FODREN 35 mg Tabletki Powlekane

Treść ulotki

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

FODREN 35 mg film-coated tablets

Risedronate sodium
“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 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 FODREN is and what it is used for
• 2. What you need to know before you take FODREN
• 3. How to take FODREN
• 4. Possible side effects
• 5. How to store FODREN
• 6. Contents of the pack and other information

1. What FODREN is and what it is used for

FODREN 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 breaks down old bone and replaces it with new bone tissue.
Postmenopausal osteoporosis is a condition that occurs in women after menopause when there is a weakening and thinning of the bones with a consequent increase in the risk of 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.
Fractures occur more frequently in the spine, hip and wrist, although they can occur throughout the body. Fractures related to osteoporosis can also cause back pain, weight loss and curvature of the spine. Many patients with osteoporosis do not have symptoms, therefore they may not even know they have it.
FODREN is used for the treatment of osteoporosis:

• in postmenopausal women, even in cases of severe osteoporosis. It reduces the risk of vertebral and hip fractures
• in men.

2. What you need to know before taking FODREN

Do not take FODREN:

• if you are allergic to sodium risedronate 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, suspect you may be pregnant, or are planning a pregnancy;
• if you are breastfeeding;
• if you suffer from severe kidney problems.

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

• If you are unable to stand or sit upright 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 tube connecting the mouth to the stomach) in the past. For example, pain or difficulty swallowing food, or if you have previously been told you have Barrett's esophagus (a condition associated with changes in the cells lining the lower esophagus).
• If you have certain risk factors, such as cancer, chemotherapy, radiotherapy, or if you are taking corticosteroid medicines.
• 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 mandible or a "heavy jaw" sensation or tooth mobility.
• If you are seeing a dentist or planning dental surgery, tell your dentist that you are being treated with sodium risedronate. Your doctor will tell you what to do while taking FODREN if you have any of the above conditions.

Pay particular attention and immediately inform your doctor if you develop the following symptoms:

• difficulty swallowing accompanied by pain (dysphagia);
• the onset and/or worsening of heartburn;
• chest pain.

This medicine can cause femur fractures; if you experience pain in the thigh, hip or groin during treatment, inform your doctor immediately.

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

Other medicinesand FODREN
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 FODREN if taken simultaneously:

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

If concomitant therapy is necessary, take these medicines at least 30 minutes after taking FODREN.

FODREN with food and drink
It is very important that you DO NOT eat or drink anything (except tap water) with the FODREN tablet so that it can work correctly. In particular, do not take this medicine at the same time as dairy products (such as milk) which contain calcium (see section 2 "Other medicines and FODREN").
Eat food and drink (except tap water) at least 30 minutes after taking the FODREN tablet (See section 3 “How to take FODREN”).

Pregnancy and breastfeeding
DO NOT take FODREN if you are pregnant, suspect you may be pregnant or are planning a pregnancy (see section 2 "Do not take FODREN"). The potential risk associated with the use of sodium risedronate (the active ingredient of FODREN) in pregnant women is unknown.
DO NOT take FODREN if you are breastfeeding (see section 2 "Do not take FODREN").

Driving and using machines
No effects on the ability to drive and use machines have been observed.

FODREN containslactose. If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine (see section 2 "Warnings and precautions").

3. How to take FODREN

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is 1 tablet of FODREN (35 mg risedronate sodium) once a
week. Choose the day of the week that best suits your activities. You must
take the FODREN tablet on the same day of each week. The box contains
compartments/spaces. Mark the chosen day of the week for taking the FODREN tablet.
Also note the days on which you will take the tablet.
Take the tablet at least 30 minutes before the first meal of the day, the first drink,
other than tap water, or before any other medicines.
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).
The tablet must be swallowedwhole. Do not chew or let it dissolve in your mouth.

Do not lie down for 30 minutesafterswallowing the tablet.
Your doctor will tell you if you need calcium and vitamin supplements, if they are not adequately
introduced with your diet. The duration of treatment should be evaluated in each individual patient based on
benefits and risks.

If you take more FODREN than you should
If you or someone else accidentally takes more FODREN tablets than prescribed,
drink a full glass of milkor take antacids containing magnesium, calcium or aluminium and

immediately inform your doctoror go to the nearest hospital.

If you forget to take FODREN
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 a missed tablet.

If you stop taking FODREN
If you stop treatment with FODREN you may start to lose bone mass. Talk to your doctor
before deciding to stop treatment with this medicine.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking FODREN and contact your doctor immediatelyif any of the following side effects occur:

• symptoms of a severe allergic reaction such as:
• swelling of the face, tongue or throat
• difficulty swallowing
• hives (red and raised skin patches) and difficulty breathing
• Severe blistering skin reactions, including blister formation. Inform your doctor promptlyif you notice 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 onset of infection, often following tooth extraction (see section 2 "Before taking FODREN"). Disorders of the esophagus such as pain when swallowing, difficulty swallowing, chest pain or appearance/worsening of heartburn.

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

Common(affects 1 to 10 users out of 100):

• Dyspepsia (digestive difficulties), feeling of nausea, stomach pain, stomach cramps or gastric discomfort, constipation, feeling of bloating, flatulence (increased intestinal gas), diarrhea.

• Bone, muscle or joint pain.
• Headache.

Uncommon(affects 1 to 10 users out of 1,000):

• Inflammation or ulcer (lesions) of the esophagus (the channel connecting the mouth to the stomach) causing difficulty and pain when swallowing (see section 2 "Before taking FODREN"), inflammation of the stomach and duodenum (the first portion of the intestine following the stomach).
• Inflammation of the colored part of the eye (iris) (red, painful eyes with possible altered vision).

Rare(affects 1 to 10 users out of 10,000):

• Inflammation of the tongue (red, swollen and sometimes painful), narrowing of the esophagus (the channel connecting the mouth to the stomach).
• narrowing of the esophagus (esophageal stenosis);
• Changes in liver function tests have been reported. These can be diagnosed by a blood test.

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

Not 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 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.
• severe allergic reaction (anaphylaxis)
• Allergic reactions (hypersensitivity).
• Severe liver disorders, especially if being treated with other medicines known to cause liver problems
• disorders of the jaw and/or mandible (osteonecrosis)
• Inflammation of the eye causing pain and redness and possible alteration of vision.

Rarely, an unusual fracture of the femur can 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.

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.

Reporting of side 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 to
http://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 FODREN

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 FODREN 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, Coating: red iron oxide, yellow iron oxide, anhydrous colloidal silica, titanium dioxide, macrogol 400, macrogol 8000, hypromellose, hydroxypropylcellulose.

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

Marketing Authorisation Holder
AGIPS FARMACEUTICI srl - Via Amendola, 4 - Rapallo (GE)

Manufacturers

• Zaklad Farmaceutyczny Adamed Pharma S.A., UL. Szkoina, 33, 95-054 Ksawerow - Poland (production and packaging) - Zaklad Adamed Sp. z o.o, Pienkòw 149, 05-152 Czosnòw - Poland (quality control and batch release)
• Pabianickie Zaklady farmaceutyczne Polfa S.A. ul. Marszalka J. Pilsudskiego 5, 95-200 Pabianice Poland

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