Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Timodine 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 Hydrocortisone, Dimeticone, Benzalkonium chloride, Nystatin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Timodine Cream is used to treat inflamed skin conditions, particularly where the fungal infection Candida albicans can occur. Timodine Cream contains four different medicines called nystatin, hydrocortisone, dimeticone and benzalkonium chloride.
- Nystatin is an antifungal agent which kills Candida albicans
- Hydrocortisone is a mild corticosteroid (or steroid) which fights the inflammation that causes redness, swelling and itchiness
- Dimeticone is a water-repellent which stops wetting and chafing
- Benzalkonium chloride is an antiseptic which kills bacteria. Where two folds of skin rub together, chafing can occur, leading to a sore inflamed area of skin. This particularly happens in places such as the groin or under the breasts where frequent sweating occurs. This combination of irritated skin and wetness is called intertrigo. The same condition happens under babies' nappies and is known as nappy rash. In both intertrigo and nappy rash the inflamed skin is easily infected by germs, in particular a fungus called Candida albicans. Timodine Cream is specially formulated to ease the soreness and treat the infections in intertrigo and inflamed nappy rash.
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Timodine Cream can also be used to treat the following skin conditions when there is infection with Candida albicans:
- Eczema
- Hand dermatitis (skin irritation caused by chemicals such as washing powders)
- Seborrhoeic dermatitis (inflammation of the scalp with excessive dandruff scales and oily secretions)
- Pruritis ani and vulvae (irritation of the external area around the anus and vagina).
What you need to know before you take it
e Timodine Cream Do not use Timodine Cream on you or your child:
- if you or your child are allergic (hypersensitive) to nystatin, hydrocortisone, dimeticone 350, benzalkonium chloride solution or any of the ingredients in Timodine Cream (see Section 6 Contents of the pack and other information)
- on any untreated bacterial, fungal or viral skin infections
- on ulcerated skin
- to treat a skin condition called perioral dermatitis. This is a red spotty rash around your mouth or chin
- to treat a skin condition called rosacea. This is redness and inflammation over your nose, cheeks, chin or forehead
- near the eyes
- under dressings on large areas of the body. Do not use Timodine Cream for longer than 7 days on infants unless your doctor tells you to If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you use Timodine Cream. Warnings and precautions
- Talk to your doctor before using Timodine Cream: − if you are pregnant or breast feeding − if you are elderly − if using on a newborn baby − if you or your child have pruritis (an itchy skin condition) − if you or your child have liver disease − on infected wounds, broken skin, thin/ raw skin or acne
- Avoid prolonged use of Timodine Cream on the face
- Prolonged use of Timodine Cream could increase the likelihood of the cream stopping being effective for you, and of you developing an allergic reaction to the cream
- If there is a worsening of your condition during use consult your prescriber – you may be experiencing an allergic reaction, have an infection or your condition requires a different treatment. If you experience a recurrence of your condition shortly after stopping Timodine PIL UK 013
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treatment, within 2 weeks, do not restart using the cream without consulting your prescriber unless your prescriber has previously advised you to do so. If your condition has resolved and on recurrence the redness extends beyond the initial treatment area and you experience a burning sensation, please seek medical advice before restarting treatment. Increased absorption of the cream may occur if the cream is used on thin/ raw skin, on areas where two skin areas touch or rub together, or under dressings. Thinning of the skin is more likely to occur if the cream is used under dressings If you are using Timodine Cream for nappy rash make sure you speak to your doctor about how you should use the cream. Nappies can make it easier for the ingredients of the cream to pass through the skin and it is possible to accidentally end up using too much cream.
If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you use Timodine Cream. Corticosteroid creams, ointments and other topical preparations come in four different potencies or strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent or strong corticosteroid has a much stronger effect than a mild corticosteroid when using the same amount. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Hydrocortisone is classed as a mild corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition. Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce build-up but not totally remove it. Other medicines and Timodine Cream Please tell your doctor or pharmacist if you are taking or have recently taken/used any other medicines, including medicines obtained without a prescription. If you are using other skin creams at the same time as Timodine Cream, make sure you leave several minutes between applying the different creams. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. There is not enough information to show that Timodine Cream can be used safely during pregnancy and breast-feeding. If you are pregnant or breastfeeding, only use Timodine Cream if advised by your doctor. Important information about some of the ingredients of Timodine Cream Timodine Cream contains:
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Butylated hydroxyanisole (E320) – which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes Cetostearyl alcohol and sorbic acid – both of these ingredients may cause local skin reactions (e.g. contact dermatitis) Propyl hydroxybenzoate (E216) and methyl hydroxybenzoate (E218) – both of these ingredients may cause allergic reactions (possibly delayed) Propylene glycol (E1520) which may cause skin irritation.
