Actonel

Actonel contains risedronate sodium, a bisphosphonate medicine used to treat and prevent osteoporosis in postmenopausal women and to treat Paget's disease of bone.

It strengthens bones by slowing the natural process of bone breakdown. Actonel is a prescription-only medicine taken under medical supervision.

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Actonel on Prescriptsy

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Important medical information

The information on this page does not replace a diagnosis or personalised medical advice from a doctor. Actonel is a prescription-only medicine (POM) that affects bone metabolism and requires medical supervision throughout treatment.

  • Actonel must be taken exactly as prescribed, following specific instructions about positioning and timing, to ensure proper absorption and reduce the risk of oesophageal side effects.
  • If you develop difficulty swallowing, chest pain, jaw pain, or new pain in your hip, groin or thigh, stop taking Actonel and contact your doctor.
  • This page provides general guidance only. Always follow the instructions from your prescriber and read the Patient Information Leaflet.

What is Actonel and how does it work?

Actonel is the brand name for a medicine containing the active substance risedronate sodium .

Risedronate belongs to a class of drugs called bisphosphonates, which are used to treat and prevent conditions involving excessive bone loss.

In the United Kingdom, Actonel is licensed for the treatment and prevention of postmenopausal osteoporosis, glucocorticoid-induced osteoporosis and Paget's disease of bone.

Bone is living tissue that is constantly being broken down by cells called osteoclasts and rebuilt by cells called osteoblasts. In healthy adults, these processes are balanced.

In conditions such as osteoporosis and Paget's disease, this balance is disrupted, leading to net bone loss or abnormal bone remodelling.

Risedronate works by binding to the mineral component of bone and being absorbed by osteoclasts when they attempt to break bone down.

Once inside the osteoclast, risedronate disrupts an essential metabolic pathway known as the mevalonate pathway, causing the cell to become inactive and eventually die.

The result is a reduction in bone resorption, an increase in bone mineral density over time, and a lower risk of fractures.

Clinical trials have demonstrated that risedronate reduces the risk of vertebral fractures by approximately 40 to 50 per cent and hip fractures by approximately 30 per cent over three years of treatment in postmenopausal women with established osteoporosis.

Conditions treated with Actonel

Postmenopausal osteoporosis

Osteoporosis is a condition in which bones become thinner and more fragile, increasing the risk of fractures, particularly of the spine, hip and wrist.

It is most common in women after the menopause, when falling oestrogen levels accelerate bone loss.

The condition develops silently over many years, and the first sign is often a fracture following a minor fall or even a simple movement such as bending or coughing.

Actonel has been shown in large clinical trials to reduce the risk of vertebral and non-vertebral fractures in postmenopausal women with osteoporosis.

Treatment is typically long-term, and your doctor will review the need for continued therapy periodically.

Glucocorticoid-induced osteoporosis

Long-term use of corticosteroid medicines such as prednisolone can lead to significant bone loss and increased fracture risk, sometimes within the first few months of treatment.

Actonel is licensed for the prevention and treatment of osteoporosis in patients who are taking or expected to take long-term systemic glucocorticoids.

It is an important preventive measure for patients who require ongoing steroid therapy for conditions such as rheumatoid arthritis, chronic obstructive pulmonary disease, inflammatory bowel disease, giant cell arteritis or severe asthma.

Paget's disease of bone

Paget's disease is a condition in which the normal cycle of bone renewal is disrupted, leading to enlarged, misshapen and weakened bones.

It most commonly affects the pelvis, spine, skull and legs.

Many patients with Paget's disease have no symptoms, but some experience bone pain, joint stiffness, deformity, nerve compression and an increased risk of fractures.

Actonel at a higher dose is used to normalise bone turnover in Paget's disease, which can reduce bone pain, lower the risk of complications and help restore more normal bone structure over time.

Who may be prescribed Actonel?

Patients who may benefit

Your doctor may prescribe Actonel if you have been diagnosed with postmenopausal osteoporosis, particularly if you have already sustained a fragility fracture or if bone density scanning (DEXA) shows significantly reduced bone mineral density.

It may also be prescribed if you are taking long-term corticosteroids and are at risk of steroid-induced bone loss, or if you have Paget's disease requiring treatment.

