10 mg\/g cream Terbinafine Apofree\u00a0cream\u00a0contains an antifungal agent used to treat skin infections caused by filamentous fungi, so-called\u00a0dermatophytes\u00a0(eg\u00a0Trichophyton<\/em>\u00a0), or yeasts (eg\u00a0Candida Albicans<\/em>\u00a0) and to treat pityriasis (\u00a0tinea\u00a0) Versicolor.\u00a0Terbinafine Apofree\u00a0cream\u00a0blocks a reaction in the fungus’s metabolism, which means that the fungus dies and the\u00a0infection\u00a0can heal faster.<\/p>\n\n\n\n Terbinafine Apofree cream is over-the-counter in the treatment of athlete’s foot between the toes and fungal infection in the groin (also candida ).<\/p>\n\n\n\n Terbinafine contained in Terbinafine Apofree\u00a0cream\u00a0may also be approved to treat other conditions not mentioned in this leaflet.\u00a0Ask your doctor, pharmacist, or other healthcare professional if you have further questions, and always follow their instructions. – if you are allergic to terbinafine or any of the ingredients of this medicine (listed in section 6).<\/p>\n\n\n\n Terbinafine Apofree\u00a0cream\u00a0is intended for\u00a0external\u00a0use only.\u00a0Avoid getting the\u00a0cream\u00a0in the eyes, on mucous membranes, or in wounds.\u00a0Rinse with copious amounts of running water if the\u00a0cream\u00a0accidentally comes into contact with any of these areas.<\/p>\n\n\n\n Terbinafine Apofree cream is not intended for the treatment of fungal infection of the nails. If you suspect that you have a fungal nail infection (eg discoloration or thickening of the nail), see a doctor.<\/a><\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.<\/p>\n\n\n\n Do not use other medications on the treated skin areas.<\/p>\n\n\n\n It is not known that Terbinafine Apofri cream would affect or be affected by other medicines.<\/a><\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.<\/p>\n\n\n\n Pregnancy<\/em><\/p>\n\n\n\n Clinical experience from the use of terbinafine in pregnant women is lacking.<\/p>\n\n\n\n If you are pregnant or planning to become pregnant, you should not use Terbinafine Apofri, unless prescribed by a doctor.<\/p>\n\n\n\n Breast-feeding<\/em><\/p>\n\n\n\n Because terbinafine passes into breast milk, you should not use Terbinafine Apofri if you are breastfeeding.\u00a0Babies must not come into contact with skin treated with Terbinafine Apofri.<\/p>\n\n\n\n Fertility<\/em><\/p>\n\n\n\n No effects have been seen on fertility when using Terbinafine Apofri.<\/a><\/p>\n\n\n\n The use of Terbinafine Apofri on the skin does not affect the ability to drive or use machinery.<\/p>\n\n\n\n Terbinafine Apofri contains the excipients stearyl alcohol<\/a> and cetyl alcohol. These substances can cause local skin reactions (e.g. contact dermatitis<\/a>).<\/p>\n\n\n\n This medicine contains 15 mg of benzyl alcohol per g of\u00a0cream.\u00a0Benzyl alcohol may cause allergic reactions and\/or mild local irritation. Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n For use on the skin.<\/p>\n\n\n\n Wash and dry the skin thoroughly before applying the\u00a0cream.<\/p>\n\n\n\n Spread a thin layer on the inflamed skin and a little around. Gently apply cream one.<\/p>\n\n\n\n If the\u00a0infection\u00a0is in a skin fold (eg in the groin), the smeared skin can be covered with\u00a0sterile\u00a0gauze, especially at night.\u00a0Wash your hands after applying the\u00a0cream,<\/p>\n\n\n\n Adults and children from 12 years<\/em><\/p>\n\n\n\n Athlete’s foot between the toes: 1 time a day for 1 week.<\/p>\n\n\n\n Fungal infection and candida in the groin: 1 time per day for 1-2 weeks.<\/p>\n\n\n\n The symptoms usually disappear after a few days and the skin heals completely after some time, but it is important to complete the treatment to avoid recurrence. Contact a doctor if improvement does not occur after 1 week (for athlete’s foot ) or 2 weeks (for fungal infection in the groin), as your discomfort may have been caused by something other than a fungal infection.<\/p>\n\n\n\n For the treatment of other fungal infections<\/a>, follow your doctor’s recommendation.