How to take it
Timodine Cream Always use Timodine Cream exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. A finger-tip length of cream should be enough for each inflamed area. It is important to apply the cream thinly, to the affected area only.
For intertrigo, eczema, hand dermatitis, seborrhoeic dermatitis, pruritis ani and vulvae: Apply a thin layer of Timodine Cream to the sore area and rub into the skin gently until the cream disappears. Repeat the treatment three times a day until the skin is healed. For severe nappy rash: Remove the soiled nappy, then clean and dry your baby's skin. Rub a thin layer of Timodine Cream into the sore areas until the cream disappears. Repeat the treatment after every nappy change.
- Do not use Timodine Cream for more than 7 days, unless your doctor tells you to. You may find a yellow stain on terry cotton nappies after using Timodine Cream. This will disappear after soaking in bleach or nappy solution followed by rinsing and normal washing. If you use more Timodine Cream than you should Over-use of any corticosteroid cream can result in:
- irreversible skin thinning, stretch marks, and dilated blood vessels near the surface of the skin
- the body absorbing too much steroid and the adrenal glands may stop working properly. Symptoms of this may include tiredness, depression and anxiety
- a condition where levels of steroid hormone become too high in the body, known as Cushing's syndrome. Symptoms include a puffy and rounded face that is also red, stretch marks and acne. Timodine Cream is for external use only and should only be applied to the skin. If you accidentally swallow the cream this may cause nausea and vomiting or diarrhoea. If the cream is swallowed, drinking a glass of water or
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milk may be helpful. You should tell your doctor at once or contact your nearest accident and emergency department. Show any left-over medicines or the empty container to your doctor. If you forget to use Timodine Cream In the case of a missed application, simply apply when the next dose is due. If you stop using Timodine Cream A worsening of symptoms can sometimes occur. If this happens to you, tell your doctor or pharmacist. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some people may be allergic to Timodine Cream. If you or your child experience an allergic reaction you should stop using Timodine Cream and tell your doctor straight away or contact the accident and emergency department of your nearest hospital. Signs of an allergic reaction may include:
- severe rash
- swallowing or breathing problems
- swelling of your lips, face, throat or tongue
- weakness, feeling dizzy or faint
- nausea. Other possible side effects:
- thinning of the skin
- stretch marks
- dilated blood vessels near the surface of the skin
- red spotty rash around your mouth or chin
- acne, or your acne may become worse
- allergic or irritant skin reactions
- loss of colour in the skin where the cream is used
- excessive hair growth
- the appearance of red or purple discolorations on the skin that do not blanch on applying pressure
- spread and worsening of untreated infection
- redness and inflammation over the nose, cheeks, chin or forehead
- adrenal glands may stop working properly. Symptoms of this may include tiredness, depression and anxiety
- Cushing's syndrome (a condition where levels of steroid hormone become too high in the body). Symptoms include a puffy and rounded face that is also red, stretch marks and acne.
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steroid withdrawal reaction: if used over prolonged periods a withdrawal reaction, which might appear to be different from the previous condition, may occur in some patients during treatment or within days to weeks after stopping treatment, with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores.
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 the 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.
How to store it
Timodine Cream Keep out of the sight and reach of children. Do not use Timodine Cream after the expiry date which is stated on the carton and on the tube (EXP). The expiry date refers to the last day of that month. Store Timodine Cream below 15 ̊C. Do not use Timodine Cream if you notice a change in the colour or feel of the cream. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required. These measures will help protect the environment.
