Aldenstad plus

Rx

Indications:

Aldenstad plus is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency. It reduces the risk of vertebral and hip fractures.

Dosage:

• The recommended dose is one tablet once weekly.
• If they miss a dose of Aldenstad plus they should take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.
• Due to the nature of the disease process in osteoporosis, Aldenstad plus is intended for long-term use.
• The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Aldenstad plus on an individual patient basis, particularly after 5 or more years of use.
• Patients should receive supplemental calcium if intake from diet is inadequate. Additional supplementation with vitamin D should be considered on an individual basis taking into account any vitamin D intake from vitamins and dietary supplements.

Usage:

Aldenstad plus is administered orally.

To permit adequate absorption of alendronate:

• Aldenstad plus must be taken with water only (not mineral water) at least 30 minutes before the first food, beverage, or medicinal product (including antacids, calcium supplements and vitamins) of the day. Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of   alendronate.
• The following instructions should be followed exactly in order to minimise the risk of oesophageal irritation andrelated adverse reactions:
  + Aldenstad plus should only be swallowed after getting up for the day with a full glass of water (not less than 200 ml or 7 fl.oz.).
  + Patients should only swallow Aldenstad plus whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
  + Patients should not lie down until after their first food of the day.
  + Patients should not lie down for at least 30 minutes after taking Aldenstad plus.
  + Aldenstad plus should not be taken at bedtime or before arising for the day.

• Hypersensitivity to the active substances or to any of the excipients.
• Abnormalities of the oesophagus and other factors which delay oesophageal emptying.
• Inability to stand or sit upright for at least 30 minutes.
• Hypocalcaemia.
• Children less than 18 years of age.

• Very common:
  Musculoskeletal (bone, muscle or joint) pain which is sometimes severe.
• Common:
  Nervous system disorders: Headache, dizziness, vertigo, abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer, dysphagia, abdominal distension, acid regurgitation, alopecia, ruritus, joint swelling, asthenia, peripheral oedema.

Alendronate

• Upper gastrointestinal adverse reactions:
  Alendronate can cause local irritation of the upper gastrointestinal mucosa. Caution should be used when alendronate is given to patients with active upper gastrointestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastrointestinal disease such as peptic ulcer, or active gastrointestinal bleeding, or surgery of the upper gastrointestinal tract other than pyloroplasty. In patients with known Barrett’s oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis.
• Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
• Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms such as pain or discharge, or chronic ear infections.
• Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. In post-marketing experience, these symptoms have rarely been severe and/or incapacitating. The time to onset of symptoms varied from one day to several months after starting treatment. Most patients had relief of symptoms after stopping treatment. A subset had recurrence of symptoms when rechallenged with the same medicinal product or another bisphosphonate.
• Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
• Aldenstad plus is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min.
• Causes of osteoporosis other than oestrogen deficiency and ageing should be considered. Hypocalcaemia must be corrected before initiating therapy with Aldenstad plus. Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting this medicinal product. The content of vitamin D in Aldenstad plus is not suitable for correction of vitamin D deficiency. In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with Aldenstad plus.

Cholecalciferol (Vitamin D3)

• Vitamin D3 may increase the magnitude of hypercalcaemia and/or hypercalciuria when administered to patients with disease associated with unregulated overproduction of calcitriol (e.g. leukaemia, lymphoma, sarcoidosis). Urine and serum calcium should be monitored in these patients.
• Patients with malabsorption may not adequately absorb vitamin D3.
• Aldenstad plus contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose  galactose malabsorption should not take this medicine.
• Pregnancy and lactation.
• Patients should be cautious when driving or operating machinery because Aldenstad plus may cause blurred vision, dizziness and severe bone muscle or joint pain.