Patient Information Leaflet

Rilovans 35 mg film-coated tablets

Sodium risedronate
generic medicine
Please read all of this leaflet carefully before you take 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 other people, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Rilovans is and what it is used for
What you need to know before taking Rilovans
How to take Rilovans
Possible side effects
How to store Rilovans
Contents of the pack and other information

1. What Rilovans is and what it is used for

Rilovans 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 prone to fractures.
Bone is a living tissue. The body continuously breaks down old bone and replaces it with new bone tissue.
Postmenopausal osteoporosis is a condition that occurs in women after menopause, when bones become weakened and thinner, increasing the risk of fractures following falls or minor trauma.
Osteoporosis can also occur in men due to various causes such as aging and/or low levels of the male hormone testosterone.
Fractures occur most frequently in the spine, hip, and wrist, although they can occur anywhere in the body. Osteoporosis-related fractures may also cause back pain, weight loss, and curvature of the spine. Many patients with osteoporosis do not have symptoms and therefore may not even be aware they have it.
Rilovans is used for the treatment of osteoporosis:

in postmenopausal women, including those with severe osteoporosis. It reduces the risk of vertebral and hip fractures;
in men.

2. What you need to know before taking Rilovans

Do not take Rilovans

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 are pregnant, think you may be pregnant, or are planning a pregnancy;
if you are breastfeeding;
if you have severe kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rilovans.
Pay special attention to Rilovans and consult your doctor:

If you are unable to stand or sit upright for at least 30 minutes.
If you have disorders of mineral and bone metabolism (for example, vitamin D deficiency, parathyroid hormone dysfunction, both of which can lead to reduced calcium levels in the blood).
If you have previously had oesophageal problems (the tube connecting the mouth to the stomach), such as pain or difficulty swallowing food, or if you 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 and/or mandible, or a sensation of "heavy jaw", or tooth mobility.
If you are under dental treatment or have a dental procedure scheduled; in this case, you must inform your dentist that you are being treated with sodium risedronate. Your doctor will advise you on what to do while taking Rilovans if you have any of the above conditions.

Children
The use of this medicine is not recommended in children under 18 years of age, as data on safety and efficacy are insufficient.
Other medicines and Rilovans
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines containing any of the following ingredients may reduce the effect of Rilovans if taken at the same time:
calcium
magnesium
aluminium (e.g. some antacids for digestive discomfort)
iron
Take these medicines at least 30 minutes after taking Rilovans.

Rilovans with food and drinks
It is very important not to take food or drinks (except tap water) together with the Rilovans tablet, so that it can work properly. In particular, do not take this medicine at the same time as dairy products (such as milk), as they contain calcium (see section 2 "Other medicines and Rilovans").
Take food and drinks (except tap water) at least 30 minutes after taking the Rilovans tablet.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Rilovans if you are pregnant, think you may be pregnant, or are planning a pregnancy (see section 2 "Do not take Rilovans"). The potential risk associated with the use of sodium risedronate (the active substance in Rilovans) in pregnant women is unknown.
Do not take Rilovans if you are breastfeeding (see section 2 "Do not take Rilovans").

Driving and using machines
No effects on the ability to drive or operate machinery have been observed.

Rilovans contains lactose
This medicine contains a small amount of lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Rilovans

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet per week.
Choose the day of the week that best fits your routine and take one Rilovans tablet on that chosen day.
The package contains compartments/spaces. Mark the day of the week selected for taking the Rilovans tablet. Also note the days on which you will take the tablet.
Take the tablet at least 30 minutes before the first daily intake of food or beverages (except tap water) or other medicines of the day.
Take the tablet while in an upright position (sitting or standing) to avoid stomach irritation.
Swallow the tablet whole with at least one glass of tap water (120 ml). Do not chew or let the tablet dissolve in the mouth.
Do not lie down for 30 minutes after swallowing the tablet.
Your doctor will assess whether you need calcium and vitamin supplements, if these are not sufficiently provided by your diet.
If you take more Rilovans than you should
If you or someone else accidentally takes more Rilovans tablets than prescribed, drink a full glass of milk and contact your doctor immediately.
If you forget to take Rilovans
If you forget to take the tablet at your usual time, take it on the same day as soon as you remember.
Resume taking one tablet once weekly on your usual tablet-taking day.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Rilovans
If you have any doubts about using this medicine, consult your doctor or pharmacist. If you stop taking this medicine, you may begin to lose bone mass. Talk to your doctor before deciding to stop treatment with Rilovans.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Rilovans and contact a doctor immediately if you experience any of the following symptoms of a severe allergic reaction:

