Actonel

Patient Information Leaflet

Actonel 5 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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Actonel is and what it is used for

What Actonel is
Actonel 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 develops in women after
menopause, during which women's bones 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 receiving long-term corticosteroid therapy.
Bones most susceptible to fracture are those of 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 (kyphosis). Many patients with osteoporosis have no symptoms and
are unaware they have the condition.
What Actonel is indicated for
For the treatment of osteoporosis

• in postmenopausal women
• for the prevention of osteoporosis in women at high risk of osteoporosis (including low bone density, early menopause or family history of osteoporosis)
• in postmenopausal women undergoing long-term systemic corticosteroid therapy. Actonel maintains or increases bone mass.

2. What you need to know before taking Actonel

Do not take Actonel:

• If you are allergic to risedronate sodium or 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 Actonel if:

• You are unable to remain upright (sitting or standing) for at least 30 minutes;
• 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);
• You have or have previously had problems with your oesophagus (the tube connecting the mouth to the stomach). For example, you may have experienced pain or difficulty swallowing food, or you have previously been diagnosed with Barrett's oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus);
• Your doctor has told you that you are intolerant to certain sugars (such as lactose);
• You have or have previously had pain, swelling or numbness in the jaw and/or mandible, or a sensation of "heavy jaw and/or mandible", or tooth loss;
• You are undergoing dental treatment or are scheduled for dental surgery, inform your dentist that you are being treated with Actonel. If you have any of these conditions, your doctor will advise you on how to take Actonel.

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

Other medicines and Actonel
Medicines containing any of the following substances reduce the effect of Actonel 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 the Actonel tablet.

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

Actonel with food and drinks
It is very important NOT to take the Actonel 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 Actonel"). Food and drinks (except tap water) should be taken at least 30 minutes after the Actonel tablet.

Pregnancy and breastfeeding
DO NOT take Actonel if you are or think you may be pregnant, or if you are planning a pregnancy (see section 2, "Do not take Actonel"). The potential risks associated with the use of risedronate sodium (the active substance in Actonel) in pregnant women are unknown.
DO NOT take Actonel if you are breastfeeding (see section 2, "Do not take Actonel").

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

Actonel 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").

Actonel 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 Actonel

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

The recommended dose is ONE Actonel tablet (5 mg of sodium risedronate) once daily.

For your convenience, the days of the week are printed on the back of the blister pack to help you remember to take your tablet.

WHEN to take the Actonel tablet

It is very IMPORTANT to take Actonel at least 30 minutes before eating or drinking any food or beverages (except tap water) or taking any other medicine during the day.

If taking Actonel before breakfast is not possible, Actonel may be taken every day at the same time on an empty stomach, using one of the following options:

• Between meals: at least 2 hours after the last intake of food, drink (except tap water), or other medicine. Do not eat or drink (except tap water) for 2 hours after taking the Actonel tablet.

Or

• In the evening: Actonel should be taken at least 2 hours after the last intake of food, drink (except tap water), or medicinal product of the day. Actonel must be taken at least 30 minutes before going to bed.

HOW to take the Actonel tablet

• Take the tablet while keeping your torso in an upright position (standing or sitting) to help avoid heartburn.
• Swallow the tablet with at least one 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 or vitamin supplements, in case your dietary intake of these substances is insufficient.

If you take more Actonel than you should

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

If you forget to take Actonel

If you have forgotten to take your tablet at the scheduled time, take it as soon as possible, following the previous instructions (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 Actonel

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 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 Actonel and contact 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 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).

Contact 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 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 (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 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).
  Unusual femoral fractures may rarely occur, particularly in patients on long-term osteoporosis treatment. 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 have generally been 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, cramps or stomach 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 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 1,000 people)

• Inflammation of the tongue (red, swollen, possibly painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach).
• Abnormal liver function test results. This condition can only be diagnosed through blood tests.

