Risedronate Accord

Package leaflet: Information for the user

Risedronato Accordpharma 75 mg film-coated tablets

Equivalent 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 other people, even if their symptoms seem identical to yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Risedronato Accordpharma is and what it is used for

Risedronato Accordpharma
Risedronato Accordpharma 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 living tissue. Old tissue is constantly removed from the skeleton and replaced with new bone tissue.
Postmenopausal osteoporosis is a condition occurring in women after menopause, in which bones weaken, become more fragile, and more prone to fractures following a fall or minor trauma.
The spine, hip, and wrist are the bones most susceptible to fractures, although any bone in the body may be affected.
Fractures related to osteoporosis may also cause back pain, loss of height, and curvature of the spine. Many patients with osteoporosis have no symptoms, and it is even possible that you may not know you have it.
Treatment of osteoporosis in postmenopausal women.

2. What you need to know before taking Risedronate Accordpharma

Do NOT take Risedronate Accordpharma:

• if you are allergic to sodium risedronate or 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, if you are pregnant, or if you 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 Accordpharma:

• 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 abnormalities of parathyroid hormone, both of which can lead to low calcium levels in the blood);
• 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 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 had or currently have pain, swelling or numbness in the jaw, or a "heavy jaw sensation", or if you have a loose tooth;
• If you are undergoing or are about to undergo dental treatment or dental surgery, inform your dentist that you are being treated with Risedronate Accordpharma.

If you suffer from any of the conditions described above, your doctor will advise you on what to do regarding taking Risedronate Accordpharma.
Children and adolescents
The use of Risedronate Accordpharma is not recommended in children under 18 years of age due to insufficient data on safety and efficacy.
Other medicines and Risedronate Accordpharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines containing any of the following substances reduce the effect of Risedronate Accordpharma when taken at the same time:

• calcium
• magnesium
• aluminium (e.g. some antacid mixtures)
• iron Take these medicines at least 30 minutes after taking the Risedronate Accordpharma tablet.

Risedronate Accordpharma with food and drinks
It is very important that you do NOT take the Risedronate Accordpharma tablet with food or drinks (other than plain water), so that it can work properly. In particular, do not take this medicine with dairy products (such as milk), as these foods contain calcium (see section 2 “Other medicines and Risedronate Accordpharma”).
Take food and drinks (other than plain water) at least 30 minutes after taking the Risedronate Accordpharma tablet.
Pregnancy, fertility and breast-feeding
DO NOT take Risedronate Accordpharma if you could be pregnant, if you are pregnant, or if you are planning a pregnancy (see section 2 “Do NOT take Risedronate Accordpharma”). The potential risk associated with the use of sodium risedronate (the active substance in Risedronate Accordpharma) in pregnant women is unknown.
DO NOT take Risedronate Accordpharma if you are breast-feeding (see section 2 “Do NOT take Risedronate Accordpharma”).
Risedronate Accordpharma should only be used to treat postmenopausal women.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Risedronate Accordpharma has no known effects on the ability to drive vehicles or operate machinery.
Important information about some excipients of Risedronate Accordpharma
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Risedronate Accordpharma

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is: Risedronate Accordpharma tablets should be taken on the SAME two consecutive
days every month, e.g. the 1st and 2nd of the month, or the 15th and 16th.
Choose the TWO consecutive days that are most convenient for you to take Risedronate Accordpharma. Take ONE
tablet of Risedronate Accordpharma in the morning on the first chosen day. Take the SECOND tablet in the
morning of the following day.
Repeat the dosing on the same two consecutive days each month. To help you remember when to take the
tablets, you may mark the dates in advance on a calendar using a pen or stickers. You may also
record the date in the space provided on the back of the pack.

When to take the Risedronate Accordpharma tablet
Take the Risedronate Accordpharma 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 Accordpharma tablet

• Take the tablet while maintaining an upright position (sitting or standing) to help avoid stomach irritation.
• Swallow the tablet with at least one glass (120 ml) of plain water (tap water). Do not take the tablet with mineral water (bottled – some mineral waters may contain high concentrations of calcium) or with any beverage other than plain 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 and vitamin supplements in case your dietary intake is insufficient.

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

If you forget to take Risedronate Accordpharma

| You forgot | When the next monthly dose is due | What to do | |----------|-------------------------------|------------| | The 1st and 2nd tablet | More than 7 days later | Take the 1st tablet the following morning and the 2nd tablet the morning after | | The 1st and 2nd tablet | Within 7 days | Do not take the missed tablets | | Only the 2nd tablet | More than 7 days later | Take the 2nd tablet the following morning | | Only the 2nd tablet | Within 7 days | Do not take the missed tablets |

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

• If you forget to take your Risedronate Accordpharma tablet in the morning, do not take it later during the day.
• Do not take three tablets within the same week.

If you stop taking Risedronate Accordpharma
If you stop treatment, you may begin to lose bone mass. Consult your doctor before considering stopping the 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 Accordpharma and contact a doctor immediately if you experience any of the following conditions:

• 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 of the skin. Contact your doctor immediately if you experience the following side effects:

• eye inflammation, usually 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 “Take special care and consult your doctor before starting to take Risedronate Accordpharma”);

• symptoms affecting the oesophagus, such as pain when swallowing, difficulty swallowing, chest pain or new onset/worsening of heartburn.

However, in clinical studies, other side effects observed were generally mild and did not lead patients to discontinue tablet intake.
Common: may affect up to 1 in 10 people

• Indigestion, nausea, vomiting, stomach ache, cramps or stomach discomfort, constipation, feeling of fullness, flatulence, diarrhoea.
• Bone, muscle or joint pain.
• Headache.

Uncommon: 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 “Take special care and consult your doctor before starting to take Risedronate Accordpharma”), inflammation of the stomach and duodenum (part of the intestine responsible for emptying the stomach).
• Inflammation of the coloured part of the eye (iris) (red, painful eyes with possible changes in vision).
• Fever and/or flu-like illness (within 5 days of the first dose).

Rare: 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: 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.

Not known: frequency cannot be estimated from the available data

• Hair loss, skin rashes;
• Liver disorders, in some cases severe.

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 rare cases, at the beginning of treatment, calcium and phosphate levels in the patient's blood 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 may 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 Accordpharma

• 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 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. Package Contents and Other Information

What Risedronate Accordpharma 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 of the tablet core are monohydrate lactose, corn starch, pregelatinized starch (corn), anhydrous colloidal silica, sodium stearyl fumarate and magnesium stearate. The other components of the film coating are Opadry Pink II85F240031 containing polyvinyl alcohol, titanium dioxide (E171), macrogol, talc and red iron oxide (E172).

Description of the Appearance of Risedronate Accordpharma and Package Contents

• Film-coated tablet.
• Pink, round, biconvex, film-coated tablet, marked with "R 75" on one side and smooth on the other.
• Tablets are available in blister packs containing: 2, 4, 6, 8 and 12 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
(ES)
Manufacturers
TEVA Pharmaceutical Works Private Limited Company - Pallagi út 13, 4042 Debrecen (Hungary)
TEVA UK Ltd -Brampton Road, Hampden Park, BN22 9AG Eastbourne, East Sussex (United Kingdom)
TEVA Czech Industries s.r.o - Ostravská 29, c.p. 305, 747 70 Opava, Komárov (Czech Republic)
Teva Pharma, S.L.U. - C/ C, n° 4, Poligono Industrial Malpica, 50016 Zaragoza (Spain)
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren-Weiler (Germany)