SOOLANTRA Cream Ref.[8175] Active ingredients: Ivermectin

Posology

One application a day for up to 4 months. Soolantra should be applied daily over the treatment course. The treatment course may be repeated.

In case of no improvement after 3 months, the treatment should be discontinued.

Special population

Renal impairment

No dosage adjustment is necessary.

Hepatic impairment

Caution should be exercised in patients with severe hepatic impairment.

Elderly patients

No dosage adjustment is necessary in the geriatric population (see also section 4.8).

Paediatric population

The safety and efficacy of Soolantra in children and adolescents aged less than 18 years have not been established. No data are available.

Method of administration

Cutaneous use only.

Cutaneous application of a pea-size amount of medicinal product to each of the five areas of the face: forehead, chin, nose, and each cheek. The medicinal product should be spread as a thin layer across the entire face, avoiding the eyes, lips and mucosa.

Soolantra should be applied only to the face.

Hands should be washed after applying the medicinal product.

Cosmetics may be applied after the medicinal product has dried.

There are no reports of overdosage with Soolantra.

In accidental or significant exposure to unknown quantities of veterinary formulations of ivermectin in humans, either by ingestion, inhalation, injection, or exposure to body surfaces, the following adverse effects have been reported most frequently: rash, oedema, headache, dizziness, asthenia, nausea, vomiting, and diarrhoea. Other adverse effects that have been reported include: seizure, ataxia, dyspnea, abdominal pain, paresthesia, urticaria, and contact dermatitis.

In case of accidental ingestion, supportive therapy, if indicated, should include parenteral fluids and electrolytes, respiratory support (oxygen and mechanical ventilation if necessary) and pressor agents if clinically significant hypotension is present. Induction of emesis and/or gastric lavage as soon as possible, followed by purgatives and other routine anti-poison measures, may be indicated if needed to prevent absorption of ingested material.

2 years.

After first opening: use within 6 months.

This medicinal product does not require any special storage condition.

Polyethylene (PE)/Aluminium (Al)/ Polyethylene (PE) laminated plastic white tubes with:

• A white high density polyethylene (HDPE) head and polypropylene (PP) child resistant closure for the 15 g, 30 g, 45 g or 60 g tubes
• A polypropylene (PP) white cap for the 2 g tubes (non child resistant closure)

Pack sizes: 1 tube of 2 g, 15 g, 30 g, 45 g or 60 g.

Not all pack sizes may be marketed.

Mitigation measures should be taken in order to prevent or reduce contamination, in particular the aquatic media.

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