Risedronate Mylan

Italy
Brand name Risedronate Mylan
Form tablets, film-coated
Active substance / Dosage
Prescription type Prescription only
ATC code
Registration number 040069
Manufacturer MYLAN S.P.A.
Risedronate Mylan tablets, film-coated

PACKAGE LEAFLET: INFORMATION FOR THE USER

Risedronato Mylan

5 mg film-coated tablets
Sodium risedronate
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to 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.

Contents of this leaflet:

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

1. WHAT RISEDRONATE MYLAN IS AND WHAT IT IS USED FOR

What Risedronate Mylan is
Risedronate Mylan belongs to a group of non-hormonal medicines called
bisphosphonates, which are used to treat bone diseases. It acts directly on the bones, strengthening them and thereby reducing the risk of fractures.
Bone is a living tissue. Old bone tissue is constantly removed from the skeleton 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 a fall or strain.
Osteoporosis is more likely to occur in women who have experienced early menopause, as well as in patients undergoing long-term treatment with steroids.
The spine, hip and wrist are the bones most likely to break, although fractures can occur in any bone of your body.
Fractures associated with osteoporosis may also cause back pain, loss of height and a curved back. Many patients with osteoporosis have no symptoms and are unaware they have the condition.

What Risedronate Mylan is indicated for
Treatment of osteoporosis

  • in postmenopausal women, Prevention of osteoporosis
  • in women at increased risk of osteoporosis (including low bone mass, early menopause and a family history of osteoporosis)
  • in postmenopausal women who have been treated with high doses of steroids for a long period of time. It maintains or increases bone mass.

2. WHAT YOU SHOULD KNOW BEFORE TAKING RISEDRONATE MYLAN
2. WHAT YOU SHOULD KNOW BEFORE TAKING RISEDRONATE MYLAN
Do not take Risedronate Mylan

  • If you are allergic to sodium risedronate or to any of the other ingredients of this medicine (listed in section 6).
  • If your doctor has told you that you have a condition called hypocalcaemia (low calcium levels in the blood)
  • If you may be pregnant or are planning a pregnancy
  • If you are breast-feeding
  • If you have severe kidney problems
  • If you are under 18 years of age

Warnings and precautions
Talk to your doctor or pharmacist before taking Risedronate Mylan

  • If you are unable to remain in an upright position (sitting or standing) for at least 30 minutes.
  • If you have a disorder of bone and mineral metabolism (for example, vitamin D deficiency, parathyroid hormone abnormalities, or conditions that cause low calcium levels in the blood).
  • If you 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 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 told you that you have an intolerance to certain sugars (such as lactose).
  • If you have had or currently have pain, swelling or numbness in the jaw, a sensation of heaviness in the jaw, or have lost a tooth.
  • If you are undergoing dental treatment or are scheduled to have dental surgery, inform your dentist that you are taking Risedronate Mylan.

If you have any of these conditions, your doctor will advise you on how to take
Risedronate Mylan.
Children and adolescents
Sodium risedronate is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.
Other medicines and Risedronate Mylan:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Medicines containing any of the following may reduce the effect of Risedronate Mylan 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 Risedronate Mylan.

Risedronate Mylan with food and drink:
It is very important that you do NOT take Risedronate Mylan with food or beverages
(except plain water) so that it can work properly. In particular, do not take this medicine with dairy products (including milk), as they contain calcium (see section 2 “Taking Risedronate Mylan with other medicines”).
Take food and beverages (except plain water) at least 30 minutes after taking Risedronate Mylan.
Pregnancy and breast-feeding
DO NOT take Risedronate Mylan if you may be pregnant, are pregnant, or are planning a pregnancy (see section 2 “Do not take Risedronate Mylan”). The potential risks associated with the use of sodium risedronate (the active substance in Risedronate Mylan) in pregnant women are not known.
DO NOT take Risedronate Mylan if you are breast-feeding (see section 2 “Do not take Risedronate Mylan”).
Driving and using machines
It is not known whether Risedronate Mylan has an effect on the ability to drive or use machines.
Risedronate Mylan contains lactose
Risedronate Mylan contains a small amount of lactose. If your doctor has told you that you are intolerant to certain sugars, contact them before taking this medicine (see section 2 “Take special care and talk to your doctor BEFORE starting to take Risedronate Mylan”).

