Canesten Internal Cream

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Clotrimazole
Available from:
Bayer Limited
ATC code:
G01AF; G01AF02
INN (International Name):
Clotrimazole
Dosage:
10 percent weight/weight
Pharmaceutical form:
Vaginal cream
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Imidazole derivatives; clotrimazole
Authorization status:
Not marketed
Authorization number:
PA1410/039/006
Authorization date:
1986-05-19

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Patient Information Leaflet

Canesten Internal Cream

Clotrimazole 10% w/w

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Canesten Internal

Cream carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve in 7 days.

If you have any unusual effects after using this product, tell your doctor or pharmacist.

IN THIS LEAFLET

1. What is Canesten Internal Cream and what is it used for?

2. Before you use Canesten Internal Cream

3. How to use Canesten Internal Cream

4. Possible side effects

5. How to store Canesten Internal Cream

6. Further information

1. WHAT IS CANESTEN® INTERNAL CREAM AND WHAT IS IT USED FOR?

Canesten Internal Cream is a single application, full course treatment for vaginal thrush. It is a

soothing intravaginal cream in a prefilled applicator for treatment at the site of infection.

Only use this product if you have been previously diagnosed by your doctor as having vaginal

thrush.

The active substance in Canesten Internal Cream is clotrimazole. Clotrimazole belongs to a

group of medicines called azoles and is an antifungal agent which fights the cause of infections

such as vaginal thrush.

2. BEFORE YOU USE CANESTEN® INTERNAL CREAM

Do not use Canesten® Internal Cream:

If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients of Canesten

Internal Cream (see Section 6. Further Information).

During your period as it may be less effective.

Before using Canesten® Internal Cream, you should see your doctor if:

You are unsure whether you have thrush or this is the first time you have had these

symptoms.

You have had more than two infections of thrush in the last two months.

You or your partner have ever had a sexually transmitted disease.

You are aged under 12 or over 60.

You are or may be pregnant.

You have ever had an allergic reaction to Canesten or any other vaginal antifungal products.

You have any of the following symptoms:

Irregular vaginal bleeding.

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Abnormal vaginal bleeding or a blood-stained discharge.

Ulcers, blisters or sores of the vagina or vulva.

Lower abdominal pain.

Back pain

Shoulder pain

Pain or difficulty in passing urine.

Fever or chills.

Feeling sick or vomiting.

Diarrhoea.

A foul smelling discharge from the vagina.

This is because Canesten Internal Cream may not be the right treatment for you.

Taking other medicines:

If you are taking tacrolimus or sirolimus (immunosuppressant medicine), then you should tell

your doctor, because he or she will monitor the levels of this medicine in your blood.

Important information about some of the ingredients:

This product contains cetostearyl alcohol which may cause local skin irritation (e.g. rash, itching

or redness). This product contains 10 mg/g benzyl alcohol. Benzyl alcohol may cause allergic

reactions. Benzyl alcohol may cause mild local irritation.

Special precautions:

Avoid sexual intercourse while using this product, as the infection could be transferred to your

partner. As with other creams, this product may reduce the effectiveness of rubber

contraceptives, such as condoms or diaphragms. Consequently, you should use alternative

precautions for at least five days after using this product.

Do not use tampons, spermicides or other vaginal products while using this product.

Pregnancy and breast-feeding:

Avoid using this medicine during the first trimester of pregnancy. If you are pregnant, breast-

feeding or trying for a baby, tell your doctor or midwife before using Canesten Internal Cream.

Use of the applicator is not advised during pregnancy. Breast-feeding should be discontinued

during treatment with this medicine.

3. HOW TO USE CANESTEN® INTERNAL CREAM

If Canesten Internal Cream has been prescribed for you by your doctor, follow any instructions

he/she may have given you. If you purchased this product without a prescription, follow these

directions closely:

The cream should be inserted as high as possible into the vagina, preferably before going to

sleep at night for convenient and comfortable treatment.

Wash your hands before removing the foil from the blister pack and again afterwards when you

have used the applicator.

1. Remove the applicator from the packaging. Keeping the red cap in place, insert the tip of

plunger A into the applicator B (approximately 1cm).

(Image 1)

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2. Twist and pull to remove the red cap C. Be careful not to press the plunger in any further

before you have inserted the applicator into the vagina. This will avoid wasting any cream.

