Serum-in-a-Cream

Product name: Renew + Me

Serum-in-a-Cream: Tretinoin

This document contains important information about using your Renew + Me treatment. Before you first use your treatment, please read all of the following information.

In this Patient Information Leaflet, you’ll find:

  1. General treatment information
  2. Information on your active and inactive ingredients
  3. Indications
  4. Contraindications
  5. Warnings and Precautions
  6. Directions and how to use
  7. Side-effects and how to report unwanted side-effects
  8. Storage
  9. Disposal

  1. General treatment information

Your Renew + Me Serum-in-a-Cream treatment is compounded by The Feel Good Pharmacy, Unit 5 Oakwood Business Park, Standard Road, London, NW10 6EX. Your treatment is prescribed for your skin, and only your skin. Please don’t share this treatment with anyone else, as it may cause harm.

  1. Information on your active and inactive ingredients

Active ingredients:

Tretinoin (0.005% to 0.1%)

Tretinoin is a form of vitamin A that helps the skin renew itself. It is commonly used to reduce the appearance of fine lines and wrinkles, improve skin texture and treat hyperpigmentation (mottled skin discolouration).

Azelaic Acid (5%) – please note not all personalised treatments contain azelaic acid. Please refer to the label on your bottle to check if your treatment contains azelaic acid.

Azelaic Acid is a dicarboxylic acid that is used topically to treat hyperpigmentation issues, skin texture as well as acne and rosacea.

Inactive ingredients:

Aqua (Water), Caprylic/Capric Triglyceride, Glycerin, Octyldodecyl Neopentanoate, Cetearyl Alcohol, C10-18 Triglycerides, Behenyl Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Extract, Prunus Armeniaca (Apricot) Kernel Oil, Phenoxyethanol, Glyceryl Stearate, Jojoba Esters, Butylene Glycol, Bisabolol, Ectoin, Xanthan Gum, Helianthus Annuus (Sunflower) Seed Wax, Sodium Stearoyl Glutamate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Benzoate, Sodium Gluconate, Potassium Sorbate, Ethylhexylglycerin, Panthenol, Glycolipids, Lecithin, 1,2-Hexanediol, Carbomer, Sodium Lactate, Polyglycerin-3, Polysorbate 20, Sodium Hyaluronate, Ceramide NP, Cholesterol, Phytosphingosine, Citric Acid, Benzoic Acid, Acetyl Hexapeptide-1, Dehydroacetic Acid, Sodium Hydroxide, Palmitoyl Tripeptide-1, Tocopherol, Palmitoyl Tetrapeptide-7, Benzyl Alcohol.

  1. Indications

This cream is intended for the treatment of fine lines, wrinkles, hyperpigmentation and uneven skin tone.

  1. Contraindications

Do not use it if you are allergic to any of the ingredients in this product (see section 2 for full details of all ingredients).

TRETINOIN MAY CAUSE HARM TO AN UNBORN BABY IF TAKEN WHILE PREGNANT OR BREASTFEEDING. DO NOT USE IF YOU ARE PREGNANT, BREASTFEEDING, BECOME PREGNANT OR ARE PLANNING A PREGNANCY WHILST USING THIS MEDICATION OR WITHIN ONE MONTH AFTER STOPPING TREATMENT, PLEASE CONTACT YOUR DOCTOR. PLEASE ENSURE ADEQUATE CONTRACEPTION IS TAKEN WHILST USING THIS MEDICATION AND STOP ONE MONTH BEFORE TRYING TO CONCEIVE.

If you develop an allergic reaction to your treatment then you must stop applying it. For your reference, signs of an allergic reaction may include rash; hives; itching; shortness of breath; wheezing; cough; swelling of the face, lips, tongue or throat.

Do not use if you are suffering from an acute facial eczema such as red, flakey, dry and inflamed skin.

If in doubt, do not hesitate to ask your doctor or pharmacist for advice and call 999 in a medical emergency.

  1. Warnings and Precautions

Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water. Do not apply to sunburnt, broken, or eczema-affected skin. Use sunscreen and protective clothing over treated areas when exposure to sunlight or UV light cannot be avoided.

If you experience any signs of an allergic reaction, such as redness, itchiness, or swelling, stop using the product and consult your healthcare provider.

Avoid using exfoliating products, soaps/cleaners with a strong drying effect, alcohol products and scented facial products as this may further irritate your skin.

Avoid waxing whilst using this treatment.

Rare reports of asthma exacerbations have been reported in patients who were treated with azelaic acid.

  1. Directions and how to use

Directions:

Apply 3 pumps to the face and 1 pump to the neck nightly. Ensure your face is clean and dry before applying the cream. For external use only. Wash hands before and after applying the treatment. Do not use your cream past the expiry date printed on your bottle.

How to use:

  1. Cleanse your face with a gentle cleanser and pat dry.
  2. Apply 3 pumps of the cream to the face and 1 pump of the cream to the neck area.
  3. Spread the cream lightly and evenly over the entire face and neck, avoiding the immediate eye area and lips.

Use this medication regularly to get the most benefit from it. Do not use more than recommended as it will not increase effectiveness and may increase side effects.

  1. Side effects and how to report unwanted side-effects

There may be a brief initial sensation of warmth or stinging immediately after applying this medication. Local side effects such as dry skin, redness, itching, rashes, irritation and mild peeling are common (seen in between one in 10 and one in 100 users). These effects tend to settle with time. There is also a small chance of an initial flare of acne and its associated complications including scarring. More severe side effects such as swelling, blisters, skin burning sensation, skin discolouration, crusting and significant skin peeling may occur uncommonly (seen in between one in 100 and one in 1000 users).

Rarely skin hyperpigmentation (darkening of the skin) and hypopigmentation (lightening of the skin) and severe allergic reactions can occur (seen in between one in 1000 and one in 10, 000 users). There have been 3 case reports of topical Tretinoin being associated with the development of Idiopathic Intracranial Hypertension. There is no evidence proving it can cause it but if you have this condition you may not want this treatment and you should stop treatment and speak to your GP or healthcare provider if you do develop any symptoms. If you experience any of these more serious skin reactions please stop treatment and contact us for further advice, or speak to your GP or healthcare provider.

You may find that your skin is more sensitive to sunlight and sunburns more easily. An appropriate sunscreen (minimum SPF 30 with UVA and UVB protection) or protective clothing should be used daily whenever applying tretinoin. Avoid using sunbeds, tanning lamps and strong sun.

The side effects mainly associated with the active ingredient Azelaic Acid:

Occasionally local skin irritation may occur, usually at the start of treatment. In most cases the irritation is mild and usually gets better as treatment continues. Contact us if you have skin irritation that is severe, worsens or does not go away. There may be skin discolouration at the application site and skin lightening can occur, particularly in darker skin types. If you have asthma, in rare cases worsening of asthma has occurred.

If you experience any unwanted side effects, you should contact us via the Dermatology Support team or talk to your GP or healthcare professional. Also, you can help to make sure medicines remain as safe as possible for everyone by reporting any unwanted side effects at www.mhra.gov.uk/yellowcard. Alternatively, you can call Freephone 0808 100 3352 (available between 10am-2pm Monday – Friday) or fill in a paper form available from your local pharmacy.

  1. Storage

Store at room temperature away from direct sunlight. Keep out of reach and sight of children.

  1. Disposal

Do not flush unused medication or pour it down the sink, and do not place it in the general waste bin. Please ask your pharmacist what to do with unused medication. These measures are in place to help the environment. Do not use your medication after the expiry date which is shown on the bottle.