Contents of the pack and other information
What Timodine Cream contains The active ingredients in this medicine are nystatin 100,000 IU/g, hydrocortisone 0.5% w/w, dimeticone 350 10% w/w and benzalkonium chloride solution 0.2% w/w. The other ingredients are dibutyl phthalate, glycerol stearate, PEG 100 stearate, purified water, stearic acid, sodium metabisulphite, cellulose nitrate, cetostearyl alcohol, butylated hydroxyanisole compound (containing butylated hydroxyanisole (E320), propyl gallate, citric acid and propylene glycol (E1520)), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), and sorbic acid. What Timodine Cream looks like and contents of the pack
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Timodine Cream is a pale yellow cream. Timodine Cream comes in aluminium tubes of 5.5g, 7.5g and 30g. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer The marketing authorisation holder is: Alliance Pharmaceuticals Limited Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK. Timodine Cream is manufactured by: Conforma N.V.,Zenderstraat 10, B-9070 Destelbergen, Belgium. The information in this leaflet applies only to Timodine Cream. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist. This leaflet was last revised in February 2024 Timodine is a registered trademark of Alliance Pharmaceuticals Limited Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited © Alliance Pharmaceuticals Limited 2024
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Frequently asked questions about Timodine Cream
How do I take Timodine Cream?
Timodine 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 Timodine Cream?
The active substance in Timodine Cream is hydrocortisone, dimeticone, benzalkonium chloride, nystatin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Timodine 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 Timodine 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: hydrocortisone, dimeticone, benzalkonium chloride, nystatin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For the treatment of dermatoses, including intertrigo, eczema, seborrhoeic dermatitis, hand dermatitis, and pruritis ani et vulvae, in which infection with Candida albicans is a factor. For the treatment of severe nappy rash in which infection with C. albicans is a factor.
4.2. Posology and method of administration
For topical application to the skin.
Adults (including the elderly) and children.
Dermatoses: Sufficient Timodine Cream should be applied to cover the lesion in a thin layer. It should then be massaged into the skin until the cream disappears.
The treatment should be repeated three times a day until the lesion has healed.
There is no indication that dosage need be modified for the elderly.
Nappy rash: After removal of the soiled nappy, the affected area should be cleaned and dried, and a thin layer of Timodine Cream applied. The treatment should be repeated after every nappy change. In infants long-term continuous topical steroid therapy should be avoided since this can lead to adrenal suppression even without occlusion. A course of treatment should not normally exceed seven days.
4.3. Contraindications
Timodine Cream is contra-indicated for use in the following conditions:
• rosacea
• perioral dermatitis
• untreated bacterial, fungal or viral skin infections
• ulcerated skin
Known hypersensitivity to nystatin, dimeticone 350, hydrocortisone or benzalkonium chloride solution, or to any of the excipients (see Section 6.1 'List of excipients').
4.4. Special warnings and precautions for use
In order to minimise the side effects of a topical corticosteroid, it is important to apply it thinly to the affected areas only. Topical corticosteroids should not be applied with an occlusive dressing to large areas of the body. Absorption is greatest on thin/raw skin, intertriginous areas, and under occlusion. Skin thinning is more likely if corticosteroids are applied under occlusion.
The label will state mild steroid.
Absorption of topical corticosteroids through the skin can rarely cause adrenal suppression and even Cushing's syndrome (see Section 4.8 'Undesirable effects' and Section 4.9 'Overdose'), depending on the area of the body being treated and the duration of treatment.
Avoid prolonged exposure on the face and keep away from the eyes. Use with caution on broken skin.
Prolonged use of compound preparations such as Timodine Cream can increase the likelihood of resistance and of sensitization. Mixing topical preparations on the skin should be avoided where possible; several minutes should elapse between application of different preparations.
Topical corticosteroids are not recommended for acne vulgaris, may worsen secondary infected lesions, and should not be used indiscriminately in pruritis.
Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered.
Timodine Cream contains butylated hydroxyanisole (E320), cetostearyl alcohol, sorbic acid which may cause local skin reactions (e.g. contact dermatitis) and propylene glycol (E1520), which may cause skin irritation. Butylated hydroxyanisole (E320) may cause irritation to the eyes and mucous membranes. Timodine Cream also contains propyl hydroxybenzoate (E216) and methyl hydroxybenzoate (E218), both of which may cause allergic reactions, which may be delayed. Nystatin can rarely cause contact dermatitis, and allergic reactions can occur after use of benzalkonium chloride.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce build-up but not totally remove it.
The elderly
The skin of the elderly is often relatively atrophic so that local and systemic side effects of hydrocortisone are more likely.