(Image 2)

3. Carefully put the applicator as deep as is comfortable into the vagina (this is easiest when

lying on your back with your knees bent up). Holding the applicator in place, slowly press the

plunger until it stops so that the pre-measured dose of cream is deposited into the vagina.

(Image 3)

4. Remove the applicator. Dispose of the applicator in a safe place, out of the reach of children.

The applicator cannot be flushed down the toilet.

The cream is deposited in the vagina, but it is quite common to notice a slight discharge after

using the cream and therefore it may be helpful to wear a panty liner. This does not mean that

the treatment has not worked.

The symptoms of thrush should disappear within three days of treatment. If no improvement is

seen after seven days you must tell your doctor. If the infection returns after seven days you

may use one further treatment, but if you have more than two infections within two months

you should see your doctor.

Canesten® Internal Cream is for use in the vagina only:

Do not put the cream in your mouth or swallow it.

If the cream is swallowed accidentally, tell your doctor straight away or contact the Accident

and Emergency Department of your nearest hospital.

Avoid contact with the eyes.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Canesten Internal Cream can cause side effects, although not everybody gets

them.

As with all medicines, some people may be allergic to the cream. If you are allergic, a reaction

will occur soon after you have used the medicine. If you experience an allergic reaction or the

redness, burning, pain, itching or swelling get worse, stop using this product and tell your doctor

straight away or contact the Accident and Emergency Department of your nearest hospital.

Signs of an allergic reaction may include:

Rash.

Swallowing or breathing problems.

Swelling of your lips, face, throat or tongue.

Weakness, feeling dizzy or faint.

Nausea.

Rarely, immediately after you apply the cream you might experience:

Mild burning or irritation.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can also report side effects directly via HPRA

Pharmacovigilance; Website: www.hpra.ie

. By reporting side effects you can help provide more

information on the safety of this medicine.

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5. HOW TO STORE CANESTEN® INTERNAL CREAM

Keep out of the reach and sight of children.

This product should be stored in the original carton.

Do not store above 25°C.

Do not use Canesten Internal Cream after the expiry date which is stated at one end of the

carton, on the applicator and on the applicator foil wrapping. The expiry date refers to the last

day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist

how to dispose of medicines no longer required. These measures will help to protect the

environment.

6. FURTHER INFORMATION

What Canesten® Internal Cream contains:

The active substance is clotrimazole at a strength of 500mg (10% w/w).

The other ingredients are benzyl alcohol, polysorbate 60, sorbitan stearate, cetostearyl

alcohol, isopropyl myristate, cetyl palmitate and water.

See Section 2 ‘Important information about some of the ingredients’ for cetostearyl alcohol

advice.

What Canesten® Internal Cream looks like and contents of the pack:

Canesten Internal Cream is available in single-dose packs containing 5g of white cream in a pre-

filled applicator.

Marketing Authorisation Holder:

Bayer Ltd, The Atrium, Blackthorn Road, Dublin 18.

Manufacturer:

Kern Pharma S.L.

Poligon Industrial Colon II, Calle Venus 72

08228 Terrassa, Barcelona, Spain.

Remember: If you have any doubts about using Canesten® Internal Cream correctly, seek the

advice of your doctor or pharmacist.

Further information about vaginal thrush:

Vaginal thrush (candidiasis) is a common infection that most women suffer from at some time in

their lives and is not caused by lack of personal hygiene.

Thrush is caused by a yeast (fungus) called Candida which lives harmlessly in the vagina and

other parts of the body, without you even noticing it. However, the natural balance that keeps

Candida under control can be upset by many factors such as hormonal changes (menstruation,

contraceptive pill, pregnancy, menopause), poor health, antibiotics, perfumed soaps, bath

additives and tight clothing.

If the natural pH balance is altered, the level of yeast increases and can develop into a thrush

infection causing any of the following symptoms: persistent burning and/or itching around the

vagina and vulva, redness, swelling and soreness of the tissues of the vagina and vulva and a

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whitish, odourless discharge from the vagina. Not everybody who has thrush has all these

symptoms; you may have only one of them.

How to avoid future recurrences:

Wear cotton knickers and loose clothing.

Wash daily.

After going to the toilet, wipe yourself from the front to back as a thrush infection may be

transferred from the bowel.

Change your sanitary protection regularly.

Try to avoid wearing tights, nylon knickers and close fitting jeans.

Try to avoid washing with perfumed soaps or using vaginal deodorants.

