Download sep_osteobon 70mg

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.
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
OSTEOBON-70
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking
this medicine.
z Keep this leaflet, you may need to read it again.
z If you have further questions please ask your doctor or your
pharmacist.
z 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.
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.
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:
ƒ Follow a healthy balanced diet:
Your doctor may advise on diet modifications or whether it is
necessary to take any dietary supplements.
ƒ Avoid excessive alcohol:
Alcohol increases the risk for osteoporosis.
ƒ Stop smoking:
Smoking appears to increase the rate of bone loss and,
therefore, the risk of osteoporosis.
ƒ 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:
ƒ Are hypersensitive (allergic) to alendronate or any of the other
ingredients of OSTEOBON-70.
ƒ Have severe kidney problems.
ƒ Have stomach, intestinal or digestive problems associated
with dyspepsia or heartburn, including inflammation of the
stomach lining and/or ulcers.
ƒ Have disorders of the oesophagus (the tube that connects
your mouth with your stomach), including difficulty in
swallowing, narrowing of the oesophagus and ulcers.
ƒ Have been told by your doctor that you have low blood calcium
or vitamin D deficiency.
ƒ 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:
ƒ 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.
ƒ 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.
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:
ƒ Should you develop chest pain, new or worsening heartburn,
or difficult or painful swallowing, stop taking OSTEOBON70 and contact your doctor.
ƒ Always take OSTEOBON-70 exactly as your doctor has
instructed you. You should check with your doctor or
pharmacist if you are unsure.
ƒ 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.
ƒ 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
Can you drive or operate machinery while taking OSTEOBON70?
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 OSTEOBON70 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.
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.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
The following adverse reactions have been reported with
Size: 250 x 350 mm
Pharmacode: 48_mini
CMYK
PANTONE 1225 C
D:\Patil\Export\Medpro (S.A.)\8213 D Osteobon 70.p65
Dt.: 16-09-05
8213 D
SCHEDULING STATUS: S3