Canesten Internal Cream / Canesten 10% VC

1. Name Of The Medicinal Product

Canesten Internal Cream

also available as Canesten 10% VC.

2. Qualitative And Quantitative Composition

Clotrimazole 10% w/w

For excipients, see 6.1

3. Pharmaceutical Form

Vaginal cream.

4. Clinical Particulars

4.1 Therapeutic Indications

Legal Category POM

Canesten 10% VC is recommended for the treatment of candidal vaginitis and mixed vaginal infections where Trichomonas is present or suspected. This product is not recommended as sole treatment for pure Trichomoniasis except in cases where systemic therapy is contra-indicated.

Legal Category P

Canesten Internal Cream is recommended for the treatment of candidal vaginitis.

4.2 Posology And Method Of Administration

The cream should be administered intravaginally using the applicator supplied.

Adults:

The contents of the filled applicator (5g) should be inserted as deeply as possible into the vagina, preferably at night. A second treatment may be carried out if necessary.

Generally:

treatment during the menstrual period should not be performed due to the risk of the cream 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.

Children:

Not for use in children under 16.

4.3 Contraindications

Hypersensitivity to clotrimazole or any other ingredient in this medicine.

Hypersensitivity to cetostearyl alcohol.

4.4 Special Warnings And Precautions For Use

Legal Category P Only

Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis.

Before using Canesten Internal Cream, 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 a sexually transmitted disease or exposure to partner with sexually transmitted disease

• pregnancy or suspected pregnancy

• aged under 16 or over 60 years

• known hypersensitivity to imidazoles or other vaginal antifungal products

Canesten Internal Cream should not be used if the patient has any of the following symptoms whereupon 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 Canesten Internal Cream. Canesten Internal Cream 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.

This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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. Patients should thus be closely monitored for signs and symptoms of tacrolimus overdosage, if necessary by determination of the respective plasma levels.

4.6 Pregnancy And Lactation

Data on a large number of exposed pregnancies indicate no adverse effects of Clotrimazole on pregnancy or on the health of the foetus/newborn child. To date, no relevant epidemiological data are available.

Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.

During pregnancy the treatment should be carried out with clotrimazole pessary, since these can be inserted without using an applicator.

4.7 Effects On Ability To Drive And Use Machines

None applicable.

4.8 Undesirable 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, discomfort, burning, irritation, pelvic pain

Gastrointestinal disorders:

abdominal pain

4.9 Overdose

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). It should be carried out only if the airway can be protected adequately.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: G01A F02

Clotrimazole is an imidazole derivative with a broad spectrum of antimycotic activity.

Mechanism of Action

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

Pharmacodynamic Effects

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

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.

5.2 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.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to the information included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sorbitan stearate

Polysorbate 60

Cetyl palmitate

Cetostearyl alcohol

Isopropyl myristate

Benzyl alcohol

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

A single dose applicator consisting of a body of HDPE (lupolene or hostalene), piston of LDPE, cap of LDPE, with a separate plunger of polystyrene. One applicator is contained in a blister pack. Pack size 5gm.

The filled applicator of cream is also available in a combination pack with a 10 g tube of Canesten Thrush Cream as Canesten Complete Cream (Legal Category: P) and Canesten Cream Combi 10% VC & 2% External Cream (Legal Category: POM).

6.6 Special Precautions For Disposal And Other Handling

1. Remove applicator from package. Insert plunger (A) into applicator (B).

2. Remove red cap (C) by turning.

3. Introduce applicator (B) as deeply as possible into the vagina (this is best done with the patient lying on her back with the knees bent up) and empty its contents into the vagina by pushing the plunger (A).

4. Remove the applicator and dispose of it.

Administrative Data

7. Marketing Authorisation Holder

Bayer plc

Bayer House

Strawberry Hill

Newbury, Berkshire

RG14 1JA

Trading as Bayer plc, Consumer Care Division

8. Marketing Authorisation Number(S)

PL 0010/0136

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 30 January 1985

Date of last renewal of authorisation: 28 April 2000

10. Date Of Revision Of The Text

12/08/2010

LEGAL STATUS

Canesten 10% VC and Canesten Cream Combi 10% VC & 2% External Cream POM

Canesten Internal Cream P