Active ingredients

• 10 mg terbinafine hydrochloride

Excipients

• 10 mg benzyl alcohol
• Cetyl palmitate
• 40 mg cetylstearyl alcohol
• 40 mg cetyl alcohol
• Sodium hydroxide for pH adjustment
• Water, purified
• Isopropyl myristate
• Polysorbate 60
• Sorbitan stearate

What is Terbinafine Hydrochloride AL 10 mg/g Cream and what is it used for?
Terbinafine Hydrochloride AL 10 mg/g Cream belongs to a group of antifungal medicines. This medicine is intended for the treatment of fungi and yeasts on the skin. Terbinafine Hydrochloride AL 10 mg/g Cream is used to treat certain yeasts and skin fungi, the most common of which is athlete's foot. Further information on other fungal infections can be found in section 3, “How to use Terbinafine Hydrochloride AL 10 mg/g Cream.”

What should you know before using Terbinafine Hydrochloride AL 10 mg/g Cream?
Do not use Terbinafine Hydrochloride AL 10 mg/g Cream if you are hypersensitive (allergic) to terbinafine or any of the other ingredients of Terbinafine Hydrochloride AL 10 mg/g Cream (see section 6, “The other ingredients are”). You can recognize hypersensitivity, for example, by red spots and swelling of the skin or itching.

Special care is required when using Terbinafine Hydrochloride AL 10 mg/g Cream. Terbinafine Hydrochloride AL 10 mg/g Cream is for external use only. Avoid contact with the eyes. in children under 12 years of age. When using Terbinafine Hydrochloride AL 10 mg/g Cream with other medicines Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, including medicines obtained without a prescription. There is no evidence that Terbinafine Hydrochloride AL 10 mg/g Cream affects other medicines.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking/using any medicine.

Pregnancy
Terbinafine Hydrochloride AL 10 mg/g Cream should not be used if you are pregnant or planning to become pregnant. Please inform your doctor if you become pregnant during treatment with Terbinafine Hydrochloride AL 10 mg/g Cream.

Breastfeeding
As terbinafine passes into breast milk, you should not use Terbinafine Hydrochloride AL 10 mg/g Cream if you are breastfeeding a child.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been conducted.

Important information about certain of the ingredients of Terbinafine Hydrochloride AL 10 mg/g Cream
Terbinafine Hydrochloride AL 10 mg/g Cream contains the other ingredients cetyl alcohol and cetostearyl alcohol. Cetyl alcohol and cetostearyl alcohol may cause local skin irritation (e.g. contact dermatitis).

How should Terbinafine Hydrochloride AL 10 mg/g Cream be used?
Always use Terbinafine Hydrochloride AL 10 mg/g Cream exactly as directed in this leaflet. Please ask your doctor or pharmacist if you are not sure.

Method of administration
For use on the skin. The opening of the tube is sealed with aluminum. This cap can be opened by gently pressing the tube cap upside down. Before applying the cream, the skin must be thoroughly cleansed and dried. Apply a thin layer of cream to the inflamed skin and slightly beyond, and rub it in gently. If the inflammation is located in a skin fold (under the breasts, between the toes or fingers, in the groin, or between the buttocks), you can cover the skin with sterile gauze, especially at night. If applying the cream is not intended to treat your hands, please wash your hands afterward.

Duration and frequency of use:

Athlete's foot (tinea pedis) once daily for 1 week. Possible symptoms of athlete's foot include itching, redness, and scaling between the toes and on the soles of the feet. Occasionally, cracks in the skin (especially between the toes) and weeping blisters can also occur. Athlete's foot often causes an unpleasant odor.

Ringworm (tinea corporis) once daily for 1 week. Ringworm consists of slow-growing, itchy, red, and scaly circular patches that can be spread all over the body.

Skin fungus (cutaneous candidiasis) once daily for 1 to 2 weeks. Candida is a yeast fungus that can cause skin infection under certain circumstances. The skin lesions are often in warm, moist areas of the body such as the groin or under the breasts. Symptoms include itching, redness, and scaling.

