Risedronate Aurobindo

Package leaflet: Information for the user

Risedronate Aurobindo 5 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
What Risedronate Aurobindo is and what it is used for
What you need to know before taking Risedronate Aurobindo
How to take Risedronate Aurobindo
Possible side effects
How to store Risedronate Aurobindo
Contents of the pack and other information

1. What Risedronate Aurobindo is and what it is used for

What Risedronate Aurobindo is
Risedronate Aurobindo belongs to a group of non-hormonal medicines called bisphosphonates, used for the
treatment of bone diseases. It acts directly on your bones, strengthening them and thereby making them
less prone to fractures.
Bones are living tissue. Old bone is continuously removed from the skeleton and replaced by new bone.
Postmenopausal osteoporosis is a condition that occurs in women after menopause, when bones weaken,
become more fragile, and are more susceptible to fractures following falls or minor trauma.
Osteoporosis is more likely to occur in women who have reached menopause early and in patients receiving long-term steroid treatment.
The spine, hip, and wrist are the bones most prone to fracture, although fractures can occur in any bone of the body. Fractures due to osteoporosis may also cause back pain, weight loss, and a curved spine. Many patients with osteoporosis have no symptoms and may not even be aware they have it.
What Risedronate Aurobindo is used for
Treatment of osteoporosis
in postmenopausal women.
Prevention of osteoporosis
in women at increased risk of osteoporosis (including bone mass loss, early menopause, or family history of osteoporosis)
in postmenopausal women who have been treated with high-dose steroids for a long time.
Maintains or increases bone mass.

2. What you need to know before taking Risedronate Aurobindo

Do NOT take Risedronate Aurobindo
if you are allergic to sodium risedronate or to any of the other ingredients of this medicine
(listed in section 6).
if your doctor has told you that you have a condition called hypocalcemia (low levels of calcium in the
blood).
if you think you are pregnant, if you are pregnant, or if you are planning a pregnancy.
if you are breast-feeding.
if you have severe kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Risedronate Aurobindo
if you are unable to remain upright (sitting or standing) for at least 30 minutes
if you have an abnormal bone and mineral metabolism (e.g. vitamin D deficiency, parathyroid hormone
abnormalities, both of which lead to low calcium levels)
if you have had certain oesophageal disorders (the tube connecting the mouth to the stomach), e.g. if you
have experienced pain or difficulty swallowing food, or if you have previously been diagnosed with Barrett’s
oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus)
if your doctor has told you that you have an intolerance to certain sugars (e.g. lactose)
if you have or have had jaw pain, swelling or numbness, a sensation of ‘heavy jaw’ or tooth loss
if you are undergoing dental treatments or are scheduled to have dental surgery
inform your dentist that you are being treated with Risedronate Aurobindo
If any of these situations apply to you, your doctor will advise you on what to do when taking Risedronate
Aurobindo.

Children and adolescents
The use of Risedronate Aurobindo is not recommended in children under 18 years of age, as data on safety and efficacy are insufficient.

Other medicines and Risedronate Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines containing any of the following substances reduce the effect of Risedronate Aurobindo if taken
simultaneously:
calcium
magnesium
aluminium (e.g. some antacid mixtures)
iron
Take these medicines at least 30 minutes before taking Risedronate Aurobindo.

Risedronate Aurobindo with food and drinks
It is very important NOT to take Risedronate Aurobindo with food or drinks (except plain water) so that it can work properly. In particular, do not take this medicine simultaneously with dairy products (such as milk), as these contain calcium (see section 2 “Other medicines and Risedronate Aurobindo”).
Take food or drinks (except plain water) at least 30 minutes after taking Risedronate Aurobindo.

Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Do NOT take Risedronate Aurobindo if you think you may be pregnant, if you are pregnant, or if you are planning a pregnancy (see section 2, “Do NOT take Risedronate Aurobindo”). The potential risk associated with the use of sodium risedronate (the active substance in Risedronate Aurobindo) in pregnant women is unknown.
Do NOT take Risedronate Aurobindo if you are breast-feeding (see section 2, “Do NOT take Risedronate Aurobindo”).

Driving and using machines
Risedronate Aurobindo does not appear to have any effect on the ability to drive or use machinery.

