NYZAMAC Prolonged-release capsule, hard (2018)
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Περιεχόμενα
1. Name of the medicinal product
Nyzamac SR 40 mg Capsules. Nyzamac SR 50 mg Capsules. Nyzamac SR 60 mg Capsules.
2. Qualitative and quantitative composition
Each 40 mg prolonged-release capsule contains 40 mg of isosorbide mononitrate. Each 50 mg prolonged-release capsule contains 50 mg of isosorbide mononitrate. Each 60 mg prolonged-release capsule contains ...
3. Pharmaceutical form
Prolonged-release capsule, hard. The 40mg capsule is a size 2 capsules and has an opaque white cap printed with «ISMN SR» in black ink and an opaque white body printed with «40» in black ink, containing ...
4.1. Therapeutic indications
Nyzamac SR capsules are indicated in adults for the prophylactic treatment of angina pectoris.
4.2. Posology and method of administration
Posology Adults One capsule once daily given in the morning. The dose may be increased up to 120 mg. The product must not be given in divided doses as a daily nitrate free period is required in order to ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. This product should not be given to patients with a known sensitivity to nitrates. Acute myocardial infarction ...
4.4. Special warnings and precautions for use
The lowest effective dose should be used. There is a risk of tolerance developing to modified release preparations. In such patients intermittent therapy may be more appropriate. Therapy should not be ...
4.5. Interaction with other medicinal products and other forms of interaction
The hypotensive effect of nitrates will be increased if used together with phosphodiesterase type-5 inhibitors (e.g. sildenafil). This might lead to life threatening cardiovascular complications. Any medication ...
4.6. Pregnancy and lactation
Pregnancy The safety and efficacy of Nyzamac SR Capsules during pregnancy in humans has not been established. Animal studies have shown reproductive toxicity (see section 5.3). Isosorbide mononitrate should ...
4.7. Effects on ability to drive and use machines
The patient should be warned not to drive or operate machinery if hypotension or dizziness occurs. These effects may be increased by alcohol.
4.8. Undesirable effects
Most of the adverse reactions are pharmacodynamically mediated and dose dependent. The frequency of possible side effects listed below is defined using the following convention: Very common (≥1/10), Common ...
4.9. Overdose
Symptoms and signs Pulsing headache. More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure. A rise in intracranial ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Vasodilator used in cardiac diseases <b>ATC code:</b> C01DA14 Mechanism of action Organic nitrates (including glyceryl trinitrate, isosorbide dinitrate and isosorbide ...
5.2. Pharmacokinetic properties
This product has all the pharmacokinetic characteristics of a true modified release dosage form. Compared with an immediate-release dosage form, the peak plasma concentration obtained is lower and occurs ...
5.3. Preclinical safety data
High concentrations of isosorbide mononitrate in rats is associated with prolonged gestation and parturition, stillbirths and deaths. After chronic administration at high doses (60mg/kg), signs of toxicity ...
6.1. List of excipients
<u>Capsule content:</u> Lactose monohydrate Sugar spheres (containing sucrose and maize starch) Bleached dewaxed shellac Dewaxed shellac Copolymer of methacrylic acid and methyl methacrylate (1:1) Copolymer ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5. Nature and contents of container
The capsules are packed in in blister packs (20 μm aluminium/250 μm PVC) and boxed in cardboard cartons containing 28, 30, 56 or 60 capsules. Sample blister pack of 8 capsules. Not all pack sizes may be ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Ethypharm, 194, Bureaux de la Colline – Bâtiment D, 92213 Saint-Cloud Cedex, France
8. Marketing authorization number(s)
PL 06934/0200 PL 06934/0207 PL 06934/0201
9. Date of first authorization / renewal of the authorization
PL 06934/0200: 2nd April 1996, 1st August 2001 PL 06934/0207: 24th June 2002, 17th March 2009 PL 06934/0201: 2nd April 1996, 1st August 2001
10. Date of revision of the text
September 2018
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