swelling of the face, tongue or throat
difficulty swallowing
hives and breathing difficulties
severe blistering skin reactions, including blister formation.

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

Eye inflammation, usually with pain, redness and sensitivity to light.
Jaw bone necrosis (osteonecrosis) associated with delayed healing and onset of infection, often following tooth extraction (see section 2 “Warnings and precautions”).
Oesophageal disorders such as painful swallowing, difficulty swallowing, chest pain or onset/worsening of heartburn.

However, other side effects observed in clinical studies have generally been mild in severity and have not led to discontinuation of treatment.

Common side effects (may affect up to 1 in 10 people)
Indigestion (dyspepsia), feeling of nausea, stomach ache, stomach cramps or gastric discomfort, constipation, bloating sensation, bloated abdomen (flatulence), diarrhoea.
Pain in bones, muscles or joints.
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 section 2 “Warnings and precautions”), inflammation of the stomach and duodenum (the first part of the intestine following the stomach).
Inflammation of the coloured part of the eye (iris) (painful red eyes with possible altered vision).

Rare side effects (may affect up to 1 in 1,000 people)
Inflammation of the tongue (red, swollen and sometimes painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach).
Changes in liver function tests. These changes may be detected by a blood test.
During post-marketing experience, the following side effects have been reported:
Rarely, at the beginning of treatment, calcium and phosphate levels in the patient's blood may decrease. These changes are usually mild and asymptomatic.
Rarely, an unusual fracture of the femur may occur, particularly in patients receiving 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 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 could be symptoms of bone damage in the ear.

Side effects with unknown frequency (frequency cannot be estimated from the available data)
Skin allergic reactions such as hives (urticaria), skin rash, swelling of the face, lips, tongue and/or throat, difficulty swallowing or breathing.
Severe skin reactions including subcutaneous blisters; inflammation of small blood vessels, characterised by palpable red spots on the skin (leucocytoclastic vasculitis); a serious condition called Stevens-Johnson syndrome (SJS) with blisters on the skin, mouth, eyes and other moist areas of the body (genitals); a serious illness called toxic epidermal necrolysis (TEN) causing red rash in many parts of the body and/or peeling of the outer layers of skin.
Hair loss.
Allergic reactions (hypersensitivity).
Severe liver disorders, especially if you are taking other medicines known to cause liver problems.
Eye inflammation causing pain and redness.

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:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rilovans

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry". The expiry date refers to the last day of that month.
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 Rilovans contains

The active substance is sodium risedronate. Each tablet contains 35 mg of sodium risedronate (as sodium risedronate hemipentahydrate).
The other components are:

Core: microcrystalline cellulose, crospovidone, magnesium stearate, lactose monohydrate;
Coating: red iron oxide, yellow iron oxide, anhydrous colloidal silica, titanium dioxide, macrogol 400,
macrogol 8000, hypromellose, hydroxypropylcellulose.

Description of the appearance of Rilovans and package contents
Rilovans are film-coated round, light orange tablets, 9 mm in diameter.
They are available in blisters containing 4 tablets or 12 tablets.

Marketing Authorization Holder
I.B.N. Savio S.r.l. – Via del Mare, 36 – Pomezia (Rm)

Manufacturer
Adamed Pharma SA - Ul. Marszalka Jozefa Pilsudskiego 5 - 95 – 200 Pabianice - Poland
Lachifarma S.p.A. – Laboratorio Chimico Farmaceutico Salentino - S.S. 16 Adriatica – zona industriale – 73010
ZOLLINO (LE) - Italy