Risedronate Aurobindo contains lactose
Risedronate Aurobindo contains a small amount of lactose (see section 2, Warnings and precautions). If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Risedronate Aurobindo

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is:
Take ONE tablet of Risedronate Aurobindo (5 mg of sodium risedronate) once daily.

WHEN to take Risedronate Aurobindo
It is BEST to take Risedronate Aurobindo at least 30 minutes before the first food, drink (except plain water), or other medicine of the day.
If you are unable to take your tablet at this time, take it on an empty stomach every day at the same time, in one of the following ways:
between meals: at least 2 hours after the last meal, drink (except plain water), or medicine. Do not eat or drink (except plain water) for 2 hours after taking the tablet.
OR
in the evening: at least 2 hours after the last meal, drink (except plain water), or medicine of the day. Sodium risedronate must be taken at least 30 minutes before going to bed.

HOW to take Risedronate Aurobindo
Take the tablet while in an upright position (sitting or standing) to avoid stomach irritation.
Swallow the tablet with at least one glass (120 ml) of plain water.
Swallow the tablet whole. Do not chew or suck it.
Do not lie down for at least 30 minutes after taking the tablet.
Your doctor will advise you if you need calcium or vitamin D supplements, especially if your diet does not provide enough.

If you take MORE Risedronate Aurobindo than you should
If you or someone else has accidentally taken more Risedronate Aurobindo than prescribed, drink a full glass of milk and contact your doctor immediately.

If you FORGET to take Risedronate Aurobindo
If you forget to take your tablet at your usual time, you may take it later in the day as soon as possible, following the instructions above (e.g., before breakfast, between meals, or in the evening).
Do not take two tablets on the same day to make up for the missed dose.

If you STOP taking Risedronate Aurobindo
If you stop treatment, you may begin to lose bone mass. Talk to your doctor before considering stopping treatment.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Risedronate Aurobindo and contact your doctor immediately if you experience any of the
following symptoms:
Symptoms of a severe allergic reaction such as:

• swelling of the face, tongue or throat
• difficulty swallowing
• hives and difficulty breathing
  Severe skin reactions which may include blistering of the skin

Contact your doctor immediately if you develop any of the following side effects:
Inflammation of the eye, usually accompanied by pain, redness and sensitivity to light
Osteonecrosis of the jaw (bone death) associated with delayed healing and infection, often following
dental extraction (see section 2 “Warnings and precautions”)
Oesophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain or new/worsening
heartburn.
However, other side effects observed in clinical studies were usually mild and did not lead to discontinuation
of the tablets by the patient.
Common side effects (may affect up to 1 in 10 people):
Indigestion, feeling of nausea, stomach ache, stomach cramps or discomfort, constipation, feeling of fullness,
bloating, diarrhoea
Pain in bones, muscles or joints
Headache
Uncommon side effects (may affect up to 14 in 100 people):
Inflammation or ulceration of the oesophagus (the tube connecting the mouth to the stomach) causing
difficulty and pain when swallowing (see also section 2, “Warnings and precautions”), inflammation of the
stomach and duodenum (the intestine draining the stomach)
Inflammation of the coloured part of the eye (iris) (red, painful eyes and possible changes in vision)
Rare side effects (may affect up to 1 in 1,000 people):
Inflammation of the tongue (swollen, red, and sometimes painful), narrowing of the oesophagus (the tube
connecting the mouth to the stomach)
Abnormal liver function test results have been reported. These can only be diagnosed by a blood test.
Very rare side effects (may affect up to 1 in 10,000 people):
Contact your doctor if you experience ear pain, ear discharge and/or ear infection.
These episodes could be signs of bone damage in the ear.
During post-marketing experience, the following side effects have been reported (frequency not known):
Hair loss
Liver disorders, which in some cases have been severe.
Rarely, at the beginning of treatment, levels of calcium and phosphate in the blood may fall. These
changes are usually mild and do not cause symptoms.
In patients treated long-term for osteoporosis, an unusual femoral fracture may rarely occur. Contact your
doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as this may be an early sign
of a possible femoral fracture.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Risedronato Aurobindo

