CEDRAVIS 35 mg Tabletki Powlekane

Treść ulotki

1. CEDRAVIS 35 mg film-coated tablets
   1. What is CEDRAVIS and what is it used for
   2. What you need to know before taking CEDRAVIS
   3. How to take CEDRAVIS
   4. Possible Undesirable Effects
   5. How to store CEDRAVIS
   6. Contents of the pack and other information

CEDRAVIS 35 mg film-coated tablets

Sodium risedronate
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 only. Do not pass it on to others, even if they have the same symptoms as you, as it may 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 CEDRAVIS is and what it is used for
• 2. What you need to know before you take 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 is CEDRAVIS and what is it 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 and therefore
making them less likely to break.
Bone is a living tissue. Old tissue is constantly removed from the skeleton and
replaced with new bone tissue.
Post-menopausal osteoporosis is a condition that occurs in womenafter menopause
when the bones become weaker, more fragile and more prone to fractures following falls or
effort.
Osteoporosis can also occur in menfollowing various causes including
aging and/or a low level of the male hormone, testosterone.
The spine, hip and wrist are the bones most prone to fracture, although all bones
of the body can fracture. Fractures related to osteoporosis can also cause back pain,
loss of height and curvature of the spine. Many patients with osteoporosis do not
present symptoms, therefore you may not even know you have it.
CEDRAVIS is used:

• in the treatment of osteoporosis in womenin post-menopause to reduce the risk of vertebral fractures;
• in the treatment of manifest osteoporosis in womenin post-menopause to reduce the risk of hip fractures;
• in the treatment of osteoporosis in menat high risk of fractures.

2. What you need to know before taking CEDRAVIS

Do not take CEDRAVIS:

• if you are allergicto risedronate sodium or to any of the other ingredients of this medicine (listed in section 6);
• if your doctor has told you that you suffer from a condition called hypocalcemia(a low level of calcium in the blood);
• if you are pregnant, ifyou think you may be pregnantor if you are planning a pregnancy;
• if you are breastfeeding;
• if you suffer from severe kidney problems.

Warnings and precautions
Talk to your doctor before taking CEDRAVIS

• If you are unable to stand or sit upright for at least 30 minutes.
• If your mineral and bone metabolism is abnormal (e.g. vitamin D deficiency, abnormality of the parathyroid hormone, conditions that both lead to a low level of calcium in the blood).
• If you have had problems with your esophagus (the tube connecting your mouth to your stomach) or stomach in the past, such as ulcers. For example, you may have experienced pain or difficulty swallowing food, or you may have been told that you suffer from Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).
• If you have or have had pain, swelling or numbness or a feeling of heaviness in the jaw and/or lower jaw or if you have lost a tooth.
• If you are being treated by a dentist or need to undergo dental surgery, tell your dentist that you are being treated with CEDRAVIS. Your doctor will tell you what to do while taking CEDRAVIS if you have any of the above conditions.

Contact your doctor if you experience pain in the thigh, groin or hip (this may be a symptom
of a femur fracture).

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

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 components decrease the effect of CEDRAVIS if taken
at the same time:

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

Take these medicines at least 30 minutes after taking CEDRAVIS.

CEDRAVIS with food and drink
It is very important that you DO NOT take the tablet with food or drink (except tap water)
so that the medicine can work correctly. 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”).
Take food and drink (except tap water) at least 30 minutes after
taking the CEDRAVIS tablet.

Pregnancy and breastfeeding

Pregnancy

DO NOTtake CEDRAVIS if you are pregnant, if you think you may be pregnant or if you are
planning a pregnancy (see section 2 “Do not take CEDRAVIS”).

Breastfeeding

DO NOTtake CEDRAVIS if you are breastfeeding (see section 2 “Do not take
CEDRAVIS”).

Driving and using machines
CEDRAVIS does not affect the ability to drive and use machines.

CEDRAVIS contains lactose
If your doctor has diagnosed you with intolerance to certain sugars (e.g. lactose),
contact him/her before taking this medicine.

