RISEDRONATO 75 mg Tabletki Powlekane

Treść ulotki

1. RISEDRONATO EUROGENERICI 75 mg film-coated tablets
   1. What is RISEDRONATO EUROGENERICI 75 mg and what is it used for
   2. What you need to know before taking RISEDRONATO EUROGENERICI 75 mg
   3. How to take RISEDRONATO EUROGENERICI 75 mg
   4. Possible side effects
   5. How to store RISEDRONATO EUROGENERICI 75 mg
   6. Contents of the pack and other information

RISEDRONATO EUROGENERICI 75 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start to use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What RISEDRONATO EUROGENERICI 75 mg is and what it is used for
• 2. What you need to know before you take RISEDRONATO EUROGENERICI 75 mg
• 3. How to take RISEDRONATO EUROGENERICI 75 mg
• 4. Possible side effects
• 5. How to store RISEDRONATO EUROGENERICI 75 mg
• 6. Contents of the pack and other information

1. What is RISEDRONATO EUROGENERICI 75 mg and what is it used for

What is RISEDRONATO EUROGENERICI 75 mg
RISEDRONATO EUROGENERICI 75 mg belongs to a group of non-hormonal medicines called
bisphosphonates, which are used to treat bone diseases. It acts directly on the bones
to make them stronger and therefore less likely to break.
Bone is a living tissue. Old tissue is constantly removed from the skeleton and
replaced with new bone tissue.
Postmenopausal osteoporosis is a condition that occurs in women after menopause,
when bones become weaker, more fragile and more prone to fractures after a fall or
effort.
The spine, hip and wrist are the bones most susceptible to fractures, although these
latter can affect any bone in the human body. Fractures related to osteoporosis
can also cause back pain, loss of height and curvature of the spine. Many
patients suffering from osteoporosis have no symptoms and it is even possible that they do not know
they have it.

What is RISEDRONATO EUROGENERICI 75 mg used for
Treatment of osteoporosis in postmenopausal women.

2. What you need to know before taking RISEDRONATO EUROGENERICI 75 mg

DO NOT take RISEDRONATO EUROGENERICI 75 mg

• if you are allergic(hypersensitive) to risedronic acid sodium or to any of the other ingredients of this medicine (listed in section 6);
• if your doctor has told you that you suffer from a condition called hypocalcemia(a low level of calcium in the blood);
• if you think you may be pregnant, are pregnant or if you are planning a pregnancy;
• if you are breast-feeding;
• if you suffer from severe kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking RISEDRONATO EUROGENERICI 75 mg:

• if you are unable to remain in an upright position (sitting or standing) for at least 30 minutes;
• if you have abnormal bone and mineral metabolism (e.g. vitamin D deficiency and abnormalities of the parathyroid hormone, both leading to a low level 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 diagnosed with Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus);
• if you have or have had pain, swelling or numbness in the jaw/lower jaw or a “feeling of heaviness in the jaw/lower jaw” or loss of a tooth;
• if you are undergoing dental treatment or will undergo dental surgery, tell your dentist that you are taking therapy with RISEDRONATO EUROGENERICI 75 mg.

The doctor will advise you on what to do when taking RISEDRONATO EUROGENERICI 75 mg if you suffer from
one of the conditions described above.

Children and adolescents
The use of risedronic acid in children under 18 years of age is not recommended as there is insufficient
safety and efficacy data available.

Other medicines and RISEDRONATO EUROGENERICI 75 mg
Medicines containing any of the following substances decrease the effect of RISEDRONATO
EUROGENERICI 75 mg if taken at the same time:

• calcium;
• magnesium;
• aluminum (e.g. some antacids);
• iron.

Take these medicines at least 30 minutes after taking RISEDRONATO EUROGENERICI 75 mg
tablets.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

RISEDRONATO EUROGENERICI 75 mg with food and drink
It is very important that you DO NOT take the RISEDRONATO EUROGENERICI 75 mg
tablet with food or drink (other than tap water), so that the medicine works
correctly. In particular, do not take this medicine at the same time as dairy products (such as
milk), as these foods contain calcium (see section 2 “Other medicines and
RISEDRONATO EUROGENERICI 75 mg tablets”).
Take food and drink (other than tap water) at least 30 minutes after taking the
RISEDRONATO EUROGENERICI 75 mg tablet.

Pregnancy and breast-feeding
DO NOT take RISEDRONATO EUROGENERICI 75 mg if you suspect you are pregnant, are pregnant or are planning a
pregnancy (see section 2 “Do not take RISEDRONATO
EUROGENERICI 75 mg”). The potential risk associated with the use of risedronic acid (the active
ingredient of RISEDRONATO EUROGENERICI 75 mg) in pregnant women is unknown.
DO NOT take RISEDRONATO EUROGENERICI 75 mg if you are breast-feeding with breast milk (see
section 2 “Do not take RISEDRONATO EUROGENERICI 75 mg”).
RISEDRONATO EUROGENERICI 75 mg should be used exclusively for the treatment of
postmenopausal women.

Driving and using machines
It is not known whether RISEDRONATO EUROGENERICI 75 mg affects your ability to drive vehicles
or use machines.

