Risedronate Accord

Patient Information Leaflet

Risedronato Accord 35 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Risedronate Accord is and what it is used for

What Risedronate Accord is
Risedronate Accord belongs to a group of non-hormonal medicines called bisphosphonates, which are used
to treat bone diseases. It works 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, in which bones weaken, become more fragile, and are more prone to fractures following a fall or minor trauma.
Osteoporosis can also occur in men due to various causes, including aging and/or low levels of testosterone, a male hormone.
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 the condition.
What Risedronate Accord 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 at high risk of fractures.

2. What you need to know before taking Risedronate Accord

Do not take Risedronate Accord

• 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 hypocalcemia (low calcium levels in the blood);
• if you could be pregnant, are pregnant, or are planning a pregnancy;
• if you are breast-feeding;
• if you have severe kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Risedronate Accord

• 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 abnormalities, 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 had pain or difficulty swallowing food, or you may have previously been diagnosed with Barrett’s esophagus (a condition associated with changes in the cells lining the lower part of the esophagus);
• if your doctor has told you that you have an intolerance to certain sugars (such as lactose);
• if you have or have had pain, swelling, or numbness in the jaw, or a “heavy jaw sensation,” or if you have lost a tooth;
• if you are undergoing or are about to undergo dental treatment or dental surgery, inform your dentist that you are taking Risedronate Accord. Your doctor will advise you on what to do if you have any of the conditions described above.

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

Other medicines and Risedronate Accord
Medicines containing any of the following substances may reduce the effect of Risedronate Accord if taken at the same time:

• calcium
• magnesium
• aluminium (for example, some antacid mixtures)
• iron

Take these medicines at least 30 minutes after taking Risedronate Accord. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Risedronate Accord with food and drinks
It is very important that you do NOT take the Risedronate Accord tablet with food or drinks other than plain 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 Accord”).
Take food and drinks (other than plain water) at least 30 minutes after taking the Risedronate Accord tablet.

Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
DO NOT take Risedronate Accord if you could be pregnant, are pregnant, or are planning a pregnancy (see section 2 “Do not take Risedronate Accord”). The potential risk associated with the use of sodium risedronate (the active substance in Risedronate Accord) in pregnant women is unknown.
DO NOT take Risedronate Accord if you are breast-feeding (see section 2 “Do not take Risedronate Accord”).
Risedronate Accord should only be used for the treatment of postmenopausal women and men.

Driving and using machines
It is unknown whether Risedronate Accord affects your ability to drive or operate machinery.

Risedronate Accord contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine (see section 2 “Warnings and precautions”).

Risedronate Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Risedronate Accord

Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Recommended dose
Take ONE tablet of Risedronate Accord (35 mg of sodium risedronate) once a week.
Choose a day of the week that is most convenient for you. Each week, take the Risedronate Accord tablet on the chosen day.
There are boxes/spaces on the packaging. Mark the day of the week you have chosen to take the Risedronate Accord tablet. Also record the dates for the period during which you will take the tablet.

When to take the Risedronate Accord tablet
Take the Risedronate Accord tablet at least 30 minutes before taking any food, drink (other than plain water) or other medicines of the day.

How to take the Risedronate Accord tablet
Take the tablet while maintaining an upright position (sitting or standing) to avoid stomach irritation.
Swallow the tablet with at least one glass (120 mL) of plain water.
Swallow the tablet whole. Do not suck or chew it.
Do not lie down for 30 minutes after taking the tablet.

Your doctor will advise you whether you need calcium and vitamin supplements if your diet does not provide sufficient amounts.

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

If you forget to take Risedronate Accord
If you forget to take your tablet on the chosen day, take it as soon as you remember.
Resume taking one tablet once a week on the same day as before.
DO NOT take a double dose to make up for the missed tablet.

If you stop taking Risedronate Accord
If you stop treatment, you may begin to lose bone mass. Consult your doctor before considering stopping treatment.

If you have any questions about 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 everyone experiences them.

• Stop taking Risedronate Accord and contact a doctor immediately if you experience any of the following conditions: Symptoms of 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 of the skin.

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

• Eye inflammation, typically associated with pain, redness and sensitivity to light.
• Jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, often following tooth extraction (see section 2 "Warnings and precautions");
• Symptoms affecting the oesophagus, such as pain when swallowing, difficulty swallowing, chest pain, or new onset/worsening of heartburn.

Rarely, an unusual femur fracture may occur, particularly in patients who have been treated for a long time 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 femur fracture.
However, in clinical studies, other side effects observed were generally mild and did not require patients to discontinue treatment.

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

• Indigestion, nausea, stomach ache, stomach cramps or discomfort, constipation, feeling of fullness, flatulence, diarrhoea.
• Pain in bones, muscles or joints.
• 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), resulting in difficulty and pain when swallowing (see also section 2 "Warnings and precautions"), inflammation of the stomach and duodenum (part of the intestine responsible for stomach emptying);
• Inflammation of the coloured part of the eye (iris) (red, painful eyes with possible changes in vision).

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

• Inflammation of the tongue (red and 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 through blood tests.

During post-marketing experience, the following side effects have been reported:

• Very rare side effects (may affect up to 1 in 10,000 people): consult your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes could be signs of bone damage in the ear.
• Not known (frequency cannot be estimated from available data):
  • Stevens-Johnson syndrome (SJS), a serious condition causing blistering of the skin, mouth, eyes and other moist surfaces of the body (genitals); toxic epidermal necrolysis (TEN), a serious condition causing a red rash in various parts of the body and/or loss of the outer layer of skin; inflammation of small blood vessels, characterised by palpable red spots on the skin (leucocytoclastic vasculitis).
  • Hair loss.
  • Severe liver disorders, some of which have been serious.

In rare cases, at the beginning of treatment, the patient's blood calcium and phosphate levels may decrease. These changes are generally mild and do not cause symptoms.

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 website www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Risedronate Accord

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 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. Contents of the Pack and Other Information

What Risedronate Accord contains

• The active substance is sodium risedronate. Each film-coated tablet contains 35 mg of sodium risedronate, equivalent to 32.5 mg of risedronic acid.
• The other components are:
  Tablet core: Pregelatinized starch (maize), microcrystalline cellulose, crospovidone, magnesium stearate.
  Film coating: Hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 4000.

Description of the appearance of Risedronate Accord and pack sizes
Risedronate Accord tablets are white, round, biconvex, film-coated tablets, 11.2 mm in diameter and 5.0 mm thick, with "35" engraved on one side. Risedronate Accord is available in blister packs containing: 1, 2, 4, 10, 12, or 16 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain.

Manufacturer
Pharmathen S.A.
6 Devernakion str., 153 51 Pallini Attiki Greece
and
Pharmathen International S.A.
Sapes Industrial Park, Block 5, 69300 Rodopi Greece