During post-marketing use, the following side effects have been reported:

• Very rare: 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.
• Frequency not known:
• Hair loss and/or body hair loss
• Liver disorders, in some cases 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 Actonel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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 Actonel 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: 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 Actonel and the contents of the pack
The 5 mg film-coated tablets of Actonel 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 containing 14, 28 (2x14), 84 (6x14), 140 (10x14) tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Theramex Ireland Limited
Kilmore House, Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland
Manufacturer:
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:
Belgium: Actonel 5 mg filmomhulde tabletten,
Actonel 5 mg comprimé pelliculé,
Actonel 5 mg Filmtabletten
France: Actonel 5 mg comprimé pelliculé
Germany: Risedronat Theramex 5 mg Filmtabletten
Italy: Actonel 5 mg compresse rivestite con film
Luxembourg: Actonel 5 mg comprimé pelliculé
Netherlands: Actonel 5 mg, filmomhulde tabletten
Spain: Actonel 5 mg comprimidos recubiertos con película
Sweden: Optinate 5 mg filmdragerade tabletter

Patient Information Leaflet: Information for the patient

Actonel 30 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 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:

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

1. What Actonel is and what it is used for

What Actonel is
Actonel 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 material is constantly being removed and
replaced with new bone.
Paget's disease occurs when this process, known as remodelling,
occurs too rapidly and in a disordered manner. The new bone formed is
weaker than normal, and the affected bones may become enlarged, painful and prone to fracture. Actonel restores the normal bone remodelling process, leading to a stronger bone structure.
What Actonel is indicated for
Actonel is used to treat Paget's disease of bone (osteitis deformans).

2. What you need to know before taking Actonel

Do not take Actonel:

• 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 breastfeeding
• If you have severe kidney problems.

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

• 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 your mouth to your stomach). For example, you may have had or currently have pain or difficulty swallowing food, or 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 previously had pain, swelling or numbness in the jaw and/or mandible, 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 Actonel. If you have any of these conditions, your doctor will advise you on how to proceed with taking Actonel.

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 Actonel
Medicines containing any of the following substances reduce the effect of Actonel 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 Actonel.

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

Actonel with food and drink
It is very important NOT to take the Actonel 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 Actonel"). Food and drinks (except tap water) should be consumed at least 30 minutes after taking the Actonel tablet.

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

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

Actonel 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").

Actonel 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 Actonel

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 Actonel tablet (30 mg of sodium risedronate)
once daily.
The recommended duration of treatment is normally 2 months.
For your convenience, the days of the week are printed on the back of the blister
to help you remember to take the tablet.

WHEN to take the Actonel tablet
It is very important to take Actonel at least 30 minutes before taking
food or beverages (except tap water) or any other medicine during the day.
If taking Actonel before breakfast is not possible, Actonel may be taken every day at the same time on an empty stomach, using one of the following options:

• Between meals: at least 2 hours after the last intake of food, drink (except tap water), or other medicine. Do not eat or drink (except tap water) for 2 hours after taking the Actonel tablet.

Or

• In the evening: Actonel should be taken at least 2 hours after the last intake of food, drink (except tap water), or medicinal product of the day. Actonel must be taken at least 30 minutes before going to bed.

HOW to take the Actonel tablet

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

Your doctor will advise you if you need calcium or vitamin supplements, should your diet not provide sufficient amounts of these substances.

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

If you forget to take Actonel
If you have forgotten to take the tablet at the scheduled 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 Actonel
It is recommended that you consult your doctor before stopping treatment earlier than prescribed.
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 will experience them.
Stop treatment with Actonel 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 and difficulty breathing

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 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 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 bones (mandible and/or maxilla) 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 receiving long-term treatment 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 femur fracture.

However, other side effects observed in clinical studies have generally been 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.
• 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 first part of the intestine receiving digested food 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 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 by blood tests.

The following side effects have been reported during post-marketing experience:

• 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 body hair loss
• Liver disorders, in some cases severe.

