Optinate: detailed information

Patient Information Leaflet

Optinate 5 mg film-coated tablets

sodium risedronate
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 effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Optinate is and what it is used for
What you need to know before taking Optinate
How to take Optinate
Possible side effects
How to store Optinate
Contents of the pack and other information

1. What Optinate is and what it is used for

What Optinate is
Optinate belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. It acts directly on the bones, strengthening them and thereby reducing the risk of fractures.
Bone is a living tissue. Old bone is constantly being removed and replaced with new bone.
Postmenopausal osteoporosis is a condition that occurs in women after menopause, causing their bones to become more fragile and more prone to fractures following falls or minor trauma.
Osteoporosis is more likely to occur in women who have reached menopause early, as well as in patients treated for prolonged periods with corticosteroid therapy.
Bones most susceptible to fractures include those in the spine, hip, and wrist, although any bone in the body may fracture. Fractures associated with osteoporosis can also cause back pain, loss of height, and dorsal curvature (kyphosis or "dowager's hump"). Many patients with osteoporosis have no symptoms and may not even be aware they have the condition.
Indications for Optinate

For the treatment of osteoporosis in postmenopausal women
For the prevention of osteoporosis in women at increased risk of osteoporosis (including low bone mass, early menopause, or family history of osteoporosis)
In postmenopausal women who have been on long-term therapy with high-dose corticosteroids. It maintains or increases bone mass.

2. What you need to know before taking Optinate

Do not take Optinate:

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 hypocalcemia (low calcium levels in the blood);
If you are pregnant, think you might be pregnant, or are planning to become pregnant;
If you are breast-feeding;
If you have severe kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Optinate:

If you are unable to remain upright (sitting or standing) for at least 30 minutes.
If you have a disorder of bone and mineral metabolism (such as vitamin D deficiency, parathyroid hormone abnormalities, conditions which both cause low calcium levels in the blood).
If you have or have previously had problems with your oesophagus (the tube connecting your mouth to your stomach), for example difficulty or pain when 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 (for example, lactose).
If you have or have had pain, swelling or numbness in the jaw and/or mandible, or a sensation of “heavy jaw and/or mandible”, or tooth loss.
If you are undergoing dental treatment or are scheduled for dental surgery, inform your dentist that you are taking Optinate. If you have any of these conditions, your doctor will advise you on how to take Optinate.

Children and adolescents
The use of sodium risedronate is not recommended in children under 18 years of age due to insufficient data on safety and efficacy.

Other medicines and Optinate
Medicines containing any of the following may reduce the effect of Optinate if taken at the same time:

calcium
magnesium
aluminium (for example, some preparations for digestive problems)
iron. These medicines should be taken at least 30 minutes after taking Optinate tablet.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Optinate with food and drink
It is very important NOT to take the Optinate tablet with food or drinks (except tap water), as this may make the medicine less effective. In particular, do not take this medicine with dairy products (including milk), as they contain calcium (see section 2 “Other medicines and Optinate”). Food and drinks (except tap water) should be taken at least 30 minutes after taking the Optinate tablet.

Pregnancy and breast-feeding
DO NOT take Optinate if you are or think you might be pregnant, or if you are planning a pregnancy (see section 2 “Do not take Optinate”). The potential risks associated with the use of sodium risedronate (the active substance in Optinate) in pregnant women are unknown.
DO NOT take Optinate if you are breast-feeding (see section 2, “Do not take Optinate”).

Driving and using machines
Optinate has no known effects that interfere with the ability to drive or use machinery.

Optinate 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”).

Optinate contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Optinate

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is ONE Optinate tablet (5 mg of sodium risedronate) once daily.
For your convenience, the days of the week are printed on the back of the blister to help you remember to take your tablet.

WHEN to take the Optinate tablet
IT IS BEST TO TAKE THE OPTINATE TABLET AT LEAST 30 MINUTES BEFORE THE FIRST FOOD, DRINK (EXCEPT TAP WATER), OR OTHER MEDICINE OF THE DAY.
If taking the tablet before breakfast is not possible, Optinate may be taken every day at the same time on an empty stomach using one of the following options:

Between meals: Optinate must be taken at least 2 hours after the last intake of food, medicinal product, or drink (except tap water). Do not eat or drink (except tap water) for 2 hours after taking the tablet.
Or in the evening: at least 2 hours after the last intake of food, drink (except tap water), or other medicine of the day. Optinate must be taken at least 30 minutes before going to bed.

