AMLOBE Tablet (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
AmloBe 5 mg tablets. AmloBe 10 mg tablets.
2. Qualitative and quantitative composition
<u>AmloBe 5 mg tablets:</u> Each tablet contains 6.94 mg amlodipine besylate equivalent to 5 mg of amlodipine. <u>AmloBe 10 mg tablets:</u> Each tablet contains 13.88 mg amlodipine besylate equivalent ...
3. Pharmaceutical form
Tablet. <u>5 mg tablets:</u> white, round, slightly biconvex, bevel-edged, scored on one side, diameter 8 mm. The tablet can be divided into equal halves. <u>10 mg tablets:</u> white, round, slightly biconvex, ...
4.1. Therapeutic indications
Essential hypertension. Chronic stable and vasospastic angina pectoris.
4.2. Posology and method of administration
Posology Adults For both hypertension and angina, the usual initial dose is 5 mg AmloBe once daily, which may be increased to a maximum dose of 10 mg depending on the individual patients response. In hypertensive ...
4.3. Contraindications
Amlodipine is contra-indicated in patients with: Hypersensitivity to dihydropyridine derivatives, amlodipine or any of the excipients listed in section 6.1. Severe hypotension. Shock (including cardiogenic ...
4.4. 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 ...
4.5. 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 ...
4.6. 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 ...
4.7. Effects on ability to drive and use machines
AmloBe 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. ...
4.8. 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 ...
4.9. 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 ...
5.1. 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 ...
5.2. 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 ...
5.3. 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 ...
6.1. List of excipients
Microcristalline cellulose (E460) Pregelatinised maize starch Sodium starch glycolate (type A) Colloidal anhydrous silica (E551) Magnesium stearate (E470b)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store in the original container in order to protect from light.
6.5. Nature and contents of container
<u>OPA-Al-PVC/Al blister:</u> 30 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Germany Tel: +49 4721 606 0, Fax: +49 4721 606 333, Email: info@tad.de Distributor: Ki.Pa pharrmacal Ltd, 9, Polygyrou Street PO Box 40608 Larnaca, ...
8. Marketing authorization number(s)
AmloBe 5 mg tablets: 21192 AmloBe 10 mg tablets: 21193
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 05.03.2012 / 20/09/2018
10. Date of revision of the text
20/09/2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