Keep out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging after EXP:. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Risedronato Aurobindo contains
The active substance is sodium risedronate. Each film-coated tablet contains 5 mg of sodium risedronate
(equivalent to 4.6 mg of risedronic acid).
The other components are:
Tablet core: lactose monohydrate, crospovidone, hydroxypropylcellulose, magnesium stearate,
microcrystalline cellulose.
Coating: hypromellose, titanium dioxide (E171), macrogol 400, hydroxypropylcellulose, yellow iron oxide
(E172), macrogol 8000 and anhydrous colloidal silica.
Description of the appearance of Risedronato Aurobindo and package contents
Film-coated tablet
Yellow, round, film-coated tablets with bevelled edges, biconvex, marked with an 'X' on one side and '61' on the other.
Transparent PVC/PE/PVdC/Aluminium blisters in a cardboard box, available in packs of 14, 20, 28, 84, 98 or 140 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102, 21047 Saronno (VA), Italy
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
Or
Milpharm Limited,
Ares Block, Odyssey Business Park,
West End Road, Ruislip HA4 6QD.
United Kingdom
This medicinal product is authorized in the European Economic Area Member States under the following
names:
Germany Risedronat Aurobindo 5 mg Filmtabletten
Ireland Risedronate Aurobindo 5 mg film-coated tablets
Italy Risedronato Aurobindo
Malta Risedronate Aurobindo 5 mg film-coated tablets
Netherlands Natriumrisedronaat Aurobindo 5 mg, filmomhulde tabletten
United Kingdom Risedronate sodium 5 mg film-coated tablets
This summary of product characteristics was last approved on

Patient Information Leaflet: Instructions for the User

Risedronate Aurobindo 35 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are
the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
See section 4.
Contents of this leaflet:
What Risedronate Aurobindo is and what it is used for
What you need to know before taking Risedronate Aurobindo
How to take Risedronate Aurobindo
Possible side effects
How to store Risedronate Aurobindo
Contents of the pack and other information

1. What Risedronate Aurobindo is and what it is used for

What Risedronate Aurobindo is
Risedronate Aurobindo belongs to a group of non-hormonal medicines called bisphosphonates, used for the
treatment of bone diseases. It acts directly on your bones, strengthening them and thereby making them
less prone to fractures.
Bones are living tissue. Old bone is continuously removed from the skeleton and replaced by new bone.
Postmenopausal osteoporosis is a condition that occurs in women after menopause, when bones weaken,
become more fragile and more susceptible to fractures following falls or minor trauma.
Osteoporosis can also occur in men for various reasons, including age and/or low levels of the male hormone
testosterone.
The spine, hip and wrist are the bones most likely to fracture, although fractures can occur in any bone of the body.
Fractures due to osteoporosis may also cause back pain, weight loss and a curved spine. Many patients with
osteoporosis have no symptoms and may not even know they have it.
What Risedronate Aurobindo is used for
Treatment of osteoporosis
in postmenopausal women, even if osteoporosis is severe. It reduces the risk of spinal and hip fractures.
in men

2. What you should know before taking Risedronate Aurobindo

DO NOT take Risedronate Aurobindo
if you are allergic to sodium risedronate or to any of the other ingredients of this medicine
(listed in section 6),
if your doctor has told you that you have a condition called hypocalcemia (low levels of calcium in the
blood),
if you think you may be pregnant, if you are pregnant or if you are planning a pregnancy,
if you are breastfeeding,
if you have severe kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Risedronate Aurobindo
if you are unable to remain upright (sitting or standing) for at least 30 minutes,
if you have an abnormal bone and mineral metabolism (e.g. vitamin D deficiency, parathyroid hormone
abnormalities, both of which can lead to low calcium levels),
if you have had certain oesophageal disorders (the tube connecting the mouth to the stomach), e.g. if you
have experienced pain or difficulty swallowing food, or if you have previously been diagnosed with
Barrett’s oesophagus (a condition associated with changes in the cells lining the lower part of the
oesophagus),
if your doctor has told you that you have an intolerance to certain sugars (e.g. lactose),
if you have or have had jaw pain, swelling or numbness, a sensation of ‘heavy jaw’ or tooth loss,
if you are undergoing dental treatment or are scheduled for dental surgery,
inform your dentist that you are being treated with Risedronate Aurobindo.
If any of these situations apply to you, your doctor will advise you on what to do when taking Risedronate
Aurobindo.

