Patient Medication Information: uses, side effects, how to take - Lidemol
What is LIDEMOL used for?
LIDEMOL is used to treat skin rashes that are inflamed, itchy, or caused by allergies.
How does LIDEMOL work?
LIDEMOL provides relief from inflammation and symptoms by blocking the body’s inflammatory response.
What are the ingredients in LIDEMOL?
Medicinal ingredients: Fluocinonide
Non-medicinal ingredients: Cetyl Alcohol, Citric Acid, Mineral Oil, Polysorbate 60, Propylene Glycol, Sorbitan Monostearate and Stearyl Alcohol.
LIDEMOL comes in the following dosage forms:
Cream, 0.05% w/w
Do not use LIDEMOL if you:
- are allergic to fluocinonide or any of the other ingredients found in LIDEMOL.
have sores, cuts or wounds on your skin from bacteria, fungus, viruses or tuberculosis that have not been treated, such as:
- herpes simplex,
- vaccinia,
- chickenpox.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LIDEMOL. Talk about any health conditions or problems you may have, including if you:
- have a skin condition related to poor blood flow.
- have stasis dermatitis. This is a condition that affects the skin of the lower legs.
- have liver problems.
- have a condition for which you were previously or are now taking other corticosteroid drugs.
- have eye problems, such as cataracts.
Other warnings you should know about:
- LIDEMOL should not be used in the eye. Be careful when applying LIDEMOL on affected skin that is close to your eye. If LIDEMOL gets into your eye, it can cause irritation. Flush it with lots of water.
Treatment with LIDEMOL can cause serious side effects including:
- adrenal gland problems (called adrenal insufficiency).
- infections. If this happens, you may be treated with other medications.
- Skin atrophy, which is also known as thinning of the skin. If you notice that your skin is thinning, contact your healthcare professional. You may need to stop using LIDEMOL.
- eye problems such as cataracts and glaucoma. Tell your healthcare professional if you notice any changes in your vision.
Some side effects are more common in children who are treated medications like LIDEMOL.
These side effects include:
- Adrenal gland problems
- Cushing’s syndrome. This condition happens when there are higher than normal levels of cortisol in the blood.
- Stretch marks
- Delayed growth and weight gain
- Intracranial hypertension.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Higher levels of LIDEMOL can be absorbed through your skin in certain situations. This can increase your risk for adrenal gland problems. To lower your risk for these side effects:
- Avoid covering the treated area with a bandage or other covering unless your healthcare professional tells you to.
- Avoid using LIDEMOL for a long time and on large areas of skin or on cuts. If you will be using LIDEMOL for a long time, your healthcare professional may tell you to take breaks from time to time. They may also tell you to use it in on one part of the body at a time.
- Tell your healthcare professional if your skin is not healing or gets worse.
- Testing: Your healthcare professional may check your blood and urine during your treatment. This will tell them if LIDEMOL is affecting your adrenal glands.
Female patients – Pregnancy and breastfeeding:
- It is not known if using LIDEMOL while pregnant is safe for an unborn baby. Tell your healthcare professional if you are pregnant, think you are pregnant or get pregnant while using LIDEMOL.
- It is not known if LIDEMOL passes into breastmilk. Tell your healthcare professional if you are or will be breastfeeding a baby.
- If you are breastfeeding, avoid applying LIDEMOL to your nipple and areola. This will help to prevent the baby from getting LIDEMOL in their mouth.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with LIDEMOL:
- There are no known interactions with LIDEMOL.
How to take LIDEMOL:
- Use exactly as directed by your healthcare professional. Your healthcare professional will tell you where to apply LIDEMOL.
- Be cautious when applying LIDEMOL on areas near the eye. Do not apply to the eyes. If LIDEMOL gets into your eye, flush it with lots of water.
- Gently apply a small amount onto the affected area 2 to 4 times per day.
- Do not cover the area with dressings unless you are told to do so by your healthcare professional.
Usual dose:
Gently apply a small amount of LIDEMOL to affected areas 2 to 4 times per day.
To reduce your risk for side effects, your healthcare professional may interrupt your dose. They may also tell you to treat one area of your body at a time.
Overdose:
| If you think you have taken too much LIDEMOL, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Missed dose:
If you miss a dose of this medication, you do not need to make up the missed dose. Skip the missed dose and continue with your usual schedule. Do not use extra medicine to make up for the missed dose.
What are possible side effects from using LIDEMOL?
These are not all the possible side effects you may feel when taking LIDEMOL. If you experience any side effects not listed here, contact your healthcare professional.
Skin problems including:
- red, sore, itchy, or oozing blisters
- itching
- burning
- scarring
- inflamed hair follicles
- stretch marks
- rash on skin around the mouth
- light coloured, wrinkly skin that may feel wet or soggy
- acne-like rash
- heat rash
- change in skin colour
- dryness and flaking
- spider veins
- excessive hair growth over the body
- infection
- tingling or prickling skin sensation
- redness, rash, tears or scrapes
- thick and leathery skin
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Dermatitis: skin rash or sores | X | ||
| Skin atrophy (thinning of the skin): skin that tears or bruises easily, may be able to see blood vessels through the skin. | X | ||
| Skin irritation at the application site: red, sore, or peeling skin; burning or stinging sensation; severe itching and / or dryness | X | ||
| COMMON | |||
| Allergic reactions: rash, hives, swelling of the skin | X | ||
| Adrenal insufficiency (when the adrenal glands don’t make enough of the hormone cortisol): worsening fatigue and muscle weakness, loss of appetite, weight loss, nausea, vomiting, and diarrhea | X | ||
| Cushing's syndrome (when the body makes too much of the hormone cortisol): rounded “moon” face, weight gain, pink or purple stretch marks on the skin, fragile skin that bruises easily, slow healing of cuts, severe fatigue, muscle weakness, headache | X | ||
| Glucosuria (sugar in the urine): feel extremely thirsty or dehydrated feel extremely hungry urinate more than usual urinate accidentally, unexplained weight loss fatigue trouble seeing slow-healing cuts, sores, or other injuries skin darkening in the folds of your neck, armpits, or other areas | X | ||
| Hyperglycemia (high blood sugar levels): frequent urination, increased thirst, blurred vision, fatigue, headache, fruity-smelling breath, nausea and vomiting, shortness of breath, dry mouth, weakness, confusion, coma and abdominal pain | X | ||
| Second skin infection (occurs during or following another infection): pus (a white, thick fluid composed of white blood cells), blisters, skin that becomes discoloured and painful | X |
| UNCOMMON | |||
| Cataracts (clouding of the lens of the eye): clouded or blurred vision, double vision, difficulty in seeing during the night, sensitivity to light and glare, need for brighter than normal, light to read or see objects, seeing halo around lights, seeing objects in faded or yellow color, eye pain, headache due to changes in vision | X | ||
| Delayed growth and weight gain (in children): poor or abnormally slow height and weight gain. | X | ||
| Erythema: redness of the skin or mucous membrane | X | ||
| Gastroenteritis (stomach flu): diarrhea, vomiting stomach pain, cramping, fever, nausea, and headaches | X | ||
| Glaucoma (increased pressure in eye): loss of side vision, seeing halos around lights, vision loss, redness in the eye, eye that looks hazy, eye pain, narrowed vision | X | ||
| Hypertension (high blood pressure): headache, dizziness, fatigue, difficulty breathing, chest pain, irregular heartbeat, nosebleed, nausea, vomiting. Sometimes there are no symptoms | X | ||
| Intracranial hypertension in children (increased pressure inside the skull): headache behind the eyes, ringing in the ears, blurred vision, double vision, short temporary episodes of blindness, nausea and vomiting, dizziness | X | ||
| Leukoderma: white patches on the skin | X | ||
| Pustular form of psoriasis: clearly defined, raised bumps that are filled with pus (a white, thick fluid composed of white blood cells) | X |
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.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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 at 15°C - 30°C.
Keep out of sight and reach of children.
If you want more information about LIDEMOL:
- 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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drugproduct-database.html); the manufacturer’s website www.bauschhealth.ca, or by calling 1-800-361-4261.
Bausch Health, Canada Inc.
2150 St-Elzear Blvd., West
Laval, QC, H7L 4A8
www.bauschhealth.ca