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.
Risedronate sodium 35 mg belongs to a group of non-hormonal medicines called bisphosphonates which are used to treat bone diseases. lt 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 can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone.
• if you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Risedronate sodium 35 mg.
Do not take Risedronate sodium 35 mg if you are breast-feeding (see section 2, "Do not take Risedronate sodium 35 mg"). Risedronate sodium 35 mg should only be used to treat postmenopausal women and men.
Your doctor will advise you on what to do when taking Risedronate sodium 35 mg if you have any of the above.
Driving and using machines Risedronate sodium 35 mg is not known to affect your ability to drive and use machines.
Children and adolescents Risedronate sodium 35 mg tablets should not be taken by children under 18 years of age.
Risedronate sodium 35 mg contains lactose Risedronate sodium 35 mg contains a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Risedronate sodium 35 mg.
Other medicines and Risedronate sodium 35 mg Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Medicines containing any of the following lessen the effect of Risedronate sodium 35 mg if taken at the same time: • calcium; • magnesium; • aluminium (for example some indigestion mixtures); • iron.
PRODUCT NAME:
Risedronate Sodium 35mg Tablets 4&12PIL GB 675-1242-APIL
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Warnings and precautions Talk to your doctor or pharmacist before taking Risedronate sodium 35 mg • 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); • if you have or have had problems in the past with your oesophagus (the tube that connects your mouth with your stomach). For instance you may have or 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 or ever had pain, swelling or numbness of the jaw or a "heavy jaw feeling" or loosening of a tooth;
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Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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Recommended dose: Take one Risedronate sodium 35 mg tablet once a week. Choose one day of the week that best fits your schedule. Every week, take the Risedronate sodium 35 mg tablet on your chosen day.
PROJECT:
Take these medicines at least 30 minutes after your Risedronate sodium 35 mg tablet.
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Risedronate sodium 35 mg with food and drink lt is very important that you do not take your Risedronate sodium 35 mg tablet 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 sodium 35 mg").
When to take the Risedronate sodium 35 mg Take your Risedronate sodium 35 mg tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.
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How to take the Risedronate sodium 35 mg • 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.
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Take food and drinks (other than plain water) at least 30 minutes after your Risedronate sodium 35 mg tablet.
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Pregnancy and breast-feeding Do not take Risedronate sodium 35 mg if you are pregnant, think you may be pregnant or are planning to have a baby (See section 2, "Do not take Risedronate sodium 35 mg"). Ask your doctor or pharmacist for advice before taking this medicine.
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 sodium 35 mg than you should lf you or somebody else has accidentally taken more Risedronate sodium 35 mg tablets than prescribed, drink one full glass of milk and seek medical attention.
The potential risk associated with the use of risedronate sodium in pregnant women is unknown.
If you forget to take Risedronate sodium 35 mg lf you have forgotten to take your tablet on your chosen day, take it on the day you remember.
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.
Return to taking one tablet once a week on the day the tablet is normally taken.
Common side effects (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.
Do not take two tablets in one day to make up for the tablet you missed.
lf you stop taking Risedronate sodium 35 mg lf you stop treatment you may begin to lose bone mass. Please talk to your doctor before you consider stopping treatment.
Uncommon side effects (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, "Warning 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).
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 sodium 35 mg and contact a doctor immediately if you experience any of the following: • Symptoms characteristic of severe tissue swelling (angioedema reaction): - Swelling of face, tongue or throat - Difficulties in swallowing - Hives and difficulties in breathing. • Severe skin reactions that can include blistering of the skin.
Rare side effects (may affect up to 1 in 1,000 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.
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 the oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new or worsened heartburn.
Very rare side effects (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.
Unusual fracture of the thigh bone particularly in patients on long-term 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.
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.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Sovereign Medical Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom.
Manufacturer:
Waymade Plc Josselin Road, Burnt Mills Industrial Estate, Basildon, Essex, SS13 1QF United Kingdom.
PRODUCT NAME:
Risedronate Sodium 35mg Tablets 4&12PIL GB 675-1242-APIL
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 after EXP. The expiry date refers to the last day of that month.
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Lea et 310x240 mm Great Britain TBC 100% Black Cutter 14.02.22 9 pt 7
Waymade Plc Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR United Kingdom.
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No special storage conditions required.
This leaflet was last revised in February 2022
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.
