Generic Risedronate Tablets (Gemfos)

Gemfos (Generic Risedronate Sodium tablets) is a bisphosphonate used for the treatment and prevention of postmenopausal osteoporosis, treatment to increase bone mass in men with osteoporosis, treatment and prevention of glucocorticoid-induced osteoporosis and treatment of Paget’s disease.

1. Generic Risedronate (Gemfos Tablets)
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2. Generic Risedronate (Gemfos Tablets)
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Gemfos (Generic Risedronate Sodium tablets)
is a bisphosphonate used for the treatment and
prevention of postmenopausal osteoporosis,
treatment to increase bone mass in men with
osteoporosis, treatment and prevention of
glucocorticoid-induced osteoporosis and
treatment of Paget’s disease.

3. Gemfos Tablets
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Gemfos Tablets are manufactured by
Alkem Laboratories Ltd., India.
(Website: www.alkemlabs.com)

4. Risedronate Sodium Tablets – Brand Names
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Risedronate Sodium Sodium tablets
are available as Gemfos, Actonel,
Fossical and Risofos.

5. Active Ingredient
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The active ingredient contained in Gemfos
tablets is Risedronate Sodium. Each tablet
contains 150 mg of Risedronate Sodium.

6. Chemical Structure
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The structure of Risedronate Sodium is
given below:

7. Uses of Gemfos Tablets
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Gemfos tablets are used for the treatment and
prevention of osteoporosis in postmenopausal
women.
This medicine is used for treatment of
Osteoporosis in Men to increase bone mass in
men with osteoporosis.
This medicine is also used for the treatment and
prevention of glucocorticoid-induced
osteoporosis in men and women who are either
initiating or continuing systemic glucocorticoid
treatment (daily dosage of 7.5 mg prednisone or
higher or equivalent) for chronic diseases and
for treatment of Paget’s disease of bone in men
and women.

8. Gemfos Dosage

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➢Treatment of Postmenopausal Osteoporosis: The
recommended dosage is: one 5 mg tablet orally,
taken daily or one 35 mg tablet orally, taken once
a week or one 75 mg tablet orally, taken on
two consecutive days for a total of two tablets each
month or one 150 mg tablet orally, taken once a
month.
The dosage of Gemfos tablets (Risedronate Sodium
tablets) should be taken at least 30 minutes before the
first food or drink of the day other than water. Gemfos
tablet must be swallowed while the patient is in an
upright position and with a full glass of plain water.
Patients should not lie down for 30 minutes after taking
the medication. The dosage is given below:

9. Gemfos Tablets Dosage

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➢Treatment to Increase Bone Mass in
Men with Osteoporosis: The
recommended dosage is: one 35 mg
tablet orally, taken once a week.
➢ Treatment and Prevention of
Glucocorticoid-Induced Osteoporosis: The
recommended dosage is: one 5 mg tablet
orally, taken daily
The dosage of Gemfos tablets (Risedronate
Sodium tablets) is given below:

10. Generic Risedronate Sodium Dosage

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➢Treatment of Paget’s Disease: The
recommended dosage is is 30 mg orally
once daily for 2 months. Re-treatment may
be considered (following post-treatment
observation of at least 2 months) in case
relapse occurs, or if treatment fails to
normalize serum alkaline phosphatase. For
re-treatment, the dose and duration of
therapy are the same as for initial treatment.
No data are available on more than 1 course
of re-treatment.
The dosage of Gemfos tablets (Risedronate
Sodium tablets) is given below:

11. Storage Instructions

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Gemfos (Generic Risedronate Sodium
tablets) have to be stored at controlled
room temperature i.e. from 20°C to 25°C
(68°F to 77°F) with excursions permitted
between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines
away from children and pets.

12. Gemfos Tablets Warnings

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Upper gastrointestinal irritation may occur.
Dosing instructions should be followed.
Discontinue use if new or worsening
symptoms occur.
Hypocalcemia may worsen and must be
corrected prior to use.
Osteonecrosis of the jaw has been reported
rarely.
Severe bone, joint, or muscle pain may occur.
Consider discontinuing use if severe
symptoms develop.

13. Gemfos Tablets Warnings

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Severe bone, joint, or muscle pain may
occur. Consider discontinuing use if severe
symptoms develop.
Before starting treatment in patients with
glucocorticoid-induced osteoporosis, sex
steroid hormonal status of both men and
women should be ascertained and
appropriate replacement considered.
Bisphosphonates may interfere with bone-
imaging agents.

14. Gemfos Tablets
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Contraindications
Gemfos tablets are contraindicated in
patients with a hypersensitivity to
Risedronate Sodium or any other
component of this medication.
Other contraindications include inability to
stand or sit upright for at least 30 minutes
and Hypocalcemia.

15. Gemfos Side Effects
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➢Most common side effects reported in
more than 10% of patients treated with
Risedronate Sodium tablets (Gemfos) and
with a higher frequency than placebo are:
back pain, arthralgia, abdominal pain, and
dyspepsia.
➢Hypersensitivity reactions (angioedema ,
generalized rash, bullous skin reactions), and
eye inflammation (iritis, uveitis) have been
reported rarely.

16. Risedronate Sodium Overdose
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Decreases in serum calcium and
phosphorus following substantial overdose
could be expected in some patients.
Signs and symptoms of hypocalcemia can
also occur in some of these patients.
Milk or antacids containing calcium must
be given to bind Risedronate Sodium
(Gemfos tablets) and reduce absorption
of the medicine.

17. Gemfos Overdose
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In cases of substantial overdose, gastric
lavage may be considered to remove
unabsorbed medicine.
Standard procedures that are effective for
treating hypocalcemia, including the
administration of calcium intravenously,
would be expected to restore physiologic
amounts of ionized calcium and to relieve
signs and symptoms of hypocalcemia.

18. Risedronate Sodium During Pregnancy
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Risedronate Sodium tablets (Gemfos) has been
classified by the US FDA as Pregnancy Category
C.
There are no adequate and well-controlled
studies of Risedronate tablets (Gemfos) in
pregnant women. However, there is a theoretical
risk of fetal harm, predominantly skeletal, if a
woman becomes pregnant after completing a
course of bisphosphonate therapy.
Gemfos should be used during pregnancy only if
the potential benefit justifies the potential risk to
the mother and fetus.

19. Risedronate Sodium During Nursing
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It is not known whether Risedronate (Gemfos
tablets) is excreted in human milk. Since many
medicines are excreted in human milk and
because of the potential for serious adverse
reactions in nursing infants from Gemfos tablets,
a decision should be made whether to
discontinue nursing or to discontinue the
medicine, taking into account the importance of
the medicine to the mother.

20. Gemfos Tablets
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Gemfos Tablets click here
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Gemfos (Risedronate Sodium tablets) by
Alkem Laboratories Ltd., India.