RAPORSIN XL Prolonged-release tablet (2019)
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Περιεχόμενα
1. Name of the medicinal product
Raporsin XL 4mg Prolonged-release Tablets.
2. Qualitative and quantitative composition
<u>Each prolonged-release tablet contains:</u> 4 mg doxazosin (as mesilate). For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet. White, round, biconvex tablets with bossing DL.
4.1. Therapeutic indications
Essential hypertension. Symptomatic treatment of benign prostatic hyperplasia.
4.2. Posology and method of administration
Posology The maximum recommended dose is 8 mg doxazosin once daily. Essential hypertension <u>Adults:</u> Usually 4 mg doxazosin once daily. If necessary, the dosage may be increased to 8 mg doxazosin ...
4.3. Contraindications
Doxazosin is contraindicated in Patients with a known hypersensitivity to the active substance, to other quinazolines (e.g.prazosin, terazosin) or to any of the excipients listed in section 6.1. Patients ...
4.4. Special warnings and precautions for use
Doxazosin is not appropriate for first-line treatment for essential hypertension. It may be used as monotheraphy in patients who have failed to respond to or have contraindications to other agents. Alternatively, ...
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant use of Phosphodiesterase-5-inhubitors (e.g. sildenafil, tadalafil, vardenafil) and doxazosin may lead to symptomatic hypotension in some patients (see section 4.4.). No studies have been conducted ...
4.6. Pregnancy and lactation
Pregnancy For the hypertension indication: As there are no adequate and well controlled studies in pregnant women, the safety of doxazosin during pregnancy has not been established. Accordingly, during ...
4.7. Effects on ability to drive and use machines
The ability to engage in activities such as operating machinery or operating a motor vehicle may be impaired, especially when initiating therapy.
4.8. Undesirable effects
The following undesirable effects have been observed and reported during treatment with doxazosin with the following frequencies: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); ...
4.9. Overdose
Should overdosage lead to hypotension, the patient should be immediately placed in a supine, head down position. Other supportive measures should be performed if thought appropriate in individual cases. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Alpha-adrenoceptor antagonists <b>ATC code:</b> C02CA04 Hypertension Administration of Raporsin XL, prolonged-release tablets in hypertensive patients causes a clinically ...
5.2. Pharmacokinetic properties
Absorption After oral administration of therapeutic doses, doxazosin in Raporsin XL, prolonged-release tablets is well absorbed with peak blood levels gradually reached at 6 to 8 hours after dosing. Peak ...
5.3. Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity. Studies in pregnant rabbits and rats ...
6.1. List of excipients
<u>Tablet core:</u> Polyethylene oxide Cellulose, microcrystalline Povidone K 29-32 Butylhydroxytoluene (E321) All-rac-α-Tocopherol Silica, colloidal anhydrous Sodium stearyl fumarate <u>Tablet coat:</u> ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
4 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/PVDC/aluminium blister. <u>Pack sizes:</u> 10, 28, 30, 50, 90, 98 and 100 prolonged-release tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
8. Marketing authorization number(s)
PL 0142/1184
9. Date of first authorization / renewal of the authorization
12.02.2009 Renewal Approved 06.02.2014
10. Date of revision of the text
07/11/2019
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