Tacrozem 0.1% Tacrolimus Ointment
What Tacrozem Is And What Tacrozem Used For
The active substance in Tacrozem, tacrolimus monohydrate, is an immunomodulatory agent.
Tacrozem, 0.1% ointment, is used to treat moderate to severe atopic dermatitis ( eczema ) in adults who have not had sufficient effect from or cannot tolerate conventional treatment such as topical corticosteroids.
When moderate to severe atopic dermatitis is completely or almost completely healed after up to 6 weeks of treatment of an eczema flare-up, and if you tend to have eczema flare-ups frequently (4 times a year or more), it may be possible to prevent the eczema flare-ups from coming back or to extend the time you have no breakouts by using Tacrozem, 0.1% ointment twice a week.
In atopic dermatitis, an overreaction in the skin’s immune system causes inflammation ( itching, redness, dryness). Tacrozem alters the abnormal immune response and relieves inflammation and itching in the skin.
The tacrolimus contained in Tacrozem may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What You Need To Know Before You Use Tacrozem
Do Not Use
- If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of this medicine (listed in section 6) or to macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin).
Warnings And Precautions
Talk to your doctor if you:
- Have liver failure.
- Have any form of skin cancer (tumour) or if you have a weakened immune system (immunodeficiency), for whatever reason.
- Have an inherited skin barrier disorder such as Netherton’s syndrome, lamellar ichthyosis (skin that scales heavily due to thickening of the outermost layer of skin), or if you have generalized erythroderma (red, inflamed, scaly skin all over the body)
- Have cutaneous Graft versus Host disease (an immune reaction in the skin that is a common complication in bone marrow transplant patients).
- Have swollen lymph nodes at the start of treatment. If your lymph nodes swell during treatment with this medicine, consult your doctor.
- Have infected eczema. Do not use the ointment on infected eczema.
- Notice any change in the appearance of the skin, and you should contact your doctor.
- The safety of long-term treatment with tacrolimus ointment is unknown. A very small number of people who have used tacrolimus ointment have developed malignancy (for example, skin cancer or lymphoma). However, the connection between tacrolimus ointment and cancer has not been proven.
- Avoid exposing the skin to sunlight for long periods and artificial sunlight such as tanning beds. If you spend a lot of time outdoors after using Tacrozem, wear sunscreen and loose clothing that protects the skin from sunlight. Ask your doctor for other appropriate ways to protect yourself from the sun. If you have been prescribed light therapy, you should inform your doctor that you are using Takrozem, as simultaneous treatment with Takrozem and light therapy is not recommended.
- If your doctor prescribes treatment with Tacrozem twice a week to keep eczema away, your condition should be evaluated by a doctor at least once a year, even if the disease is under control. For children, a break must be made in the maintenance treatment after 12 months to assess whether continued treatment is needed.
- You should not bathe, shower, or swim immediately after using the ointment; water can wash away the medicine.
Children
- Tacrozem, 0.1% ointment, is not approved for treating children under 16 years of age. The ointment should, therefore, not be used in this age group. Consult your doctor.
- The effect of treatment with Tacrozem on a developing immune system in children, especially young children, have not been investigated.
Other Medicines, Cosmetics, And Tacrozem
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
You can use emollient creams and skin lotions during treatment with Tacrozem 0.1% ointment, and these products should not be used within two hours before and after using Tacrozem.
The use of tacrolimus at the same time as other drugs for external use or during simultaneous treatment with oral corticosteroids (e.g. cortisone ) or medications that affect the immune system has not been studied.
Tacrozem With Alcohol
When using Tacrozem, consuming alcohol may cause flushing or redness and a feeling of warmth in the skin or face.
Pregnancy And Breastfeeding
Do not use Tacrozem if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine
Tacrozem Contains
White petroleum jelly, liquid paraffin, propylene carbonate, white wax, and solid paraffin.
How To Use Tacrozem
Always use Tacrozem as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
- Apply a thin layer of Tacrozem to the affected skin areas.
- Tacrozem can be used on most body parts, including the face and neck and in the creases of the elbows and knees.
- Avoid using the ointment on the inside of the nose or mouth or in the eyes. If the ointment comes into contact with any of these areas, it should be wiped off thoroughly or rinsed with water.