Children and adolescents
The use of Risedronate Aurobindo is not recommended in children under 18 years of age, as data on safety
and efficacy are insufficient.

Other medicines and Risedronate Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines containing any of the following substances reduce the effect of Risedronate Aurobindo if taken
concurrently:
calcium
magnesium
aluminium (e.g. some antacid mixtures)
iron
Take these medicines at least 30 minutes after taking Risedronate Aurobindo.

Risedronate Aurobindo with food and drink
It is very important NOT to take Risedronate Aurobindo with food or drinks (except plain water) so that it
can work properly. In particular, do not take this medicine at the same time as dairy products (such as milk),
as they contain calcium (see section 2, “Other medicines and Risedronate Aurobindo”).
Take food or drinks (except plain water) at least 30 minutes after taking Risedronate Aurobindo.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Do not take Risedronate Aurobindo if you think you are pregnant, if you are pregnant or if you are planning
a pregnancy (see section 2, “Do not take Risedronate Aurobindo”). The potential risk associated with the use
of sodium risedronate (the active substance in Risedronate Aurobindo) in pregnant women is unknown.
DO NOT take Risedronate Aurobindo if you are breastfeeding (see section 2, “Do not take Risedronate
Aurobindo”).
Risedronate Aurobindo should only be used in postmenopausal women and men.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Risedronate Aurobindo does not appear to have any effect on the ability to drive or use machinery.

Risedronate Aurobindo contains lactose
Risedronate Aurobindo contains a small amount of lactose (see section 2, “Warnings and precautions”). If your
doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Risedronate Aurobindo

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Recommended dose:
Take ONE tablet of Risedronate Aurobindo (35 mg of sodium risedronate) once a week.
Choose a day of the week that best fits your routine. Each week, take Risedronate Aurobindo on the chosen day.

To help you remember to take the tablet on the correct day every week, the Risedronate Aurobindo packaging includes a designated space:
WHEN to take Risedronate Aurobindo

Take Risedronate Aurobindo at least 30 minutes before the first food, drink (except plain water), or other medicine of the day.

HOW to take Risedronate Aurobindo
Take the tablet while in an upright position (sitting or standing) to help avoid stomach irritation.
Swallow the tablet whole with at least a full glass (120 ml) of plain water.
Do not chew or suck the tablet.
Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will advise you if you need calcium or vitamin D supplements, especially if your diet does not provide enough.

If you take MORE Risedronate Aurobindo than you should
If you or someone else has accidentally taken more Risedronate Aurobindo than prescribed, drink a full glass of milk and contact your doctor immediately.

If you FORGET to take Risedronate Aurobindo
If you forget to take your tablet on the chosen day, take it as soon as you remember.
Then resume taking one tablet once a week on your usual day.
DO NOT take two tablets on the same day to make up for the missed dose.

If you STOP treatment with Risedronate Aurobindo
If you stop treatment, you may begin to lose bone mass. Talk to your doctor before considering stopping treatment.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking Risedronate Aurobindo and contact your doctor immediately if you experience any of the
following symptoms:
Symptoms of a severe allergic reaction such as:

• Swelling of the face, tongue or throat
• Difficulty swallowing
• Hives and difficulty breathing
  Severe skin reactions which may include blistering of the skin

Inform your doctor immediately if you develop any of the following side effects:
Eye inflammation, usually accompanied by pain, redness and sensitivity to light
Jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, often following tooth extraction (see section 2, "Warnings and precautions")
Symptoms affecting the oesophagus such as pain when swallowing, difficulty swallowing, chest pain or new/worsening heartburn.
However, other side effects observed in clinical studies were usually mild and did not lead to discontinuation of the tablets by the patient.
Common side effects (may affect up to 1 in 10 people):
Indigestion, feeling of nausea, stomach ache, stomach cramps or discomfort, constipation, feeling of fullness, bloating, diarrhoea
Pain in bones, muscles or joints
Headache
Uncommon side effects (may affect up to 1 in 100 people):
Inflammation or ulceration of the oesophagus (the tube connecting the mouth to the stomach), causing difficulty and pain when swallowing (see also section 2, "Warnings and precautions"), inflammation of the stomach and duodenum (the intestine draining the stomach)
Inflammation of the coloured part of the eye (iris) (red, painful eyes and possible changes in vision)
Rare side effects (may affect up to 1 in 1,000 people):
Inflammation of the tongue (swollen, red, and sometimes painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach)
Abnormal liver function test results have been reported. These can only be diagnosed by a blood test.
Very rare side effects (may affect up to 1 in 10,000 people):
Consult your doctor if you experience ear pain, ear discharge and/or ear infection.
These episodes could be signs of bone damage in the ear.
During post-marketing experience, the following side effects have been reported (frequency not known):
Hair loss
Liver disorders, which in some cases have been severe
Rarely, at the beginning of treatment, levels of calcium and phosphate in the blood may decrease. These changes are usually mild and do not cause symptoms.
In patients receiving long-term treatment for osteoporosis, an unusual fracture of the thigh bone may rarely occur. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as this may be an early sign of a possible fracture of the thigh bone.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Risedronate Aurobindo

