DENEX Tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Denex 100mg tablets.
2. Qualitative and quantitative composition
Each tablet contains 100 mg metoprolol tartrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. White, round, flat, scored tablets. The tablet can be divided into equal doses.
4.1. Therapeutic indications
Hypertension and angina pectoris, cardiac arrhythmias, especially supraventricular tachyarrhythmias. Adjunct to treatment of thyrotoxicosis. Early intervention with metoprolol in myocardial infarction ...
4.2. Posology and method of administration
Method of administration Denex tablets should be administered orally and swallowed unchewed. The dose must always be adjusted to the individual requirements of the patient, but should not exceed 400 mg/day. ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Known hypersensitivity to metoprolol and related derivatives. Severe asthma or history of severe bronchospasm. ...
4.4. Special warnings and precautions for use
A warning stating Do not take this medicine if you have a history of wheezing or asthma will appear on the label. Although cardioselective beta-blockers may have less effect on lung function than non-selective ...
4.5. Interaction with other medicinal products and other forms of interaction
The effects of metoprolol and other antihypertensive drugs on blood pressure are usually additive and care should be taken to avoid hypotension. However, combinations of antihypertensive drugs may often ...
4.6. Pregnancy and lactation
Beta-blockers reduce placental perfusion which may result in intrauterine foetal death, immature and premature deliveries. Denex should not be used in pregnancy or lactation unless it is considered that ...
4.7. Effects on ability to drive and use machines
As with all beta-blockers, metoprolol may affect patients' ability to drive and operate machinery. Patients should be warned accordingly.
4.8. Undesirable effects
The following definitions of frequencies are used: very common (1/10)>, common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be ...
4.9. Overdose
Signs and symptoms In more severe cases an overdosage of metoprolol may lead to severe hypotension, sinus bradycardia, atrioventricular block, heart failure, cardiogenic shock, cardiac arrest, bronchospasm, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Beta blocking agents, selective <b>ATC code:</b> C07AB02 Denex is a cardioselective beta-adrenergic blocking agent. Mechanism of action It has a relatively greater blocking ...
5.2. Pharmacokinetic properties
Absorption Metoprolol is well absorbed after oral administration, peak plasma concentrations occurring 1.5-2 hours after dosing. The bioavailability of a single dose is approximately 50%, increasing to ...
5.3. Preclinical safety data
There are no further data of relevance to the prescriber.
6.1. List of excipients
Croscarmellose sodium Povidone Microcrystalline cellulose Colloidal silicon dioxide Purified talc Magnesium stearate
6.2. Incompatibilities
No known incompatibilities.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
PVC-Al blisters of 10 tablets in packs of 30, 50, 100, 500 and 1000 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
8270
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 11.02.1982 Date of latest renewal: 30.04.2010
10. Date of revision of the text
10/2021
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