Treatment of osteoporosis, postmenopausal.

Alendronic acid reduces the risk of vertebral and hip fractures

The recommended dosage is 1 tablet at 70 mg once a week.


ALENDRONIC ACID TEVA HEALTH should be taken at least half an hour before absorption of the first foods, drinks or medicine of the day with a large glass of tap water. Other drinks (including mineral water), foods or certain drugs may decrease the absorption of alendronate (see Interactions with other medicines and other forms of interactions.).

To facilitate passage through the stomach and thereby reduce the potential for irritation or local and esophageal adverse reactions (see section 4.4) Br>

· ALENDRONIC ACID TEVA HEALTH must be taken strictly with a large glass of tap water (minimum 200 ml).

· Patients must swallow the entire TEVA SANTE ALENDRONIC ACID tablet. Patients should not crush or chew the tablet or allow it to dissolve in their mouth because of the potential risk of ulcers oropharyngeal

Patients should not lie down until absorption, the first foods of the day to be taken at least thirty minutes after taking the tablet. >

· Patients should not lie down for at least 30 minutes after taking TEVA SANTE ALENDRONIC ACID

· ALDERRONIC ACID TEVA HEALTH should not be taken at bedtime or before getting up.

Treated patients should be supplemented with calcium and vitamin D, and if their dietary intakes are insufficient (see Warnings and Precautions for Use). >
Use in elderly patients

Clinical studies did not reveal any differences related to age in the efficacy and safety profiles of alendronate. Therefore, no change in dosage is necessary in elderly patients.


No change in dosage is necessary in patients with glomerular filtration rate> 35 ml / min. Due to a lack of experience, alendronate is not recommended in patients with renal impairment characterized by a glomerular filtration rate
Esophageal reactions (sometimes severe and requiring hospitalization), such as oesophagitis, ulcers, esophagitis and oesophageal erosions, rarely followed by oesophageal stenosis, have been reported in patients treated with alendronate. Doctors should therefore be alert to the presence of any signs or symptoms indicating a possible esophageal reaction, and instruct patients to stop alendronate and see if they have symptoms of irritation Esophagitis such as dysphagia, odynophagia, retrosternal pain, onset or aggravation of retrosternal burns

The risk of adverse, severe esophageal effects appears to be greater, in patients who do not follow instructions correctly, how alendronate is administered, and / or who continue to take alendronate after taking , Symptoms suggestive of esophageal irritation It is very important that all instructions regarding the administration of alendronate are given to and understood by the patient (see Posology and method of administration). Patients should be advised of the increased risk of onset of adverse events in the esophagus if they do not follow the administration instructions strictly.

Although no increase in risk has been observed over the long term, clinical studies, rare cases of gastric or duodenal ulcers have been reported since, marketing in some severe cases, accompanied by complications. Code>
Osteonecrosis of the jaw, generally associated with dental extraction and / or local infection (including osteomyelitis), has been reported in cancer patients receiving treatment with bisphosphonates mainly administered intravenously. Many of these patients also received chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients treated for osteoporosis receiving oral bisphosphonates.

The following risk factors should be considered when evaluating the patient at risk for developing osteonecrosis of the jaw

· The potency of the bisphosphonate (the strongest being that of zoledronic acid), the route of administration (see above) and the cumulative doses


· Cancer, chemotherapy, radiotherapy, corticosteroid therapy, smoking

· History of dental disease, poor oral hygiene, periodontal disease, interventions, invasive dental care and improperly adjusted dental appliances

A dental examination with appropriate preventive dental care should be considered prior to oral bisphosphonate treatment in patients with poorly functioning teeth

During treatment, these patients should, if possible, avoid invasive dental procedures. Dental surgery can worsen the condition of patients developing osteonecrosis of the jaw during bisphosphonate treatment. For patients requiring dental procedures, there is no available data suggesting that interruption of bisphosphonate therapy reduces the risk of osteonecrosis of the jaw. The clinical judgment of the attending physician should guide the conduct to be taken for each patient based on the assessment of the benefit / risk ratio.

During treatment with bisphosphonates, each patient should be encouraged to maintain good oral hygiene, regular dental checks, and to report any oral symptoms such as teeth mobility, pain or swelling.

In patients taking bisphosphonates, bone, joint and / or muscle pain has been reported. Since onset in the market, these symptoms have rarely been severe and / or disabling (see section 4.4). The time to onset was between one day and several months after the start of treatment. In most patients, symptoms disappeared after cessation of treatment. In some cases, symptoms have reappeared in another treatment with the same drug or other bisphosphonate.


%

Alendronate

10 mg / day

(N '= 370)

%

Alendronate

10 mg / day

(N '= 196)

%

Placebo

(N '= 397)

%

Gastrointestinal

Abdominal pain

3.7

3.0

6,6

4.8

Dyspepsia

2.7

2.2

3.6

3,5

Acid regurgitation

1.9

2.4

2.0

4.3

Nausea

1.9

2.4

3.6

4.0

Abdominal bloating

1.0

1,4

1.0

0.8

Constipation

0.8

1.6

3.1

1.8

Diarrhea

0.6

0.5

3.1

1.8

Dysphagia

0.4

0.5

1.0

0.0

Flatulence

0.4

1.6

2.6

0.5

Gastritis

0.2

1.1

0.5

1.3

Gastric ulcer

0.0

1.1

0.0

0.0

Oesophageal ulcer

0.0

0.0

1.5

0.0

Musculoskeletal diseases

Pains, osteoarticular or muscular

2.9

3.2

4.1

2.5

Cramps, muscle

0.2

1.1

0.0

1.0

Neurological

Headache

0.4

0.3

2.6

1.5

The following adverse events have also been reported in clinical trials and / or marketing studies

(≥1 / 100,