Vantage Thrush Duo
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Thrush 1% w/w Cream
Teva Thrush Relief 1% w/w Cream
Lloydspharmacy Thrush Femme 1% w/w Cream
Asda Thrush Relief 1% w/w Cream
Morrisons Thrush Relief 1% w/w Cream
Tesco Thrush Relief 1% w/w Cream
Clotrimazole 1% w/w Cream
Boots Thrush Oral Capsule and Cream Duo
Lloyds Pharmacy Thrush Duo
Teva Thrush Duo
Vantage Thrush Duo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1% w/w For excipients see 6.1
3 PHARMACEUTICAL FORM
Cream
A white cream.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of candidal vulvitis, adjunct to the treatment of candidal vaginitis. It can also be used for treatment of candidal balanitis of the sexual partner.
4.2 Posology and method of administration
Adults (over 16 and under 60 years old)
Apply to the affected area two or three times daily Candida infections: treat for at least two weeks
Route of administration:
For cutaneous use, for the treatment of candidal vaginitis and candidal balanitis. The cream should be applied to the vulva and surrounding area. It can also be applied to the sexual partner’s penis.
A doctor should be consulted if symptoms do not improve within 7 days.
4.3 Contraindications
Known hypersensitivity to any of the components.
4.4 Special warnings and precautions for use
To be used only if candidal vulvitis has previously been confirmed by a doctor.
The patient should be referred for medical advice if:
1. Previous history of STD or exposure to partner with STD.
2. More than two previous attacks in the last 6 months.
3. Known hypersensitivity to imidazoles or other vaginal antifungal products.
4. Pregnancy or suspected pregnancy.
5. Patients aged less than 16 or over 60.
6. Any abnormal or irregular vaginal bleeding.
7. Any blood staining of a vaginal or penile discharge.
8. Any vulval, vaginal or penile sores, ulcers or blisters.
9. Any associated lower abdominal pain or dysuria
10. No improvement in 7 days.
11. Any adverse effects such as redness, irritation or swelling associated with the treatment
The cream contains cetyl alcohol and stearyl alcohol, which may cause local skin reaction (e.g. contact dermatitis)
4.5 Interaction with other medicinal products and other forms of interaction
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 5 days after using the product.
4.6 Pregnancy and lactation
Pregnancy
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 other relevant epidemiological data are available.
Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.
Breast-feeding
It is unknown whether clotrimazole is excreted in breast milk, so it should be given with caution to lactating mothers.
4.7 Effects on ability to drive and use machines
None known
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, dyspnoea, urticaria)
Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema, irritation, peeling/exfoliation, pruritus, rash, stinging/burning
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
In the event of accidental oral ingestion, gastric lavage is rarely required and should be considered only if a life-threatening amount of clotrimazole has been ingested within the preceding hour or 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.
5.1 Pharmacodynamic properties
ATC code: D01A C01
Clotrimazole is an imidazole derivative with a broad spectrum of antimycotic activity. It also exhibits activity against Trichomonas, staphylococci, streptococci and Bacteroides. It has no effect on lactobacilli.
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 dermal application have shown that clotrimazole is minimally 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 mcg/ml, suggesting that clotrimazole applied topically is unlikely to lead to measurable systemic effects or side effects.
5.3 Preclinical safety data
There are no preclinical data of reference 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 Stearyl alcohol Cetyl alcohol 2-octyldodecanol Benzyl alcohol Purified water
6.2 Incompatibilities
None known
6.3 Shelf life
36 months
6.4 Special precautions for storage
No special precautions for storage
6.5 Nature and contents of container
Aluminium tube with polypropylene screw-on cap containing 20g of cream.
Thrush Duo pack only: Aluminium tube with polypropylene screw-on cap containing 20g of cream and PVC/Aluminium blisters containing 1 capsule.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Teva UK Limited Brampton Road Hampden Park Eastbourne East Sussex
BN22 9AG
MARKETING AUTHORISATION NUMBER(S)
PL 00289/1476
9
10
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07/06/2010
DATE OF REVISION OF THE TEXT
24/10/2016