Riseceus

Package leaflet: Information for the user

RISECEUS 35 mg film-coated tablets

Sodium risedronate
Generic 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT Riseceus IS AND WHAT IT IS USED FOR

What Riseceus is
Riseceus belongs to a group of non-hormonal medicines called bisphosphonates, used for the treatment of bone diseases. Riseceus 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. Osteoporosis can also occur in men, for various reasons, including aging and/or low levels of the male hormone testosterone.

The bones most likely to fracture are the spine, hip, and wrist, although fractures can 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 Riseceus is used for
For the treatment of osteoporosis

• in postmenopausal women, even if osteoporosis is severe. It reduces the risk of vertebral fractures and hip fractures.
• in men at high risk of fractures.

2. WHAT YOU NEED TO KNOW BEFORE TAKING Riseceus
   Do not take Riseceus

• If you are allergic (hypersensitive) to sodium risedronate or to any of the other ingredients of Riseceus (see section 6 “What Riseceus contains”).
• If your doctor has told you that you have a condition called hypocalcaemia (low levels of calcium in the blood).
• If you think you may be pregnant, if you are pregnant, or if you are planning to become pregnant.
• If you are breastfeeding.
• If you have severe kidney problems.

Warnings and precautions
Take particular care and inform your doctor BEFORE starting to take Riseceus

• 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, vitamin D deficiency, parathyroid hormone abnormalities, both of which result in low levels of calcium in the blood).
• If you have previously had problems with your oesophagus (the tube connecting the mouth to the 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 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 if you have a “heavy jaw” sensation, or if you have lost a tooth.
• If you are undergoing or are scheduled for dental treatment or dental surgery, inform your dentist that you are taking Riseceus. Your doctor will advise you on what to do if any of the above conditions apply to you.

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

Taking other medicines
Concomitant use of medicines containing any of the following substances reduces the effect of Riseceus:

• Calcium
• Magnesium
• Aluminium (for example, some antacid preparations)
• Iron. Take these medicines at least 30 minutes after taking the Riseceus tablet. Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.

Use of Riseceus with food and drinks
It is very important not to take the Riseceus 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 other medicines”).
Take food and drinks (except plain water) at least 30 minutes after taking the Riseceus tablet.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Riseceus if you think you may be pregnant, if you are pregnant, or if you are planning a pregnancy (see section 2 “Do not take Riseceus”). The potential risk associated with the use of sodium risedronate (the active substance in Riseceus) in pregnant women is unknown.
Do not take Riseceus if you are breastfeeding (see section 2 “Do not take Riseceus”).
Riseceus should be used exclusively for the treatment of postmenopausal women and men.

Driving and using machines
It is not known whether Riseceus affects your ability to drive or use machinery.

Important information about some ingredients of Riseceus
Riseceus contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE Riseceus

Dosage
Always take Riseceus exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
Usual dose:
Take one tablet of Riseceus (35 mg of sodium risedronate) once a week. Choose the day of the week that best fits your schedule. Each week, take the Riseceus tablet on the chosen day.
For your convenience, so that you can take the tablet on the correct day every week, the carton includes printed boxes/spaces.
Mark the day of the week on which you have chosen to take your Riseceus tablet.

When to take the Riseceus tablet
Take your Riseceus tablet at least 30 minutes before the first intake of food, beverages (except plain water), or other medications of the day.

How to take the Riseceus tablets

• Take the tablet while remaining in an upright position (you may sit or stand) to help prevent heartburn.
• Take the tablet with at least one glass of plain water (120 ml).
• 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 and vitamin supplements, in case your dietary intake is insufficient.

If you take more Riseceus than you should
If you or someone else has accidentally taken more Riseceus tablets than prescribed, drink a full glass of milk and contact a doctor immediately.

If you forget to take Riseceus
If you forget to take your tablet on the chosen day, take it as soon as you remember on the same day.
Resume taking the tablet once a week on your usual day.
Do not take a double dose to make up for the missed dose.

If you stop taking Riseceus
If you stop treatment, you may begin to lose bone mass. Speak with your doctor before stopping treatment.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Riseceus may cause side effects, although not everyone experiences them.
Atypical femoral fractures may rarely occur, particularly in patients receiving long-term treatment for osteoporosis. Inform 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.
Stop treatment with Riseceus and contact a doctor immediately if you experience any of the following:

• Symptoms of a severe allergic reaction such as: ◊ Swelling of the face, tongue, or throat ◊ Difficulty swallowing ◊ Hives and breathing difficulties
• Severe skin reactions which may include blistering of the skin.

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

• Eye inflammation, 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 “Warnings and precautions”).
• Oesophageal symptoms such as painful swallowing, difficulty swallowing, chest pain, or onset or worsening of heartburn.

However, other side effects observed during clinical studies have generally been mild and have not required discontinuation of therapy.
Side effects are listed below according to their frequency of occurrence. The following classification has been used:
Very common: affects more than 1 in 10 people
Common: affects 1 to 10 in 100 people
Uncommon: affects 1 to 10 in 1,000 people
Rare: affects 1 to 10 in 10,000 people
Very rare: affects fewer than 1 in 10,000 people
Not known: frequency cannot be estimated from available data

Common side effects

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

Uncommon side effects

• 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 Riseceus”), inflammation of the stomach and duodenum (intestinal emptying into the stomach).
• Inflammation of the coloured part of the eye (iris) (painful red eyes with possible visual disturbances).

Rare side effects

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

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, mainly affecting the skin (leukocytoclastic vasculitis).

Rarely, at the beginning of treatment, patients' blood levels of calcium and phosphates may decrease. These changes are usually minor and do not cause symptoms.
Very rare side effects:
Contact your doctor if you experience ear pain, ear discharge, and/or ear infection.
These events could be symptoms of bone damage in the ear.

Reporting of side effects
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform 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 Riseceus

Keep out of the sight and reach of children.
Do not use Riseceus after the expiry date stated on the label, the carton, and the blister after
EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENT AND OTHER INFORMATION

What Riseceus contains

• The active substance is sodium risedronate (amorphous). Each tablet contains 35 mg of sodium risedronate, equivalent to 32.48 mg of risedronic acid.
• The other components are: magnesium stearate, crospovidone, lactose monohydrate, microcrystalline cellulose, hypromellose (E464), anhydrous colloidal silica, hydroxypropylcellulose (E463), polyethylene glycol 400, polyethylene glycol 8000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Riseceus and contents of the pack
Film-coated tablet.
Orange, round, biconvex, film-coated tablets with a diameter of 9 mm.
Packs:
Blister: 4 film-coated tablets.
Bottles: 50 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Genetic S.p.A.
Via Della Monica, 26
84083 Castel San Giorgio (SA), Italy

Manufacturer responsible for batch release
Actavis hf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA), Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Riseceus

This summary of product characteristics was last approved on: