Alendronic Acid Abbreviated Prescribing Information

Abbreviated Prescribing Information: Alendronic Acid Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: Each 100 ml single-dose contains 70 mg alendronic acid (as 91.35 mg sodium alendronate trihydrate). Orange coloured opalescent oral solution. Therapeutic Indications: Treatment of post-menopausal osteoporosis. Alendronic acid reduces the risk of vertebral and hip fractures. Posology and Method of Administration: The recommended dosage is one 70mg unit-dose (100 ml) once weekly. The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Alendronic Acid 70 mg Oral Solution on an individual patient basis, particularly after 5 or more years of use. Alendronic acid 70 mg is for oral administration which should be taken on arising at least 30 minutes before the first food, beverage, or medicinal product of the day as a single 100 ml dose (entire content of bottle) followed by 30 ml of plain water only and patient should not lie down to facilitate delivery to stomach. Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronic acid. Alendronic acid should not be given at bedtime or before arising for the day. Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.  Paediatric population: Alendronic acid is not recommended for use in children under the age of 18 years. Contra-indications: Alendronic acid is contraindicated if patient has hypersensitivity to alendronic acid or any of the excipients, abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia, if patient has inability to stand or sit upright for at least 30 minutes, has hypocalcaemia, patient has difficulty in swallowing and at risk of aspiration. Special Warnings and Precautions for use: Alendronic Acid 70 mg Oral Solution can cause local irritation of the upper gastro-intestinal mucosa and esophagus. Alendronic acid should not be given to patients with active upper gastro-intestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastro-intestinal disease such as peptic ulcer, or active gastro-intestinal bleeding, or surgery of the upper gastro-intestinal tract other than pyloroplasty. Should only be given in Barrett’s oesophagus after considering the benefit and potential risk on an individual basis. Oesophageal reactions (sometimes severe and requiring hospitalisation), such as oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophageal stricture, have been reported in patients receiving alendronic acid. Patients should be instructed to discontinue alendronic acid and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing or retrosternal pain, new or worsening heartburn. Risk of oesophageal adverse experiences appear to be greater in patients who fail to take alendronic acid properly and/or who continue to take alendronic acid after developing symptoms suggestive of oesophageal irritation. It is very important that the full dosing instructions are provided to and understood by the patient. There have been rare (post-marketing) reports of gastric and duodenal ulcers, some severe and with complications.  Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis), has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered and also reported on oral bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. Risk factors for developing osteonecrosis of jaw are: potency of the bisphosphonate (highest for zoledronic acid), route of administration (more in intravenous) and cumulative dose; cancer, chemotherapy, radiotherapy, corticosteroids, angiogenesis inhibitors, smoking; history of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures and poorly fitting dentures. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with poor dental status and also avoid invasive dental procedure while on treatment. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment. During bisphosphonate treatment, all patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms such as dental mobility, pain or swelling. 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 including chronic ear infections. Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. Atypical fracture of femur has been reported. These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture. Fractures are often bilateral; therefore, the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures has also been reported and hence discontinuation to be considered on an individual benefit risk assessment. There have been rare reports of severe skin reactions including Stevens Johnson syndrome and toxic epidermal necrolysis. If the patient missed a day, they should not take two doses on the same day but should take once a week as originally scheduled on chosen day. Alendronic acid is not recommended for patients with renal impairment where GFR is less than 35 ml/min. Hypocalcaemia must be corrected before initiating therapy with alendronic acid. Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated. In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with Alendronic Acid 70 mg Oral Solution. There have been rare reports of symptomatic hypocalcaemia, which have occasionally been severe and often occurred in patients with predisposing conditions (e.g. hypoparathyroidism, vitamin D deficiency and calcium malabsorption). Ensuring adequate calcium and vitamin D intake is particularly important in patients receiving glucocorticoids since decreases in serum calcium and phosphate may occur. This medicinal product contains 0.15 % volume ethanol (alcohol), i.e. up to 115 mg per dose, equivalent to 3 ml beer or 1.3 ml wine per dose. Hence, harmful for those suffering from alcoholism. To be taken into account in high-risk groups such as patients with liver disease, or epilepsy. Any warning from the MC, CHM CSM or MHRA: [None] Black Triangle notice (if relevant): [No]. A list of common and serious adverse reactions (include a statement to consult the SmPC for full details of other adverse reactions). Very common: musculoskeletal (bone, muscle or joint) pain. Common: headache, dizziness, vertigo, abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer, dysphagia, abdominal distension, acid regurgitation, alopecia, pruritus, Joint swelling, asthenia, peripheral oedema. Serious: atypical femoral fractures, symptomatic hypocalcaemia, rash with photosensitivity, hypersensitivity reactions including urticaria and angioedema. oesophageal erosions, melena, oesophageal stricture, oropharyngeal ulceration, upper gastrointestinal PUBs (perforation, ulcers, bleeding), severe skin reactions including Stevens Johnson syndrome and toxic dermal necrolysis, osteonecrosis of jaw, severe musculoskeletal (bone, muscle or joint) pain, osteonecrosis of the external auditory canal. Pack Size and NHS Price: 100ml – £23.80. Legal Category: [POM]. Marketing Authorisation Number: PL 34111/0001 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [September 2025]