LAMPRENE Soft gelatin capsule (2022)

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Περιεχόμενα

1. Name of the medicinal product

LAMPRENE 50 mg Soft Gelatin Capsules. LAMPRENE 100mg Soft Gelatin Capsules.

2. Qualitative and quantitative composition

Active ingredient: LAMPRENE 50 mg Soft Gelatin Capsules: Each capsule contains 50 mg clofazimine present as a microcrystalline suspension in an oil-wax base. LAMPRENE 100 mg Soft Gelatin Capsules: ...

3. Pharmaceutical form

LAMPRENE 50 mg soft gelatin capsule: Spherical, brown, opaque soft gelatin capsules with no imprint on the capsules. Diameter approximately 7,2 mm. LAMPRENE 100 mg soft gelatin capsule: Brown, ...

4.1. Therapeutic indications

Leprosy LAMPRENE 50/100 mg soft gelatin capsules, used only in combination with rifampicin and dapsone, is indicated as treatment for multibacillary (MB) forms of leprosy, including erythema nodosum leprosum ...

4.2. Posology and method of administration

Multibacillary leprosy LAMPRENE is administered as part of a multidrug therapy, in combination with dapsone and rifampicin for the treatment of multibacillary leprosy. Multidrug therapy (MDT) is necessary ...

4.3. Contraindications

Known hypersensitivity to clofazimine or to any of the excipients of LAMPRENE 50/100 mg soft gelatin capsules. Patients with acquired or congenital QT interval prolongation including torsades de Pointes ...

4.4. Special warnings and precautions for use

Efficacy and safety have not been investigated in children, pregnancy, patients with impaired liver function, and not established in patients co-infected with HIV and treated for HIV infection, hepatitis ...

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

Dapsone LAMPRENE appears to have no important effects on the pharmacokinetics of dapsone, although a transient increase in the urinary excretion of dapsone occurred in a few patients. Limited data suggesting ...

4.6. Fertility, pregnancy and lactation

Pregnancy Safety of clofazimine in pregnancy has not been established and experience with LAMPRENE 50/100 mg soft gelatin capsules in pregnancy is limited. Clofazimine crosses the placenta and harm to ...

4.7. Effects on ability to drive and use machines

Dizziness, reduced visual acuity, nausea, fatigue and headache have been reported on LAMPRENE 50/100 mg soft gelatin capsules therapy. Patients experiencing such adverse reactions should not drive a vehicle ...

4.8. Undesirable effects

Summary of the safety profile The safety profile of LAMPRENE 50/100 mg soft gelatin capsules is similar when used in leprosy and DR-TB. Tabulated summary of side effects Side effects are listed in Table ...

4.9. Overdose

Please refer to the Torsades de pointes and QT prolongation subsection in the Special warnings and precautions for use section. No specific data are available on the treatment of overdose with LAMPRENE ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group, ATC: Drugs for the treatment of lepra, J04BA01 Clofazimine is thought to exert its anti-mycobacterial effect through multiple mechanisms. The primary mechanism of action ...

5.2. Pharmacokinetic properties

Absorption Clofazimine is absorbed slowly. Bioavailability of the micronised suspension in an oil-wax base is up to 70% after a 100 mg dose and decreases with higher doses. The time to reach peak plasma ...

6.1. List of excipients

Capsule content: Butylated hydroxytoluene Citric acid (anhydrous) Propylene glycol Rapeseed oil (refined) Lecithin (E322) Beeswax (yellow) Soybean oil (hydrogenated) Soya-bean oils (partially hydrogenated) ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store at or below 25°C and protect from moisture. Keep out of the reach of children.

6.5. Nature and contents of container

LAMPRENE 50/100 mg soft gelatin capsules are either packaged in white to off-white high density polyethylene (HDPE) bottles with a HDPE screw cap with a yellow tamper proof ring, further packaged in paper ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Novartis South Africa (Pty) Ltd, Magwa Crescent West, Jukskei View, Waterfall City, Johannesburg, 2090

8. Marketing authorization number(s)

LAMPRENE 50 mg soft gelatin capsules: 53/20.2.4/0472 LAMPRENE 100 mg soft gelatin capsules: B/20.2.4/108

9. Date of first authorization / renewal of the authorization

19 April 2018

10. Date of revision of the text

04 November 2019

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