The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: betamethasone dipropionate, clotrimazoleOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

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Lotriderm 0.05% w/w /1.0% w/w Cream

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Betamethasone dipropionate, Clotrimazole may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Betamethasone dipropionate, Clotrimazole

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

for

Lotriderm Cream contains the active ingredients 0.064% w/w betamethasone dipropionate (equivalent to 0.05 % w/w betamethasone) and 1.0% w/w clotrimazole. Betamethasone belongs to a group of medicines called topical corticosteroids which are used on the surface of the skin to reduce the redness and itchiness caused by certain skin problems. Clotrimazole is a topical anti-fungal medicine used to treat some fungal infections of the skin. Lotriderm Cream is used for the short-term treatment of certain fungal infections of the skin, when redness and itchiness may also be a problem. 2.

What you need to know before you take it

e Lotriderm Cream

Do not use Lotriderm Cream

if you are allergic to betamethasone dipropionate, clotrimazole or any of the other ingredients of this medicine (listed in section 6).
if your skin becomes irritated, or you develop an allergic reaction.
on any other skin infections as it could make them worse, especially rosacea (a skin condition affecting the face), acne, dermatitis (skin inflammation) around the mouth, nappy rash or other skin infections. Warnings and precautions If you have psoriasis, your doctor may want to review your treatment regularly. Contact your doctor if your psoriasis gets worse or you get raised bumps filled with pus under your skin. Contact your doctor immediately if you, or your child, experience blurred vision or other visual disturbances. Side effects that may happen with inhaled or oral corticosteroids may also occur with corticosteroids used on the skin, especially in infants and children. If you use more than the correct amount of cream and/or use it for longer than is recommended, it can affect the levels of certain hormones in the body, particularly in infants and children. 1

In adults the changes in hormone levels may lead rarely to puffiness or rounding of the face, weakness, tiredness, and dizziness when standing or sitting down. Children Do not use this medicine on children under 12 years of age unless advised by your doctor. If you use more than the correct amount of cream and/or use it for longer than is recommended, it can affect your child's hormones. Rarely this may lead to:

Delayed growth and development
A moon face or rounding of the face
A build-up of pressure around the brain which can produce
a bulging of the fontanelle (the soft spot in the top of the skull) in infants
a constant thumping headache
blurred vision or other visual disturbances Other medicines and Lotriderm Cream Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Lotriderm Cream contains:
cetostearyl alcohol, which may cause localised skin reactions (e.g. contact dermatitis).
100mg propylene glycol in each gram, which may cause skin irritation. Because this medicine contains propylene glycol, do not use it on open wounds or large areas of broken or damaged skin (such as burns) without checking with your doctor or pharmacist.
10mg benzyl alcohol in each gram, which may cause allergic reactions or mild local irritation. 3.

How to take it

Lotriderm Cream

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

For adults and children over the age of 12 years a layer of cream should be gently massaged into the affected and surrounding skin areas twice a day, in the morning and evening.
Usually the cream should be used for either two weeks or four weeks, depending on the type of infection you have.
Your doctor will tell you how long to use the cream for. Your skin infection should start to improve and the redness and itchiness will ease within the first few days of treatment.
If your skin infection does not appear to get any better, you should see your doctor. You should always follow these instructions when using Lotriderm Cream:
Keep the cream away from your eyes.
If Lotriderm Cream is used in children, it should not be used on any part of their body for more than 5 days.
Do not put the cream under a dressing, such as a plaster or bandage, as this makes it easier for the active ingredient of the medicine to pass through the skin and possibly cause some unwanted effects.
You must not use a large amount of cream on large areas of the body for a long time (for example every day for many weeks or months).
Do not apply the cream to the face for more than 5 days, in places where the skin folds (e.g. the back of the knee) or on large areas of damaged skin. 2

If you use more Lotriderm Cream than you should Tell your doctor if:

you (or someone else) accidentally swallows the cream, it should not produce any undesirable effects.
you use the cream more often than you should, or on large areas of the body, it may cause some side effects.
you have not followed the dosage instructions, or your doctor's advice and have used the cream too frequently and/or for a long time If you forget to use Lotriderm Cream If you forget to use your cream at the right time, use it as soon as you remember, then carry on as before. 4.

Possible side effects

A few people may find that they suffer from some of the following side effects after using Lotriderm Cream:

burning and stinging
rash; swelling and other skin infections. In addition, the following side effects have been reported to occur following the use of other medicines containing either clotrimazole or betamethasone dipropionate:
redness, stinging, blistering, peeling, swelling, itching, burning, skin rash, dryness of the skin
inflammation of the hair follicles; excessive hair growth
darkening of the skin; allergic skin reactions; dermatitis (skin inflammation) around the mouth; other skin infections, thinning of the skin and red marks.
blurred vision. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5. • • • •

How to store it

Lotriderm Cream Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Lotriderm Cream contains

The active substances are betamethasone dipropionate and clotrimazole. Each gram contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) and 10 mg clotrimazole.
The other ingredients are: liquid paraffin; white soft paraffin; cetostearyl alcohol; macrogol cetostearyl ether; benzyl alcohol; sodium dihydrogen phosphate dihydrate; phosphoric acid concentrated; sodium hydroxide; propylene glycol (E 1520); purified water. What Lotriderm Cream looks like and contents of the pack Lotriderm Cream is a smooth, white to off white cream. It is available in tubes containing 15g, 30g or 50g. Not all pack sizes may be marketed. 3

Marketing Authorisation Holder and Manufacturer The holder of the Marketing Authorisation is: Organon Pharma (UK) Limited, Shotton Lane, Cramlington, United Kingdom, NE23 3JU.