Patients with hepatic failure
The reduced metabolism of hydrocortisone in patients with hepatic failure increases the theoretical risk of adrenal suppression.
Paediatric population
Avoid prolonged use in children.
Caution is required in dermatoses of infancy including nappy rash. Care should be taken as the nappy can act as an occlusive dressing and thus allow an increase in absorption of the steroid component of the cream.
In infants, long-term continuous topical steroid therapy should be avoided since this can lead to adrenal suppression even without occlusion. A course of treatment should not normally exceed seven days.
Use of hydrocortisone should be avoided in neonates. Any proposed use of hydrocortisone in neonates should be carefully assessed, as the high body surface area:weight ratio allows a proportionate increase in percutaneous absorption. Consideration should be given to the relative fragility of neonatal skin.
4.5. Interaction with other medicinal products and other forms of interaction
None known.
4.6. Fertility, pregnancy and lactation
Fertility
No data available.
Pregnancy
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established. However, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods.
Breast-feeding
Although poorly absorbed, it is not known whether nystatin enters breast milk. Caution should be exercised when nystatin is prescribed for nursing mothers.
Corticosteroids cross the placenta to varying degrees and may be distributed in small amounts in breast milk. Any topically applied hydrocortisone should be wiped off thoroughly prior to nursing if it is being applied to the breast or nipple area.
4.7. Effects on ability to drive and use machines
No data available.
4.8. Undesirable effects
Tabulated list of adverse reactions
Undesirable effects are listed by MedDRA System Organ Classes.
Assessment of undesirable effects is based on the following frequency groupings:
Very common: ≥ 1/10
Common: ≥ 1/100 to <1/10
Uncommon: ≥ 1/1,000 to <1/100
Rare: ≥ 1/10,000 to <1/1,000
Very rare: <1/10,000
Not known: cannot be estimated from the available data
System Organ Class
Frequency
Undesirable Effect
Endocrine disorders
Not known
• adrenal suppression (see Section 4.4 'Special warnings and precautions for use')
Immune system disorders
Not known
• hypersensitivity reactions*
Infections and infestations
Not known
• spread and worsening of untreated infection (see Section 4.4 'Special warnings and precautions for use')
Metabolism and nutrition disorders
Not known
• Cushing's syndrome (see Section 4.4 'Special warnings and precautions for use')
Skin and subcutaneous tissue disorder
Not known
• thinning of the skin* (see Section 4.4 'Special warnings and precautions for use' and Section 4.9 'Overdose')
• irreversible striae atrophicae (see Section 4.9 'Overdose')
• telangiectasia (see Section 4.9 'Overdose')
• contact dermatitis (see Section 4.4 'Special warnings and precautions for use')
• perioral dermatitis
• acne or worsening of acne
• rosacea
• mild depigmentation*
• hypertrichosis
• contact sensitisation
• purpura
• loss of skin collagen and subcutaneous atrophy
• withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules (see section 4.4).
*see section 'Description of selected adverse reactions'.
Description of selected adverse reactions
If signs of hypersensitivity appear, application should stop immediately.
Thinning of the skin may be restored over a period after stopping treatment but the original structure may never return.
Mild depigmentation may be reversible.
Exacerbation of symptoms may occur.
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
Prolonged administration of hydrocortisone, especially to sensitive areas, such as the face and flexures, may result in irreversible adverse effects such as epidermal thinning, telangiectasia and striae. Chronic administration of hydrocortisone may lead to systemic absorption and thereby suppression of the pituitary-adrenal axis. High doses of corticosteroids can cause Cushing's syndrome.
It is possible that nausea and vomiting or diarrhoea may occur after ingestion of this product. Treat symptomatically. A small glass of milk or water may be helpful.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Hydrocortisone, Dimeticone, Benzalkonium chloride, Nystatin. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- HIDROCORTIZON FITERMAN 10 mg/g prescription partial — not the same combinationHYDROCORTISONUM · skin / topical
- HIDROCORTIZON ATB 10 mg/g prescription partial — not the same combinationHYDROCORTISONUM · skin / topical
- PHARMATEX 12 mg/g over the counter partial — not the same combinationBENZALKONII CHLORIDUM · 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. 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 Hydrocortisone, Dimeticone, Benzalkonium chloride, Nystatin. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Hydrocort CHEMA partial — not the same combinationHydrocortisoni acetas · 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 Timodine 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.