Risencal

Package leaflet: Information for the user

RISENCAL 35 mg film-coated tablets

Sodium risedronate
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 give it to other people, even if their symptoms are the same as 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 RISENCAL is and what it is used for
2. What you need to know before taking RISENCAL
3. How to take RISENCAL
4. Possible side effects
5. How to store RISENCAL
6. Contents of the pack and other information

1. What RISENCAL is and what it is used for

RISENCAL 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 removes old bone tissue and replaces it with new bone tissue.
Postmenopausal osteoporosis is a condition that develops in women after menopause, causing women's bones to become more fragile and more susceptible to fractures following falls or injuries.
Osteoporosis can also occur in men due to various causes such as aging and/or low levels of the male hormone, testosterone.
Bones most likely to fracture are those in the spine, hip, and wrist, although any bone in the body can fracture. Fractures related to osteoporosis may also cause back pain, loss of body weight (height), and curvature of the spine. Many patients with osteoporosis do not have symptoms and therefore may not even know they have it.
RISENCAL is used for the treatment of osteoporosis:

• in postmenopausal women
• in men.

2. What you need to know before taking RISENCAL

Do not take RISENCAL:

• if you are allergic to sodium risedronate or any of the other ingredients of this medicine (listed in
  section 6);
• if you have a condition called hypocalcemia (low calcium levels in the blood);
• if you are pregnant, suspect 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 RISENCAL.
In particular:

• If you are unable to remain upright (standing or sitting) for at least 30 minutes.
• If you have disorders of mineral and bone metabolism (e.g. 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 the mouth to the stomach), for example pain or difficulty swallowing food.
• 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 and/or jawbone, a sensation of "heavy jaw", or loose teeth.
• If you are under dental treatment or are scheduled for dental surgery, inform your dentist that you are being treated with sodium risedronate.
• If you have or have previously had oesophageal disorders (the part of the digestive tract connecting the mouth to the stomach), for example pain or difficulty swallowing food, or delayed gastric emptying (such as narrowing or achalasia).
• If you have or have recently had oesophageal problems, including Barrett’s oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus). Your doctor will advise you on what to do while taking RISENCAL if you have any of the above conditions.

Children and adolescents
The use of sodium risedronate is not recommended in children and adolescents under 18 years of age, as data on safety and efficacy are insufficient.

Other medicines and RISENCAL
Medicines containing any of the following ingredients may reduce the effect of RISENCAL if taken at the same time:

• calcium
• magnesium
• aluminium (e.g. some antacid preparations)
• iron

Take these medicines at least 30 minutes after taking RISENCAL.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

RISENCAL with food and drinks
It is very important that you do NOT take food or drinks (except tap water) together with the RISENCAL tablet, as this may make the medicine less effective. In particular, do not take this medicine at the same time as dairy products (including milk), as they contain calcium (see section 2 “Other medicines and RISENCAL”).
Take food or drinks (except tap water) at least 30 minutes after taking the RISENCAL tablet.

Pregnancy and breastfeeding
DO NOT take RISENCAL if you are pregnant, suspect you may be pregnant, or are planning a pregnancy (see section 2 “Do not take RISENCAL”). The potential risks associated with the use of sodium risedronate (the active substance in RISENCAL) in pregnant women are unknown.
DO NOT take RISENCAL if you are breastfeeding (see section 2 “Do not take RISENCAL”).

Driving and using machines
RISENCAL has no known effects that impair the ability to drive vehicles or operate machinery.

RISENCAL contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine (see section 2 “Warnings and precautions”).

3. How to take RISENCAL

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is 1 RISENCAL tablet (35 mg sodium risedronate) once a week.
Choose the day of the week that best fits your routine. Take one RISENCAL tablet once a week on your chosen day.
The package contains compartments/spaces. Mark the day of the week you have chosen for taking the RISENCAL tablet. Also note the days on which you will take the tablet.

WHEN to take the RISENCAL tablet
Take the tablet at least 30 minutes before your first meal of the day, your first drink (other than tap water), or before taking any other medicines.