<\/p>\n\n\n\n Experience from the use of Terbinafine Apofri cream in children under 12 years of age is limited. Use in this age group is therefore not recommended.<\/a><\/p>\n\n\n\n Overdose of Terbinafine Apofri, when used on the skin, is not likely.\u00a0However, if you ingest the\u00a0cream\u00a0by mistake, you may have\u00a0side effects\u00a0similar to those that can be expected from an overdose of terbinafine in tablet form.\u00a0These include headache, nausea, stomach pain<\/a>, and dizziness.<\/p>\n\n\n\n If you have ingested too much medicine or if, for example,\u00a0a child accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.<\/p>\n\n\n\n Continue with treatment as usual.\u00a0Do not use a double\u00a0dose\u00a0to make up for a missed\u00a0dose.<\/p>\n\n\n\n If you have further questions about this medicine, contact your doctor or pharmacist.<\/a><\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Local symptoms such as\u00a0itching, skin flaking, pain, irritation, pigment changes, burning sensation in the skin, skin redness, and scabs may appear at the application site.\u00a0These symptoms must be distinguished from allergic reactions that can cause swelling, pain, skin rash, or\u00a0hives<\/a>.\u00a0The treatment may then have to be terminated.<\/p>\n\n\n\n Common side effects (<\/em> may affect up to 1 in 10 users): Flaking skin, itching<\/p>\n\n\n\n Uncommon side effects (<\/em> may affect up to 1 in 100 users): Skin and pigment changes, skin redness, burning sensation in the skin, pain at the application site, irritation at the application site.<\/p>\n\n\n\n Rare side effects (<\/em> may affect up to 1 in 1,000 users): Eye irritation, dry skin, contact dermatitis, worsening fungal infection.<\/p>\n\n\n\n Unknown frequency (occurs in an unknown number of users):\u00a0Hypersensitivity reaction, rash<\/p>\n\n\n\n Store out of sight and reach of children.<\/p>\n\n\n\n No special storage instructions.<\/p>\n\n\n\n Use before the expiry date stated on the packaging after the Expiration date.\u00a0The expiration date is the last day of the specified month.<\/p>\n\n\n\n Once the tube has been opened, the cream must be used within 6 months.<\/p>\n\n\n\n Do not use Terbinafine Apofri if you notice that the cream has changed.<\/p>\n\n\n\n Medicines should not be thrown down the drain or among the household waste.\u00a0Ask the pharmacist how to deal with medicines that are no longer used.\u00a0These measures will help to protect the environment.<\/p>\n\n\n\n One gram of cream contains 10 mg of terbinafine hydrochloride.<\/p>\n\n\n\n Other ingredients are Stearyl alcohol, cetyl alcohol, sorbitan stearate, cetyl palmitate, isopropyl myristate, benzyl alcohol, polysorbate 60, sodium hydroxide, and purified water.<\/p>\n\n\n\n White\u00a0cream.\u00a0The cream\u00a0is supplied either in a white collapsible aluminum tube with a lacquered interior, sealed with latex, and with a perforated polypropylene screw cap, or in an aluminum laminated plastic tube with a polypropylene screw cap.<\/p>\n\n\n\n
Terbinafine hydrochloride<\/a><\/p>\n\n\n\nWhat Terbinafine Apofri is and what it is used for<\/h2>\n\n\n\n
<\/p>\n\n\n\nWhat you need to know before using Terbinafine Apofri<\/h2>\n\n\n\n
Do not use Terbinafine Apofri<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Other medicines and Terbinafine Apofri<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
Terbinafine Apofri contains stearyl alcohol, cetyl alcohol, and benzyl alcohol<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow to use Terbinafine Apofri<\/h2>\n\n\n\n
Use for children<\/h2>\n\n\n\n
If you have used too much Terbinafine Apofri <\/h2>\n\n\n\n
If you forget to use Terbinafine Apofri<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How Terbinafine Apofri should be stored<\/h2>\n\n\n\n
Contents of the packaging and other information<\/h2>\n\n\n\n
Contents declaration<\/h2>\n\n\n\n
Appearance and package sizes of the medicine<\/h2>\n\n\n\n