Sunday, April 16, 2023

CANIFUG CREMOLUM 200 MG VAGINAL SUPPOSITORIES N3

 Canifug Cremolum 200 mg ovules

Clotrimazole

 

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor has told you.

  • Do not throw this leaflet away as you may need to read it again.
  • If you want to know more or consult, ask your pharmacist.
  • If you experience side effects (even if they are not listed in this leaflet), contact your doctor or pharmacist. See Chapter 4.
  • If your condition has not improved or even worsened within 3 days, consult a doctor.

 

What is this leaflet about?

 

  1. What Canifug Cremolum is and what it is used for
  2. What you need to know before using Canifug Cremolum
  3. How to use Canifug Cremolum
  4. Possible side effects
  5. How to store Canifug Cremolum
  6. Package contents and other information

 

1. What Canifug Cremolum is and what it is used for

 

Canifug Cremolum is an ovule drug for vaginal use against fungal diseases.

The effect of clotrimazole on fungi is explained by the inhibitory effect on ergosterol biosynthesis. Since ergosterol is a necessary substance in the structure of the fungal cell membrane, the cell wall is damaged and the fungal cell disintegrates under the influence of clotrimazole.

 

Canifug Cremolum is used to treat vaginitis caused by yeast (most commonly white fungus).

If the disease occurs for the first time or if the disease has occurred more than 4 times in the last 12 months, the drug can only be used under the supervision of a doctor.

 

2. What you need to know before taking Canifug Cremolum

 

Canifug Cremolum is prohibited for use:

  •  if you are allergic to clotrimazole or any of the excipients of this medicine (listed in section 6).

 

Warnings and precautions

Talk to your doctor or pharmacist before taking Canifug Cremolum.

 

Special precautions are required:

  • if you are pregnant, think you may be pregnant, or are planning to become pregnant;
  • if deodorants or intimate hygiene products are used; they can be used only after consulting a doctor, as the effectiveness of Canifug Cremolum may decrease;
  • if you are diagnosed with an infection caused by fungi of the labia and surrounding areas at the same time, and/or if your partner is diagnosed with an infection caused by fungi of the head of the penis and foreskin. In this case, it is necessary to additionally use drug forms suitable for local treatment;
  • if there is redness, tingling, itching, discharge from the vagina, and painful inflammation of the vagina, it can also be caused by factors that Canifug Cremolum does not work on. Only a doctor can make the correct diagnosis;
  • when you use Canifug Cremolum and latex products (eg condoms, diaphragms) at the same time, as the excipients (especially stearates) may reduce the effectiveness of these products and make them less reliable.

 

Warnings

It is best to treat outside of menstruation and/or end treatment before menstruation. Treatment during menstruation is possible only in case of severe clinical symptoms. Consult your doctor about this.

 

During pregnancy, treatment can only be prescribed by a doctor (see also section 2 "What you need to know before taking Canifug Cremolum").

 

If you have a fungal infection of the labia and the surrounding areas, and/or if your partner has a fungal infection of the head of the penis or the foreskin, additional local treatment should be used. To avoid possible re-infection, the partner should be medically examined at the same time.

 

For children

Canifug Cremolum is not recommended for use in children, as dosage recommendations for this age group have not been established.

 

Other medicines and Canifug Cremolum

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, or if you are not sure.

 

The active substance of Canifug Cremolum (clotrimazole) can reduce the effectiveness of amphotericin B and other polyene antibiotics (nystatin, natamycin)

 

Pregnancy, lactation, and fertility

During pregnancy and breastfeeding, you can use Canifug Cremolum 200 vaginally, but only on the doctor's prescription.

 

Driving and machine control

No special precautions are required.

 

Canifug Cremolum contains cetostearyl alcohol. It may cause local skin reactions (e.g. contact dermatitis).

 

3. How to use Canifug Cremolum

 

Always take this medicine exactly as described in this leaflet or as your doctor has told you. If in doubt, ask your doctor or pharmacist.