HOW to take the Optinate tablet

The tablet must be taken while keeping your upper body upright (standing or sitting) to avoid heartburn.
The tablet must be swallowed with at least one full glass (120 ml) of tap water.
The tablet must be swallowed whole and not dissolved or chewed.
After swallowing the tablet, do not lie down for 30 minutes.

Your doctor will advise you if you need calcium or vitamin supplements, should your dietary intake of these substances be insufficient.

If you take more Optinate than you should
If you or anyone else has accidentally taken more Optinate tablets than prescribed, drink a full glass of milk and contact a doctor immediately.

If you forget to take Optinate
If you forget to take a tablet at your usual time, take it as soon as possible, following the instructions above (e.g. before breakfast, between meals, or in the evening).
Do not take a double dose to make up for the missed tablet.

If you stop taking Optinate
If you stop treatment, you may begin to lose bone mass. Therefore, it is recommended that you consult your doctor before stopping the treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop treatment with Optinate and consult your doctor immediately if you experience any of the following side effects:

Symptoms of a severe allergic reaction such as:
Swelling of the face, tongue or throat
Difficulty swallowing
Hives and breathing difficulties The frequency of this side effect is not known (cannot be estimated based on available data).
Severe skin reactions, which may include blistering skin reactions. The frequency of this side effect is not known (cannot be estimated based on available data).

Consult your doctor promptly if you experience any of the following side effects:

Eye inflammation, usually with pain, redness and sensitivity to light. The frequency of this side effect is not known (cannot be estimated based on available data).
Orbital inflammation – inflammation of the structures surrounding the eyeball. Symptoms may include: pain, swelling, redness, protrusion of the eyeball and vision disturbances. The frequency of this side effect is not known (cannot be estimated based on available data).
Osteonecrosis of the jaw and/or maxilla (jawbone) associated with delayed healing and infection, often following tooth extraction (see section 2, "Warnings and precautions"). The frequency of this side effect is not known (cannot be estimated based on available data).
Oesophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or onset/worsening of heartburn. This side effect is uncommon (may affect up to 1 in 100 people). 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.

However, other side effects observed in clinical studies were generally mild in severity and did not require discontinuation of treatment.
Common side effects (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 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 first part of the intestine where digested food passes from the stomach).
Inflammation of the coloured part of the eye (iris) (red, painful eyes with possible changes in vision).

Rare side effects (may affect up to 1 in 1000 people)

Inflammation of the tongue (red, swollen, possibly painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach).
Abnormalities in liver function tests have been reported. This can only be diagnosed through blood tests.

During the post-marketing period of the medicine, the following side effects have been reported:

Very rare: Contact your doctor if you experience ear pain, ear discharge and/or ear infection. These events could be signs of bone damage in the ear.
Frequency not known:
Hair loss and/or loss of body hair
Liver disorders; some cases were severe.

Rarely, at the beginning of treatment, the patient's plasma levels of calcium and phosphate may decrease; usually these changes are mild and do not cause symptoms.
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Optinate

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 any medicine 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 Optinate 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 components are:
Tablet core: monohydrate lactose (see section 2), crospovidone,
magnesium stearate and microcrystalline cellulose
Coating: hypromellose, macrogol, hydroxypropylcellulose, anhydrous colloidal silica,
titanium dioxide [E171], yellow iron oxide [E172].
Description of the appearance of Optinate and package contents
Optinate 5 mg film-coated tablets are oval-shaped, yellow in colour, and marked with the letters “RSN” on one side and “5 mg” on the other.
They are available in packs of 14, 28 (2x14), 84 (6x14), 98 (7x14) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Theramex Ireland Limited
3rd Floor, Kilmore House, Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland
Manufacturer responsible for batch release:
Warner Chilcott Deutschland Germany GmbH, - Dr.-Otto-Röhm-Str. 2-4, - 64331
Weiterstadt, Germany
Balkanpharma-Dupnitsa AD 3, Samokovsko Shosse Str. 2600 Dupnitsa Bulgaria
This medicinal product is authorised in the European Economic Area member states under the following names:
Italy: Optinate 5 mg film-coated tablets
Sweden: Avestra 5 mg film-coated tablets

