Patient Medication Information: uses, side effects, how to take - Sarna Hc
ABOUT THIS MEDICATION
What the medication is used for:
SARNA HC® is used to help relieve the redness and itchiness of certain skin problems for up to 4 weeks.
What it does:
SARNA HC® 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 SARNA HC® if you:
- are allergic to hydrocortisone, any component of the container, or to any of the other ingredients in SARNA HC® (see What the nonmedicinal ingredients are).
- are allergic to other corticosteroids, camphor, or menthol
- 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.
Do not use on infants and children under 2 years of age.
If you think any of these apply to you, don’t use SARNA HC® until you have checked with your doctor or pharmacist.
What the medicinal ingredient is:
Hydrocortisone
What the nonmedicinal ingredients are:
The nonmedicinal ingredients in SARNA HC® Lotion are camphor, citric acid anhydrous, cetyl alcohol, edetate disodium, Aerosil 200, Arlacel 165, Parfum Bouget MR 564 (fragrance), isopropyl myristate, menthol crystals, PEG 400 monostearate, purified water, stearic acid, white petrolatum, xantham gum and Glydant as the preserving agent.
What dosage forms it comes in:
SARNA HC® Lotion 1% is available in a 150 mL bottle.
SARNA HC® Lotion 2.5% is available in a 75 mL tube.
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. SARNA HC® should not be applied over large areas unless advised by a physician.
Only use SARNA HC® for as long as your doctor recommends.
Inform your doctor if you have previously used corticosteroids.
Before using SARNA HC®, talk to your doctor or pharmacist if:
you are pregnant or planning to become pregnant.
- you are breastfeeding. If you do SARNA HC® 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 SARNA HC® or use it less often.
While using SARNA HC®, 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 SARNA HC®:
- Avoid use on sensitive areas such as broken or very swollen skin.
- Do not apply SARNA HC® over large areas of the body, as camphor (an ingredient in SARNA HC®) can be absorbed into the body and cause side effects including convulsions.
- SARNA HC® contains traces if formaldehyde which may cause allergic reactions or irritation upon contact with the skin.
- SARNA HC® should be used with caution on the face, or in skin fold areas, such as the groin or the armpit.
- Avoid SARNA HC® from getting in the eye, or other mucous membranes including the nostrils or mouth. 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 SARNA HC® with caution. You may need to use a smaller amount of SARNA HC® or use it less often
- Children absorb larger amounts of topical corticosteroids and therefore, may be more likely to develop side effects. Do not use SARNA HC® on infants and children less than 2 years of age.
- 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.
- Keep out of the reach and sight of children.
INTERACTIONS WITH THIS MEDICATION
Some medicines may affect how SARNA HC® 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.
If your condition does not improve within 2-4 weeks of treatment, speak to your doctor or pharmacist. It is important to not stop using SARNA HC® suddenly or your skin condition could flare up again.
If you use SARNA HC® regularly make sure you talk to your doctor before you stop using it.
How to Apply SARNA HC®:
- Apply a thin layer 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.
Do not use SARNA HC® on infants and children less than 2 years of age.
SARNA HC® should be used for the minimum amount of time required to achieve the desired results, but always use SARNA HC® exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Overdose:
| In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose:
If you forget to use SARNA HC®, 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 SARNA HC® to make up for missed doses.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines SARNA HC® 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 SARNA HC® and tell your doctor as soon as possible.
The following side effects have been reported in patients using SARNA HC® and other corticosteroids:
- local hypersensitivity
- contact dermatitis/dermatitis (a type of eczema)
- redness
- rash
- hives
- itching
- blisters
- skin irritation
- 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, pain or swelling
The following have been observed with the use of airtight dressings:
- pus-filled bumps (pustules), heat rash (miliaria), inflammation of the hair follicles (folliculitis), non-healing 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 or pharmacist | Stop taking drug and call your doctor or pharmacist | |
| Only if severe | In all cases | ||
| 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 SARNA HC® contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15° and 30°C. Keep out of the reach and sight of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: --------------------------------------------------------------------------
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect. NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.stiefel.ca or by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
Last revised: March 26, 2014
© 2014 GlaxoSmithKline Inc. All Rights Reserved
®SARNA HC is a registered trademark, used under license by GlaxoSmithKline Inc.
