Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ACITRETIN
SCHMIDT BIOMEDTECH SDN BHD
ACITRETIN
60capsule Capsules
Micro-sphere SA
DESCRIPTION : Novatretin Caps PIL MY 310083 SIZE : 510 x 210 mm PRINTED : Black DATE : Wednesday 02 August 2023 Novatretin Capsules ® Acitretin (10 mg and 25) _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ _ _ _ _ WHAT IS IN THIS LEAFLET 1. What NOVATRETIN CAPSULES is used for 2. How NOVATRETIN CAPSULES works 3. Before you use NOVATRETIN CAPSULES 4. How to use NOVATRETIN CAPSULES 5. While you are using it 6. Side effects 7. Storage and Disposal of NOVATRETIN CAPSULES 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT NOVATRETIN CAPSULES IS USED FOR NOVATRETIN is used to treat severe forms of psoriasis and severe disorders of keratinization HOW NOVATRETIN CAPSULES WORKS The active ingredient in NOVATRETIN capsules is acitretin, which belongs to a group of medicines called retinoids. It is very similar to Vitamin A which is obtained from our diet and is vital for the normal growth and development of the body, especially the skin. NOVATRETIN works to return skin to normal when problems with the normal development of the skin are present, as in the case of severe psoriasis and some other skin disorders. There are various types of medicines used to treat skin conditions. You may have been prescribed NOVATRETIN by your doctor for another reason. If you have any questions about why NOVATRETIN has been prescribed for you, ask your doctor. NOVATRETIN is only accessible with a doctor’s prescription BEFORE YOU USE NOVATRETIN CAPSULES _-_ _ _ _When you must not use it_ _ _ Do not take NOVATRETIN capsules if: • you are pregnant or you intend to become pregnant in the next 36 months. Any possibility that you may be pregnant must be ruled out by both yourself and your doctor before you start taking NOVATRETIN capsules. The result of a pregnancy test must be negative when performed within one week before beginning of NOVATRETIN treatment. NOVATRETIN is highly teratogenic i.e. there is an extremely high risk of having a baby that is severely deformed. This means you must u Baca dokumen lengkap
Novatretin TM Package Insert Acitretin 10 mg and 25 mg Capsules DESCRIPTION: Novatretin Caps MY 310082 SIZE: 510 x 210 mm PRINTED: Black (50% - 100%) DATE: Wednesday 22 February 2023 PRESENTATION Novatretin 10 mg Capsules are hard gelatin capsules containing a yellow powder with a white to off-white body and a brown cap printed in black with “A10” on the capsule body. Novatretin 25 Capsules are hard gelatin capsules containing a yellow powder with a yellow to light yellow body and a brown cap printed in black with “A25” on the capsule body. ACTIONS Acitretin, the active ingredient of NOVATRETIN, is a synthetic aromatic analogue of retinoic acid. In preclinical investigations of the tolerability of acitretin, no relevant mutagenic or carcinogenic effects were found, nor was there any evidence of direct liver toxicity. Acitretin was found to be highly teratogenic in animals. Clinical trials confirmed that, in psoriasis and disorders of keratinization, acitretin brought about normalization of epidermal cell proliferation, differentiation and cornification, while the side effects were, in general, tolerable. The effect of acitretin is purely symptomatic; the mechanism of action is as yet largely unknown. PHARMACOKINETICS Absorption Acitretin reaches peak plasma concentration 1-4 hours after ingestion of the medicine. Bioavailability of orally administered acitretin is best when the medicine is taken together with food. Bioavailability of a single dose is approximately 60%, but this may vary considerably (36-95%). Distribution Acitretin is highly lipophilic and penetrates readily into body tissues. Protein binding of acitretin exceeds 99%. In animal studies, acitretin passed the placental barrier in quantities sufficient to produce foetal malformations. Due to its lipophilic nature, it can be assumed that acitretin passes into breast milk in considerable quantities. Metabolism Acitretin is metabolized by isomerization into its 13-cis isomer (cis acitretin), by glucuronidation and cleavage of the side chain. El Baca dokumen lengkap