Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
What Risedronate tablets is Risedronate tablets belongs to a group of non-hormonal medicines called bisphosphonates which are used to treat bone diseases. It works directly on your bones to make them stronger and therefore less likely to break.
Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced with new bone.
Postmenopausal osteoporosis is a condition occurring in women after the menopause where the bones become weaker, more fragile and more likely to break after a fall or strain. Osteoporosis is more likely to occur in women who have reached the menopause early and also in patients treated long-term with steroids.
The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in your body. Osteoporosisrelated fractures can also cause back pain, height loss and a curved back. Many patients with osteoporosis have no symptoms and you may not even have known that you had it.
What Risedronate tablets is used for The treatment of osteoporosis • in postmenopausal women. The prevention of osteoporosis • in women with an increased risk of osteoporosis (including low bone mass, early menopause or a family history of osteoporosis). • in postmenopausal women who have been on high doses of steroid drugs for a long time. It maintains or increases bone mass.
Do not take Risedronate tablets • If you are allergic to risedronate sodium or any of the other ingredients of this medicine (listed in section 6). • If your doctor has told you that you have a condition called hypocalcaemia (a low blood calcium level). • If you may be pregnant, are pregnant or planning to become pregnant. • If you are breast-feeding. • If you have severe kidney problems.
Warnings and precautions Talk to your doctor or pharmacist before taking Risedronate tablets • If you are unable to stay in an upright position (sitting or standing) for at least 30 minutes. • If you have abnormal bone and mineral metabolism (for example lack of vitamin D, parathyroid hormone abnormalities, both leading to a low blood calcium level).
Black A/s: 210 x 360 mm
Product Name
Risedronate 5 mg Leaflet P1540244
Reason Of Issue Version No. Customer / Country Reviewed / Approved
Packaging Development
Milpharm_Unit 3 Revision 01
Team Leader
Ramesh P
No. of Colours : 01
Dimensions
210 x 360 mm
Initiator
Jaya Durga
Pharmacode
Artist:
Additional Information :
Supersede item Code: P1525528
Pharmacode position may change as per Supplier's m/c requirement &additional
Risedronate sodium
• If you have had problems in the past with your oesophagus (the tube that connects your mouth with your stomach). For instance you may have had pain or difficulty in swallowing food or you have previously been told that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus). • If you have been told by your doctor that you have an intolerance to some sugars (such as lactose). • If you have had or have pain, swelling or numbness of the jaw or a "heavy jaw feeling" or loosening of a tooth. • If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Risedronate tablets. Your doctor will advise you on what to do when taking Risedronate tablets if you have any of the above.
Children and adolescents Risedronate tablets are not recommended for use in children and adolescents below age 18 due to insufficient data on safety and efficacy.
Other medicines and Risedronate tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Medicines containing one of the following lessen the effect of Risedronate tablets if taken at the same time: • calcium • magnesium • aluminium (for example some indigestion mixtures) • iron
Take these medicines at least 30 minutes after your Risedronate tablets.
Risedronate tablets with food and drink It is very important that you do not take your Risedronate tablets with food or drinks (other than plain water) so that it can work properly. In particular do not take this medicine at the same time as dairy products (such as milk) as they contain calcium (see section 2, "Other medicines and Risedronate tablets").
Take food and drinks (other than plain water) at least 30 minutes after your Risedronate tablets.
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Risedronate tablets if you may be pregnant, are pregnant or planning to become pregnant (see section 2, "Do not take Risedronate tablets"). The potential risk associated with the use of risedronate sodium (active substance in Risedronate tablets) in pregnant women is unknown.
Do not take Risedronate tablets if you are breast-feeding (see section 2, "Do not take Risedronate tablets").
Driving and using machines Risedronate tablets is not known to affect your ability to drive and use machines.
Risedronate tablets contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Risedronate contains sodium This medicine contains less than 1 mmol sodium (23 mg) per filmcoated tablet, that is to say essentially 'sodium-free'.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is: Take one Risedronate tablets (5 mg of risedronate sodium) once a day.
When to take the Risedronate tablets It is best to take your Risedronate tablets at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.
If in particular instance you are unable to take your Risedronate tablets at this time, you may take it on an empty stomach, at the same time every day, in one of the following ways: • EITHER
Date & Time Component Item Code
06.10.2025 & 9:15 AM
Sign / Date
Between meals: at least 2 hours after your last food, drink (other than plain water) or other medicine. Do not eat or drink (other than plain water) for 2 hours after taking the tablet. • OR In the evening: at least 2 hours after your last food, drink (other than plain water) or other medicine of the day. Risedronate tablets should be taken at least 30 minutes before going to bed.