Keep out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Risedronato Aurobindo contains
The active substance is sodium risedronate. Each tablet contains 35 mg of sodium risedronate (equivalent
to 32.4 mg of risedronic acid).
The other components are:
Tablet core: monohydrate lactose, crospovidone, hydroxypropylcellulose, magnesium stearate,
microcrystalline cellulose.
Coating: hypromellose, titanium dioxide (E171), macrogol 400, hydroxypropylcellulose, yellow iron oxide
(E172), macrogol 8000, red iron oxide (E172), and anhydrous colloidal silica.

Description of the appearance of Risedronato Aurobindo and package contents
Film-coated tablet
Orange, circular, film-coated, biconvex tablets with 'F27' engraved on one side and smooth on the other.
Packaged in transparent PVC/PE/PVdC/Aluminum blisters inside a cardboard box, available in pack sizes of 1, 2, 4, 10, 12 or 16 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102, 21047 Saronno (VA)

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
Or
Milpharm Limited,
Ares Block, Odyssey Business Park,
West End Road, Rusip HA46QD.
United Kingdom

This medicinal product is authorized in the European Economic Area countries under the following
names:
France Risédronate Arrow 35 mg, film-coated tablet
Germany Risedronat Aurobindo einmal wöchentlich 35 mg Filmtabletten
Ireland Risedronate Aurobindo Once a Week 35 mg film-coated tablets
Italy Risedronato Aurobindo
Malta Risedronate Aurobindo Once a Week 35 mg film-coated tablets
Romania Risedronat Aurobindo 35 mg comprimate filmate
Spain Risedronat Semanal Aurobindo 35 mg comprimidos recubiertos con película EFG
Netherlands Natriumrisedronaat Aurobindo Wekelijks 35 mg, filmomhulde tabletten
United Kingdom Risedronate sodium 35mg film-coated tablets

This Patient Information Leaflet was last approved in July 2016.

Package leaflet: information for the user

Risedronate Aurobindo 30 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be dangerous.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:
What Risedronate Aurobindo is and what it is used for
What you need to know before taking Risedronate Aurobindo 30 mg film-coated tablets
How to take Risedronate Aurobindo 30 mg film-coated tablets
Possible side effects
How to store Risedronate Aurobindo 30 mg film-coated tablets
Contents of the pack and other information

1. What Risedronato Aurobindo is and what it is used for

What is Risedronato Aurobindo 30 mg film-coated tablets
Risedronato Aurobindo belongs to a group of non-hormonal medicines called bisphosphonates, used for the treatment of bone diseases. It acts directly on your bones, strengthening them and thereby making them less prone to fractures.
Bones are living tissue. Old bone is continuously removed from the skeleton and replaced by new bone.
Paget's disease occurs when this process, called remodelling, occurs too rapidly and in a disordered manner. The new bone that forms is weaker than normal, and the affected bones may become larger, painful, and may fracture. Risedronato Aurobindo 30 mg film-coated tablets modify the bone remodelling process, restoring it to normal and improving the strength of the bone structure.
What Risedronato Aurobindo is used for
Treatment of Paget's disease of the bone (osteitis deformans).

