Risedronate Eg

Package leaflet: Information for the user

RISEDRONATE EG 5 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Risedronate EG is and what it is used for
2. What you need to know before taking Risedronate EG
3. How to take Risedronate EG
4. Possible side effects
5. How to store Risedronate EG
6. Contents of the pack and other information

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

What Risedronato EG is
Risedronato EG belongs to a group of non-hormonal medicines called bisphosphonates, used for the treatment of bone diseases. It acts directly on your bones to make them stronger and therefore less likely to break.
Bone is living tissue. Old bone tissue is constantly removed from the skeleton and replaced with new bone tissue.
Postmenopausal osteoporosis is a condition that occurs in women after menopause, when bones become weaker, more fragile and more prone to fractures following a fall or strain.
Osteoporosis is more likely to occur in women who have reached menopause early and in patients receiving long-term treatment with steroids.
The spine, hip and wrist are the bones most likely to fracture, although this can occur in any bone of your body. Osteoporosis-related fractures may also cause back pain, loss of height and curvature of the spine. Many patients with osteoporosis have no symptoms and you may not even know you have it.

What Risedronato EG is used for
Treatment of osteoporosis

• in postmenopausal women. Prevention of osteoporosis
• in women with an increased risk of osteoporosis (including reduced bone mass, early menopause or a family history of osteoporosis).
• in postmenopausal women who have been treated with high doses of steroid medicines for a long period of time. The medicine maintains or increases bone mass.

2. What you need to know before taking Risedronate EG

Do not take Risedronate EG
if you are allergic to risedronate sodium 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 known as hypocalcemia (low
calcium levels in the blood).
if you suspect you are pregnant, are pregnant, or are planning a pregnancy.
if you are breastfeeding.
if you have severe kidney problems.

Warnings and precautions
Talk to your doctor before taking Risedronate EG

• if you are unable to remain upright (sitting or standing) for at least 30 minutes;
• if your bone and mineral metabolism is abnormal (for example, vitamin D deficiency, parathyroid hormone disorder, conditions that both cause reduced blood calcium levels);
• if you have a history of esophageal problems (the tube connecting your mouth to your stomach). For example, if you have experienced pain or difficulty swallowing food, or if you have previously been diagnosed with Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus);
• if your doctor has informed you about an intolerance to certain sugars (such as lactose);
• if you have or have had pain, swelling, or numbness or a "heavy sensation" in your jaw/mandible, or if you have lost a tooth;
• if you are undergoing dental treatment or are scheduled for a dental procedure, inform your dentist that you are taking Risedronate EG. Your doctor will advise you on what to do while taking Risedronate EG if any of the above conditions apply to you.

Children and adolescents
Risedronate EG is not recommended for children under 18 years of age due to insufficient data
on safety and efficacy.

Other medicines and Risedronate EG
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 EG when
taken at the same time:

• calcium
• magnesium
• aluminium (e.g. certain compounds used to treat indigestion)
• iron

Take these medicines at least 30 minutes after taking Risedronate EG.

Risedronate EG with food and drinks
It is very important NOT to take the Risedronate EG tablet 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) due to their calcium content (see section 2 "Other medicines and Risedronate EG").
Take food and drinks (except plain water) at least 30 minutes after taking the Risedronate EG tablet.

Pregnancy and breastfeeding
DO NOT take Risedronate EG if you suspect you are pregnant, if you are pregnant, or if you are planning a
pregnancy (see section 2 “Do not take Risedronate EG”). The potential risk associated with the use of risedronate sodium (the active substance in Risedronate EG) in pregnant women is unknown.
DO NOT take Risedronate EG if you are breastfeeding (see section 2 "Do not take Risedronate EG").

Driving and using machines
It is unknown whether Risedronate EG has an effect on your ability to drive or operate machinery.

