Actonel. 35 mg. 4 tablets
Actonel. 35 mg. 4 tablets
Qualitative and quantitative composition
Each tablet contains :
• The active ingredient is risedronate sodium. 35 mg risedronate sodium match 32,5 risedronic acid.
• Excipients in the tablet core are lactose monohydrate, crospovidone, magnesium stearate and microcrystalline cellulose .
• Excipients in film- coating are: yellow iron oxide E172 , red iron oxide E172 , hydroxypropyl cellulose , hypromellose , macrogol 8000, macrogol 400 , silicon dioxide , titanium dioxide E171 .
Marketing Authorisation Holder:
Aventis Pharma Deutschland Gmbh D- 65926 Frankfurt am Main-Germany
ProzvodntelProcter & Gamble Pharmaceuticals Germany GmbH 1. What is Actonel and what is use.Drug form - film-coated tablets , oval light orange .
Actonel Once a week belongs to the pharmaceutical group of bisphosphonates , non-hormonal drugs , which are used for the treatment of bone diseases. Actonel Once a week, acting on the skeleton , reducing the likelihood of your bones break
Indications ( in which cases apply this medicine Actonel
Once a week is intended for use in these indications.
Treatment of postmenopausal osteoporosis to reduce the risk of vertebral fractures .
Treatment of osteoporosis postmenupauzna proven to reduce the risk of hip fracture .
Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis.
2 . Before you start taking Actonel once a week.
DO NOT USE Actonel Once a week in the following cases :
• If you are hypersensitive (allergic ) compared to risedronate sodium or to any of the excipients of Actonel once a week.
• If your doctor tells you that you have a condition called hypocalcaemia ( low calcium levels in the blood) .
• If you are pregnant or breastfeeding.
• If you have severe renal impairment (creatinine clearance <30 ml / min). If you are unsure, you should consult your doctor or pharmacist.
Take special care when taking Actonel once a week :
• If you have disturbances of bone and mineral metabolism (eg, lack of vitamin D, abnormal levels of parathyroid hormone ) .
• If you have had problems from the esophagus in the past.
If any of these apply to you, please talk to your doctor before you start taking Actonel once a week.
Hypocalcemia should be treated before starting Actonel therapy once a week.
Other disturbances in bone and mineral metabolism (eg parathyroid dysfunction glands, hypovitaminosis D) should be treated at the time of initiation of treatment with Actonel once a week. In patients with a deficiency of vitamin D, or such breaches of the parathyroid glands, Actonel Once a week should be used especially vnimatelno.Nyakoi bisphosphonates are linked to oesophagitis (inflammation of the esophagus ) and esophageal ulcers ( ulcers of the esophagus ) . Therefore , patients must follow the dosing instructions . In patients with a history of esophageal disease , delaying its passage or emptying (eg stricture or achalasia ) or patients unable to remain upright for at least 30 minutes after taking the tablet , Actonel Once a week should be given with caution due to the limited clinical experience in such patients. Prescribers should emphasize to patients the importance of these compliance guidelines use.In the event that you are unsure, you should consult your doctor or pharmacist.
Use of Actonel once a week with food and drink :
It is very important not to take Actonel tablet once a week with food or drink other than plain water. Absorption of Actonel Once a week the body decreases when taking certain foods. Food and drink can impair the absorption of Actonel once a week. Therefore, Actonel Once a week should be taken at least 30 minutes before the first food or drink (other than water ) of the day , or at least 2 hours after eating or drinking for the rest of the day , and at least 30 minutes before bedtime .
Precautions for use
Children: The safety and efficacy of Actonel Once a week not been established in children and adolescents.
Use by pregnant or lactating women
There is a possibility of damage to the fetus. Pregnant women should not use AktonelVednazh week.
It is not known whether risedronate passes into breast milk . Breast-feeding women should not take Actonel once a week.
Driving and using machines
In Actonel Once a week No effects impair the ability to drive and use machines.