3. How to take CEDRAVIS

Dosage
Take CEDRAVIS following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one CEDRAVIS tablet (35 mg risedronate sodium) once a
week.
Choose the day of the week that best suits your activities. Take one CEDRAVIS tablet once a week on the
chosen day.
For your convenience, to help you take the tablet on the same day of the week, there are
compartments/spaces on the packaging where you can mark the chosen day of the week to
take the CEDRAVIS tablet. Also write the dates on which you will take the tablet.

When to take the CEDRAVIS tablet
Take the tablet at least 30 minutes before ingesting the first food, drink (except for 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 heartburn.

Swallowthe tablet with at least one glass of tap water(120 ml).

Swallow it whole. Do not chew or dissolve the tablet in your mouth.

Do not lie down for 30 minutes aftertaking the tablet.
The doctor will assess whether to have you take calcium and vitamin supplements if they are not
introduced sufficiently with the diet.

Use in children and adolescents
The use of CEDRAVIS is not recommended in children and adolescents under 18 years of age because
the data relating to safety and efficacy are insufficient.

If you take more CEDRAVIS than you should
If you or someone else has accidentally taken more CEDRAVIS tablets than prescribed, drink a
full glass of milkand consult your doctor immediately.

If you forget to take CEDRAVIS
If you forget to take the tablet at the usual time, take it on the same day you remember.
Return to 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 the forgotten tablet.

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

4. Possible Undesirable Effects

Like all medicines, CEDRAVIS can cause undesirable effects, although not everybody gets them.
manifest.

Stop taking CEDRAVIS and contact your doctor immediatelyif any of the following symptoms appear:
of the following symptoms:

• symptoms of a severe allergic reaction such as:
• swelling of the face, lips, tongue, throat and/or neck
• difficulty swallowing
• urticaria (hives) and difficulty breathing
• severe blistering skin reactions, including blister formation under the skin.

Inform your doctor promptlyif you notice the appearance of the following undesirable effects:

• Inflammation of the eyes, usually with pain, redness and sensitivity to light.
• Severe degeneration (osteonecrosis) of the jaw/mandible bone tissue associated with delayed healing and the onset of infection, often following tooth extraction (see section 2 “Warnings and precautions”).
• Esophageal disorders (the tube connecting the mouth to the stomach) such as pain when swallowing, difficulty swallowing, chest pain, or the appearance/worsening of heartburn.

Common(may affect up to 1 in 10 people):
Digestive disorders, nausea, stomach pain, cramps or stomach discomfort, constipation,
feeling of fullness, abdominal bloating, diarrhea.
Pain in the bones, muscles or joints.
Headache.

Uncommon(may affect up to 1 in 100 people):
Inflammation or ulceration of the esophagus (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 colored part of the eye (iris) (red, painful eyes with possible altered vision).

Rare(may affect up to 1 in 1000 people):
Inflammation of the tongue (red, swollen and sometimes painful), narrowing of the esophagus (the
tube connecting the mouth to the stomach).
Changes in liver function tests have been reported. These can only be
diagnosed with a blood test.

Very rare: see your doctor if you experience ear pain, ear discharge and/or
ear infection. These episodes may be signs of bone damage in the ear.
The following undesirable effects have been reported during post-marketing experience, with an unknown frequency.

• 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 shedding of outer skin layers;
• hair loss;
• cases of allergic reactions (including swelling of the face, lips, tongue and/or neck, widespread rash, urticaria);
• 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, at the beginning of treatment, calcium and phosphate levels in the patient's blood may decrease. These changes are usually mild and without symptoms;
• 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

Reporting of Undesirable Effects
If you get any side effects, even those not listed in this leaflet, 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 CEDRAVIS

Keep this medicine out of the sight and reach of children.
This medicine does not require particular precautions for storage.
Do not use this medicine after the expiry date which is reported on the package after Expiry.
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 eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CEDRAVIS contains

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

Marketing Authorisation Holder
SPA – Società Prodotti Antibiotici S.p.A. – Via Biella, 8 -20143 Milan.

Manufacturer
Pabianickie Zakłady Farmaceutyczne Połfa S.A. – ul. Marszałka J. Piłsudskiego 5, 95-200 Pabianice -
Poland.