2. What you need to know before taking Risedronate Aurobindo

DO NOT take Risedronate Aurobindo
If you are allergic to sodium risedronate or to any of the other ingredients of this medicine
(listed in section 6).
If your doctor has told you that you have a condition called hypocalcemia (low levels of calcium in the
blood).
If you think you may be pregnant, if you are pregnant, or if you are planning to become pregnant.
If you are breastfeeding.
If you have s evere kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Risedronate Aurobindo
If you are unable to remain upright (sitting or standing) for at least 30 minutes.
If you have an abnormal bone and mineral metabolism (e.g. vitamin D deficiency, parathyroid hormone
abnormalities, both of which can lead to low calcium levels).
If you have had certain oesophageal disorders (the tube connecting the mouth to the stomach), for example, if you have experienced pain or difficulty swallowing food, or if you have previously been diagnosed with Barrett’s oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus).
If your doctor has told you that you have an intolerance to certain sugars (e.g. lactose).
If you have or have had pain, swelling or numbness in the jaw, a sensation of 'heavy jaw', or tooth loss.
If you are undergoing dental treatments or are scheduled for dental surgery, inform your dentist that you are being treated with Risedronate Aurobindo 30 mg film-coated tablets.
If any of these situations apply to you, your doctor will advise you on what to do when taking Risedronate
Aurobindo 30 mg film-coated tablets.

Children and adolescents
The use of Risedronate Aurobindo is not recommended in children under 18 years of age, as data on safety and efficacy are insufficient.

Other medicines and Risedronate Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines containing any of the following substances may reduce the effect of Risedronate Aurobindo if taken at the same time:
calcium
magnesium
aluminium (e.g. some antacid mixtures)
iron
Take these medicines at least 30 minutes before taking Risedronate Aurobindo 30 mg film-coated tablets.

Risedronate Aurobindo with food and drinks
It is very important NOT to take Risedronate Aurobindo with food or drinks (except plain water) so that it can work properly. In particular, do not take this medicine at the same time as dairy products (such as milk), as they contain calcium (see section 2, “Other medicines and Risedronate Aurobindo”).
Take food or drinks (except plain water) at least 30 minutes after taking Risedronate Aurobindo 30 mg film-coated tablets.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
DO NOT take Risedronate Aurobindo if you think you may be pregnant, if you are pregnant, or if you are planning a pregnancy (see section 2, “Do not take Risedronate Aurobindo 30 mg film-coated tablets”).
The potential risk associated with the use of sodium risedronate (the active substance in Risedronate Aurobindo 30 mg film-coated tablets) in pregnant women is unknown.
DO NOT take Risedronate Aurobindo if you are breastfeeding (see section 2, “Do not take Risedronate Aurobindo 30 mg film-coated tablets”).

Driving and using machines
Risedronate Aurobindo does not appear to have any effect on the ability to drive or use machinery.

Risedronate Aurobindo contains lactose
Risedronate Aurobindo contains a small amount of lactose (see section 2, “Warnings and precautions”). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Risedronate Aurobindo

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is:
Take ONE tablet of Risedronate Aurobindo (30 mg of sodium risedronate) once daily.
The recommended duration of treatment is usually 2 months.

WHEN to take Risedronate Aurobindo
It is BEST to take Risedronate Aurobindo at least 30 minutes before the first food, drink (except plain water) or other medicine of the day.
In the specific case that you are unable to take your Risedronate Aurobindo tablet at this time, take it on an empty stomach every day at the same time, in one of the following ways:
between meals: at least 2 hours after the last meal, drink (except plain water) or medicine. Do not eat or drink (except plain water) for 2 hours after taking the tablet.
OR
in the evening: at least 2 hours after the last meal, drink (except plain water) or medicine of the day. Sodium risedronate must be taken at least 30 minutes before going to bed.

HOW to take Risedronate Aurobindo
Take the tablet while in an upright position (sitting or standing) to avoid stomach irritation.
Swallow it with at least one glass (120 ml) of plain water.
Swallow the tablet whole. Do not chew or suck it.
Do not lie down for at least 30 minutes after taking the tablet.
Your doctor will advise you if you need calcium or vitamin D supplements, if your diet does not provide enough.

If you take MORE Risedronate Aurobindo than you should
If you or someone else has accidentally taken more Risedronate Aurobindo than prescribed, drink a
full glass of milk and contact your doctor immediately.

If you FORGET to take Risedronate Aurobindo
If you forgot to take your tablet at the usual time, you may take it later as soon as possible, following the instructions above (e.g. before breakfast, between meals, or in the evening).
Do not take two tablets on the same day to make up for a missed dose.