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

3. How to take Risedronate EG

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Recommended dose:
Take one Risedronate EG tablet (5 mg of sodium risedronate) once daily.
Method of administration
IT IS BEST TO TAKE THE TABLET AT LEAST 30 MINUTES BEFORE TAKING THE FIRST FOOD, DRINK (OTHER THAN STILL WATER) OR OTHER MEDICINE OF THE DAY.
If under specific circumstances you are unable to take the Risedronate EG tablet at this time, you may take it on an empty stomach at the same time each day in one of the following ways:
OR:
Between meals: at least 2 hours after taking your last food, drink (except in the case of still water) or other medicine. Do not eat or drink (except still water) for 2 hours after taking the tablet.
OR:
In the evening: at least 2 hours after taking your last food, drink (except still water) or other medicine of the day. Risedronate EG must be taken at least 30 minutes before going to bed.
How to take Risedronate EG tablets:

• Take the tablet while maintaining an upright position (you may be sitting or standing) to avoid stomach irritation.
• Swallow the tablet with at least one glass of still water (120 ml).
• Swallow the tablet whole. Do not suck or chew the tablet.
• Do not lie down for 30 minutes after taking the tablet.

Your doctor will advise you if you need calcium or vitamin supplements, in case your current diet does not provide sufficient intake.
If you take more Risedronate EG than you should
If you or someone else has accidentally taken more Risedronate EG tablets than prescribed, drink a full glass of milk and contact a doctor immediately.
If you forget to take Risedronate EG
If you have forgotten to take your tablet at the scheduled time, you may take it as soon as possible, following the instructions above (i.e. 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 taking Risedronate EG
If you stop treatment, you may begin to lose bone mass. Consult 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 treatment with Risedronate EG 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 breathing difficulties
• Severe skin reactions with possible blistering of the skin.

Contact your doctor immediately if you experience any of the following side effects:

• Inflammation of the eye, usually associated with pain, redness and sensitivity to light.
• Osteonecrosis of the jaw 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 onset/worsening of heartburn.

Other side effects observed in clinical studies have generally been mild and have not led to discontinuation of treatment.
Common: may affect up to 1 in 10 people

• Indigestion, nausea, stomach ache, stomach cramps or discomfort, constipation, feeling of fullness, bloating, diarrhoea.
• Bone, muscle or joint pain.
• Headache.

Uncommon: may affect up to 1 in 100 people

• Inflammation or ulcers of the oesophagus (the tube connecting your mouth to your stomach), causing pain and difficulty swallowing (see also section 2 "Warnings and precautions"), inflammation of the stomach and duodenum (part of the intestine involved in emptying the stomach).
• Inflammation of the coloured part of the eye (iris) (painful, red eyes with possible changes in vision).

Rare: may affect up to 1 in 1,000 people

• Inflammation of the tongue (swollen, red, possibly painful), narrowing of the oesophagus (the tube connecting your mouth to your stomach).
• Abnormalities in liver function tests have been reported. These can only be diagnosed by a blood test.
• Rarely, an unusual fracture of the femur (thigh bone) may occur, particularly in patients who have been treated for a long time for osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin, as this could be an early sign of a possible femoral fracture.

Very rare: may affect up to 1 in 10,000 people

• Consult your doctor if you experience ear pain, ear discharge and/or ear infection. These symptoms could be signs of bone damage in the ear.

Not known (frequency cannot be estimated from the available data)
The following side effects have been reported during post-marketing experience:
Skin allergic reactions such as hives, skin rash, swelling of the face, lips, tongue and/or throat, breathing or swallowing difficulties. Severe skin reactions including blistering (formation of blisters) under the skin; inflammation of small blood vessels, characterised by palpable red spots on the skin (leucocytoclastic vasculitis); a serious condition called Stevens-Johnson syndrome (SJS), characterised by blistering of the skin, mouth, eyes and other moist body surfaces (genitals); a serious condition called toxic epidermal necrolysis (TEN), causing a red rash on many parts of the body and/or loss of the outer layer of skin.
Hair loss. Allergic reactions (hypersensitivity). Severe liver problems, especially if you are taking other medicines known to cause liver problems. Inflammation of the eye causing pain and redness.
Rarely, at the beginning of treatment, a decrease in calcium and phosphate levels in the patient's blood may occur.
These are usually mild and asymptomatic changes.

