NIDEF Prolonged release tablet (2020)
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Περιεχόμενα
Name of the medicinal product
Nidef 30 mg Prolonged Release Tablets. Nifedipine Morningside 30 mg Prolonged Release Tablets.
Qualitative and quantitative composition
Each prolonged release tablet contains 30 mg nifedipine. Each tablet contains a 10% overage of nifedipine to deliver the label claim. For the full list of excipients, see section 6.1.
Pharmaceutical form
Pink coloured, film coated circular biconvex prolonged release tablets, having orifice on one side and plain on the other side.
Therapeutic indications
For the treatment of all grades of hypertension. For the prophylaxis of chronic stable angina pectoris either as monotherapy or in combination with a beta-blocker.
Posology and method of administration
Posology In mild to moderate hypertension, the recommended initial dose is one 20 mg tablet once daily. In severe hypertension, the recommended initial dose is one 30 mg tablet once daily. If necessary, ...
Contraindications
Nidef/Nifedipine Prolonged Released Tablets not be administered to patients with known hypersensitivity to the active substance, or to other dihydropyridines because of the theoretical risk of cross-reactivity, ...
Special warnings and precautions for use
Nidef/Nifedipine Prolonged Released Tablets must be swallowed whole; under no circumstances should they be bitten, chewed or broken up. Caution should be exercised in patients with hypotension as there ...
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 ...
Fertility, pregnancy and lactation
Pregnancy Nifedipine should not be used during pregnancy unless the clinical condition of the woman requires treatment with nifedipine (see section 4.4). In animal studies nifedipine has been shown to ...
Effects on ability to drive and use machines
Reactions to the drug, which vary in intensity from individual to individual, can impair the ability to drive or to operate machinery (see section 4.8). This applies particularly at the start of treatment, ...
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 ...
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, heart rhythm ...
Pharmacodynamic properties
Pharmacotherapeutic group: selective calcium channel blockers with mainly vascular effect, dihydropyridine derivatives ATC code: C08CA05 Nifedipine is a calcium antagonist of the 1,4-dihydropyridine type. ...
Pharmacokinetic properties
General characteristics Nidef/Nifedipine Prolonged Released Tablets are formulated to provide nifedipine at an approximately constant rate over 24 hours. Nifedipine is released from the tablet at a zero-order ...
Preclinical safety data
Preclinical data reveal no special hazards for humans based on conventional studies of single and repeated dose toxicity, genotoxicity and carcinogenic potential. Following acute oral and intravenous administration ...
List of excipients
<u>Core:</u> Polyethylene oxide Hydroxy propyl methyl cellulose (E463) Sodium chloride Polyethylene oxide Ferric oxide (E172) Magnesium stearate (E572) <u>Seal coating:</u> Hypromellose (E464) Cellulose ...
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Store in the original container.
Nature and contents of container
PVC/PE/PVDC, Aluminium Blister. Blister packs of 10, 14, 15, 28, 30, 56, 60, 90 and 112 Prolonged Release Tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special precautions.
Marketing authorization holder
Morningside Healthcare Ltd, Unit C, Harcourt Way, Leicester, LE19 1WP, UK
Marketing authorization number(s)
PL 20117/0228
Date of first authorization / renewal of the authorization
29/07/2013
Date of revision of the text
22/10/2020
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