RISEDRONATO 75 mg Film-Coated Tablets

Зміст інструкції

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

RISEDRONATO DOC 75 mg film-coated tablets

Generic medicine

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

1. What RISEDRONATO DOC 75 mg film-coated tablets are and what they are used for

What RISEDRONATO DOC 75 mg is
RISEDRONATO DOC 75 mg belongs to a group of non-hormonal medicines called bisphosphonates used for the
treatment of bone diseases. RISEDRONATO DOC 75 mg acts directly on the bones strengthening them and
therefore reducing the risk of fractures.
Bone is a living tissue. Old bone is constantly removed from the skeleton and replaced by new bone.
Postmenopausal osteoporosis is a condition that occurs in women after menopause, when the bones
become weaker, more fragile and are more likely to break after a fall or effort.
The bones most likely to break are the spine, hip and wrist, although this
can occur in any bone in the body. Fractures due to osteoporosis can also cause pain
to the back, loss of height and curvature of the spine. Many patients with osteoporosis do not present
symptoms and may not even know they have it.

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

2. What you need to know before taking RISEDRONATO DOC 75 mg film-coated tablets

Do not take RISEDRONATO DOC 75 mg:

• If you are allergicto risedronic acid sodium or 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(low levels of calcium in the blood).
• If you believe you are pregnant, if you are pregnant, or if you are planning a pregnancy.
• If you are breastfeeding.
• If you have severe kidney problems.

Warnings and precautions
Before starting to take RISEDRONATO DOC 75 mg, tell your doctor or pharmacist:

• If you are unable to remain upright (sitting or standing) for at least 30 minutes.
• If you have an abnormal bone and mineral metabolism (for example, a vitamin D deficiency, abnormalities of parathyroid hormone, both conditions that result in a low level of calcium in the blood).
• If you have had problems with your esophagus (the channel connecting the mouth to the stomach) in the past. For example, you may have experienced 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 esophagus).
• If you have or have had pain, swelling or numbness in the jaw or if you feel like your jaw is heavy or if you have lost a tooth.
• If you are undergoing dental treatment or are to undergo dental surgery, inform your dentist that you are taking RISEDRONATO DOC 75 mg. Your doctor will advise you on what to do when taking RISEDRONATO DOC 75 mg if any of the above conditions apply to you.

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

Other medicines and RISEDRONATO DOC 75 mg
Concomitant intake of medicines containing any of the following substances decreases the effect of
RISEDRONATO DOC:

• calcium
• magnesium
• aluminum (for example, some antacids)
• iron. Take these medicines at least 30 minutes after taking the RISEDRONATO DOC 75 mg tablet.

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

RISEDRONATO DOC 75 mg with food and drink
It is very important not to take the RISEDRONATO DOC 75 mg tablet with food or drink (except plain
water) so that it can work properly. In particular, do not take this medicine
together with dairy products (such as milk) as they contain calcium (see section 2 “Do not take RISEDRONATO DOC 75 mg”).
Take food and drink (except plain water) at least 30 minutes after taking the RISEDRONATO DOC 75 mg tablet.

Pregnancy and breastfeeding
Do not take RISEDRONATO DOC 75 mg if you believe you are pregnant, if you are pregnant or if you are planning a
pregnancy (see section 2 “Do not take RISEDRONATO DOC 75 mg”). The potential risk associated with
the use of risedronic acid sodium (the active ingredient of RISEDRONATO DOC 75 mg) in pregnant
women is not known.
Do not take RISEDRONATO DOC 75 mg if you are breastfeeding (see section 2 “Do not take RISEDRONATO
DOC 75 mg”).
RISEDRONATO DOC 75 mg should be used exclusively for the treatment of postmenopausal women.

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

3. How to take RISEDRONATO DOC 75 mg film-coated tablets

Dosage
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Usual dose:
Take one tablet of RISEDRONATO DOC 75 mg on the same two consecutive dates each month, e.g. on the
1st and 2nd day of the month, or on the 15th and 16th of the month.
Choose TWO consecutive dates that best suit your schedule to take RISEDRONATO DOC.
Take ONE tablet of RISEDRONATO DOC 75 mg in the morning of the first chosen date. Take the
SECOND tablet in the morning of the next day.
Repeat this procedure every month, keeping the same two consecutive dates. To help you remember when
to take the next tablets, you can mark the day on the calendar with a pen or sticker.

When to take the RISEDRONATO DOC 75 mg tablet
Take your RISEDRONATO DOC 75 mg tablet at least 30 minutes before the first intake of
food, drinks (except plain water), or other medicines of the day.

