Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
verapamil hydrochloride, Quantity: 80 mg
Viatris Pty Ltd
Tablet, film coated
Excipient Ingredients: calcium hydrogen phosphate dihydrate; microcrystalline cellulose; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; hypromellose; sodium lauryl sulfate; macrogol 6000; purified talc; titanium dioxide
Oral
100 tablets
(S4) Prescription Only Medicine
ANPEC is indicated for:,-Hypertension,-Angina of effort,-Angina at rest,-Vasospastic angina (including Prinzmetal?s variant angina),-Tachyarrhythmias including paroxysmal supra-ventricular tachycardia,-Atrial fibrillation with rapid ventricular response,-Atrial flutter with rapid ventricular response
Visual Identification: White, biconvex film coated tablets; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-11-07
ANPEC _(NEW FORMULATION)_ _verapamil hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Anpec. 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 Anpec against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ANPEC IS USED FOR There are two types of Anpec: • Anpec tablets (available as Anpec 40mg and 80mg,) Anpec is used in the treatment of: • high blood pressure, also called hypertension • angina (chest pain) Anpec tablets are also used to treat irregular heartbeats, also called arrhythmias Your doctor may have prescribed Anpec for another reason. Ask your doctor if you have any questions about why Anpec has been prescribed for you. Anpec belongs to a group of medicines called calcium channel blockers or calcium antagonists. They work by opening up blood vessels, which lets more blood and oxygen reach the heart and at the same time lowers high blood pressure. Anpec tablets also help to control fast or irregular heartbeats. Anpec does not change the amount of calcium in your blood or bones. Calcium in your diet or in calcium supplements will not interfere with the way Anpec works. Anpec is available only with a doctor's prescription. There is no evidence that Anpec is addictive. BEFORE YOU TAKE ANPEC _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ANPEC IF YOU HAVE AN ALLERGY TO VERAPAMIL HYDROCHLORIDE OR 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 skin DO NOT TAKE ANPEC IF YOU: • have certain heart conditions Přečtěte si celý dokument
AUSTRALIAN PRODUCT INFORMATION ANPEC _Verapamil hydrochloride tablets _ 1 NAME OF THE MEDICINE Verapamil hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). Each ANPEC (immediate release formulation) tablet contains 40 mg or 80 mg of verapamil hydrochloride as the active ingredient. Excipients with known effect: None For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM ANPEC 40 mg tablets are available for oral administration as white, biconvex, film coated tablets, embossed "40" on one side and the Knoll triangle on the other side. ANPEC 80 mg tablets are available for oral administration as white, biconvex, film coated tablets. ANPEC tablets contain verapamil hydrochloride 40 mg or 80 mg as the active ingredient. Verapamil hydrochloride is present as a racemic mixture and different activities reside in the two enantiomers. Verapamil HCl is an almost white, crystalline powder, practically free of odour, with a bitter taste. It is soluble in water, sparingly soluble in alcohol, and practically insoluble in ether. Verapamil HCl is not chemically related to other cardioactive drugs. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ANPEC Tablets are indicated for: • Hypertension • Angina of effort • Angina at rest • Vasospastic angina (including Prinzmetal’s variant angina) • Tachyarrhythmias including paroxysmal supra-ventricular tachycardia • Atrial fibrillation with rapid ventricular response • Atrial flutter with rapid ventricular response 4.2 DOSE AND METHOD OF ADMINISTRATION All tablets of Anpec are to be swallowed whole. The tablets are not designed to be broken. The individual dose, and frequency of dosing, should be determined in accordance with the indication and individual patient response. ANPEC – PRODUCT INFORMATION 2 The usual starting dose is one 80 mg tablet two or three times a day. The maintenance dose may be adjusted to two 80 m Přečtěte si celý dokument