RISEDRONATE SODIUM 35 mg Film-coated tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Risedronate sodium 35 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 35 mg risedronate sodium which is equivalent to 32.5 mg risedronic acid. Excipients with known effect: Each film-coated tablet contains 1.9 mg lactose. Each film-coated ...
Pharmaceutical form
Film-coated tablet. White round biconvex film-coated tablet with diameter of 11.2 mm, 5.0 mm in thickness and embossed with 35 on one side.
Therapeutic indications
Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures (see section 5.1). Treatment ...
Posology and method of administration
Posology The recommended dose in adults is one 35 mg tablet orally once a week. The tablet should be taken on the same day each week. Special populations Elderly No dose adjustment is necessary since bioavailability, ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypocalcaemia (see section 4.4). Pregnancy and lactation. Severe renal impairment (creatinine clearance <30 ml/min). ...
Special warnings and precautions for use
Foods, drinks (other than plain water) and medicinal products containing polyvalent cations (such as calcium, magnesium, iron and aluminium) interfere with the absorption of bisphosphonates and should ...
Interaction with other medicinal products and other forms of interaction
No formal interaction studies have been performed, however no clinically relevant interactions with other medicinal products were found during clinical trials. Concomitant ingestion of medicines containing ...
Pregnancy and lactation
There are no adequate data from the use of risedronate sodium in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Studies ...
Effects on ability to drive and use machines
Risedronate sodium has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Risedronate sodium has been studied in phase III clinical trials involving more than 15,000 patients. The majority of undesirable effects observed in clinical trials were mild to moderate in severity and ...
Overdose
No specific information is available on the treatment of overdose with risedronate sodium. Decreases in serum calcium following substantial overdose may be expected. Signs and symptoms of hypocalcaemia ...
Pharmacodynamic properties
Pharmacotherapeutic group: Bisphosphonates ATC code: M05BA07 Mechanism of action Risedronate sodium is a pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone ...
Pharmacokinetic properties
Absorption Absorption after an oral dose is relatively rapid (t<sub>max</sub> ~1 hour) and is independent of dose over the range studied (single dose study, 2.5 to 30 mg; multiple dose studies, 2.5 to ...
Preclinical safety data
In toxicological studies in rat and dog dose dependent liver toxic effects of risedronate sodium were seen, primarily as enzyme increases with histological changes in rat. The clinical relevance of these ...
List of excipients
Tablet core: Starch, pregelatinised (maize) Cellulose, microcrystalline Crospovidone Magnesium stearate Film coating: Hypromellose Lactose monohydrate Titanium dioxide (E171) Macrogol 4000
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Nature of container: Opaque PVC/PE/PVDC/Aluminium blister in a carton box. Pack sizes: 1, 2, 4, 10, 12, 16, 24 film-coated tablets Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pharmathen S.A., 6, Dervenakion str., 153 51 Pallini, Attiki, Greece
Marketing authorization number(s)
PL 17277/0239
Date of first authorization / renewal of the authorization
11/06/2014
Date of revision of the text
16/01/2019
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