Rarely, at the beginning of treatment, plasma levels of calcium and phosphate may decrease; usually these changes are mild and do not cause symptoms.
During a clinical study in patients with Paget's disease, the following additional side effects were also observed: visual disturbances, difficulty breathing, 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 at night, unusual swellings or lumps, chest pain, skin rash, runny nose, 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 the following website:
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 Actonel

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 Actonel 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 ingredients are:
Tablet core: monohydrate lactose (see section 2), crospovidone,
magnesium stearate and microcrystalline cellulose.
Coating: hypromellose, macrogol, hydroxypropylcellulose, anhydrous colloidal silica,
titanium dioxide [E171].
Description of the appearance of Actonel and package contents
Actonel 30 mg film-coated tablets are oval-shaped, white tablets marked with the letters “RSN” on one side and “30 mg” on the other. They are available in packages containing 1x3, 1x14, and 28 (2x14) tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Theramex Ireland Limited
Kilmore House, Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland
Manufacturer:
Balkanpharma-Dupnitsa AD
3, Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
This medicinal product is authorised in the European Economic Area countries
under the following names:
Belgium: Actonel 30 mg filmomhulde tabletten,
Actonel 30 mg comprimé pelliculé,
Actonel 30 mg Filmtabletten
France: Actonel 30 mg comprimé pelliculé
Germany: Actonel 30 mg Filmtabletten
Greece: Actonel 30 mg επικαλυμμένα με λεπτό υμένιο δισκία
Italy: Actonel 30 mg compresse rivestite con film
Luxembourg: Actonel 30 mg comprimé pelliculé
The Netherlands: Actonel 30 mg filmomhulde tabletten
Spain: Actonel 30 mg comprimidos recubiertos con película
Sweden: Optinate 30 mg filmdragerade tabletter

Patient Information Leaflet: Information for the patient

Actonel 35 mg film-coated tablets

risedronate sodium
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 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Actonel and what is it used for

What is Actonel
Actonel 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 living tissue. Old bone is constantly being removed and replaced with new bone.
Postmenopausal osteoporosis is a condition that develops in women after menopause,
causing their bones to become more fragile and more prone to fractures following falls or minor trauma. Osteoporosis can also occur in men due to various causes, including aging and/or low levels of the male hormone testosterone.
Bones most susceptible to fracture include 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 kyphosis (dowager's hump). Many patients with osteoporosis have no symptoms and may not even be aware they have the condition.
What Actonel is indicated for
Treatment of osteoporosis in postmenopausal women, including those with severe osteoporosis. It reduces the risk of vertebral and hip fractures.
Treatment of osteoporosis in men at high risk of fractures.

2. What you need to know before taking Actonel

Do not take Actonel:

• 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 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 breastfeeding
• If you have severe kidney problems.

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

• If you are unable to remain upright (sitting or standing) for at least thirty 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, you may have had pain or difficulty swallowing food, or you may have 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 previously had pain, swelling or numbness in the jaw and/or mandible, a sensation of “heavy jaw and/or mandible”, or tooth loss.
• If you are undergoing dental treatment or need to have dental surgery, inform your dentist that you are being treated with Actonel. If you have any of these conditions, your doctor will advise you on how to take Actonel.

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 Actonel
Medicines containing any of the following ingredients reduce the effect of Actonel if taken at the same time:

• calcium
• magnesium
• aluminium (e.g. some preparations for digestive problems)
• iron. These medicines should be taken at least thirty minutes after taking the Actonel tablet.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Actonel with food and drinks
It is very important NOT to take the Actonel 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 Actonel”). Food and drinks (except tap water) should be taken at least 30 minutes after taking the Actonel tablet.
Pregnancy and breastfeeding
DO NOT take Actonel if you are or think you might be pregnant, or if you are planning a pregnancy (see section 2 “Do not take Actonel”). The potential risks associated with the use of sodium risedronate (the active substance in Actonel) during pregnancy are unknown.
DO NOT take Actonel if you are breastfeeding (see section 2 “Do not take Actonel”).
Actonel should only be used for the treatment of postmenopausal women and men.
Driving and using machines
Actonel has no known effects that would interfere with the ability to drive or use machinery.
Actonel 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”).
Actonel 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 Actonel

