MedPath
HSA Approval

FINAB CREAM 1% W/W

SIN16896P

FINAB CREAM 1% W/W

FINAB CREAM 1% W/W

November 7, 2023

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Regulatory Information

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Therapeutic

General Sale List

Formulation Information

CREAM

**WHILE YOU ARE USING FINAB CREAM** — _USUAL DURATION OF TREATMENT_ - Athlete’s foot, superficial skin mycoses: apply once a day for 1 week. - Skin candidiasis (intertrigo or sweat rash): apply 1–2 times a day for 1 week. - Pityriasis versicolor: apply 1–2 times a day for 2 weeks. Use the cream for the recommended treatment period even if the infection seems to be better after a few days. Infections usually appear to improve within a few days, but may reappear if the cream is not applied regularly or is stopped too early. The cream should start to improve your skin condition in a few days. The cream will continue to work even after you have completed the treatment. — _HOW LONG TO USE_ If you have not noticed any signs of improvement within 2 weeks of first starting treatment, please see your doctor or pharmacist who will advise you. — _IF YOU FORGET TO USE IT_ If you forget an application of Finab Cream, apply it as soon as possible and then carry on as normal. If you only remember at the time of the next application, just apply the usual amount and then carry on as normal. Do not take a double dose to make up for a forgotten dose. — _IF YOU USE TOO MUCH (OVERDOSE)_ **Symptoms** In the event a larger amount of Finab Cream is inadvertently ingested, adverse effects similar to those observed with an overdosage of Terbinafine Hydrochloride tablets are to be expected. Symptoms include headache, nausea, epigastric pain and dizziness. **Apart from treatment what steps can be taken** In order to prevent mycoses, observe the following rules: Change your clothes every day because it is possible that the germs remain attached to parts of the clothes which are in contact with infected regions of the skin. Avoid wearing clothes which fit too tightly or have little permeability to air. Carefully dry the affected parts after washing. Change your flannel and towel every day. If you are suffering from athlete’s foot, do not walk barefoot. In addition, sprinkle or spray the inside of your socks or shoes every day with a powder or spray which is effective against fungal infections. **What other precautionary measures should be observed** Finab cream should only be used externally. Do not use in the mouth or swallow. Avoid all contact with your eyes. If by accident the product comes into contact with the eyes, they should be carefully flushed with cold water. Consult your doctor if there is still discomfort. Consult your doctor in the case of large-scale mycoses or when the mycosis involves the nails. Please inform your doctor or pharmacist if you suffer from other illnesses, allergies or use other medicines for internal or external use (even under self-medication). Do not apply other medicinal products on the areas being treated. Finab Cream contains cetyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

TOPICAL

Medical Information

**WHAT FINAB CREAM IS USED FOR** Finab Cream is a medicine (antifungal agents) intended for treatment of skin infections caused by fungi (mycoses) such as athlete's foot or other supercifial mycoses of the skin and pityriasis versicolor. It is also effective against infections caused by yeasts (candidoses of the skin).

**BEFORE YOU USE FINAB CREAM** As the experience in children under 12 years of age is limited, the use of Finab Cream is not recommended in children under 12 years of age. If you have a fungal nail infection (fungus inside and under the nail), with discoloration of the nails and change in nail texture (thick, flaky), you should see your doctor because Finab Cream is NOT appropriate for this type of infection. - Before using Finab Cream determine if you are allergic to it; or to other allylamine antifungals. - Finab Cream may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. - Finab Cream should not be used during pregnancy unless clearly necessary. - Do not use Finab Cream while breastfeeding. The ingredients can pass into your breast milk. - Do not allow infants to come into contact with any treated areas, including the breasts.

D01AE15

terbinafine

Manufacturer Information

GOLDPLUS UNIVERSAL PTE LTD

Hovid Bhd.

Active Ingredients

Terbinafine Hydrochloride

1% w/w

Terbinafine

Documents

Patient Information Leaflets

Finab cream 1pc ww PIL.pdf

Approved: November 7, 2023

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