Interactions with other medicaments and other forms of interaction
Please inform your doctor or pharmacist about other medicines you are taking or vzemalinaposledak , even those not prescribed . | There have been no formal interaction studies , but during klinichniteizpitvaniya not found clinically significant interactions with other drugs. If it is considered suitable chee , Actonel Once a week can be administered in conjunction with therapy sestrogeni.Produkti substituent containing calcium (including dairy products such as milk ) , magnesium, aluminum (e.g., certain mixtures alimentary problems) and reducing the effect of the iron Actonel once a week. These products should be taken at different times of Actonel once a week.
3 . How to use Actonel once a week.
Always strictly observe the prescriptions of your doctor . Once a week Actonel tablet taken once a week. Choose one day of the week that is most convenient for you. Take the weekly one tablet Actonel once a week on your chosen day .
It is very important not to take the tablets Actonel once a week with food or drink other than water. The tablets should be swallowed whole and not sucked or chewed. Take one tablet once a week Actonel in the following ways : • At least 30 minutes before the first food or drink (other than water) of the day
• at least 2 hours after eating or drinking beverages at any time of the day , and at least 30 minutes before bedtime
The tablets should be swallowed whole and not sucked or chewed. To support delivery of the tablet to the stomach , Actonel Once a week should be taken in an upright position with a glass of pure water (> 120 ml). Patients should not lie down for 30 minutes after taking tabletkata.Dnite of the week printed on the packaging of tablets for convenience when taking Actonel Once sedmichno.Vazhno is your diet includes products containing calcium and vitamin D ( eg, dairy products). If dietary intake is inadequate , consideration should be given to the question of added calcium and vitamin D.Vashiyat doctor will tell you how long treatment with Actonel once a week. Please predida stop treatment , talk with your doctor .
If you take Actonel Once a week more than they should
If you or someone you accidentally take large numbers of tablets , drink a full glass of milk and seek medical pomosht.Nyama specific information available on the treatment of overdose with Actonel Once sedmichno.Sled substantial overdose may be expected decreases in serum calcium. In some of these patients may manifest signs and symptoms of hipokaltsiemiya.Za connect risedronate and reduce absorption of the drug should not be given milk or antacids containing magnesium, calcium or aluminum. In cases of substantial overdose may be considered if gastric lavage to remove unabsorbed drug from .
If you forget to take Actonel Once a week
If you miss a dose, just take one tablet once a week Actonel in the day that you remember it. Do not take two tablets on the same day. Then continue taking one tablet once a week at a set day. 4 . Possible side reaktsii.Kakto all medicines and Actonel Once a week can cause adverse reaktsii.Ne hesitate to seek advice from your doctor or pharmacist to report any type of adverse events that are not mentioned in this leaflet . The majority of adverse drug reactions in clinical trials were mild doumereni .
Common side effects (occurring in 1 to 10 patients in 100 ): pain, constipation , dyspepsia, nausea , abdominal pain, diarrhea , bone pain , muscle and joint pain , gastrointestinal disorders and glavobolie.Po less common side effects (occurring in less than 1 in 100 patients): inflammation of the esophagus ( esophagitis ) , ulcers hranoprovoda.Pri small number of patients reported iritis (inflammation of the colored part of the eye). ) In clinical trials, the following rare side effects: inflammation of the duodenum ( duodenitis ) , difficulty swallowing ( dysphagia ) . Moreover, in the rare cases of elevated functional chernodrobniizsledvaniya . These phenomena can only be diagnosed using blood izsledvaniya.Pri some patients were seen early , transient, asymptomatic and mild decreases in the levels of calcium and naserumniya fosfati.Ako notice any side effects not listed in this leaflet, tell them your doctor or pharmacist.
5 . How to store Actonel once a week.
Keep out of reach of children !
Shelf life : 3 years .
Observe the expiry date stated on the carton. Do not store above 25 ° C.