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 EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister
after EXP. The expiry date refers to the last day of that 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 EG contains
The active substance is sodium risedronate. Each tablet contains 5 mg of sodium risedronate,
equivalent to 4.64 mg of risedronic acid.
The other ingredients are:
Tablet core: pregelatinized starch (maize); microcrystalline cellulose;
crospovidone; magnesium stearate.
Tablet coating: hypromellose, monohydrate lactose, titanium dioxide (E171),
Macrogol 4000.
Description of the appearance of Risedronato EG and contents of the pack
Risedronato EG tablets are film-coated, biconvex, round, white tablets with a diameter of 6.1 mm and a thickness of 2.6 mm. Risedronato EG is available in blister packs of:
14, 20, 26, 28, 30, 50, 56, 84, 90, 140, 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 - 20136 Milan, Italy
Manufacturers
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)
Centrafarm Services B.V., Nieuwe Donk 9, 4879 Etten-Leur (Netherlands)
STADA Production Ireland, Waterford Road, Clonmel, Co Tipperary (Ireland)
Eurogenerics N.V./S.A., Heizel Esplanade B22, 1020 Brussels (Belgium)
LAMP SAN PROSPERO S.p.A., Via della Pace, 25/A, 41030 San Prospero - Modena (Italy)
This medicinal product is authorized in the European Economic Area countries under the
following names:
Denmark Risedronatnatrium STADA
Belgium Risedronate EG 5mg filmomhulde tabletten
Italy Risedronato EG 5 mg compresse rivestite con film
Luxembourg Risedronate EG 5 mg comprimés pelliculés
Netherlands Risedronaatnatrium CF 5 mg filmomhulde tabletten
Package leaflet: information for the user

RISEDRONATE EG 30 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, consult 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 side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Risedronate EG is and what it is used for
2. What you need to know before taking Risedronate EG
3. How to take Risedronate EG
4. Possible side effects
5. How to store Risedronate EG
6. Contents of the pack and other information

2. What is Risedronate EG and what is it used for

What is Risedronate EG
Risedronate EG belongs to a group of non-hormonal medicines called bisphosphonates, used for the treatment of bone diseases. It acts directly on your bones to make them stronger, thereby making fractures less likely.
Bone is living tissue. Old bone tissue is constantly being removed from the skeleton and replaced with new bone tissue.
Paget's disease occurs when this process, known as remodelling, occurs too rapidly and in a disordered manner. The new bone that forms is weaker than normal, and affected bones may become enlarged, painful, and prone to fractures. Risedronate EG restores the bone remodelling process back to normal, thereby improving bone strength and structure.
What Risedronate EG is used for
Treatment of Paget's disease of the bone (osteitis deformans).

4. What you need to know before taking Risedronate EG

Do not take Risedronate EG
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 known as hypocalcaemia (low
calcium levels in the blood).
if you suspect you are pregnant, are pregnant, or are planning a pregnancy.
if you are breastfeeding.
if you have severe kidney problems.

Warnings and precautions
Talk to your doctor before taking Risedronate EG

• if you are unable to remain upright (sitting or standing) for at least 30 minutes;
• if your bone and mineral metabolism is abnormal (for example, vitamin D deficiency, parathyroid hormone abnormality, conditions that both lead to reduced blood calcium levels);
• if you have a history of oesophageal problems (the tube connecting your mouth to your 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 informed you of an intolerance to certain sugars (such as lactose);
• if you have or have had pain, swelling, numbness, or a "heavy sensation" in your jaw/mandible, or if you have lost a tooth;
• if you are undergoing dental treatment or are scheduled for a dental procedure, inform your dentist that you are taking Risedronate EG. Your doctor will advise you on what to do while taking Risedronate EG if any of the above conditions apply to you.

Children and adolescents
Risedronate EG is not recommended for children under 18 years of age due to insufficient data
on safety and efficacy.

Other medicines and Risedronate EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Medicines containing any of the following ingredients reduce the effect of Risedronate EG when
taken at the same time:

• calcium
• magnesium
• aluminium (for example, some compounds used to treat indigestion)
• iron
  Take these medicines at least 30 minutes after taking Risedronate EG.

Risedronate EG with food and drinks
It is very important NOT to take the Risedronate EG tablet 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) due to their calcium content (see section 2 "Other medicines and Risedronate EG").
Consume food and drinks (except plain water) at least 30 minutes after taking the Risedronate EG tablet.