Patient information leaflet

Optinate 35 mg film-coated tablets

sodium risedronate
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, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Optinate is and what it is used for
What you need to know before taking Optinate
How to take Optinate
Possible side effects
How to store Optinate
Contents of the pack and other information

1. What Optinate is and what it is used for

What Optinate is
Optinate belongs to a group of non-hormonal medicines called bisphosphonates, which
are used to treat bone diseases. It acts directly on the bones, strengthening them and thereby reducing the risk of fractures.
Bone is a living tissue. Old bone tissue is constantly removed and replaced with new bone.
Postmenopausal osteoporosis is a condition that occurs in women after menopause, in which women's bones become more fragile and more prone to fractures due to falls or strain.
Osteoporosis can also occur in men for a variety of reasons, including aging and/or low levels of the male hormone testosterone.
Bones most likely to fracture are those in the spine, hip, and wrist, although any bone in the body can fracture. Fractures associated with osteoporosis may also cause back pain, loss of height, and curvature of the back (kyphosis). Many patients with osteoporosis have no symptoms and are unaware they have it.
What Optinate is indicated for
For the treatment of osteoporosis in postmenopausal women, including those with severe osteoporosis.
Reduces the risk of vertebral and hip fractures.
For the treatment of osteoporosis in men at high risk of fractures.

2. What you need to know before taking Optinate

DO NOT take Optinate:

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 hypocalcemia (low calcium levels in the blood);
If you are pregnant, think you may be pregnant, or are planning to become pregnant;
If you are breastfeeding;
If you have severe kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Optinate:

If you are unable to remain upright (sitting or standing) for at least 30 minutes.
If you have a disorder of bone and mineral metabolism (such as vitamin D deficiency, parathyroid hormone abnormalities, conditions that both cause low calcium levels in the blood).
If you have or have previously had problems with your oesophagus (the tube connecting the mouth to the stomach), for example difficulty or pain when 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 (for example, lactose).
If you have or have had pain, swelling or numbness in the jaw and/or maxilla, or a sensation of "heavy jaw and/or maxilla", or tooth loss.
If you are undergoing dental treatment or are due to have dental surgery, inform your dentist that you are taking Optinate. If you have any of these conditions, your doctor will advise you on how to take Optinate.

Children and adolescents
The use of sodium risedronate is not recommended in children under 18 years of age due to insufficient data on safety and efficacy.

Other medicines and Optinate
Medicines containing any of the following substances reduce the effect of Optinate if taken at the same time:

calcium;
magnesium;
aluminium (e.g. some preparations for digestive problems);
iron. These medicines should be taken at least 30 minutes after the Optinate tablet.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Optinate with food and drinks
It is very important NOT to take the Optinate tablet with food or drinks (except tap water), as this may make the medicine less effective.
In particular, do not take this medicine with dairy products (including milk), as they contain calcium (see section 2 “Other medicines and Optinate”).
Food and drinks (except tap water) should be taken at least 30 minutes after the Optinate tablet.

Pregnancy and breastfeeding
DO NOT take Optinate if you are or think you may be pregnant, or if you are planning a pregnancy (see section 2 “Do not take Optinate”). The potential risks associated with the use of sodium risedronate (the active substance in Optinate) in pregnant women are unknown.
DO NOT take Optinate if you are breastfeeding (see section 2, “Do not take Optinate”).
Optinate should only be used for the treatment of postmenopausal women and men.

Driving and using machines
Optinate has no known effects that interfere with the ability to drive or use machinery.

Optinate 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”).

Optinate contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Optinate

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is ONE Optinate tablet (35 mg of sodium risedronate) once a week.
Choose one day of the week that best fits your routine. Every week, take one Optinate tablet on the chosen day.

For your convenience, and to help you take the tablet on the same day each week, the Optinate packaging has a special feature: on the back of the blister, there are boxes/spaces where you can mark the day of the week you have chosen for taking the Optinate tablet. We also recommend that you write down the dates on which you take the tablets.

WHEN to take the Optinate tablet
The Optinate tablet must be taken at least 30 minutes before the first food, drink (except tap water) or other medicine of the day.

HOW to take the Optinate tablet

The tablet must be taken while keeping your upper body upright (standing or sitting), to avoid stomach irritation.
The tablet must be swallowed with at least one full glass (120 ml) of tap water.
The tablet must be swallowed whole and must not be crushed or chewed.
After swallowing the tablet, avoid lying down for 30 minutes.

