Medicinal Products

ALENDRONATE TEVA 10 mg

Generic drug of Fosamax
Therapeutic class: Rheumatology
active ingredients: Alendronic acid
laboratory: Teva Sante

Compressed
Box of 28
All forms

Indication

Treatment of postmenopausal osteoporosis.

Alendronate reduces the risk of vertebral and hip fractures.

Dosage ALENDRONATE TEVA 10 mg Tablet Box of 28

Alendronate should be taken on an empty stomach with a full glass of tap water, immediately after sunrise, half an hour before the first intake of food, drink or other medication. Other beverages (including mineral waters containing bicarbonate), foods and other medications may decrease the absorption of alendronate (see section 4.5. Interactions with other medicinal products and other forms of interaction ).

In order to promote gastric absorption and to reduce the risk of local adverse reactions and esophageal irritation (see Warnings and Precautions ), the following measures should be taken:

· Alendronate should be taken only at early morning with a large glass of tap water.

· Alendronate tablets should be swallowed without chewing. The tablets should not be chewed or sucked because of the risk of oro-oesophageal ulceration.

· Patients should not lie down (they should stand or sit) until the first meal of the day is taken at least half an hour after taking the tablet.

· Alendronate should not be taken at bedtime or before morning sunrise.

Calcium and vitamin D supplementation is recommended in case of insufficient dietary intake (see Warnings and Precautions ).

The recommended dosage is 10 mg once a day.

There is no need to change the dosage in elderly patients or in mild to moderate renal impairment (creatinine clearance 35-60 mg / min).

Due to insufficient experience with use, alendronate is not recommended in patients with severe renal impairment (creatinine clearance <35 ml / min).

Use in children (under 18 years)

Alendronate has been studied in a limited number of patients under 18 years of age with osteogenesis imperfecta. The results are insufficient to support its use in children.

Against indications

· Esophageal diseases, such as stenosis or achalasia, that delay esophageal transit.

· Unable to stand or sit for at least 30 minutes.

Hypersensitivity to alendronate, other bisphosphonates, or any of the excipients.

· Hypocalcemia.

See Warnings and precautions for use .

Alendronate Teva side effects

In two three-year studies with almost identical conditions, in postmenopausal women (alendronate 10 mg: n = 196, placebo: n = 397) the overall safety profile of alendronate 10 mg / day and placebo were similar.

The undesirable effects presented by the investigators as being in possible or probable relation with the active principle or incontestably related to it are presented below if they appeared in ³ 1% of the patients treated by 10 mg / day of alendronate and at a higher frequency than in patients receiving placebo in three-year studies:

Three years studies

alendronate

Placebo

10 mg / day

(n = 397)

(n = 196)

%

%

Gastrointestinal effects

abdominal pain

6.6

4.8

dyspepsia

3.6

3.5

acid regurgitation

2.0

4.3

nausea

3.6

4.0

abdominal bloating

1.0

0.8

constipation

3.1

1.8

diarrhea

3.1

1.8

dysphagia

1.0

0.0

flatulence

2.6

0.5

gastritis

0.5

1.3

gastric ulcer

0.0

0.0

oesophageal ulceration

1.5

0.0

Musculoskeletal effects

musculoskeletal pain (bone, muscle or joint pain)

4.1

2.5

muscle cramps

0.0

1.0

Neurological effects

headaches

2.6

1.5

The following adverse events have been reported in clinical and / or post-marketing studies with alendronate:

· Frequent (> 1/100, <1/10)

· Uncommon (> 1/1000, <1/100)

· Rare (> 1/10 000, <1/1 000)

· Very rare (<1/10 00)

· Frequency unknown (can not be estimated from the available data)

Neurological disorders

Frequent

headaches

Ophthalmological disorders

Rare

Uveitis, scleritis

Gastrointestinal disorders

Frequent

Abdominal pain, dyspepsia, constipation, diarrhea, flatulence, oesophageal ulceration *, melena, dysphagia *, abdominal distension, acid regurgitation.

Rare

Nausea, vomiting, gastritis, oesophagitis *, oesophageal erosions *, melena.

Rare

Oesophageal stenosis *, oropharyngeal ulcerations *, PUS (perforations, ulcers, bleeding) of the upper gastrointestinal tract, although no cause-and-effect relationship can be ruled out.

Skin and subcutaneous tissue disorders

Rare

Rash, pruritus, erythema

Rare

Rash with photosensitivity.

Very rare, unknown (not estimable based on available data)

Isolated cases of severe skin reactions, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported.

Musculoskeletal and connective tissue disorders

Frequent

Osteoarticular or muscular pains.

Frequency unknown

Fracture of fatigue of the proximal end of the femur

Metabolic and nutritional disorders

Rare

Symptomatic hypocalcemia, occasionally severe, usually on predisposed terrain (see Warnings and Precautions for Use section ).

General disorders and administration site reactions

Rare

Hypersensitivity reactions including urticaria and angioedema. Transient symptoms such as acute myalgia, malaise and, rarely, fever, usually seen at the beginning of treatment.

* (see section Posology and method of administration and Warnings and precautions for use .)

Biological data

In clinical studies, discrete, transient and asymptomatic decreases in serum calcium and phosphate were observed in 18% and 10% of patients receiving alendronate 10 mg / day versus approximately 12% and 3% of patients receiving placebo respectively. . Nevertheless, the incidence of decreased serum calcium at <8.0 mg / dl (2.0 mmol / l) and phosphatemia at <2.0 mg / dl (0.65 mmol / l) ) were similar in both treatment groups.

Osteonecrosis of the jaw was observed in patients treated with bisphosphonates. In the majority of cases, the treatment was related to cancer patients, but some cases were also observed in patients treated for osteoporosis. Osteonecrosis of the jaw was generally associated with tooth extraction and / or local infection (including osteomyelitis). Cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also considered as risk factors (see Warnings and Precautions ).

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