RISEDRONATE SODIUM

Posology The recommended daily dose in adults is one 5 mg tablet orally.

Special populations Elderly:

No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (>60 years of age) compared to younger subjects.

Renal Impairment:

No dosage adjustment is required for those patients with mild to moderate renal impairment. 2). 1). Method of administration The absorption of Risedronate sodium 5 mg is affected by food, thus to ensure adequate absorption patients should take Risedronate sodium 5 mg: • Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day.

In the particular instance that before breakfast dosing is not practical, Risedronate sodium 5 mg can be taken between meals or in the evening at the same time every day, with strict adherence to the following instructions, to ensure Risedronate sodium 5 mg is taken on an empty stomach: • Between meals: Risedronate sodium 5 mg should be taken at least 2 hours before and at least 2 hours after any food, medicinal product or drink (other than plain water).

• In the evening: Risedronate sodium 5 mg should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day. Risedronate sodium 5 mg should be taken at least 30 minutes before going to bed.

If an occasional dose is missed, Risedronate sodium 5 mg can be taken before breakfast, between meals, or in the evening according to the instructions above. The tablets must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Risedronate sodium 5 mg is to be taken while in an upright position with a glass of plain water (≥120 ml).

4). Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate. 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 risedronate on an individual patient basis, particularly after 5 or more years of use.

Risedronate sodium has been studied in phase III clinical trials involving more than 15,000 patients. The majority of undesirable effects observed in clinical trials were mild to moderate in severity and usually did not require cessation of therapy.

Adverse experiences reported in phase III clinical trials in postmenopausal women with osteoporosis treated for up to 36 months with risedronate 5mg/day (n=5020) or placebo (n=5048) and considered possibly or probably related to risedronate are listed below using the following convention (incidences versus placebo are shown in brackets): very common (≥1/10); common (≥1/100; <1/10); uncommon (≥1/1,000; <1/100); rare (≥1/10,000; <1/1,000); very rare (<1/10,000).

8% vs. 0% vs. 5% vs. 3% vs. 5% vs. 0% vs. 9% vs. 9% vs. 4% vs. 2% vs. 2% vs. 1% vs. 1% vs. 1% vs. 9%) Very rare: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction).

Investigations:

Rare: abnormal liver function tests* * No relevant incidences from Phase III osteoporosis studies; frequency based on adverse event/laboratory/rechallenge findings in earlier clinical trials.

Laboratory findings:

Early, transient, asymptomatic and mild decreases in serum calcium and phosphate levels have been observed in some patients. The following additional adverse reactions have been reported during post-marketing use (frequency unknown): Eye disorders: iritis, uveitis Musculoskeletal and connective tissues disorders: osteonecrosis of the jaw Skin and subcutaneous tissue disorders: hypersensitivity and skin reactions, including angioedema, generalised rash, urticaria and bullous skin reactions, some severe including isolated reports of Stevens-Johnson syndrome, toxic epidermal necrolysis and leukocytoclastic vasculitis.

hair loss. Immune system disorders: anaphylactic reaction Hepatobiliary disorders: serious hepatic disorders. In most of the reported cases the patients were also treated with other products known to cause hepatic disorders. During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).

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 the Google Play or Apple App Store.

2). 5 SD) and/or prevalent fracture. High age or clinical risk factors for fracture alone are not reasons to initiate treatment of osteoporosis with a bisphosphonate. 1). Bisphosphonates have been associated with oesophagitis, gastritis, oesophageal ulcerations and gastroduodenal ulcerations.

g. stricture or achalasia. • In patients who are unable to stay in the upright position for at least 30 minutes after taking the tablet. • If risedronate is given to patients with active or recent oesophageal or upper gastrointestinal problems (including known Barrett’s oesophagus).

Prescribers should emphasise to patients the importance of paying attention to the dosing instructions and be alert to any signs or symptoms of possible oesophageal reaction. The patients should be instructed to seek timely medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing, retrosternal pain or new/worsened heartburn.

Hypocalcaemia should be treated before starting Risedronate sodium 5 mg therapy. g. parathyroid dysfunction, hypovitaminosis D) should be treated at the time of starting Risedronate sodium 5 mg therapy. 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. g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).

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 surgery 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 judgment of the treating physician should guide the management plan of each patient based on individual benefit /risk assessment. 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.

Atypical fractures of the femur 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. This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. 4). Pregnancy and lactation. Severe renal impairment (creatinine clearance <30ml/min).