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ALENDRONIC ACID AND CALCIUM/CHOLECALCIFEROL is a brand name for Cholecalciferol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of post-menopausal osteoporosis. Alendronate reduces the risk of vertebral and hip fractures. Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets is only intended for use in assessed patients for whom the amount of calcium and vitamin D3 included is considered to provide adequate…
Verbatim from this product's MHRA label. Tap a section to expand.
Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets is a weekly therapy of 1 Alendronate 70 mg film-coated tablet and 6 calcium/vitamin D3 effervescent tablets. The recommended dose is one Alendronate 70 mg film-coated tablet on the first day followed on the next day by 1 calcium/vitamin D3 effervescent tablet daily for 6 days.
This 7-day sequence is then repeated each week starting with Alendronate 70 mg film-coated tablet. Alendronate 70 mg (film-coated tablet) Posology The Alendronate 70 mg film-coated tablet should be taken orally on the same day each week.
The recommended dose is one 70 mg tablet 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 Alendronate 70 mg film-coated tablet on an individual patient basis, particularly after 5 or more years of use.
Use in the elderly In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate. Therefore no dosage adjustment is necessary for the elderly. Use in renal impairement No dose adjustment is necessary for patients with a glomerular filtration rate (GFR) greater than 35 ml/min.
Alendronate is not recommended for patients with renal impairment where GFR is less than 35 ml/min, due to the lack of experience. Use in impaired hepatic function No dose adjustment is necessary. 1).. Alendronate has not been investigated in the treatment of glucocorticoid- induced osteoporosis.
Method of administration To permit adequate absorption of alendronate Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets must be taken on an empty stomach immediately on rising in the morning, with plain water only, at least 30 minutes before the first food, drink or other medicinal product of the day.
5). 4). - Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml or 7 fl. oz). - Patients should swallow Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets whole.
Patients should not crush or chew, or allow the tablet to dissolve in their mouth because of the potential for oropharyngeal ulceration. - Patients should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet.
Summary of the safety profile Alendronate In a one-year study in post-menopausal women with osteoporosis the overall safety profiles for alendronate once-weekly tablets (n=519) and alendronate 10 mg/day (n=370) were similar. In two three-year studies of virtually identical design, in post-menopausal women (alendronate 10 mg: n=196; placebo: n= 397) the overall safety profiles of alendronate 10 mg daily and placebo were similar.
4 †Frequency in clinical trials was similar in the medicinal product and placebo group. 4 ‡This adverse reaction was identified through post-marketing surveillance. The frequency of rare was estimated based on relevant clinical trials 1Identified in postmarketing experience.
Osteonecrosis of the jaw Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates. The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis.
Osteonecrosis of the jaw is generally associated with tooth extraction and/or local infection (including osteomyelistis). 4). Calcium carbonate/vitamin D3 MedDRA- system organ class Very common Common Uncommon Rare Very rare Not known Immune system disorders Hypersensitiv ity reactions Isolated cases of systemic allergic reactions (anaphylactic reaction, face oedema, laryngeal oedema, angioneurotic oedema) have been reported.
MedDRA- system organ class Very common Common Uncommon Rare Very rare Not known Metabolism and nutrition disorders Hypercalcae mia and hypercalciuria Milk-alkali syndrome (frequent urge to urinate, continuing headache, continuing loss of appetite, nausea or vomiting, unusual tiredness or weakness, hypercalcaem ia, alkalosis and renal impairment).
9). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in Google play or Apple App store.
Alendronate Alendronate can cause local irritation of the upper gastro-intestinal mucosa. 3). In patients with known Barrett's oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient 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 alendronate.
The physician should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing, or retrosternal pain, new or worsening heartburn.
The risk of severe oesophageal side effects appears to be greater in patients who fail to take alendronate properly and/or who continue to take alendronate after developing symptoms suggestive of oesophageal irritation. 2). Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems.
While no increased risk was observed in extensive clinical trials, there have been rarer (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 bisphosphonates.
Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates. The following risk factors should be considered when evaluating an individual’s risk of developing osteonecrosis of the jaw: • potency of the bisphosphonate (highest for zoledronic acid), route of administration (see above) and cumulative dose • cancer, chemotherapy, radiotherapy, corticosteroids, smoking • a history of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures and poorly fitting dentures.
1. 4.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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- Patients should not lie down for at least 30 minutes after taking Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets. Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets should not be taken at bedtime or before arising for the day.
Calcium/vitamin D3 (effervescent tablet) Posology Calcium/vitamin D3 effervescent tablet should be taken each day for 6 days per week starting on the day after the Alendronate 70 mg film-coated tablet is taken. In case the Alendronate 70 mg film-coated tablet dose is missed, patients should be instructed that the Alendronate 70 mg film-coated tablet should be taken on the next day in the morning according to the dosing instructions.
In this particular instance, patients should then take their calcium/vitamin D3 effervescent tablet on the following day. Patients should be instructed that they should never take the film-coated tablet and the effervescent tablet the same day.
If the calcium/vitamin D3 effervescent tablet dose is missed, the patient should be instructed to continue taking one effervescent tablet each day beginning on the day the missed dose is remembered. Patient should be instructed that they should not take two effervescent tablets on the same day.
Any remaining calcium/vitamin D3 effervescent tablet at the end of the weekly cycle should be discarded. Paediatric population Calcium/vitamin D3 is not intended for intake in children. Method of administration The effervescent tablet is taken dissolved in a glass of water.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with oral bisphosphonates in patients with poor dental status. While on treatment, these patients should avoid invasive dental procedures if possible.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental sugery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
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.
8). The time to onset of symptoms varied from one day to several months after starting treatment. Most patients had relief of symptoms after stopping. 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. These transverse or short oblique, fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
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. Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
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. In post-marketing experience, there have been rare reports of severe skin reactions including Stevens Johnson syndrome and toxic epidermal necrolysis.
Patients […]