What Actonel is and what it is used for
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. Paget’s disease occurs when this process, called remodeling, happens too quickly and in a disordered way. The new bone that is produced is weaker than normal and the affected bones may become enlarged, painful and may fracture. Actonel changes the bone remodeling process back to normal, returning the strength to the bone structure What Actonel is used for Treatment of Paget’s disease of the bone (osteitis deformans).
How to take Actonel
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
The recommended dose is ONE Actonel tablet (30 mg of
risedronate sodium) once a day.
The recommended treatment duration is usually 2 months.
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
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. Please turn over... * Please note that only Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date Proof Round [email protected] Technical Approval Colours Non Printing Colours Date sent: Date received: Item number: Originator: Origination Date: Revision Date: Revised By: Dimensions: Min Body Text Size: Supplier: 1. 2. 3. 4. 5. 6. 1. 2. 3. FMD info NA (not a carton) No Yes Details Risedronic Acid (Actonel) 30mg Film-coated Tablets PIL
•UK Black BBBA2294 S.Anson 22.06.18 28.06.18 S.Anson 210 x 320 9pt Warner Chilcott (DE) GmbH n/a 2 n/a Version 2 01.11.2017 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 a double dose to make up for a forgotten tablet. If you stop taking Actonel Please talk to your doctor if you consider stopping treatment before the end of prescribed duration. 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 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, “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 longterm 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.
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.
Very rare (may affect up to 1 in 10,000 people)
• Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear. 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. The additional following adverse events has also been observed in a clinical study in patients with Paget’s disease: vision difficulties, breathing difficulties, coughing, inflammation of the large intestine, surface of the eye damage, cramps, dizziness, dryness of the eye, flu-like symptoms, muscle weakness, abnormal growth of cells, a frequent need to pass water at night, unusual lumps or swellings, chest pain, rash, runny nose, ringing in the ears and weight loss.
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.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Actonel
Keep this medicine 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. This medicine does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
2 to 3 weeks on average
The average shipping time is 2 weeks in North America and 4 weeks internationally. We offer free shipping on all orders shipped to North America. Shipping is a flat rate of $20.00 for all other countries.
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