GRANPIDAM Film-coated tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Granpidam 20 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 20 mg of sildenafil (as citrate). <u>Excipient(s) with known effect:</u> Each tablet also contains 0.2 mg of lactose (as monohydrate). For the full list of excipients, ...
3. Pharmaceutical form
Film-coated tablet (tablet). White to off white, round shaped, approximately 6.6 mm in diameter, biconvex, film-coated tablets, debossed with 20 on one side and plain on other side.
4.1. Therapeutic indications
Adults Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension ...
4.2. Posology and method of administration
Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. In case of clinical deterioration in spite of Granpidam treatment, alternative ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form due to the hypotensive ...
4.4. Special warnings and precautions for use
The efficacy of sildenafil has not been established in patients with severe pulmonary arterial hypertension (functional class IV). If the clinical situation deteriorates, therapies that are recommended ...
4.5. Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on sildenafil <em>In vitro</em> studies Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route). ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential and contraception in males and females Due to lack of data on effects of sildenafil in pregnant women, Granpidam is not recommended for women of childbearing potential unless ...
4.7. Effects on ability to drive and use machines
Sildenafil has moderate influence on the ability to drive and use machines. As dizziness and altered vision were reported in clinical studies with sildenafil, patients should be aware of how they might ...
4.8. Undesirable effects
Summary of the safety profile In the pivotal placebo-controlled study of sildenafil in pulmonary arterial hypertension, a total of 207 patients were randomised to and treated with 20 mg, 40 mg, or 80 mg ...
4.9. Overdose
In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. At single doses of 200 mg the ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Urologicals, Drugs used in erectile dysfunction, <b>ATC code:</b> G04BE03 Mechanism of action Sildenafil is a potent and selective inhibitor of cyclic guanosine monophosphate ...
5.2. Pharmacokinetic properties
Absorption Sildenafil is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. The mean absolute oral bioavailability ...
5.3. Preclinical safety data
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential, toxicity to reproduction and ...
6.1. List of excipients
<u>Tablet core:</u> Microcrystalline cellulose Calcium hydrogen phosphate Croscarmellose sodium Hypromellose 2910 (E464) Magnesium stearate <u>Film coat:</u> Hypromellose 2910 (E464) Titanium dioxide (E171) ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
PVC/Alu blisters packs containing 90 tablets and 300 tablets. PVC/Alu perforated unit dose blister packs containing 15x1, 90x1 and 300x1 tablets. 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
Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain
8. Marketing authorization number(s)
EU/1/16/1137/001 EU/1/16/1137/002 EU/1/16/1137/003 EU/1/16/1137/004 EU/1/16/1137/005
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 14<sup>th</sup> November 2016
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