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PL 06464/2739 Risedronate Sodium 35 mg Film-coated Tablets
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To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the above address or telephone: 01268 535200 (select option Medical Information) / e-mail: [email protected]
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What Risedronate sodium 35 mg contains The active substance is risedronate sodium. Each tablet contains 35 mg risedronate sodium, equivalent to 32.5 mg risedronic acid.
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The other ingredients are: Tablet core: lactose monohydrate, crospovidone, magnesium stearate and microcrystalline cellulose.
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Film coating: iron oxide yellow (E172), iron oxide red (E172), hypromellose, macrogol, hydroxypropyl cellulose, colloidal anhydrous silica and titanium dioxide (E171).
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What Risedronate sodium 35 mg looks like and contents of the pack Risedronate sodium 35 mg film-coated tablets are light-orange coloured round film-coated tablets debossed with "35" on one side and plain on the other side. The tablets are supplied in blister packs of 4 or 12 tablets. Not all pack sizes may be marketed.
Risedronate sodium 35 mg film-coated tablets comes as tablet containing 35mg. 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 35 mg film-coated tablets is risedronate sodium.
Medicines with the same active substance, strength and form include: Risedronate sodium 35 mg film-coated tablets, Risedronate sodium 35 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 35 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 (see section 5.1).
Treatment of osteoporosis in men at high risk of fractures.(see section 5.1).
Posology
The recommended dose in adults is one 35 mg tablet orally once a week. The tablet should be taken on the same day each week.
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.
This has also been shown in the very elderly, 75 years old and above postmenopausal population.
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 30ml/min) (see sections 4.3 and 5.2).
Paediatric population: Risedronate sodium is not recommended for use in children below age 18 due to insufficient data on safety and efficacy (also see section 5.1).
Method of administration
The absorption of risedronate sodium is affected by food, thus to ensure adequate absorption patients should take Risedronate sodium 35 mg:
• Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day.
Patients should be instructed that if a dose is missed, one Risedronate sodium 35 mg tablet should be taken on the day that the tablet is remembered. Patients should then return to taking one tablet once a week on the day the tablet is normally taken. Two tablets should not be taken on the same day.
The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Risedronate sodium 35 mg 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 on an individual patient basis, particularly after 5 or more years of use.
Hypersensitivity to risedronate sodium or to any of the excipients listed 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 35 mg (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 osteoporosis is related to the presence of low bone mineral density and/or prevalent fracture.
High age or clinical risk factors for fracture alone are not sufficient reasons to initiate treatment of osteoporosis with a bisphosphonate.
The evidence to support efficacy of bisphosphonates including risedronate in the very elderly (>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 and 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 35 mg therapy. Other disturbances of bone and mineral metabolism (i.e. parathyroid dysfunction, hypovitaminosis D) should be treated at the time of starting Risedronate sodium 35 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.
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.
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.
No formal 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 with daily dosing, acetyl salicylic acid or NSAID use was reported by 33% and 45% of patients respectively. In the Phase III once a week study in postmenopausal women, acetyl salicylic acid or NSAID use was reported by 57% and 40% of patients respectively. Among regular acetyl salicylic acid or NSAID users (3 or more days per week) the incidence of upper gastrointestinal adverse events in risedronate sodium treated patients was similar to that in control patients.
If considered appropriate risedronate sodium may be used concomitantly with oestrogen supplementation (for women only).
Concomitant ingestion of medications containing polyvalent cations (e.g. calcium, magnesium, iron and aluminium) will interfere with the absorption of Risedronate sodium 35 mg (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 35 mg 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 sodium 5mg/day (n=5020) or placebo (n=5048) and considered possibly or probably related to risedronate sodium 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).
Nervous system disorders:
Common: headache (1.8% vs. 1.4%)
Eye disorders:
Uncommon: iritis*
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%)
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.
In a one-year, double-blind, multicentre study comparing risedronate sodium 5 mg daily (n=480) and risedronate sodium 35 mg weekly (n=485) in postmenopausal women with osteoporosis, the overall safety and tolerability profiles were similar. The following additional adverse experiences considered possibly or probably drug related by investigators have been reported (incidence greater in risedronate 35 mg than in risedronate sodium 5 mg group): gastrointestinal disorder (1.6% vs. 1.0%) and pain (1.2% vs. 0.8%).
In a 2-year study in men with osteoporosis, the overall safety and tolerability were similar between the treatment and the placebo groups. Adverse experiences were consistent with those previously observed in women.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 35 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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