RISECEUS 35 мг Фильм-coated таблетки

Содержание инструкции

1. RISECEUS 35 mg film-coated tablets
   1. WHAT IS Riseceus AND WHAT IS IT USED FOR
   2. HOW TO TAKE Riseceus
   3. POSSIBLE SIDE EFFECTS
   4. HOW TO STORE Riseceus
   5. PACKAGE CONTENTS AND OTHER INFORMATION

RISECEUS 35 mg film-coated tablets

Risedronate sodium
Generic Medicine

Read this leaflet carefully before you start 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 or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any of the side effects gets worse or if you notice any side effect

paragraph 4.

Contents of this leaflet:

• 1. What Riseceus is and what it is used for
• 2. What you need to know before you take 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 IS Riseceus AND WHAT IS IT USED FOR

What is Riseceus
Riseceus belongs to a group of non-hormonal medicines called bisphosphonates used for the treatment of
bone diseases. Riseceusacts directly on the bones strengthening them and therefore making them less at 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 the
bones become weaker, more fragile and are more likely to break after a fall or
effort. Osteoporosis can also occur in men, for a number of reasons, including aging and/or
low levels of the male hormone, testosterone.
The bones that are most likely to break are the spine, hip and wrist, although
this can occur in any bone in your body.
Fractures due to osteoporosis can also cause back pain, loss of height and
curvature of the spine. Many patients with osteoporosis have no symptoms and may not even
know they have it.

What is Riseceus used for
For the treatment of osteoporosis

• in women in postmenopause, even if the osteoporosis is severe. It reduces the risk of vertebral fractures and hip fractures.
• in men with a high risk of fractures.
• 2.What you need to know before you take RiseceusDo not take Riseceus
• If you are allergic (hypersensitive) to sodium risedronate or any of the other ingredients of Riseceus (see section 6 “What Riseceus contains”).
• If your doctor has told you that you suffer from a condition called hypocalcemia (low levels of calcium in the blood).
• If you believe you are pregnant, if you are pregnant, or if you are planning a pregnancy.
• If you are breastfeeding.
• If you have severe kidney problems.

Warnings and precautions
Pay particular attention and tell your doctor BEFORE starting to take Riseceus

• If you are unable to keep your torso upright (sitting or standing) for at least 30 minutes.
• If you have an abnormal bone and mineral metabolism (for example, a vitamin D deficiency, abnormalities of the parathyroid hormone, both conditions that result in a low level of calcium in the blood).
• If you have had problems with your esophagus (the channel connecting the mouth to the stomach) in the past. For example, you may have had pain or difficulty swallowing food or have previously been told you have 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 if you have a “feeling of heaviness in the jaw” or if you have lost a tooth.
• If you are undergoing dental treatment or are to undergo dental surgery, tell your dentist that you are taking Riseceus. Your doctor will advise you on what to do when taking Riseceus 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 Riseceus with other medicines
The concomitant taking of medicines containing any of the following substances decreases the effect of
Riseceus:

• Calcium
• Magnesium
• Aluminum (for example, some preparations for indigestion)
• Iron. Take these medicines at least 30 minutes after taking the Riseceus tablet. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those available 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 correctly. In particular, do not take this medicine with dairy products
(such as milk) as they contain calcium (see section 2 “Taking with 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 believe you are pregnant, if you are pregnant or are planning a pregnancy (see
section 2 “Do not take Riseceus”). The potential risk associated with the use of sodium risedronate
(the active ingredient of Riseceus) in pregnant women is unknown.
Do not take Riseceus if you are breastfeeding (see section 2 “Do not take Riseceus”).
Riseceus must be used exclusively for the treatment of postmenopausal women and men.

Driving and using machines
It is not known whether Riseceus has an effect on your ability to drive and use machines.

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

3. HOW TO TAKE Riseceus

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

• Take the tablet while in an upright position (you can sit or stand) to avoid 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 tell you if you need calcium and vitamin supplements if you do not take enough with your diet.

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.

If you forget to take Riseceus
If you forget to take the tablet on the chosen day, take the tablet on the same day you
remember it.
Return to taking the tablet once a week on the day the tablet is usually taken.
Do not take a double dose to make up for a missed dose.

If you stop taking Riseceus
If you stop treatment, you may start to lose bone mass. Consult your doctor before stopping
treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Riseceus can cause side effects, although not everybody gets them.
Rarely, atypical fractures of the femur can occur, particularly in patients treated for a
long period 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 femur fracture.

Stop treatment with Riseceus and contact a doctor if you experience any of these signs:

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

Inform your doctor immediatelyif you notice 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 “Warnings and precautions”).
• Esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or the appearance or worsening of heartburn.

However, other side effects observed during clinical studies were usually mild and did not
require discontinuation of therapy.
Side effects are reported according to the frequency with which they occur. The following convention has been used:
Very common: affects more than 1 in 10 users
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 in 10,000
Not known: the frequency cannot be estimated from available data

Common side effects

• Indigestion, nausea, stomach pain, cramps or discomfort in the stomach, constipation, feeling of fullness, flatulence, diarrhea.
• Bone, muscle or joint pain.
• Headache.

Uncommon side effects

• Inflammation or ulceration of the esophagus (the tube connecting the mouth to the stomach) causing difficulty and pain when swallowing (see also section 2 “Pay particular attention and consult your doctor before taking Riseceus”), inflammation of the stomach and duodenum (intestinal emptying into the stomach)
• Inflammation of the colored part of the eye (iris) (painful redness of the eyes with possible visual disturbances).

Rare side effects

• Inflammation of the tongue (redness and swelling, possible pain), narrowing of the esophagus (the tube connecting the mouth to the stomach).
• Abnormalities in liver function tests have been reported. This can only be diagnosed by blood tests.

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 (leucocytoclastic vasculitis).

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

Very rare side effects:
Contact your doctor in case of ear pain, ear discharge and/or ear infection.
These episodes could be symptoms of bone damage to the ear.

Reporting of side effects
If any of the side effects gets worse or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 sight and reach of children.
Do not use Riseceus after the expiry date stated on the label, 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.
Medicines should 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. PACKAGE CONTENTS AND OTHER INFORMATION

What Riseceus contains

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

Description of the appearance of Riseceus and package contents
Film-coated tablet.
Round, biconvex, film-coated tablets with a diameter of 9 mm, orange in colour.

Packs:
Blisters: 4 film-coated tablets.
Tablet containers: 50 film-coated tablets.
Not all pack sizes may be marketed.

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

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

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy: Riseceus