Ukraine Product

Clofan Suppositories

Clofan Suppositoriess

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:

Clofan suppository is recommended for the treatment of candidal vaginitis.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

You should consult your doctor if you experience any of the following:
Immune system disorders:

  • Allergic reaction (syncope, hypotension, dyspnea, urticaria, pruritus).

Reproductive system and breast disorders:

  • Genital peeling, pruritus, rash, oedema, erythema, discomfort, burning, irritation, pelvic pain, vaginal haemorrhage.

Gastrointestinal disorders:

    • Abdominal pain.

WHAT TO DO IF YOU MISS A DOSE?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis.
Before using clofan suppository, medical advice must be sought if any of the following are applicable:

• More than two infections of candidal vaginitis in the last 6 months.
• Previous history of sexually transmitted disease or exposure to partner with sexually transmitted disease.
• Pregnancy or suspected pregnancy.
• Agedunder 16 or over 60 years.
• Known hypersensitivity to imidazoles or other vaginal antifungal products.
Clofan suppository should not be used if the patient has any of the following symptoms where upon medical advice should be sought:
• Irregular vaginal bleeding.
• Abnormal vaginal bleeding or a blood-stained discharge.
• vulval or vaginal ulcers, blisters or sores.
• Lower abdominal pain or dysuria.
• Any adverse events such as redness, irritation or swelling associated with the treatment.
• Fever or chills.
• Nausea or vomiting.
• Diarrhoea.
• Foul smelling vaginal discharge.

Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using clofan 500 mg suppository. Clofan 500 mg suppository can be used again if the candidal infection returns after 7 days. However, if the candidal infection recurs more than twice within six months, patients should be advised to consult their physician.

Influence on velocity reactions while driving motor transport and operating other mechanisms:

The medication has no or negligible influence on the ability to drive or use machinery.

What to do if you accidentally take too much (overdose) of the medicine?

No risk of acute intoxication is seen as it is unlikely to occur following a single vaginal or dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote.
However, in the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). Gastric lavage should be carried out only if the airway can be protected adequately.

 

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store at room temperature below 25°C. Protect from moisture.

Drug Description

Active substance:
Each vaginal suppository contains …….  Clotrimazole BP    500 mg

Additional ingredients: Hard fat (Suppocire NAI 25 A)

General physic-chemical properties: White to light yellow color torpedo shaped suppositories

Indications and dosage.

Indications:
Clofan suppository is recommended for the treatment of candidal vaginitis.

Dosage:
The suppository should be inserted into the vagina, as high as possible.
Adults: One 500mg suppository should be inserted at night; the suppository should be inserted as high as possible into the vagina. This is best achieved when lying back with legs bent up. A second treatment may be carried out if necessary.
Clofan suppository need moisture in the vagina in order to dissolve completely, otherwise undissolved pieces of the suppository might crumble out of the vagina. Pieces of undissolved suppository may be noticed by women who experience vaginal dryness. To help prevent this it is important that the suppository is inserted as high as possible into the vagina at bedtime. Generally:Treatment during the menstrual period should not be performed due to the risk of the suppository being washed out by the menstrual flow. The treatment should be finished before the onset of menstruation.
Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product.
Vaginal intercourse should be avoided in case of vaginal infection and while using this product because the partner could become infected.
Children: Paediatric usage is not recommended.

Route of administration: Vaginal

Side effects and drug interactions.

Side effects: As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible.

Immune system disorders:

  • Allergic reaction (syncope, hypotension, dyspnea, urticaria, pruritus).

Reproductive system and breast disorders:

  • Genital peeling, pruritus, rash, oedema, erythema, discomfort, burning, irritation, pelvic pain, vaginal haemorrhage.

Gastrointestinal disorders:

  • Abdominal pain.

 Drug interactions
Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least five days after using this product.
Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) might lead to increased tacrolimus plasma levels and similarly with sirolimus. Patients should thus be closely monitored for signs and symptoms of tacrolimus or sirolimus overdosage, if necessary by determination of the respective plasma levels.

 

Warnings and precautions

Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis.
Before using clofan suppository, medical advice must be sought if any of the following are applicable:

• More than two infections of candidal vaginitis in the last 6 months.
• Previous history of sexually transmitted disease or exposure to partner with sexually transmitted disease.
• Pregnancy or suspected pregnancy.
• Agedunder 16 or over 60 years.
• Known hypersensitivity to imidazoles or other vaginal antifungal products.
Clofan suppository should not be used if the patient has any of the following symptoms where upon medical advice should be sought:
• Irregular vaginal bleeding.
• Abnormal vaginal bleeding or a blood-stained discharge.
• vulval or vaginal ulcers, blisters or sores.
• Lower abdominal pain or dysuria.
• Any adverse events such as redness, irritation or swelling associated with the treatment.
• Fever or chills.
• Nausea or vomiting.
• Diarrhoea.
• Foul smelling vaginal discharge.

Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using clofan 500 mg suppository. Clofan 500 mg suppository can be used again if the candidal infection returns after 7 days. However, if the candidal infection recurs more than twice within six months, patients should be advised to consult their physician.


Overdosage and Contraindications

Overdosage:
No risk of acute intoxication is seen as it is unlikely to occur following a single vaginal or dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote.
However, in the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). Gastric lavage should be carried out only if the airway can be protected adequately.

 Contraindications
Hypersensitivity to the active substance or to any of the excipients.

Clinical pharmacology.

Pharmacodynamic properties

Pharmacotherapeutic group: Gynaecological anti-infectives and antiseptics – imidazole derivatives

ATC Code: G01A F02

Mechanism of Action
Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane.

Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.

Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062-8.0 μg/ml substrate.The mode of action of clotrimazole is fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In-vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive.
Primarily resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions.

 

Pharmacokinetic properties
Pharmacokinetic investigations after vaginal application have shown that only a small amount of clotrimazole (3 – 10% of the dose) is absorbed. Due to the rapid hepatic metabolism of absorbed clotrimazole into pharmacologically inactive metabolites the resulting peak plasma concentrations of clotrimazole after vaginal application of a 500mg dose were less than 10 ng/ml, reflecting that clotrimazole applied intravaginally does not lead to measurable systemic effects or side effects.

Pharmaceutical characteristics:

Shelf-life: 2 Years

Storage: Store at room temperature below 25°C. Protect from moisture

Package: 1 vaginal suppository is packed in PVC/PE strip and 1 strip is packed in a carton along with pack insert.

Conditions of supply:
By prescription.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575