Risedronate Alter

Package leaflet: Information for the patient

RISEDRONATO ALTER 35 mg film-coated tablets

Sodium risedronate
Equivalent medicine
Please read all of this leaflet carefully before you 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What RISEDRONATE ALTER is and what it is used for

RISEDRONATE ALTER belongs to a group of medicines called bisphosphonates that act directly on your bones to make them stronger and therefore less prone to fractures.
Bone is living tissue. The body continuously removes 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, increasing the 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 anywhere in the body. Osteoporosis-related fractures may also cause back pain, weight loss, and curvature of the spine. Many patients with osteoporosis do not have symptoms and therefore may not even know they have it.
RISEDRONATE ALTER is used for the treatment of osteoporosis in both postmenopausal women (to reduce the risk of vertebral and hip fractures) and in men at high risk of fractures.

2. What you should know before taking RISEDRONATE ALTER

Do not take RISEDRONATE ALTER

• if you are allergic to risedronate or to any of the other ingredients of this medicine (listed in section 6),
• if you have low levels of calcium in your blood (hypocalcemia);
• if you are pregnant;
• if you are breastfeeding;
• if you have severe kidney problems (severe renal insufficiency).

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

• if you are unable to remain upright (standing or sitting) for at least 30 minutes (See section 3 “How to take RISEDRONATE ALTER”);
• 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 or have had esophageal problems (the tube connecting the mouth to the stomach), such as strictures or failure to relax, or if you have a condition called 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, corticosteroid therapy, or poor oral hygiene, as preventive dental measures are required. During treatment with this medicine, avoid invasive dental procedures.

Pay special attention if you are scheduled for dental surgery and if you have developed jaw and/or mandible problems (osteonecrosis) while being treated with bisphosphonates; dental surgery may worsen the condition.
Pay special attention and immediately inform your doctor if you develop any of the following symptoms:

• difficulty swallowing accompanied by pain (dysphagia);
• onset and/or worsening of a burning sensation in the stomach;
• chest pain.

This medicine may cause femoral fractures; if you experience pain in the thigh, hip, or groin during treatment, inform your doctor immediately.
Children and adolescents
The use of sodium risedronate is not recommended in individuals under 18 years of age, as data on safety and efficacy are insufficient.
Other medicines and RISEDRONATE ALTER
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, medicines containing any of the following ingredients reduce the effect of RISEDRONATE ALTER if taken simultaneously:

• calcium
• magnesium
• aluminium (e.g. certain antacid mixtures)
• iron If concomitant therapy is necessary, take these medicines at least 30 minutes after taking RISEDRONATE ALTER.

RISEDRONATE ALTER with food and drink
It is very important not to take food or drinks (except tap water) together with this medicine, so that it can work properly. In particular, do not take this medicine at the same time as dairy products (such as milk) containing calcium (see section 2 “Other medicines and RISEDRONATE ALTER”).
Take food and drinks (except tap water) at least 30 minutes after taking the RISEDRONATE ALTER tablet (see section 3 “How to take RISEDRONATE ALTER”).
Pregnancy and breastfeeding
Do not take RISEDRONATE ALTER if you are pregnant or breastfeeding (see section 2 “Do not take RISEDRONATE ALTER”).
Driving and using machines
This medicine does not affect your ability to drive or operate machinery.
RISEDRONATE ALTER contains lactose
This medicine contains a sugar, lactose. If your doctor has informed you that you are intolerant to certain sugars, contact them before taking this medicine.

3. How to take RISEDRONATE ALTER

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet of 35 mg once a week. You must take the tablet on the same day every week.
Take the tablet in the morning, at least 30 minutes before eating food or drinking any beverage (except tap water) or taking other medicines.
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 the tablet or allow it to dissolve in the mouth.
Do not lie down for 30 minutes after swallowing the tablet.
Your doctor will assess 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 RISEDRONATE ALTER than you should
In case of accidental ingestion/overdose of RISEDRONATE ALTER, drink a full glass of milk or take antacids containing magnesium, calcium, or aluminium, and immediately contact your doctor or go to the nearest hospital.

