Boots Thrush Treatment Clotrimazole

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

Clotrimazole 1% w/wFor excipients see 6.1

CreamA white cream.

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.

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 weeksRoute 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.

Known hypersensitivity to any of the components.

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 dysuria10. No improvement in 7 days.11. Any adverse effects such as redness, irritation or swelling associated with the treatmentThe cream contains cetyl alcohol and stearyl alcohol, which may cause local skin reaction (e.g. contact dermatitis)

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.

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.

None known

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

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.

ATC code: D01A C 01Clotrimazole 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.

There are no preclinical data of reference to the prescriber which are additional to the information included in other sections of the SPC.

Sorbitan stearatePolysorbate 60Cetyl palmitateStearyl alcoholCetyl alcohol2-octyldodecanolBenzyl alcoholPurified water

None known

36 months

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.

None

Teva UK LimitedBrampton RoadHampden ParkEastbourneEast SussexBN22 9AG

PL 00289/1476

28/10/2005 / 07/06/2010

03/03/2014