ORATANE Soft capsule (2022)

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Περιεχόμενα

1. Name of the medicinal product

ORATANE 5 mg soft gelatin capsule. ORATANE 10 mg soft gelatin capsule. ORATANE 20 mg soft gelatin capsule. ORATANE 30 mg soft gelatin capsule. ORATANE 40 mg soft gelatin capsule.

2. Qualitative and quantitative composition

Each ORATANE 5 mg soft gelatin capsule contains 5 mg of isotretinoin. Each ORATANE 10 mg soft gelatin capsule contains 10 mg of isotretinoin. Each ORATANE 20 mg soft gelatin capsule contains 20 mg of isotretinoin. ...

3. Pharmaceutical form

ORATANE 5 mg capsules: Soft gelatin oval opaque white capsules, approximately 8 mm in length and 5 mm in diameter. ORATANE 10 mg capsules: Soft gelatin oval opaque violet capsules, approximately ...

4.1. Therapeutic indications

Severe forms of nodulo-cystic acne which are resistant to therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk. ORATANE should only be prescribed by physicians ...

4.2. Posology and method of administration

Dose Patient response to isotretinoin is dose-related and varies from case to case. This necessitates adapting the dosage to individual needs according to severity of the clinical picture and side effects. ...

4.3. Contraindications

Isotretinoin is contraindicated in women who are pregnant, (refer to section 4.6), or who may become pregnant while undergoing treatment. Isotretinoin is contraindicated in women of childbearing potential ...

4.4. Special warnings and precautions for use

Pregnancy Prevention Isotretinoin is highly TERATOGENIC. It is, therefore, contraindicated not only in women who are pregnant or who may become pregnant while undergoing treatment but also in all ...

4.5. Interaction with other medicinal products and other forms of interaction

Concurrent therapy with ORATANE and vitamin A must be avoided, as symptoms of hypervitaminosis A may be intensified (refer to section 4.3 and 4.8). Cases of pseudotumour cerebri and/or papilloedema have ...

4.6. Fertility, pregnancy and lactation

Pregnancy Pregnancy (Category X). Isotretinoin is highly teratogenic and must not be given to women who are pregnant (refer to section 4.3). Isotretinoin crosses the placental barrier in amounts that lead ...

4.7. Effects on ability to drive and use machines

Changes in vision, including decreased night vision, have been reported during isotretinoin therapy (refer to section4.4 and 4.8). Patients should be advised of this potential problem and warned to be ...

4.8. Undesirable effects

Most of the adverse effects of isotretinoin are dose related with more pronounced effects occurring at doses above 1 mg/kg/day. The adverse effects may recede during continued therapy and the mucocutaneous ...

4.9. Overdose

Although the acute toxicity of overdosage is low, signs of hypervitaminosis A could appear in cases of accidental overdose. Such symptoms are reversible. Nevertheless, evacuation of the stomach may be ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Retinoids for treatment of acne ATC code: D10BA01 Pharmacodynamic effects Administered orally, isotretinoin has a marked effect in severe forms of acne, which have ...

5.2. Pharmacokinetic properties

Absorption There is considerable inter-individual variation in the bioavailability of oral isotretinoin. After oral administration of 80 mg (2 40 mg capsules) given in the fasting state peak plasma concentrations ...

5.3. Preclinical safety data

In the reproductive studies in rats (2, 8 or 32 mg/kg/day; 2-generation), no adverse effects were noted on gonadal function, fertility, gestation or neonatal viability, although the average weight in the ...

6.1. List of excipients

ORATANE 5 mg soft gelatin capsules contains the following excipients: Butylated hydroxyanisole, disodium edetate, dl-Alpha tocopherol, gelatin, glycerol, hydrogenated vegetable oil, purified water, ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

ORATANE 5 mg, 10 mg, 20 mg, and 40 mg soft gelatin capsule: 36 months from date of manufacture. ORATANE 30 mg soft gelatin capsule: 24 months from date of manufacture.

6.4. Special precautions for storage

ORATANE 5 mg, 10 mg, 30 mg, and 40 mg soft gelatin capsule: Store at or below 25°C and protect from light. ORATANE 20 mg soft gelatin capsule: Store at or below 30°C and protect from light.

6.5. Nature and contents of container

ORATANE 5 mg soft gelatin capsules: PVC/PVDC-Aluminium blister packs containing 60 capsules. ORATANE 10 mg soft gelatin capsules: PVC/PVDC-Aluminium blister packs containing 15 capsules as ...

6.6. Special precautions for disposal and other handling

Any unused medicine or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Douglas Pharmaceuticals Ltd, PO Box 45 027, Auckland 0651, New Zealand, Phone: (09) 835 0660

9. Date of first authorization / renewal of the authorization

ORATANE 5 mg soft gelatin capsules: 06 August 2009 ORATANE 10 mg soft gelatin capsules: 24 May 2001 ORATANE 20 mg soft gelatin capsules: 20 May 1999 ORATANE 30 mg soft gelatin capsules: 26 July 2012 ORATANE ...

10. Date of revision of the text

8 February 2022

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