NICE technology appraisals provide guidance on when bisphosphonate treatment is recommended within the NHS, taking into account factors such as age, bone density, fracture history and other clinical risk factors assessed using tools like FRAX.

Patients who may not be suitable

Actonel may not be appropriate for you if you have oesophageal problems that delay emptying, such as strictures or achalasia, if you cannot stand or sit upright for at least 30 minutes after taking the tablet, if you have severe kidney disease (creatinine clearance below 30 ml per minute), if you have low blood calcium levels that have not been corrected, or if you are allergic to risedronate or any of the tablet's other ingredients.

It must not be used during pregnancy or breastfeeding.

How to take Actonel correctly

The way you take Actonel is critical to both its effectiveness and your safety.

Bisphosphonates are poorly absorbed from the gut, and food, drinks and other medicines can interfere with this process significantly.

Following the correct administration procedure ensures that the medicine works properly and reduces the risk of irritation to the food pipe.

  1. Choose a time when you can take the tablet on a completely empty stomach, first thing in the morning before breakfast.
  2. Swallow the tablet whole with a full glass of plain tap water (at least 120 ml). Do not use mineral water, as the calcium and magnesium content may reduce absorption.
  3. Do not chew, crush or suck the tablet, as this may cause mouth or throat irritation.
  4. Remain sitting upright or standing for at least 30 minutes after taking the tablet. Do not lie down during this period.
  5. Wait at least 30 minutes before eating, drinking anything other than plain water, or taking other medicines, including calcium and vitamin D supplements.

If you are taking the once-weekly 35 mg tablet, choose a day that suits your routine and take it on the same day each week.

If you forget your weekly dose, take it on the morning after you remember, then return to your usual schedule the following week.

Never take two tablets on the same day.

For the daily 5 mg tablet, if you miss a dose, take it the next morning and resume your normal schedule.

Actonel and the NHS

Bisphosphonates, including risedronate, are a cornerstone of osteoporosis treatment within the NHS.

Generic risedronate sodium is widely available and is one of the more cost-effective options for fracture prevention.

NICE recommends bisphosphonates as a first-line pharmacological treatment for osteoporosis in most eligible patients, alongside lifestyle measures, adequate calcium and vitamin D intake, and falls prevention strategies.

The standard NHS prescription charge in England is nine pounds and ninety pence per item, with exemptions available for certain groups including people aged 60 and over, those with certain medical conditions, and those on low incomes.

Prescription charges do not apply in Scotland, Wales or Northern Ireland. If you are on long-term treatment and pay for prescriptions, a pre-payment certificate can save money.

Your pharmacist can provide details.

Side effects of Actonel

The most commonly reported side effects include headache, constipation, diarrhoea, nausea, abdominal pain, indigestion and musculoskeletal pain including bone, joint and muscle aches.

These are generally mild and may settle as your body adjusts to the medicine. Musculoskeletal pain can sometimes be more noticeable in the early weeks of treatment.

Less commonly, Actonel may cause gastrointestinal effects such as gastritis, oesophagitis (inflammation of the food pipe) or, rarely, oesophageal ulceration. Correct administration technique greatly reduces this risk.

Eye inflammation (iritis or uveitis) has been reported uncommonly and should prompt urgent medical review if you develop eye pain, redness or blurred vision.

Rare but important side effects include osteonecrosis of the jaw, in which part of the jawbone fails to heal properly, and atypical femoral fractures, which are unusual stress fractures of the thigh bone.

Both are discussed in more detail in the warnings section. Severe skin reactions including Stevens-Johnson syndrome and hypersensitivity reactions have also been reported rarely.

Dental health and bisphosphonates

If you are taking Actonel, it is important to maintain good oral hygiene and attend regular dental check-ups.

Before any dental procedure, particularly extractions, implant surgery or other invasive dental work, inform your dentist that you are taking a bisphosphonate.

Your dentist and doctor can then collaborate to minimise the risk of osteonecrosis of the jaw.

Preventive dental work, including treatment of any existing dental infections, should ideally be completed before starting bisphosphonate therapy.

The risk of osteonecrosis of the jaw is low with oral bisphosphonates used for osteoporosis, but it increases with longer duration of use, concurrent corticosteroid therapy, poor dental hygiene and invasive dental procedures.

