Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
felodipine, Quantity: 10 mg
AstraZeneca Pty Ltd
Tablet, modified release
Excipient Ingredients: microcrystalline cellulose; titanium dioxide; PEG-40 hydrogenated castor oil; propyl gallate; hyprolose; iron oxide red; hypromellose; macrogol 6000; iron oxide yellow; sodium stearylfumarate; aluminium sodium silicate; lactose; Carnauba Wax
Oral
7 (sample), 30
(S4) Prescription Only Medicine
Hypertension.
Visual Identification: Circular, red-brown, biconvex film-coated tablet with A/FE impressed on one side and 10 on the other side; 9 mm diameter; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
1995-07-06
PLENDIL ® ER _Felodipine_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about PLENDIL ER. It does not contain all the information that is known about PLENDIL ER. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking PLENDIL ER 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 PLENDIL ER IS FOR PLENDIL ER is used to treat high blood pressure, also called hypertension. PLENDIL ER lowers blood pressure by dilating (expanding) small blood vessels, letting the blood be pumped around the body more easily. Your doctor will have explained why you are being treated with PLENDIL ER and told you what dose to take. The ER in PLENDIL ER stands for Extended Release. This means that the tablets are designed to work over a 24 hour period. PLENDIL ER contains felodipine, which belongs to the family of medicines known as calcium channel blockers. These medicines do not change the way the body takes in calcium from food. FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR CAREFULLY. They may differ from the information contained in this leaflet. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. PLENDIL ER is only available with a doctor's prescription. PLENDIL ER is not addictive. BEFORE YOU USE PLENDIL ER _WHEN YOU MUST NOT USE IT_ DO NOT TAKE PLENDIL ER IF YOU HAVE AN ALLERGY TO ANY MEDICINE CONTAINING FELODIPINE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THE LEAFLET. Some of the symptoms of an allergic reaction may include, tightness of the chest, wheezing, coughing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives. DO NOT TA Lesen Sie das vollständige Dokument
1 of 10 AUSTRALIAN PRODUCT INFORMATION PLENDIL ® ER (FELODIPINE) EXTENDED RELEASE TABLETS 1 NAME OF THE MEDICINE Felodipine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PLENDIL ER tablets contain 2.5mg, 5mg or 10 mg felodipine. EXCIPIENT WITH KNOWN EFFECT Lactose. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM PLENDIL ER TABLETS 2.5MG: Yellow, circular, biconvex, film-coated, engraved A/FL on one side and 2.5 on the other. Diameter 8.5 mm. PLENDIL ER TABLETS 5MG: Pink, circular, biconvex, film-coated, engraved A/Fm on one side and 5 on the other. Diameter 9 mm. PLENDIL ER TABLETS 10MG: Red-brown, circular, biconvex, film-coated, engraved A/FE on one side and 10 on the other. Diameter 9 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS _HYPERTENSION _ The dose should be adjusted individually. Treatment should be started with 5mg once daily. In elderly patients a starting dose of 2.5mg once daily should be considered. If necessary, the dose can be increased in 2.5 or 5mg/day increments. The usual maintenance dose is 5mg to 10mg daily. Doses higher than 20mg daily of PLENDIL ER are not recommended. 2 of 10 SPECIAL PATIENT POPULATIONS _RENAL IMPAIRMENT _ Impaired renal function does not influence felodipine peak plasma concentrations or AUC, and a dosage reduction is not necessary for patients with renal impairment. _HEPATIC IMPAIRMENT _ The dose of felodipine should be reduced in patients with severely impaired liver function. Patients with impaired hepatic function may have elevated plasma concentrations of felodipine and may respond to lower doses. _USE IN THE ELDERLY _ The dose should be adjusted individually, taking patient age into consideration (see Section 4.4 Special warnings and precautions for use). An initial dose of 2.5mg once daily should be considered. _PAEDIATRIC USE _ Due to limited clinical trial experience, felodipine should not be used in paediatric patients. METHOD OF ADMINISTRATION PLENDIL Lesen Sie das vollständige Dokument