Your doctor will advise you if you need calcium and vitamin supplements, should your dietary intake of these substances be insufficient.

If you take more Optinate than you should
If you or anyone else has accidentally taken more Optinate tablets than prescribed, drink a full glass of milk and contact a doctor immediately.

If you forget to take Optinate
If you forget to take a tablet on your chosen day, take it on the day you remember. After that, continue taking the tablet on your originally chosen day.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Optinate
If you stop treatment, you may begin to lose bone mass. Therefore, it is recommended that you consult your doctor before stopping therapy.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop treatment with Optinate and consult your doctor immediately if any of the following side effects occur:

Symptoms of a severe allergic reaction such as: swelling of the face, tongue or throat, difficulty swallowing, hives, or breathing difficulties. The frequency of this side effect is unknown (cannot be estimated based on available data).
Severe skin reactions which may include blistering skin reactions. The frequency of this side effect is unknown (cannot be estimated based on available data).

Consult your doctor promptly if any of the following side effects occur:

Eye inflammation, usually with pain, redness, and sensitivity to light. The frequency of this side effect is unknown (cannot be estimated based on available data).
Orbital inflammation – inflammation of the structures surrounding the eyeball. Symptoms may include pain, swelling, redness, protrusion of the eyeball, and vision disturbances. The frequency of this side effect is unknown (cannot be estimated based on available data).
Osteonecrosis of the jaw and/or maxilla (jaw bones) associated with delayed healing and infection, often following tooth extraction (see section 2, "Warnings and precautions"). The frequency of this side effect is unknown (cannot be estimated based on available data).
Oesophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or onset/worsening of heartburn. This side effect is uncommon (may affect up to 1 in 100 people). Rarely, an unusual femur fracture 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 could be an early sign of a possible femur fracture.

However, other side effects observed in clinical studies were generally mild in severity and did not require discontinuation of treatment.
Common side effects (may affect up to 1 in 10 people)

Indigestion, malaise, stomach discomfort, stomach cramps or disturbances, constipation, feeling of fullness, bloating, diarrhoea.
Bone, muscle or joint pain.
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 first part of the intestine where food passes after leaving the stomach).
Inflammation of the coloured part of the eye (iris) (red, painful eyes with possible changes in vision).

Rare side effects (may affect up to 1 in 1,000 people)

Inflammation of the tongue (red, swollen, possibly painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach).
Abnormalities in liver function tests have been reported. This can only be diagnosed through blood tests.

During the post-marketing period of the medicine, the following side effects have been reported:

Very rare: Contact your doctor if you experience ear pain, ear discharge, and/or ear infection. These events could be signs of bone damage in the ear.
Frequency not known:
- Hair loss and/or loss of body hair
- Liver disorders; some cases were severe.

Rarely, at the beginning of treatment, the patient's plasma calcium and phosphate levels may decrease; usually these changes are mild and do not cause symptoms.
Reporting of side effects
If you experience any side effects, 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Optinate

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 Optinate 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: monohydrate lactose (see section 2), crospovidone A,
magnesium stearate and microcrystalline cellulose
Coating: hypromellose, macrogol, hydroxypropylcellulose, anhydrous colloidal silica,
titanium dioxide [E171], yellow iron oxide [E172], red iron oxide [E172].
Description of the Appearance of Optinate and Pack Contents
The Optinate 35 mg film-coated tablets are light orange, oval-shaped tablets measuring 11.7 x 5.8 mm,
marked with the letters “RSN” on one side and “35 mg” on the other. They are available in packs of 1, 2, 4, 10, 12 or 16 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Theramex Ireland Limited
3rd Floor, Kilmore House, Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland
Manufacturer
Warner Chilcott Deutschland GmbH, - Dr.-Otto-Röhm-Str. 2-4, - 64331 Weiterstadt,
Germany
Balkanpharma-Dupnitsa AD - 3, Samokovsko Shosse Str. - 2600 Dupnitsa, Bulgaria
This medicinal product is authorized in the Member States of the European Economic Area
under the following names:
Italy: Optinate 35mg film-coated tablets
Sweden: Avestra Septimum 35 mg film-coated tablets

Patient information leaflet

Optinate 75 mg film-coated tablets

risedronate sodium
Please read this entire 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 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 Optinate is and what it is used for
What you need to know before taking Optinate
How to take Optinate
Possible side effects
How to store Optinate
Contents of the pack and other information

