Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
sodium clodronate tetrahydrate
Bayer Australia Ltd
Registered
1308 BONEFOS ® Tablets and Capsules 1 BONEFOS (BON·E·FOS) _ _ _sodium clodronate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Bonefos. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Bonefos against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT BONEFOS IS USED FOR Certain cancers increase bone breakdown and lead to an increased amount of calcium circulating in the bloodstream. This can result in high calcium levels in the blood (hypercalcaemia) or bone destruction (osteolysis) which increases your risk of bone fractures and bone pain. Bonefos works by stopping calcium from coming out of your bones and keeps your blood calcium at normal levels (normocalcaemia). Bonefos can be used to either bring your blood calcium levels down to a normal level (acute treatment) or to keep it down at a normal level (maintenance treatment). Bonefos can also be used to treat bone destruction due to breast cancer and bone marrow cancer. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. There is not enough information to recommend the use of this medicine for children. BEFORE YOU TAKE BONEFOS _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE BONEFOS IF YOU HAVE AN ALLERGY TO: • sodium clodronate, the active ingredient in Bonefos • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the Lees het volledige document
1308 Bonefos PI Page 1 of 11 PRODUCT INFORMATION BONEFOS ® (SODIUM CLODRONATE) NAME OF THE MEDICINE BONEFOS contains sodium clodronate which is a bone metabolism regulator. CHEMICAL NAME The chemical name of sodium clodronate tetrahydrate is disodium (dichloromethylene) bisphosphonate tetrahydrate. STRUCTURAL FORMULA DESCRIPTION CHEMICAL PROPERTIES _Sodium clodronate:_ A white to off-white, odourless powder which is freely soluble in water, slightly soluble in methanol, very slightly soluble in dehydrated alcohol and insoluble in toluene, acetone and diethylether. _BONEFOS capsules 400 mg:_ One capsule contains 500 mg sodium clodronate tetrahydrate, equivalent to 400 mg anhydrous sodium clodronate. Each capsule also contains purified talc, calcium stearate, colloidal anhydrous silica, lactose, gelatin, purified water, iron oxide red, iron oxide yellow, Tekprint SW-9008 black ink and titanium dioxide. Each capsule contains the equivalent of 64 mg sodium. _BONEFOS tablets 800 mg:_ Each 800 mg tablet contains 1000 mg sodium clodronate tetrahydrate, equivalent to 800 mg anhydrous sodium clodronate. Each tablet also contains croscarmellose sodium, microcrystalline cellulose, stearic acid, magnesium stearate, colloidal anhydrous silica and Opadry II complete film coating system 85F18422 white. Each tablet contains the equivalent of 128 mg sodium. 1308 Bonefos PI Page 2 of 11 PHARMACOLOGY PHARMACODYNAMICS Sodium clodronate belongs chemically to the bisphosphonate group, which act primarily on bone tissue. Its major pharmacological action is inhibition of bone resorption. The mechanism of sodium clodronate’s action lies in its protection against the dissolution of hydroxyapatite crystals and direct reduction of osteoclast activity. There is some evidence that sodium clodronate also has indirect effects on osteoclast activity by inhibition of various mediators. The selectivity of the direct effects most likely arises from the strong affinity of sodium clodronate for calcium phosphate and it will, therefore, be distribu Lees het volledige document