Medicinal Products

ADROVANCE 70 mg / 5,600 IU

Generic drug of the therapeutic class: Rheumatology
Active ingredients: Alendronic acid, Colecalciferol
laboratory: Msd Limited

Compressed
Box of 1 Case of 4
All forms

Indication

Treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency and not receiving additional vitamin D supplementation.


ADROVANCE reduces the risk of vertebral and hip fractures.

Dosage ADROVANCE 70 mg / 5 600 IU Tablet Box of 1 Case of 4

The recommended dosage is one ADROVANCE tablet once a week.


Because of the pathophysiology of osteoporosis, ADROVANCE is intended for long-term treatment.


To allow adequate absorption of alendronate:


ADROVANCE should be taken at least 30 minutes before the first foods, drinks or medications of the day (including antacids, calcium-containing medicines and vitamins) are taken with a large glass of tap water ( no water mineral). Other drinks (including mineral water), foods, or certain medications may decrease the absorption of alendronate (see section 4.5 ).


The following instructions must be followed exactly to reduce the risk of esophageal irritation and the associated adverse effects (see section 4.4 ).


• ADROVANCE should be taken after sunrise with a large glass of tap water (minimum 200 ml).


• Patients must swallow the entire ADROVANCE tablet. Patients should not crush or chew the tablet or allow it to dissolve in their mouths because of the potential risk of oropharyngeal ulcers.


• Patients should not lie down until the first foods of the day are absorbed and should be taken at least 30 minutes after taking the tablet.


• Patients should not lie down for at least 30 minutes after taking ADROVANCE.


• ADROVANCE should not be taken at bedtime or before sunrise.


Patients treated should be supplemented with calcium if their dietary intake is inadequate (see section 4.4 ). The equivalence between weekly ADROVANCE (equivalent to 5600 IU vitamin D 3 ) and a daily dose of 800 IU vitamin D has not been studied.


Use in elderly patients:

Clinical studies have not revealed any age-related differences in the efficacy and safety profiles of alendronate. Therefore, no dosage modification is necessary in elderly patients .


Use in case of renal failure:

No dosage adjustment is necessary for patients with a glomerular filtration rate greater than 35 ml / min. Due to lack of experience, ADROVANCE should not be used in patients with renal impairment characterized by a glomerular filtration rate of less than 35 ml / min.


Use in children and adolescents:

ADROVANCE has not been studied in children and adolescents and should not be given to them.

Against indications

• Hypersensitivity to the active substances or to any of the excipients.

• Esophageal diseases and other factors that delay oesophageal transit such as stenosis and achalasia.

• Unable to stand upright or sit upright for at least 30 minutes.

• Hypocalcemia.

Adrovance side effects

The following side effects have been reported in clinical studies and / or since the marketing of alendronate.


There was no additional adverse event observed with ADROVANCE.


[Common (≥1 / 100, <1/10), uncommon (≥1 / 1, 000, <1/100), rare (≥1 / 10, 000, <1/1000), very rare (<1 / 10, 000)

Nervous system disorders:

Frequent: headache.

Eye disorders:

Rare: uveitis, scleritis, episcleritis.

Gastrointestinal disorders:

Common: abdominal pain, dyspepsia, constipation,

diarrhea, flatulence, oesophageal ulcer *, dysphagia *,

abdominal bloating, acid regurgitation.

Uncommon: nausea, vomiting, gastritis, esophagitis *,

oesophageal erosions *, melena.

Rare: oesophageal stenosis *, oropharyngeal ulceration *,

PUS (perforation, ulcers, bleeding) from the upper part of the

gastrointestinal tract (see section 4.4 Special warnings and precautions for use ).

* See sections Posology and method of administration and special warnings and precautions for use .

Skin and subcutaneous tissue disorders:

Uncommon: rash, pruritus, erythema.

Rare: rash with photosensitivity.

Very rare: severe skin reactions, including syndrome

Stevens Johnson and toxic epidermal necrolysis

(Lyell's syndrome).

Musculoskeletal and systemic disorders:

Frequent: musculoskeletal pain (bone, muscle and

joints).

Rare: musculoskeletal pain (bone, muscle and

joints) (see section 4.4 Special warnings and precautions for use ).

Metabolism and nutrition disorders:

Rare: symptomatic hypocalcemia, often associated with risk factors (see section 4.4 ).

General disorders and administration site defects:

Rare: transient symptoms of the acute reaction type (myalgia, malaise and rarely fever), usually observed at the beginning of treatment.

Immune system disorders:

Rare: Hypersensitivity reactions including urticaria and angioedema.

Since marketing, the following side effects have been reported (frequency unknown):

Nervous system disorders:

dizziness, dysgeusia.

Affections of the ear and labyrinth:

fear of heights.

Skin and subcutaneous tissue disorders:

alopecia.

Musculoskeletal, systemic and bone disorders:

cases of osteonecrosis of the jaw have been reported in patients treated with bisphosphonates. The majority of these cases involve cancer patients, but some of them have also been reported in patients treated for osteoporosis. Osteonecrosis of the jaw is usually associated with tooth extraction and / or local infection (including osteomyelitis). Cancer, chemotherapy, radiation, corticosteroids and poor oral hygiene are also considered as risk factors (see section 4.4 Special warnings and precautions for use ); swelling of the joints; Stress fractures of the proximal end of the femoral shaft (see section 4.4 ).

General disorders and administration site defects:

asthenia, peripheral edema.


Results of biological tests

In clinical studies, asymptomatic, mild and transient decreases in serum calcium and phosphorus levels were observed in approximately 18% and 10%, respectively, patients taking alendronate 10 mg / day versus approximately 12% and 3% of patients taking placebo. However, the incidences of decreases in serum calcium at a level <8.0 mg / dl (2.0 mmol / l) and phosphoremia at a rate ≤ 2.0 mg / dl (0.65 mmol / l) were similar in both treatment groups.

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