3. How to take RISEDRONATO EUROGENERICI 75 mg

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
Recommended dose:
Take the tablets of RISEDRONATO EUROGENERICI 75 mg on the SAME two consecutive days
each month, for example the first and second day of the month or the fifteenth and sixteenth
day of the month.
Choose TWO consecutive days that are most convenient for you to take RISEDRONATO
EUROGENERICI 75 mg. Take ONE tablet of RISEDRONATO EUROGENERICI 75 mg in the morning
of the first chosen date. Take the SECOND tablet the morning of the following day.
Repeat taking it every month on the same two consecutive days. To remind yourself when
to take the next tablets, write a note or put a sticker in advance on your
calendar.

WHEN to take the RISEDRONATO EUROGENERICI 75 mg tablet
Take the RISEDRONATO EUROGENERICI 75 mg tablet at least 30 minutes before the first
daily intake of food, other medicines or beverages (except for tap water).

HOW to take the RISEDRONATO EUROGENERICI 75 mg tablet
This medicine is for oral use.

• Take the tablet while maintaining an upright position(sitting or standing) to avoid heartburn.
• Swallowthe tablet with at least one glass(120 ml) of tap water. Do not takeyour tablet with mineral water or beverages other than tap water.
• Swallow it whole.Do not suck or chew the tablet.
• Do not lie down before 30 minuteshave passed after taking the tablet.

Your doctor will tell you if you need calcium and vitamin supplements, if you are not taking enough through your diet.

If you take more RISEDRONATO EUROGENERICI 75 mg than you should
If you or someone else has accidentally taken more RISEDRONATO EUROGENERICI
75 mg tablets than prescribed, drink a full glass of milkand seek medical assistance.

If you forget to take RISEDRONATO EUROGENERICI 75 mg
You forgot When What to do
More than 7 days
until the next monthly dose
Take the first tablet the morning
after and the second the morning of the day
following
The next monthly dose
is within 7 days
First and second
tablet
Do not take the tablets you forgot
More than 7 days
until the next monthly dose
Take the second tablet the morning
after
The next monthly dose
is within 7 days
Only the second
tablet Do not take the tablet you forgot

In the next month, take the tablets again as usual
In any case:

• If you forgot the dose of RISEDRONATO EUROGENERICI 75 mg in the morning, do NOT take it later in the same day.
• Do not take three tablets in the same week.

If you stop taking RISEDRONATO EUROGENERICI 75 mg
If you stop treatment you may start to lose bone mass. Talk to your doctor before
stopping treatment.
If you have further questions about the use of this medicine, ask your doctor, nurse or
pharmacist.

4. Possible side effects

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

Stop taking risedronate and contact your doctor immediatelyif you experience the following symptoms:

• symptoms of a severe allergic reactionsuch as
• swelling of the face, tongue, or throat,
• difficulty swallowing,
• hives and difficulty breathing;
• severe skin reactionssuch as
• blistering of the skin, mouth, eyes and other mucous membranes (genitals) (Stevens-Johnson syndrome),
• palpable red spots on the skin (leucocytoclastic vasculitis),
• red rash in many parts of the body and/or loss of the outer layer of skin (toxic epidermal necrolysis).

Contact your doctor immediatelyif you experience the following side effects:

• eye inflammation, usually associated with pain, redness and sensitivity to light;
• osteonecrosis of the jaw/mandible (bone in the jaw) with delayed healing and infection, often after tooth extraction (see section 2 “Warnings and precautions”);
• symptoms related to the esophagus such as pain when swallowing, difficulty swallowing, chest pain or onset/worsening of heartburn.

Rarely, an atypical fracture of the femur may occur, particularly in patients being 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.
In any case, 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 full, flatulence, diarrhea;
• bone, muscle or joint pain;
• headache.

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

• inflammation or ulcers of the esophagus (the tube connecting the mouth to the stomach) causing difficulty and pain in swallowing (see also section 2 “Warnings and precautions”), inflammation of the stomach and duodenum (the 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 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 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 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 in the ear.

The following reactions have been reported during the post-marketing period (frequency unknown):

• hair loss;
• liver disorders, sometimes severe.

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store RISEDRONATO EUROGENERICI 75 mg

• 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 the wording EXP. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C.

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 RISEDRONATO EUROGENERICI 75 mg contains
The active ingredient is sodium risedronate. Each tablet contains 75 mg of sodium risedronate,
equivalent to 69.6 mg of risedronic acid.
The other ingredients are:

Tablet core:Microcrystalline cellulose, crospovidone A, magnesium stearate.

Tablet coating:Opadry II Pink [polyvinyl alcohol, talc, macrogol 3350, titanium
dioxide (E171), red iron oxide (E172)].

Description of the appearance of RISEDRONATO EUROGENERICI 75 mg and contents of the pack
RISEDRONATO EUROGENERICI 75 mg film-coated tablets are oblong, pink tablets.
The tablets are available in blister packs of 2, 4, 6, 12, 18, 24 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6, 20136 Milan - Italy

Manufacturers
BLUEPHARMA – Indústria Farmacêutica S.A., S. Martinho do Bispo, Coimbra, 3045-016 – Portugal
STADA Arzneimittel AG, Stadastrasse 2 – 18 61118 Bad Vilbel – Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
DE Risedronat AL 75 mg Filmtabletten
BE Risedronate EG 75 mg film-coated tablets
ES Risedronato CDRD 75 mg film-coated tablets EFG
IT RISEDRONATO EUROGENERICI
LU Risedronate EG 75 mg comprimés pelliculés