Canesten Cream Combi Internal & External Creams

1. Name Of The Medicinal Product

Canesten Cream Combi Internal & External Creams

2. Qualitative And Quantitative Composition

Canesten Combi 10% Internal Cream contains Clotrimazole 10% w/w.

Canesten Combi 2% External Cream contains Clotrimazole 2% w/w.

For excipients, see 6.1

3. Pharmaceutical Form

Cream.

4. Clinical Particulars

4.1 Therapeutic Indications

The internal cream is recommended for the treatment of candidal vaginitis.

The external cream is recommended for the treatment of candidal vulvitis. It should be used as an adjunct to treatment of candidal vaginitis.

These products should only be used if candidal vulvovaginitis (thrush) was previously diagnosed by a doctor.

4.2 Posology And Method Of Administration

Adults

The internal cream should be administered intravaginally using the applicator supplied. The contents of the filled applicator (5g) should be inserted as deeply as possible into the vagina, preferably at night.

The external cream should be thinly applied to the vulva and surrounding area, two or three times daily and rubbed in gently.

Treatment with the external cream should be continued until symptoms of the infection disappear. However, if after concomitant treatment of the vaginitis, the symptoms do not improve within seven days, the patient should consult a physician.

Generally:

Treatment during the menstrual period should be avoided 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 and any of the other ingredients.

Hypersensitivity to cetostearyl alcohol.

Do not use to treat nail or scalp infections.

4.4 Special Warnings And Precautions For Use

These products contain cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

Before using Canesten Cream Combi Internal & External Creams 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

The creams 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

If no improvement in symptoms is seen after 7 days the patient should consult their doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Laboratory tests have suggested that 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.

Well-conducted epidemiological studies indicate no adverse effects of clotrimazole on pregnancy or on the health of the fetus/newborn child.

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

Not 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)

Canesten Internal Cream

Reproductive system and breast disorders:

genital peeling, pruritus, rash, oedema, discomfort, burning, irritation, pelvic pain

Gastrointestinal disorders:

abdominal pain

Canesten Cream

Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema, irritation, peeling/exfoliation, pruritus, rash, stinging/burning

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 F18 Gynecological antiinfectives and antiseptics – imidazole derivative.

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

Canesten Combi 10% Internal Cream contains:

Sorbitan stearate

Polysorbate 60

Cetyl palmitate

Cetostearyl alcohol

Isopropyl myristate

Benzyl alcohol

Purified water

Canesten Combi 2% External Cream contains:

Sorbitan stearate

Polysorbate 60

Cetyl palmitate

Cetostearyl alcohol

Octyldodecanol

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

Canesten Combi 10% Internal Cream:

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 5g.

Canesten Combi 2% External Cream:

The cream is filled into Aluminium tubes (10g) with internal lacquer coating, latex stopper and HDPE screw top.

The blister pack and tube are enclosed in a cardboard carton.

6.6 Special Precautions For Disposal And Other Handling

Canesten Combi 10% Internal Cream:

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 hygienically.

Canesten Combi 2% External Cream:

There are no special instructions for use of the cream.

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 0010/0301

9. Date Of First Authorisation/Renewal Of The Authorisation

03/08/2009

10. Date Of Revision Of The Text

12/08/2010

LEGAL CATEGORY

GSL