Pregnancy and breastfeeding
DO NOT take Risedronate EG if you suspect you are pregnant, if you are pregnant, or if you are planning a pregnancy (see section 2 "Do not take Risedronate EG"). The potential risk associated with the use of sodium risedronate (the active substance in Risedronate EG) in pregnant women is unknown.
DO NOT take Risedronate EG if you are breastfeeding (see section 2 "Do not take Risedronate EG").

Driving and using machines
It is unknown whether Risedronate EG affects your ability to drive or use machinery.

Risedronate EG contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine (see section 2 "Warnings and precautions").

5. How to take Risedronate EG

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 EG (30 mg of sodium risedronate) once daily.
Administration instructions
IT IS BEST TO TAKE THE TABLET AT LEAST 30 MINUTES BEFORE TAKING ANY FOOD, DRINK (OTHER THAN STILL WATER), OR OTHER MEDICINE OF THE DAY.
If under certain circumstances you are unable to take the Risedronate EG tablet at this time, you may take it on an empty stomach at the same time each day in one of the following ways:
OR:
Between meals: at least 2 hours after taking your last food, drink (except still water), or other medicine. Do not eat or drink (except still water) for 2 hours after taking the tablet.
OR:
In the evening: at least 2 hours after taking your last food, drink (except still water), or other medicine of the day. Risedronate EG must be taken at least 30 minutes before going to bed.
How to take Risedronate EG tablets:

• Take the tablet while maintaining an upright position (you may sit or stand) to avoid stomach irritation.
• Swallow the tablet with at least one glass of still water (120 ml).
• Swallow the tablet whole. Do not suck or chew the tablet.
• Do not lie down for 30 minutes after taking the tablet.

Your doctor will advise you whether you need calcium and vitamin supplements if your dietary intake is insufficient.
Duration of treatment
The recommended duration of treatment is usually 2 months.
If you take more Risedronate EG than you should
If you or someone else has accidentally taken more Risedronate EG tablets than prescribed, drink a full glass of milk and contact a doctor immediately.
If you forget to take Risedronate EG
If you have forgotten to take your tablet at the scheduled time, you may take it as soon as possible, following the instructions above (i.e., 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 taking Risedronate EG
Consult your doctor before considering stopping the 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 everybody gets them.
Stop treatment with Risedronate EG 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 breathing difficulties.
• Severe skin reactions possibly leading to blistering of the skin.

Contact your doctor immediately if you experience any of the following side effects:

• Eye inflammation, usually associated with pain, redness and sensitivity to light.
• Osteonecrosis of the jaw 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 onset/worsening of heartburn.

Other side effects observed in clinical studies have generally been mild and did not lead to discontinuation of treatment.
Common: may affect up to 1 in 10 people

• Indigestion, nausea, stomach ache, stomach cramps or discomfort, constipation, feeling of fullness, bloating, diarrhoea.
• Bone, muscle or joint pain.
• Headache.

Uncommon: may affect up to 1 in 100 people

• Inflammation or ulcers of the oesophagus (the tube connecting your mouth to your stomach), resulting in pain and difficulty swallowing (see also section 2 "Warnings and precautions"), inflammation of the stomach and duodenum (part of the intestine responsible for emptying the stomach).
• Inflammation of the coloured part of the eye (iris) (painful, red eyes possibly with changes in vision).

Rare: may affect up to 1 in 1,000 people

• Inflammation of the tongue (swollen, red, possibly painful), narrowing of the oesophagus (the tube connecting your mouth to your stomach).
• Abnormal liver function test results have been reported. These can only be detected by blood tests.
• Rarely, an unusual fracture of the femur may occur, particularly in patients treated for a long time for osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin, as this may be an early sign of a possible femoral fracture.

Very rare: may affect up to 1 in 10,000 people

• Consult your doctor if you experience ear pain, ear discharge and/or ear infection. These symptoms could be signs of bone damage in the ear.

