ACTONEL 5 mg Film-Coated Tablets

Зміст інструкції

1. Actonel 5 mg film-coated tablets
   1. What is Actonel and what is it 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. Package Contents and Other Information
2. Actonel 30 mg film-coated tablets
   1. What is Actonel and what is it 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
3. Actonel 35 mg film-coated tablets
   1. What is Actonel and what is it 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
4. Actonel 75 mg film-coated tablets
   1. What is Actonel and what is it used for
   2. What you need to know before taking Actonel
   3. How to take Actonel
5. Take Actonel as prescribed, drink a full glass of milk and consult a doctor.
   1. Possible side effects
   2. How to store Actonel
   3. Contents of the pack and other information
6. Actonel 35 mg gastro-resistant tablets
   1. What is Actonel and what is it 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. Package Contents and Other Information

Actonel 5 mg film-coated tablets

risedronate sodium

Read this leaflet carefully before you start taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 therefore reducing the risk of fractures.
Bone is a living tissue. Old bone material is constantly removed and
replaced with new bone.
Postmenopausal osteoporosis is a disease that develops in women after
menopause, whereby women's bones become more fragile and more prone to fractures
following falls or exertion.
Osteoporosis occurs more easily in women who have reached menopause
early and also in patients treated for prolonged periods with corticosteroid
therapy.
The bones most prone to fracture are those of the spine, hip and
wrist, although all bones in the body can fracture. Fractures associated
with osteoporosis can also cause back pain, loss of height and dorsal curvature
(hunchback). Many patients with osteoporosis have no symptoms and
do not even know they have it.

What is Actonel 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 a family history of osteoporosis)
• in postmenopausal women undergoing systemic corticosteroid therapy for prolonged periods. Actonel maintains or increases bone mass.

2. What you need to know before taking Actonel

Do not take Actonel:

• If you are allergic to risedronic acid 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 level of calcium in the blood);
• If you are pregnant, or if you might be pregnant, or if you are still planning a pregnancy;
• 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 an alteration of bone and mineral metabolism (such as vitamin D deficiency, abnormalities of the parathyroid hormone, conditions that induce both low levels of calcium in the blood).
• If you have or have had problems with the esophagus (the channel connecting the mouth to the stomach). For example, you may have or have had pain or difficulty swallowing food or you have previously been told you suffer from Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).
• If you have been told by your doctor that you have an intolerance to some sugars (such as lactose).
• If you have or have had pain, swelling or numbness in the jaw and/or mandible, or a feeling of “jaw and/or mandible heaviness” or tooth loss.
• If you are undergoing dental treatment or need to undergo dental surgery, inform your dentist that you are being treated with Actonel. If you have any of these problems, your doctor will tell you what to do to take Actonel.

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

Other medicines and Actonel
Medicines that contain any of the following elements reduce the effect of Actonel, if taken at the same time:

• calcium
• magnesium
• aluminum (for example some preparations for digestive problems)
• iron. These medicines must be taken at least thirty minutes after 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 drink
It is very important NOT to take the Actonel tablet with food or drink (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) must be taken at least 30 minutes after the Actonel tablet.

Pregnancy and breastfeeding
DO NOT take Actonel if you are or could be pregnant, or if you are planning a pregnancy (see section 2 “Do not take Actonel”). The potential risks associated with the use of risedronic acid sodium (the active ingredient of Actonel) in pregnant women are not known.
DO NOT take Actonel if you are breastfeeding (see section 2, “Do not take Actonel”).

Driving and using machines
Actonel has no known effects on the ability to drive or operate machinery.

Actonel contains lactose
If your doctor has diagnosed you with an intolerance to some sugars, contact them 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 following exactly the instructions of your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is ONE Actonel tablet (5 mg of risedronate sodium) once
a day.
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 any
food or beverages (except tap water) or other medicine to be taken during
the day.
In the specific case where taking it before breakfast is not possible,
Actonel can be taken every day at the same time, on an empty stomach, in one of
the following ways:

• between meals: at least 2 hours after the last intake of food, beverage (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 must be taken at least 2 hours after the last intake of food, beverage (except tap water) or medicinal product of the day. Actonel must be taken at least 30 minutes before bedtime.

