FENAMON SR Modified release tablet (2016)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Fenamon SR 20 mg modified release tablets.
2. Qualitative and quantitative composition
Each modified release tablet contains 20 mg of nifedipine. <u>Excipients with known effect:</u> lactose, sunset yellow. Each modified release tablet contains 19.00 mg lactose monohydrate and 0.79 mg sunset ...
3. Pharmaceutical form
Modified release tablet. Yellow, round, convex modified release tablet.
4.1. Therapeutic indications
For the prophylaxis of chronic stable angina pectoris and the treatment of hypertension.
4.2. Posology and method of administration
Posology The recommended starting dose of nifedipine is 10 mg every 12 hours swallowed with water with subsequent titration of dosage according to response. The dose may be adjusted to 40 mg every 12 hours, ...
4.3. Contraindications
Hypersensitivity to the active substance, to other dihydropyridines because of the theoretical risk of cross-reactivity or to any of the excipients (see section 4.4 and 6.1). Nifedipine must not be used ...
4.4. Special warnings and precautions for use
Nifedipine is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be a gradual reduction of the dose of beta-blocker preferably ...
4.5. Interaction with other medicinal products and other forms of interaction
Drugs that affect nifedipine Nifedipine is metabolised via the cytochrome P450 3A4 system, located both in the intestinal mucosa and in the liver. Drugs that are known to either inhibit or to induce this ...
4.6. Fertility, pregnancy and lactation
Pregnancy Nifedipine should not be used during pregnancy unless the clinical condition of the woman requires treatment with nifedipine. Nifedipine should be reserved for women with severe hypertension ...
4.7. Effects on ability to drive and use machines
Reactions to the drug, which vary in intensity from individual to individual, may impair the ability to drive or to operate machinery (see section 4.8). This applies particularly at the start of treatment, ...
4.8. Undesirable effects
Adverse drug reactions (ADRs) based on placebo-controlled studies with nifedipine sorted by CIOMS III categories of frequency (clinical trial data base: nifedipine n=2,661; placebo n=1,486; status: 22 ...
4.9. Overdose
Symptoms The following symptoms are observed in cases of severe nifedipine intoxication: Disturbances of consciousness to the point of coma, a drop in blood pressure, tachycardia, bradycardia, hyperglycaemia, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Dihydropyridine derivatives, Calcium Channel Blockers <b>ATC code:</b> C08CA05 Nifedipine is a specific and potent calcium antagonist of the 1, 4-dihydropyridine type. ...
5.2. Pharmacokinetic properties
Absorption After oral administration nifedipine is rapidly and almost completely absorbed. The systemic availability of orally administered nifedipine is 45-56% owing to a first pass effect. Maximum plasma ...
5.3. Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity and carcinogenic potential. Reproduction toxicology Nifedipine has ...
6.1. List of excipients
Lactose monohydrate Starch maize Polysorbate 80 Cellulose microcrystalline Colloidal silica gel Magnesium stearate <u>The film coating consists of:</u> Hypromellose Polyethylene glycol 400 Titanium dioxide ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25°C in the original package, in order to protect from light and moisture.
6.5. Nature and contents of container
White polyvinylchloride film – aluminium foil blisters of ten tablets. Packs, with a patient information leaflet, containing 20, 30 or 50 tablets are available. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
19938
9. Date of first authorization / renewal of the authorization
22/12/2005
10. Date of revision of the text
10/2016
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