Not known (frequency cannot be estimated from the available data)
During post-marketing experience, the following adverse reactions have been reported:
Skin allergic reactions such as hives, rash, swelling of the face, lips, tongue and/or throat, breathing or swallowing difficulties. Severe skin reactions including blistering (formation of blisters) under the skin; inflammation of small blood vessels, characterised by palpable red spots on the skin (leucocytoclastic vasculitis); a serious condition called Stevens-Johnson syndrome (SJS), characterised by blistering of the skin, mouth, eyes and other moist surfaces of the body (genitals); a serious condition called toxic epidermal necrolysis (TEN), causing a red rash over many parts of the body and/or loss of the outer layer of skin.
Hair loss. Allergic reactions (hypersensitivity). Severe liver disorders, particularly if you are taking other medicines known to cause liver problems. Eye inflammation resulting in pain and redness.
Rarely, at the beginning of treatment, a decrease in calcium and phosphate levels in the patient's blood may occur.
These are usually mild and asymptomatic changes.
The following additional adverse events have also been observed in a clinical trial in patients with Paget’s disease: visual disturbances, breathing difficulties, cough, inflammation of the large intestine, damage to the surface of the eye, cramps, dizziness, dry eyes, flu-like symptoms, muscle weakness, abnormal cell growth, frequent need to urinate during the night, unusual lumps or swellings, chest pain, skin rash, runny nose, tinnitus (ringing in the ears) and weight loss.

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 EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of that 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 EG 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: pregelatinized starch (maize); microcrystalline cellulose;
crospovidone; magnesium stearate.
Tablet coating: hypromellose, monohydrate lactose, titanium dioxide (E171),
Macrogol 4000.
Description of the appearance of Risedronato EG and package contents
Risedronato EG tablets are film-coated, biconvex, round, white tablets with a diameter of 11.2 mm, a thickness of 4.5 mm, and engraved with "30" on one side.
Risedronato EG is available in blister packs containing:
14, 28, 30, 50, 56, 90, 98, 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 - 20136 Milan, Italy
Manufacturers
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)
Centrafarm Services B.V., Nieuwe Donk 9, 4879 Etten-Leur (Netherlands)
STADA Production Ireland, Waterford Road, Clonmel, Co. Tipperary (Ireland)
Eurogenerics N.V./S.A., Heizel Esplanade B22, 1020 Brussels (Belgium)
LAMP SAN PROSPERO S.p.A., Via della Pace, 25/A, 41030 San Prospero - Modena (Italy)
This medicinal product is authorized in the European Economic Area countries under the
following names:
Denmark: Risedronatnatrium STADA
Belgium: Risedronate EG 30 mg filmomhulde tabletten
Italy: Risedronato EG 30 mg compresse rivestite con film
Luxembourg: Risedronate EG 30 mg comprimés pelliculés
Netherlands: Risedronaatnatrium CF 30 mg filmomhulde tabletten
Package leaflet: Information for the user

RISEDRONATE EG 35 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 questions, ask 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, as it could 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:

1. What Risedronate EG is and what it is used for
2. What you need to know before taking Risedronate EG
3. How to take Risedronate EG
4. Possible side effects
5. How to store Risedronate EG
6. Contents of the pack and other information

3. What Risedronato EG is and what it is used for

What Risedronato EG is
Risedronato EG belongs to a group of non-hormonal medicines called bisphosphonates, used for the treatment of bone diseases. It works directly on your bones to make them stronger and therefore less likely to break.
Bone is living tissue. Old bone tissue is constantly removed from the skeleton and replaced with new bone tissue.
Postmenopausal osteoporosis is a condition that occurs in women after menopause, when bones become weaker, more fragile, and more prone to fractures following a fall or strain.
Osteoporosis can also occur in men for a number of reasons, including aging and/or low levels of the male hormone testosterone.
The spine, hip, and wrist are the bones most likely to fracture, although fractures may occur in any bone of your body. Osteoporosis-related fractures may also cause back pain, loss of height, and curvature of the spine. Many patients with osteoporosis have no symptoms, and you may not know you have it.

What Risedronato EG is used for
Treatment of osteoporosis

• in postmenopausal women, even those with severe osteoporosis. It reduces the risk of vertebral and hip fractures.
• in men.

