTEOBON-70 treatment.
You should stop taking OSTEOBON-70 and consult your doctor if you develop chest pain, difficulty with swallowing or painful swallowing, or worsening heartburn.
Taking OSTEOBON-70 with food and drink:
See ‘HOW TO TAKE OSTEOBON-70’.

Use in pregnancy and breast-feeding:
Do not take OSTEOBON-70 whilst you are pregnant or breastfeeding. If you are pregnant or breast-feeding your baby while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

Use in children:
OSTEOBON-70
is not indicated for children.

Use in elderly:
OSTEOBON-70
is as effective and just as well tolerated by older and younger patients.

Can you drive or operate machinery while taking OSTEOBON-70?
OSTEOBON-70
should not affect your ability to operate machinery or drive.

Taking other medicines with OSTEOBON-70:
See ‘HOW TO TAKE OSTEOBON-70’.
Oral medicines, including calcium supplements and antacids, will interfere with the absorption (and affect the effectiveness) of OSTEOBON-70. Wait at least 30 minutes after OSTEOBON-70 before taking any other oral medicines.
If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of OSTEOBON-70 with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional, for advice.

HOW TO TAKE OSTEOBON-70:
These are the important things you must do to help make sure you will benefit from OSTEOBON-70.
[The steps are illustrated here please consult the original pack for details. Ed]
STEP 1
As OSTEOBON-70 is only taken once weekly, you must pick a day of the week that suits your schedule best. Take one OSTEOBON-70 tablet on your chosen day every week immediately after you get up. Do not take OSTEOBON-70 at bedtime or before arising for the day.
STEP 2
After getting up in the morning, swallow one OSTEOBON-70 tablet with a full glass (200 –240 mL) of plain water, on an empty stomach.
Do not suck or chew the OSTEOBON-70 tablet.
STEP 3
Do not take the tablet with coffee or tea, mineral water, juice or any beverage other than plain water, since these decrease the amount of OSTEOBON-70 absorbed by the body.
STEP 4
Do not lie down after swallowing your OSTEOBON-70 tablet. Remain upright (sitting, standing or walking) for at least 30 minutes and until you have eaten your first food of the day.
STEP 5
Wait at least 30 minutes after swallowing your OSTEOBON-70 tablet before taking your first beverage, food or other medicines of the day. It is important to take OSTEOBON-70 on an empty stomach.

By following steps 1 –5 you will ensure maximum absorption of your OSTEOBON-70 tablet, and help avoid irritation of your oesophagus.

Other important points to remember while taking OSTEOBON-70:
Should you develop chest pain, new or worsening heartburn, or difficult or painful swallowing, stop taking OSTEOBON- 70 and contact your doctor.
Always take OSTEOBON-70 exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
For full benefit of this medicine it is important that you take OSTEOBON-70 for as long as your doctor prescribes it. You can only treat your osteoporosis if you continue to take OSTEOBON-70.
It is important to tell your doctor about all medicines that you are taking or plan to take, including those medicines obtained without a prescription.
If you take more OSTEOBON-70 than you should:
In the event of overdosage (if you take too many tablets), drink a full glass of milk and contact your doctor or pharmacist immediately. If neither is available, seek help at the nearest hospital or poison control centre. Do not induce vomiting. Do not lie down.
If you forget to take OSTEOBON-70:
Do not take the missed dose later in the day. Resume the usual routine the next morning. Never take two tablets on the same day. Return to taking one tablet once a week on the day that you originally chose according to your schedule.

POSSIBLE SIDE-EFFECTS:
OSTEOBON-70 can have side-effects. Some patients may experience digestive problems, such as nausea, vomiting, heartburn, ulcers of the oesophagus, difficulty in swallowing, inflammation of the oesophagus, stomach pain and discomfort, abdominal distension, diarrhoea, flatulence, constipation and bloody or black stools.
Headaches, bone, muscle or joint pain have also been experienced.
Other less frequent side-effects that have been reported include ulcers of the mouth and throat, narrowing of the oesophagus, stomach ulcers, inflammation of the eye, redness of the skin and rash, pain in the jaw and allergic reactions, such as hives or swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing. Mouth ulcers have been reported when the tablet was chewed or dissolved in the mouth.
Not all side-effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

STORAGE AND DISPOSING OF OSTEOBON-70:
Keep all medicines out of the reach and sight of children.
Store OSTEOBON-70 in a dry place below 25°C.
Do not use OSTEOBON-70 after the month and year following the expiry date stated on the packaging material.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems, for example toilets.
Keep the blisters in the outer carton until required for use.

PRESENTATION OF OSTEOBON-70:
OSTEOBON-70 tablets are supplied as a blister strip of 4 tablets.

IDENTIFICATION OF OSTEOBON-70:
White, capsule-shaped, biconvex tablets plain on one side and ‘3173’debossed on the other side.

REGISTRATION NUMBER:
A39/3.2/0396

NAME AND ADDRESS OF REGISTRATION HOLDER:
CIPLA MEDPRO (PTY) LTD
Rosen Heights, Pasita Street
Rosen Park, Bellville, 7530 RSA

DATE OF PUBLICATION OF THIS PATIENT LEAFLET:
September 2005

© CIPLA MEDPRO (PTY) LTD

New addition to this site: November 2016
Source: Pharmaceutical Industry
http://www.cipla.co.za/wp-content/uploads/2013/10/sep_osteobon-70mg.pdf

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