Fodren

Package leaflet: Information for the user

FODREN 35 mg film-coated tablets

Sodium risedronate
“Generic medicine”
Please read this entire leaflet carefully before 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 give it to others, even if their symptoms are similar to yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking 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 bones become weakened and thinner, resulting in an increased risk of fractures following falls or minor trauma.

Osteoporosis can also occur in men due to various causes, such as aging and/or low levels of the male hormone testosterone.

Fractures occur most frequently in the spine, hip, and wrist, although they can occur throughout the body. Osteoporosis-related fractures may also cause back pain, loss of height, and curvature of the spine. Many patients with osteoporosis have no symptoms and therefore may not even know they have it.

FODREN is used for the treatment of osteoporosis:

• in postmenopausal women, including those with 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 to 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 FODREN, particularly:

• If you are unable to stand or sit upright for at least 30 minutes.
• If you have disorders of mineral and bone metabolism (for example, vitamin D deficiency, parathyroid hormone dysfunction, both of which can lead to reduced calcium levels in the blood).
• If you have previously had esophageal problems (the tube connecting the mouth to the stomach), such as pain or difficulty swallowing food, or if you have been diagnosed with Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the 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, a sensation of "heavy jaw", or loose teeth.
• If you are under dental treatment or have a dental procedure scheduled, inform your dentist that you are being treated with sodium risedronate. Your doctor will advise you on what to do while taking FODREN if you have any of the conditions listed above.

Be especially careful and inform your doctor immediately if you develop any of the following symptoms:

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

This medicine may cause femoral fractures; if you experience pain in your thigh, hip, or groin during treatment, inform your doctor immediately.
Children and adolescents
The use of sodium risedronate is not recommended in children under 18 years of age, as data on safety and efficacy are insufficient.
Other medicines and FODREN
Inform 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 FODREN if taken at the same time:

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

If concomitant therapy is necessary, take these medicines at least 30 minutes after taking FODREN.
FODREN with food and drinks
It is very important that you do NOT take food or drinks (except tap water) together with the FODREN tablet, so that it can work properly. 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").
Wait at least 30 minutes after taking the FODREN tablet before consuming food or drinks (except tap water) (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 substance in 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 or operate machinery have been observed.
FODREN contains lactose. If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine (see section 2 "Warnings and precautions").

3. How to take FODREN

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is 1 FODREN tablet (35 mg sodium risedronate) once a week. Choose the day of the week that best fits your routine. You must take the FODREN tablet on the same day every week. The pack contains compartments/spaces. Mark the day of the week you have chosen for taking the FODREN tablet. Also note the days on which you will take the tablet.
Take the tablet at least 30 minutes before your first meal, first drink (other than tap water), or first medicinal product of the day.
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).
The tablet must be swallowed whole. Do not chew or allow the tablet to dissolve in the mouth.
Do not lie down for 30 minutes after swallowing the tablet.
Your doctor will advise you whether you need calcium and vitamin supplements if these are not sufficiently provided by your diet. The duration of treatment should be evaluated individually based on benefits and risks.

If you take more FODREN than you should
If you or someone else has accidentally taken more FODREN tablets than prescribed, drink a full glass of milk or take antacids containing magnesium, calcium, or aluminium, and contact your doctor immediately or go to the nearest hospital.

If you forget to take FODREN
If you forget to take the tablet at your usual time, take it on the same day as soon as you remember. Then resume 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 tablet.

If you stop taking FODREN
If you stop treatment with FODREN, 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 everyone gets them.
Stop taking FODREN and contact a doctor immediately if you experience any of the following side effects:

• Symptoms of a severe allergic reaction such as:

• 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. Contact your doctor promptly if you notice any of the following side effects:

• Eye inflammation, usually with pain, redness and sensitivity to light.

• Necrosis (destruction) of the jawbone and/or maxilla (osteonecrosis), associated with delayed healing and onset of infection, often following dental extraction (see section 2 "Before taking FODREN").

• Disorders of the oesophagus such as pain when 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 require discontinuation of treatment in patients.

Common (may affect up to 1 in 100 people):

• Dyspepsia (digestive discomfort), feeling of nausea, stomach ache, stomach cramps or gastric discomfort, constipation, bloating, flatulence (increased intestinal gas), diarrhoea.
• Pain in bones, muscles or joints.
• Headache.

Uncommon (may affect up to 1 in 1,000 people):

• Inflammation or ulceration (lesions) of the oesophagus (the tube 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 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 10,000 people):

• Inflammation of the tongue (red, swollen and sometimes painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach).
• narrowing of the oesophagus (oesophageal stricture);
• Liver function test abnormalities have been reported. These can be diagnosed by a blood test.

The following side effects have been reported during post-marketing experience:
Frequency not known (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;
• Serious skin reactions including subcutaneous blisters; inflammation of small blood vessels, characterised 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 illness called toxic epidermal necrolysis (TEN) causing red rash on many parts of the body and/or peeling of outer skin layers.
• Hair loss.
• Severe allergic reaction (anaphylaxis)
• Allergic reactions (hypersensitivity).
• Severe liver disorders, especially if you are taking other medicines known to cause liver problems.
• Jaw and/or maxilla disorders (osteonecrosis).
• Eye inflammation causing pain, redness and possible vision changes.

An unusual femoral fracture may rarely occur, particularly in patients receiving 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.

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.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via
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 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 medicines 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 FODREN 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, monohydrate lactose.
  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 package contents
Film-coated round, light orange tablets, 9 mm in diameter. They are available in
blister packs containing 4 tablets.

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

Manufacturers

• Zaklad Farmaceutyczny Adamed Pharma S.A., UL. Szkolna, 33, 95-054 Ksawerow - Poland (manufacturing and packaging) - Zaklad Adamed Sp. z o.o, Pienkow 149, 05-152 Czosnow - 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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