If you STOP treatment with Risedronate Aurobindo
Consult your doctor before considering stopping treatment before the prescribed duration is completed.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking Risedronate Aurobindo and contact your doctor immediately if you experience any of the
following symptoms:
Symptoms of a severe allergic reaction such as:

• Swelling of the face, tongue or throat
• Difficulty swallowing
• Hives and difficulty breathing
  Severe skin reactions which may include blistering of the skin

Contact your doctor immediately if you develop any of the following side effects:
Inflammation of the eye, usually accompanied by pain, redness and sensitivity to light
Jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, often following tooth
extraction (see section 2, "Warnings and precautions")
Symptoms affecting the oesophagus such as pain when swallowing, difficulty swallowing, chest pain, or new/worsening heartburn.
However, other side effects observed in clinical studies were usually mild and did not lead to discontinuation of the tablets by the patient.
Common side effects (may affect up to 1 in 10 people)
Indigestion, feeling of nausea, stomach ache, stomach cramps or discomfort, constipation, feeling of fullness, bloating, diarrhoea
Pain in bones, muscles or joints
Headache
Uncommon side effects (may affect up to 1 in 100 people)
Inflammation or ulceration of the oesophagus (the tube connecting the mouth to the stomach), causing difficulty and pain when swallowing (see also section 2, "Warnings and precautions"), inflammation of the stomach and duodenum (the intestine draining the stomach)
Inflammation of the coloured part of the eye (iris) (red, painful eyes and possible changes in vision)
Rare side effects (may affect up to 1 in 1,000 people):
Inflammation of the tongue (swollen, red and sometimes painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach)
Abnormal liver function test results have been reported. These can only be diagnosed by a blood test.
Very rare side effects (may affect up to 1 in 10,000 people):
Consult your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes could be signs of bone damage in the ear.
During post-marketing experience, the following side effects have been reported (frequency not known):
Hair loss
Liver disorders, which in some cases have been severe
Rarely, at the beginning of treatment, levels of calcium and phosphate in the blood may decrease. These changes are usually mild and do not cause symptoms.
In a clinical study on Paget's disease, the following additional adverse events were reported: visual disturbances, difficulty breathing, cough, inflammation of the large intestine, damage to the surface of the eye, cramps, dizziness, dry eyes, flu-like syndrome, muscle weakness, abnormal cell growth, frequent need to urinate at night, unusual lumps or swellings, chest pain, rash, runny nose, ringing in the ears and weight loss.
In patients treated long-term for osteoporosis, an unusual fracture of the thigh bone may rarely occur. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as this may be an early sign of a possible fracture of the thigh bone.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Risedronate Aurobindo

Keep out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the pack after EXP:. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Risedronato Aurobindo contains
The active substance is sodium risedronate. Each tablet contains 30 mg of sodium risedronate (equivalent
to 27.8 mg of risedronic acid).
The other components are:
Tablet core: monohydrate lactose, crospovidone, hydroxypropylcellulose, magnesium stearate,
microcrystalline cellulose.
Coating: hypromellose, titanium dioxide (E171), macrogol 400, hydroxypropylcellulose.
Description of the appearance of Risedronato Aurobindo and package contents
Film-coated tablet
White to almost white, circular, film-coated, biconvex tablets with 'L' engraved on one side and '30' on the other.
Transparent PVC/PE/PVdC/Aluminum blisters in cardboard boxes containing 14 or 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102, 21047 Saronno (VA)
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
Or
Milpharm Limited,
Ares Block, Odyssey Business Park,
West End Road, Ruislip HA46QD.
United Kingdom
This medicinal product is authorized in the European Economic Area countries under the following
names:
Germany Risedronat Aurobindo 30 mg Filmtabletten
Ireland Risedronate Aurobindo 30 mg film-coated tablets
Italy Risedronato Aurobindo
Malta Risedronate Aurobindo 30 mg film-coated tablets
Spain Risedronat Aurobindo 30 mg comprimidos recubiertos con película
Netherlands Natriumrisedronaat Aurobindo 30 mg, filmomhulde tabletten
United Kingdom Risedronate sodium 30 mg film-coated tablets
This summary of product characteristics was last approved on