Risectol

Italy
Brand name Risectol
Form tablets, film-coated
Active substance / Dosage
Risedronate Sodium
Prescription type Prescription only
ATC code
M05BA07
Registration number 039519
Manufacturer DYMALIFE PHARMACEUTICAL S.R.L.

Table of Contents

Patient Information Leaflet

RISECTOL 35 mg film-coated tablets

Sodium risedronate
Equivalent medicine
Please read all of 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 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, tell your doctor or pharmacist. See section 4.
  • Contents of this leaflet:
    1. What Risectol is and what it is used for
    2. What you need to know before taking Risectol
    3. How to take Risectol
    4. Possible side effects
    5. How to store Risectol
    6. Contents of the pack and other information

1. What RISECTOL is and what it is used for

What RISECTOL is
RISECTOL belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat
bone disorders. It acts directly on the bones to make them stronger and therefore less prone to
fractures.
Bone is 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, resulting in an increased 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 throughout the body. Osteoporosis-related fractures may also cause back pain, loss of height, and curvature of the spine. Many patients with osteoporosis do not have symptoms and therefore may not even know they have it.
What RISECTOL is used for
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 should know before taking Risectol

Do not take Risectol:

  • 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 are pregnant, if you think you might be pregnant, or if you 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 Risectol

  • 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 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 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 your jaw and/or jawbone, or a sensation of "heavy jaw" or loose teeth.
  • If you are undergoing dental treatment or have a dental procedure scheduled, inform your dentist that you are being treated with sodium risedronate.

Contact your doctor if you experience ear pain, ear discharge, and/or ear infection
(see section 4).
Your doctor will advise you on what to do while taking Risectol if you have any of the above conditions.
Children and adolescents
The use of sodium risedronate is not recommended in children under 18 years of age, as there is insufficient data on safety and efficacy.
Other medicines and Risectol
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 reduce the effect of Risectol if taken at the same time:
calcium
magnesium
aluminium (e.g. some antacid mixtures)
iron
Take these medicines at least 30 minutes after taking Risectol.
Risectol with food and drinks
It is very important that you do NOT take food or drinks (except tap water) together with the Risectol 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 Risectol”).
Take food and drinks (except tap water) at least 30 minutes after taking the Risectol tablet.
Pregnancy and breast-feeding
If you are pregnant, suspect you might be pregnant, are planning a pregnancy, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
DO NOT take Risectol if you are pregnant, think you might be pregnant, or are planning a pregnancy
(see section 2 “Do not take Risectol”). The potential risk associated with the use of sodium risedronate (the active substance in Risectol) in pregnant women is unknown.
DO NOT take Risectol if you are breast-feeding (see section 2 “Do not take Risectol”).
Driving and using machines
No effects on the ability to drive or use machines have been observed.
Risectol contains lactose If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Risectol

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Usual dose
Take one tablet of RISECTOL (35 mg sodium risedronate) once a week.
Choose the day of the week that best fits your routine. Take one RISECTOL tablet once a week on the chosen day.
The package contains compartments/spaces. Mark the day of the week selected for taking the
RISECTOL tablet. Also note down the days on which you will take the tablet.
When to take the RISECTOL tablet:
Take the tablet at least 30 minutes before the first food, drink (other than tap water), or other
medicines of the day.
How to take the RISECTOL tablet:
Take the tablet while in an upright position (sitting or standing) to avoid stomach irritation.
Swallow the tablet with at least one glass of tap water (120 ml).
Swallow the tablet whole. Do not chew or allow the tablet to 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 your diet does not provide sufficient amounts.
If you take more RISECTOL than you should
If you or someone else accidentally takes more RISECTOL tablets than prescribed, drink a
full glass of milk and contact your doctor immediately.
If you forget to take RISECTOL
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 a week on your usual tablet-taking day.
Do not take two tablets in one day to make up for a missed tablet.
If you stop taking RISECTOL
If you stop taking this medicine, you may begin to lose bone mass. Talk to your doctor before deciding to stop treatment with this medicine.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Risectol may cause adverse reactions, although not everyone experiences them.
Stop taking Risectol 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.

Promptly inform your doctor if you notice any of the following adverse reactions:
Inflammation of the eyes, usually with pain, redness and sensitivity to light.
Osteonecrosis of the jaw (jaw bone necrosis) associated with delayed healing and onset of infection, often following dental extraction (see section 2 “Warnings and precautions”).
Oesophageal disorders such as pain when swallowing, difficulty swallowing, chest pain or onset/worsening of heartburn.
However, other adverse reactions observed in clinical studies were generally mild in severity and did not lead to treatment discontinuation in patients.
Common adverse reactions (affect 1 to 10 users in 100):
Dyspepsia, nausea, stomach ache, stomach cramps or gastric discomfort, constipation, bloating, flatulence, diarrhoea.
Pain in bones, muscles or joints.
Headache.
Uncommon adverse reactions (affect 1 to 10 users in 1,000):
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 adverse reactions (affect 1 to 10 users in 10,000):
Inflammation of the tongue (red, swollen and sometimes painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach).
Alterations in liver function tests have been reported. These can be diagnosed by a blood test.
Very rare adverse reactions (affect fewer than 1 to 10 users in 10,000):
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.
During post-marketing experience, the following adverse reactions have been reported (frequency not known).
Skin allergic reactions such as urticaria (hives), 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, characterized 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 disease called toxic epidermal necrolysis (TEN) causing red rash on many parts of the body and/or peeling of outer skin layers.
Hair loss. Allergic reactions (hypersensitivity). Severe liver disorders, particularly if you are being treated with other medicines known to cause liver problems. Inflammation of the eye causing pain and redness.
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 femur fracture may 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 femur fracture.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Risectol

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use Risectol after the expiry date stated on the packaging after "Exp". 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 RISECTOL contains

  • The active substance is risedronate sodium. Each tablet contains 35 mg of risedronate sodium (as sodium risedronate hemipentahydrate).
  • The other components are:
    Core: Microcrystalline cellulose, crospovidone, magnesium stearate, monohydrate lactose.
    Coating: Red iron oxide, yellow iron oxide, anhydrous colloidal silica, titanium dioxide, macrogol 400, macrogol 8000, hypromellose, hydroxypropylcellulose.

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

Marketing Authorization Holder
DYMALIFE PHARMACEUTICAL S.R.L., VIA BAGNULO 95, 80063 - PIANO DI SORRENTO - NAPOLI (NA).

Manufacturer
Pabianickie Zakłady Farmaceutyczne Polfa S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland.

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