Terbilum

Package leaflet: Information for the patient

Terbilum, 10 mg/g, cream
Terbinafini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your physician or pharmacist. See section 4.
• If there is no improvement after 14 days of treatment, or if your condition worsens, contact your physician.

Table of contents

1. What Terbilum is and what it is used for
2. Important information before using Terbilum
3. How to use Terbilum
4. Possible side effects
5. How to store Terbilum
6. Contents of the pack and other information

1. What Terbilum is and what it is used for

Terbilum is an antifungal medicine presented as a cream for topical application. The medicine contains
the active substance terbinafine hydrochloride.
Indications:

• Athlete's foot (tinea pedis),
• Fungal infection of skin folds (tinea intertrigo),
• Cutaneous fungal infections (tinea corporis),
• Cutaneous candidiasis,
• Pityriasis versicolor.

2. Important information before using Terbilum

When not to use Terbilum

• if the patient is allergic to terbinafine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Terbilum, consult your doctor or pharmacist.
Terbilum is intended for topical use only.
Avoid contact with the eyes. Do not apply the cream near the eyes or touch the eyes with hands still contaminated with the cream. If the medicine accidentally gets into the eyes, rinse thoroughly with running water.
The medicine may cause local skin reactions.
Inform your doctor about any previous allergic reactions to any ingredient of the medicine.

Children
Use of Terbilum is not recommended in children under 12 years of age.

Terbilum and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
No interactions between Terbilum and other medicines are known.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.

Pregnancy
Terbilum should not be used during pregnancy unless otherwise directed by a doctor.

Breastfeeding
Women who are breastfeeding should not use Terbilum, as terbinafine passes into breast milk.
Infants and young children should not have access to skin treated with Terbilum, including the breast area.

Fertility
Animal studies have not shown any effect of terbinafine on fertility.

Driving and operating machinery
Terbilum does not impair the ability to drive or operate machinery.

Terbilum contains benzyl alcohol, cetyl alcohol and stearyl alcohol
The medicine contains 10 mg of benzyl alcohol in each gram of cream.
Benzyl alcohol may cause allergic reactions or mild local irritation.
Due to the presence of cetyl alcohol and stearyl alcohol, the medicine may cause local skin reactions (e.g. contact dermatitis).

3. How to use Terbilum

This medicine should always be used exactly as described in this patient leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Terbilum should be applied to a thoroughly cleansed and dried area of skin. A thin layer of cream should be applied to the affected area and surrounding skin and gently rubbed in.
If the infected area involves skin folds (e.g. between the toes, under the arms, under the breasts, between the buttocks, in the groin), the area where the cream has been applied may be covered with gauze. This is particularly recommended before going to sleep.
Unless otherwise directed by a physician, the medicine should be used as described below.
Adults and children over 12 years of age:

• Athlete's foot: once daily for 1 week,
• Fungal infection of skin folds: once daily for 1 week,
• Cutaneous candidiasis: once daily for 1 week,
• Tinea of glabrous skin: once daily for 1 week,
• Pityriasis versicolor: once daily for 2 weeks.

Clinical improvement is usually observed within a few days of starting treatment with Terbilum. The medicine should be used for the entire recommended duration, as irregular use or premature discontinuation of treatment may lead to recurrence of the infection. If no improvement is observed within 2 weeks of starting treatment, consult your doctor.

Elderly patients:
There are no data indicating that dosage adjustment is required in elderly patients, or that adverse reactions differ from those observed in younger patients.
Children under 12 years of age:
Terbilum is not recommended for use in children under 12 years of age.
Use of more than the recommended dose of Terbilum
If more than the recommended dose is used, consult your doctor or pharmacist immediately.
In case of accidental ingestion of a large amount of Terbilum, adverse effects similar to those observed with overdose of oral terbinafine tablets (e.g. headache, nausea, vomiting, epigastric pain, dizziness) may be expected. In such a case, consult your doctor.
Missed dose of Terbilum
If a dose is missed, apply it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and apply the next dose at the scheduled time. Do not increase the dose independently. Do not use a double dose to make up for a missed dose.
Discontinuation of Terbilum
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Some people may experience the following adverse reactions at the site of application of Terbilum.
If these symptoms occur, inform your doctor, as they may indicate hypersensitivity to Terbilum. In such a case, your doctor will advise discontinuing the use of the medicine.

Common adverse reactions (occurring in more than 1 in 100 but less than 1 in 10 patients):

• Skin peeling, itching.

Uncommon adverse reactions (occurring in more than 1 in 1,000 but less than 1 in 100 patients):

• Skin changes, crusts, skin disorders, pigmentation disorders, erythema, burning sensation of the skin,
• Pain, pain at application site, irritation at application site.

Rare adverse reactions (occurring in more than 1 in 10,000 but less than 1 in 1,000 patients):

• Dry skin, contact dermatitis, eczema,
• Worsening of symptoms.

Frequency not known (cannot be estimated from the available data):

• Hypersensitivity*,
• Rash*.

*Data obtained after marketing authorization of the medicine.

If Terbilum comes into contact with the eyes, irritation may occur.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 4921301, Fax: +48 22 4921309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the Marketing Authorization Holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Terbilum

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Terbilum contains

• The active substance is terbinafine hydrochloride. 1 g of cream contains 10 mg of terbinafine hydrochloride.
• Other ingredients: isopropyl myristate, polysorbate 60, cetyl alcohol, stearyl alcohol, cetyl palmitate, sorbitan stearate, benzyl alcohol, sodium hydroxide, purified water.

What Terbilum looks like and contents of the pack
Terbilum is a cream.
The medicine is packed in an aluminium tube containing 15 g of cream, placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
OCEANIC Joint Stock Company
Łokietka 58
81-736 Sopot

Manufacturer:
OCEANIC Joint Stock Company
Gdańska 5
Trąbki Małe
83-034 Trąbki Wielkie

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
OCEANIC Joint Stock Company, Gdańska 5, Trąbki Małe, 83-034 Trąbki Wielkie, Tel.: + 48 58 692 10