CEDRAVIS

Package leaflet: Information for the patient

CEDRAVIS 35 mg film-coated tablets

Sodium risedronate
Equivalent medicine
Please read this leaflet carefully before 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 side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CEDRAVIS is and what it is used for

CEDRAVIS belongs to a group of non-hormonal medicines called bisphosphonates, which are used for the treatment of bone diseases. It acts directly on your bones to make them stronger, thereby making fractures less likely.
Bone is a living tissue. Old tissue is constantly removed from the skeleton and replaced with new bone tissue.

Postmenopausal osteoporosis is a condition that occurs in women after menopause, when bones become weaker, more fragile, and more prone to fractures following falls or minor trauma.
Osteoporosis can also occur in men due to various causes, including aging and/or low levels of the male hormone testosterone.
The spine, hip, and wrist are the bones most likely to fracture, although any bone in the body may break. Fractures related to osteoporosis may also cause back pain, loss of height, and curvature of the spine. Many patients with osteoporosis have no symptoms, so you may not even know you have it.

CEDRAVIS is used:

• for the treatment of osteoporosis in postmenopausal women to reduce the risk of vertebral fractures;
• for the treatment of established osteoporosis in postmenopausal women to reduce the risk of hip fractures;
• for the treatment of osteoporosis in men at high risk of fractures.

2. What you should know before taking CEDRAVIS

Do not take CEDRAVIS:

• if you are allergic to sodium risedronate or to any of the other ingredients of this medicine (listed in section 6);
• if your doctor has told you that you have a condition called hypocalcaemia (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 before taking CEDRAVIS

• If you are unable to stand or sit upright with your torso erect for at least 30 minutes.
• If you have an abnormal mineral and bone metabolism (e.g. vitamin D deficiency, parathyroid hormone disorder, conditions that both lead to low calcium levels in the blood).
• If you have previously had problems with your oesophagus (the tube connecting your mouth to your stomach) or stomach, such as ulcers. For example, if you have experienced pain or difficulty swallowing food, or if you have been diagnosed with Barrett’s oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus).
• If you have or have had pain, swelling, numbness, or a heavy sensation in your jaw and/or mandible, or if you have lost a tooth.
• If you are under dental treatment or are scheduled to undergo a dental procedure, inform your dentist that you are being treated with CEDRAVIS. Your doctor will advise you on what to do while taking CEDRAVIS if you have any of the conditions listed above.

Contact your doctor if you experience pain in your thigh, groin, or hip (this could be a sign of a femur fracture).
Children and adolescents
The use of sodium risedronate is not recommended in children and adolescents under 18 years of age, as there is insufficient data on safety and efficacy.
Other medicines and CEDRAVIS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines containing any of the following ingredients may reduce the effect of CEDRAVIS if taken at the same time:

• calcium
• magnesium
• aluminium (e.g. some antacids for digestive discomfort)
• iron

Take these medicines at least 30 minutes after taking CEDRAVIS.
Cedravis with food and drinks
It is very important NOT to take the tablet with food or drinks (except tap water) so that the medicine 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 CEDRAVIS”).
Wait at least 30 minutes after taking the CEDRAVIS tablet before consuming food or drinks (except tap water).
Pregnancy and breast-feeding
Pregnancy
DO NOT take CEDRAVIS if you are pregnant, think you might be pregnant, or are planning a pregnancy (see section 2 “Do not take CEDRAVIS”).
Breast-feeding
DO NOT take CEDRAVIS if you are breast-feeding (see section 2 “Do not take CEDRAVIS”).
Driving and using machines
CEDRAVIS does not affect or has negligible effect on the ability to drive vehicles and use machinery.
Cedravis contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Cedravis contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take CEDRAVIS

Dosage
Take CEDRAVIS exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet of CEDRAVIS (35 mg sodium risedronate) once a week.
Choose the day of the week that best fits your routine. Take one tablet of CEDRAVIS once a week on the chosen day.
For your convenience, to help you take the tablet on the same day each week, there are compartments/spaces on the packaging where you can mark the selected day of the week for taking the CEDRAVIS tablet. You may also write down the dates on which you will take the tablet.

When to take the CEDRAVIS tablet
Take the tablet at least 30 minutes before taking any food, drink (except tap water), or other medicines of the day.