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 Actonel tablet (35 mg of sodium risedronate) once
weekly.
Choose a day of the week that best fits your routine. Every
week, take one Actonel tablet on the chosen day.
For your convenience, to help you take the tablet on the same day each
week, the Actonel 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 Actonel tablet. We also recommend that you write down the dates
when you take the tablet.
WHEN to take the Actonel tablet
Take the Actonel tablet at least 30 minutes before the first food, drink
(except tap water) or other medicine of the day.
HOW to take the Actonel tablet

• Take the tablet while keeping your body upright (standing or sitting) to avoid stomach irritation or heartburn.
• Swallow the tablet with at least one glass (120 ml) of tap water.
• Swallow the tablet whole; do not crush or chew it.
• After taking the tablet, remain upright (do not lie down) for at least 30 minutes.

Your doctor will advise you if you need calcium or vitamin supplements, in case your
diet does not provide sufficient amounts of these substances.
If you take more Actonel than you should
If you or anyone else has accidentally taken more Actonel tablets
than prescribed, drink a full glass of milk and contact a doctor immediately.
If you forget to take Actonel
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 missed tablet.
If you stop taking Actonel
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 how to use this medicine, ask 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 Actonel and contact 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 and 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 rashes.
  The frequency of this side effect is unknown (cannot be estimated based on available data).

Contact 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).
  Unusual femur fractures may rarely 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 the thigh, hip or groin, as this could be an early sign of a possible femoral 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, malaise, stomach ache, cramps or stomach 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 1,000 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 can only be diagnosed through blood tests.

The following side effects have been reported during post-marketing use:

• Very rare: 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.
• Frequency not known:
• Hair loss and/or loss of body hair
• Liver disorders, some cases being 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 Actonel

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 Actonel 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 [E 172], red iron oxide [E 172].
Description of the appearance of Actonel and contents of the pack
Actonel 35 mg film-coated tablets are oval-shaped, light orange in colour, measuring 11.7 x 5.8 mm, and marked with the letters “RSN” on one side and “35 mg” on the other. They are available in packs containing 1, 2, 4, 10, 12 or 16 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Theramex Ireland Limited
Kilmore House, Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland
Manufacturer:
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:
Austria: Actonel einmal wöchentlich 35 mg Filmtabletten
Belgium: Actonel 35 mg Wekelijks filmomhulde tabletten,
Actonel 35 mg hebdomadaire comprimé pelliculé,
Actonel 35 mg Wöchentlich Filmtabletten
Cyprus: Actonel OAW / ''μία φορά την εβδομάδα''
Denmark: Optinate Septimum filmovertrukne tabletter
Finland: Optinate Septimum 35 mg kalvopäällysteiset tabletit
France: Actonel 35 mg comprimé pelliculé
Germany: Risedronat Theramex einmal wöchentlich 35 mg Filmtabletten
Greece: Actonel OAW/''μία φορά την εβδομάδα''
Hungary: Actonel 35 mg filmtabletta
Iceland: Optinate Septimum 35 mg filmuhúðaðar töflur
Italy: Actonel 35 mg compresse rivestite con film
Luxembourg: Actonel 35 mg hebdomadaire comprimé pelliculé
Malta: Actonel “Once a Week” 35 mg film-coated tablet
Netherlands: Actonel Wekelijks 35 mg, filmomhulde tabletten
Portugal: Actonel 35 mg comprimidos revestidos por película
Spain: Actonel semanal 35 mg comprimidos recubiertos con película
Sweden: Optinate Septimum 35 mg filmdragerade tabletter

Patient information leaflet

Actonel 75 mg film-coated tablets

risedronate sodium
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 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Actonel is and what it is used for

What Actonel is
Actonel 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, causing women's bones to become more fragile and more prone to fractures
following falls or minor trauma.
Bones most susceptible to fracture include 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 (kyphosis). Many patients with osteoporosis do not have symptoms and are unaware
they have the condition.
What Actonel is indicated for
For the treatment of osteoporosis in postmenopausal women.

2. What you need to know before taking Actonel

Do not take Actonel:

• 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 Actonel:

• If you are unable to remain upright (sitting or standing) for at least thirty 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 esophagus (the tube connecting the mouth to the stomach). For example, you may have or have had pain or difficulty swallowing food, or 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 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 need dental surgery, inform your dentist that you are being treated with Actonel.

