How does it work?

Actonel 5mg tablets contain the active ingredient risedronatesodium, which is a type of medicine known as a bisphosphonate. Bisphosphonatesare medicines that prevent the breakdown of bone. (Risedronate 5mg tablets are also available without a brand name, ie as the generic medicine.)

Bone is not a static structure. It is continually shaped,reformed and rebuilt by cells called osteoblasts and osteoclasts. These cellscontinously deposit and remove calcium and phophorous, stored in a proteinnetwork that makes up the structure of the bone. Old bone is broken down by theosteoclasts and new bone is formed by the osteoblasts.

In women at the menopause, blood levels of the female hormoneoestrogen start to decrease. This results in an increase in bone breakdown bythe osteoclasts, which can lead to a loss of bone density. Bone loss isparticularly rapid for the first ten years after the menopause and it may leadto the development of osteoporosis - a condition in which the bones become weakand brittle and break (fracture) more easily.

Osteoporosis can also as a result of long-term treatment withcorticosteroid medicines such as prednisolone. Other risk factors includesmoking, a family history of osteoporosis, early menopause and thin bodybuild.

Risedronate sodium is used both to prevent bone loss inpostmenopausal women at risk of developing osteoporosis, and to preventfractures in postmenopausal women who already have osteoporosis. The medicineworks by binding very tightly to the bone and preventing the calcium beingremoved by the osteoclasts. This stops the osteoclasts from breaking down thebone, which helps to keep the bones strong and less likely to break.

Calcium andvitamin D are also needed for strong bones and yourdoctor may ask you to take supplements of these if your dietary intake is toolow.

What is it used for?

• Treatment of osteoporosis in women who have passed the menopause.
• Prevention of bone loss in women who have passed the menopause and are at risk of developing osteoporosis, eg due to long-term (more than three months) treatment with corticosteroids such as prednisolone.

Risedronate has been shown to reduce the risk of hip and spinefactures in postmenopausal women with osteoporosis.

How do I take it?

• It is very important that the instructions for taking Actonel tablets are followed completely. This is because when the medicine is taken by mouth it can cause irritation and ulceration of the foodpipe (oesophagus). Following the instructions below minimises this risk. If you are unclear about anything ask your pharmacist for advice.
• One 5mg tablet should be taken once a day, preferably in the morning, at least 30 minutes before the first food, drink or medicine of the day.
• The tablet should be swallowed whole with a glass of plain water (at least 120ml, not mineral water) while you are sitting or standing in an upright position. Do not crush, chew or suck the tablet.
• You should not lie down for at least 30 minutes after taking the tablet. You should not eat or drink anything other than plain water for at least 30 minutes after taking the tablet. This is because food, some drinks (including mineral water) and some medicines can interfere with the absorption of the medicine from the gut and hence make it less effective.
• If you can't take the tablet in the morning, you can take it between meals or in the evening. However, it should always be taken at the same time each day and it must be taken on an empty stomach.
• If taken during the day, it should be taken at least two hours before and at least two hours after any food, medicinal product or drink (other than plain water). If taken in the evening, it should be taken at least two hours after your last food, medicine or drink (other than plain water) of the day. The tablet should be taken at least 30 minutes before going to bed. Again, the tablet must be swallowed whole with a glass of plain water (at least 120ml, not mineral water) while you are sitting or standing in an upright position. Do not chew or suck the tablet and don't lie down for at least 30 minutes after taking the tablet.

Warning!

