Patient Information Article
SCHEDULING STATUS
S1
Product Name
CANDASPOR® VAGINAL CREAM
Active Ingredient
Clotrimazole
Read Before Using CANDASPOR® VAGINAL CREAM
Read this information carefully before starting to use CANDASPOR® VAGINAL CREAM.
Keep this information because it may be needed again. Do not share CANDASPOR® VAGINAL CREAM with any other person. Ask a healthcare provider or pharmacist if more information or advice is needed.
A doctor should be consulted if symptoms worsen or do not improve after 7 days.
What Is in This Article
- What CANDASPOR® VAGINAL CREAM is and what it is used for
- What you need to know before you use CANDASPOR® VAGINAL CREAM
- How to use CANDASPOR® VAGINAL CREAM
- Possible side effects
- How to store CANDASPOR® VAGINAL CREAM
- Contents of the pack and other information
1. What CANDASPOR® VAGINAL CREAM Is and What It Is Used For
CANDASPOR® VAGINAL CREAM is used for the relief of vaginal itching, burning and discharge associated with vaginal yeast infection, also known as vaginal thrush.
The active substance is clotrimazole. Clotrimazole belongs to a group of medicines called azoles and works as an antifungal agent that helps fight the cause of infections such as vaginal thrush.
2. What You Need to Know Before You Use CANDASPOR® VAGINAL CREAM
Do Not Use CANDASPOR® VAGINAL CREAM
Do not use CANDASPOR® VAGINAL CREAM if any of the following apply:
| Do not use CANDASPOR® VAGINAL CREAM if | Details |
|---|---|
| You are allergic to clotrimazole | This includes allergy to the active substance |
| You are allergic to any other ingredient in CANDASPOR® VAGINAL CREAM | See the contents section |
| You are in the first three months of pregnancy | Medical advice is required |
| You are under 12 years of age | CANDASPOR® VAGINAL CREAM is intended for adults and children 12 years and older |
| You are having your menstrual period | Treatment should not be performed during menstruation |
Warnings and Precautions
Take Special Care With CANDASPOR® VAGINAL CREAM
Consult a doctor if you have vaginal infection symptoms such as itching, burning and sometimes white discharge.
You should also consult your doctor if:
| Situation requiring medical advice |
|---|
| There is no improvement within 3 days |
| Symptoms persist for more than 7 days |
| You have abdominal pain |
| You have fever |
| You have a foul-smelling vaginal discharge |
| You are pregnant or think you may be pregnant |
| You are nursing |
| Symptoms return within 2 months |
| You are menstruating |
Do not use tampons, intra-vaginal douches, spermicides or other vaginal preparations while using CANDASPOR® VAGINAL CREAM.
Avoid vaginal intercourse during treatment, because vaginal infection may be transmitted and your partner could become infected.
CANDASPOR® VAGINAL CREAM is intended for use by adults and children 12 years of age and older only.
CANDASPOR® VAGINAL CREAM may reduce the effectiveness and safety of latex products such as condoms and diaphragms. Additional contraceptive measures are needed while using CANDASPOR® VAGINAL CREAM.
Because the cream may reduce the effectiveness of condoms and diaphragms, it is best to avoid vaginal intercourse during treatment to help prevent transmission of HIV and sexually transmitted diseases until symptoms of the candidiasis infection have resolved.
Other Medicines and CANDASPOR® VAGINAL CREAM
Always tell your healthcare provider if you are taking any other medicine, including complementary or traditional medicines.
Inform your doctor or pharmacist if you are taking:
| Medicine | Use |
|---|---|
| Tacrolimus | Used to reduce the immune response and prevent rejection after an organ transplant |
| Sirolimus | Used to reduce the immune response and prevent rejection after an organ transplant |
Pregnancy, Breastfeeding and Fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor, pharmacist or other healthcare provider before using this medicine.
The safety and efficacy of CANDASPOR® VAGINAL CREAM have not been established in pregnancy.
Breastfeeding should be discontinued during treatment with CANDASPOR® VAGINAL CREAM.
Driving and Using Machines
CANDASPOR® VAGINAL CREAM has no or negligible influence on the ability to drive or use machinery.
CANDASPOR® VAGINAL CREAM Contains Cetostearyl Alcohol
CANDASPOR® VAGINAL CREAM contains cetostearyl alcohol, which may cause local skin irritation such as rash, itching or redness.
3. How to Use CANDASPOR® VAGINAL CREAM
Do not share medicines prescribed for you with any other person.
CANDASPOR® VAGINAL CREAM should be inserted as deeply as possible into the vagina every night for six or seven days.
Insertion is best achieved while lying back with the legs pulled slightly towards the body.
Two applications of 5 g vaginal cream may be used daily: one in the morning and one in the evening, for 6 days.
The treatment should be completed for the full course, even if symptoms disappear.
For prevention of re-infection, the partner should be treated locally with CANDASPOR® CREAM at the same time.
This preparation does not stain underwear.
