Terbilum

Leaflet attached to the packaging: patient information

Terbilum, 10 mg/g, cream

Terbinafine hydrochloride

Please read carefully the contents of the leaflet 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
your doctor or pharmacist.

• This leaflet should be kept, so that it can be re-read if necessary.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform
  their doctor or pharmacist. See section 4.
• If after 14 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Terbilum and what is it 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 packaging and other information

1. What is Terbilum and what is it used for

Terbilum is an antifungal medicine in the form of a cream for application to the skin. The medicine contains
the active substance terbinafine hydrochloride.

Indications for use:

• athlete's foot,
• fungal infections of skin folds,
• fungal infections of smooth skin,
• 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, the patient should discuss it with their doctor or pharmacist.
Terbilum is intended for use on the skin only.
The eyes should be protected from contact with the medicine. The patient should avoid applying the cream to the area around the eyes and touching their eyes if they still have the cream on their hands. If the medicine accidentally gets into the eyes, they should be rinsed with running water.
The medicine may cause a local skin reaction.
The patient should inform their doctor about any previous allergic reactions to any ingredient of the medicine.

Children

Terbilum is not recommended for use in children under 12 years of age.

Terbilum and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to use.
No interactions with other medicines are known for Terbilum.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Pregnancy
Terbilum should not be used during pregnancy, unless decided by the 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 the skin area treated with Terbilum, including the breasts .
Fertility
Animal studies have not shown any effect of terbinafine on fertility.

Driving and using machines

Terbilum does not affect the ability to drive or use machines.

Terbilum contains benzyl alcohol, cetyl alcohol, and stearyl alcohol

The medicine contains 10 mg of benzyl alcohol per 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 a local skin reaction (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, the patient should consult their doctor or pharmacist.
Terbilum should be applied to a clean and dry skin surface. A thin layer of cream should be applied to the affected areas and surrounding skin and gently rubbed in. If the infected area involves skin folds (e.g., between the toes, under the arm, under the breasts, between the buttocks, in the groin), the area where the cream is applied can be covered with gauze. This is especially recommended before bedtime.
Unless otherwise directed by the doctor, the medicine should be used as described below.
Adults and children over 12 years of age:

• athlete's foot: once a day for 1 week,
• fungal infections of skin folds: once a day for 1 week,
• cutaneous candidiasis: once a day for 1 week,
• fungal infections of smooth skin: once a day for 1 week,
• pityriasis versicolor: once a day for 2 weeks. Clinical improvement is usually seen after a few days of using Terbilum. The medicine should be used for the entire recommended period, as irregular use or premature discontinuation of treatment may lead to recurrence of the disease. If after 2 weeks from the start of treatment there is no improvement, the patient should consult their doctor.

Elderly patients:
There are no data indicating that elderly patients require different dosing, nor have there been reports of adverse reactions different from those in younger patients.
Children under 12 years of age:
Terbilum is not recommended for use in children under 12 years of age.

Using more than the recommended dose of Terbilum

In case of using more than the recommended dose, the patient should immediately consult their doctor or pharmacist.
In case of accidental ingestion of a large amount of Terbilum, the patient should expect side effects similar to those that occur with terbinafine tablet overdose (e.g., headache, nausea, vomiting, abdominal pain, and dizziness). In such a case, the patient should consult their doctor.

Missing a dose of Terbilum

If a dose is missed, it should be applied as soon as possible. However, if it is almost time for the next dose, the patient should apply the next scheduled dose at the scheduled time. The patient should not increase the dose themselves. The patient should not apply a double dose to make up for a missed dose.

Stopping use of Terbilum

In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Terbilum can cause side effects, although not everybody gets them.
In some people, the following side effects may occur at the site of application of Terbilum. If these symptoms occur, the patient should inform their doctor, as they may indicate an allergy to Terbilum. In such a case, the doctor will advise the patient to stop using the medicine.

Common side effects (occurring in more than 1 in 100 but less than 1 in 10 patients):

• skin peeling, itching.

Uncommon side effects (occurring in more than 1 in 1,000 but less than 1 in 100 patients):

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

Rare side effects (occurring in more than 1 in 10,000 but less than 1 in 1,000 patients):

• dryness of the skin, contact dermatitis, eczema,
• exacerbation of symptoms.

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

• hypersensitivity*,
• rash*.

*Data obtained after the medicine was placed on the market.
In case of contact of Terbilum with the eyes, irritation may occur.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform
their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Terbilum

The medicine should be stored out of sight and reach of children.
Store at a temperature 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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Terbilum contains

• The active substance of the medicine is terbinafine hydrochloride. 1 g of cream contains 10 mg of terbinafine hydrochloride.
• The other ingredients are: 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 packaging

Terbilum is a cream.
The packaging of the medicine is an aluminum tube containing 15 g of cream, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

OCEANIC Spółka Akcyjna
ul. Łokietka 58
81-736 Sopot

Manufacturer:

OCEANIC Spółka Akcyjna
ul. Gdańska 5
Trąbki Małe
83-034 Trąbki Wielkie
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
OCEANIC Spółka Akcyjna, ul. Gdańska 5, Trąbki Małe, 83-034 Trąbki Wielkie, Tel.: + 48 58 692 10 00

Date of last revision of the leaflet: