Patient Medication Information: uses, side effects, how to take - Twyneo
What TWYNEO is used for:
TWYNEO is used on the skin to treat acne in adults and children 9 years of age and older. It is not approved for use in children younger than 9 years of age.
How TWYNEO works:
TWYNEO has microcapsules that control the release of tretinoin and benzoyl peroxide on the skin. This means that tretinoin and benzoyl peroxide are gradually released onto your skin to treat acne. Tretinoin keeps skin cells from clogging pores and helps old skin come off so new skin can grow. Benzoyl peroxide is kills bacteria and helps to release dead skin cells.
The ingredients in TWYNEO are:
Medicinal ingredients: tretinoin and benzoyl peroxide
Non-medicinal ingredients: anhydrous citric acid, butylated hydroxytoluence, carbomer homopolymer, cetrimonium chloride, cetyl alcohol, cyclomethicone, edetate disodium, glycerin, hydrochloric acid, imidurea, lactic acid, macrogol stearate, mono and di-glycerides, polyquaternium-7, purified water, silicon dioxide, sodium hydroxide, squalene, tetraethyl orthosilicate and white wax.
TWYNEO comes in the following dosage forms:
Cream, 0.1 % tretinoin and 3 % benzoyl peroxide.
Do not use TWYNEO if:
- You are pregnant or planning to become pregnant
- You are allergic to tretinoin, benzoyl peroxide or to any of the other ingredients in TWYNEO.
- You are allergic to any part of the container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TWYNEO. Talk about any health conditions or problems you may have, including if you:
- have skin sensitivity to the sun
Other warnings you should know about:
Applying TWYNEO
TWYNEO should be used on skin only. You must not swallow TWYNEO or use it in your mouth. Do not apply it to your eyes or inside your vagina. Do not use TWYNEO on skin areas with cuts, lesions, abrasions, eczema, or on sunburned skin or any place you are not treating. If contact occurs, rinse thoroughly with plenty of water. Do not apply TWYNEO more often or in larger amounts than prescribed.
Avoid the use of TWYNEO with other acne products that have a drying effect on the skin, such products that peel or scrub the skin. Avoid the use of TWYNEO with other potentially irritating products, such as soaps or cosmetics containing drying agents (e.g. alcohol) or other irritants (astringents, spices, limes etc.).
Avoid using electrolysis, waxing, or chemical hair removal creams on skin treated with TWYNEO. TWYNEO may bleach hair or colored fabrics. Be careful when applying near the hairline and avoid contact with clothing or bedding. Avoid getting TWYNEO in your hair or on colored fabric since TWYNEO may bleach hair or coloured fabric.
Use makeup and skin products that don’t clog pores.
Skin Irritation
You may have dryness, pain, peeling, redness, rash, itching, or irritation on the skin that you applied TWYNEO to. If this happens, talk to your healthcare professional. Depending on your symptoms, they may tell you to use a moisturizer, use TWYNEO less often or stop using it.
Sensitivity to Light
TWYNEO may increase your sensitivity to light. Minimize or avoid exposure to natural or artificial sunlight such as tanning beds while using TWYNEO. Wear sunscreen or cover your skin when sunlight exposure cannot be avoided. Stop using TWYNEO if you get a sunburn. Do not apply it to sunburned skin.
Pregnancy
Tell your healthcare professional if you are pregnant or think you might be pregnant. You must not use TWYNEO if you are pregnant or planning to become pregnant. There is a risk that more of the medicine could be absorbed into the body, especially if skin is damaged or if TWYNEO is used too often. This could cause harm to an unborn baby.
Breastfeeding
Before you use TWYNEO, tell your healthcare provider if you are breastfeeding or are planning to breastfeed. If you use TWYNEO while breastfeeding, TWYNEO should not be applied to your chest region. It is not known if TWYNEO is safe to use while breastfeeding TWYNEO may pass into breastmilk. If you are breastfeeding or planning to, your healthcare professional will tell you if you can keep using TWYNEO.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take TWYNEO:
- Use TWYNEO exactly as your healthcare professional tells you to.
- Before you use TWYNEO for the first time, prime the pump by pressing down until the first drop of cream is released.
- Dispense a small amount of TWYNEO onto your fingertip. Apply a thin layer of TWYNEO to the affected skin areas. Make sure these areas are clean and dry before you apply TWYNEO.
- Avoid applying TWYNEO near your eyes, lips, or the corners of your nose and mouth or inside them.
- If TWYNEO gets in your eyes, rinse thoroughly with water.
- Wash your hands right away after applying TWYNEO.
- Avoid applying TWYNEO to cuts, scrapes, areas with eczema, or sunburned skin.
- Throw away any unused TWYNEO 12 weeks after you receive it from your healthcare professional or from the pharmacy, or 60 days after first opening, whichever comes first.
Usual dose:
Apply a thin layer or TWYNEO to affected areas once a day on clean and dry skin.
Overdose:
If you think you, or a person you are caring for, have taken too much TWYNEO, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you forget to apply TWYNEO skip the missed dose. Then, continue the next day with the usual dose. Never take a double dose to make up for a missed dose.
Possible side effects from using TWYNEO:
These are not all the possible side effects you may have when taking TWYNEO. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- skin discolouration
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Very Common | |||
| Skin irritation: pain, dryness, peeling, redness, swelling, itching, irritation, stinging or burning. | √ | ||
| Unknown Frequency | |||
| Allergic reactions: hives, rash, severe itching, swelling of your face, lips, throat, tongue, trouble breathing, throat tightness, nausea, vomiting, diarrhea, feeling faint, dizzy, lightheaded. | √ | ||
| Sensitivity to sunlight: itchy or burning rashes, blisters, hives, and a sensation of heat or pain on sun-exposed areas. | √ | ||
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store TWYNEO at room temperature between 15-30°C. Throw away TWYNEO 12 weeks after you obtain TWYNEO from the pharmacy or 60 days after first opening, whichever is sooner. Do not freeze TWYNEO.
Keep TWYNEO out of reach and sight of children.
If you want more information about TWYNEO:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website (http://www.searchlightpharma.com); or by calling 1-800-667-4708.