RISEDRONATE DOC GENERICI

PACKAGE LEAFLET: INFORMATION FOR THE USER

RISEDRONATE DOC Generics 35 mg film-coated tablets

Generic medicine
Please read all of 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 experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.

In this leaflet:

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

1. WHAT RISEDRONATO DOC Generici IS AND WHAT IT IS USED FOR

RISEDRONATO DOC Generici belongs to a group of non-hormonal medicines called bisphosphonates,
which are used to treat bone diseases. It acts directly on the bones to strengthen them and make fractures less likely.
Bones are living tissue. Old bone is constantly removed from the skeleton and replaced with new bone.
Postmenopausal osteoporosis occurs in women after menopause, when bones become weak and may break following a fall or strain.
Osteoporosis can also occur in men for various reasons, including age and/or 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 due to osteoporosis can also cause:
back pain
loss of height
curved spine.
Many patients with osteoporosis have no symptoms, and you may not even be aware that you have it.
RISEDRONATO DOC Generici is used for:
Treatment of osteoporosis

• in postmenopausal women, even if osteoporosis is severe. It reduces the risk of vertebral and hip fractures
• in men.

2. What you need to know before taking RISEDRONATE DOC Generici

Do not take RISEDRONATE DOC Generici:
if you are allergic to the active substance or to any of the other ingredients of this medicine (listed
in section 6)
if you have a condition known as hypocalcemia (low calcium levels in the blood)
if you may be pregnant, are pregnant, or are planning a pregnancy
if you are breastfeeding
if you have severe kidney problems.
Do not take this medicine if any of these situations apply to you. If you are unsure, speak with your doctor or
pharmacist before taking RISEDRONATE DOC Generici.

Warnings and precautions
Talk to your doctor or pharmacist before taking RISEDRONATE DOC Generici:
if you are unable to sit upright or stand for at least 30 minutes
if you have an abnormal bone and mineral metabolism (for example, vitamin D deficiency, parathyroid hormone abnormalities, both of which can cause low calcium levels in the blood)
if you have or have previously had problems with your oesophagus (the tube connecting your mouth to your stomach). For example, you may have experienced pain or difficulty swallowing food, or you may have previously been diagnosed with Barrett’s oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus)
if you have or have had pain, swelling, or numbness in the jaw, such as a feeling of heaviness in the jaw or loose teeth
if you are undergoing or are scheduled to undergo dental treatment or dental surgery. You must also inform your dentist that you are taking RISEDRONATE DOC Generici.
If any of the conditions described above apply to you (or if you are unsure), talk to your doctor or pharmacist before taking RISEDRONATE DOC Generici.

Children and adolescents
RISEDRONATE DOC Generici is not recommended for children under 18 years of age due to insufficient data on safety and efficacy.

Other medicines and RISEDRONATE DOC Generici
Taking medicines containing any of the following substances at the same time may reduce the effect of RISEDRONATE DOC Generici:

• calcium
• magnesium
• aluminium (for example, some antacid preparations)
• iron. Take these medicines at least 30 minutes after taking the RISEDRONATE DOC Generici tablet.

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

RISEDRONATE DOC Generici with food and drink
It is very important that you do NOT take RISEDRONATE DOC Generici with food or drinks (except water) so that it can work properly. In particular, do not take this medicine with dairy products (such as milk) because they contain calcium (see section 2, “Other medicines and RISEDRONATE DOC Generici”).
Food and drinks (except water) may be consumed at least 30 minutes after taking the RISEDRONATE DOC Generici tablet.

Pregnancy and breastfeeding
Do not take RISEDRONATE DOC Generici if:
you may be pregnant, are pregnant, or are planning a pregnancy (see section 2, “Do not take RISEDRONATE DOC Generici”). The potential risk associated with the use of sodium risedronate (the active substance in RISEDRONATE DOC Generici) during pregnancy is unknown
you are breastfeeding (see section 2, “Do not take RISEDRONATE DOC Generici”)
RISEDRONATE DOC Generici should be used exclusively by postmenopausal women and men.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
RISEDRONATE DOC Generici has no effect on your ability to drive. However, do not drive or operate machinery until you know how this medicine affects you. Ask your doctor or pharmacist if you are unsure.

RISEDRONATE DOC Generici contains lactose
If your doctor has told you that you cannot tolerate or digest certain sugars (have an intolerance to certain sugars), speak with your doctor before taking this medicine.

3. HOW TO TAKE RISEDRONATE DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Recommended dose:
Take ONE tablet of RISEDRONATE DOC Generici once a week.
Choose the day of the week that best fits your routine. Each week, take the tablet
on the same day you have chosen.
WHEN to take the RISEDRONATE DOC Generici tablet
Take your RISEDRONATE DOC Generici tablet at least 30 minutes before your first
food, drink (except plain water), or other medicines of the day.
HOW to take the RISEDRONATE DOC Generici tablet

• Take the tablet while standing or sitting upright to avoid heartburn.
• Take the tablet with at least one glass (120 ml) of plain water.
• Swallow the tablet whole. Do not chew or suck it.
• Do not lie down for 30 minutes after taking the tablet.

