KAMIREN Prolonged-release tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Kamiren 4 mg prolonged-release tablets.
2. Qualitative and quantitative composition
Each tablet contains 4mg doxazosin (as mesilate). <u>Excipient(s) with known effect:</u> Lactose Monohydrate 74.27mg. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablets. Kamiren 4 mg prolonged-release tablets are white, round, biconvex tablets.
4.1. Therapeutic indications
Hypertension Kamiren 4 mg prolonged-release tablets are indicated for the treatment of hypertension and can be used as a sole agent to control blood pressure in hypertensive patients. In patients inadequately ...
4.2. Posology and method of administration
Posology The initial dose of Kamiren prolonged-release tablets is 4 mg once daily. A significant number of patients will be controlled on this dose. If necessary, the dosage may be increased to 8 mg once ...
4.3. Contraindications
Kamiren prolonged-release tablets are contraindicated in Patients who are hypersensitive to the active substance, other types of quinazolines (e.g. prazosin, terazosin), or to any of the excipients listed ...
4.4. Special warnings and precautions for use
Information to be given to the patient Patients should be informed that Kamiren prolonged-release tablets should be swallowed whole. Patients should not chew, divide or crush the tablets. In Kamiren the ...
4.5. Interaction with other medicinal products and other forms of interaction
Phosphodiesterase Type-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) Concomitant administration of an alpha blocker with a PDE-5 inhibitor may lead to symptomatic hypotension in some patients (see ...
4.6. Pregnancy and lactation
For the hypertension indication Pregnancy As there are no adequate and well-controlled studies in pregnant women, the safety of Kamiren prolonged-release tablets during pregnancy has not yet been established. ...
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. The drug may also induce drowsiness. Patients should not ...
4.8. Undesirable effects
In clinical trials, the most common reactions associated with Kamiren prolonged-release tablets were of a postural type (rarely associated with fainting) or non-specific. The undesirable effects for doxazosin ...
4.9. Overdose
Should overdosage lead to hypotension, the patient should be immediately placed in a supine, head down position. Other supportive measures may be appropriate in individual cases. Since doxazosin is highly ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antihypertensives, alpha-adrenoceptor antagonists <b>ATC code:</b> C02CA04 Mode of action Doxazosin is a potent and selective post-junctional alpha<sub>1</sub>-adrenoceptor ...
5.2. Pharmacokinetic properties
Absorption After oral administration of therapeutic doses, Doxazosin prolonged-release tablets are well absorbed with peak blood levels gradually reached at 8 to 9 hours after dosing. Peak plasma levels ...
5.3. Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional animal studies in safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity. For further information see section ...
6.1. List of excipients
<u>Tablet core:</u> Hypromellose Calcium hydrogen phosphate Lactose monohydrate Magnesium stearate <u>Coating:</u> Opadry white Y-1-7000 consists of: Hypromellose Titanium dioxide (E171) Macrogol 400 ...
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
Kamiren 4 mg prolonged-release tablets are available as pack of 28 tablets. OPA/Alu/PVC film with Alu foil blister strips in a carton box.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
8. Marketing authorization number(s)
PA1347/038/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 3<sup>rd</sup> March 2006 Date of last renewal: 3<sup>rd</sup> March 2011
10. Date of revision of the text
August 2021
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