MONOREM Tablet (2019)
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Περιεχόμενα
1. Name of the medicinal product
Monorem 20 mg tablets.
2. Qualitative and quantitative composition
Each tablet contains diluted isosorbide mononitrate equivalent to 20 mg isosorbide mononitrate. <u>Excipients with known effect:</u> Each tablet contains 146,7 mg lactose monohydrate. For the full list ...
3. Pharmaceutical form
Tablet. White, round, flat, scored tablets with Remedicas logo on one side. The tablet can be divided into equal doses.
4.1. Therapeutic indications
For the prophylaxis and long term management of angina pectoris. As adjunctive therapy after acute myocardial infraction and chronic congestive heart failure.
4.2. Posology and method of administration
Posology Adults One tablet to be taken asymmetrically (to allow a nitrate low period) two or three times a day. The dosage may be increased up to 120 mg per day. Dosage regime should be designed according ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Monorem should not be used in cases of acute myocardial infarction with low filling pressure, acute circulatory ...
4.4. Special warnings and precautions for use
This product may give rise to postural hypotension and syncope in some patients. Severe postural hypotension with light-headedness and dizziness is frequently observed after the consumption of alcohol. ...
4.5. Interaction with other medicinal products and other forms of interaction
Concurrent adminitration of drugs with blood pressure lowering properties e.g. beta-blockers, calcium channel blockers, vasodilators, alprostadil, aldesleukin, ACE-inhibitors, monoamine oxidase inhibitors, ...
4.6. Fertility, pregnancy and lactation
Pregnancy Safety in pregnancy has not been established for isosorbide mononitarte. There is data that nitrates are excreted in breast milk and may cause methemoglobinemia in infants. Therefore, Monorem ...
4.7. Effects on ability to drive and use machines
Dizziness, tiredness or blurred vision might occur at the start of treatment. If affected, do not drive or operate machinery. This effect may be increased by alcohol.
4.8. Undesirable effects
Undesirable effects frequencies are defined as: very common (≥1/10), common (≥1/100<1/10), uncommon (≥1/1,000<1/100), rare (≥1/10,000<1/1,000), very rare (<1/10,000), not known (cannot be estimated from ...
4.9. Overdose
Animal experience In rats and mice, significant lethality at oral doses of 1965 mg/kg and 2581 g/kg, respectively, was observed. Human experience Symptoms: fall of blood pressure ≤90 mmHg. paleness. sweating. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Cardiac therapy; Vasodilator used in cardiac diseases <b>ATC code:</b> C01DA14 Isosorbide mononitrate is an organic nitrate which in common with other cardioactive nitrates ...
5.2. Pharmacokinetic properties
Isosorbide-5-mononitrate is rapidly absorbed and peak plasma levels occur approx. 1 hour following oral dosing. Isosorbide-5-mononitrate is completely bioavailable after oral doses and is not subject to ...
5.3. Preclinical safety data
Acute toxicity Studies on acute toxicity in mice and rats with different routes of administration indicate a low acute toxicity (LD<sub>50</sub> oral approximately 2,000-2,500 mg/kg b.w.). Chronic toxicity ...
6.1. List of excipients
Lactose monohydrate Talc Silica, colloidal anhydrous Maize starch Cellulose, microcrystalline 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
PVC/Aluminium blisters. Pack sizes of 50, 100 and 1000 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 Street, Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
21074
9. Date of first authorization / renewal of the authorization
Date of first authorization: 24 August 2011 Date of latest renewal: 07 August 2018
10. Date of revision of the text
15/01/2019
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