Pelpharma Amykal 1% cream 15 gr

Amykal 1% cream is a medicine for the local treatment of fungal infections of the skin. It works by killing the fungus that causes skin problems.

Amykal 1% cream is used in adults and adolescents (from 12 years of age).
Amykal 1% Cream is available without a prescription for self-treatment of the following skin infections (although you must use it carefully to get the best results):

• Fungal infection of the feet (tinea pedis)*
• Fungal infection on the thighs and body (ringworm = tinea corporis)*
• Fungal infection on the lower legs (tinea cruris)*
• Yeast fungus infections of the skin, mainly caused by the genus Candida (= skin candidiasis)*
• Pityriasis versicolor of the skin*

* see "How do you know that you have one of the diseases mentioned above?"

Amykal 1% cream has a long-lasting effect. When used as recommended, fewer than 10 in 100 people will have athlete's foot again within 3 months of starting treatment.

Contraindications

Do not use Amykal 1% Cream if you are allergic to terbinafine hydrochloride, benzyl alcohol (a preservative) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Amykal 1% cream.

• Only for external use.
• Avoid application to the face.
• Do not use Amykal 1% cream in or around the mouth. Don't swallow.
• Amykal 1% cream should not come into contact with eyes, mucous membranes or open wounds. In the event of accidental contact, these areas should be thoroughly rinsed under running water. Consult a doctor if symptoms persist after accidental contact.
• Using Amykal 1% cream in the genital or anal area can lead to a reduction in the tear strength of latex condoms and thus to an impairment of the safety of this contraceptive.

interactions

Other medicines
and Amykal 1% Cream Do not use any other medicines or treatments on the affected area while you are being treated with Amykal 1% Cream, even if they are non-prescription medicines.
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

Pregnancy, lactation and fertility

Pregnancy
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.
Amykal 1% cream should only be used during pregnancy if clearly necessary.

Breastfeeding
Mothers who are breastfeeding should not use Amykal 1% cream. Infants should not come into contact with treated skin, including the breast.

application

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

It is important to use Amykal 1% Cream correctly. Follow the instructions carefully.

If you have a nail fungus infection (fungus in and under the nail) with nail discolouration and nail structure changes (thick, scaly), consult your doctor as Amykal 1% cream is NOT suitable for this type of infection.

Method of administration For cutaneous use
only.

Adults and teenagers (from 12 years):

• Before the first use, the sealing membrane of the tube must be pierced with the spike in the screw cap.
• Wash and dry the affected skin and surrounding areas and wash your hands.
• Open the tube and put a small amount of cream on your finger.
• Put the cap back on the tube.
• Apply a thin layer of cream to the affected areas of skin and surrounding areas.
• Gently rub the cream into the skin.
• Wash your hands after using the cream, otherwise the infection may spread to other parts of the skin or to other people.

When treating an infection in the skin folds, you can cover the affected area with a piece of gauze, especially at night. If you do this, use a fresh, clean gauze strip each time you apply the cream.

Duration and frequency of treatment
Apply Amykal 1% cream to the infected areas as follows:

• Fungal infection of the feet (Tinea pedis): Use once a day for 1 week.
• Fungal infection of the thighs and body (ringworm = tinea corporis): Use once a day for 1 week.
• Fungal infection on the lower legs (tinea cruris): Use once a day for 1 week.
• Fungal infections caused by yeast fungi (Candida, skin candidiasis): Use 1-2 times a day for 1-2 weeks. This fungal infection can look like ringworm or a fungal infection of the groin, but it occurs in older or overweight patients with moist areas in the overlapping skin folds, or in those with other conditions such as diabetes. The longer treatment period (2 weeks) may be required to treat candidiasis.
• Pityriasis versicolor of the skin: use twice a day for 1 week.

Use the cream for the recommended duration of treatment, even if the infection gets better after a few days. Infections usually get better within a few days but can recur if the cream is not applied regularly or treatment is stopped too soon.

Amykal 1% Cream should improve the condition of your skin in a few days. However, once the infection has cleared, it takes longer for the skin to fully heal, possibly up to 4 weeks. Amykal 1% cream continues to work even after you have completed the treatment.

Elderly patients (over 65 years of age):
There is no evidence that elderly patients require a different dosage or experience side effects that are not seen in younger patients.

Use in children
As experience with topical terbinafine in children is limited, use in children under 12 years of age is not recommended.

If there is no improvement two weeks after the start of treatment or if you suffer from nail fungus, tell your doctor.
Please talk to your doctor or pharmacist if you have the impression that the effect of Amykal 1% Cream is too strong or too weak.

What measures can be taken to support the treatment?

• Keep the affected areas clean and wash them regularly. Dry them carefully without rubbing or pat them gently. Also, if the areas of skin are itchy, try not to scratch them as this can worsen the discomfort and slow down the healing process or spread the infection further.
• Use your own towels and clothing and do not share them with other people as these infections are easily transmitted. Wash your clothes and towels frequently to protect yourself from reinfection.

side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP using Amykal 1% Cream and seek medical advice straight away if you get any of the following, which could be signs of an allergic reaction:

• Difficulty breathing or swallowing
• swelling of the face, lips, tongue or throat
• Severe itching of the skin with a red rash or raised bumps.

Common: affects 1 to 10 users in 100

• peeling skin, itching

Uncommon: affects 1 to 10 users in 1,000

• Skin injuries, scabs, skin problems, skin color changes, redness, burning
• Pain, soreness and/or irritation at the treated site

Rare: affects 1 to 10 users in 10,000

• dry skin, rash (contact dermatitis, eczema)
• Worsening of the original condition

Eye irritation may occur if Amykal 1% Cream accidentally gets into the eyes.

Very rare: affects less than 1 in 10,000 people

• rash

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

• hypersensitivity

composition

The active substance is: terbinafine hydrochloride
1 g cream contains 10 mg terbinafine hydrochloride

The other ingredients are: 10 mg benzyl alcohol as a preservative, sodium hydroxide, cetostearyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, sorbitan monostearate, water