HOW to take the Actonel tablet

• The tablet must be taken while keeping the torso in an upright position (standing or sitting) to avoid heartburn.
• The tablet must be swallowed with at least one glass (120 ml) of tap water.
• The tablet must be swallowed whole and not dissolved or chewed .
• Once the tablet has been swallowed, avoid lying down for 30 minutes.

Your doctor will tell you if you need calcium and vitamin supplements, if your intake of
these substances with your diet is insufficient.

If you take more Actonel than you should
In the event that you or anyone else has accidentally ingested more Actonel tablets than
prescribed, drink a full glass of milk and consult a doctor.

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 previous instructions (e.g. before breakfast, between meals, or in the evening).
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Actonel
If you stop treatment you may begin to lose bone mass. It is therefore recommended
to consult your doctor before stopping therapy.
If you have any doubts 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 immediatelyif 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 not known (cannot be estimated based on available data).
• Severe skin reactions that may include blistering skin reactions. The frequency of this side effect is not known (cannot be estimated based on available data).

Consult your doctor promptlyif any of the following side effects occur:

• 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 visual disturbances. The frequency of this side effect is not known (cannot be estimated based on available data).
• Osteonecrosis of the jaw (osteonecrosis) associated with delayed healing and infection, often after tooth extraction (see section 2, “Warnings and precautions”). The frequency of this side effect is not known (cannot be estimated based on available data).
• Esophageal 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 treated for osteoporosis for a long time. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as this may be an early indication of a possible femur fracture.

However, other side effects observed in clinical studies were generally mild and did not require discontinuation of treatment.

Common side effects(may affect up to 1 in 10 people)

• Indigestion, nausea, stomach pain, cramps or stomach discomfort, constipation, feeling of fullness, flatulence, diarrhea.
• Bone, muscle or joint pain.
• Headache.

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

• Inflammation or ulceration of the esophagus (the channel 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 through which food digested by the stomach passes).
• Inflammation of the colored part of the eye (iris) (red and painful eyes with possible visual disturbances).

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

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

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

• Very rare: See your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes may 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 calcium and phosphate levels may decrease; normally 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, please tell your doctor or pharmacist. You can also report side effects directly through 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 package and on the
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 in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Package Contents and Other Information

What Actonel contains
The active ingredient is sodium risedronate. Each tablet contains 5 mg of risedronate
sodium, equivalent to 4.64 mg of risedronic acid.
The other ingredients are:

Tablet core: lactose monohydrate (see section 2), crospovidone,
magnesium stearate and microcrystalline cellulose.

Coating: hypromellose, macrogol, hydroxypropyl cellulose, anhydrous colloidal silica,
titanium dioxide [E171], yellow iron oxide [E172].

Description of the appearance of Actonel and package contents
Actonel 5 mg film-coated tablets are oval in shape and yellow in colour and bear the letters “RSN” on one side and the inscription “5 mg” on the other. They are
available in packs of 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 film-coated tablets,
Actonel 5 mg coated tablet,
Actonel 5 mg Film tablets
France: Actonel 5 mg coated tablet
Germany: Risedronat Theramex 5 mg Film tablets
Italy: Actonel 5 mg film-coated tablets
Luxembourg: Actonel 5 mg coated tablet
Netherlands: Actonel 5 mg, film-coated tablets
Spain: Actonel 5 mg film-coated tablets
Sweden: Optinate 5 mg film-coated tablets

Actonel 30 mg film-coated tablets

risedronate sodium

Read this leaflet carefully before you start taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 therefore reducing the risk of fractures.
Bone is a living tissue. Old bone material is constantly removed and
replaced with new bone.
Paget's disease occurs when this process, called remodeling,
takes place too quickly and in a disorganized manner. The new bone that is
produced is weaker than normal, and the affected bones may become
enlarged, painful and prone to fracture. Actonel restores the normal process of
bone remodeling, leading to a stronger bone structure.

What is Actonel indicated for
Actonel is used to treat Paget's disease of the bone (deforming osteitis).