 

Unless otherwise prescribed by your doctor, the recommended dose is:

1 Canifug Cremolum ovule (= 200 mg clotrimazole) is inserted into the vagina once a day for 3 consecutive days.

 

No dose adjustment is necessary for elderly women.

 

Method of use

Canifug Cremolum ovule is intended for vaginal use.

In the evening, after washing your hands cleanly, use your finger to push the egg into the vagina as deeply as possible. It is more convenient to do this lying on your back with your legs slightly bent.

 

To remove the ovule from the package, tear off the film by pulling it down; use a device that facilitates opening - a V-shaped cut in the film. After that, the ovule can be expelled.

 

To prevent the formation of grease stains on clothes, a pad should be inserted into the panties during the use of ovules.

 

Duration of use

A 3-day course of treatment with Canifug Cremolum 200 mg ovules is usually sufficient. Use as many times as indicated, even if you feel better. If necessary, a second 3-day course of treatment can be prescribed.

 

What to do if you take too much Canifug Cremolum

If you have taken too much Canifug Cremolum vaginally, continue treatment with the next normal dose. There is almost no risk of overdose.

 

If you accidentally swallow Canifug Cremolum, possible signs of an overdose are:

loss of appetite, vomiting, stomach pain, liver problems, fatigue, drowsiness, hallucinations, frequent urination, and allergic skin reactions.

In such cases, consult your doctor.

 

If you forget to take Canifug Cremolum

Do not take a double dose to make up for a missed dose. Continue treatment at the prescribed dose.

 

When you stop taking Canifug Cremolum

Consult your doctor for further action as treatment may fail.

 

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

 

4. Possible side effects

 

Like all medicines, this medicine can cause side effects, although not everybody gets them.

 

If you experience the side effects listed below, stop taking Canifug Cremolum and consult your doctor as soon as possible.

 

If there is hypersensitivity to the active substance clotrimazole or any component of Canifug Cremolum 200 (eg cetostearyl alcohol), allergic reactions may occur.

 

Frequency not known (cannot be estimated from the available data): in some cases, generalized (widespread) hypersensitivity reactions of varying severity may occur. These can be skin (eg, itching, redness), respiratory (eg, shortness of breath), circulatory (eg, a drop in blood pressure requiring treatment, which may cause unconsciousness), and gastrointestinal (eg, nausea, diarrhea).

In isolated cases, vaginal bleeding may occur.

 

Uncommon (may affect up to 1 in 100 people) skin irritation such as burning, stinging or temporary redness may occur.

 

Side effect reporting

If you get any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can report side effects in the following ways: by directly filling out the online form of the State Medicines Control Service under the Ministry of Health of the Republic of Lithuania in the Medicinal Products Information System https://vapris.vvkt.lt/vvkt-web/public/nrv or by filling in the Patient Report on Suspected adverse reaction (ADR) form, which is published at https://www.vvkt.lt/index.php?4004286486, and by sending it by e-mail (address: NepageidaujamaR@vvkt.lt ) or by free phone 8 800 73 568. By reporting side effects you can help us get more information about the safety of this medicine

 

5. How to store Canifug Cremolum

 

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

 

Store at a temperature not higher than 25 °C.

 

Do not use this medicine after the expiry date which is stated on the carton and double-sided strip after EXP. The drug is suitable for use until the last day of the specified month.

 

Medicines must not be disposed of in the sewer or with household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help protect the environment.

 

6. Package contents and other information

 

Composition of Canifug Cremolum

  • The active ingredient is clotrimazole. One ovule contains 200 mg of clotrimazole.
  • Excipients are cetostearyl alcohol, solid fat, macrogol 20 glycerol monostearate, and sodium salt of polyacrylic acid.

 

Canifug Cremolum appearance and content in the package

 

White or slightly brown oblong ovules in a two-layer strip, packed in a cardboard box.

There are 3 ovules in the package.

4750919000146



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