RISENCAL 35 mg Film-Coated Tablets

Зміст інструкції

1. RISENCAL 35 mg film-coated tablets
   1. What is RISENCAL and what is it 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

RISENCAL 35 mg film-coated tablets

Risedronate sodium
equivalent medicine

Read this leaflet carefully before you start to 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is RISENCAL and what is it 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 more resistant 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 whereby the bones
of women become more fragile and more susceptible to fractures following falls or exertion..
Osteoporosis can also occur in men following various causes such as aging and/or a low
level of the male hormone, testosterone.
The bones most prone to fracture are those of the spine, hip and wrist, although all bones
of the body can fracture. Fractures related to osteoporosis can also cause back pain,
weight loss (height) and curvature of the spine. Many patients with osteoporosis do not present symptoms,
therefore they may also not be aware of having 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 risedronate sodium or any of the other ingredients of this medicine (listed in
section 6);

• if you suffer from a condition called hypocalcemia(a low level of calcium in the blood);
• if you are pregnant, ifyou suspect you areorare planning to becomepregnant;
• if you are breastfeeding;
• if you suffer from severe kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking RISENCAL.
In particular:

• If you are unable to keep your torso upright (standing or sitting) for at least 30 minutes.
• If you have disorders of mineral metabolism and bone (e.g. vitamin D deficiency, parathyroid hormone dysfunction leading to a reduction in blood calcium levels).
• If you have had problems with your esophagus (the channel connecting the mouth to the stomach) in the past. For example, pain or difficulty swallowing food.
• If your doctor has told you that you suffer from an intolerance to certain sugars (such as lactose).
• If you have or have had pain, swelling or numbness in the jaw and/or mandible or a “heavy jaw” sensation or tooth mobility.
• If you are being treated by a dentist or need to undergo dental surgery, tell your dentist that you are being treated with risedronate sodium.
• If you have or have recently had problems with the esophagus (the part of the digestive tract that connects the mouth to the stomach) for example pain or difficulty associated with swallowing food or difficulty emptying the stomach (stenosis or achalasia).
• If you have or have recently had problems with the esophagus, including Barrett's esophagus (a condition associatedwith alterations of the cells lining the lower part of the esophagus). Your doctor will tell you what to do while taking RISENCAL if you have any of the above conditions.

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

Other medicines and RISENCAL
Medicines containing any of the following ingredients reduce the effect of RISENCAL if taken
simultaneously:

• calcium
• magnesium
• aluminum (e.g. some remedies for digestive problems)
• iron

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

RISENCAL with food and drink
It is very important that you DO NOT take food or drink (except tap water) with the RISENCAL tablet because 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 drink (except tap water) at least 30 minutes after the RISENCAL tablet.

Pregnancy and breastfeeding
DO NOT take RISENCAL if you are pregnant, suspect you are or are planning to become pregnant (see
section 2 “Do not take RISENCAL”). The potential risks associated with the use of risedronate sodium (the active substance
of RISENCAL) in pregnant women are not known.
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 interfere with the ability to drive and use machines.

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

3. How to take RISENCAL

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your doctor
or pharmacist.
The recommended dose is 1 RISENCAL tablet (35 mg risedronate sodium) once a week.
Choose the day of the week that best suits your activities. Take one RISENCAL tablet
once a week on the chosen day.
The box has compartments/spaces. Mark the chosen day of the week 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 the first meal of the day, the first drink, other than
tap water, or before other medicines.

HOW to take the RISENCAL tablet

• Take the tablet while in an upright position(sitting or standing) to avoid heartburn.
• Swallow the tablet with at least one glass of tap water(120 ml).
• The tablet must be swallowedwhole. Do not chew or let it dissolve in your mouth.
• Once the tablet has been swallowed, do not lie down for 30 minutes. Your doctor will tell you if you need calcium and vitamin supplements, if your intake of these substances with your diet is insufficient.

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

If you forget to take RISENCAL
If you forget to take the tablet at the usual time, take it on the same day you remember.
Resume taking one tablet once a week on the day the tablet is usually taken.
DO NOT take two tablets on the same day to make up for forgetting the tablet.

If you stop taking RISENCAL
If you stop taking RISENCAL, you may start to lose bone mass. Talk to your doctor before
deciding to stop treatment with this medicine.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• Stop taking RISENCAL and contact your doctor immediatelyif you experience any of the following symptoms of a severe allergic reaction such as:
• swelling of the face, tongue or throat
• difficulty swallowing
• urticaria (red and raised patches on the skin) and difficulty breathing
• Severe skin reactions with blistering, including blister formation.

Consult your doctor promptlyif you notice the appearance of the following side effects:

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

However, other side effects observed in clinical studies were usually mild and did not cause
patients to discontinue treatment.

Common side effects (affect 1 to 10 users out of 100):

• difficulty digesting food (Dyspepsia), nausea, stomach pain, stomach cramps or gastrointestinal disorders, constipation, feeling of fullness, flatulence (increased intestinal gas), diarrhea.
• Bone, muscle or joint pain.
• Headache.

Uncommon side effects (affect 1 to 10 users out of 1000):

• Inflammation or ulceration of the esophagus (the part of the digestive tract that connects 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 colored part of the eye (iris) (red, painful eyes with possible altered vision).

Rare side effects(affect 1 to 10 users out of 10,000):

• Inflammation of the tongue (red, swollen and sometimes painful), narrowing of the esophagus (the part of the digestive tract that connects the mouth to the stomach).
• Changes in liver function tests have been reported. These can be diagnosed by a blood test.

Very rare side effects(affect up to 1 user out of 10,000)

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

The following side effects have been reported during post-marketing experience with

frequencynot known(frequency cannot be estimated based on available data)

• Allergic skin reactions such as urticaria (hives), skin rash (sudden redness of the skin), swelling of the face, lips, tongue and/or throat, difficulty swallowing or breathing.
• Severe skin reactions including blisters under the skin; 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) that causes a red rash on many parts of the body and/or peeling of outer skin layers.
• Hair loss.
• Allergic reactions (hypersensitivity).
• Severe liver disorders, especially if you are being treated with 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 treated for a long time
for osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin
as this may be an early indication of a possible femur 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, 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 contribute to providing 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 particular storage conditions.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to
the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What RISENCAL contains

• The active ingredient is risedronate sodium. Each tablet contains 35 mg of risedronate sodium (as risedronate sodium hemi-pentahydrate).
• The other ingredients 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 contents of the pack
RISENCAL are film-coated tablets, round, light orange in color with a diameter of 9 mm.
They are available in blisters containing 4 tablets.

Marketing Authorisation Holder
EURO-PHARMA S.r.l. – Via Garzigliana, 8 – 10127 Torino

Manufacturer
Pabianickie Zaklady Farmaceutyczne Polfa S. A. – Ul. Marszalka J. Pilsudskiego n. 5 – 95200 Pabianice,
Poland

This leaflet was last revised in