2. What you need to know before taking Actonel

Do not take Actonel:

• If you are allergic to risedronic acid 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 level of calcium in the blood)
• If you are pregnant, if you might be pregnant, or if you are still planning a pregnancy
• 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 an alteration of bone and mineral metabolism (such as in the case of vitamin D deficiency, abnormalities of the parathyroid hormone, conditions that induce both low levels of calcium in the blood).
• If you have or have had problems with your esophagus (the channel that connects the mouth to the stomach). For example, you may have or have had pain or difficulty swallowing food or you have previously been told that you suffer from Barrett's esophagus (a condition associated with changes in the cells that line the lower part of the esophagus)
• If you have been told by your doctor that you have an intolerance to some sugars (such as lactose).
• If you have or have had pain, swelling or numbness of the jaw and/or mandible, or a feeling of “jaw and/or mandible heaviness” or tooth loss.
• If you are undergoing dental treatment or need to undergo dental surgery, tell your dentist that you are being treated with Actonel. If you have any of these problems, your doctor will tell you what to do to take Actonel.

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

Other medicines and Actonel
Medicines that contain any of the following elements reduce the effect of Actonel, if taken at the same time:

• calcium
• magnesium
• aluminum (for example some preparations for digestive problems)
• iron. These medicines must be taken at least thirty minutes after the Actonel tablet.

Tell your doctor or pharmacist if you are taking, have recently taken or could 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) must be taken at least 30 minutes after the Actonel tablet.

Pregnancy and breastfeeding
DO NOT take Actonel if you are or could be pregnant, or if you are planning a pregnancy (see section 2 “Do not take Actonel”). The potential risks associated with the use of risedronic acid sodium (the active ingredient of Actonel) in pregnant women are not known.
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 operate machinery.

Actonel contains lactose
If your doctor has diagnosed you with an intolerance to some sugars, contact him 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 following exactly the instructions of your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is ONE tablet of Actonel (30 mg of risedronate sodium)
once a day.
The normally recommended duration of therapy is 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 any
food or beverages (except tap water) or other medicine to be taken
during the day.
In the specific case where administration before breakfast is not
possible, Actonel can be taken every day at the same time, on an empty stomach, in
one of the following ways:

• between meals: at least 2 hours after the last intake of food, beverage (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 must be taken at least 2 hours after the last intake of food, beverage (except tap water) or medicinal product of the day. Actonel must be taken at least 30 minutes before bedtime.

HOW to take the Actonel tablet

• The tablet must be taken while keeping the torso in an upright position (standing or sitting) to avoid heartburn.
• The tablet must be swallowed with at least one glass (120 ml) of tap water.
• The tablet must be swallowed whole and not dissolved or chewed .
• Once the tablet has been swallowed, avoid lying down for 30 minutes.

Your doctor will tell you if you need calcium and vitamin supplements, if your intake of
these substances with your diet is insufficient.

If you take more Actonel than you should
In the event that you or anyone else has accidentally ingested more tablets of
Actonel than prescribed, drink a full glass of milk and consult a
doctor.

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 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
It is recommended to consult your doctor before stopping therapy before
as prescribed.
If you have any doubts 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 consult your doctor immediatelyif 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 not known (cannot be estimated based on
available data).

• Severe skin reactions that may include blistering skin reactions. The frequency of this side effect is not known (cannot be estimated based on available data).

Consult your doctor promptlyif any of the following side effects
occur:

• 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, proptosis (bulging of the eyeball) and visual disturbances. The frequency of this side effect is not known (cannot be estimated based on available data).
• Osteonecrosis of the jaw (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 based on available data).
• Esophageal 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 treated for osteoporosis for a long time. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin as this could be an early indication of a possible femur fracture.

However, other side effects observed in clinical studies were generally mild and did not require discontinuation of treatment.

Common side effects(may affect up to 1 in 10 people)

• Indigestion, nausea, stomach pain, cramps or stomach discomfort, constipation, feeling of fullness, flatulence, diarrhea.
• Bone, muscle or joint pain.
• Headache.

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

• Inflammation or ulceration of the esophagus (the channel 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 digested by the stomach passes).
• Inflammation of the colored part of the eye (iris) (red and painful eyes with possible visual changes).

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

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

The following side effects have been reported during post-marketing surveillance

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

Rarely, at the beginning of treatment, plasma calcium and phosphate levels in the
patient may decrease; these changes are usually 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 nighttime urination,
swellings or unusual bumps, chest pain, skin rash, runny nose, ringing in the ears, and weight loss.