Directions for Using the Applicator
Preparation of the Applicator
| Step | Instruction |
|---|---|
| 1 | Wash your hands thoroughly. |
| 2 | Ensure that the plunger is released and moves freely before attaching the applicator to the tube. |
| 3 | Screw the open end of one applicator over the opening of the tube of cream. The plunger of the applicator should be pushed fully in at this stage. |
| 4 | Gently squeeze the bottom of the tube so that the cream fills the applicator until the plunger reaches a stop. |
| 5 | Unscrew the tube of cream and replace the cap. |
Inserting the Applicator
| Step | Instruction |
|---|---|
| 6 | Carefully insert the end of the applicator as deeply as possible into the vagina, making sure the plunger does not fall out. This is best done while lying on the back with the legs pulled slightly towards the body. |
| 7 | Slowly push the plunger with the forefinger until it stops. |
| 8 | Remove the applicator from the vagina and discard it. |
Each Applicator Is for Use Once Only
Each applicator should be used once and then discarded.
The surplus cream may be used to treat inflammation of the vulva, which is the outer vaginal area, and nearby areas.
The cream should be applied thinly and rubbed in gently 2 to 3 times a day.
If You Use More CANDASPOR® VAGINAL CREAM Than You Should
In the event of overdose, consult your doctor or pharmacist.
If neither is available, contact the nearest hospital or poison control centre.
In case of unintended oral ingestion, symptoms may include:
| Possible symptoms |
|---|
| Stomach pain |
| Loss of consciousness |
| Shortness of breath |
Treatment is symptomatic and supportive.
If You Forget to Use CANDASPOR® VAGINAL CREAM
Do not use a double dose to make up for forgotten individual doses.
4. Possible Side Effects
CANDASPOR® VAGINAL CREAM can have side effects.
Not all side effects reported for CANDASPOR® VAGINAL CREAM are included here. If general health worsens or any unwanted effects occur while using CANDASPOR® VAGINAL CREAM, consult a healthcare provider for advice.
Side Effects Table
| Side-effect category | Side effects / symptoms | Recommended action |
|---|---|---|
| Very serious side effects | Hives or skin rash | Stop using CANDASPOR® VAGINAL CREAM and tell your doctor immediately or go to the casualty department at the nearest hospital |
| Very serious side effects | Temporary loss of consciousness as a result of an allergic reaction to the ingredients | Stop using CANDASPOR® VAGINAL CREAM and seek urgent medical attention |
| Very serious side effects | Itching | Stop using CANDASPOR® VAGINAL CREAM and seek urgent medical attention |
| Very serious side effects | Vaginal oedema or swelling | Stop using CANDASPOR® VAGINAL CREAM and seek urgent medical attention |
| Serious side effects | Pelvic pain | Tell your doctor immediately or go to the casualty department at the nearest hospital |
| Serious side effects | Shortness of breath | Tell your doctor immediately or go to the casualty department at the nearest hospital |
| Serious side effects | Vaginal bleeding | Tell your doctor immediately or go to the casualty department at the nearest hospital |
| Other side effects | Abnormally low blood pressure, with symptoms such as dizziness, light-headedness, fainting or feeling sick | Tell your doctor |
| Other side effects | Genital peeling as part of the exfoliation process of removing damaged vaginal epithelium | Tell your doctor |
| Other side effects | Redness of the skin | Tell your doctor |
| Other side effects | Discomfort | Tell your doctor |
| Other side effects | Burning | Tell your doctor |
| Other side effects | Irritation | Tell your doctor |
| Other side effects | Abdominal pain | Tell your doctor |
| Side effects not listed | Any side effect not mentioned or any unexpected health change | Inform your doctor or pharmacist |
Reporting of Side Effects
If side effects occur, talk to your doctor or pharmacist.
Reporting side effects helps provide more information on the safety of CANDASPOR® VAGINAL CREAM.
5. How to Store CANDASPOR® VAGINAL CREAM
Store all medicines out of reach of children.
Store at or below 25 ºC.
Protect from light.
Do not use after the expiry date on the carton.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewage systems, including toilets.
6. Contents of the Pack and Other Information
What CANDASPOR® VAGINAL CREAM Contains
The active substance is clotrimazole.
Each 1 g of cream contains 10 mg clotrimazole.
The other ingredients are:
| Other ingredients |
|---|
| Biopure 100 |
| Ceteareth-25 |
| Ceteareth-6 and stearyl alcohol |
| Cetostearyl alcohol |
| Liquid paraffin |
| Nipastat |
| Propylene glycol |
What CANDASPOR® VAGINAL CREAM Looks Like and Contents of the Pack
CANDASPOR® VAGINAL CREAM is a soft, white cream.
It is supplied in a 50 g tube with 7 vaginal applicators.
Holder of Certificate of Registration
Ranbaxy Pharmaceuticals (Pty) Ltd
14 Lautre Road, Stormill Ext 1
Roodepoort, 1724
South Africa
This Leaflet Was Last Revised In
13 January 2022
Registration Numbers
| Country | Registration number |
|---|---|
| South Africa | Y/20.2.2/289 |
| Botswana | S2 BOT 0500761 |
| Namibia | NS1 04/20.2.2/1000 |
Medical Disclaimer
This article is intended as patient information based on the approved leaflet structure. It does not replace advice from a doctor, pharmacist or other healthcare provider. For regulated medical product use, follow the approved patient information leaflet and healthcare professional guidance.
