Risedronate EG Stada

Patient Information Leaflet: Information for the Patient

RISEDRONATE EUROGENERICI 75 mg Film-coated Tablets

Equivalent Medicine
Please read this leaflet carefully before using 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

What RISEDRONATO EUROGENERICI 75 mg is
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
weaken, become more fragile and more prone to fractures following a fall or strain.
The spine, hip and wrist are the bones most susceptible to fractures, although fractures can affect
any bone in the human body. Osteoporosis-related fractures may also cause back pain, loss of
height and curvature of the spine. Many patients with osteoporosis have no symptoms and may not
even be aware they have it.

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

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

Do NOT take RISEDRONATE EUROGENERICI 75 mg

• if you are allergic (hypersensitive) 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 think you may be pregnant, are pregnant, or are planning to become pregnant;
• if you are breast-feeding;
• if you have severe kidney problems.

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

• if you are unable to remain in an upright position (sitting or standing) for at least 30 minutes;
• if you have an abnormal bone and mineral metabolism (for example, vitamin D deficiency or parathyroid hormone disorders, both of which can lead to low calcium levels in the blood);
• if you have or have previously had esophageal problems (the tube connecting the mouth to the stomach). For example, you may have or have previously experienced pain or difficulty swallowing food, or have been previously 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, or a “heavy sensation in the jaw,” or tooth loss;
• if you are undergoing or are scheduled to undergo dental treatment or dental surgery, inform your dentist that you are taking RISEDRONATE EUROGENERICI 75 mg.

Your doctor will advise you on what to do when taking RISEDRONATE EUROGENERICI 75 mg if you have any of the conditions described above.
Children and adolescents
The use of sodium risedronate in children under 18 years of age is not recommended, as sufficient data on safety and efficacy are not available.
Other medicines and RISEDRONATE EUROGENERICI 75 mg
Medicines containing any of the following substances may reduce the effect of RISEDRONATE EUROGENERICI 75 mg if taken at the same time:

• calcium;
• magnesium;
• aluminium (e.g. some antacid mixtures);
• iron.

Take these medicines at least 30 minutes after taking RISEDRONATE EUROGENERICI 75 mg tablets.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
RISEDRONATE EUROGENERICI 75 mg with food and drink
It is very important that you do NOT take the RISEDRONATE EUROGENERICI 75 mg tablet with food or drinks (other than tap water), so that the medicine works properly. In particular, do not take this medicine together with dairy products (such as milk), as these foods contain calcium (see section 2 “Other medicines and RISEDRONATE EUROGENERICI 75 mg tablets”).
Take food and drinks (other than tap water) at least 30 minutes after taking the RISEDRONATE EUROGENERICI 75 mg tablet.
Pregnancy and breast-feeding
DO NOT take RISEDRONATE EUROGENERICI 75 mg if you suspect you are pregnant, are pregnant, or are planning a pregnancy (see section 2 “Do NOT take RISEDRONATE EUROGENERICI 75 mg”). The potential risk associated with the use of sodium risedronate (the active substance in RISEDRONATE EUROGENERICI 75 mg) during pregnancy is unknown.
DO NOT take RISEDRONATE EUROGENERICI 75 mg if you are breast-feeding (see section 2 “Do NOT take RISEDRONATE EUROGENERICI 75 mg”).
RISEDRONATE EUROGENERICI 75 mg should be used only for the treatment of postmenopausal women.
Driving and using machines
It is unknown whether RISEDRONATE EUROGENERICI 75 mg affects your ability to drive or use machinery.

3. How to take RISEDRONATE EUROGENERICI 75 mg

Take this medicine exactly as your doctor has told you. If you are unsure,
consult your doctor or pharmacist.

Recommended dose:
Take the RISEDRONATE EUROGENERICI 75 mg tablets 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 RISEDRONATE
EUROGENERICI 75 mg. Take ONE tablet of RISEDRONATE EUROGENERICI 75 mg in the morning
of the first chosen day. Take the SECOND tablet the following morning.
Repeat this dosing every month on the same two consecutive days. To help you remember when
to take the next tablets, make a written note or place a sticker in advance on your calendar.

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

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

• Take the tablet while remaining in an upright position (sitting or standing) to help avoid heartburn.
• Swallow the tablet with at least one glass (120 ml) of tap water. Do not take your tablet with mineral water or any other beverage besides tap water.
• Swallow the tablet whole. Do not suck or chew the tablet.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will advise you if you need calcium or vitamin supplements, in case your diet does not provide sufficient amounts.