If you have any of these conditions, your doctor will advise you on how to proceed with taking Actonel.
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 Actonel
Medicines containing any of the following substances reduce the effect of Actonel if taken at the same time:

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

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Actonel with food and drinks
It is very important NOT to take the Actonel 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 Actonel”).
Food and drinks (except tap water) should be consumed at least 30 minutes after taking the Actonel tablet.
Pregnancy and breastfeeding
DO NOT take Actonel if you are or think you may be pregnant, or if you are planning a pregnancy (see section 2 “Do not take Actonel”). The potential risks associated with the use of sodium risedronate (the active substance in Actonel) in pregnant women are unknown.
DO NOT take Actonel if you are breastfeeding (see section 2 “Do not take Actonel”).
Actonel should only be used for the treatment of postmenopausal women.
Driving and using machines
Actonel has no known effects that interfere with the ability to drive or use machinery.
Actonel 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 Actonel

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

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

WHEN to take the Actonel tablet
Take the Actonel tablet at least 30 minutes before the first food, drink (except tap water), or other medicine of the day.

HOW to take the Actonel tablet

• The tablet must be taken while keeping your upper body upright (standing or sitting) to avoid stomach irritation.
• Swallow the tablet with at least one glass (120 ml) of tap water. Do not take the tablet with mineral water or any beverage other than 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, in case your diet does not provide sufficient amounts.

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

If you forget to take Actonel

| If you forgot | What to do | |--------------|------------| | The next monthly dose is more than seven days away | Take the 1st tablet the next morning and the 2nd tablet the following morning | | The next monthly dose is within seven days | Do not take the tablets you missed | | Only the 2nd tablet of the monthly dose is missed and the next monthly dose is more than seven days away | Take the 2nd tablet the following morning | | Only the 2nd tablet of the monthly dose is missed and the next monthly dose is within seven days | Do not take the tablet you missed |

The following month, take the tablets as usual.

In any case:

• If you forget to take your Actonel tablet in the morning, do NOT take it later during the day.
• Do NOT take three tablets within the same week.

If you stop taking Actonel
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

Like all medicines, this medicine can cause side effects, although not
everyone experiences them.
Stop treatment with Actonel and contact 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 difficulty breathing The frequency of this side effect is not known (cannot be estimated from the available data).
• Severe skin reactions which may include blistering skin reactions. The frequency of this side effect is not known (cannot be estimated from the available data).

Contact 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 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 not known (cannot be estimated from the available data).
• Osteonecrosis of the jaw and/or maxilla (bone necrosis) 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 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 femoral fracture 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 the thigh, hip or groin, as this could be an early sign of a possible femoral fracture.

However, other side effects observed in clinical studies have generally been mild in severity and did not require 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 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 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 1,000 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 can only be diagnosed through blood tests.

The following side effects have been reported during post-marketing use:

• 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 of which were severe.

Rarely, at the beginning of treatment, plasma levels of calcium and phosphate in the patient 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 Actonel

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 Actonel 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 [E 172].

Description of the Appearance of Actonel and Contents of the Package
Actonel 75 mg film-coated tablets are oval-shaped, pink in colour, measuring 11.7 x 5.8 mm, marked 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 Authorization Holder and Manufacturer
Marketing Authorization Holder:
Theramex Ireland Limited
Kilmore House, Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland

Manufacturer:
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:
Belgium: Actonel 75 mg filmomhulde tabletten,
Actonel 75 mg comprimé pelliculé,
Actonel 75 mg Filmtabletten
Cyprus: Actonel / ''2 consecutive days per month'' 75 mg film-coated tablets
France: Actonel 75 mg comprimé pelliculé
Germany: Risedronat Theramex 75 mg Filmtabletten
Greece: Actonel / ''2 συνεχόμενες ημέρες το μήνα'' 75 mg επικαλυμμένα με λεπτό υμένιο δισκία
Italy: Actonel 75 mg film-coated tablets
Luxembourg: Actonel 75 mg comprimé pelliculé
Netherlands: Actonel 75 mg, filmomhulde tabletten
Romania: Actonel 75 mg comprimate filmate
Slovenia: Actonel 75 mg filmsko obložene tablete
Spain: Actonel 75 mg comprimidos recubiertos con película
Sweden: Optinate 75 mg filmdragerade tabletter