3. HOW TO TAKE RISEDRONATE MYLAN

Dosage
Always take Risedronate Mylan exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet of Risedronate Mylan (5 mg of sodium risedronate) once daily.

When to take Risedronate Mylan tablets:
IT IS BEST TO TAKE THE TABLET AT LEAST 30 MINUTES BEFORE THE FIRST MEAL, DRINK (EXCEPT PLAIN WATER), OR OTHER MEDICINES OF THE DAY.
If, under particular circumstances, you are unable to take the Risedronate Mylan tablet at this time, you may take it on an empty stomach, every day at the same time, in one of the following ways:

OR:
Between meals: at least 2 hours after the last meal, drink (except plain water), or other medicines of the day. Do not eat or drink (except plain water) for 2 hours after taking the tablet.

OR:
In the evening: at least 2 hours after the last meal, drink (except plain water), or other medicines of the day. Risedronate Mylan must be taken at least 30 minutes before going to bed.

How to take Risedronate Mylan tablets:

  • Swallow the tablet whole, while in an upright position (you may be sitting or standing) to help avoid heartburn.
  • Swallow the tablet with at least one full glass of plain water (120 ml).
  • Swallow the tablet whole. Do not suck or chew the tablet.
  • Do not lie down for 30 minutes after taking the tablet.

Your doctor will advise you whether you need to take calcium and vitamin supplements if your diet does not provide sufficient amounts.

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

If you forget to take Risedronate Mylan:
If you have forgotten to take the tablet at your usual time, you may 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 Risedronate Mylan:
If you stop treatment, you may begin to lose bone mass. Talk to your doctor before stopping treatment.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Risedronate Mylan can cause adverse reactions, although not
everyone experiences them.
Stop treatment and contact your doctor immediately if you experience any of the
following adverse reactions:
Symptoms of a severe allergic reaction such as:

  • swelling of the face, tongue, and throat
  • difficulty swallowing
  • hives and breathing difficulties
    Severe skin reactions that may include blistering skin reactions.

Contact your doctor promptly if you experience any of the following adverse reactions:

  • eye inflammation, usually with pain, redness, and sensitivity to light
  • jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, often following tooth extraction (see section 2 “Take special care and consult your doctor BEFORE starting Risedronate Mylan”)
  • oesophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or onset/worsening of heartburn.

However, most of the adverse reactions observed in clinical studies were generally mild in severity and did not require discontinuation of treatment.
Common adverse reactions (affect between 1 and 10 out of 100 patients):

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

Uncommon adverse reactions (affect between 1 and 10 out of 1,000 patients):

  • Inflammation or ulcers of the oesophagus (the tube connecting the mouth to the stomach), causing difficulty and pain when swallowing (see section 2 “Take special care and consult your doctor BEFORE starting Risedronate Mylan”), inflammation of the stomach and duodenum (the part of the intestine receiving digested food from the stomach).
  • Inflammation of the coloured part of the eye (iris) (red, painful eyes possibly with altered vision).

Rare adverse reactions (affect between 1 and 10 out of 10,000 patients):

  • Inflammation of the tongue (red, swollen and possibly painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach).
  • Abnormal liver function test results have been reported. These can only be diagnosed by blood tests.

