Canesten Duopak

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Clotrimazole; Clotrimazole
Available from:
Bayer Limited
ATC code:
G01AF; G01AF02
INN (International Name):
Clotrimazole; Clotrimazole
Dosage:
100mg/1 percent weight/weight
Pharmaceutical form:
Pessaries and Cream
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Imidazole derivatives; clotrimazole
Authorization status:
Marketed
Authorization number:
PA1410/039/005
Authorization date:
1977-04-01

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Canesten® Duopak

clotrimazole

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 Duopak

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 Duopak and what is it used for?

2. Before you use Canesten Duopak

3. How to use Canesten Duopak

4. Possible side effects

5. How to store Canesten Duopak

6. Further information

1. WHAT IS CANESTEN® DUOPAK AND WHAT IS IT USED FOR?

Canesten Duopak is a complete treatment for vaginal thrush because it treats both the internal

cause and external symptoms.

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

thrush.

The active substance in Canesten Duopak 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.

Some women suffer from recurrent attacks of thrush. To reduce the frequency of these attacks,

the sexual partner’s penis can be treated with this cream to prevent reinfection, even if they

have no symptoms of thrush.

2. BEFORE YOU USE CANESTEN® DUOPAK

Do not use Canesten® Duopak:

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

Duopak (see Section 6. Further information).

During your period as it may be less effective.

Before using Canesten® Duopak, 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 six months.

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

You are aged under 12 or over 60.

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.

Abnormal vaginal bleeding or a blood-stained discharge.

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Ulcers, blisters or sores of the vagina or vulva.

Redness, irritation or swelling associated with recent use of Canesten Duopak.

Lower abdominal pain.

Shoulder pain.

Back 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 Duopak 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:

The cream contains cetostearyl alcohol which may cause local skin irritation (e.g. rash, itching or

redness). This product contains 20mg/g benzyl alcohol. Benzyl alcohol may cause allergic

reactions. Benzyl alcohol may cause mild local irritation.

Special precautions:

Sexual intercourse should be avoided while using this product.

As with other creams and pessaries, 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 Duopak. Use of

the applicator is not advised during pregnancy.

Breast-feeding should be discontinued during

treatment with this medicine.

3. HOW TO USE CANESTEN® DUOPAK

The Pessary:

If Canesten Duopak 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 applicator should be used to insert the pessary as high as possible into the vagina,

preferably before going to sleep on six consecutive nights for convenient and comfortable

treatment. Alternatively, two pessaries may be inserted into the vagina before going to sleep on

three consecutive nights.

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

have used the applicator.

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1. Remove the applicator from the packaging. Pull out the plunger A until it stops. Remove the

pessary from the foil blister pack and place firmly into the applicator B.

(Image 1)

2. To fit the pessary into the applicator, the holder of the applicator needs to be squeezed lightly

at both sides. The pessary fits tightly into the applicator and needs to be squeezed into the

holder to about 1cm.

(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 pessary is deposited into the vagina.

(Image 3)

4. Remove the applicator. After use, remove plunger A completely by pulling it out of the

applicator B. Then wash it in warm (not boiling) soapy water, rinse and dry carefully.

5. After completing the treatment, dispose of the applicator in a safe place, out of the reach of

children. The applicator cannot be flushed down the toilet.

Since the pessary dissolves in the vagina, it may be helpful to wear a panty liner because it is

quite common to notice a white chalky residue after using the pessary. This does not mean that

the treatment has not worked. However, if you notice pieces of undissolved pessary, speak to

your doctor or a pharmacist, as the treatment may not have worked properly.

The Cream:

Before use, pierce the tube seal by inverting the cap over the end of the tube and press.

Women:

To treat the itching and soreness of the vulva (vulvitis), the cream should be thinly and evenly

applied to the area around the entrance of the vagina, 2 or 3 times a day and smoothed in

gently.

Treating your sexual partner:

If your sexual partner is treated with this cream, the cream should be applied to the end of the

penis 2 or 3 times a day for up to two weeks.

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.

The pessary is for use in the vagina only. The cream is for external use only:

Do not put the pessary or cream in your mouth or swallow them.

If the pessary or cream are 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 Duopak can cause side effects, although not everybody gets them.

As with all medicines, some people may be allergic to the pessary or 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.

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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 insert the pessary or apply the cream you might experience:

Mild burning or irritation.

Other potential side effects that have been reported:

Discomfort of the vagina or vulva, redness, swelling, burning, bleeding, peeling skin in the

genital area, irritation, itching, pain the lower stomach region, low blood pressure.

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, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side effects you can help

provide more information on the safety of this medicine.

5. HOW TO STORE CANESTEN® DUOPAK

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not use the pessary or cream after the expiry date which is stated at one end of the carton,

on the foil blister strip of the pessaries and on the end of the tube of cream. 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® Duopak contains:

Pessary:

The active substance is clotrimazole at a strength of 100mg.

The other ingredients are lactose monohydrate, microcrystalline cellulose, lactic acid, maize

starch, crospovidone, calcium lactate pentahydrate, magnesium stearate, colloidal

anhydrous silica and hypromellose.