Patient Information Leaflet

Actonel 35 mg gastro-resistant tablets

sodium risedronate
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 could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Actonel is and what it is used for

What Actonel is
Actonel belongs to a group of non-hormonal medicines called bisphosphonates,
which are used to treat bone diseases. It works 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 develops in women after
menopause, in which bones become weaker, more fragile and more prone to fractures
following falls or minor trauma.
Osteoporosis can also occur in men due to a variety of causes, including
ageing and/or low levels of the male hormone testosterone.
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 curvature of the back (kyphosis). Many patients with osteoporosis have no symptoms and are unaware
they have the condition.
What Actonel is used for
Treatment of osteoporosis in postmenopausal women, including cases of severe osteoporosis. It reduces the risk of vertebral and hip fractures.

2. What you need to know before taking Actonel

Do not take Actonel:

• 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 Actonel:

• 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 lead to low calcium levels in the blood).
• If you have or have previously had problems with your esophagus (the tube connecting the mouth to the stomach). For example, you may have had or currently have pain or difficulty swallowing food, or you may have previously been diagnosed with Barrett’s esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).
• If you have had or currently have pain, swelling or numbness in the jaw and/or mandible, a sensation of “heavy jaw and/or mandible”, or tooth loss.
• If you are undergoing dental treatment or need dental surgery, inform your dentist that you are being treated with Actonel.

If you have any of these conditions, your doctor will advise you on how to proceed with taking Actonel.
Children and adolescents
The use of Actonel is not recommended in children under 18 years of age due to
insufficient data on safety and efficacy.
Other medicines and Actonel
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 Actonel
when taken at the same time:

• Calcium
• Magnesium
• Aluminium (e.g. some preparations for digestive problems)
• Iron

Take these medicines at a different time of day compared to Actonel.
Actonel with food and drink
Actonel should be taken immediately after breakfast.
Pregnancy and breastfeeding
Do not take Actonel if you are pregnant, suspect you may be pregnant, or are planning a
pregnancy (see section 2, “Do not take Actonel”).
Do not take Actonel if you are breastfeeding (see section 2, “Do not take Actonel”).
Actonel should only be used for the treatment of postmenopausal women.
Driving and using machines
Actonel has no known effects that interfere with the ability to drive or use machinery.
Actonel contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant tablet,
i.e. essentially “sodium-free”.

3. How to take Actonel

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 Actonel tablet (35 mg of sodium risedronate) once a week.
Choose a day of the week that best fits your routine. Every week, take one Actonel tablet on the chosen day.
For your convenience, to help you remember to take the tablet on the same day each week, the Actonel packaging has a special feature:
On the back of the blister pack there are boxes/spaces. Mark the day of the week you have chosen for taking the Actonel tablet. In addition, write down the dates when you take the tablet.

When to take Actonel
The Actonel tablet should be taken immediately after breakfast. The risk of stomach pain is increased if Actonel is taken on an empty stomach.

How to take Actonel

• Actonel is for oral use.
• Take the tablet while keeping your body in an upright position (you may be sitting or standing) to help avoid heartburn.
• Swallow the tablet with at least one glass (120 ml) of tap water.
• The tablet must be swallowed whole. Do not suck or chew the tablet.
• After taking the tablet, do not lie 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 Actonel than you should
If you or anyone else has accidentally taken more tablets than prescribed, drink a full glass of milk and contact a doctor immediately.

If you forget to take Actonel
If you have forgotten to take the tablet on your chosen day, take it on the day you remember. Then resume taking one tablet once a week on your regular day. Do not take two tablets on the same day.

