LOGIMAX Prolonged-release tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Logimax 5 mg/50 mg prolonged-release tablets.
2. Qualitative and quantitative composition
1 prolonged-release tablet contains: 5 mg felodipine and metoprolol succinate equivalent to 50 mg metoprolol tartrate. <u>Excipients with known effect:</u> polyoxyl 40 hydrogenated castor, lactose and ...
3. Pharmaceutical form
Prolonged-release tablet. Logimax prolonged-release tablets contain metoprolol succinate in the form of granules, which each form an individual depot unit, and which together with felodipine are embedded ...
4.1. Therapeutic indications
Hypertension. Logimax can be used when treatment with beta-blockers or calcium antagonists of the dihydropyridine type in monotherapy has not produced an adequate effect.
4.2. Posology and method of administration
Adults One Logimax 5/50 tablet once daily, if needed the dose may be doubled to two Logimax 5/50 tablets once daily. Patients with renal impairment Dose adjustment is not needed in patients with impaired ...
4.3. Contraindications
Known hypersensitivity to the active substances, to any of the excipients listed in section 6 to other dihydropyridines or beta-blockers. Pregnancy. Acute myocardial infarction. Unstable angina pectoris. ...
4.4. Special warnings and precautions for use
The fixed combination of felodipine and metoprolol, can like other antihypertensives, cause hypotension. Felodipine may cause significant hypotension with subsequent tachycardia. This may in susceptible ...
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant administration of substances that influence the cytochrome P450 system can affect the plasma concentration of both felodipine and metoprolol. Felodipine and metoprolol do not interact with ...
4.6. Fertility, pregnancy and lactation
Fertility Data on male and female fertility in patients are missing (see section 5.3). Pregnancy Logimax should not be given during pregnancy. Breast-feeding Felodipine passes into human milk. When taken ...
4.7. Effects on ability to drive and use machines
Since dizziness and fatigue can occur during treatment with Logimax, this should be taken into account when increased alertness is required, for instance when driving a vehicle or using a machine. The ...
4.8. Undesirable effects
Logimax is well tolerated and adverse reactions have generally been mild and reversible. The most common undesirable effects reported in clinical trials with Logimax are headache, swelling of the ankles, ...
4.9. Overdose
Toxicity Felodipine 10 mg in a 2-year-old caused mild intoxication. 150-200 mg in a 17-year-old and 250 mg in an adult caused mild to moderate intoxication. Probably a more pronounced effect on the peripheral ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Calcium antagonists and beta-blockers <b>ATC code:</b> C07FB02 Logimax is an antihypertensive preparation consisting of a combination of felodipine, which is a calcium ...
5.2. Pharmacokinetic properties
Felodipine Bioavailability is approx. 15% and is not influenced by concomitant food intake. The rate –but not the extent– of absorption is affected by concomitant food intake, which is why the maximum ...
5.3. Preclinical safety data
Available studies concerning general toxicity, genotoxicity and carcinogenicity did not reveal any special risks for humans. In animal studies beta-receptor blockers caused bradycardia in the foetuses. ...
6.1. List of excipients
Colouring agents (titanium dioxide E171, iron oxide E172), lactose anhydrous 42 mg, propyl gallate, silicon dioxide, paraffin, hypromellose, cellulose microcrystalline, ethylcellulose, hydroxypropylcellulose, ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
PVC/PVDC blister packs. 28 tablets.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Recordati Ireland Ltd, Raheens East, Ringaskiddy, Co. Cork, Ireland Τel.: +353 21 4379 400, Fax: +353 21 4379 264
8. Marketing authorization number(s)
16252
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 19 July 1995 Date of latest renewal: 16 September 2011
10. Date of revision of the text
28/9/2020
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