Download Dosage and route of administration The recommended

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Leserichtung
80 mm von unten
Code: 8 mm breit
(mind. 6 mm)
ACTONEL® Once-a-Week 35 mg, film-coated tablets
Composition
Active ingredient: risedronate sodium.
One oval light orange film-coated tablet contains 35 mg
risedronate sodium equivalent to 32.5 mg risedronic acid.
Excipients: Tablet core: lactose monohydrate, microcrystalline
cellulose, crospovidone, magnesium stearate.
Film-coating: ferric oxide yellow E172, ferric oxide red E172,
hypromellose, macrogol 400, hydroxypropyl cellulose,
macrogol 8000, silicon dioxide, titanium dioxide E171.
Pharmacological properties
Pharmaco-therapeutic class: Drug for treatment of bone diseases
(M05 BA: bisphosphonates).
ACTONEL belongs to a group of non-hormonal medicines called
bisphosphonates, which are used to treat bone diseases. ACTONEL
works directly on the skeleton and therefore makes it less probable
that your bones might break.
ACTONEL has an affinity for hydroxyapatite crystals in bone and
acts as an antiresorptive agent. At the cellular level, ACTONEL
inhibits osteoclasts. The osteoclasts adhere normally to the bone
surface, but show evidence of reduced active resorption (e.g., lack
of ruffled border). Histomorphometry in rats, dogs and minipigs
showed that ACTONEL treatment reduces bone turnover (activation
frequency, i.e., the rate at which bone remodeling sites are
activated) and bone resorption at remodeling sites. During
pharmacodynamic and clinical studies, decreases in biochemical
markers of bone turnover were observed within 1 month and
reached a maximum in 3–6 months.
Pharmacokinetic properties
Absorption: Absorption after an oral dose is relatively rapid
(tmax ~1 hour) and is independent of dose over the range studied
(2.5 to 30 mg). Mean oral bioavailability of the tablet is 0.63% and
is decreased when risedronate sodium is administered with food.
Bioavailability was similar in men and women.
Distribution: The mean steady state volume of distribution is
6.3 l/kg in humans. Plasma protein binding is about 24%.
Metabolism: There is no evidence of systemic metabolism of
risedronate sodium.
Elimination: Approximately half of the absorbed dose is excreted in
urine within 24 hours. Mean renal clearance is 105 ml/min and
mean total clearance is 122 ml/min, with the difference probably
attributed to clearance due to adsorption to bone. The renal clearance is not concentration dependent, and there is a linear relationship between renal clearance and creatinine clearance. Unabsorbed drug is eliminated unchanged in faeces.
When should this drug be used (Therapeutic indications)
ACTONEL Once-a-Week 35 mg is indicated for:
● Treatment of postmenopausal osteoporosis,
● Prevention of osteoporosis in postmenopausal women with
increased risk of osteoporosis.
How should this drug be used
Strictly follow the recommended dosage unless directed otherwise by
the physician.
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25.11.2002 vOe/Kan
11.12.02 vOe/Kan
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Actonel SCV 2
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Leserichtung
80 mm von oben
Code: 8 mm breit
(mind. 6 mm)
35mg
(risedronate sodium)
95010358
®
Dosage and route of administration
The recommended dose in adults is one 35 mg tablet once weekly
by oral route.
Method of administration
The tablet should be taken on the same day each week. Food and
drinks may interfere with the absorption of ACTONEL Once-a-Week
35 mg. Therefore, it is very important that you do NOT take your
ACTONEL Once-a-Week 35 mg tablet with food, other medicinal
product or drinks (other than water).
Take ONE tablet at least 30 minutes before the first food, other
medicinal product or drink other than water of the day.
The tablet must be swallowed whole and not sucked or chewed.
To aid delivery of the tablet to the stomach ACTONEL Once-a-Week
35 mg is to be taken while in an upright position with a glass of
plain water (≥ 120 ml). Patients should not lie down for 30 minutes
after taking the tablet.
If you miss a dose of ACTONEL Once-a-Week 35 mg tablet, you
should take one tablet on the morning after you remember and
return to taking one ACTONEL Once-a-Week 35 mg tablet as
originally scheduled on your chosen day. Never take two tablets
on the same day.
It is important that your diet includes products containing calcium
and vitamin D (for example, dairy products). Supplemental calcium
and vitamin D should be considered if the dietary intake is
inadequate.
When should this drug not be used (Contraindications)
ACTONEL Once-a-Week 35 mg is contraindicated in the following
cases:
● Known hypersensitivity to risedronate sodium or to any of the
excipients,
● Hypocalcemia (decrease in blood calcium levels)
(see Warnings and precautions),
● Pregnancy and lactation,
● Severe renal impairment (creatinine clearance < 30 ml/min).
Warnings and precautions
Food and drinks (other than plain water) and products containing
calcium, magnesium, iron or aluminium may interfere with the
absorption of ACTONEL Once-A-Week 35 mg and should not be
taken at the same time. Therefore, ACTONEL Once-a-Week 35 mg
should be taken at least 30 minutes before the first food, other
medicinal product or drink of the day. Some bisphosphonates have
been associated with oesophagitis and oesophageal ulcerations.