How to take the Risedronate tablets • Take the tablet whilst you are in an upright position (you may sit or stand) to avoid heartburn. • Swallow it with at least one glass (120 ml) of plain water. • Swallow it whole. Do not suck or chew it. • Do not lie down for 30 minutes after taking your tablet. Your doctor will tell you if you need calcium and vitamin supplements, if you are not taking enough from your diet.
If you take more Risedronate tablets than you should If you or somebody else has accidentally taken more Risedronate tablets than prescribed, drink one full glass of milk and seek medical attention.
If you forget to take Risedronate tablets If you have forgotten to take your tablet at your regular time, you can take it at the next possible time according to the instruction above (i.e. before breakfast, between meals, or in the evening).
Do not take a double dose to make up for a forgotten dose.
If you stop taking Risedronate tablets If you stop treatment you may begin to lose bone mass. Please talk to your doctor before you consider stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Risedronate tablets and contact a doctor immediately if you experience any of the following: • Symptoms of a severe allergic reaction such as: – Swelling of the face, tongue or throat. – Difficulties in swallowing. – Hives and difficulties in breathing. • Severe skin reactions that can include blistering of the skin.
Tell your doctor promptly if you experience the following side effects: • Eye inflammation, usually with pain, redness and light sensitivity. • Bone necrosis of the jaw (osteonecrosis) associated with delayed healing and infection, often following tooth extraction (see section 2, "Warnings and precautions"). • Symptoms from oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new/worsened heartburn.
However in clinical studies the other side effects that were observed were usually mild and did not cause the patient to stop taking their tablets.
Common:may affect up to 1 in 10 people • Indigestion, feeling sick, stomach ache, stomach cramps or discomfort, constipation, feelings of fullness, bloating, diarrhoea. • Pain in your bones, muscles or joints. • Headache.
Uncommon:may affect up to 1 in 100 people • Inflammation or ulcer of the oesophagus (the tube that connects your mouth with your stomach) causing difficulty and pain in swallowing (see also section 2," Warnings and precautions"), inflammation of the stomach and duodenum (bowel draining the stomach). • Inflammation of the coloured part of the eye (iris) (red painful eyes with a possible change in vision).
Rare:may affect up to 1 in 1000 people • Inflammation of the tongue (red swollen, possibly painful), narrowing of the oesophagus (the tube that connects your mouth with your stomach). • Abnormal liver tests have been reported. These can only be diagnosed from a blood test.
Very rare:- (may affect up to 1 in 10,000 people): • Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.
During post-marketing experience, the following have been reported (unknown frequency); • Hair loss. • Liver disorders, some cases were severe.
Rarely, at the beginning of treatment, a patient's blood calcium and phosphate levels may fall. These changes are usually small and cause no symptoms.
Unusual fracture of the thigh bone particularly in patients on longterm treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Yellow Card Scheme Website: www. mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Risedronate tablets contains The active substance is risedronate sodium. Each film-coated tablet contains 5 mg risedronate sodium (equivalent to 4.6 mg risedronic acid).
The other ingredients are: Tablet core: Lactose monohydrate, crospovidone, hydroxy propyl cellulose, magnesium stearate and cellulose microcrystalline. Film coating: Hypromellose, titanium dioxide (E171), macrogol 400, hydroxy propyl cellulose, iron oxide yellow (E172), macrogol 8000 and silica colloidal Anhydrous.
What Risedronate tablets looks like and contents of the pack Film-coated tablet.
Yellow coloured, circular shaped, beveled edge, film-coated biconvex tablets debossed with 'X' on one side and '61' on the other side.
Transparent PVC / PE / PVdC / Aluminium blisters in a cardboard box, Packs 14, 20, 28, 84, 98 or 140 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Milpharm Limited 1 Roundwood Avenue Stockley Park, Uxbridge UB11 1AF United Kingdom
Manufacturer APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta
Milpharm Limited 1 Roundwood Avenue Stockley Park, Uxbridge UB11 1AF United Kingdom
This leaflet was last revised in 10/2025.
Risedronate sodium 5 mg film-coated tablets comes as tablet containing 5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Risedronate sodium 5 mg film-coated tablets is risedronate sodium.
Medicines with the same active substance, strength and form include: Risedronate sodium 5 mg film-coated tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Risedronate sodium 5 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures. Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis (see section 5.1).
To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months), systemic corticosteroid treatment at doses ≥7.5mg/day prednisone or equivalent.
Posology
The recommended daily dose in adults is one 5 mg tablet orally. The absorption of risedronate sodium is affected by food, thus to ensure adequate absorption patients should take risedronate sodium:
• 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 can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure risedronate sodium is taken on an empty stomach:
• Between meals: risedronate sodium 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 should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day. Risedronate sodium should be taken at least 30 minutes before going to bed.
