Risedronate Doc Generici

Patient Information Leaflet

RISEDRONATE DOC 75 mg film-coated tablets

Equivalent medicine
Please read this entire leaflet carefully before 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 give it to others, even if they have the same symptoms as you, as it may 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 DOC 75 mg film-coated tablets are and what they are used for
2. What you need to know before taking RISEDRONATE DOC 75 mg film-coated tablets
3. How to take RISEDRONATE DOC 75 mg film-coated tablets
4. Possible side effects
5. How to store RISEDRONATE DOC 75 mg film-coated tablets
6. Contents of the pack and other information

1. What RISEDRONATE DOC 75 mg film-coated tablets is and what it is used for

What RISEDRONATE DOC 75 mg is
RISEDRONATE DOC 75 mg belongs to a group of non-hormonal medicines called bisphosphonates, used for the
treatment of bone diseases. RISEDRONATE DOC 75 mg acts directly on the bones, strengthening them and thereby
reducing their 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 bones become weaker, more fragile, and more likely to break following a fall or strain.
The bones most likely to fracture are the spine, hip, and wrist, although fractures may occur in any bone of the body. Fractures due to osteoporosis may also cause back pain, loss of height, and curvature of the spine. Many patients with osteoporosis do not have symptoms and may not even know they have it.
What RISEDRONATE 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 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 think you are pregnant, if you are pregnant, or if you are planning a pregnancy.
• If you are breast-feeding.
• If you have severe kidney problems.

Warnings and precautions
Before starting to take RISEDRONATO DOC 75 mg, inform 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 or mineral metabolism (for example, vitamin D deficiency, parathyroid hormone abnormalities, both of which result in low blood calcium levels).
• If you 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 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, or if you feel a sensation of heaviness in the jaw, or if you have lost a tooth.
• If you are undergoing dental treatment or are scheduled for dental surgery, inform your dentist that you are taking RISEDRONATO DOC 75 mg. Your doctor will advise you on what to do if any of the above conditions apply to you.

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

Other medicines and RISEDRONATO DOC 75 mg
Taking medicines containing any of the following substances at the same time may reduce the effect of RISEDRONATO DOC:

• calcium
• magnesium
• aluminium (e.g. some antacid preparations)
• iron. Take these medicines at least 30 minutes after taking the RISEDRONATO DOC 75 mg tablet.

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

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

Pregnancy and breast-feeding
Do not take RISEDRONATO DOC 75 mg if you think 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 sodium risedronate (the active substance in RISEDRONATO DOC 75 mg) in pregnant women is unknown.
Do not take RISEDRONATO DOC 75 mg if you are breast-feeding (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 or operate machinery.

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

Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure,
please consult your doctor or pharmacist.
Usual dose:
Take one tablet of RISEDRONATE DOC 75 mg on the same two consecutive days each month, e.g. the
1st and 2nd day of the month, or the 15th and 16th of the month.
Choose TWO consecutive days that best fit your schedule to take RISEDRONATE DOC.
Take ONE tablet of RISEDRONATE DOC 75 mg in the morning on the first chosen day. Take the
SECOND tablet in the morning of the following day.
Repeat this procedure every month, keeping the same two consecutive days. To help you remember when
to take the tablets, you may mark the days on your calendar with a pen or a sticker.

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

How to take the RISEDRONATE DOC 75 mg tablets

• Take the tablet while in an upright position (you may sit or stand) to help prevent stomach irritation.
• Take the tablet with at least one full glass of plain water (120 ml). Do not take the tablet with mineral water or any other beverage besides 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 advise you if you need calcium or vitamin supplements, especially if your diet does not provide sufficient amounts.

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

If you forget to take RISEDRONATE DOC 75 mg

| You forgot: | What to do: | |------------|-------------| | The 1st and 2nd tablet, and the next monthly dose is scheduled more than 7 days later | Take the 1st tablet in the morning and the 2nd tablet in the morning of the following day | | The 1st and 2nd tablet, and the next monthly dose is scheduled within 7 days | Do not take the tablets you missed | | Only the 2nd tablet, and the next monthly dose is scheduled more than 7 days later | Take the 2nd tablet in the morning after | | Only the 2nd tablet, and the next monthly dose is scheduled within 7 days | Do not take the tablet you missed |

The following month, resume taking the tablets as usual.

In any case:

• If you forget a dose of RISEDRONATE DOC 75 mg in the morning, do not take it later during the day.
• Do not take 3 tablets within the same week.

If you stop taking RISEDRONATE DOC 75 mg
If you stop treatment, you may begin to lose bone mass. Please consult your doctor before stopping treatment.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following signs, stop treatment with Risedronate and consult a doctor immediately:

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

Contact your doctor immediately if 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) associated with delayed healing and infection, often following tooth extraction (see section 2, “Take special care and consult your doctor before taking RISEDRONATE DOC 75 mg”).
• Oesophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or onset or worsening of heartburn.

However, other side effects observed during 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 ache, stomach cramps or discomfort, constipation, sensation of fullness, flatulence, diarrhoea.
• Bone, muscle or joint pain.
• Headache.

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

• Inflammation or ulceration of the oesophagus (the tube connecting the mouth to the stomach), causing difficulty and pain when swallowing (see also section 2 “Take special care and consult your doctor before taking RISEDRONATE DOC 75 mg”), inflammation of the stomach and duodenum.
• Inflammation of the coloured part of the eye (iris) (painful eye redness 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 oesophagus (the tube connecting the mouth to the stomach).
• Abnormalities in liver function tests have been reported. These 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 events could 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 patient's blood levels of calcium and phosphate may decrease. These changes are usually minor and do not cause symptoms.
Unusual femoral (thigh bone) fractures may rarely occur, particularly in patients on long-term treatment for osteoporosis. Contact your doctor immediately if you experience pain, weakness or discomfort in the thigh, hip or groin, as these may be early signs of a possible femoral fracture.
If any of the side effects worsen or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 RISEDRONATE 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 stated on the carton and blister after “Exp”. The expiry date refers to the last day of the month.
• This medicine does not require any special storage conditions.

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

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

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
(FR) Risedronato BGR 75 mg, comprimé pelliculé
(DE) Risedronat AL 75 mg Filmtabletten
(EL) Bondamax 75
(ES) Risedronato Farma Qualigen 75 mg comprimidos recubiertos con película
(IT) RISEDRONATO DOC 75 mg compresse rivestite con film