- Do not cover skin areas treated with the ointment with bandages or the like.
- Wash your hands after using Tacrozem, unless your hands are also to be treated.
- Before using Tacrozem after showering or bathing, the skin must be completely dry.
- You should not bathe, shower, or swim immediately after using the ointment. Water can wash away the medicine.
Adults (16 years and older)
For adult patients (16 years and older), there are two strengths of tacrolimus ointment (tacrolimus 0.03% ointment and tacrolimus 0.1% ointment). Your doctor will decide which strength is best for you.
Treatment usually begins with Tacrozem 0.1% ointment twice daily, once in the morning and once in the evening, until the eczema is healed. Depending on the effect on your eczema, the doctor will decide if you can use the ointment less often or if the lower strength, tacrolimus 0.03% ointment, can be used.
Treat each affected skin area until the eczema is gone. Improvement usually occurs within a week. If you do not notice any improvement within two weeks, consult your doctor about other possible treatments.
Your doctor may prescribe you to use Tacrozem 0.1% ointment twice a week when the eczema is completely or almost healed. Tacrozem, 0.1% ointment, should be used once a day, two days a week (e.g. Monday and Thursday) on the skin areas where you usually get eczema. Between each treatment session, there must be 2-3 days without treatment with Takrozem.
If the symptoms of the disease return, you should use Tacrozem twice daily, in the same way described above, and contact your doctor to review the treatment.
If You Accidentally Swallow The Ointment
If you accidentally swallow the ointment, talk to your doctor or pharmacist as soon as possible. Do not try to induce vomiting.
If you have used too much medicine or, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If You Forget To Use Tacrozem
If you forget to apply the ointment when you are supposed to, do it as soon as you remember and then continue as before.
Contact your doctor or pharmacist if you have further questions about this medicine.
Possible Tacrozem Side Effects
Like all medicines, although not everybody gets them, Tacrozem can cause side effects.
Very common (may affect more than 1 in 10 users):
- Burning sensation and itching
These symptoms are normally mild to moderate and usually disappear within a week of starting treatment with Tacrozem.
Common (may affect up to 1 in 10 users):
- Redness
- Feeling of warmth
- Pain
- Increased sensitivity of the skin (especially to heat and cold)
- Skin crawling and irritated skin
- Rash
- Local skin reactions of any cause; a reaction may be inflamed or infected hair follicles, herpes virus infections e.g.
- Cold sores
- Generalized herpes simplex infections
- Facial redness or skin irritation after drinking alcohol
- Hypersensitivity at the treatment site
Uncommon Tacrozem side effects (may affect up to 1 in 100 users
- Acne
After treatment twice a week, adult infection at the treatment site has been reported.
Rosacea ( redness of the face), rosacea-like skin inflammation, lentigo (flat brown spots on the skin), edema (fluid accumulation) at the treatment site, as well as herpes infection of the eye, have been reported after the product was introduced to the market.
After the market introduction, a very small number of people who used tacrolimus ointment have developed malignancies (e.g., lymphoma, including skin lymphoma and other skin tumours). Still, an association with treatment with tacrolimus ointment has not been proven or disproved.
How To Store Tacrozem
- Keep this medicine out of sight and reach of children.
- Use before the expiry date stated on the tube and the carton after “EXP”. The expiration date is the last day of the specified month.
- Store at a maximum of 25 °C.
- Throw away opened tubes 90 days after opening, even if they are not empty. Do not save them for later use.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents Of The Packaging And Other Information
Contents Declaration
- The active substance is tacrolimus monohydrate.
- 1 g of Tacrozem, 0.1% ointment contains 1.0 mg of tacrolimus (as tacrolimus monohydrate).
- Other ingredients are white vaseline, liquid paraffin, propylene carbonate, white wax, and solid paraffin.
Appearance And Package Sizes Of The Medicine
- Tacrozem is a white to slightly yellowish ointment. It is supplied in tubes containing 10, 30, or 60 grams ointment.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder:
Pierre Fabre Dermatology
45, Place Abel Gance
92 100 Boulogne
France
Manufacturer:
Pierre Fabre Medicament Production
Aquitaine Pharm International 1
Avenue du Béarn
64320 Idron
France
This medicine is approved in the European Economic Area under the names:
Tacrozem: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, and Great Britain.