Your doctor will inform you if you need calcium and vitamin supplements, if your diet does not
provide sufficient amounts.
Patients with kidney problems
If you have severe kidney problems, RISEDRONATE DOC Generici is not suitable for you. Ask your doctor or
pharmacist if you are unsure.
Children and adolescents
RISEDRONATE DOC Generici must not be taken by children and young people under 18 years of age.
If you take more RISEDRONATE DOC Generici than you should:
drink a full glass of milk
contact a doctor or go immediately to the nearest hospital
take the medicine package with you.
If you forget to take RISEDRONATE DOC Generici
If you forget to take a dose, take it on the same day you remember.
Resume taking one tablet weekly on your usual day.
Do not take a double dose on the same day to make up for the missed dose.
If you stop taking RISEDRONATE DOC Generici
Do not stop taking RISEDRONATE DOC Generici without first talking to your doctor. If you need
to stop taking this medicine, your doctor will gradually reduce the dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur with this medicine:
Stop taking RISEDRONATE DOC Generici and contact a doctor immediately if you notice any of the
following adverse reactions:

• symptoms of a severe allergic reaction such as:
  • swelling of the face, tongue or throat
  • difficulty swallowing
  • hives and difficulty breathing
• severe skin reactions which may include blistering.

Contact your doctor immediately if any of the following adverse reactions occur:

• eye inflammation, usually painful, redness and sensitivity to light
• jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, often following dental extraction
• oesophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain or stomach pain that is new or worsening
• an allergic inflammation of blood vessels (leucocytoclastic vasculitis), characterized by leakage of blood cells (purpura), especially in the legs, and skin lesions. Patients may experience itching, burning, joint pain (arthralgia) and fever.

However, in clinical studies, other observed adverse reactions were generally mild and did not lead to treatment discontinuation.
Common (affects less than 1 in 10 people):
headache
constipation, indigestion, bloating, fullness
malaise (nausea)
stomach pain, cramps or discomfort in the stomach
diarrhoea
muscle, bone or joint pain.
Uncommon (affects less than 1 in 100 people):
inflammation or ulceration of the oesophagus (the tube connecting the mouth to the stomach), causing pain and difficulty swallowing
inflammation of the stomach and duodenum (the part of the intestine connected to the stomach)
inflammation of the coloured part of the eye (iris) (red, painful eyes with possible changes in vision).
Rare (affects less than 1 in 1000 people):
inflammation of the tongue (red, swollen, sometimes 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.

During post-marketing experience, the following adverse reactions have been reported (frequency not known):

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

Rarely, at the beginning of treatment, blood levels of calcium and phosphate may decrease. These changes are usually mild and do not cause symptoms.
Rarely, an unusual femoral fracture may occur, particularly in patients undergoing 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.
Very rare

• Consult your doctor if you experience ear pain, ear discharge and/or ear infection. These events could be signs of bone damage in the ear.

If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor. 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 DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after “Exp”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What RISEDRONATE DOC Generici contains

• The active substance is sodium risedronate (as hemipentahydrate).
• One 35 mg film-coated tablet of RISEDRONATE DOC Generici contains 35 mg of sodium risedronate equivalent to 32.5 mg of risedronic acid. The other ingredients are anhydrous lactose, crospovidone, magnesium stearate (E572), anhydrous colloidal silicon dioxide, hypromellose (E464), hydroxypropylcellulose (E463), macrogol, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of RISEDRONATE DOC Generici and contents of the package
RISEDRONATE DOC Generici 35 mg film-coated tablet is orange, round, biconvex, with
‘APO’ imprinted on one side and ‘RIS’ above ‘35’ on the other side.
The tablets are available in PVC/PVdC-Alu blisters in pack sizes of 4 and 12 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturers
Apotex Nederland BV
Archimedesweg 2
2333 CN Leiden
The Netherlands
Lamp S. Prospero S.p.A.
Via della Pace 25/A, San Prospero (MO)
Italy
Lachifarma S.r.l.
S.S. 16 Zona Industriale – 73010 Zollino (LE)
Italy

This medicinal product is authorised in the European Economic Area Member States under the following names:
Belgium Risedronate Apotex® 35mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Spain Risedronato Semanal APOTEX 35 mg comprimidos recubiertos con película
Luxembourg Risedronate Apotex® 35mg comprimés pelliculés
Netherlands Risedronaatnatrium Apotex wekelijks 35 mg, filmomhulde tabletten