1. What Optinate is and what it is used for

What Optinate is
Optinate belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. It acts directly on the bones, strengthening them and thereby reducing the risk of fractures.
Bone is a living tissue. Old bone matrix is constantly being removed and replaced with new bone.
Postmenopausal osteoporosis is a condition that develops in women after menopause, in which women's bones become more fragile and more prone to fractures following falls or stress.
Bones most susceptible to fracture are those in the spine, hip, and wrist, although any bone in the body may fracture. Fractures associated with osteoporosis may also cause back pain, loss of height, and dorsal curvature (dowager's hump). Many patients with osteoporosis have no symptoms and are unaware they have the condition.
What Optinate is indicated for
For the treatment of osteoporosis in postmenopausal women.

2. What you need to know before taking Optinate

Do not take Optinate

If you are allergic to sodium risedronate or any of the other ingredients of this medicine (listed in section 6);
If your doctor has told you that you have hypocalcaemia (low calcium levels in the blood);
If you are pregnant, think you may be pregnant, or are planning to become pregnant;
If you are breast-feeding;
If you have severe kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Optinate:

If you are unable to remain upright (sitting or standing) for at least 30 minutes.
If you have a disorder of bone and mineral metabolism (such as vitamin D deficiency, parathyroid hormone abnormalities, conditions which both cause low levels of calcium in the blood).
If you have or have previously had problems with your oesophagus (the part of the digestive tract that connects the mouth to the stomach), for example difficulty or pain when 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 you have or have had pain, swelling or numbness in the jaw and/or mandible, or a sensation of “heavy jaw and/or mandible”, or tooth loss.
If you are undergoing dental treatment or are scheduled for dental surgery, inform your dentist that you are being treated with Optinate.

If you have any of these conditions, your doctor will advise you on how to take Optinate.
Children and adolescents
The use of sodium risedronate is not recommended in children under 18 years of age due to insufficient data on safety and efficacy.
Other medicines and Optinate
Medicines containing any of the following ingredients reduce the effect of Optinate if taken at the same time:

calcium
magnesium
aluminium (e.g. some preparations for digestive problems)
iron.

These medicines should be taken at least 30 minutes after taking Optinate tablet.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Optinate with food and drink
It is very important NOT to take the Optinate tablet with food or drinks (except tap water), as this may make the medicine less effective.
In particular, do not take this medicine with dairy products (including milk), as they contain calcium (see section 2 “Other medicines and Optinate”).
Food and drinks (except tap water) should be taken at least 30 minutes after taking the Optinate tablet.
Pregnancy and breast-feeding
DO NOT take Optinate if you are or think you may be pregnant, or if you are planning a pregnancy (see section 2 “Do not take Optinate”). The potential risks associated with the use of sodium risedronate (the active substance in Optinate) in pregnant women are unknown.
DO NOT take Optinate if you are breast-feeding (see section 2, “Do not take Optinate”).
Optinate should only be used for the treatment of postmenopausal women.
Driving and using machines
Optinate has no known effects that interfere with the ability to drive or use machinery.
Optinate contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Optinate

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose:
Optinate tablets should be taken on the SAME two consecutive days every month, for example, the 1st and 2nd day of the month, or the 15th and 16th day of the month.
Choose TWO consecutive days that best fit your routine to take Optinate. Take ONE tablet of Optinate in the morning on the first chosen day. Take the SECOND tablet in the morning on the following day.
Repeat this every month, always keeping the same two consecutive days. To help you remember when to take the next tablets, you may mark the dates in advance on your calendar with a pen or a sticker.

WHEN to take the Optinate tablet
The Optinate tablet should be taken at least 30 minutes before the first food, drink (except tap water), or other medicine of the day.

HOW to take the Optinate tablet

The tablet should be taken while keeping your upper body in an upright position (standing or sitting) to help avoid stomach irritation.
The tablet should be swallowed with at least one full glass (120 ml) of tap water. Do not take the tablet with mineral water or any other beverage besides tap water.
The tablet should be swallowed whole and must not be crushed or chewed.
After swallowing the tablet, remain upright and avoid lying down for at least 30 minutes.

Your doctor will advise you if you need calcium and vitamin supplements, should your dietary intake of these nutrients be insufficient.

If you take more Optinate than you should
If you or anyone else has accidentally taken more Optinate tablets than prescribed, drink a full glass of milk and contact a doctor immediately.