Reporting of side effects
If you experience any side effects, including those not listed in this
leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 package and on the
blister after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Contents of the pack and other information

What Actonel contains
The active ingredient 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: lactose monohydrate (see section 2), crospovidone,
magnesium stearate and microcrystalline cellulose.

Coating: hypromellose, macrogol, hydroxypropyl cellulose, anhydrous colloidal silica,
titanium dioxide [E171].

Description of Actonel and contents of the pack
Actonel 30 mg film-coated tablets are oval in shape and
white in colour and bear the letters “RSN” on one side and the inscription “30 mg” on the other. They
are available in packs of 1x3, 1x14, 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 Member States of the European
Economic Area under the following denominations:
Belgium: Actonel 30 mg film-coated tablets,
Actonel 30 mg coated tablet,
Actonel 30 mg film tablets
France: Actonel 30 mg coated tablet
Germany: Actonel 30 mg film tablets
Greece: Actonel 30 mg film-coated tablets
Italy: Actonel 30 mg film-coated tablets
Luxembourg: Actonel 30 mg coated tablet
The Netherlands: Actonel 30 mg film-coated tablets
Spain: Actonel 30 mg film-coated tablets
Sweden: Optinate 30 mg film-coated tablets

Actonel 35 mg film-coated tablets

risedronate sodium

Read this leaflet carefully before you start taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 therefore reducing the risk of fractures.
Bone is a living tissue. Old bone material is constantly removed and
replaced with new bone.
Postmenopausal osteoporosis is a disease that develops in women after
menopause, whereby women's bones become more fragile and more prone to fractures
following falls or exertion. Osteoporosis can also occur in men for a
number of reasons, including aging and/or a low level of the male hormone,
testosterone.
The bones most prone to fracture are those of the spine, hip and
wrist, although all bones in the body can fracture. Fractures associated
with osteoporosis can also cause back pain, loss of height and dorsal curvature
(hunchback). Many patients with osteoporosis have no symptoms and don't even know they have it.

What is Actonel indicated for
Treatment of osteoporosis in postmenopausal women, even with severe osteoporosis.
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 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 level of calcium in the blood)
• If you are pregnant, or could be pregnant, or if you are still planning a pregnancy
• 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 an alteration of bone and mineral metabolism (such as in the case of vitamin D deficiency, abnormalities of parathyroid hormone, conditions that induce both low levels of calcium in the blood).
• If you have or have 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 told you suffer from Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).
• If you have been told by your doctor that you have an intolerance to some sugars (such as lactose).
• If you have or have had pain, swelling or numbness in the jaw and/or jawbone or a feeling of “jaw and/or jawbone heaviness” or tooth loss.
• If you are undergoing dental treatment or must undergo dental surgery, inform your dentist that you are being treated with Actonel. If you have any of these problems, your doctor will tell you what to do 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 that contain any of the following elements reduce the effect of Actonel, if taken at the same time:

• calcium
• magnesium
• aluminum (for example some preparations for digestive problems)
• iron. These medicines must be taken at least thirty minutes after the Actonel tablet.

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

Actonel with food and drink
It is very important NOT to take the Actonel tablet with food or drink (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 drink (except tap water) must be taken at least 30 minutes after the Actonel tablet.

Pregnancy and breastfeeding
DO NOT take Actonel if you are or could 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 ingredient of Actonel) in pregnant women are not known.
DO NOT take Actonel if you are breastfeeding (see section 2, “Do not take Actonel”).
Actonel must be used only for the treatment of postmenopausal women and men.

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

Actonel contains lactose
If your doctor has diagnosed you with an intolerance to some sugars, contact them 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 following the instructions of your doctor or pharmacist exactly as
indicated. 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 suits your habits. Every week you must 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 feature: on the back of the blister there are boxes/spaces
where you can mark the day of the week you have chosen to take the Actonel tablet. We
also recommend that you write down the dates of taking 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

• The tablet must be taken while keeping the torso in an upright position (standing or sitting) to avoid heartburn.
• The tablet must be swallowed with at least one glass (120 ml) of tap water.
• The tablet must be swallowed whole and not dissolved or chewed .
• Once the tablet has been swallowed, avoid lying down for 30 minutes.

Your doctor will tell you if you need calcium and vitamin supplements, if your intake of
these substances with your diet is insufficient.