• If you experience any signs of irritation to your foodpipe during treatment with this medicine, for example new or worsening problems with swallowing, pain on swallowing, pain behind your breastbone, or heartburn, you should stop taking these tablets and inform your doctor.
• The class of medicines that risedronate belongs to (bisphosphonates) has been associated with a rare condition called osteonecrosis of the jaw. The majority of cases of this condition have been in cancer patients treated with bisphosphonates by injection into a vein, and many of these people were also having treatment with chemotherapy or corticosteroids. However, the condition has also been seen in people taking bisphosphonates by mouth. The risk may also be increased by poor oral hygiene, dental problems such as gum disease or poorly fitting dentures, teeth extractions, oral surgery and smoking. For this reason, you should have a dental examination and, if necessary, appropriate preventive dentistry, before you start treatment with this medicine. Discuss this with your doctor. It is important to look after your mouth and teeth as much as possible while you are taking this medicine. You should have regular check-ups with your dentist and get advice straight away if you have any problems with your mouth or teeth. When you see a dentist during treatment, make sure they know you are taking this medicine. Invasive dental procedures such as tooth extraction or surgery should be avoided if possible.
• Some people being treated with bisphosphonates (mainly people having long-term treatment for osteoporosis) have experienced an unusual fracture of their thigh bone. For this reason it is important to let your doctor know if you get any pain in your thighs, hips or groin while you are having treatment with this medicine. These symptoms could be an early indication of a possible fracture.

Use with caution in

• People with conditions that cause difficulty swallowing or delayed passage of food through the foodpipe (oesophagus), eg narrowing or obstruction of the foodpipe.
• People who cannot stand or sit upright for at least 30 minutes.
• People with active disorders of the upper part of the digestive system, such as difficulty swallowing, disorders affecting the foodpipe (eg reflux disease), ulcers, inflammation of the lining of the stomach (gastritis), inflammation of the small intestine (duodenitis).
• Disorders of the parathyroid gland (gland that produces hormones responsible for regulating calcium metabolism).
• Vitamin D deficiency.

Not to be used in

• Children.
• Severely decreased kidney function.
• People who have a low level of calcium in their blood (hypocalcaemia).
• Pregnancy.
• Breastfeeding.
• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Actonel tablets contain lactose).

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy. If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• This medicine has not been studied in pregnant women, hence its safety has not been established. It should not be used during pregnancy.
• It is not known if this medicine passes into breast milk. It should not be used by breastfeeding mothers.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience thator any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Disturbances of the gut such as diarrhoea, constipation, nausea, indigestion or abdominal pain.
• Headache.
• Pain in joints, muscles or bones (musculoskeletal pain).

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Difficulty or pain when swallowing (dysphagia).
• Inflammation of the stomach (gastritis).
• Inflammation of the food pipe (oesophagitis).
• Ulceration of the food pipe.
• Inflammation of the small intestine (duodenitis).
• Inflammation of the coloured part of the eye (iritis).

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Inflammation of the tongue (glossitis).

Unknown frequency (reported since the medicine has been on the market)

• Skin reactions, eg rash (including severe allergic skin reactions).
• Hair loss.
• Eye inflammation (uveitis).
• Osteonecrosis of the jaw (see warning section above).
• Unusual fractures of the thigh bone (see warning section above).

The side effects listed above may not include all of the sideeffects reported by the medicine'smanufacturer. For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to make sure that thecombination is safe.

Other medicines may interfere with the absorption of risedronate from the gut and could therefore make the medicine lesseffective. For this reason, you should not take other medicines by mouth in the two hours before and two hours after taking risedronate. This is particularly important for the medicines listed below:

• antacids (indigestion remedies)
• calcium supplements
• iron supplements
• laxatives containing magnesium
• mineral supplements
• multivitamins containing minerals such as calcium, iron, magnesium or zinc
• zinc supplements.

There may an increased chance of the amount of calcium in the blood falling too low if aminoglycoside antibiotics such as gentamicin are used in combination with this medicine.

There may be an increased risk of side effects on the digestive system if non-steroidal anti-inflammatory drugs such as ibuprofen or diclofenac are taken in combination with this medicine. You should ask your doctor or pharmacist for advice before taking this type of painkiller.

Other medicines containing the same active ingredient

Risedronate 5mg and 30mg tablets are also available without a brand name, ie as the generic medicine.