Pityriasis versicolor 1 to 2 times daily for 2 weeks. The yeast that causes pityriasis versicolor is called Malassezia furfur. Infection with this yeast occurs mainly on the shoulders, torso, and upper arms. Symptoms consist of slightly itchy and slightly scaly patches. In people with a suntan, the patches are generally lighter than the rest of the skin, whereas in people with little or no sun exposure they usually appear light brown. Symptoms generally improve after a few days. Irregular use or stopping treatment too soon increases the chance that symptoms will recur. If you do not notice any improvement after 1 to 2 weeks, please inform your doctor or pharmacist.

Elderly people
There is no evidence that elderly patients require different dosages or experience different side effects than younger patients.

Children:
Since there is only limited experience with the use of Terbinafine Hydrochloride 10 mg/g Cream in children under 12 years of age, the use of this medicine is not recommended in this age group. Please talk to your doctor or pharmacist if you have the impression that the effect of Terbinafine Hydrochloride AL 10 mg/g Cream is too strong or too weak.

If you use more Terbinafine Hydrochloride AL 10 mg/g Cream than you should
If you use too much Terbinafine Hydrochloride AL 10 mg/g Cream, it will not cause any harm. However, if you are unsure, consult your doctor or pharmacist. If Terbinafine Cream is accidentally ingested, for example by a child, you should expect side effects similar to those observed with an overdose of Terbinafine tablets (e.g., headache, nausea, upper abdominal pain, and dizziness).

In this case, a doctor or emergency physician should be contacted. If the cream accidentally gets into the eyes, you should rinse them thoroughly under running water.

If you forget to use Terbinafine Hydrochloride AL 10 mg/g Cream
Continue treatment without applying Terbinafine Hydrochloride AL 10 mg/g Cream an extra time or applying a larger amount than usual. If you stop using Terbinafine Hydrochloride AL 10 mg/g Cream If you stop using Terbinafine Hydrochloride AL 10 mg/g Cream too early, the original symptoms may recur. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are the possible side effects?
Like all medicines, Terbinafine Hydrochloride AL 10 mg/g Cream can cause side effects, although not everybody gets them. The following categories are used to indicate the frequency of side effects:
Very common : affects more than 1 in 10 people
Common : affects 1 to 10 in 100 people
Uncommon : affects 1 to 10 in 1,000
people Rare: affects 1 to 10 in 10,000 people
Very rare : affects less than 1 in 10,000 people
Frequency not known : cannot be estimated from the available data

Redness, rash, itching and a burning sensation may occur at the site where the cream is applied. Allergic reactions such as itching (pruritus), rash, bullous dermatitis and nettle rash (urticaria) have occurred rarely.

If you suffer severely from the side effects mentioned, it is advisable to speak to your doctor, as this could indicate an allergic reaction. Please inform your doctor or pharmacist if any of the side effects listed affect you seriously, or if you notice any side effects not listed in this leaflet.

How should Terbinafine Hydrochloride AL 10 mg/g Cream be stored?
Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and tube after "Use by". The expiry date refers to the last day of that month. Store in the original packaging! Do not freeze! Keep the tube tightly closed! Once opened, Terbinafine Hydrochloride AL 10 mg/g Cream has a shelf life of 3 months if stored properly.

Further information
What Terbinafine Hydrochloride AL 10 mg/g Cream contains:

The active ingredient is terbinafine hydrochloride. 1 g of cream contains 10 mg terbinafine hydrochloride.

The other ingredients are:
benzyl alcohol, cetyl alcohol (Ph. Eur.), cetyl palmitate (Ph. Eur.), cetylstearyl alcohol (Ph. Eur.), isopropyl myristate (Ph. Eur.), sodium hydroxide, polysorbate 60, sorbitan stearate, purified water.

Mandatory text:
Terbinafine hydrochloride AL 10 mg/g cream
. Active ingredient: Terbinafine hydrochloride. For use against certain yeasts and skin fungi, the most common of which is athlete's foot. Contains benzyl alcohol, cetyl alcohol, and cetylstearyl alcohol.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.

ALIUD PHARMA® GmbH, PO Box 1380, 89146 Laichingen , Germany
. Status: August 2024