Therefore, patients should pay attention to the dosing instructions
(see Method of administration). The tablet must be swallowed
whole and not sucked or chewed. To aid delivery of the tablet to
the stomach ACTONEL Once-a-Week 35 mg is to be taken while in
an upright position with a glass of plain water (≥ 120 ml). Patients
should not lie down for 30 minutes after taking the tablet. In
patients who have a history of oesophageal disorders which delay
oesophageal transit or emptying (e.g. stricture or achalasia), or who
are unable to stay in the upright position for at least 30 minutes
after taking the tablet, ACTONEL Once-a-Week 35 mg should be
used with special caution because of limited clinical experience in
these patients. Prescribers should emphasise the importance of the
dosing instructions to these patients.
Hypocalcemia should be treated before starting ACTONEL
Once-a-Week 35 mg therapy. Other disturbances of bone and mineral metabolism (e.g. parathyroid dysfunction, hypovitaminosis D)
should be treated at the time of starting ACTONEL Once-a-Week
35 mg therapy. The evidence to support efficacy of bisphosphonates including ACTONEL Once-a-Week 35 mg in very elderly
women (> 80 years) is limited.
In case of doubt you should consult your physician or pharmacist.
Special populations
Children
Safety and efficacy of ACTONEL Once-a-Week 35 mg have not been
established in children and adolescents.
Elderly
No dosage adjustment is necessary in the elderly.
Interactions
In order to avoid possible interactions with other medicines, inform
your physician or pharmacist about any other current treatment.
The majority of the undesirable effects in clinical studies were mild
to moderate and usually did not require cessation of therapy. The
most common undesirable effects are pain in your bones, muscles
and joints, dyspepsia (gastric discomfort), nausea and headache.
In a small number of patients, the following uncommon undesirable effects have been reported: gastritis (inflammation of the
stomach), duodenitis (inflammation of the small intestine), glossitis
(inflammation of the tongue) and dysphagia (difficulty in
swallowing). Iritis (inflammation of the coloured part of the eye)
was uncommonly reported in clinical trials. Early, transient,
asymptomatic and mild decreases in serum calcium and phosphate levels have been observed in some patients. Rarely
abnormal liver tests have been reported.
Expiry date
Respect the expiry date indicated on the outer packaging.
Storage
Do not store above 30°C.
Keep out of the reach of children.
Presentation
PVC/aluminium foil blister cards of 1, 2, 4 and 12 tablets in
a cardboard carton.
Manufactured by:
OSG Norwich Pharmaceuticals, Inc.
6826 State Highway route 12,
North Norwich, NY, 13814 USA.
Packed by:
Procter & Gamble Pharmaceuticals – Germany GmbH
Dr.-Otto-Röhm-Straße 2–4
64331 Weiterstadt, Germany
Aventis Pharma AG
65926 Frankfurt am Main, Germany
Leserichtung
80 mm von oben
Code: 8 mm breit
(mind. 6 mm)
No formal interaction studies have been performed, however no
clinically relevant interactions with other medicinal products were
found during clinical trials. If considered appropriate ACTONEL
Once-a-Week 35 mg may be used concomitantly with oestrogen
supplementation. Concomitant ingestion of products containing
calcium, magnesium, iron and aluminium may interfere with the
absorption of ACTONEL Once-a-Week 35 mg. These products should
be taken at a different time of day to your ACTONEL Once-a-Week
35 mg dose (see Warnings and precautions).
ACTONEL Once-a-Week 35 mg is not systemically metabolised,
does not induce cytochrome P450 enzymes, and has low protein
binding.
Pregnancy and lactation
ACTONEL must not be used during pregnancy or by breast-feeding
women.
Drivers and machinery operators
No effects on ability to drive and use machines have been
observed with ACTONEL Once-a-Week 35 mg.
Overdosage
In case of overdosage or accidental intoxication you should drink
a full glass of milk and immediately contact your physician or
a hospital.
No specific information is available on the treatment of acute
overdose with ACTONEL Once-a-Week 35 mg. Decreases in serum
calcium following substantial overdose may be expected. Signs and
symptoms of hypocalcemia may also occur in some of these
patients. Milk or antacids containing magnesium, calcium or
aluminium should be given to bind risedronate sodium and reduce
absorption of the drug. In cases of substantial overdose, gastric
lavage may be considered to remove unabsorbed drug.
Undesirable effects
Like any active product, this drug may induce in some patients,
undesirable effect to a greater or lesser degree. Do not hesitate to
ask your physician or pharmacist for advice and to report any
undesirable effect not mentioned in this leaflet.
Date of issue: November 2002.
95010358
Leserichtung
80 mm von unten
Code: 8 mm breit
(mind. 6 mm)
Gebrauchsinformation: Seite 2
SAP-Nr.:
Land:
Erstellversion:
Erstellt:
Geändert am:
95010358
Asien
2
25.11.2002 vOe/Kan
11.12.02 vOe/Kan
Abmessung:
Logoversion:
Kleinster verwendeter
Schriftgrad (X pt):
Seiten:
Farben:
200 x 290 mm
Actonel SCV 2
❑ Techn. Zeichnung
(Größe, Perforation, Etikett)
❑ Farben
❑ Pharma Code (Laetus), Strichlänge,
Plazierung, Typ und Nummer
❑ Warencode (Typ und Nummer)
❑ Gestaltungsrichtlinien
❑ Index und Erstellversion
8,3 pt
2
PMS Reflex Blue ■
Word by word checked and approved by local regulatory
Datum/Date: ............................ Unterschrift/Sign: .....................................................