If you take more Actonel than you should
If you or anyone else accidentally swallows more Actonel tablets than prescribed, drink a
full glass of milk and see a doctor.

If you forget to take Actonel
If you have forgotten to take a tablet on the chosen day, take it on the same day you
remember. Afterwards, continue to take the tablet on the day you initially chose.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Actonel
If you stop treatment, you may start to lose bone mass. It is therefore recommended
to consult your doctor before stopping therapy.
If you have any doubts about the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Stop treatment with Actonel and consult your doctor immediatelyif 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 not known (cannot be estimated based on available data).
• Severe skin reactions that may include blistering skin reactions. The frequency of this side effect is not known (cannot be estimated based on available data).

Consult your doctor promptlyif any of the following side effects occur:

• 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 visual disturbances. The frequency of this side effect is not known (cannot be estimated based on available data).
• Osteonecrosis of the jaw and/or mandible (osteonecrosis) associated with delayed healing and infection, often after tooth extraction (see section 2, “Warnings and precautions”). The frequency of this side effect is not known (cannot be estimated based on available data).
• Esophageal symptoms, such as pain when swallowing, difficulty swallowing, chest pain, or the appearance/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 treated for osteoporosis for a long time. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin as this may be an early indication of a possible femur fracture.

However, other side effects observed in clinical studies were generally mild and did not require discontinuation of treatment.

Common side effects(may affect up to 1 in 10 people)

• Indigestion, discomfort, stomach pain, cramps or stomach upset, constipation, feeling of fullness, flatulence, diarrhea.
• Bone, muscle or joint pain.
• Headache.

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

• Inflammation or ulceration of the esophagus (the channel 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 through which food digested by the stomach passes).
• Inflammation of the colored part of the eye (iris) (red and painful eyes with possible visual disturbances).

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

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

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

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

Rarely, at the beginning of treatment, the patient's plasma calcium and phosphate levels may decrease; normally these changes are mild and do not cause symptoms.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 reported
on the package and blister after “Exp.”. The expiry date refers to the last
day of that month.
This medicine does not require any particular storage
conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Contents of the pack and other information

What Actonel contains
The active ingredient is sodium risedronate. Each tablet contains 35 mg of
sodium risedronate, equivalent to 32.5 mg of risedronic acid.
The other ingredients are:

Tablet core: lactose monohydrate (see section 2), crospovidone A,
magnesium stearate and microcrystalline cellulose.

Coating: hypromellose, macrogol, hydroxypropylcellulose, anhydrous colloidal silicon dioxide,
titanium dioxide [E171], yellow iron oxide [E 172], red iron oxide [E 172].

Description of Actonel and contents of the pack
Actonel 35 mg film-coated tablets are oval in shape, light orange in colour, measuring
11.7 x 5.8 mm and bear the letters “RSN” on one side and the inscription
“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 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 denominations:
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

Actonel 75 mg film-coated tablets

risedronate sodium

Read this leaflet carefully before you start taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 therefore reducing the risk of fractures.
Bone is a living tissue. Old bone matrix is constantly removed and
replaced with new bone.
Postmenopausal osteoporosis is a disease that develops in women after
menopause, whereby women's bones become more fragile and more prone to fractures in
following falls or exertion.
The bones most prone to fracture are those of the spine, hip and
wrist, although all bones in the body can fracture. Fractures associated
with osteoporosis can also cause back pain, loss of height and dorsal curvature
(hunchback). Many patients with osteoporosis have no symptoms and don't even know
they have it.

What is Actonel 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 risedronic acid 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 level of calcium in the blood)
• If you are pregnant, if you might be pregnant, or if you are still planning a pregnancy
• 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 disturbance of bone and mineral metabolism (such as vitamin D deficiency, abnormalities of parathyroid hormone, conditions that induce both low levels of calcium in the blood).
• If you have or have had problems with your esophagus (the channel connecting the mouth to the stomach). For example, you may have or have had pain or difficulty swallowing food or you have previously been told that you suffer from 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 lower jaw, or a feeling of “jaw and/or lower jaw heavy” or tooth loss.
• If you are receiving dental treatment or must undergo dental surgery, inform your dentist that you are being treated with Actonel.

If you have any of these problems, your doctor will tell you what to do to take Actonel.