Maintaining excellent oral hygiene, using a soft toothbrush and attending regular dental appointments are practical steps you can take to reduce your risk.

How long should treatment continue?

The optimal duration of bisphosphonate therapy is an area of ongoing clinical discussion.

Current guidance from NICE and expert bodies suggests that most patients should have their treatment reviewed after three to five years.

At this point, your doctor will reassess your fracture risk, bone density and clinical situation.

Some patients at high fracture risk, such as those who have already had a hip or vertebral fracture or whose bone density remains very low, may benefit from continuing beyond five years.

Others may have a drug holiday during which treatment is paused while the bisphosphonate continues to exert a residual protective effect from the amount already deposited in bone.

During a drug holiday, your doctor will continue to monitor your bone health and fracture risk, typically with periodic DEXA scans and clinical assessment, and will restart treatment if indicated.

It is important not to stop or change your treatment without discussing it with your doctor first.

The benefits and risks of continued therapy depend on your individual circumstances.

Bone density testing and fracture risk assessment

Bone mineral density is measured using a DEXA scan, which is a painless, low-dose X-ray that takes only a few minutes.

The results are reported as a T-score, which compares your bone density to that of a healthy young adult. A T-score of minus 2.5 or below indicates osteoporosis.

Your doctor may also use a fracture risk assessment tool such as FRAX or QFracture, which incorporates additional factors like age, weight, smoking status, alcohol intake, family history and corticosteroid use to estimate your 10-year probability of fracture.

Lifestyle measures for bone health

Medicines such as Actonel are most effective when combined with healthy lifestyle practices that support bone strength.

  • Ensure an adequate intake of calcium and vitamin D through diet and supplements if necessary. Good dietary sources of calcium include dairy products, green leafy vegetables such as broccoli and kale, fortified foods and tinned fish with bones such as sardines.
  • Engage in regular weight-bearing and muscle-strengthening exercise, such as walking, dancing, stair climbing or resistance training. These activities stimulate bone formation and improve balance and muscle strength.
  • Avoid smoking, which accelerates bone loss and increases fracture risk.
  • Limit alcohol intake, as excessive alcohol can weaken bones and increase the risk of falls.
  • Take steps to prevent falls, particularly if you are elderly, by keeping your home well-lit, removing trip hazards such as loose rugs, installing grab rails where needed, wearing supportive footwear and having your eyesight and hearing checked regularly.

Generic risedronate and other bisphosphonates

Actonel is the original brand name for risedronate sodium. Generic versions are now widely available in the UK and contain the same active substance at the same strength.

Your pharmacist may dispense a generic version when fulfilling your prescription, and this is clinically equivalent to the branded product.

Other bisphosphonates used for osteoporosis in the UK include alendronic acid (the most commonly prescribed bisphosphonate and typically the first choice), ibandronic acid (available as a monthly tablet or quarterly injection) and zoledronic acid (given as an annual intravenous infusion in a hospital or clinic setting).

Each has slightly different dosing schedules, indications and side effect profiles.

Your doctor will choose the most appropriate bisphosphonate for your situation based on your medical history, tolerance, adherence and personal preferences.

When to seek medical advice

Contact your GP or call NHS 111 if you develop persistent heartburn, difficulty swallowing, unusual bone pain (particularly in the thigh, hip or groin), jaw problems or eye pain or redness during treatment with Actonel.

Seek emergency medical help by calling 999 if you experience signs of a severe allergic reaction, including swelling of the face, lips or throat, difficulty breathing, or widespread skin blistering.

Sources and further reading

  • Summary of Product Characteristics, Actonel, EMC (medicines.org.uk)
  • British National Formulary, Risedronate sodium, bnf.nice.org.uk
  • NICE Technology Appraisal TA464, Bisphosphonates for preventing osteoporotic fragility fractures, nice.org.uk
  • NICE Clinical Knowledge Summaries, Osteoporosis prevention and treatment, cks.nice.org.uk
  • Royal Osteoporosis Society, Information and support, theros.org.uk
  • NHS, Osteoporosis, nhs.uk
  • MHRA Yellow Card Scheme, yellowcard.mhra.gov.uk

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