6. What you need to know before taking Risedronate EG

Do not take Risedronate EG
if you are allergic to sodium risedronate or to any of the other ingredients of this
medicinal product (listed in section 6).
if your doctor has told you that you have a condition known as hypocalcaemia (low
calcium levels in the blood).
if you suspect you are pregnant, 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 before taking Risedronate EG

• 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 disorder, conditions which both lead to reduced blood calcium levels);
• if you have a history of oesophageal problems (the tube connecting your mouth to your 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 informed you that you have an intolerance to certain sugars (such as lactose);
• if you have or have had pain, swelling, or numbness or a “heavy sensation” in your jaw/mandible, or if you have lost a tooth;
• if you are undergoing dental treatment or if you need to undergo a dental procedure, inform your dentist that you are taking Risedronate EG.

Your doctor will advise you on what to do while taking Risedronate EG if any of the above conditions apply to you.

Children and adolescents
Risedronate EG is not recommended for children under 18 years of age due to insufficient data on safety and efficacy.

Other medicines and Risedronate EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines containing any of the following elements reduce the effect of Risedronate EG when taken at the same time:

• calcium
• magnesium
• aluminium (e.g. certain compounds used to treat indigestion)
• iron

Take these medicines at least 30 minutes after taking Risedronate EG.

Risedronate EG with food and drinks
It is very important NOT to take the Risedronate EG tablet 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) due to their calcium content (see section 2 "Other medicines and Risedronate EG").
Take food and drinks (except plain water) at least 30 minutes after taking the Risedronate EG tablet.

Pregnancy and breastfeeding
DO NOT take Risedronate EG if you suspect you are pregnant, if you are pregnant, or if you are planning a pregnancy (see section 2 “Do not take Risedronate EG”). The potential risk associated with the use of sodium risedronate (the active substance in Risedronate EG) during pregnancy is unknown.
DO NOT take Risedronate EG if you are breastfeeding (see section 2 “Do not take Risedronate EG”).

Driving and using machines
It is unknown whether Risedronate EG has an effect on your ability to drive or use machinery.

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

7. How to take Risedronate EG

Take this medicine exactly as your doctor has told you. If you have any doubts,
ask your doctor or pharmacist.
The recommended dose is:
Take one Risedronate EG tablet (35 mg of sodium risedronate) once a week.
Choose a day of the week that best suits your routine. Each week, take the
Risedronate EG tablet on the chosen day.
There are spaces on the packaging. Mark the day of the week you have chosen to
take the Risedronate EG tablet. Also write down the dates on which you will take the tablet.
Method of administration
Take the risedronate tablet at least 30 minutes before taking any food, drink (other than
plain water) or other medicine of the day.
How to take Risedronate EG:

• Take the tablet while maintaining an upright position (you may sit or stand) to help prevent stomach irritation.
• Swallow the tablet with at least one glass of plain water (120 ml).
• Swallow the tablet whole. Do not suck or chew the tablet.
• Do not lie down for 30 minutes after taking the tablet.

Your doctor will advise you if you need calcium and vitamin supplements, in case your
diet does not provide sufficient intake.
If you take more Risedronate EG than you should
If you or someone else has accidentally taken more Risedronate EG tablets than prescribed,
drink a full glass of milk and contact a doctor immediately.
If you forget to take Risedronate EG
If you have forgotten to take the tablet on the chosen day, take it on the day you remember.
Then return to taking one tablet per week on the usual day.
Do not take two tablets on the same day to make up for a missed dose.
If you stop taking Risedronate EG
If you stop treatment, you may begin to lose bone mass. Consult your doctor before
considering stopping treatment.
If you have any questions about the use of this medicine, ask 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 EG 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 breathing difficulties.
• Severe skin reactions possibly with blistering of the skin.

Contact your doctor immediately if any of the following side effects affect you:

• Ocular inflammation, usually associated with pain, redness and sensitivity to light.
• Osteonecrosis of the jaw associated with delayed healing and infection, often following dental extraction (see section 2 “Warnings and precautions”).
• Symptoms affecting the oesophagus such as pain when swallowing, difficulty swallowing, chest pain, or onset/worsening of heartburn.

