10 mg / g cream 
Terbinafine hydrochloride

1. What Azurifine is and what it is used for

Azurifin cream is a fungicide used to treat skin infections caused by filamentous fungi, so-called dermatophytes (eg Trichophyton ), or yeasts (eg Candida Albicans ), and to treat pityriasis ( tinea ) Versicolor.

Azurifine is over-the-counter for treating foot fungus between the toes and fungal infection of the groin (including candida ).

Terbinafine contained in Azurifine may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before you use Azurifine

Do not use Azurifine

– if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Azurifine cream is for topical use only. Avoid getting cream in your eyes, on mucous membranes, or in wounds. Rinse with copious amounts of running water if cream one accidentally comes in contact with any of these areas.

Azurifine cream is not intended for the treatment of fungal infections of the nails. If you suspect that you have a fungal infection of the nails (eg discoloration or thickening of the nail), consult a doctor.

Children and young people

Not recommended for children under 12 years.

Other medicines and Azurifine

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not use other medicines on the treated skin areas.

It is not known that Azurifin would affect or be affected by other drugs.

Pregnancy, breastfeeding, and fertility

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 taking this medicine.

Pregnancy

There is no clinical experience with the use of terbinafine in pregnant women.

Breast-feeding

As terbinafine is excreted in human milk, do not use Azurifine while breast-feeding, unless your doctor tells you to. Talk to your doctor about whether you should stop breast-feeding while using Azurifin.

Driving and using machines

The use of Azurifine on the skin does not affect the ability to drive or use machines.

Azurifine contains excipients

These substances can cause local skin reactions (eg contact dermatitis).

3. How to use Azurifin

Always use this medicine as described in this leaflet, as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

For use on the skin.

Use in adults and children from 12 years

Wash and dry the skin thoroughly before applying the cream.

Apply a thin layer on the inflamed skin and a little around. Gently lubricate cream one.

If an infection is in a fold of skin (between the toes or in the groin), the lubricated skin can be covered with sterile gauze, especially at night. Wash your hands after applying the cream,

Foot fungus between the toes: Once daily for a week.

Fungal infection in the groin (also Candidia): Once daily for one to two weeks.

The symptoms usually disappear after a few days and the skin heals completely after some time, but it is important to complete the treatment so as not to have a relapse. Contact a doctor if the symptoms worsen or do not improve within 1 week (in case of athlete’s foot ) or two weeks (in case of fungal infection in the groin) as your problems may have been caused by something other than a fungal infection.

For the treatment of other fungal infections, follow your doctor’s recommendation.

Use in children

Experience with the use of Azurifin cream in children under 12 years of age is limited. Use in this age group is therefore not recommended.

If you forget to use Azurifine

Continue treatment as usual.

Do not use a double dose to make up for a forgotten dose.

If you stop using Azurifin

Use cream one for the entire recommended treatment time. If treatment is stopped prematurely, the risk of recurrence of symptoms increases. If you have not seen any improvement after 1 to 2 weeks, contact your doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Common (affects up to 1 in 10 users)

Scaly skin, itching or burning sensation

Uncommon (affects up to 1 in 100 people)

Wounds, scabs, discoloration of the skin, reddening of the skin, burning sensation, pain, or irritation at the application site.

Rare side effects are (affects 1 to 10 of 10 000):

Dry skin, localized rash, flaky and itchy rash ( eczema ), eye irritation. Underlying fungal infection can worsen.

No known frequency (cannot be calculated from the available data)

Rash

Allergic reactions

If you get an allergic reaction, stop taking this medicine and talk to a doctor.

Reporting of side effects is
if you get side effects are, speak with your doctor pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via the Medical Products Agency, Box 26, SE-751 03 Uppsala. Website:  www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information

5. How to store Azurifine

Keep this medicine out of the sight and reach of children.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Once the tube has been opened, cream one should be used within 6 months. Do not use Azurifin if you notice that the cream has changed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

One gram of cream contains 10 mg of terbinafine hydrochloride.

The other ingredients are Stearyl alcohol, cetyl alcohol, sorbitan stearate, cetyl palmitate, isopropyl myristate, benzyl alcohol, polysorbate 60, sodium hydroxide, and purified water.

What the medicine looks like and the contents of the pack

White cream. The cream one is delivered in a white, foldable tube with lacquered inside, closed with latex, with a perforating screw cap.

Pack sizes:

7.5 g tub

15 g tub

30 g tub

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Rivopharm Ltd

17 Corrig Road, Sandyford

Dublin 18

Ireland

Manufacturer:

Parboil Waltrop GmbH

Im Wirrigen 25

DE-45731 Waltrop

Germany

Agent:

SanoSwiss UAB

Aukstaiciu str. 26A

LT-44169 Kaunas

Lithuania

+370 700 01320

info@sanoswiss.com

Muhammad Nadeem

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