Consumer Information for: SANDOZ HYDROCORTISONE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

SANDOZ HYDROCORTISONE is used to help relieve the redness and itchiness of certain skin problems for up to 4 weeks.

What it does

SANDOZ HYDROCORTISONE contains hydrocortisone which belongs to a group of medicines called steroids. Steroids help to reduce redness, swelling and irritation of the skin.

When it should not be used

Do not use SANDOZ HYDROCORTISONE if you:

  • are allergic to hydrocortisone, other corticosteroids, any component of the container, or to any of the other ingredients in SANDOZ HYDROCORTISONE (see What the non-medicinal ingredients are).
  • have bacterial, tubercular, fungal, parasitic, viral skin infections (e.g. herpes simplex, chicken pox, vaccinia), tuberculosis or syphilis skin lesions, or a skin reaction following a recent vaccination.
  • have acne, rosacea (a facial skin condition where the nose, cheeks, chin, forehead or entire face are unusually red, with or without tiny visible blood vessels, bumps (papules) or pus-filled bumps (pustules)), or itchy skin which is not inflamed.
Do not apply in or near the eye.

If you think any of these apply to you, don’t use SANDOZ HYDROCORTISONE until you have checked with your doctor or pharmacist.
What the medicinal ingredient is

Hydrocortisone

What the non-medicinal ingredients are

The non-medicinal ingredients in SANDOZ HYDROCORTISONE are: Ceteareth-20, Cetostearyl Alcohol, Germaben II (Diazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben), Light Mineral Oil, Purified Water, White Petrolatum.

What dosage form it comes in

SANDOZ HYDROCORTISONE is available in a 45 g plastic tube and 225 g plastic jar.

Warnings and precautions

Topical corticosteroids when used over large areas, on sensitive areas such as the face, in skin-fold areas like the armpit and groin, on broken skin, for prolonged periods or under an airtight dressing are more likely to be absorbed into the bloodstream and cause side effects. Apply only enough to cover the affected areas. SANDOZ HYDROCORTISONE should not be applied over large areas unless advised by a physician.

Only use SANDOZ HYDROCORTISONE for as long as your doctor recommends.

Inform your doctor if you have previously used corticosteroids.

Before using SANDOZ HYDROCORTISONE, talk to your doctor or pharmacist if:

  • you are pregnant or planning to become pregnant.
  • you are breastfeeding. If you do use SANDOZ HYDROCORTISONE when breastfeeding, do not use on your breast area to ensure that the baby does not accidentally get it in their mouth.
  • you have other inflammatory skin diseases in the leg as a result of impaired circulation (such as stasis dermatitis).
  • you have problems with your kidney or liver. You may need to use a smaller amount of SANDOZ HYDROCORTISONE or use it less often.
While using SANDOZ HYDROCORTISONE, talk to your doctor or pharmacist if:
  • you develop any skin infection
  • you have an allergic reaction
  • you develop significant skin irritation
  • you experience skin thinning or softening
  • your condition worsens or does not improve
While using SANDOZ HYDROCORTISONE:
  • SANDOZ HYDROCORTISONE should be used with caution on the face, or in skin fold areas, such as the groin or the armpit.
  • Avoid SANDOZ HYDROCORTISONE from getting in the eye, or other mucous membranes. In case of contact, wash with water. Absorption in the body may cause increased pressure in the eye (glaucoma), or a cloudy lens in the eye (cataracts).
  • Do not use occlusive dressings such as a bandage, nor cover the treated areas tightly.
  • If you are over 65 years of age, use SANDOZ HYDROCORTISONE with caution. You may need to use a smaller amount of SANDOZ HYDROCORTISONE or use it less often.
  • Children absorb larger amounts of topical corticosteroids and therefore, may be more likely to develop side effects.
  • If you have any skin disease around a leg ulcer, use of a topical corticosteroid may increase the risk of an allergic reaction or an infection around the ulcer.
Interactions with this medication

Some medicines may affect how SANDOZ HYDROCORTISONE works, or make it more likely that you’ll have side effects. Examples of these medicines include:

  • Ritonavir (for HIV).
  • Itraconazole (for fungal infections).
Tell your doctor or pharmacist about all your other medications, including medicines that you bought without prescription and natural health products.
Proper use of this medication

For topical use only and not for use in the eyes.

Usual Dose

Apply a thin film to the affected areas once or twice a day for a maximum of 4 weeks.

It is important to not stop using SANDOZ HYDROCORTISONE suddenly or your skin condition could flare up again. If your condition does not improve within 2-4 weeks of treatment, speak to your doctor or pharmacist.

If you use SANDOZ HYDROCORTISONE regularly make sure you talk to your doctor before you stop using it.

How to Apply SANDOZ HYDROCORTISONE:

  • Apply a thin layer and gently rub in, using only enough to cover the entire affected area.
  • Wash your hands after use unless treating the hands.
  • Excess product should not be returned to the container, since it may cause contamination.
  • A moisturizer should be used as maintenance therapy.
SANDOZ HYDROCORTISONE should be used for the minimum amount of time required to achieve the desired results, but always use SANDOZ HYDROCORTISONE exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Overdose

If you think you have taken too much SANDOZ HYDROCORTISONE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you forget to use SANDOZ HYDROCORTISONE, apply it as soon as you remember. If it is close to the time scheduled to apply your next dose, wait and apply your next scheduled dose and then continue as before. Do not apply extra SANDOZ HYDROCORTISONE to make up for missed doses.

Side effects and what to do about them

Like all medicines SANDOZ HYDROCORTISONE can have side effects although not everybody gets them. Side effects will affect your skin and may have an effect on other parts of your body if a sufficient quantity of medicine is absorbed through the skin and enters your blood stream.

If your skin condition gets worse or your skin becomes swollen during treatment. You may be allergic to the medicine or need other treatment. Stop using SANDOZ HYDROCORTISONE and tell your doctor as soon as possible.

The following side effects have been reported in patients using Hydrocortisone and other corticosteroids:

  • local hypersensitivity
  • contact dermatitis/dermatitis (a type of eczema)
  • redness
  • rash
  • hives
  • itching
  • skin burning
  • skin pain
  • skin dryness or flaking
  • skin thinning or softening
  • stretch marks
  • changes in the colour of your skin
  • increased body hair
  • the appearance of blood vessels under the surface of
  • your skin (telangiectasia)
  • worsening of condition
  • secondary infection
  • application site irritation or pain
The following have been observed with the use of airtight dressings:
  • pus-filled bumps (pustules), heat rash (miliaria), inflammation of the hair follicles (folliculitis), nonhealing wounds (pyoderma)
Serious side effects such as Cushing’s syndrome may be associated with absorption in the body of topical corticosteroids (for example, from long-term, improper or excessive use). Symptoms include: increased weight, moon face / rounding of the face and obesity. Other side effects may include weight loss, fatigue, nausea, diarrhea and abdominal pain (steroid withdrawal syndrome). Also, look out for delayed weight gain and slow growth in children.

Other symptoms that may only show in blood tests or when your doctor gives you a medical examination are: decreased hormone cortisol levels in your blood, increased sugar levels in your blood or urine, high blood pressure, cloudy lens in the eye (cataract), increased pressure in the eye (glaucoma), as well as weakening of the bones through gradual mineral loss (osteoporosis) and additional tests may be needed after your medical examination to confirm whether you have osteoporosis.

If any of the side effects listed becomes severe or troublesome, tell your doctor or pharmacist.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and call your doctor or pharmacist
Allergic reactions: rash, hives, swelling of the skin.     ✔
Cushing's syndrome: weight gain, moon face / rounding of the face and obesity.     ✔

This is not a complete list of side effects. For any unexpected effects while taking SANDOZ HYDROCORTISONE contact your doctor or pharmacist.

How to store

45 g tube: Store between 15°C and 25°C. Do not freeze. 225 g jar: Store between 15°C and 25°C. Store in an upright position. Do not freeze.

Keep this product out of the reach and sight of children.

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.
More information

If you want more information about SANDOZ HYDROCORTISONE:

  • 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/indexeng.php); the manufacturer’s website (www.sandoz.ca), or by calling 1-800-361-3062.
This leaflet was prepared by Sandoz Canada Inc.
Last revised: April 17, 2018

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