RISEDRONATE SODIUM WARNINGS
Risedronate sodium should be used with caution in:
- People with intestinal problems such as stomach or intestinal ulcers, problems swallowing, heartburn and acid reflux
- People who have had problems of delayed transit or emptying of the oesophagus or intestine due to narrowing or other conditions
- People who are unable to stay in the upright position for at least 30 minutes after taking the tablet
- People who have or have had any jaw or dental health problems or have other risk factors for a bone condition with jaw damage (osteonecrosis of the jaw) such as cancer, chemotherapy, radiotherapy or treatment with systemic corticosteroids
- People with parathyroid gland problems, as the gland produces hormones which are important in calcium metabolism
- People with vitamin D deficiency
It should not be used in:
- People with a hypersensitivity (allergy) to risedronate sodium or to any of the ingredients in the medication
- People with a low blood calcium (hypocalcaemia) - this must be corrected before starting treatment
- People with severely reduced kidney function
- Pregnant women
- Breast feeding women
- People with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Also see list of precautions and interactions
This medicinal product does not require any special storage conditions.
RISEDRONATE SODIUM USES
What is it used for?
- Risedronate sodium is used to strengthen bones in women who have gone through the menopause and have, or are at risk of having, weak bones (osteoporosis) and in people with Paget's disease of the bone.
- It is a bisphosphonate.
- It is used to inhibit the loss of calcium from the bones and increase bone mass. Risedronate sodium is used to treat women with or at risk from osteoporosis after the menopause. Osteoporosis is a thinning and weakening of the bones, which is common in post-menopausal women. Women with this condition are more likely to get a fracture from any falls. Risedronate sodium is also used to increase bone mass in people with Paget's disease of the bone. In this condition new bone is formed that is not as strong as normal bone. These bones may become painful and more likely to fracture.
- In general this drug is used to increase bone mass leading to stronger bones and reducing the risk of fractures in Paget's disease of the bone and osteoporosis after the menopause.
- Benefits of being on this drug can include increased bone mass and a reduced risk of getting a bone fracture. In Paget's disease of the bone, there is a decrease in the extent of bone changes and fewer new fractures.
Listed below are the typical uses of risedronate sodium.
- Treatment of Paget's disease of the bone.
- Treatment of weak and brittle bones (osteoporosis) in postmenopausal women to reduce the risk of fractures.
- Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis (such as low bone mass, early menopause or a family history of bone disease).
- To maintain or increase bone mass in postmenopausal women who have been on high doses of corticosteroids for a long time.
- Treatment of osteoporosis in men at high risk of fractures.
On occasion your doctor may prescribe this medicine to treat a condition not on the above list.
HOW TO USE/TAKE
How often do I take it?
- Daily tablets
Take this medication by mouth usually once daily, without food. The tablets should be taken on an empty stomach in the morning 30 minutes before you eat any food, take any other medications or have a drink other than water. If you cannot manage this, you can take the tablet at other times, but it must be 2 hours since you last ate and 2 hours before you eat again. Swallow the tablet whole with a glass of water while sitting or standing. Avoid chewing or sucking the tablet and also avoid lying down for 30 minutes after taking this medication.
Remember to use it at the same time each day - unless specifically told not to by your doctor.
- Once a week tablets
Take this medication by mouth usually once a week, without food. The tablets should be taken on an empty stomach in the morning 30 minutes before you eat any food, take any other medications or have a drink other than water. If you cannot manage this, you can take the tablet at other times, but it must be 2 hours since you last ate and 2 hours before you eat again. Swallow the tablet whole with a glass of water while sitting or standing. Avoid chewing or sucking the tablet and also avoid lying down for 30 minutes after taking this medication.
- Remember to use it at the same time each week- unless specifically told not to by your doctor.
- Use this medication regularly in order to get the most benefit from it.
- It may take up to a few months before the full benefit of this drug takes effect.
- Certain medical conditions may require different dosage instructions as directed by your doctor.
- Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines.
Do I need to avoid anything?
- Avoid taking the medication with food, drink (other than water) or other medication. Food, particularly products containing calcium such as milk, cheese, yoghurts and other metals such as aluminium, magnesium, iron (e.g. fortified cereals) must be avoided for at least 2 hours before or after you take risedronate sodium.
Avoid lying down for 30 minutes after taking this medication.