Very rare adverse reactions (affect up to 1 in 10,000 patients):
Contact your doctor if you experience ear pain, ear discharge and/or ear infection. These symptoms could indicate bone damage in the ear.
During post-marketing experience, the following adverse reactions have been reported
(frequency not known):
Skin allergic reactions such as hives, skin rash, swelling of the face, lips, tongue and/or throat, difficulty swallowing or breathing. Severe skin reactions including blistering reactions (blisters) under the skin; inflammation of small blood vessels characterized by palpable red spots on the skin (leucocytoclastic vasculitis); a serious condition called Stevens-Johnson syndrome (SJS) with blistering of the skin, mouth, eyes, and other body mucous membranes (genitals); a serious condition called toxic epidermal necrolysis (TEN) causing widespread erythematous redness and/or loss of the outer layer of skin. Hair loss. Allergic reactions (hypersensitivity). Severe liver disorders, especially if you are taking other medicines known to cause liver problems. Eye inflammation causing pain and redness.
Rarely, at the beginning of treatment, the patient's plasma levels of calcium and phosphate may decrease. These changes are usually mild and do not cause symptoms.
Rarely, an unusual femur fracture may occur, particularly in patients on long-term treatment for osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as this could be an early sign of a possible femur fracture.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE RISEDRONATE MYLAN

Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Risedronate Mylan after the expiry date stated on the packaging. The
expiry date refers to the last day of the month.
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. PACKAGING CONTENTS AND OTHER INFORMATION

What Risedronato Mylan contains:

  • The active substance is sodium risedronate. Each tablet contains 5 mg of sodium risedronate, equivalent to 4.64 mg of risedronic acid.
  • The other components are:
    Tablet core: pregelatinized corn starch, microcrystalline cellulose, crospovidone, magnesium stearate
    Film coating: hypromellose, monohydrate lactose, titanium dioxide (E171), macrogol 4000

Description of the appearance of Risedronato Mylan and packaging contents:
Risedronato Mylan tablets are white, round, biconvex, film-coated, with a diameter of 6.1 mm and a thickness of 2.6 mm.
Available in blisters containing 14 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy

Manufacturer Responsible for Batch Release:
Pharmathen S.A.
6 Devernakion str., 153 51 Pallini Attikis
Greece
McDermott Laboratories Ltd t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland

This medicinal product is authorized in EEA Member States under the following names:
DK Vionate
BE Risemylan 5 mg filmomhulde tabletten
IT Risedronato Mylan 5mg compresse rivestite con film
NL Risedronaatnatrium Mylan 5mg filmomhulde tabletten
PT Vicendrolin 5mg
SE Vionate 5mg filmdragerad tabletter
UK Risedronate Sodium 5mg film-coated tablet

This leaflet was last revised on
PATIENT INFORMATION LEAFLET

Risedronate Mylan

35 mg film-coated tablets
Risedronate sodium
Generic medicine
Read this leaflet carefully before taking this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT RISEDRONATE MYLAN IS AND WHAT IT IS USED FOR

What Risedronate Mylan is
Risedronate Mylan 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 tissue is constantly removed from the skeleton and replaced with new bone.
Postmenopausal osteoporosis is a condition that develops in women after menopause, causing bones to become weaker, more fragile and more prone to fractures following a fall or strain.
Osteoporosis can also occur in men due to a number of causes, including aging and/or low levels of the male hormone testosterone.
The spine, hip and wrist are the bones most likely to break, although fractures can occur in any bone of the body.
Fractures associated with osteoporosis may also cause back pain, loss of height and a curved spine. Many patients with osteoporosis have no symptoms and are not even aware they have it.
What Risedronate Mylan is indicated for
The treatment of osteoporosis

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

2. WHAT YOU NEED TO KNOW BEFORE TAKING RISEDRONATE MYLAN

Do not take Risedronate Mylan

  • If you are allergic to sodium risedronate or to any of the other ingredients of this medicine (listed in section 6).
  • If your doctor has told you that you have a condition called hypocalcemia (low calcium levels in the blood).
  • If you may be pregnant, are pregnant, or are planning to become pregnant.
  • If you are breastfeeding.
  • If you have severe kidney problems.
  • If you are under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before starting to take Risedronate Mylan:

  • 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 (for example, vitamin D deficiency, parathyroid hormone abnormalities, conditions that both cause low calcium levels in the blood).
  • If you 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).
  • If your doctor has told you that you have an intolerance to certain sugars (such as lactose).
  • If you have had or currently have pain, swelling or numbness in the jaw, a sensation of heaviness in the jaw, or have lost a tooth.
  • If you are undergoing dental treatment or are scheduled to have dental surgery, inform your dentist that you are taking Risedronate Mylan.

