DYNACIRC SRO Modified release capsule (2019)
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Περιεχόμενα
Name of the medicinal product
DYNACIRC SRO 2.5mg Modified Release (SRO) Capsules. DYNACIRC SRO 5mg Modified Release (SRO) Capsules.
Qualitative and quantitative composition
One 2.5mg Modified Release (SRO) Capsule contains 2.5 mg of isradipine. One 5 mg Modified Release (SRO) Capsule contains 5 mg of isradipine. For the full list of excipients, see Section 6.1.
Pharmaceutical form
2.5 mg and 5 mg modified release capsules (SRO capsules) for oral administration.
Therapeutic indications
Treatment of hypertension.
Posology and method of administration
The recommended dosage in mild to moderate hypertension is one 5 mg SRO capsule once a day. Dynacirc SRO capsules must be swallowed whole. If one 5 mg SRO capsule once a day is not sufficiently effective ...
Contraindications
Known hypersensitivity to isradipine, to other calcium channel blockers of the dihydropyridine type or to any of the excipients (see section 6.1 List of Excipients). As with other calcium channel blockers ...
Special warnings and precautions for use
Individualized dosing of Dynacirc SRO is recommended for elderly patients and patients with hepatic impairment. A cautious dosing regimen is recommended for patients with renal impairment or chronic heart ...
Interaction with other medicinal products and other forms of interaction
Interactions resulting in a concomitant use not recommended Effects of other drugs / enzymatic systems on isradipine Anticonvulsant drugs Concurrent administration of rifampicin greatly reduces the plasma ...
Fertility, Pregnancy and lactation
Women of child-bearing potential There are no data supporting any special recommendations in women of child-bearing potential. Fertility Animal studies do not show any harmful effects on fertility (see ...
Effects on ability to drive and use machines
There are no data on the effects of Dynacirc SRO on the ability to drive or use machines.As with other calcium channel blockers, syncope, dizziness, hypotension, visual disturbances and blurred vision ...
Undesirable effects
Most adverse reactions observed in clinical trials were mild, generally dose-dependent and related to the vasodilating properties of Dynacirc: dizziness, headache, flushing, tachycardia, palpitations and ...
Overdose
Signs and Symptoms Experience with Dynacirc SRO overdosage is limited. The available data suggests that overdosage might result in marked and prolonged hypotension. Treatment Patients should be admitted ...
Pharmacodynamic properties
Pharmacotherapeutic group: Selective calcium channel blockers with mainly vascular effects, dihydropyridine derivatives ATC code: C08CA03 Isradipine, the active substance of Dynacirc, is a potent dihydropyridine ...
Pharmacokinetic properties
Absorption After 90 to 95% absorption from the gastrointestinal tract, Dynacirc undergoes extensive first-pass metabolism resulting in a bioavailability of about 16 to 18%. After doses of up to 20 mg, ...
Preclinical safety data
Preclinical data-based on conventional studies of single and multiple dose toxicity reveal no special hazard for humans. There is no genotoxic, clastogenic or carcinogenic potential. Animal studies do ...
List of excipients
Cellulose, microcrystalline Cetyl palmitate Gelatine Iron oxide, black (only for Dynacirc 2.5 mg SRO) Iron oxide, red (only for Dynacirc 5 mg SRO) Iron oxide, yellow Magnesium stearate Hypromellose Shellac ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store below 30°C. Dynacirc SRO must be kept out of the reach and sight of children.
Nature and contents of container
Alu/PVC/PVDC blister pack containing 10 or 30 capsules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Novartis New Zealand Limited, 109 Carlton Gore Road, Newmarket, Auckland 1023, PO Box 99102, Newmarket, Auckland 1149, Telephone: 0800 354 335
Date of first authorization / renewal of the authorization
30 May 1991
Date of revision of the text
27 May 2019
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