Other side effects observed in clinical studies have generally been mild and have not led to discontinuation of treatment.
Common: may affect up to 1 in 10 people

• Indigestion, nausea, stomach ache, stomach cramps or discomfort, constipation, feeling of fullness, bloating, diarrhoea.
• Bone, muscle or joint pain.
• Headache.

Uncommon: may affect up to 1 in 100 people

• Inflammation or ulcers in the oesophagus (the tube connecting your mouth to your stomach), causing pain and difficulty swallowing (see also section 2 “Warnings and precautions”), inflammation of the stomach and duodenum (part of the intestine responsible for emptying the stomach).
• Inflammation of the coloured part of the eye (iris) (painful, red eyes with possible changes in vision).

Rare: may affect up to 1 in 1,000 people

• Inflammation of the tongue (swollen, red, possibly painful), narrowing of the oesophagus (the tube connecting your mouth to your stomach).
• Abnormal liver function test results have been reported. These can only be diagnosed by a blood test.
• Rarely, an unusual fracture of the femur may occur, particularly in patients on long-term treatment for osteoporosis. 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.

Very rare: may affect up to 1 in 10,000 people

• Consult your doctor if you experience ear pain, ear discharge and/or ear infection. These events could be signs of bone damage in the ear.

Not known (frequency cannot be estimated from the available data)
During post-marketing experience, the following adverse reactions have been reported:
Skin allergic reactions such as hives, rash, swelling of the face, lips, tongue and/or throat, difficulty breathing or swallowing. Severe skin reactions including blistering (formation of blisters) under the skin; inflammation of small blood vessels, characterised by palpable red spots on the skin (leucocytoclastic vasculitis); a serious condition called Stevens-Johnson syndrome (SJS), characterised by blistering of the skin, mouth, eyes and other moist surfaces of the body (genitals); a serious condition called toxic epidermal necrolysis (TEN), causing a red rash over many parts of the body and/or loss of the outer layer of skin.
Hair loss. Allergic reactions (hypersensitivity). Severe liver disorders, especially if you are being treated with other medicines known to cause liver problems. Eye inflammation resulting in pain and redness.
Rarely, at the beginning of treatment, a decrease in calcium and phosphate levels in the patient's blood may occur.
These are usually mild and asymptomatic changes.

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 EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister after EXP.. The expiry date refers to the last day of that 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 EG contains
The active substance is sodium risedronate. Each tablet contains 35 mg of sodium risedronate,
equivalent to 32.5 mg of risedronic acid.
The other components are:
Tablet core: pregelatinized maize starch; microcrystalline cellulose;
crospovidone; magnesium stearate.
Tablet coating: hypromellose, monohydrate lactose, titanium dioxide (E171),
Macrogol 4000.
Description of the appearance of Risedronato EG and package contents
Risedronato EG tablets are film-coated, biconvex, round, white tablets,
with a diameter of 11.2 mm, a thickness of 5.0 mm, and engraved with “35” on one side. Risedronato EG is
available in blister packs containing:
1, 2, 4, 8, 10, 12, 16, 20, 24, 28, 50, 90, 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 - 20136 Milan, Italy
Manufacturers
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)
Centrafarm Services B.V., Nieuwe Donk 9, 4879 Etten-Leur (The Netherlands)
STADA Production Ireland, Waterford Road, Clonmel, Co Tipperary (Ireland)
Eurogenerics N.V./S.A., Heizel Esplanade B22, 1020 Brussels (Belgium)
LAMP SAN PROSPERO S.p.A., Via della Pace, 25/A, 41030 San Prospero - Modena (Italy)
Pharmathen International S.A., Sapes industrial Park, Block 5, 69300 Rodopi (Greece)
This medicinal product is authorized in the European Economic Area countries under the
following names:
Denmark: Risedronatnatrium STADA
Belgium: Risedronate EG 35 mg filmomhulde tabletten
Germany: Risedronat STADA 35 mg Filmtabletten
Italy: Risedronato EG 35 mg compresse rivestite con film
Lithuania: Risedronate sodium STADA 35 mg plévele denoto tabletés
Luxembourg: Risedronate EG 35 mg comprimés pelliculés
Netherlands: Risedronaatnatrium CF wekelijks 35 mg, filmomhulde tabletten
Slovak Republic: Risedronat STADA 35 mg