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

Other medicines and Actonel
Medicines that contain any of the following elements reduce the effect of Actonel, if
taken at the same time:

• calcium
• magnesium
• aluminum (for example, some preparations for digestive problems)
• iron. These medicines must be taken at least thirty minutes after 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 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) must be taken at least 30 minutes
after the Actonel tablet.

Pregnancy and breastfeeding
DO NOT take Actonel if you are or could be pregnant, or if you are planning a
pregnancy (see section 2 “Do not take Actonel”). The potential risks associated
with the use of risedronic acid sodium (the active ingredient of Actonel) in
pregnant women are not known.
DO NOT take Actonel if you are breastfeeding (see section 2 “Do not take
Actonel”).
Actonel must be used only for the treatment of postmenopausal women.

Driving and using machines
Actonel has no known effects that interfere with the ability to drive or operate
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 following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Recommended dose:
Actonel tablets must be taken on the SAME two consecutive days of each 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 suit your habits for taking Actonel. Take ONE Actonel tablet in the morning of the first chosen day.
Take the SECOND tablet in the morning of the following day.
Repeat every month, maintaining the same two consecutive days. To help you remember when to take the next tablets, you can mark the days on the calendar in advance with a pen or 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 keeping the torso in an upright position (standing or sitting) to avoid heartburn.
• The tablet must be swallowed with at least one glass (120 ml) of tap water. Do not take the tablet with mineral water or with beverages other than tap water.
• The tablet must be swallowed whole and not dissolved or chewed .
• Once the tablet has been swallowed, avoid lying down for 30 minutes.

Your doctor will tell you if you need calcium and vitamin supplements, if your intake of these substances with your diet is insufficient.

If you take more Actonel than you should
In the event that you or anyone else has accidentally ingested more tablets of

Take Actonel as prescribed, drink a full glass of milk and consult a doctor.

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

The following month, take the tablets as usual.
In any case:

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

If you stop taking Actonel
If you stop treatment, you may begin to lose bone mass. It is therefore recommended
to consult your doctor before stopping therapy.
If you have any doubts about the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Stop treatment with Actonel and consult your doctor immediatelyif 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 not known (cannot be estimated based on available data).
• Severe skin reactions that may include blistering skin reactions. The frequency of this side effect is not known (cannot be estimated based on available data).

Consult your doctor promptlyif any of the following side effects occur:

• 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, bulging of the eyeball and visual disturbances. The frequency of this side effect is not known (cannot be estimated based on available data).
• Osteonecrosis of the jaw and/or mandible (bone necrosis) associated with delayed healing and infection, often after tooth extraction (see section 2, “Warnings and precautions”). The frequency of this side effect is not known (cannot be estimated based on available data).
• Esophageal symptoms, such as pain when swallowing, difficulty swallowing, chest pain, or the appearance/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 treated for osteoporosis for a long time. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin as this may be an early indication of a possible femur fracture.

However, other side effects observed in clinical studies were generally mild and did not require discontinuation of treatment.

Common side effects(may affect up to 1 in 10 people)

• Indigestion, nausea, vomiting, stomach pain, cramps or stomach discomfort, constipation, feeling of fullness, flatulence, diarrhea.
• Bone, muscle or joint pain.
• Headache.

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

• Inflammation or ulceration of the esophagus (the channel 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 through which digested food passes from the stomach).
• Inflammation of the colored part of the eye (iris) (red and 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 esophagus (the channel connecting the mouth to the stomach).
• Abnormalities in liver function tests have been reported. This can only be diagnosed following blood tests.

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

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

Rarely, at the beginning of treatment, the patient's plasma calcium and phosphate levels may decrease; normally these changes are mild and do not cause symptoms.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 package and on the
blister after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 Actonel contains
The active ingredient is sodium risedronate. Each tablet contains 75 mg of risedronate
sodium, equivalent to 69.6 mg of risedronic acid.
The other ingredients are:

Tablet core: microcrystalline cellulose, crospovidone A and magnesium
stearate.

Coating: hypromellose, macrogol 400, macrogol 8000, hydroxypropylcellulose, colloidal
anhydrous silica, titanium dioxide [E171], iron oxide red [E 172].

