ISTIN Tablet (2022)
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Περιεχόμενα
Name of the medicinal product
ISTIN 5 mg tablets.
Qualitative and quantitative composition
Each tablet contains amlodipine besilate equivalent to 5 mg amlodipine. Excipients: For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White to off-white, emerald-shaped tablets engraved AML 5 and breaker score on one side and Pfizer logo on the other side. The 5 mg tablet can be divided into equal halves.
Therapeutic indications
Hypertension. Chronic stable angina pectoris. Vasospastic (Prinzmetals) angina.
Posology and method of administration
Posology Adults For both hypertension and angina the usual initial dose is 5 mg Istin once daily which may be increased to a maximum dose of 10 mg depending on the individual patients response. In hypertensive ...
Contraindications
Amlodipine is contraindicated in patients with: hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1. severe hypotension. shock (including cardiogenic ...
Special warnings and precautions for use
The safety and efficacy of amlodipine in hypertensive crisis has not been established. Patients with cardiac failure Patients with heart failure should be treated with caution. In a long-term, placebo ...
Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on amlodipine CYP3A4 inhibitors Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides like erythromycin ...
Fertility, pregnancy and lactation
Pregnancy The safety of amlodipine in human pregnancy has not been established. In animal studies, reproductive toxicity was observed at high doses (see section 5.3). Use in pregnancy is only recommended ...
Effects on ability to drive and use machines
Amlodipine can have minor or moderate influence on the ability to drive and use machines. If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired. ...
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions during treatment are somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and ...
Overdose
In humans experience with intentional overdose is limited. Symptoms Available data suggest that gross overdosage could result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Calcium channel blockers, selective calcium channel blockers with mainly vascular effects <b>ATC Code:</b> C08CA01 Amlodipine is a calcium ion influx inhibitor of the ...
Pharmacokinetic properties
Absorption, distribution, plasma protein binding After oral administration of therapeutic doses, amlodipine is well absorbed with peak blood levels between 6-12 hours post dose. Absolute bioavailability ...
Preclinical safety data
Reproductive toxicology Reproductive studies in rats and mice have shown delayed date of delivery, prolonged duration of labour and decreased pup survival at dosages approximately 50 times greater than ...
List of excipients
Microcrystalline cellulose Calcium hydrogen phosphate anhydrous Sodium starch glycolate Type A Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
PVC-PVDC/Aluminium foil blisters containing 4, 10, 14, 20, 28, 30, 50, 60, 98, 100, 300, 500 tablets. PVC-PVDC/Aluminium foil blisters in calendar packs containing 28 and 98 tablets. PVC-PVDC/Aluminium ...
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Upjohn UK Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 50622/0033
Date of first authorization / renewal of the authorization
18<sup>th</sup> September 1989 / 8<sup>th</sup> February 2013
Date of revision of the text
06/2022
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