MONOREM Prolonged-release tablet (2021)
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
Monorem R 60 mg prolonged-release tablets.
2. Qualitative and quantitative composition
Each prolonged-release tablet contains diluted isosorbide mononitrate equivalent to 60 mg isosorbide mononitrate. <u>Excipient(s) with known effect:</u> This product contains 215 mg lactose. For the full ...
3. Pharmaceutical form
Prolonged-release tablet. White, oval tablets, scored on both sides and embossed with R/R on one side. The tablet can be divided into equal doses.
4.1. Therapeutic indications
Prophylactic treatment of angina pectoris. Monorem R is not indicated for relief of acute angina attacks; in the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets should be used. ...
4.2. Posology and method of administration
Posology Adults Monorem R 60 mg (one tablet) once daily given in the morning. The dose may be increased to 120 mg (two tablets) daily, both to be taken once daily in the morning. This will produce effective ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Monorem R should not be used in patients with constrictive cardiomyopathy and pericarditis, acute myocardial ...
4.4. Special warnings and precautions for use
Nitrates may give rise to symptoms of collapse after the first dose in patients with labile circulation. These symptoms can largely be avoided if the treatment is started with a 30 mg dose. The safety ...
4.5. Interaction with other medicinal products and other forms of interaction
Some of the effects of alcohol and other vasodilators may be potentiated by this agent. Concomitant administration of Monorem R and Phosphodiesterase Type 5 Inhibitors can potentiate the vasodilatory effect ...
4.6. Pregnancy and lactation
The safety and efficacy of Monorem R during pregnancy or lactation has not been established. Monorem R should not be used during pregnancy or lactation unless considered essential by the physician. Breast-feeding ...
4.7. Effects on ability to drive and use machines
Patients may develop dizziness when first using Monorem R. Patients should be advised to determine how they react to Monorem R before they drive or operate machinery.
4.8. Undesirable effects
Most of the adverse reactions are pharmacodynamically mediated and dose dependent. Headache may occur when treatment is initiated, but usually disappears during continued treatment. Hypotension, with symptoms ...
4.9. Overdose
Symptoms Pulsing headache. More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure. Management Induction of emesis, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Cardiac therapy, Vasodilators used in cardiac diseases <b>ATC Code:</b> C01DA14 The principal pharmacological action of isosorbide mononitrate, an active metabolite of ...
5.2. Pharmacokinetic properties
The active substance contained in isosorbide mononitrate prolonged-release tablets is released independently of pH. Compared to ordinary tablets the absorption phase is prolonged and the duration of effect ...
5.3. Preclinical safety data
The accessible data indicate that isosorbide mononitrate has expected pharmacodynamic properties of an organic nitrate ester, has simple pharmacokinetic properties, and is devoid of toxic, mutagenic or ...
6.1. List of excipients
Lactose monohydrate Hypromellose Maize starch Glyceryl palmitostearate Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light and moisture.
6.5. Nature and contents of container
Aluminium/PVC blisters. Pack sizes of 30 and 100 prolonged-release tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Remedica Ltd, Aharnon Str, Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
21764
9. Date of first authorization / renewal of the authorization
Date of first authorization: 27 May 2013 Date of latest renewal: 03 March 2020
10. Date of revision of the text
12 January 2021
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
