Actonel 5mg tablets

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How does it work?

Actonel 5mg tablets contain the active ingredient risedronate sodium, which is a type of medicine known as a bisphosphonate. Bisphosphonates are medicines that prevent the breakdown of bone.

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

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

Osteoporosis can also as a result of long-term treatment with corticosteroid medicines such as prednisolone. Other risk factors include smoking, a family history of osteoporosis, early menopause and thin body build.

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

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

Calcium and vitamin D are also needed for strong bones and your doctor may ask you to take supplements of these if your dietary intake is too low.

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.

Warning!

- 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.
- Your 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 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.
- 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 patients were also having treatment with chemotherapy or corticosteroids. However, the condition has also been seen in people taking bisphosphonates by mouth. The risk may be increased by poor oral hygiene, dental problems, teeth extractions and oral surgery. For this reason, your doctor may want you to 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 receiving this medicine. Invasive dental procedures such as tooth extraction or surgery should be avoided if possible. If you need to see a dentist during treatment, make sure they know you are receiving this medicine.

Use with caution in

.

- Decreased kidney function
- 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
- Disorders of the parathyroid gland (gland that produces hormones responsible for regulating calcium metabolism)
- Vitamin D deficiency.

Not to be used in

- Children
- Low levels of calcium in the 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 or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

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

- The safety of this medicine during pregnancy has not been established, therefore it should not be used by pregnant women. Consult your doctor.
- It is not known if this medicine passes into breast milk. It should not be used during breastfeeding. Seek medical advice from your doctor.

Label warnings

- This medication is to be swallowed whole, not chewed.

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