Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nicardipine hydrochloride
Laboratoire X.O
C08CA04
Nicardipine hydrochloride
30mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060200; GTIN: 5013346070021
WHAT IS IN THIS LEAFLET: 1. What Cardene is and what it is used for 2. What you need to know before you take Cardene 3. How to take Cardene 4. Possible side effects 5. How to store Cardene 6. Contents of the pack and other information The name of your medicine is Cardene 20mg/30mg capsules. However, it will be referred to as Cardene capsules throughout the remainder of the leaflet. 1. WHAT CARDENE IS AND WHAT IT IS USED FOR WHAT ARE CARDENE CAPSULES Cardene capsules contain the active ingredient nicardipine hydrochloride which belongs to the class of drugs called calcium channel blockers. These cause relaxation of the smooth muscle of the blood vessels causing these vessels to widen or dilate. WHAT CARDENE CAPSULES ARE USED FOR Your medicine is used for the treatment of mild to moderate high blood pressure (hypertension) and to help prevent attacks of chest pain diagnosed by your doctor as chronic stable angina. Chronic stable angina is a pattern of attacks of chest pain that are predictable and reproducible under certain conditions such as after exercise, stress or in cold weather. They are short in duration and can be relieved by rest or certain drugs. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARDENE DO NOT TAKE CARDENE • if you are ALLERGIC to NICARDIPINE, OTHER DIHYDROPYRIDINES, or ANY OF THE OTHER INGREDIENTS OF THIS MEDICINE (listed in section 6) • if you have had a RECENT HEART ATTACK (ie. within the last month) • if you suffer from a condition called SEVERE AORTIC STENOSIS which is narrowing of your aortic heart valve • if your CHEST PAIN IS DIAGNOSED BY YOUR DOCTOR AS UNSTABLE ANGINA (for example, if the pattern of attacks of chest pain changes and occurs without exertion, you should contact your doctor immediately) • if you need IMMEDIATE RELIEF OF CHEST PAIN IN A SUDDEN OR ACUTE ANGINA ATTACK (this situation should be treated with a different class of medicine) • TO TRY TO PREVENT THE OCCURRENCE OF FUTURE HEART ATTACKS (if you have already had at least one heart attack) • if you are PREGN Aqra d-dokument sħiħ
OBJECT 1 CARDENE 20MG Summary of Product Characteristics Updated 27-Apr-2017 | Astellas Pharma Ltd 1. Name of the medicinal product Cardene 20 mg Cardene 30 mg 2. Qualitative and quantitative composition Each Cardene 20 mg hard capsule contains nicardipine hydrochloride 20 mg Each Cardene 30 mg hard capsule contains nicardipine hydrochloride 30 mg For the full list of excipients, see section 6.1. 3. Pharmaceutical form Cardene 20 mg: Hard capsule with an opaque blue cap and opaque white body, marked in red ink with the strength and company logo. Cardene 30 mg: Hard capsule with an opaque blue cap and opaque pale blue body, marked in red ink with the strength and company logo. 4. Clinical particulars 4.1 Therapeutic indications Cardene is indicated in adults for the prophylaxis of patients with chronic stable angina. For the treatment of hypertension considered to be mild to moderate in severity. 4.2 Posology and method of administration Posology _Prophylaxis of chronic stable angina:_ Starting dose: 20 mg every 8 hours titrating upwards as required. Usual effective dose: 30 mg every 8 hours (range of total dose 60 mg - 120 mg per day). Allow at least 3 days before increasing the dose of Cardene to ensure steady state plasma levels have been achieved. _Hypertension:_ Starting dose: 20 mg every 8 hours titrating upwards as required. Usual effective dose: 30 mg every 8 hours (range of total dose 60 mg - 120 mg per day). _Use in elderly_ Starting dose is 20 mg 3 times a day. Titrate upwards with care as nicardipine may lower systolic pressure more than diastolic pressure in these patients. _Paediatric population_ The safety and efficacy in low birth weight infants, newborns, nursing infants, infants, and children has not been established. Cardene is not recommended in patients under the age of 18. Method of administration Cardene capsules are for oral administration. The capsules should be taken with a little water and swallowed whole. 4.3 Contraindications Pregnancy and lactation. Hypersensitivity to the active subs Aqra d-dokument sħiħ