HOW to take the RISENCAL tablet

• Take the tablet while in an upright position (sitting or standing) to avoid stomach irritation.
• Swallow the tablet with at least one full glass of tap water (120 ml).
• The tablet must be swallowed whole. Do not chew or allow the tablet to dissolve in the mouth.
• After swallowing the tablet, you must remain upright for at least 30 minutes.
  Your doctor will advise you if you need calcium or vitamin supplements, should your dietary intake of these substances be insufficient.

If you take more RISENCAL than you should
If you accidentally take more RISENCAL tablets than prescribed, drink a full glass of milk and contact your doctor immediately.

If you forget to take RISENCAL
If you forget to take your tablet at the usual time, take it on the same day as soon as you remember.
Then continue taking one tablet once a week on your usual day.
DO NOT take two tablets on the same day to make up for a missed dose.

If you stop taking RISENCAL
If you stop treatment with RISENCAL, you may begin to lose bone mass. Talk to your doctor before deciding to stop treatment with this medicine.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

• Stop taking RISENCAL 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 (red, raised patches on the skin) and difficulty breathing
  • Severe blistering skin reactions, including blister formation.

Consult your doctor promptly if you notice any of the following side effects:

• Inflammation of the eyes, usually with pain, redness and sensitivity to light.
• Jaw and/or facial bone necrosis (bone destruction) associated with delayed healing and onset of infection, often following tooth extraction (see section 2 “Before taking RISENCAL”).
• Esophageal disorders such as painful swallowing, difficulty swallowing, chest pain, or onset/worsening of heartburn.

However, other side effects observed in clinical studies were generally mild in severity and did not lead to treatment discontinuation in patients.
Common side effects (may affect from 1 to 10 users in 100):

• Indigestion (dyspepsia), nausea, stomach ache, stomach cramps or gastric discomfort, constipation, bloating, flatulence (increased intestinal gas), diarrhoea.
• Bone, muscle or joint pain.
• Headache.

Uncommon side effects (may affect from 1 to 10 users in 1,000):

• Inflammation or ulceration of the oesophagus (the part of the digestive tract connecting the mouth to the stomach), causing difficulty and pain when swallowing (see section 2 “Before taking RISENCAL”), 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 from 1 to 10 users in 10,000):

• Inflammation of the tongue (red, swollen and sometimes painful), narrowing of the oesophagus (the part of the digestive tract connecting the mouth to the stomach).
• Abnormal liver function test results have been reported. These can be detected by a blood test.

Very rare side effects (may affect up to 1 user in 10,000):

• Contact your doctor if you experience ear pain, ear discharge and/or ear infections. These events could be signs of bone damage in the ear.

During post-marketing experience, the following side effects have been reported with unknown frequency (frequency cannot be estimated from the available data):

• Skin allergic reactions such as urticaria (hives), skin rash (sudden reddening of the skin), swelling of the face, lips, tongue and/or neck, difficulty swallowing or breathing.
• Severe skin reactions including subcutaneous blisters; inflammation of small blood vessels, characterized by palpable red spots on the skin (leukocytoclastic vasculitis);
• A serious condition called Stevens-Johnson syndrome (SJS) with blistering of the skin, mouth, eyes and other moist areas of the body (genitals); a serious condition called toxic epidermal necrolysis (TEN) causing red rash in many parts of the body and/or peeling of the outer layers of the skin.
• Hair loss.
• Allergic reactions (hypersensitivity).
• Severe liver disorders, particularly if you are taking other medicines known to cause liver problems.
• Inflammation of the eye causing pain and redness.

Rarely, an unusual fracture of the femur 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 femoral fracture.
Rarely, at the beginning of treatment, calcium and phosphate levels in the patient's blood may decrease. These changes are usually mild and asymptomatic.
Reporting of side effects
If you experience any side effects, 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 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 RISENCAL

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging. 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 RISENCAL 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 RISENCAL and package contents
RISENCAL are film-coated tablets, round, light orange, 9 mm in diameter.
They are available in blisters containing 4 tablets.
Marketing Authorization Holder
EURO-PHARMA S.r.l. – Via Garzigliana, 8 – 10127 Turin, Italy
Manufacturer
Pabianickie Zaklady Farmaceutyczne Polfa S. A. – Ul. Marszalka J. Pilsudskiego n. 5 – 95200 Pabianice, Poland
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