Cream:

The active substance is clotrimazole at a strength of 1% w/w (10mg/g).

The other ingredients are benzyl alcohol, polysorbate 60, sorbitan stearate, cetyl palmitate,

cetostearyl alcohol, octyldodecanol and purified water.

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

cetostearyl alcohol advice.

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What Canesten® Duopak looks like and contents of the pack:

Canesten Duopak contains a full course of treatment, which consists of six 100mg pessaries held

inside a foil blister pack, one applicator for insertion of the pessary into the vagina and one 20g

tube of white external cream.

The Canesten 100mg Pessaries and 1% cream are also available separately. The pessaries come

in a box of six and the cream comes in tubes of 20g and 50g.

Marketing Authorisation Holder:

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

Manufacturer:

GP Grenzach Produktions GmBH, Germany

Remember: If you have any doubts about using Canesten® Duopak 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

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 September 2019.

Canesten is a registered trademark of Bayer AG, Germany.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Canesten Duopak

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each pessary contains Clotrimazole 100 mg.

The cream contains clotrimazole 1% w/w.

Excipients:

Cream contains 10% w/w cetostearyl alcohol.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Pessaries and cream

White biconvex, oblong pessaries with the name “Bayer” engraved on one side and the letters “P3” on the other.

A white oil-in-water type cream.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Canesten 100mg pessaries are recommended for the treatment of candidal vaginitis.

The cream is recommended for associated vulvitis and treatment of the sexual partner to prevent re-infection.

4.2 Posology and method of administration

Canesten 100mg Pessaries should be inserted intravaginally, as high as possible, using the applicator supplied.

The cream is for topical application to the vulva and surrounding area.

Adults and children of 12 years of age and older:

Insert one pessary daily, preferably at night, before going to bed, for six consecutive days.

Alternatively, two pessaries

can be inserted for three consecutive days.

The cream should be applied two or three times daily.

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.

Canesten pessaries need moisture in the vagina in order to dissolve completely, otherwise undissolved pieces of the

pessary might crumble out of the vagina. Pieces of undissolved pessary may be noticed by women who experience

vaginal dryness. To help prevent this it is important that the pessary is inserted as deeply as possible into the vagina at

bedtime.

Treatment during the menstrual period should not be performed due to the risk of the pessary 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.

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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 pessaries are used with an applicator, paediatric usage is not recommended.

Pull out plunger until it stops. Place a pessary into the applicator.

Insert applicator containing the pessary carefully as deeply as is comfortable into the vagina. (This is best

done with the patient lying on her back with the knees bent up.)

3. Push plunger until it stops, thereby depositing the pessary into the vagina. Remove the applicator.

After use, remove plunger completely by pulling it out of the applicator. Then wash it in warm (not boiling)

soapy water, rinse and dry carefully.

4.3 Contraindications

Hypersensitivity to the active substance clotrimazole 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 100mg Pessaries, 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 a sexually transmitted disease.

Pregnancy or suspected pregnancy.

Aged under 12 or over 60 years.

Known hypersensitivity to imidazoles or other vaginal antifungal products.

Canesten 100mg Pessaries 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

All possible infected areas should be treated at the same time.

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

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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 and similarly with sirolimus

Patients should thus be thoroughly monitored for

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

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 a 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, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

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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: Gynaecological antiinfectives and antiseptics – imidazole derivatives.

ATC Code: G01AF02

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.

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.

Pharmacokinetic investigations after dermal application have shown that clotrimazole is practically not absorbed from the

intact or inflamed skin into the human blood circulation. The resulting peak serum concentrations of clotrimazole were

below the detection limit of 0.001 micrograms/ml, reflecting that clotrimazole applied topically 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.

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6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Pessaries:

Calcium Lactate Pentahydrate

Maize Starch

Crospovidone

Colloidal Anhydrous Silica

Lactic Acid

Lactose Monohydrate

Magnesium Stearate

Hypromellose

Microcrystalline Cellulose

Cream:

Sorbitan stearate

Polysorbate 60

Cetyl Palmitate

Cetostearyl Alcohol

Octyldodecanol

Benzyl Alcohol

Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Six pessaries are packed into a blister consisting of 25 µm PA/ 45 µm soft aluminium/ 60 µm PVC and 20 µm hard

aluminium/ 7 g/m

heat seal lacquer. An applicator is also provided.

20g of a smooth, white, oil-in-water type cream is packed in an aluminium tube with internal lacquer coating, tamper

evident seal and HDPE screw on cap.

The pessaries, cream and applicator are enclosed in a cardboard carton.

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 to protect the environment.

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7 MARKETING AUTHORISATION HOLDER

Bayer Ltd

The Atrium

Blackthorn Road

Dublin 18

Ireland

8 MARKETING AUTHORISATION NUMBER

PA 1410/039/005

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 01 April 1977

Date of last renewal: 01 April 2007

10 DATE OF REVISION OF THE TEXT

March 2015

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6

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