Actonel 5mg
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Actonel® 5mg Film-Coated Tablets T03803
(risedronate sodium)
The name of your medicine is Actonel 5mg Film-Coated Tables but will be referred to as Actonel through out the following:
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Actonel is and what it is used for
2. Before you take Actonel
3. How to take Actonel
4. Possible side effects
5. How to store Actonel
6. Further information
1. WHAT ACTONEL IS AND WHAT IT IS USED FOR What Actonel is
Actonel belongs to a group of non-hormonal medicines called bisphosphonates which are used to treat bone diseases. It 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 is more likely to occur in women who have reached the menopause early and also in patients treated long-term with steroids.
The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in your body. Osteoporos is related fractures can also cause back pain, height loss and a curved back. Many patients with osteoporosis have no symptoms and you may not even have known that you had it.
What Actonel is used for
The treatment of osteoporosis
• in postmenopausal women.
The prevention of osteoporosis
• in women with an increased risk of osteoporosis (including low bone mass, early menopause or a family history of osteoporosis).
• in postmenopausal women who have been on high doses of steroid drugs for a long time. It
maintains or increases bone mass.
2. BEFORE YOU TAKE ACTONEL Do NOT take Actonel
• If you are allergic to risedronate sodium or any of the other ingredients of Actonel (see section 6, “What Actonel contains”).
• If your doctor has told you that you have a condition called hypocalcaemia (a low blood calcium level).
• If you may be pregnant, are pregnant or planning to become pregnant.
• If you are breast-feeding.
• If you have severe kidney problems.
Take special care and talk to your doctor BEFORE you start taking Actonel
• 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 had problems in the past with your oesophagus (the tube that connects your mouth with your stomach). For instance you may 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 had or have pain, swelling or numbness of the jaw or a “heavy jaw feeling” or loosening of a tooth.
• If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Actonel.
Your doctor will advise you on what to do when taking Actonel if you have any of the above.
Children
Risedronate sodium is not recommended for use in children below age 18 due to insufficient data on safety and efficacy.
Taking other medicines
Medicines containing one of the following lessen the effect of Actonel if taken at the same time:
• calcium
• magnesium
• aluminium (for example some indigestion mixtures)
• iron.
Take these medicines at least 30 minutes after your Actonel tablet. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Actonel with food and drink
It is very important that you do NOT take your Actonel 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,
“Taking other medicines”).
Take food and drinks (other than plain water) at least 30 minutes after your Actonel tablet.
Pregnancy and breast-feeding
Do NOT take Actonel if you may be pregnant, are pregnant or planning to become pregnant (see section
2, “Do not take Actonel”). The potential risk associated with the use of risedronate sodium (active substance in Actonel) in pregnant women is unknown.
Do NOT take Actonel if you are breast-feeding (see section 2, “Do not take Actonel”).
Driving and using machines
Actonel is not known to affect your ability to drive and use machines.
Important information about some of the ingredients of Actonel
Actonel contains a small amount of lactose (see section 2, “Take special care and talk to your doctor before you start taking Actonel”).
3. HOW TO TAKE ACTONEL Dosage
Always take Actonel exactly as your doctor has told you. You should check with your doctor if you are not sure.
Usual dose:
Take ONE Actonel tablet (5 mg of risedronate sodium) once a day.
For your convenience, the days of the week are printed on the blister foil to help you remember to take your medicine.
WHEN to take the Actonel tablet
IT IS BEST to take your Actonel tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day. If in particular instance you are unable to take your Actonel tablet at this time, you may take it on an empty stomach, at the same time every day, in one of the following ways:
• EITHER
Between meals: at least 2 hours after your last food, drink (other than plain water) or other medicine. Do not eat or drink (other than plain water) for 2 hours after taking the tablet.
• OR
In the evening: at least 2 hours after your last food, drink (other than plain water) or other medicine of the day. Actonel should be taken at least 30 minutes before going to bed.
HOW to take the Actonel tablet
• 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.
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 Actonel than you should
If you or somebody else has accidentally taken more Actonel tablets than prescribed, drink one full glass of milk and seek medical attention.
If you FORGET to take Actonel
If you have forgotten to take your tablet at your regular time, you can take it at the next possible time according to the instruction above (i.e. before breakfast, between meals, or in the evening).
Do NOT take two tablets in one day to make up for the tablet you missed.
If you STOP taking Actonel
If you stop treatment you may begin to lose bone mass. Please talk to your doctor before you consider stopping treatment.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Actonel can cause side effects, although not everybody gets them.
Stop taking Actonel and contact a doctor immediately
if you experience any of the following:
• Symptoms of a severe allergic reaction such as:
- Swelling of the face, tongue or throat.
- Difficulties in swallowing.
- Hives and difficulties in breathing.
• Severe skin reactions that can include blistering of the skin.
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, “Take special care and talk to your doctor before you start taking Actonel”).
• Symptoms from oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new/worsened heartburn.
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.
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.
Common side effects (affects 1 to 10 users in 100)
• Indigestion, feeling sick, stomach ache, stomach cramps or discomfort, constipation, feelings of fullness, bloating, diarrhoea.
• Pain in your bones, muscles or joints.
• Headache.
Uncommon side effects (affects 1 to 10 users in 1,000)
• 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, “Take special care and talk to your doctor before you start taking Actonel”), 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).
Rare side effects (affects 1 to 10 users in 10,000)
• 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.
During post-marketing experience, the following have been reported (unknown frequency);
• Hair loss.
• Liver disorders, some cases were severe.
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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ACTONEL
Keep out of the sight and reach of children.
Do not take this medicine after the expiry date marked on the pack.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Actonel contains
The active substance is called risedronate sodium. Each tablet contains 5mg of risedronate sodium (equivalent to 4.64mg risedronic acid). The tablets also contain the following inactive ingredients:
Tablet core: lactose monohydrate, crospovidone, magnesium stearate and microcrystalline cellulose. Film coat: yellow iron oxide (E172), hyprolose, hypromellose, macrogol 8000, macrogol 400, silicon dioxide, titanium dioxide (E171).
What Actonel looks like and contents of the pack
Actonel 5mg Tablets are oval yellow tablets with the letters RSN engraved on one side and 5mg on the other side. Actonel 5mg Tablets are supplied in calendar blister packs of 28 tablets.
Manufacturer and Product Licence Holder
The manufacturer is Procter & Gamble Pharmaceuticals Germany GmbH, Dr.-Otto-Roehm-Str. 2-4, 64331 Weiterstadt, Germany. It is procured from with in the EU by the PL Holder: Swinghope Ltd, Brandon House, Marlowe Way, Croydon CRO 4XS and repackaged by Interport Limited, Brandon House, Marlowe Way, Croydon CRO 4XS.
POM
PL No: 10380/1258
Leaflet revision date: 17/09/12
T03803