How to take the CEDRAVIS 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 dissolve the tablet in the mouth.
Do not lie down for 30 minutes after taking the tablet.
Your doctor will assess whether you need calcium and vitamin supplements, if your dietary intake is insufficient.

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

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

If you forget to take CEDRAVIS
If you forget to take the tablet at your usual time, take it on the same day when you remember.
Resume taking one tablet once weekly on your usual tablet-taking day.
DO NOT take two tablets on the same day to make up for the missed tablet.

If you stop taking CEDRAVIS
If you stop taking this medicine, you may begin to lose bone mass.
Consult your doctor before considering stopping treatment with this medicine.

4. Possible adverse effects

Like all medicines, CEDRAVIS can cause adverse effects, although not everyone experiences them.
Stop taking CEDRAVIS and contact a doctor immediately if you experience any of the following adverse effects:
➢ symptoms of a severe allergic reaction such as:

• swelling of the face, lips, tongue, throat and/or neck
• difficulty swallowing
• hives and difficulty breathing
  ➢ severe blistering skin reactions, including formation of blisters under the skin.
  The frequency of these adverse effects is unknown (cannot be estimated from the available data).

Promptly inform your doctor if you notice any of the following adverse effects:
➢ Inflammation of the eyes, usually with pain, redness, and sensitivity to light.
The frequency of this adverse effect is unknown (cannot be estimated from the available data).
➢ Orbital inflammation – inflammation of the structures surrounding the eyeball. Symptoms may include: pain, swelling, redness, protrusion of the eyeball, and vision disturbances.
The frequency of this adverse effect is unknown (cannot be estimated from the available data).
➢ Severe degeneration (osteonecrosis) of the jawbone/mandible associated with delayed healing and onset of infection, often following dental extraction (see section 2 “Warnings and precautions”).
The frequency of this adverse effect is unknown (cannot be estimated from the available data).
➢ Oesophageal disorders (the tube connecting the mouth to the stomach), such as painful swallowing, difficulty swallowing, chest pain, or onset/worsening of heartburn.
The frequency of this adverse effect is uncommon (may affect up to 1 in 100 people).

Common (may affect up to 1 in 10 people):
Indigestion, nausea, stomach ache, stomach cramps or discomfort, constipation, feeling of fullness, abdominal bloating, diarrhoea.
Pain in bones, muscles, or joints.
Headache.

Uncommon (may affect up to 1 in 100 people):
Inflammation or ulceration of the oesophagus (the tube connecting the mouth to the stomach), causing difficulty and pain on 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 (may affect up to 1 in 1,000 people):
Inflammation of the tongue (red, swollen and sometimes painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach).
Abnormalities in liver function tests have been reported. These can only be diagnosed by a blood test.

Very rare: consult your doctor if you experience ear pain, ear discharge, and/or ear infection. These events could be signs of bone damage in the ear.

During post-marketing experience, the following adverse effects have been reported, with frequency unknown:
➢ 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 and/or body hair loss;
➢ cases of allergic reactions (including swelling of the face, lips, tongue and/or throat, generalized skin rash, hives);
➢ severe liver disorders, particularly if you are being treated with other medicines known to cause liver problems;
➢ eye inflammation causing pain and redness;
➢ rarely, at the beginning of treatment, levels of calcium and phosphate in the patient's blood may decrease. These changes are usually mild and asymptomatic;
➢ rarely, an unusual femoral 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 femoral fracture.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, speak to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at the following address:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store CEDRAVIS

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 carton 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 CEDRAVIS 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 (see section 2 “CEDRAVIS contains lactose”). Coating: Red iron oxide, yellow iron oxide, anhydrous colloidal silica, titanium dioxide, macrogol 400, macrogol 8000, hypromellose, hydroxypropylcellulose.

Description of the appearance of CEDRAVIS and pack contents
CEDRAVIS are film-coated tablets, round, light orange, 9 mm in diameter.
They are available in packs containing 4 or 12 tablets in blisters.
Marketing Authorization Holder
SPA – Società Prodotti Antibiotici S.p.A. – Via Biella, 8 - 20143 Milan, Italy.
Manufacturer
Adamed Pharma S.A. – ul. Marszałka J. Piłsudskiego 5, 95-200 Pabianice - Poland.
Lachifarma S.p.A. Laboratorio Chimico Farmaceutico Salentino, S.S. 16 Zona Industriale - 73010
Zollino (LE), Italy.