If you take more RISEDRONATE EUROGENERICI 75 mg than you should
If you or someone else has accidentally taken more tablets of RISEDRONATE EUROGENERICI
75 mg than prescribed, drink a full glass of milk and seek medical help immediately.

If you forget to take RISEDRONATE EUROGENERICI 75 mg

| If you forgot | What to do | |--------------|------------| | More than 7 days until the next monthly dose | Take the first tablet in the morning of the next monthly cycle, and the second tablet the following morning | | First and second tablet | The next monthly dose is due within 7 days | Do not take the tablets you missed | | More than 7 days until the next monthly dose | Take the second tablet in the morning of the next monthly cycle | | Only the second tablet | The next monthly dose is due within 7 days | Do not take the tablet you missed |

In the following month, take the tablets again as usual.

In any case:

• If you forget to take your RISEDRONATE EUROGENERICI 75 mg dose in the morning, do not take it later the same day.
• Do not take three tablets within the same week.

If you stop taking RISEDRONATE EUROGENERICI 75 mg
If you stop treatment, you may begin to lose bone mass. Talk to your doctor before stopping treatment.

If you have any 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 immediately if you experience the following symptoms:

• signs of a severe allergic reaction such as
• swelling of the face, tongue, or throat,
• difficulty swallowing,
• hives and breathing difficulties;
• serious skin reactions such as
• blistering of the skin, mouth, eyes, and other moist body surfaces (genitals) (Stevens-Johnson syndrome),
• palpable red spots on the skin (leukocytoclastic vasculitis),
• widespread red rash and/or shedding of the outer layer of skin (toxic epidermal necrolysis).

Contact your doctor immediately if you experience the following side effects:

• eye inflammation, usually associated with pain, redness, and sensitivity to light;
• jawbone/mouthbone necrosis (osteonecrosis) with delayed healing and infection, often following tooth extraction (see section 2 “Warnings and precautions”);
• esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or onset/worsening of heartburn.

An unusual femoral fracture may rarely 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 femoral fracture.
In any case, other side effects observed in clinical studies have generally been mild in severity and have not required discontinuation of treatment.
Common side effects (may affect up to 1 in 10 people)

• indigestion, nausea, vomiting, stomach ache, stomach cramps or discomfort, constipation, feeling of fullness, bloating, diarrhoea;
• bone, muscle or joint pain;
• headache.

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

• inflammation or ulcers of the oesophagus (the tube connecting the mouth to the stomach), causing difficulty and pain when swallowing (see also section 2 “Warnings and precautions”), inflammation of the stomach and duodenum (the part of the intestine receiving digested food from the stomach);
• inflammation of the coloured part of the eye (iris) (red, painful eyes with possible changes in vision);
• 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 oesophagus (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 could be signs of bone damage in the ear.

During the post-marketing period, the following reactions have been reported (frequency unknown):

• hair loss;
• liver disorders, in some cases severe.

Rarely, at the beginning of treatment, the patient's plasma levels of calcium and phosphate may decrease. These changes are usually mild and do not cause symptoms.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at the website
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 RISEDRONATE 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 carton and blister after the wording EXP. The expiry date refers to the last day of that month.
• Do not store above 30°C.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What RISEDRONATO EUROGENERICI 75 mg contains
The active substance is sodium risedronate. Each tablet contains 75 mg of sodium risedronate,
equivalent to 69.6 mg of risedronic acid.
The other components are:
Tablet core: Microcrystalline cellulose, crospovidone A, magnesium stearate.
Tablet coating: Opadry II Pink [polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E171), iron oxide red (E172)].
Description of the appearance of RISEDRONATO EUROGENERICI 75 mg and pack sizes
RISEDRONATO EUROGENERICI 75 mg film-coated tablets are pink, oblong tablets.
The tablets are available in blister packs containing 2, 4, 6, 12, 18, or 24 tablets.
Not all pack sizes may be marketed.
Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names:
DE Risedronat AL 75 mg Filmtabletten
BE Risedronate EG 75 mg filmomhulde tabletten
ES Risedronato CDRD 75 mg comprimidos recubiertos con película EFG
IT RISEDRONATO EUROGENERICI
LU Risedronate EG 75 mg comprimés pelliculés