If you stop taking Actonel
If you stop treatment, you may begin to lose bone mass. Therefore, it is recommended that you consult your doctor before considering 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 Actonel and contact 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 difficulty breathing
    The frequency of this side effect is not known (cannot be estimated from the available data).

• Severe skin reactions such as:

  • Blisters on the skin, mouth, eyes and other mucous membranes (genitals) (Stevens-Johnson syndrome)
  • Palpable red spots on the skin (leukocytoclastic vasculitis)
  • Red rash affecting many parts of the body and/or shedding of the top layer of the skin (toxic epidermal necrolysis).
    The frequency of this side effect is not known (cannot be estimated from the available data).
    Contact 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 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 not known (cannot be estimated from the 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 not known (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 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 have generally been mild in severity and have not required discontinuation of treatment.
Other possible side effects:
Common side effects (may affect up to 1 in 10 people):

• Indigestion, malaise, stomach discomfort, cramps or stomach upset, constipation, feeling of fullness, bloating, diarrhoea, vomiting, abdominal pain
• Bone, muscle or joint pain
• Headache

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

• Influenza-like illness
• Decrease in the number of white blood cells in the blood
• Depression
• Dizziness, numbness, tingling or burning sensation, decreased sensation
• Inflammation of the coloured part of the eye (iris) (red, painful eyes with possible changes in vision), inflammation of the outer layer of the eye and the inner surface of the eyelids (conjunctivitis), eye redness, blurred vision
• Hot flushes, low blood pressure
• Cough
• 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), oesophageal or gastric reflux, gastritis, increased stomach acid, stomach hernia, intestinal inflammation, intestinal distension, belching, flatulence, blood in the stools, gastrointestinal bleeding, heartburn, haemorrhoids, faecal incontinence
• Mouth blisters, swelling of the tongue and lips, dry mouth, gingivitis, mouth ulcers
• Skin redness, rash, itching, purple spots on the skin, allergic dermatitis
• Muscle weakness/tiredness, muscle spasms, back pain, limb pain, jaw and/or maxilla pain, joint pain, neck pain
• Kidney stones
• Ovarian cyst
• Fatigue, chills, influenza-like syndrome, chest pain, fever, facial or generalised swelling, pain, exhaustion
• Increased activity of the parathyroid gland
• Decreased plasma levels of calcium and phosphate, increased plasma calcium levels, decreased platelet count, irregular heart rate, occult blood in stools, abnormalities in urine tests
• Allergic reactions

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

• Narrowing of the oesophagus (the tube connecting the mouth to the stomach), inflammation of the tongue.
• Abnormal liver function tests have been reported. This can only be diagnosed by blood tests.

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 events could be signs of bone damage in the ear.

The following side effects have been reported during post-marketing experience
(frequency not known):

• Hair loss
• Liver disorders, some of which were severe.

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 Actonel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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 Actonel 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:
Microcrystalline cellulose, anhydrous colloidal silica, disodium edetate, sodium starch glycolate, stearic acid, magnesium stearate.
Enteric coating:
Methacrylic acid – ethyl acrylate copolymer (1:1), triethyl citrate, talc, yellow iron oxide
E 172, simethicone, polysorbate 80.
Description of the appearance of Actonel and package contents
Actonel tablets are oval-shaped, yellow, with "EC 35" engraved on one side.
The dimensions of the tablets are as follows: width 13 mm, length 6 mm.
Pack sizes of 1, 2, 4, 10, 12 or 16 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Theramex Ireland Limited
Kilmore House, Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland
Manufacturer:
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:
Belgium: Actonel 35 mg wekelijks maagsapresistente tabletten
France: Actonel GR 35 mg comprimé gastro-résistant
Germany: Actonel einmal wöchentlich 35 mg magensaftresistente Tabletten
Greece: Actonel GR
Italy: Actonel
Netherlands: Actonel Wekelijks MSR35 mg, maagsapresistente tabletten
Portugal: Actonel 35 mg comprimido gastrorresistente
Romania: Actonel 35 mg comprimate gastrorezistente
Spain: Actonel semanal 35 mg comprimidos gastroresistentes
Sweden: Optinate Septimum