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.
36 months
Known hypersensitivity to any of the components.
None known
Sorbitan stearate
Polysorbate 60
Cetyl palmitate
Stearyl alcohol
Cetyl alcohol
2-octyldodecanol
Benzyl alcohol
Purified water
Cream
A white cream.
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
There are no preclinical data of reference to the prescriber which are additional to the information included in other sections of the SPC.
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.
ATC code: D01A C 01
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.
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.
03/03/2014
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
Clotrimazole 1% w/w Cream
Boots Thrush Duo
Boots Thrush Oral Capsule and Cream Duo
Lloyds Pharmacy Thrush Duo
Teva Thrush Duo
Vantage Thrush Duo
Teva UK Limited
Brampton Road
Hampden Park
Eastbourne
East Sussex
BN22 9AG
No special precautions for storage
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.
PL 00289/1476
Clotrimazole 1% w/w
For excipients see 6.1
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)
None known
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.
None
28/10/2005 / 07/06/2010