Do not wash or rub yourself hard with sponges or flannels and avoid hot baths with strong

perfumed oils.

If you are still worried or have any questions about the symptoms or the treatment of thrush, do

not hesitate to ask your doctor or pharmacist for advice.

This leaflet was last approved in

Canesten is a registered trademark of Bayer AG, Germany.

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Canesten Internal Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram of cream contains 100mg clotrimazole equivalent to clotrimazole 10% w/w

Excipients: Cetostearyl alcohol 35mg/g

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Vaginal cream.

A soft, white cream.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

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

4.2 Posology and method of administration

Canesten Internal Cream should be administered intravaginally using the applicator supplied.

Adults and children of 12 years of age and older:

The contents of the filled applicator (5g) should be inserted as deeply as possible into the vagina, preferably at night, before

going to bed.

If symptoms persist for more than 7 days the patient may have a medical condition that requires treatment by a doctor.

The treatment can be repeated if necessary, however, recurrent infections may indicate an underlying medical cause.

Patient should seek medical advice if symptoms return within 2 months.

If the labia and adjacent areas are simultaneously infected, local treatment with an external cream should also be given in

addition to the intravaginal treatment (combination treatment).

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.

Avoidance of vaginal intercourse is recommended in case of vaginal infection while using this product because your partner

could become infected.

Children under 12 years of age:

As the product is used with an applicator, paediatric usage is not recommended.

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Instructions for use:

1. Remove applicator from package.

Insert plunger into applicator.

2. Remove red cap by turning.

3. Introduce applicator 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.

4. Remove the applicator and dispose of it.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

4.4 Special warnings and precautions for use

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 12 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 (vaginal haemorrhage) 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 (temperature of 38°C or above)or chills

- nausea or vomiting

- diarrhoea

- foul smelling vaginal discharge

- Back pain.

- Associated shoulder pain.

Avoid contact with eyes and do not swallow.

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 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 thoroughly monitored for symptoms of

tacrolimus or sirolimus overdosage, if necessary by determination of the respective plasma levels.

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4.6 Fertility, pregnancy and lactation

Fertility:

No human studies of the effects of clotrimazole on fertility have been performed, however, animal studies have not

demonstrated any effects of the drug on fertility.

Pregnancy:

There are limited amount of data from the use of clotrimazole in pregnant women. Animal studies do not indicate direct or

indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to

avoid the use of clotrimazole during the first trimester of pregnancy.

During pregnancy the treatment should be carried out with clotrimazole vaginal tablets, since these can be inserted without

using an applicator.

Lactation:

Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk (see

section 5.3). Breast-feeding should be discontinued during treatment with clotrimazole.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

The following adverse reactions have been identified during post-approval use of Clotrimazole. Because these reactions are

reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Immune system disorders

Allergic reaction (ME) with symptoms such as dyspnea (PT), hypotension (PT), syncope (PT), and urticaria (ME),

Reproductive system and breast disorders

Vulvovaginal discomfort (PT), edema (PT), burning (PT), genital peeling, irritation, pruritus (ME), pelvic pain (PT), rash (ME) ,

vaginal haemorrhage (PT), erythema (PT).

Gastrointestinal disorders

Abdominal pain (ME)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to

report any suspected adverse reactions via HPRA Pharmacovigilance; Website: www.hpra.ie.

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).

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antifungals for topical use – imidazole and triazole derivates

ATC Code: D01A C01

Mechanism of Action

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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.

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.

In addition to its antimycotic action, clotrimazole also acts on, gram-positive microorganisms (streptococci/staphylococci/

Gardnerella vagiinalis),) and gram-negative microorganisms (Bacteroides). It has no effect on lactobacilli.

In vitro, clotrimazole inhibits the multiplication of Corynebacteria and gram-positive cocci – with the exception of enterococci –

in concentrations of 0.5 – 10 µg/ml substrate.

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 applications 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

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose

toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sorbitan stearate (Type I)

Polysorbate 60

Cetyl palmitate

Cetostearyl alcohol

Isopropyl myristate

Benzyl alcohol

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25ºC.

6.5 Nature and contents of container

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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.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal

product and other handling of the product

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no

longer required. These measures will help protect the environment.

7 MARKETING AUTHORISATION HOLDER

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

8 MARKETING AUTHORISATION NUMBER

PA1410/039/006

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19 May 1986

Date of last renewal: 19 May 2006

10 DATE OF REVISION OF THE TEXT

May 2020

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