Actonel Once A Week 35mg Film-Coated Tablets
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Actonel® Once a Week 35mg film-coated tablets
(risedronate sodium)
Your medicine is available using the above name, but will be referred to as Actonel Once a Week throughout the remainder of this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Actonel Once a Week is and what it is used for
2. What you need to know before you take Actonel Once a Week
3. How to take Actonel Once a Week
4. Possible side effects
5. How to store Actonel Once a Week
6. Contents of the pack and other information
1. What Actonel Once a Week is and what it is used for
What Actonel Once a Week is
Actonel Once a Week 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 can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone.
The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in your body. Osteoporosis - 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.
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What Actonel Once a Week is used for
Treatment of osteoporosis in postmenopausal women, even if osteoporosis is severe. It reduces the risk of spinal and hip fractures. Treatment of osteoporosis in men at high risk of fractures.
2. What you need to know before you take Actonel Once a Week
Do not take Actonel Once a Week
• If you are allergic to risedronate sodium or any of the other ingredients of this medicine (listed in section 6)
• 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Actonel Once a Week:
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 or have had problems in the past with your oesophagus (the tube that connects your mouth with your stomach). For instance you may have or 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 Once a Week.
Your doctor will advise you on what to do when taking Actonel Once a Week if you have any of the above.
Children and adolescents
Risedronate sodium is not recommended for use in children below 18 due to insufficient data on safety and efficacy.
Other medicines and Actonel Once a Week
Medicines containing one of the following lessen the effect of Actonel Once a Week 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 Once a Week tablet.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Actonel Once a Week with food and drink
It is very important that you do NOT take your Actonel Once a Week 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, “Other medicines and Actonel Once a Week”).
Take food and drinks (other than plain water) at least 30 minutes after your Actonel Once a Week tablet.
Pregnancy and breast-feeding
Do NOT take Actonel Once a Week if you may be pregnant, are pregnant or planning to become pregnant (see section 2, “Do not take Actonel Once a Week”).
The potential risk associated with the use of risedronate sodium (active substance in Actonel Once a Week) in pregnant women is unknown.
Do NOT take Actonel Once a Week if you are breastfeeding (see section 2, “Do not take Actonel Once a Week”). Actonel Once a Week should only be used to treat postmenopausal women and men.
Driving and using machines
Actonel Once a Week is not known to affect your ability to drive and use machines.
Actonel Once a Week contains a small amount of lactose (see section 2, “Warnings and precautions”).
How to take Actonel Once a Week
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Recommended dose:
Take ONE Actonel Once a Week tablet (35 mg of risedronate sodium) once a week.
Choose one day of the week that best fits your schedule. Every week, take the Actonel Once a Week tablet on your chosen day.
For your convenience, so that you take your tablet on the right day every week, there is a feature included with the Actonel Once a Week pack:
There are boxes/spaces on the back of the blister card. Please mark the day of the week you have chosen to take your Actonel Once a Week tablet. Also, write in the dates you will take the tablet.
WHEN to take the Actonel Once a Week tablet
Take your Actonel Once a Week tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.
HOW to take the Actonel Once a Week 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 Once a Week than you should
If you or somebody else has accidentally taken more Actonel Once a Week tablets than prescribed, drink one full glass of milk and seek medical attention.
If you forget to take Actonel Once a Week
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.
If you stop taking Actonel Once a Week
If you stop treatment you may begin to lose bone mass. Please talk to your doctor before you consider stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Actonel Once a Week and contact a doctor immediately if you experience any of the following:
• Symptoms of a severe allergic reaction such as;
- Swelling of 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, “Warnings and precautions”).
• Symptoms from oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new or 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 (may affect up to 1 in 10 people)
• 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 (may affect up to 1 in 100 people)
• 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, “Warnings and precautions”), 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 (may affect up to 1 in 1,000 people)
• 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.qov.uk/vellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
How to store Actonel Once a Week
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C. Store in the original package.
• 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.
• If the tablets become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist.
6. Contents of the pack and other information
What Actonel Once a Week contains
The active substance is risedronate sodium. Each tablet contains risedronate sodium 35mg equivalent to 32.5mg risedronic acid.
The other ingredients are:
Tablet core: lactose monohydrate (see section 2), crospovidone, magnesium stearate and microcrystalline cellulose.
Film coating: macrogol, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol, colloidal anhydrous silica, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).
What Actonel Once a Week looks like and contents of the pack
Actonel Once a Week are oval light orange 11.7 x 5.8mm film coated tablets with RSN on one side and 35 mg on the other.
The tablets are supplied in calendar blister packs of 4. Manufacturer:
Warner Chilcott Deutschland GmbH,
Dr.-Otto-Rohm-Str. 2-4,
64331 Weiterstadt, Germany
Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, NW9 6AQ. Product Licence Holder: Sam Pharma Ltd, Unit 20 Garrick Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.
POM
PL 33902/0601
Leaflet revision date: 30/11/2015
Actonel® is a registered trademark of Warner Chilcott Company, LLC.
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