The manufacturer is: Organon Heist bv, Industriepark 30, 2220 Heist-op-den-Berg, Belgium.

Frequently asked questions about Lotriderm 0.05% w/w /1.0% w/w Cream

How do I take Lotriderm 0.05% w/w /1.0% w/w Cream?

Lotriderm 0.05% w/w /1.0% w/w Cream comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Lotriderm 0.05% w/w /1.0% w/w Cream?

The active substance in Lotriderm 0.05% w/w /1.0% w/w Cream is betamethasone dipropionate, clotrimazole.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Lotriderm 0.05% w/w /1.0% w/w Cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Lotriderm 0.05% w/w /1.0% w/w Cream without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Active substance: betamethasone dipropionate, clotrimazole
Official document: view the original leaflet on emc →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Betamethasone dipropionate (14 medicines), Betamethasone dipropionate, clotrimazole (1 medicine), Clotrimazole (23 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Short-term topical treatment of tinea infections due to Trichophyton rubrum; T.mentagrophytes; Epidermophyton floccusum and Microsporum canis; candidiasis due to Candida albicans.

4.2. Posology and method of administration

Posology

Adults and children over the age of 12 years. Topical administration twice daily for two weeks (tinea cruris, tinea corporis and candidiasis) or for four weeks (tinea pedis).

Paediatric population

Lotriderm cream is not recommended for children under the age of twelve years.

Method of administration

Topical administration only.

4.3. Contraindications

Lotriderm is contraindicated in those patients with a history of sensitivity to any of its components or to other corticosteroids or imidazoles.

If irritation or sensitisation develops with the use of Lotriderm cream, treatment should be discontinued and appropriate therapy instituted.

Lotriderm is contraindicated in facial rosacea, acne vulgaris, perioral dermatitis, napkin eruptions and bacterial or viral infections.

4.4. Special warnings and precautions for use

Local and systemic toxicity is common especially following long continued use on large areas of damaged skin and in flexures. If used on the face, courses should be limited to 5 days.

LOTRIDERM CREAM SHOULD NOT BE USED WITH OCCLUSIVE DRESSING.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following the development of tolerance, risk of generalised pustular psoriasis and local and systemic toxicity due to impaired barrier function of the skin.

Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, manifestation of Cushing's syndrome, hyperglycemia, and glycosuria may also occur with topical steroids, especially in infants and children.

Lotriderm Cream is not intended for ophthalmic use.

Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Paediatric population

• Long term continuous therapy should be avoided in all children irrespective of age.

• Lotriderm cream should not be used with adhesive dressing.

• The safety and effectiveness of Lotriderm cream has not been established in children below the age of 12.

• If used on children, courses should be limited to 5 days.

Hypothalamic-pituitary adrenal axis suppression, Cushing's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestation of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestation of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilloedema.

Lotriderm cream contains:

Cetostearyl alcohol which may cause localised skin reactions (e.g. contact dermatitis).

Propylene glycol which may cause skin irritation. Because this medicine contains propylene glycol, do not use it on open wounds or large areas of broken or damaged skin (such as burns).

Benzyl alcohol which may cause allergic reactions or mild local irritation.

4.5. Interaction with other medicinal products and other forms of interaction

There are no known interactions.

4.6. Fertility, pregnancy and lactation

Pregnancy

There is inadequate evidence of safety in pregnancy. Clotrimazole has shown no teratogenic effect in animals but is foetotoxic at high oral doses.

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in human foetus. Hence Lotriderm Cream should only be used in pregnancy if the benefit justifies the potential risk to the foetus and such use should not be extensive i.e. in large amounts or for long periods.

Breast-feeding

It is not known whether the components of Lotriderm are excreted in human milk and therefore caution should be exercised when treating nursing mothers.

4.7. Effects on ability to drive and use machines

Lotriderm cream has no influence on the ability to drive and use machines.

4.8. Undesirable effects

Adverse reactions reported for Lotriderm include: burning and stinging, maculopapular rash, oedema, paraesthesia and secondary infection.

Reported reactions to clotrimazole include erythema, stinging, blistering, peeling, oedema, pruritus, urticaria and general irritation of the skin.

Reactions to betamethasone dipropionate include: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hyperpigmentation, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae miliaria, capillary fragility (ecchymoses), blurred vision and sensitisation.

In children receiving topical corticosteroids, Hypothalamic-pituitary adrenal (HPA) axis suppression (HPA) axis suppression, Cushing's syndrome and intracranial hypertension have been reported. (See section 4.4)

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Acute overdosage with topical application of Lotriderm cream is unlikely and would not be expected to lead to a life-threatening situation; however topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.

Toxic effects are unlikely to occur following accidental ingestion of Lotriderm cream. Signs of toxicology appearing after such accidental ingestion should be treated symptomatically.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

CLO-EKARZIN 0,50 mg/10 mg prescriptionCOMBINATII (BETAMETHASONUM+CLOTRIMAZOLUM) · skin / topical

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

⚠ Not the same combination. This medicine contains Betamethasone dipropionate, Clotrimazole. The products below do not contain exactly the same set of active substances — they are not direct substitutes.

Fungidermin partial — not the same combinationClotrimazolum · skin / topical
Triderm partial — not the same combinationBetamethasoni dipropionas + Clotrimazolum + Gentamicinum · skin / topical

Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Lotriderm 0.05% w/w /1.0% w/w Cream. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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