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NIFELAT Film-coated tablet (2021)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Nifelat 10 mg film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains 10 mg nifedipine. <u>Excipient(s) with known effect:</u> This product contains 60,9 mg lactose. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablet. Yellow, round, scored, film-coated tablets with Remedicas logo on one side. The tablet can be divided into equal doses using a pill cutter.

4.1. Therapeutic indications

Stable angina pectoris. Hypertension. Short-term treatment of Raynauds disease, primary as well as secondary.

4.2. Posology and method of administration

Posology The dose is adjusted individually. The tablets are swallowed whole with liquid, independently of meals. The tablets must not be crushed. Grapefruit juice should be avoided when taking these tablets ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, see also 4.4. Untreated heart failure. Acute myocardial infarction. Nifelat should not be used for the first ...

4.4. Special warnings and precautions for use

Caution is advised in patients with very low blood pressure (severe hypotension with systolic pressure <90 mm Hg), in case of manifest heart failure and severe aortic stenosis. Like other vascular active ...

4.5. Interaction with other medicinal products and other forms of interaction

Drugs that affect nifedipine Nifedipine is metabolised by the enzyme system cytochrome P450 3A4 (CYP3A4), which is located in both intestinal mucosa and in the liver. Medicinal products which inhibit or ...

4.6. Fertility, pregnancy and lactation

Pregnancy Nifedipine is contraindicated during pregnancy prior to week 20. Nifelat should not be used during pregnancy unless treatment with nifedipine is warranted by clinical condition of the woman. ...

4.7. Effects on ability to drive and use machines

Reactions to the drug, which may vary in intensity from person to person, may affect the ability to drive or perform precision work (see section 4.8). This applies above all when treatment is started, ...

4.8. Undesirable effects

Listed below are undesirable effects based on placebo-controlled studies with nifedipine according to CIOMS III frequency categories (clinical trial database: nifedipine n=2,661; placebo n=1,486; status: ...

4.9. Overdose

<u>Toxicity:</u> 60 mg in a 3-year-old caused mild to moderate intoxication after gastric emptying. 100 mg in a 12-year-old caused mild intoxication after gastric emptying. Three doses of 30 mg in an elderly ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Calcium channel blockers; Selective calcium channel blockers with mainly vascular effects <b>ATC code:</b> C08CA05 The active substance in Nifelat, the dihydropyridine ...

5.2. Pharmacokinetic properties

The bioavailability is 40-60%. Maximum plasma concentration is reached after about 2-4 hours. Concomitant food intake delays absorption without reducing it. In plasma nifedipine is highly protein bound ...

5.3. Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies regarding single and multiple dose toxicity, genotoxicity and carcinogenic potential. Reproductive toxicity Nifedipine ...

6.1. List of excipients

<u>Core:</u> Povidone Cellulose, microcrystalline Magnesium stearate Sodium starch glycolate (Type A) Lactose monohydrate Maize starch Silica, colloidal anhydrous <u>Coating:</u> Hypromellose Macrogol ...

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 30, 100 and 1000 film-coated tablets. PP/PE containers with PE closure. Pack sizes of 100 and 1000 film-coated 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 Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

8. Marketing authorization number(s)

19905

9. Date of first authorization / renewal of the authorization

Date of first authorization: 29 December 2005 Date of latest renewal: 10 July 2013

10. Date of revision of the text

16/02/2021

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