Travocort Cream

• are allergic (hypersensitive) to isoconazole nitrate or di ucortolone-valerate or any of the other ingredients of this medicine,
• have skin lesions in the area to be treated which are associated with a tuberculosis or syphilis infection,
• have a viral infection e.g. herpes, shingles or chicken-pox (varicella, herpes zoster),
• have a chronic skin in ammation of the face (rosacea), skin in ammation around the mouth (perioral dermatitis) or a skin reaction following vaccination in the area to be treated.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Travocort. When using Travocort it is important to know the following:

If you also have a bacterial infection of the skin, your doctor will prescribe you another medicine to use in addition to Travocort, to treat this infection.

• Do not allow Travocort to come into contact with the eyes when applying it to your face. Extensive application of glucocorticoid-containing topical medicines to large areas of the body or for prolonged periods of time, in particular under occlusion (e.g. diapers, dressings) increases the risk of side effects.
• There is a risk of developing an eye condition called glaucoma if you apply Travocort covered by a dressing, in large amounts, over a long period of time or if Travocort is applied to the area around the eyes.
• If Travocort is applied to the genital areas, some of its ingredients may cause damage to latex products such as condoms or diaphragms. Therefore, these may no lo longer be effective as contraception or as protection against sexually transmitted diseases such as HIV infection. Talk to your doctor or pharmacist, if you require more information.
• Regular hygienic measures are essential for successful Travocort treatment: To avoid renewed infection, you should change your personal linen (face cloths, underwear etc. preferably of cotton) daily and boil them, dry the area between the toes thoroughly after washing, change your socks and stockings daily.

If symptoms do not improve, consult the doctor again.

Other medicines and Travocort

• Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Interactions of Travocort with other medicines are not known so far.

Pregnancy, breast-feeding and fertility

• 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 using this medicine. Your doctor will carefully weigh the bene ts against the risks connected with the use of Travocort. Glucocorticoids should not be applied during the  rst three months of pregnancy to avoid any risk to the development of the unborn baby.
• If you are pregnant, you should in particular avoid applying Travocort covered by a dressing, to large areas of the body or using the cream for a longer time period.
• It is not known whether the active ingredients of Travocort pass into breast milk. A risk to the suckling child cannot be excluded.

If you are breast-feeding you should

• not apply Travocort to the breasts;
• avoid applying Travocort covered by a dressing or to large areas of the body;
• avoid using Travocort for a longer time period. There are no data showing that fertility is affected by the use of Travocort.

Driving and using machines:

• No effects on ability to drive and use machines have been observed in patients treated with Travocort. Travocort contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

How to use Travocort

• Always use Travocort exactly as your doctor or pharmacist has told you. You should check with them if you are not sure. Do not use Travocort for more than 2 weeks.
• Always wash your hands before and after applying Travocort.
• Travocort should be applied twice daily to the diseased areas of skin. Stop using Travocort when the skin conditions have improved. In general, the duration of treatment must not exceed 2 weeks. If necessary, your doctor may then prescribe a follow-up treatment with a glucocorticoid-free anti-fungal preparation. This applies in particular if Travocort is applied to the groin or the genital area.
• Regular hygienic measures are essential for successful Travocort treatment.

Use in children and adolescents

• There is no need to adjust the dose when children aged 2 years or older and adolescents are treated with Travocort.
• Only limited data on the safety of Travocort in children aged below 2 years are available.

If you use more Travocort than you should

• If you apply too much Travocort once, or accidentally swallow Travocort this is unlikely to be dangerous but contact your doctor or pharmacist if you are worried.

If you forget to use Travocort

• Do not use a double dose to make up for a forgotten dose. When you remember, use the next dose and continue with the treatment as prescribed. See your doctor or pharmacist, if you are worried.
• If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Side effects

Like all medicines, Travocort can cause side effects, although not everybody gets them.
The following side effects occurred in clinical studies, they are listed according to their frequency:

Common: may affect up to 1 in 10 people

• skin irritation or burning feeling at the application site

Uncommon: may affect up to 1 in 100 people

• redness (erythema) or dryness at the application site R stretch marks (skin striae)

Not known: frequency cannot be estimated from the available data

• itching (pruritus) or blisters (vesicles) at the application site

As with other glucocorticoids that are applied to the skin, such as Travocort, the following local side effects may also occur (their frequency cannot be estimated from the available data):

Thinning of the skin (skin atrophy), in ammation of hair follicles (folliculitis), increased body hair growth (hypertrichosis), expansion of small super cial blood vessels in the skin (telangiectasia), skin in ammation around the mouth (perioral dermatitis), changes in skin color, acne, and/or allergic skin reactions to any of the ingredients of Travocort. Since the ingredients of Travocort are absorbed by the body through the skin, further side effects to other parts of the body (systemic effects) may occur.

How to store Travocort

• Store Travocort out of the sight and reach of children.
• Do not store above 30°C.
• Do not use this medicine after the expiry date which is stated on the tube and carton after ‘EXP’.
• The expiry date refers to the last day of that month. Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

References

http://www.medicines.ie/medicine/1993/SPC

https://www.hpra.ie/img/uploaded/swedocuments/2154780.PA1410_073_001.a8de0ee4-32be-4f52-a790-488c4dd27cfc.000001Travocort%20PIL.160114.pdf

http://www.tabletwise.com/uae/travocort-cream

http://www.mims.com/singapore/drug/info/travocort?type=full

http://home.intekom.com/pharm/schering/travocrt.html