Patient Medication Information: uses, side effects, how to take - Clotrimaderm External Cream
ABOUT THIS MEDICATION
What the medication is used for:
Clotrimaderm Vaginal 6 is used to treat vaginal yeast infections. Clotrimazole can cure most vaginal yeast infections. Even though the symptoms of an infection may be relieved in only a few hours or days, you should use Clotrimaderm Vaginal 6 for a full 6 days. This will decrease the chance of the infection returning.
What is a “yeast infection”?
A "yeast infection" may occur any time there is an overgrowth of yeast organisms in the vagina. The vagina normally has bacteria and yeast organisms present. Under some conditions, the number of yeast organisms rises, irritating the delicate tissues of the vagina and vaginal opening. Conditions that make this more likely to occur are illness and the use of antibiotics (antibiotics do not affect the yeast organism). Changes in hormone levels may also increase the risk of a yeast infection. Changes that can occur during pregnancy, with the use of oral contraceptive pills, or just before a woman’s period, may all increase the risk of a vaginal yeast infection. Some diseases, such as diabetes, can also make a person more susceptible. Even such things as hot humid weather, continuous use of panty liners, or tight, non- breathing clothing may increase a woman’s chances of developing a yeast infection. These infections are not usually transmitted through sexual relations, even though a small percentage of male partners do have infections at the same time.
How do I know if I have a “yeast infection”?
When a "yeast infection" occurs, the body responds
with an increase in vaginal secretions. These secretions are generally thick and sticky, but odourless. These are often referred to as “cheesy” or “curd-like” because of
their similarity to cottage cheese. These secretions are irritating to the tissues of the vaginal area, causing intense itching, redness, and swelling. Sometimes red spots or sores may develop, especially if the area has been scratched in response to the itching. Soreness in the vagina, discomfort when passing urine and pain during sexual relations is common.
What it does:
Clotrimazole is an antifungal that kills the overgrowth of yeast organisms that cause the infection.
When it should not be used:
Do not use Clotrimaderm Vaginal 6:
if you are allergic to clotrimazole or any ingredient in the formulation.
in girls less than 12 years of age unless advised by a physician.
What the medicinal ingredient is: Clotrimazole 1% w/w
What the important non-medicinal ingredients are: Benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyl dodecanol, polysorbate 60, sorbitan monostearate, water.
What dosage forms it comes in:
vaginal cream: 1%
WARNINGS AND PRECAUTIONS
BEFORE you use Clotrimaderm Vaginal 6 talk to your doctor or pharmacist if:
you are at increased risk for sexually transmitted diseases (e.g. HIV-AIDS), have multiple sexual partners or change partners often
you have diabetes
this is your first yeast infection
you have frequent vaginal infections, or if your yeast infection returns in less than 2 months
you are pregnant, think you are, or are nursing
Clotrimaderm Vaginal 6 is for vaginal use only. Do not use Clotrimaderm Vaginal 6 if you have abdominal pain, fever or a foul-smelling discharge. If these symptoms are present, you could have a more serious condition and should consult your physician immediately.
Do not use tampons, intravaginal douches or other vaginal products while using this product.
Yeast infections do not cause fevers, chills, nausea, vomiting, diarrhoea, back pain, shoulder pain or vaginal haemorrhaging. If these symptoms are present, or if the vaginal discharge is foul-smelling, a more serious condition may be present and you should consult your physician immediately.
If there is no improvement in your symptoms in 3 days or if they have not disappeared within 7 days, you might not have a vaginal yeast infection. Discontinue treatment and contact your physician.
Contact your physician if symptoms worsen.
Avoid contact with eyes; if this happens, rinse thoroughly with water.
If Clotrimaderm Vaginal 6 is accidentally swallowed, contact your local emergency room or Poison Control Centre immediately.
If you have any questions about Clotrimaderm Vaginal 6 or vaginal infections, contact your pharmacist or physician.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with Clotrimaderm Vaginal 6 include:
tacrolimus, sirolimus (immunosuppressant)
Clotrimazole may reduce the effectiveness of some birth control methods, such as condoms, diaphragms, or vaginal spermicides. This effect is temporary and occurs only during treatment.
PROPER USE OF THIS MEDICATION
Usual dose:
Clotrimaderm Vaginal 6 is inserted high into the vagina once a day (preferably at bedtime) for 6 consecutive days. Sufficient cream is provided for 6 intravaginal applications. Extra cream is supplied for use in relieving the external itching and burning sometimes associated with a vaginal yeast infection. Clotrimaderm Vaginal 6 is only for use in the vagina and should never be taken by mouth. Treatment during the menstrual period should not be performed. The treatment should be finished before the onset of menstruation. While
you may have sexual relations during treatment with Clotrimaderm Vaginal 6, most couples wait until treatment has finished as your partner could become infected.
Filling the Applicator:
Remove the cap from the tube of Clotrimaderm Vaginal
6 and reverse it to puncture the safety seal over the end of the tube. To fill the applicator, screw the open end of the applicator on the end of the tube. Gently squeeze the tube at the bottom. The plunger will rise as cream enters the applicator. When the plunger stops, the proper amount of Clotrimaderm Vaginal 6 has been pushed into the applicator and the applicator may be removed. Replace the cap and roll up the tube from the bottom so that the tube will be ready for the next use.
Inserting the Medication:
Clotrimaderm Vaginal 6 is inserted into the vagina in much the same way as a tampon. Stand, squat, or lie on your back in a comfortable position. Insert the filled applicator into the vagina as far as it will comfortably go. Holding the barrel of the applicator steady, gently depress the plunger until it stops. This will release the medication high in the vagina where it will be most effective. Remove the applicator.
Using the Cream Externally:
A small amount of Clotrimaderm Vaginal 6 may be applied to the opening of the vagina to help provide extra relief of external symptoms. Squeeze a small amount of cream onto your finger and gently spread over the irritated vaginal area. Use the cream once or twice a day and only during the period when external symptoms are present, to a maximum of 7 days.
Disposing of the Applicator:
The Clotrimaderm Vaginal 6 vaginal applicator is recyclable where facilities exist.
Overdose:
| In case of drug overdose, call a poison control center or get medical help right away even if there are no symptoms. |
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
If you experience a rash or new irritation while using the product, discontinue use and contact your doctor. Rarely, severe allergic reactions (swelling of face, eyes, mouth, hands and feet) have occurred.
This is not a complete list of side effects. For any unexpected effects while taking Clotrimaderm Vaginal 6, contact your doctor or pharmacist.
HOW TO STORE IT
Keep Clotrimaderm Vaginal 6 and all other medications out of the reach and sight of children.
Store at room temperature between 15°C and 30 °C.
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(https://www.canada.ca/en/health- canada/services/drugs-health- products/medeffect-canada/adverse- reaction-reporting.html) 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
If you want more information about Clotrimaderm
Vaginal 6:
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://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website (www.taro.ca), or by calling 1-800-268-1975.
130 East Drive, Brampton, ON, L6T 1C1