This medicine is unlikely to affect your ability to drive or operate machinery. Consult your doctor or pharmacist for more details.
When can I stop?
- It is important to continue taking this medication even if you feel well, unless your doctor tells you to stop. If you stop treatment you may begin to lose bone mass. Treatment of Paget's disease of the bone is normally for 2 months.
RISEDRONATE SODIUM SIDE EFFECTS
- Feeling sick (nausea)
- Stomach ache
- Feeling bloated (flatulence)
- Muscle, bone and joint pain
- Inflammation of the iris of the eye (iritis)
- Oesophageal ulcer
- Inflammation of the oesophagus (oesophagitis)
- Difficulty swallowing
- Stomach ache
- Inflammation of the stomach (gastritis)
- Narrowing of the oesophagus (oesophageal stricture)
- Swelling of the tongue (glossitis)
- Abnormal blood tests - liver function tests, low calcium and phosphate levels
- Allergic reaction including itching, hives, swelling of the skin and swelling of the face, lips and mouth
- Bone condition with damage to the jaw (osteonecrosis)
If any of these persist or you consider them severe then inform your doctor or pharmacist.
Tell your doctor immediately and stop taking risedronate sodium if you develop any of the following symptoms:
- Signs of a serious allergic reaction (see below)
Tell your doctor promptly if you develop any of the following symptoms:
- Eye problems including inflammation, pain and redness
- Jaw problems which may be associated with slow healing and infections after a tooth extraction.
- Severe pains in the chest or after swallowing, new or worsening heartburn, difficulties in swallowing, severe nausea or vomiting
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
The Yellow Card Scheme allows you to report suspected side effects from any type of medicine (which includes vaccines, herbals and over the counter medicines) that you are taking. It is run by the medicines safety watchdog called the Medicines and Healthcare products Regulatory agency (MHRA). Please report any suspected side effect on the Yellow Card Scheme website.
RISEDRONATE SODIUM PRECAUTIONS
Before taking risedronate sodium, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates; or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist in case of:
- Hypersensitivity (allergy) to risedronate sodium or to any of the ingredients in the medication
- Low blood calcium (hypocalcaemia)
- Severe kidney problems
- Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Before using this medication tell your doctor or pharmacist your medical history, especially any of the following:
- Intestinal problems such as stomach or intestinal ulcers, problems swallowing, heartburn and acid reflux
- Delayed transit or emptying of the oesophagus or intestine the due to narrowing or other conditions
- You are unable to stay in the upright position for at least 30 minutes after taking the tablet
- Any jaw or dental health problems
- Parathyroid gland problems, as the gland produces hormones which are important in calcium metabolism
- Vitamin D deficiency
Before having surgery, tell your doctor or dentist that you are taking this medication.
Does alcohol intake affect this drug?
- Alcohol intake is not known to affect risedronate sodium.
The elderly: risedronate sodium can be used in the elderly.
Pregnancy and breastfeeding - please ensure you read the detailed information below
Risedronate sodium is not safe to take if you are, or are planning to become, pregnant.
It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.
If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.
Risedronate sodium is not safe to take if you are breastfeeding.
It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.
If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.
RISEDRONATE SODIUM INTERACTIONS
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medications because very serious, possibly fatal interactions may occur: None known
Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:
- Calcium supplements
- Antacids used to treat indigestion
- Ferrous sulphate (iron) used to treat anaemia
- Any other medications containing aluminium, calcium, iron or magnesium
This information does not contain all possible interactions. Therefore, before using risedronate sodium, tell your doctor or pharmacist of all the products you use.
RISEDRONATE SODIUM OVERDOSE
Taking too much risedronate sodium may cause the following: low blood calcium leading to muscle cramps and tingling feeling (pins and needles).
People who have taken too much risedronate sodium, should drink a full glass of milk and talk to a doctor straight away.
If you think you, or someone you care for, might have accidentally taken more than the recommended dose of risedronate sodium or intentional overdose is suspected, contact your local hospital, GP or if in England call 111. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical emergencies, always dial 999.
If you miss a dose, take the tablet the next day and then resume your usual dosing schedule. Do not double the dose to catch up.
If you have forgotten to take your tablet on your chosen day, take it on the day you remember. Return to taking one tablet once a week on the day the tablet is normally taken. Do not take two tablets in one day to make up for the tablet you missed.