Description of the appearance of Actonel and contents of the pack
Actonel 75 mg film-coated tablets are oval in shape, pink in colour
11.7 x 5.8 mm and bear the letters “RSN” on one side and “75 mg” on the other. They are
available in blisters in packs of 2, 4, 6 or 8 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 denominations:
Belgium: Actonel 75 mg film-coated tablets,
Actonel 75 mg coated tablet,
Actonel 75 mg film tablets
Cyprus: Actonel / ''2 consecutive days per month'' 75 mg film-coated
tablets
France: Actonel 75 mg coated tablet
Germany: Risedronat Theramex 75 mg film tablets
Greece: Actonel / ''2 consecutive days per month'' 75 mg film-coated
tablets
Italy: Actonel 75 mg film-coated tablets
Luxembourg: Actonel 75 mg coated tablet,
Netherlands: Actonel 75 mg, film-coated tablets
Romania: Actonel 75 mg film-coated tablets
Slovenia: Actonel 75 mg film-coated tablets
Spain: Actonel 75 mg film-coated tablets
Sweden: Optinate 75 mg film-coated tablets

Actonel 35 mg gastro-resistant tablets

risedronate sodium

Read this leaflet carefully before you start taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 therefore reducing the risk of fractures.
Bone is a living tissue. Old bone material is constantly removed and
replaced with new bone.
Postmenopausal osteoporosis is a condition that develops in women after
menopause, whereby bones become weaker, more fragile and more prone to fractures in
following falls or exertion.
Osteoporosis can also occur in men for a number of reasons, including
ageing and/or a low level of the male hormone, testosterone.
The bones most prone to fracture are those of the spine, hip and
wrist, although all bones in the body can fracture. Fractures associated
with osteoporosis can also cause back pain, loss of height and curvature
of the back (hunchback). Many patients with osteoporosis do not present symptoms and do not even know they have it.

What is Actonel used for
Treatment of osteoporosis in postmenopausal women, even in 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 any of the other ingredients of this medicine (listed in section 6)
• If your doctor has told you that you have hypocalcemia (low level of calcium in the blood)
• If you are pregnant, if you might be pregnant, or if you are still planning a pregnancy
• 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 disturbance of bone and mineral metabolism (such as in the case of vitamin D deficiency, abnormalities of parathyroid hormone, conditions that induce both low levels of calcium in the blood).
• If you have or have had problems with your esophagus (the channel connecting the mouth to the stomach). For example, you may have or have had pain or difficulty swallowing food, or you have previously been told that you suffer from Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).
• If you have had or have pain, swelling or numbness of the jaw and/or mandible or a feeling of “jaw and/or mandible heaviness” or tooth loss.
• If you are undergoing dental treatment or are to undergo dental surgery, inform your dentist that you are being treated with Actonel.

If you have any of these problems, your doctor will tell you what to do to take Actonel.

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

Other medicines and Actonel
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicine.
Medicines that contain any of the following elements reduce the effect of Actonel
when taken at the same time:

• Calcium
• Magnesium
• Aluminum (for example, some preparations for digestive problems)
• Iron

Take these medicines at a different time of day than Actonel.

Actonel with food and drink
Actonel must be taken immediately after breakfast.

Pregnancy and breastfeeding
Do not take Actonel if you are pregnant, suspect you are pregnant or are planning a
pregnancy (see section 2, “Do not take Actonel”).
Do not take Actonel if you are breastfeeding with breast milk (see section 2, “Do
not take Actonel”).
Actonel must 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 operate
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 following exactly the instructions of your doctor or
pharmacist. If you have 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 suits your habits. Every
week you must take one Actonel tablet on the chosen day.
For your convenience, to help you take the tablet on the same day of each
week, the Actonel packaging has a feature:
On the back of the blister pack there are boxes/spaces. Mark the day of the week
you have chosen to take the Actonel tablet. Also, write the dates of
taking the tablet.

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

How to take Actonel

• Actonel is for oral use.
• Take the tablet keeping your torso in an upright position (you can sit or stand) to 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 .
• Once you have taken the tablet, do not lie down for 30 minutes.

Your doctor will tell you if you need calcium and vitamin supplements, if your intake of
these substances with your diet is 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 see a doctor.

If you forget to take Actonel
If you have forgotten to take the tablet on the chosen day, take it on the same
day you remember it. Start taking one tablet a week again
on the day the tablet is normally taken. Do not take two tablets
on the same day.