If you forget to take Optinate:

| Missed dose | Next monthly dose is | What to do | |-------------|------------------------|------------| | Both the 1st and 2nd tablet | More than 7 days away | Take the 1st tablet the following morning, and the 2nd tablet the morning after that | | | Within 7 days | Do not take the missed tablets | | Only the 2nd tablet | More than 7 days away | Take the 2nd tablet the following morning | | | Within 7 days | Do not take the missed tablet |

The following month, take the tablets as usual.

In any case:

If you forget to take your Optinate tablet in the morning, do not take it later in the day
Do not take three tablets within the same week

If you stop taking Optinate
If you stop treatment, you may begin to lose bone mass.
Therefore, it is recommended that you consult your doctor before stopping the treatment.

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

4. Possible side effects

Symptoms of a severe allergic reaction such as:
- Swelling of the face, tongue or throat
- Difficulty swallowing
- Hives and breathing difficulties
  The frequency of this side effect is unknown (cannot be estimated from the available data).
Severe skin reactions which may include blistering skin reactions.
The frequency of this side effect is unknown (cannot be estimated from the available data).

Consult your doctor promptly if you experience any of the following side effects:

Eye inflammation, usually with pain, redness and sensitivity to light.
The frequency of this side effect is unknown (cannot be estimated from the available data).
Orbital inflammation – inflammation of the structures surrounding the eyeball. Symptoms may include: pain, swelling, redness, protrusion of the eyeball and vision disturbances.
The frequency of this side effect is unknown (cannot be estimated from the available data).
Osteonecrosis of the jaw and/or maxilla (osteonecrosis) associated with delayed healing and infection, often following tooth extraction (see section 2, "Warnings and precautions").
The frequency of this side effect is unknown (cannot be estimated from the available data).
Oesophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain or onset/worsening of heartburn. This side effect is uncommon (may affect up to 1 in 100 people). Rarely, an unusual femur fracture 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 could be an early sign of a possible femur fracture.

However, other side effects observed in clinical studies have generally been mild in severity and have not required discontinuation of treatment.
Common side effects (may affect up to 1 in 10 people)

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

Uncommon side effects (may affect up to 1 in 100 people)

Inflammation or ulceration of the oesophagus (the part of the digestive tract 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 first part of the intestine where food passes after being digested in the stomach).
Inflammation of the coloured part of the eye (iris) (red, painful eyes with possible changes in vision).
Fever and/or flu-like symptoms.

Rare side effects (may affect up to 1 in 1000 people)

Inflammation of the tongue (red, swollen, possibly painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach).
Liver function test abnormalities have been reported. This may only be detected through blood tests.

During the post-marketing period of the medicine, the following side effects have been reported:

Very rare: Contact your doctor if you experience ear pain, ear discharge and/or ear infection. These events could be signs of bone damage in the ear.
Frequency not known:
- Hair loss and/or loss of body hair
- Liver disorders; some cases were severe.

Rarely, at the start of treatment, the patient's plasma calcium and phosphate levels may decrease; these changes are usually mild and do not cause symptoms.
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Optinate

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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. Contents of the pack and other information

What Optinate contains
The active substance is sodium risedronate. Each tablet contains 75 mg of sodium risedronate,
equivalent to 69.6 mg of risedronic acid.
The other components are:
Tablet core: microcrystalline cellulose, crospovidone A, magnesium stearate.
Coating: hypromellose, macrogol 400, macrogol 8000, hydroxypropylcellulose, anhydrous colloidal silica, titanium dioxide (E171), iron oxide red (E172).
Description of the appearance of Optinate and the contents of the pack
The Optinate 75 mg film-coated tablets are oval-shaped, pink in colour, 11.7 x 5.8 mm in size, with the letters “RSN” on one side and “75 mg” on the other. They are available in blisters containing 2, 4, 6 or 8 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Theramex Ireland Limited
3rd Floor, Kilmore House, Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland
Manufacturer
Warner Chilcott Deutschland GmbH - Dr.-Otto-Rohm-Str. 2-4, - 64331 Weiterstadt,
Germany
Balkanpharma-Dupnitsa AD - 3, Samokovsko Shosse Str. - 2600 Dupnitsa, Bulgaria
This medicinal product is authorised in the Member States of the European Economic Area
under the following names:
Italy: Optinate 75 mg film-coated tablets
Sweden: Avestra 75 mg film-coated tablets