If you forget to take RISEDRONATE ALTER
Do not take a double dose to make up for the missed tablet. 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 a week on your usual tablet day.

If you stop taking RISEDRONATE ALTER
If you have any questions about the use of 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 RISEDRONATE ALTER and contact a doctor immediately if you experience any of the following symptoms of a severe allergic reaction:

• swelling of the face, tongue or throat
• difficulty swallowing
• hives (red, raised skin patches) and difficulty breathing
• severe blistering skin reactions, including blister formation.

Tell 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 tooth extraction (see section 2 “Take special care and consult your doctor before starting RISEDRONATE ALTER”).
Oesophageal disorders 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 lead to treatment discontinuation in patients.
Common (may affect up to 1 in 10 people):

• headache;
• constipation;
• digestive discomfort (dyspepsia);
• nausea;
• abdominal pain;
• diarrhoea;
• bone, muscle and joint pain (musculoskeletal pain).

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

• inflammation or lesions of the oesophagus causing difficulty and pain when swallowing (oesophagitis);
• difficulty and pain when swallowing (dysphagia);
• inflammation of the stomach or duodenum, the first part of the intestine following the stomach (duodenitis);
• formation of lesions in the oesophagus (the tube connecting the mouth to the stomach) (oesophageal ulcers);
• inflammation of the coloured part of the eye (iris) (painful red eyes with possible altered vision) (iritis).

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

• inflammation of the tongue, red tongue and sometimes painful (glossitis);
• narrowing of the oesophagus (oesophageal stricture);
• unusual femur fracture, especially in patients on long-term treatment for osteoporosis (see section 2 “Warnings and precautions”);
• liver function test abnormalities have been reported. These may be detected by a blood test.

Very rare (may affect up to 1 in 10,000 people):
Contact your doctor if you experience ear pain, ear discharge and/or ear infection.
These episodes could be symptoms of bone damage in the ear.
During post-marketing experience, the following adverse reactions have been reported:
Not known (frequency cannot be estimated from the available data)

• eye inflammation causing pain, redness and possible changes in vision (iritis, uveitis);
• jaw and/or maxilla disorders (osteonecrosis);
• allergic-type reactions (hypersensitivity), such as swelling of the face, lips, tongue and/or throat (angioedema), and skin irritation such as hives (wheals) and skin rash (sudden reddening of the skin);
• severe skin problems such as blister formation under the skin (blistering skin reactions), inflammation of small blood vessels characterised by palpable red spots on the skin (leucocytoclastic vasculitis), Stevens-Johnson syndrome characterised by blisters on the skin, mouth, eyes and other moist areas of the body (genitals), and a serious condition called toxic epidermal necrolysis causing widespread red rash and/or peeling of the outer layers of the skin;
• hair loss;
• severe allergic reaction (anaphylaxis);
• severe liver disorders, especially if you are taking other medicines known to cause liver problems;
• decreased levels of calcium and phosphate in the blood, especially at the beginning of treatment.

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 the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store RISEDRONATE ALTER

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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What RISEDRONATO ALTER contains

• The active substance is sodium risedronate. Each tablet contains 35 mg of sodium risedronate (as sodium risedronate hemipentahydrate 40.2 mg).
• The other components are: microcrystalline cellulose, crospovidone, magnesium stearate, lactose monohydrate, red iron oxide, yellow iron oxide, Opadry White (glyceryl triacetate, hypromellose, titanium dioxide).

Description of the appearance of RISEDRONATO ALTER and contents of the pack
RISEDRONATO ALTER is presented as round, biconvex, salmon-pink film-coated tablets.
It is available in blisters containing 1, 2, 4, 10, 12, or 16 tablets of 35 mg each.
Marketing Authorization Holder
Laboratori Alter srl - Via Egadi, 7 - 20144 Milano - Italy
Manufacturer
LABORATORIOS ALTER S.A. - c/ Mateo Inurria nº30 - MADRID - Spain