If you have any of these conditions, your doctor will advise you on how to take Risedronate Mylan.

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

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

  • Calcium
  • Magnesium
  • Aluminium (for example, some preparations for digestive problems)
  • Iron
    These medicines should be taken at least 30 minutes after taking Risedronate Mylan.

Risedronate Mylan with food and drinks:
It is very important that you do NOT take Risedronate Mylan with food or drinks (except plain water) so that it can work properly. In particular, do not take this medicine with dairy products (including milk), as they contain calcium (see section 2 “Taking Risedronate Mylan with other medicines”).
Take food and drinks (except plain water) at least 30 minutes after taking Risedronate Mylan.

Pregnancy and breastfeeding
DO NOT take Risedronate Mylan if you may be pregnant, are pregnant, or are planning to become pregnant (see section 2 “Do not take Risedronate Mylan”). The potential risks associated with the use of sodium risedronate (the active substance in Risedronate Mylan) in pregnant women are unknown.
DO NOT take Risedronate Mylan if you are breastfeeding (see section 2 “Do not take Risedronate Mylan”).

Driving and using machines
It is not known whether Risedronate Mylan affects the ability to drive or operate machinery.

Risedronate Mylan contains lactose
Risedronate Mylan contains a small amount of lactose. If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine (see section 2 “Take special care and talk to your doctor BEFORE starting to take Risedronate Mylan”).

3. HOW TO TAKE RISEDRONATE MYLAN

Dosage
Always take Risedronate Mylan exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is ONE Risedronate Mylan tablet (35 mg of sodium risedronate) once a week.
Choose a day of the week that best fits your routine. Each week, take the Risedronate Mylan tablet on the same chosen day.
The packaging contains boxes/spaces. Mark the day of the week you have selected for taking the Risedronate Mylan tablet. Additionally, write down the date on which you take the tablet.

When to take Risedronate Mylan tablets:
Take the risedronate tablet at least 30 minutes before the first food, drink (except plain water), or other medication of the day.

How to take Risedronate Mylan tablets:

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

Your doctor will advise you whether you need calcium and vitamin supplements if your diet does not provide enough.

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

If you forget to take Risedronate Mylan:
If you forget to take the tablet on your chosen day, take it on the day you remember. After that, continue taking one tablet per week on the originally chosen day.
Do NOT take a double dose to make up for the missed tablet.

If you stop taking Risedronate Mylan:
If you stop treatment, you may begin to lose bone mass. Talk to your doctor before stopping treatment.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Risedronato Mylan can cause adverse reactions, although not
all people experience them.
Stop taking the medicine and contact your doctor immediately if you experience any of
the following adverse reactions:
Symptoms of a severe allergic reaction such as:

  • swelling of the face, tongue, and throat
  • difficulty swallowing
  • hives and breathing difficulties
    Severe skin reactions that may include blistering skin reactions.

Contact your doctor promptly if you experience any of the following adverse reactions:

  • Eye inflammation, usually with pain, redness, and sensitivity to light
  • Jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, often after tooth extraction (see section 2 “Take special care and consult your doctor BEFORE starting Risedronato Mylan”)
  • Esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or onset/worsening of heartburn.

However, most of the adverse reactions observed in clinical studies were generally mild in severity and did not require discontinuation of treatment.
Common adverse reactions (affecting 1 to 10 patients in 100):

  • Indigestion, feeling unwell, stomach discomfort, stomach cramps or upset, constipation, feeling of fullness, flatulence, diarrhea.
  • Pain in bones, muscles, or joints.
  • Headache.

