Advantan Scalp 1 mg Solution

ADVANTAN SCALP SOLUTION contains methylprednisolone aceponate which is an anti-inflammatory medicine (a corticosteroid) that is intended to be used on the scalp. It reduces the inflammation and allergic reaction of the skin. Therefore, it lessens redness (erythema), fluid build-up (oedema) and fluid oozing from the inflamed skin. It also relieves the itchiness, burning sensation or pain you may feel. ADVANTAN SCALP SOLUTION is used for treatment of different types of eczema (atopic dermatitis, neurodermatitis), seborrheic eczema, contact eczema, nummular eczema and vulgar eczema. Eczema is a skin condition that makes your skin red and itchy.

Do not use ADVANTAN SCALP SOLUTION:

• if you are allergic (hypersensitive) to methylprednisolone aceponate (MPA) or any of the other ingredients listed in section 6.1.
• if you are pregnant.
• if you have a tuberculosis (TB) or syphilis related skin conditions.
• if you have a viral infection affecting the skin, such as herpes or varicella that causes painful sores (ulcers) on the skin.
• if you have a bacterial or fungal skin infection/disease.
• if you have skin ulcers in the area to be treated.
• if you have skin affected by rosacea (rosy/red coloured skin in the face, often accompanied by small, red, pus-filled bumps).
• if you have skin affected by acne vulgaris (when hair follicles plug with oil and dead skin cells causes acne/pimples).
• if you have an inflammatory rash involving the skin around the mouth (perioral dermatitis).
• if you have a skin disease accompanied by a thinning of the skin (atrophic skin diseases).
• if you have a skin reaction following vaccination in the area to be treated.

Warnings and precautions

Take special care with ADVANTAN SCALP SOLUTION:

• Long-term treatment should be avoided as this may cause changes in the skin that will lead to thinning and loss of elasticity.
• Long-term use may also cause spider veins (telangiectasia), discolouration of the skin resulting from bleeding underneath (bruising/ecchymoses) and dilated blood vessels on the surface of the skin.
• Corticosteroids like ADVANTAN SCALP SOLUTION shows strong effects on the body. It is not recommended to use ADVANTAN SCALP SOLUTION on damaged skin, or for prolonged periods of time as this will significantly increase the risk of side effects. These effects are most likely to be worse in children.
• If your skin disease is accompanied by bacterial or fungal infections, additional specific medication will be prescribed by your doctor. Notify your doctor if the infection spreads or gets worse.
• Avoid contact with the eyes, deep open wounds and mucus membranes such as the lining of the mouth, nose, eyelids, and parts of the male and female genitals.
• ADVANTAN SCALP SOLUTION is flammable, and should not be used near open flames.
• Application of ADVANTAN SCALP SOLUTION under air- and water-tight dressing increases the risk of side effects. Treatment under these conditions should be avoided unless indicated by your doctor.
• Diapers as well as areas where two skin areas touch or rub together (such as skin folds/creases) might represent occlusive conditions.
• Glaucoma (increase of pressure in the eye) may develop when ADVANTAN SCALP SOLUTION is used on large areas, or extensive applications over a prolonged period, with air- and water-tight dressings.
• Your vision may be affected by the use of ADVANTAN SCALP SOLUTION as blurred vision has been reported with the use of corticosteroids such as in ADVANTAN SCALP SOLUTION.
• If there is a worsening of your condition during use consult your prescriber – you may be experiencing an allergic reaction, have an infection or your condition requires a different treatment.
• If you experience a recurrence of your condition shortly after stopping treatment, within 2 weeks, do not restart using the solution without consulting your prescriber unless your prescriber has previously advised you to do so. If your condition has resolved and on recurrence the redness extends beyond the initial treatment area and you experience a burning sensation, please seek medical advice before restarting treatment.

Children

ADVANTAN SCALP SOLUTION should ideally not be used in infants and young children.

Other medicines and ADVANTAN SCALP SOLUTION

No information is available.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

The safety of this medicines in pregnancy has not been established. As a general rule, topical preparations containing corticosteroids should not be applied during the first three months of pregnancy. Prolonged use or use of air- and water-tight dressings should be avoided in pregnancy. Do not use ADVANTAN SCALP SOLUTION if you are pregnant.

The safety of this medicines in breastfeeding has not been established. Do not use ADVANTAN SCALP SOLUTION if you are breastfeeding unless your doctor considers it necessary.

Driving and using machines

ADVANTAN SCALP SOLUTION has no influence on the ability to drive and use machines.

Do not share medicines prescribed for you with any other person. Always use ADVANTAN SCALP SOLUTION exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. ADVANTAN SCALP SOLUTION is to be used only as necessary and applied dropwise once per day to the affected areas of the scalp and rubbed in lightly. In general, the duration of use should not exceed four weeks. Your doctor will tell you how long your treatment with ADVANTAN SCALP SOLUTION will last.

If you have the impression that the effect of ADVANTAN SCALP SOLUTION is too strong or too weak, tell your doctor or pharmacist.

If you use more ADVANTAN SCALP SOLUTION than you should

No risk is to be expected from a one-time overdose (too large amount or too large skin area) or accidental oral ingestion (when swallowed). ADVANTAN SCALP SOLUTION contains isopropyl alcohol. Unintentional ingestion (even if only a few drops) of can result in symptoms of feeling sad (depression). In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to use ADVANTAN SCALP SOLUTION

Do not use the double amount the next time, but continue the use as prescribed by your doctor.

If you stop using ADVANTAN SCALP SOLUTION

Don’t stop using ADVANTAN SCALP SOLUTION without talking to your doctor first.

ADVANTAN SCALP SOLUTION can have side effects. Not all side effects reported for ADVANTAN SCALP SOLUTION are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ADVANTAN SCALP SOLUTION, please consult your health care provider for advice. ADVANTAN SCALP SOLUTION, may occasionally, lead to local skin irritations such as a mild burning sensation. Less frequently, itching, redness of the skin, dry skin, scaling, inflammation and infection of hair follicles may arise. Allergic reactions to the components of ADVANTAN SCALP SOLUTION may occur.

The following side effects have been reported:

• Frequent:
• Burning sensation at the site of application.
• Less frequent:
• Hair loss.
• A skin condition that mainly affects your scalp, known as seborrhoea capitis. It causes scaly patches, red skin and stubborn dandruff.
• Itching.
• Pain.
• Hair follicle infection.
• Warm sensation on the skin.
• Dryness.
• Irritation.
• Eczema.
• Frequency unknown:
• Blurred vision.
• Acne (pimples).
• Small blood vessels on the surface of the skin (telangiectasia).
• Thinning of the skin (atrophy).
• Stretch marks (striae).
• Specific skin inflammation in the area of the upper lip and chin (perioral dermatitis).
• Changes in skin colour.
• Allergic skin reaction.
• Blisters.
• Redness of the skin.
• Increased body hair growth (hypertrichosis).
• Steroid withdrawal reaction: If used continuously for prolonged periods a withdrawal reaction may occur on stopping treatment with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ADVANTAN SCALP SOLUTION.

Store all medicines out of reach of children. Store at or below 30 °C. Keep well closed. Do not use after the expiry date. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).