Stieva-A Cream (Tretinoin)

STIEVA-A topical cream should only be applied to your skin.

If your doctor recommends (prescribes) another topical acne product, this should be applied at a different time of day as STIEVA-A topical cream.

Do not apply STIEVA-A to areas of skin where you have problems such as eczema, severely inflamed skin or other open lesions.

Do not use on sensitive areas such as irritated skin, eyes, mouth, lips, angles of nose, and corners of eyes and mouth and mucous producing areas.

How to Apply STIEVA-A Topical Cream:

1. Wash your hands thoroughly before applying STIEVA-A.
2. Completely remove any make-up.
3. Wash affected area gently with warm water and a mild, non-irritating soap or cleanser, and pat dry.
4. Apply STIEVA-A sparingly and evenly once daily, preferably before bedtime. Use your finger-tip to apply enough to cover the required area, and smooth in. Allow your skin to dry fully before applying cosmetics.
5. Wash your hands thoroughly after applying STIEVA-A.
6. In the morning, wash your face gently using a mild, non-irritating soap or cleanser.

At the beginning, you may experience redness, a burning sensation, peeling, or possibly a worsening of your acne while your skin adjusts to the medication.

Your doctor may recommend a daytime moisturizer if your skin is particularly dry.

To minimize these reactions, your doctor may start you on the mildest strength of STIEVA-A and go up gradually until you reach the strength that your doctor feels is most suitable for your skin type. Your doctor may advise you to apply the STIEVA-A less frequently than every day.

It takes several weeks of regular use of STIEVA-A before you can expect noticeable improvement and 8-10 weeks for optimal results, so be patient. Treat your acne with STIEVA-A for as long as your doctor tells you.

Applying too much or applying it more frequently will not help your skin clear up more quickly, and may cause skin irritation.

It is important to understand that your doctor has given you a prescription specially suited to your particular needs and skin type. Do not allow others to use it. Always use STIEVA-A exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Overdose:

In case of drug overdose, contact your healthcare professional, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms.

If you accidentally swallow STIEVA-A, seek medical advice.

Missed dose:

If you forget to apply STIEVA-A topical cream at your regular time, apply STIEVA-A at the next usual time. Do not apply more than once a day to make up for forgotten applications.

During the first weeks of using STIEVA-A, you may notice some skin irritation such as redness and skin flaking. These symptoms will normally subside if you use STIEVA-A less often or stop using it for a few days and then start again.

Other side effects that have been reported are: skin pain, itching/itchy skin, skin irritation, tenderness, warm skin, especially when first applied, stinging or burning sensation, dry skin, swelling at the site of application, rash at the site of application, redness at the site of application, skin blistering, skin crusting, allergic reaction, darkening of skin, lightening of skin, sensitivity to sunlight and skin thinning. Talk to your doctor if any of the side effects become severe or troublesome.

Severe skin reactions (severe burning, peeling or itching of your skin) have also been reported. Stop taking STIEVA-A and contact your doctor immediately if you get any of these symptoms.

BEFORE you use STIEVA-A topical cream, talk to your doctor or pharmacist if:

• You are currently or about to start using any other acne or skin medications.
• You have had a previous reaction to any other acne or skin medication.
• You have a family history of skin cancer.
• You have any other skin condition, such as eczema any inflammatory skin condition, photoallergy, sensitive skin, or a fair complexion.
• You have any ongoing skin irritation. This irritation should be resolved before starting treatment with STIEVA-A.
• You are pregnant or planning to become pregnant. Topical tretinoin should not be used by pregnant women as rare birth defects have been reported with the use of topical tretinoin. It is not known if the birth defects were caused by topical tretinoin.
• You are breastfeeding or planning to breastfeed.
• You cannot avoid extensive exposure to sunlight, e.g., due to work requirements.

If you are a female of childbearing age, you should only use STIEVA-A topical cream after consulting your doctor and seeking his/her advice for contraceptive counselling. If you are pregnant or nursing a child, you should discontinue the use of STIEVA-A topical cream and consult your doctor. There is no information on how STIEVA-A might affect fertility.

STIEVA-A topical cream is for external use only. If you accidentally get STIEVA-A on irritated skin, in the eyes, mouth, or lips, rinse the affected area immediately with plenty of water.

Avoid or minimize exposure to sunlight and sun lamps because STIEVA-A topical cream heightens the susceptibility of your skin to the adverse effects of the sun. Use of a broad spectrum sunscreen with a sun protection factor (SPF) of at least 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. If you have a sunburn, allow the sunburn to settle before starting treatment with STIEVA-A. If sunburn occurs while using STIEVA-A, stop using STIEVA-A and call your doctor for advice.

Extreme weather (e.g. cold or wind) may irritate your skin, avoid or minimize exposure.

Stop treatment and see your doctor if skin irritation is severe (severe redness, dryness, itching, stinging or burning) or your acne does not improve.

Some medicines, skin procedures, or cosmetic products may affect how STIEVA-A topical cream works and may make it more likely that you will have side effects. Some of these may include:

• Other acne or skin preparations including peeling agents (e.g. sulfur, resorcinol, salicylic acid). If irritation or dermatitis (redness, peeling, or discomfort) occurs, reduce the number of times you apply STIEVA-A or temporarily stop using STIEVA-A. Start usingSTIEVA-A again when the irritation goes away.
• Drugs that make you more sensitive to light (e.g. thiazides, tetracycline, fluoroquinolones, phenothiazines, sulphonamides).
• Drugs that contain benzoyl peroxide.
• Skin procedures such as depilation, chemical hair treatments, chemical peels, dermabrasion or laser resurfacing. Following these procedures, allow skin to recover before starting treatment with STIEVA-A.
• Cosmetics or skin products that have a strong drying effect (e.g., products with a high alcohol content, astringents, skin drying agents, after shave lotions) as they may irritate your skin. It is best to use only water-based cosmetics.
• Cosmetic products that have a potential irritating effect (e.g., abrasive agents, products containing spices or limes).

Tell your doctor or pharmacist about all your other medications, including those you can buy without a prescription as well as herbal and alternative medications.