Details for: SPECTRO ECZEMACARE MEDICATED CREAM
Company: GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02214415 | SPECTRO ECZEMACARE MEDICATED CREAM | CLOBETASONE BUTYRATE | 0.05 % / W/W | CREAM | TOPICAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
- This cream is available without a healthcare professional’s prescription to treat small patches of eczema and dermatitis. It can help you to control small patches of red, itchy, dry and inflamed skin caused by eczema and dermatitis. Follow the advice and instructions in this leaflet to make sure the cream is used properly.
What it does
The cream is one of a family of medicines called topical corticosteroids. Topical means it goes on the skin. Corticosteroids are used to control inflammation and itch. It helps control the inflammation that causes eczema or dermatitis. The cream works to stop the skin’s overreaction to the triggers that cause skin flare-ups. The cream base has moisturising properties to help restore the skin barrier
When it should not be used
- You have ever had an allergic reaction to clobetsone butyrate or to any other ingredients in the cream (See What are the ingredients in Spectro EczemaCare Medicated Cream).
- You are using another corticosteroid.
- You have infected skin like cold sores, herpes, chicken pox, impetigo, ringworm, athlete’s foot or thrush. Corticosteroids do not cure infections caused by bacteria, yeast, viruses or fungi.
- You have cuts and open wounds, eczema around a leg ulcer, itchy skin which is not red or inflamed, rosacea (a condition where the skin on the face is unusually red and small spots may develop), or acne (spots or pimples).
- You have psoriasis since this cream has not been shown to be effective in the treatment of psoriasis.
- You have seborrheic dermatitis since this involves areas of skin where this cream should not be used.
- You have skin problem on the groin, genitals, armpit, between toes, scalp or face
- Child is under 12 years
What the medicinal ingredient is
clobetasone butyrate, present at a concentration of 0.05% w/w.
What the non-medicinal ingredients are
arlacel 165, beeswax substitute, cetostearyl alcohol, chlorocresol, citric acid monohydrate, dimethicone 20, glycerin, glyceryl monostearate, purified water, sodium citrate dihydrate.
What dosage form it comes in
The cream comes in a 30 g tube.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Spectro EczemaCare Medicated Cream. Talk about any health conditions or problems you may have, including if you:
- You are pregnant, may be pregnant, are planning to become pregnant or breast feeding without first consulting a healthcare professional.
- Want to use the cream over large areas of skin.
- Have any other skin diseases.
- Experience blurred vision or other visual disturbances.
- Are taking other medications that contain corticosteroids, either prescribed or over-thecounter. These medications may include some eczema creams, asthma inhalers, tablets, injections, nasal sprays, and eye or nose drops.
Other warnings you should know about
- For external use only
- Use on intact skin only
- Keep out of the reach of children
- Avoid contact with eyes as cataracts or glaucoma may develop
- Using steroids on the skin continuously over many weeks or months can cause skin thinning.
- Prolonged use in children may delay weight gain and cause growth retardation
- Do not cover the skin you treated with anything (plasters, dressings, gloves or cling film). It can cause more of the medicine to pass through the skin which can cause side effects.
Spectro EczemaCare Medicated Cream is meant to control skin conditions that improve within 7 days of treating yourself. If you think you need further treatment after that, see a healthcare professional for advice. Do not continue using it..
If your skin condition clears up in less than 7 days, stop using Spectro EczemaCare Medicated Cream. You may use emollient (moisturising) products to help stop the condition from coming back.
If your skin gets worse, or if it does not improve within 7 days, or if initially improves but then begins to get worse, or you experience any changes to the vision, stop using Spectro EczemaCare Medicated Cream and see your healthcare professional. If your skin gets better but the redness or itching comes back within a short time, your skin may still be reacting to something that is touching it. This is often caused by their trigger, the thing that caused the reaction. Examples of common metal triggers are: ear rings, other jewellery, coins, metal studs or fastening on jeans, bras or underwear, etc. Other examples of common triggers include rubber and pine tree sap that can be found in household items such as cleaning products, rubber gloves, or glues. Certain plants or weeds can also act as triggers. If you cannot discover the reason, ask your healthcare professional for advice.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- Medications that contain ritonavir and itraconazole. Do not use these medications together with this cream
Proper use of this medication
Adults or children over 12 years
Usual Dose
Use the cream twice a day, for up to 7 days. Do not use for more than 7 days and do not use more than 1/2 tube (15 g) in 7 days.
Use the cream on patches of red, itchy, dry and inflamed skin caused by eczema or dermatitis. Use the minimum amount of cream for the shortest time necessary to relieve symptoms.
How to apply:
- Supervise children when they use the product
- Be especially careful that you do not get the cream in your eyes.
- Wash your hands and dry them.
- Squeeze out the cream along the top of your index finger: see the picture.
- A single streak of cream from the top crease in the finger to the fingertip is one “fingertip unit”. This is enough to treat a patch area equal to the front and back of one hand. For smaller areas, squeeze out half a fingertip unit – enough to cover a patch of skin the same size as the palm of one hand. You only need a thin layer.
- Gently rub cream into the skin you are treating.
- Wash your hands again (unless it is your hands you are treating).
- Try to keep to the fingertip unit.
Overdose
If you apply a large amount of Spectro EczemaCare Medicated Cream or accidentally swallow a lot of Spectro EczemaCare Medicated Cream, it could make you ill.
Missed Dose
If you forget or miss a dose, use it when you remember.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking Spectro EczemaCare Medicated Cream. If you experience any side effects not listed here, contact your healthcare professional.
Local burning, itchiness, dryness of the skin have been observed.
Possible but rare reactions include skin atrophy (skin thinning), dryness of the skin, atrophy of subcutaneous tissues (thinning of tissues under the skin), telangiectasia (dilation of blood vessels), striae (stretch marks), and change in pigmentation (skin discolouration). However, this cream is unlikely to cause such problems as long as you follow the advice in this leaflet and do not apply it to your face or scalp, groins, genital areas, armpits or between your toes, and limit its use to small areas of the body for periods not longer than 7 days.
If you use more than the correct amount of cream or for longer than recommended you may experience: increased weight, rounding of the face, obesity, skin thinning or changes to the colour of your skin and increased body hair. Other side effects may include: a decrease in the hormone cortisol in your blood, increased levels of sugar in your blood or urine, high blood pressure, cloudy lens in the eye (cataract), increased pressure in the eye (glaucoma), or weakening of the bones through gradual loss of mineral (osteoporosis).
Stop using and tell your healthcare professional immediately if you experience any of the following: allergic reaction such as skin rashes, redness and itching.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Keep out of reach and sight of children.
Store between 15-25ºC.
Do not use the cream after the expiry date on the tube end or carton. Dispose of it safely.
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 (http://www.hc-sc.gc.ca/dhpmps/medeff/report-declaration/index-eng.php) 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.
More information
- 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 website (http://hc-sc.gc.ca/index-eng.php) or by calling 1-800-563-7546.
This leaflet was prepared by GlaxoSmithKline Consumer Healthcare Inc.
Last Revised <September 27, 2019>