Uncommon adverse reactions (affecting 1 to 10 patients in 1,000):

  • Inflammation or ulcers of the esophagus (the tube connecting the mouth to the stomach), causing difficulty and pain when swallowing (see section 2 “Take special care and consult your doctor BEFORE starting Risedronato Mylan”), inflammation of the stomach and duodenum (the part of the intestine receiving digested food from the stomach).
  • Inflammation of the colored part of the eye (iris) (red, painful eyes with possible vision changes).

Rare adverse reactions (affecting 1 to 10 patients in 10,000):

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

Very rare adverse reactions (affecting up to 1 patient in 10,000):
Contact your doctor if you experience ear pain, ear discharge, and/or ear infection.
These episodes could be signs of bone damage in the ear.
During post-marketing experience, the following adverse reactions have been reported
(frequency not known):
Skin allergic reactions such as hives, rash, swelling of the face, lips, tongue, and/or throat,
difficulty swallowing or breathing. Severe skin reactions including blistering (blisters) under the skin; inflammation of small blood vessels characterized by palpable red spots on the skin (leucocytoclastic vasculitis); a serious condition called Stevens-Johnson syndrome (SJS) with blistering of the skin, mouth, eyes, and other body mucous membranes (genitals); a serious condition called toxic epidermal necrolysis (TEN) causing erythematous redness over many parts of the body and/or loss of the skin's superficial layer. Hair loss. Allergic reactions (hypersensitivity). Severe liver disorders, especially if you are taking other medicines known to cause liver problems. Eye inflammation causing pain and redness.
Rarely, at the beginning of treatment, patients' blood levels of calcium and phosphate may decrease. These changes are usually mild and do not cause symptoms.
Rarely, an unusual femur fracture may occur, particularly in patients on long-term treatment for osteoporosis. Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin, as this could be an early sign of a possible femur fracture.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You may also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE RISEDRONATE MYLAN

Keep out of the reach and sight of children.
This medicine does not require any special storage conditions.
Do not use Risedronate Mylan after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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. PACK CONTENTS AND OTHER INFORMATION

What Risedronato Mylan contains:

  • The active substance is sodium risedronate. Each tablet contains 35 mg of sodium risedronate, equivalent to 32.5 mg of risedronic acid.
  • The other components are: Tablet core: pregelatinized maize starch, microcrystalline cellulose, crospovidone, magnesium stearate. Film coating: hypromellose, monohydrate lactose, titanium dioxide (E171), macrogol 4000.

Description of the appearance of Risedronato Mylan and pack contents:
Risedronato Mylan tablets are white, round, biconvex, film-coated, with a diameter of 11.2 mm and a thickness of 5.0 mm, marked with "35" on one side.
Available in blisters containing 4 or 12 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano, Italy

Responsible Pharmacist for Batch Release:
Pharmathen S.A.
6 Devernakion str., 153 51 Pallini Attikis, Greece
McDermott Laboratories Ltd t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Pharmathen International S.A.
Sapes Industrial Park
Block 5, 69300 Rodopi, Greece

This medicinal product is authorized in the EEA Member States under the following names:
AT Risedronat Arcana 35 mg - once weekly – Film tablets
BE Risemylan 5 mg film-coated tablets
CZ Risedronat Mylan 35 mg potahovaná tableta
DE Risedronat-dura 35 mg film tablets
DK Vionate
ES Risedronato semanal Mylan Pharmaceuticals 35 mg film-coated tablets
EL Risedronate/Mylan 35 mg Επικαλυμμένο με λεπτό υμένιο δισκίο
IE Risedronate Mylan Once a Week 35 mg film-coated tablet
IT Risedronato Mylan 35 mg film-coated tablets
NL Risedronaatnatrium Mylan wekelijks 35 mg filmomhulde tabletten
PT Vicendrolin 35 mg Comprimido revestido por película
SK Risedronat Mylan 35 mg filmom obalená tableta
SE Vionate 35 mg filmdragerad tabletter
UK Risedronate Sodium 35 mg film coated tablets

This leaflet was last reviewed on