If you stop taking Actonel
If you stop treatment, you may start to lose bone mass. It is therefore recommended
to consult your doctor before considering stopping
therapy.
If you have any doubts 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 immediatelyif 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 based on available data).
• Severe skin reactions such as:
• Blisters on the skin, mouth, eyes and other moist surfaces of the body (genitals) (Stevens-Johnson syndrome)
• Palpable red spots on the skin (leucocytoclastic vasculitis)
• Red skin rash on many parts of the body and/or loss of the superficial layer of the skin (toxic epidermal necrolysis).

The frequency of this side effect is not known (cannot be estimated based on available data).

Consult your doctor promptlyif you experience 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 visual disturbances. The frequency of this side effect is not known (cannot be estimated based on available data).
• Osteonecrosis of the jaw and/or mandible (bone necrosis) associated with delayed healing and infection, often after tooth extraction (see section 2, “Warnings and precautions”). The frequency of this side effect is not known (cannot be estimated based on available data).
• Esophageal 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 treated for osteoporosis for a long time. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as this could be an early indication of a possible femur fracture.

However, other side effects observed in clinical studies were generally mild and did not require discontinuation of treatment.

Other possible side effects:
Common side effects(may affect up to 1 in 10 people):

• Indigestion, feeling unwell, stomach pain, cramps or stomach discomfort, constipation, feeling of fullness, flatulence, diarrhea, vomiting, abdominal pain
• Bone, muscle or joint pain
• Headache

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

• Influenza
• Decreased number of white blood cells in the blood
• Depression
• Dizziness, numbness, tingling or burning sensation, decreased sensitivity
• Inflammation of the colored part of the eye (iris) (red and painful eyes with possible visual changes), inflammation of the outermost layer of the eye and the inner surface of the eyelids (conjunctivitis), red eyes, blurred vision
• Hot flushes, low blood pressure
• Cough
• Inflammation or ulceration of the esophagus (the channel 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 into which food digested by the stomach passes), esophageal or gastric reflux, gastritis, increased stomach acid, stomach hernia, intestinal inflammation, intestinal distension, belching, flatulence, blood in the stool, bleeding from the viscera, heartburn, hemorrhoids, fecal leakage
• Blisters on the mouth, swelling of the tongue and lips, dry mouth, gum inflammation, mouth ulcers
• Skin redness, rash, itching, purple spots on the skin, allergic dermatitis
• Muscle weakness/fatigue, muscle spasms, back pain, pain in the extremities, pain in the jaw and/or mandible, joint pain, neck pain
• Kidney stones
• Ovarian cysts
• Fatigue, chills, flu-like syndrome, chest pain, fever, swelling of the face or body, pain, tiredness
• Increased activity of the parathyroid gland
• Decreased levels of calcium and phosphate in the plasma, increased levels of calcium in the plasma, decreased platelet count, irregular heartbeat, occult blood in the stool, urine test abnormalities
• Allergic reactions

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

• Narrowing of the esophagus (the channel connecting the mouth to the stomach), inflammation of the tongue.
• Abnormalities in liver function tests have been reported. This can only be diagnosed following 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 episodes may be signs of bone damage to the ear.

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

• Hair loss
• Liver disorders, some cases were serious.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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
box and on the blister after EXP. The expiry date refers to the last day
of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Package Contents and Other Information

What Actonel contains
The active ingredient is sodium risedronate. Each tablet contains 35 mg of
sodium risedronate, equivalent to 32.5 mg of risedronic acid.
The other ingredients 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 in shape, yellow in color, with “EC 35” imprinted on one
side.
The dimensions of the tablets are as follows: width 13 mm, length 6 mm.
Packs 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
with the following denominations:
Belgium: Actonel 35 mg weekly gastro-resistant tablets
France: Actonel GR 35 mg gastro-resistant tablet
Germany: Actonel once weekly 35 mg gastro-resistant tablets
Greece: Actonel GR
Italy: Actonel
Netherlands: Actonel Weekly MSR35 mg, gastro-resistant tablets
Portugal: Actonel 35 mg gastro-resistant tablet
Romania: Actonel 35 mg gastro-resistant tablets
Spain: Actonel semanal 35 mg gastro-resistant tablets
Sweden: Optinate Septimum