How to take the RISEDRONATO DOC 75 mg tablets

• Take the tablet while standing upright(you can sit or stand) to avoid heartburn.
• Takethe tablet with at least one glassof plain water(120 ml). Do not take the tablet withmineral wateror drinks other than plain water.
• Swallow the tablet whole. Do not chew or suck it.
• Do not lie down for 30 minutes aftertaking the tablet.

Your doctor will tell you if you need calcium and vitamin supplements if you do not take them in sufficient
quantities with your diet.

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

If you forget to take RISEDRONATO DOC 75mg
You forgot When What to do
The next monthly
dose is scheduled
more than 7 days after
Take the 1st tablet in the morning
after and the 2nd in the morning of the day
after
The next monthly
dose is scheduled
within 7 days
The 1st and the 2nd
tablet Do not take the tablets you
forgot
The next monthly
dose is scheduled
more than 7 days after
Take the 2nd tablet in the morning
after
The next monthly
dose is scheduled
within 7 days
Only the 2nd
tablet Do not take the tablets you
forgot

The following month, return to taking the tablets as usual.
In any case:

• If you forget a dose of RISEDRONATO DOC 75 mg in the morning, DO NOT take it later during the day.
• DO NOT take 3 tablets in the same week.

If you stop taking RISEDRONATO DOC 75 mg
If you stop treatment you may start to lose bone mass. Ask your doctor before stopping the
treatment.
If you have any further questions on 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 everybody gets them.
If you experience any of the following signs, stop treatment with Risedronate and contact a doctor:

• Symptoms of a severe allergic reactionsuch as:
• swelling of the face, lips, tongue, throat and/or nose
• difficulty swallowing
• difficulty breathing
• hives, skin rashes.
• Severe skin reactionssuch as:
• blisters on the skin, mouth, eyes and on other moist surfaces of the body (genitals) (Stevens-Johnson syndrome)
• palpable red spots on the skin (leucocytoclastic vasculitis)
• rashes and redness on many parts of the body and/or loss of the outer layer of skin (toxic epidermal necrolysis).

Tell your doctor immediatelyif you develop any of the following side effects:

• Inflammation of the eye, usually with pain, redness and sensitivity to light.
• Osteonecrosis of the jaw (bone necrosis of the jaw) associated with delayed healing and infection, often following tooth extraction (see section 2, “Pay particular attention and consult your doctor before taking RISEDRONATO DOC 75 mg”).
• Esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or the appearance or worsening of heartburn.

However, other side effects observed during clinical studies were usually mild and did not
require discontinuation of therapy.

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

• Indigestion, nausea, vomiting, stomach pain, cramps or discomfort in the stomach, 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 tube connecting the mouth to the stomach) causing difficulty and pain when swallowing (see also section 2 “Pay particular attention and consult your doctor before taking RISEDRONATO DOC 75 mg”), inflammation of the stomach and duodenum.
• Inflammation of the colored part of the eye (iris) (painful red eyes with possible visual disturbances).
• Fever and/or flu-like symptoms.

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

• Inflammation of the tongue (redness and swelling, possible pain), narrowing of the esophagus (the tube connecting the mouth to the stomach).
• Abnormalities in liver function tests have been reported. This can only be diagnosed by a blood test.

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.

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

• hair loss
• liver disorders, in some cases severe
• inflammation of small blood vessels

Rarely, at the beginning of treatment, the levels of calcium and phosphate in the patient's blood may decrease. These
changes are generally minimal and do not cause symptoms.
Rarely, unusual fractures of the thigh bone may occur, particularly in patients treated for
osteoporosis for a long time. Contact your doctor immediately if you experience pain, weakness or discomfort in the
thigh, hip or groin as these may be an early indication of a possible fracture of the thigh
bone.
If any of these side effects gets serious or if you notice any side effects not

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 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 DOC 75 mg film-coated tablets

• 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 the 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 RISEDRONATO DOC 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, magnesium stearate. Coating: Opadry II Pink [polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E171), red iron oxide (E172)].

Description of the appearance of RISEDRONATO DOC 75 mg and contents of the pack
RISEDRONATO DOC 75 mg film-coated tablets are oblong, pink tablets. The tablets are
available in blister packs of 2, 4, 6 or 8 tablets. Not all pack sizes may be
marketed.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – Italy.

Manufacturer
BLUEPHARMA - Sao Martinho do Bispo, 3040-086 Coimbra – Portugal.

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
(FR) Risedronato BGR 75 mg, coated tablet
(DE) Risedronat AL 75 mg film-coated tablets
(EL) Bondamax 75
(ES) Risedronato Farma Qualigen 75 mg film-coated tablets
(IT) RISEDRONATO DOC 75 mg film-coated tablets