If an occasional dose is missed, risedronate sodium 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 is to be taken while in an upright position with a glass of plain water (≥120 ml). Patients should not lie down for 30 minutes after taking the tablet (see section 4.4).
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 sodium on an individual patient basis, particularly after 5 or more years of use.
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. The use of risedronate sodium is contraindicated in patients with severe renal impairment (creatinine clearance lower than 30 ml/min) (see sections 4.3 and 5.2).
Paediatric population:-
Risedronate sodium is not recommended for use in children and adolescents below age 18 due to insufficient data on safety and efficacy (see also section 5.1).
Hypersensitivity to risedronate sodium or to any of the excipientslisted in section 6.1.
Hypocalcaemia (see section 4.4).
Pregnancy and lactation.
Severe renal impairment (creatinine clearance <30ml/min).
Foods, drinks (other than plain water) and medicinal products containing polyvalent cations (such as calcium, magnesium, iron and aluminium) interfere with the absorption of bisphosphonates and should not be taken at the same time as risedronate sodium (see section 4.5) In order to achieve the intended efficacy, strict adherence to dosing recommendations is necessary (see section 4.2)
Efficacy of bisphosphonates in the treatment of postmenopausal osteoporosis is related to the presence of low bone mineral density (BMD T-score at hip or lumbar spine <-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.
The evidence to support efficacy of bisphosphonates including risedronate sodium in very elderly women (>80 years) is limited (see section 5.1).
Bisphosphonates have been associated with oesophagitis, gastritis, oesophageal ulcerations and gastroduodenal ulcerations. Thus caution should be used:
• In patients who have a history of oesophageal disorders which delay oesophageal transit or emptying e.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 therapy. Other disturbances of bone and mineral metabolism (e.g. parathyroid dysfunction, hypovitaminosis D) should be treated at the time of starting risedronate sodium 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 bisphophonates. 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.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.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.
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.
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.
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.
Excipients
Lactose
This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially 'sodium-free'.
No interaction studies have been performed, however no clinically relevant interactions with other medicinal products were found during clinical trials.
In the risedronate sodium Phase III osteoporosis studies, acetyl salicylic acid or NSAID use was reported by 33% and 45% of patients respectively.
If considered appropriate risedronate sodium may be used concomitantly with oestrogen supplementation.
Concomitant ingestion of medications containing polyvalent cations (e.g. calcium, magnesium, iron and aluminium) will interfere with the absorption of risedronate sodium (see section 4.4).
Risedronate sodium is not systemically metabolised, does not induce cytochrome P450 enzymes, and has low protein binding.
There are no adequate data from the use of risedronate sodium in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Studies in animal indicate that a small amount of risedronate sodium pass into breast milk.
Risedronate sodium must not be used during pregnancy or by breast-feeding women.
No effects on ability to drive and use machines have been observed.
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 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Unknown (cannot be estimated from the available data).
Nervous system disorders:
Common:
headache (1.8% vs. 1.4%)
Eye disorders:
Uncommon:
iritis*
Ear and labyrinth disorders:
Very rare:
Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction).
Gastrointestinal disorders:
Common:
constipation (5.0% vs. 4.8%), dyspepsia (4.5% vs. 4.1%), nausea (4.3% vs. 4.0%), abdominal pain (3.5% vs. 3.3%), diarrhoea (3.0% vs. 2.7%)
Uncommon:
gastritis (0.9% vs. 0.7%), oesophagitis (0.9% vs. 0.9%), dysphagia (0.4% vs. 0.2%), duodenitis (0.2% vs. 0.1%), oesophageal ulcer (0.2% vs. 0.2%)
Rare:
glossitis (<0.1% vs. 0.1%), oesophageal stricture (<0.1% vs. 0.0%),
Musculoskeletal and connective tissues disorders:
Common:
musculoskeletal pain (2.1% vs. 1.9%)
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 :
Immune system disorders:
Unknown
anaphylactic reaction
Eye disorders:
Unknown:
Iritis, uveitis
Hepatobiliary disorders:
Unknown:
serious hepatic disorders. In most of the reported cases the patients were also treated with other products known to cause hepatic disorders.
Skin and subcutaneous tissue disorders:
Unknown:
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.
Unknown:
Hair loss.
Muskuloskeletal and connective tissue disorders:
Rare:
Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)
Unknown:
Osteonecrosis of the jaw
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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
No specific information is available on the treatment of overdose with risedronate sodium.
Decreases in serum calcium following substantial overdose may be expected. Signs and symptoms of hypocalcaemia may also occur in some of these patients.
Milk or antacids containing magnesium, calcium or aluminium should be given to bind risedronate and reduce absorption of risedronate sodium. In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed risedronate sodium.
Ask anything about Risedronate sodium 5 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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