Timodine Cream

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Timodine Cream is and what it is used for
2. What you need to know before you use Timodine Cream
3. How to use Timodine Cream
4. Possible side effects
5. How to store Timodine Cream
6. Contents of the pack and other information

• 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.

• 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 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.

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.

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 breast-feeding, only use Timodine Cream if advised by your doctor.

Timodine Cream contains:

• 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.

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 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.

In the case of a missed application, simply apply when the next dose is due.

A worsening of symptoms can sometimes occur. If this happens to you, tell your doctor or pharmacist.

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.

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.

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.

The marketing authorisation holder is:

Timodine Cream is manufactured by: